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アメリカ合衆国

証券取引委員会

ワシントン D. C. 20549

形式 10-Q

(マーク1)

 

」と

1934年証券取引法第13条又は15(D)条に規定する四半期報告

 

本四半期末まで九月三十日2024

OR

 

↓ ↓

1934 年の交換法第 13 条または第 15 条 （ d ） に基づく移行報告書

 

移行期から to .

手数料書類番号001-36076

FATE Therapeutics， INC.

(登録者の正確な氏名はその定款に記載)

 

デラウェア州

 

65-1311552

(国やその他の管轄区域

会社や組織のこと

 

アメリカ国税局の雇用主は

識別番号)

 

 

 

12278 スクリップスサミットドライブ, サンディエゴ, カルシウム.カルシウム

 

92131

（ 主 要 執行 役 所の 住 所 ）

 

(郵便番号)

 

(858) 875-1800

 

(登録者の電話番号、市外局番を含む)

 

同法第12条(B)に基づいて登録された証券：

 

クラスごとのタイトル

取引コード

登録された各取引所の名称

普通株

運命

ナスダックグローバルマーケット

 

再選択マークは、登録者が(1)過去12ヶ月以内(または登録者がそのような報告の提出を要求されたより短い期間)に、1934年の証券取引法第13条または15(D)節に提出されたすべての報告書を提出したかどうか、および(2)過去90日以内にそのような提出要件に適合しているかどうかを示すはい 」と No ▽

再選択マークは、登録者が過去12ヶ月以内(または登録者がそのような文書の提出を要求されたより短い時間以内)に、S−T規則405条(本章232.405節)に従って提出を要求した各相互作用データファイルを電子的に提出したか否かを示すはい 」と No ▽

登録者が大型加速申告会社，加速申告会社，非加速申告会社，小さな報告会社，あるいは新興成長型会社であることを再選択マークで示す。取引法第12 b-2条の規則における“大型加速申告会社”、“加速申告会社”、“小申告会社”、“新興成長型会社”の定義を参照されたい。

 

大型加速ファイルサーバ

↓ ↓

ファイルマネージャを加速する

↓ ↓

非加速ファイルサーバ

」と

 

規模の小さい報告会社

」と

新興成長型会社

↓ ↓

新興成長会社の場合は、登録者が取引法第 13 条 （ a ） に基づいて提供される新しいまたは改訂された財務会計基準を遵守するために延長された移行期間を使用しないことを選択したかどうかをチェックマークで示します。 ↓ ↓

 

登録者が空殻会社であるか否かをチェックマークで示す(取引法第12 b-2条で定義されている)。はい、違います」と

AS 2024 年 11 月 5 日、 113,894,333 登録者の普通株式の株式、 1 株当たり $0.001 の額面価値は、発行され、発行されました。

 

 

 

FATE Therapeutics， INC.

表格10-Q

目次ページ

 

 

 

 

ページ

リスク要因の概要

 

3

 

 

 

第1部財務情報

 

 

第1項。

連結財務諸表 （ 監査なし ）

 

5

 

連結バランスシート 2024 年 9 月 30 日 （ 未監査 ） および 2023 年 12 月 31 日

 

5

 

2024 年 9 月 30 日期および 2023 年 9 月期 3 ヶ月間および 9 ヶ月間の連結営業損失計算書 （ 監査済み ）

 

6

 

2024 年 9 月 30 日期および 2023 年 9 月 30 日期連結キャッシュ · フロー決算書 （ 監査済み ）

 

7

 

簡明合併財務諸表付記(未監査)

 

8

項目 2 。

経営陣の財務状況と経営成果の検討と分析

 

23

項目 3 。

市場リスクの定量的·定性的開示について

 

32

項目 4 。

制御とプログラム

 

32

 

 

 

 

第2部：その他の情報

 

 

項目 1 。

法律訴訟

 

34

第1 A項。

リスク要因

 

35

項目 2 。

未登録株式証券販売と収益の使用

 

79

項目 3 。

高級証券違約

 

79

項目 4 。

炭鉱安全情報開示

 

79

五番目です。

その他の情報

 

79

第六項です。

展示品

 

80

 

 

 

 

署名

 

82

 

 

2

 

 

リスクファクター 概要

以下は、当社の普通株式への投資を投機的またはリスクの高いものにする主な要因の概要です。この要約は、私たちが直面するすべてのリスクに対処していません。本リスク要因の概要に要約されたリスク、および当社が直面するその他のリスクについての追加的な議論は、下記の「リスク要因」の見出しでご覧いただけます。当社の普通株式に関する投資決定を下す前に、このフォーム 10—Q の四半期報告書およびその他の米国証券取引委員会 （ SEC ） への当社の提出書類に記載されているその他の情報とともに、慎重に検討する必要があります。

•
当社の製品候補およびプログラムは、がんおよび自己免疫疾患の治療のための新規な治療アプローチを表しており、当社の製品候補は、望ましくない副作用を引き起こしたり、臨床前または臨床開発を遅らせたり停止したり、規制承認を妨げたり、商業的可能性を制限したり、重大な悪影響を及ぼす可能性のあるその他の特性を有する可能性があります。当社が製品候補の前臨床開発または臨床開発をタイムリーに完了し、または規制当局の承認を得ることができなかった場合、当社の事業は著しく損なわれます。
•
当社の独自の誘導多能性幹細胞製品プラットフォームにより、次世代製品候補の生産が可能となり、現在臨床開発中の複数の iPSC 由来の NK 細胞および t 細胞製品候補があります。当社は、事業戦略の変更、当社の製品候補の優先順位付け、進行中の臨床試験のデータまたは結果、および当社の製品候補が開発されている競争的な治療環境を含む、さまざまな理由で、 1 つ以上の製品候補の臨床開発を優先順位から外すまたは中止することを選択することがあります。また、臨床開発中の 1 つ以上の製品候補は、複数の疾患領域において治療の可能性を有する場合があり、他の疾患領域における製品候補の開発を進めるために、 1 つの疾患領域における臨床開発を中止することを選択する場合があります。
•
iPSC 技術と遺伝子編集技術を使用して、製品候補を作成しています。両技術とも比較的新しい技術であるため、製品候補の開発や規制承認の取得にかかる時間とコストを予測することは困難です。これらの技術を製品候補の作成に使用できなければ、当社のビジネスに大きな被害をもたらします。
•
当社は、適切な臨床試験研究者の募集や臨床試験への患者の登録、当社の製品候補の適切な臨床供給の製造、および当社の臨床試験の実施に必要なその他の構成部品および供給品の十分な量の入手が困難であることなど、臨床試験の開始、実施または完了が遅延し、当社が開始できない場合があります。臨床試験の実施や完了です。
•
急速な技術変化の環境の中で、他のバイオテクノロジー企業や製薬企業との競争が激化し、効果的に競争できなければ業績が悪くなります。
•
当社の既存および将来の製品候補の成功は、がんおよび自己免疫の分野における開発、および競争力のある治療環境および臨床治療基準の変化に大きく依存しています。
•
当社が随時発表または公表する前臨床試験または臨床試験からの初期、中間および予備データは、より多くのデータが利用可能になるにつれて変更される可能性があり、最終データの重大な変更をもたらす可能性のある監査および検証手順の対象となります。さらに、当社の製品候補を含む現在または将来の臨床試験の結果は、初期、中間および暫定データと大きく異なる場合があります。
•
当社の製品候補の製造と流通は複雑で、多くのリスクにさらされています。これらのリスクは、当社の製品候補の臨床および商業的供給を大幅に制限し、コストを増加させる可能性があります。米国食品医薬品局が批准した場合、当社の製品候補の開発および商業化は大幅に遅延または制限される可能性があります。その他の規制当局が当社の製造業務に追加要件を課す場合、または規制に準拠するために製造業務を変更する必要がある場合。要求事項
•
臨床規模での製品候補の製造経験は限られており、商業規模での製造経験はありません。当社の製品候補を一貫して、許容可能な品質およびコストで十分な数量で製造できない場合、当社の臨床開発計画の遅延をもたらし、当社の製品候補の承認または商業化の能力を損なう可能性があり、当社の事業に重大な悪影響を及ぼす可能性があります。
•
当社の製品候補の開発には、相当な追加資金が必要であり、利用可能な場合には株主に対して希釈を引き起こす可能性があります。これがなければ、当社は、製品候補の臨床前または臨床開発を完了したり、規制当局の承認を得ることができず、受け入れ可能な条件またはタイムリーに適切な資金を確保することができない可能性があります。

3

 

•
当社は、当社が製品候補の製造に使用する試薬、材料、デバイスおよび機器の供給について、単独のソースサプライヤーを含む第三者サプライヤーに依存しており、これらの損失は、承認された場合、当社の臨床試験実施または製品候補の商業化能力に悪影響を及ぼす可能性があります。
•
労働市場の変化、有能な候補者の可用性、他社からの従業員競争により、重要な人材の採用と維持が困難になる可能性があります。
•
材料価格や人件費の上昇など、コスト変動やインフレ圧力に直面し、業績、経費、現金利用率、業績に悪影響を及ぼす可能性があります。
•
当社は、特定の適応症または地理的地域における当社の製品候補の特定の開発および商業化のために戦略的パートナーシップおよびコラボレーションの取り決めに依存しており、これらの取り決めが失敗または終了した場合、当社の製品候補の開発、製造または商業化の遅延およびその他の障害をもたらし、当社の営業結果に重大な損害を与える可能性があります。
•
当社は、有限な事業履歴を有し、創業以来大きな損失を計上しており、製品候補の潜在的な開発に関連して、当社は今後も大きな損失を計上し続けると予想しています。
•
当社が知的財産を保護したり、当社の技術および製品候補に対する特許保護を取得し維持することができない場合、他の企業が当社の技術や発見に基づく製品を開発する可能性があります。
•
当社がライセンス契約上の義務を遵守しない場合、当社の製品候補または主要技術に対する権利を失う可能性があります。
•
当社は、当社の製品候補の開発または製造のための製品コンポーネントおよびプロセスに必要な権利を取得または維持することに成功しない可能性があり、予想外のコストがかかるまたはその他の不利な方法で事業を運営する可能性があります。
•
当社は、製品候補のマーケティング経験がなく、販売力や流通能力がなく、製品が承認された場合、商品化を成功させることができない可能性があります。
•
当社の製品候補の商業的成功は、医師、患者、第三者支払者、および医療コミュニティの他者による市場受け入れの程度に依存し、予想される短期および長期のコスト、標準ケアおよび新興治療法に対する比較リスクとベネフィット、およびその他の価値実証を支持するための追加的なエビデンスの生成が必要になる場合があります。
•
セキュリティ侵害、データの損失、その他の障害は、当社のビジネスに関連する機密情報を侵害する可能性があります。
•
当社の主要株主および経営陣は、当社の株式のかなりの割合を所有しており、当社に対して重要な支配権を行使できる可能性があります。
•
当社の株価は、様々な要因に基づいて変動します。
•
当社は現在、「小規模報告会社」および「非加速ファイリング会社」として認定されており、そのような会社に適用される特定の報告および開示要件を遵守する当社の決定は、投資家にとって当社の株式の魅力性を低下させる可能性があります。
•
世界の経済 · 市場情勢、 COVID—19 のパンデミックに類似した継続的かつ長期にわたる公衆衛生緊急事態、戦争やその他の武力紛争を含む世界的な地政学的緊張は、当社の事業、業績、財務状況の様々な側面に悪影響を及ぼし、当社のサプライチェーンおよび製品候補の開発 · 製造に混乱を引き起こす可能性があります。
 

 

4

 

パート I 。金融AL情報

項目 1 。 コンデンサ連結財務ial ステートメント （ 未監査 ）

Fate Therapeutics 株式会社

凝縮固体ted バランスシート （ 未監査 ）

(千単位で1株当たりおよび1株当たりのデータは含まれていない)

 

 

 

九月三十日

 

 

十二月三十一日

 

 

 

2024

 

 

2023

 

 

 

(未監査)

 

 

 

 

資産

 

 

 

 

 

 

流動資産：

 

 

 

 

 

 

現金 · 現金同等物

 

$

37,909

 

 

$

41,870

 

売掛金

 

 

4,127

 

 

 

1,826

 

短期投資

 

 

259,014

 

 

 

273,305

 

前払い費用と他の流動資産

 

 

9,244

 

 

 

14,539

 

流動資産総額

 

 

310,294

 

 

 

331,540

 

長期投資

 

 

33,607

 

 

 

980

 

財産と設備、純額

 

 

82,392

 

 

 

96,836

 

経営的リース使用権資産

 

 

58,441

 

 

 

61,675

 

制限現金

 

 

10,227

 

 

 

15,177

 

その他の資産

 

 

9

 

 

 

9

 

総資産

 

$

494,970

 

 

$

506,217

 

 

 

 

 

 

 

 

負債と株主権益

 

 

 

 

 

 

流動負債：

 

 

 

 

 

 

売掛金

 

$

6,349

 

 

$

4,719

 

発生経費

 

 

23,580

 

 

 

27,514

 

繰延収入

 

 

600

 

 

 

685

 

賃貸負債を経営し、今期の部分

 

 

6,893

 

 

 

6,176

 

流動負債総額

 

 

37,422

 

 

 

39,094

 

CIRm 賞の責任

 

 

1,940

 

 

 

—

 

賃貸負債を経営し，当期分を差し引く

 

 

92,085

 

 

 

97,360

 

株価上昇のマイルストーン

 

 

1,197

 

 

 

1,346

 

引受金とその他の事項

 

 

 

 

 

 

株主権益：

 

 

 

 

 

 

優先株、$0.001 名額； 承認株式 —5,000,000； クラス A コンバーチブル
発行済優先株式および発行済優先株式 — 2,761,108

 

 

3

 

 

 

3

 

普通株、$0.001 名額； 承認株式 —250,000,000発行および
優秀な — 113,884,884 2024 年 9 月 30 日 98,627,076 12 月 31 日
   2023

 

 

114

 

 

 

99

 

追加実収資本

 

 

1,707,215

 

 

 

1,580,032

 

その他の総合収益を累計する

 

 

835

 

 

 

15

 

赤字を累計する

 

 

(1,345,841

)

 

 

(1,211,732

)

株主権益総額

 

 

362,326

 

 

 

368,417

 

総負債と株主権益

 

$

494,970

 

 

$

506,217

 

 

添付の説明を参照してください。

5

 

Fate Therapeutics 株式会社

連結財務諸表の概要 営業 · 総合損失 （ 未監査 ）

(千単位で1株当たりおよび1株当たりのデータは含まれていない)

 

 

9 月 30 日までの 3 ヶ月間

 

 

9 月 30 日までの 9 ヶ月間

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(未監査)

 

 

(未監査)

 

協力収入

 

$

3,074

 

 

$

1,944

 

 

$

11,771

 

 

$

61,857

 

運営費用：

 

 

 

 

 

 

 

 

 

 

 

 

研究 · 開発

 

 

34,650

 

 

 

34,275

 

 

 

101,392

 

 

 

140,780

 

一般と行政

 

 

20,801

 

 

 

18,948

 

 

 

58,907

 

 

 

63,513

 

総運営費

 

 

55,451

 

 

 

53,223

 

 

 

160,299

 

 

 

204,293

 

運営損失

 

 

(52,377

)

 

 

(51,279

)

 

 

(148,528

)

 

 

(142,436

)

その他の収入(支出)：

 

 

 

 

 

 

 

 

 

 

 

 

利 子 収入

 

 

4,438

 

 

 

4,697

 

 

 

13,414

 

 

 

12,772

 

株価上昇マイルストーンの公正価値の変化

 

 

(13

)

 

 

1,049

 

 

 

149

 

 

 

3,160

 

その他の収入

 

 

274

 

 

 

363

 

 

 

856

 

 

 

9,698

 

その他収入合計

 

 

4,699

 

 

 

6,109

 

 

 

14,419

 

 

 

25,630

 

純損失

 

$

(47,678

)

 

$

(45,170

)

 

$

(134,109

)

 

$

(116,806

)

他の全面的な収入：

 

 

 

 

 

 

 

 

 

 

 

 

販売可能有価証券の未実現利益 （ ネット ）

 

 

1,257

 

 

 

88

 

 

 

820

 

 

 

1,355

 

総合損失

 

$

(46,421

)

 

$

(45,082

)

 

$

(133,289

)

 

$

(115,451

)

普通株1株当たりの基本損失と償却後の純損失

 

$

(0.40

)

 

$

(0.46

)

 

$

(1.19

)

 

$

(1.19

)

1 株当たり基本損失および希釈純損失の算出に使用される加重平均普通株式

 

 

117,769,161

 

 

 

98,568,012

 

 

 

112,305,430

 

 

 

98,342,898

 

 

添付の説明を参照してください。

 

6

 

Fate Therapeutics 株式会社

凝縮固体 Sキャッシュ · フローの状況 （ 未監査 ）

(単位：千)

 

 

9 月 30 日までの 9 ヶ月間

 

 

 

2024

 

 

2023

 

 

 

(未監査)

 

事業活動

 

 

 

 

 

 

純損失

 

$

(134,109

)

 

$

(116,806

)

純損失と経営活動で使用される現金純額の調整：

 

 

 

 

 

 

減価償却 · 償却

 

 

14,149

 

 

 

13,397

 

株式報酬

 

 

32,376

 

 

 

33,984

 

投資に対するプレミアム · 割引の累積 · 償却額、純

 

 

(7,550

)

 

 

(8,492

)

協力契約資産の償却

 

 

—

 

 

 

7,196

 

繰延収入

 

 

(685

)

 

 

(41,116

)

株価上昇マイルストーンの公正価値の変化

 

 

(149

)

 

 

(3,160

)

FT 516 CIRm Award からの助成金収入

 

 

—

 

 

 

(4,000

)

財産と設備処分損失

 

 

942

 

 

 

—

 

営業資産 · 負債の変動

 

 

 

 

 

 

売掛金

 

 

(1,701

)

 

 

36,942

 

前払い費用と他の資産

 

 

5,294

 

 

 

14,512

 

売掛金と売掛金

 

 

(2,316

)

 

 

(27,047

)

使用権資産 · リース負債純

 

 

(1,326

)

 

 

(1,036

)

経営活動のための現金純額

 

 

(95,075

)

 

 

(95,626

)

投資活動

 

 

 

 

 

 

財産と設備を購入する

 

 

(632

)

 

 

(5,972

)

購入投資

 

 

(279,745

)

 

 

(308,844

)

投資期日

 

 

269,779

 

 

 

382,128

 

投資活動が提供する現金純額

 

 

(10,598

)

 

 

67,312

 

資金調達活動

 

 

 

 

 

 

株式インセンティブプランによる普通株式の発行 （ 発行コストを差し引いたもの ）

 

 

295

 

 

 

265

 

発行原価を差し引いた普通株式の公募収益

 

 

74,531

 

 

 

—

 

発行費用を差し引いた事前資金付きワラントの発行収益

 

 

19,996

 

 

 

—

 

FT 819 CIRm 賞の収益

 

 

1,940

 

 

 

—

 

融資活動が提供する現金純額

 

 

96,762

 

 

 

265

 

現金、現金等価物、および限定的な現金純変化

 

 

(8,911

)

 

 

(28,049

)

期初現金、現金等価物、および限定現金

 

 

57,047

 

 

 

76,560

 

期末現金、現金等価物、および制限現金

 

$

48,136

 

 

$

48,511

 

非現金投融資活動補足付表

 

 

 

 

 

 

買掛金における財産設備の購入

 

$

16

 

 

$

168

 

賃貸義務と引き換えに使用権資産

 

$

—

 

 

$

62

 

 

添付の説明を参照してください。

7

 

Fate Therapeutics 株式会社

凝縮コンソリへの注釈日付財務諸表

（ 未監査 ）

1.重要な会計政策の組織とまとめ

組織する

Fate治療会社(当社)は2007年4月27日にデラウェア州に登録設立され、その主な業務はカリフォルニア州のサンディエゴに設置された。同社は臨床段階の生物製薬会社であり，患者に既製の，多重工学的，多能性幹細胞(IPSC)由来の細胞免疫療法を提供し，癌や自己免疫疾患の治療に取り組んでいる。

同社は2024年9月30日現在、そのほとんどの努力を製品開発、資金調達、インフラ建設に投入しており、その候補治療製品のどの販売からも何の収入も得ていない。これまで、同社の収入は協力協定と政府からの贈与から来ていた。

株式を公開発行する

2024年3月、会社は普通株の公開発行を完了し、投資家は購入した14,545,454会社普通株、公開発行価格は$5.50棚に声明の下の各株を登録する。公募株の総収益は約#ドル80.0100万ドルが実施されています5.5公募株に関するコストのうち，純収益は約$である74.5 100 万ドル

個人配給事前出資株式証

2024年3月、公開発売と同時に、当社は普通株購入の代わりに私募方式で複数の投資家に予資権証を発行した3,636,364当社普通株(2024年予備融資権証)(付記8参照)。2024年の事前資金調達権証の購入価格は$5.4991株当たりの事前資金権証は、2024年3月に公開発行された普通株の1株当たり公開発行価格に等しく、$を引く0.0011部あたりの事前資金権証の使用価格は，純収益総額は約$である20.0百万ドルです。

予算の使用

会社が監査を受けていない簡明総合財務諸表はアメリカ公認会計原則(アメリカ公認会計原則)に基づいて作成された。当社が審査を経ていない簡明総合財務諸表を作成するためには、管理層は見積もりと仮定を行い、当社が審査を経ていない総合財務諸表及び付記が提出した資産、負債、収入及び支出金額、及び或いは有資産及び負債の開示に影響を与える必要がある。同社が監査していない簡明総合財務諸表の中で最も重要な見積もりと仮定は、その株価切り上げマイルストーン債務、リースを含む契約と計上費用と関係がある。これらの推定は，現在の事件や将来とりうる行動に対する会社の理解に基づいているが，実際の結果は最終的にはこれらの推定や仮定とは大きく異なる可能性がある.

合併原則

未監査連結財務諸表には、当社およびその子会社の会計が含まれます。これまでのところ、これらの子会社の総事業は大きくなく、会社間取引および残高をすべて連結して排除しています。

現金、現金等価物、および限定現金

現金および現金等価物には、容易に利用可能な営業勘定、マネーマーケット勘定およびマネーマーケットファンドの現金が含まれます。当社は、購入日から 3 ヶ月以下の元の満期を有する流動性の高い投資を、現金相当とみなします。

以下の表は、未監査連結集計バランスシートに記載された現金、現金同等物および制限現金の合計を、未監査連結集計キャッシュ · フロー計算書に示した同金額の合計に算込んだ調整を示しています。 2024 年 9 月 30 日と 2023 年 （ 千単位 ） ：

8

 

 

 

 

9 月 30 日までの 9 ヶ月間

 

 

 

2024

 

 

2023

 

現金 · 現金同等物

 

$

37,909

 

 

$

33,334

 

制限現金

 

 

10,227

 

 

 

15,177

 

監査されていない簡明な統合現金フロー表に示されている現金、現金等価物、および限定的な現金総額

 

$

48,136

 

 

$

48,511

 

 

2024年9月30日と2023年9月30日まで、制限された現金残高は現金担保の取消不可予備信用状を含むその価格は$です10.2百万ドルとドル15.2百万ドルはそれぞれ当社の施設レンタルに関連しています。

監査されていない中期財務情報

添付されている中期簡明総合財務諸表は監査されていない。これらの監査されていない中期簡明総合財務諸表は、米国公認会計原則と米国証券取引委員会(米国証券取引委員会)の中間報告要求に基づいて作成されている。これらの規則が許容される場合、一般に必要とされるいくつかの脚注または他の財務情報は、省略または省略することができる。監査されていない中期簡明総合財務諸表は、会社が2023年12月31日までの財政年度の財務諸表および付記とともに読まなければならない。これらの財務諸表は、会社が2024年2月26日に米国証券取引委員会に提出した2023年12月31日現在の会社10-K表年次報告書に含まれている。経営陣は、審査されていない中期簡明総合財務諸表はすでに審査財務諸表の同じ基準に従って作成され、すべての調整を含み、その中には当社の財務状況及びその経営業績と全面赤字及びその期間の現金流量を公平に報告するために必要な正常な経常的調整のみが含まれていると考えている。2024年9月30日までの3カ月と9カ月の業績財政年度全体または任意の他の移行期間または任意の今後1年または任意の時期の予想結果を示すとは限らない。

 

協力手配

同社は、それらがASCテーマ808-協力スケジュール(ASC 808)の範囲内にあるかどうかを評価して、そのような手配が双方による共同経営活動に関連するかどうかを決定するために、それらがASCテーマ808-協力スケジュール(ASC 808)の範囲内にあるかどうかを評価し、これらの当事者は活動の積極的な参加者であり、そのような活動の商業成功に依存する重大なリスクおよびリターンに直面する。ASC 808の範囲内に配置されている場合、会社は、会社とそのパートナーとの間の配置の様々な態様が、ASC主題606、顧客との契約収入(ASC 606)を含む他の会計文書の範囲内にあるかどうかを評価する。スケジュールの一部または全部が顧客との取引を表すと結論付けられた場合、当社は、ASC 606の範囲内でスケジュールのこれらの態様を考慮する。

ASC 808は、協調スケジュールにおける取引の提示および開示にガイドを提供するが、確認または測定ガイドを提供しない。したがって、当社が1つの取引の取引相手が顧客ではないか、またはASC 606の範囲内でないと判断した場合、当社は他の会計文献における指導意見が適用されるか、またはアナロジーによって当該取引を説明すると考えられる。当社が手配した取引分類は、手配の性質と契約条項及び参加者の経営性質に基づいて決定されます。

 

収入確認

当社は、ASC 808の範囲内にあるかどうかを評価するために、その協力スケジュールを分析して、これらのスケジュールが、活動の積極的な参加者であり、重大なリスクおよびリターンに直面する当事者による共同経営活動に関与しているかどうかを決定し、これらのリスクおよびリターンは、活動の商業的成功に依存する。当社がその手配の一部または全部が顧客との取引を代表していると結論した場合、当社はASC 606の範囲内で当該手配のこれらの方面を会計処理する。

ASC 606に起因することができるスケジュールの場合、会社が収入を確認する方法は、製品またはサービスの制御権を顧客に転送することを説明し、会社が製品またはサービスと交換する権利がある対価格金額を反映する。この場合、会社は、(I)顧客との契約を決定するステップ、(Ii)契約における履行義務を決定するステップ、(Iii)取引価格を決定するステップ、(Iv)取引価格を履行義務に割り当てるステップ、および(V)顧客が製品またはサービス制御権を取得したときに収入を確認するステップの5つのステップに従う。

リース事業

♪the the the当社は、契約開始時に契約にリースが含まれているかどうかを判断します。当社は、現在、事業用リースに分類されるオフィス · 研究室用施設のリースについて、リースを行っています。これらのリースは運営

9

 

使用権(ROU)当社の総合貸借対照表の資産、流動経営賃貸負債、および非流動経営賃貸負債。当社には融資リースは何もありません。レンタル期間は12か月またはそれ以下は短期的と考えられ、ROU資産およびレンタル義務は確認されない。短期賃貸に関する支払いはレンタル期間内に直線的に計算されます。

リース負債とはリースによるリース金の支払い義務であり，純資産とはリース期間内にリースで決定された標的資産を使用する権利である。賃貸負債は、リース開始日に決定された賃貸割引率割引後に支払われていない賃貸支払いの現在値で計測する。現在値を決定するために、確定が容易な場合に暗黙的金利が使用される。暗黙的な金利を提供していないレンタルについては、当社はレンタル開始日の情報に基づいて逓増借款金利を決定し、レンタル支払いの現在値を決定します。純収益資産は、レンタル支払いの現在値に応じて計量され、支払われた任意の前払い賃貸支払いおよび生成された任意の他の間接コストも含まれ、受信されたいかなるレンタル報酬も含まれない。賃貸条項には、会社が選択権を行使することを合理的に決定した場合、賃貸借契約の選択権を延長または終了する影響が含まれる可能性がある。経営的リースのレンタル料金はレンタル期間内に直線法で確認します。同社は各種類の対象資産のすべての賃貸と非レンタル構成要素を単一賃貸構成要素にまとめた。

株に基づく報酬

株式ベースの報酬支出とは、付与日のコストであり、従業員株式オプション及び制限株式単位が付与する公正価値は、奨励に必要なサービス期間(通常は授権期間)内で直線的に確認される。業績に基づく株式単位/奨励とは、帰属期間中に会社の業績目標の実現と継続雇用に基づいて一定数の会社普通株を獲得する権利をいう。報告期間ごとに、1つまたはいずれかの業績条件を達成する可能性があれば、当社は同社などの業績目標を達成する可能性を再評価し、公表する株式を調整することで株式ベースの報酬支出を増加または減少させることを調整期間の累積追跡とする。株式奨励については，その帰属は業績マイルストーンと市場状況の制約を同時に受け，業績マイルストーンの実現や業績状況に達した派生サービス期間内に費用を記録することが可能である.

同社はBlack−Scholesオプション定価モデルを用いて株式オプション付与の公正価値を推定しているが，オプション付与は除外し，オプション付与の帰属は業績に基づくマイルストーンと市場状況の影響を同時に受け，後者は格子に基づくモデルを用いて評価を行っている。制限株式単位は、業績に基づく制限株式単位を含み、その公正価値は、日ナスダックグローバル市場報告を付与する会社の普通株終値に基づく。当社はこのような没収が発生したため、すべての奨励の没収を認めます。

総合損失

全面損失は、一定期間内に非所有者由来の取引や他の事件や状況によって発生する権益変化と定義される。その他の全面的な損失には、証券を売却可能な投資に分類された未実現損益が含まれているが、証券を売却可能な投資に分類される信用損失による損失を除くことは、適用期間中の純損失と全面赤字との唯一の違いである。

普通株1株当たり純損失

普通株1株あたりの基本純損失の計算方法は純損失を割ることであるGHTT−中では、普通株式等価物の発行済み普通株の平均数は考慮されていない。♪the the the3,893,6742021年1月の公募及び2024年3月の公募と同時に行った私募に関する事前資本承認株式証(付記8参照)は、基本的に1株当たり利益計算の加重平均で普通株を発行し、その名義で価格を行使した。普通株を希釈して同値期間中の企業純利益には、転換可能な優先株、普通株を購入する引受権証、および会社の株式オプションおよびインセンティブ計画に基づいて発行される普通株オプションおよび制限株式単位が含まれる。列報のすべての期間において、会社の純損失状況により、基本と希釈後の流通株を計算するための株式数に差はなかった。

年度株主は1株当たりの基本と償却純損失を占めるべきである2024年9月30日と2023年9月30日までの3ヶ月と9ヶ月は、以下のように計算されます(単位は千で、1株および1株当たりのデータは含まれていません)

10

 

 

 

9 月 30 日までの 3 ヶ月間

 

 

9 月 30 日までの 9 ヶ月間

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

分子：

 

 

 

 

 

 

 

 

 

 

 

 

純損失

 

$

(47,678

)

 

$

(45,170

)

 

$

(134,109

)

 

$

(116,806

)

分母：

 

 

 

 

 

 

 

 

 

 

 

 

1 株当たり純損失計算に使用される株式、基本および希釈

 

 

 

 

 

 

 

 

 

 

 

 

加重平均普通株式発行済み

 

 

113,875,487

 

 

 

98,310,702

 

 

 

109,486,740

 

 

 

98,085,588

 

加重平均事前資金調達令状

 

 

3,893,674

 

 

 

257,310

 

 

 

2,818,690

 

 

 

257,310

 

使用された加重平均普通株式発行済
1 株当たり基本損失と希釈純損失の計算

 

 

117,769,161

 

 

 

98,568,012

 

 

 

112,305,430

 

 

 

98,342,898

 

1株当たり基本と希釈して純損失

 

 

 

 

 

 

 

 

 

 

 

 

基本および希釈

 

$

(0.40

)

 

$

(0.46

)

 

$

(1.19

)

 

$

(1.19

)

 

以下の希薄化可能性のある有価証券の加重平均発行済株式は、希薄化防止効果があるため、当期における 1 株当たり希薄化純損失の計算から除外されます。

 

 

 

9 月 30 日現在、

 

 

 

2024

 

 

2023

 

転換可能優先株

 

 

13,805,540

 

 

 

13,805,540

 

普通株購入の未償還オプション

 

 

11,238,387

 

 

 

10,336,936

 

発行された限定株式単位

 

 

6,207,574

 

 

 

3,367,713

 

合計

 

 

31,251,501

 

 

 

27,510,189

 

 

2.協力と許可協定

小野洋子協力とオプション協議

2018年9月14日、当社は小野薬業と協力及びオプション協定を締結しました(小野協定MPharmtics Co.，Ltd.(Ono)は2種類の既製のIPSC由来自動車t-cell製品(候補1と候補2)を共同開発と商業化した。小野合意の条項によると、同社は前払い、払い戻し不可、貸切不可の金#ドルを受け取った10.0百万ドルです。また，共同研究計画によると，同社は研究や臨床前開発を行う資金を得る権利があり，費用は#ドルと見積もられている20.0合計百万ドルになります。

2020年12月、小野は特定の固形腫瘍に発現する抗原に対する固有抗原結合ドメインを交付し、候補2を組み込むための書面協定(小野書簡協定)を締結し、会社に記念碑的費用$を支払った10.0また、ONOは候補1に関するすべてのさらなる研究および臨床前開発を終了し、会社はONOに何の義務も負うことなく、候補1を世界的に研究、開発、商業化するすべての権利を保持している。

2022年6月、当社は小野と“小野協定改正案”(“2022年小野改正案”)を締結した。“2022年小野修正案”によると、両社は、研究および臨床前開発のために特定の固形腫瘍上で発現される追加抗原を指定することに同意し、小野は、このような追加の固形腫瘍抗原に対する独自の抗原結合ドメイン(候補3)に貢献することに同意した。さらに、候補2および候補3について、小野および同社は、指定された固形腫瘍抗原に対するIPSC由来CAR NK細胞候補製品(IPSC由来CAR T細胞候補製品を除く)の研究および臨床前開発を含む協力範囲を拡大した。候補2と同様に、会社は、特定の時間内に小野に臨床前オプション(候補3開発オプション)を付与して、特定の知的財産権の下で独占的な許可を得ることが条件であり、条件は、小野が、世界のすべての地域でさらに開発および商業化候補3を開発および商業化するために会社にオプション費用を支払うことであり、会社は、小野との共同配置に基づいて米国とヨーロッパで共同開発および共同商業化候補3を共同開発する権利を保持し、この手配に基づいて、会社は少なくとも共有する資格がある50利益と損失の%です。候補3開発オプションは、実質的な権利のないオプションを表す。“2022年小野改正案”によると，推計された研究と臨床前開発費用の総額は約1ドル増加した9.3100万ドルと推定されています29.3共同研究計画期間中，研究と臨床前開発費用は合計100万ドルであった。

11

 

2022年11月、小野はその選択権を行使し、開発候補2を取得して商業化するライセンス(候補2開発オプション)を獲得した。同社はその選択権(CDCC選択権)を行使し、米国と欧州で共同開発と共同商業化候補2を開発した。そこで，会社はオプション行権支払い(小野プロトコルと定義)#ドルを受け取った12.5百万ドルです。当社と小野正は、共同開発計画に基づいて候補2の持続的な発展を行っています。小野合意の開始時、当社は候補2の発展案は、双方が行っている候補2の持続的な発展とは異なり、分離可能な実質的な権利の選択を表していると考えています。したがって、オプション行使は、小野社にさらに開発·商業化候補2の許可証を付与·交付する義務のみが単独の契約とみなされている。同社は、候補2開発オプションに関する履行義務を完了し、それに応じてオプション行使支払いを2022年12月31日までの年間収入として確認している。この共同開発計画のコストはASC 808に基づいて入金され，小野社が会社に支払ったコスト分担金の純額は研究と開発費用に計上されている。また、進行中の候補2の共同開発については、同社は、いくつかの臨床、規制、およびビジネスマイルストーンを実現する際に追加支払いを受ける資格がある(以下に述べる).

2023年11月、当社は小野と“小野協定改正案”(“2023年小野改正案”)を締結した。“2023年小野改正案”によると，小野が候補3社に支払う見積研究と臨床前開発費用総額は約1ドル増加した1.4100万ドルと推定されています30.7共同研究計画期間中，研究と臨床前開発費用は合計100万ドルであった。

2024年5月、小野に続いてSが候補二期開発選択権を行使して開発と商業化許可証を付与した後，会社は実現した5.0候補2の臨床開発マイルストーンは100万ドルであり，同社はその間に収入としてこの金額を確認した。

当社は2024年8月に小野と“小野合意”の修正(“2024年小野修正”および“2023年小野修正”および“2022年小野修正”，“小野修正”)を締結した。“2024年小野改正案”によると，小野が候補3社に支払う見積研究と臨床前開発費総額は約1ドル増加した7.3100万ドルと推定されています38.0共同研究計画期間中，研究と臨床前開発費用は合計100万ドルであった。小野さんは2025年6月まで、共同研究計画に基づいて約束された資金を獲得し続ける。候補3開発オプションは、(A)2025年6月30日または(B)候補3共同研究計画の下での所定の臨床前マイルストーンの実現の早い日に満了する。小野が延期費用を支払う場合、小野は、候補3開発オプションの行使の決定を2026年6月まで延期することを選択することができる。

小野合意(小野修正案により改正された)の条項によると、候補者2および候補3(小野がその候補3の開発選択権を行使することに依存する)については、特定の臨床、規制、ビジネスマイルストーン(小野マイルストーン)を実現する際に各候補者に関する追加支払いを得る資格があり、金額は最高$に達する843.0合計100万ドルで、アメリカとヨーロッパの適用マイルストーンの支払いは減少します50%企業が上述したように米国とヨーロッパで共同開発および共同商業化候補を選択した場合。また、小野社が独占的に商業化する権利を持っている地域では、当社は小野社の同地域における候補者1人あたりの年間純売上高に応じて、そこから下位2桁までの階層的特許権使用料(特許権使用料)を獲得する資格があり、特許権使用料が減少する可能性がある。

小野が選択期間内に候補者のための発展選択権を行使していない場合や，小野が候補者それぞれの選択期間内に候補者のための発展選択権を行使していなければ，小野プロトコルは候補者について終了する.さらに、他方が違約、破産、または特許に挑戦した場合、どちらも小野プロトコルを終了することができるが、条件は、小野プロトコルの発効日の2周年後の任意の時間に小野プロトコルを候補者単位で終了することができるか、または(Y)開発選択期間が満了した後の任意の時間に候補者または国単位で小野プロトコルを終了することができるが、いくつかの制限を受ける必要があることである。“小野プロトコル”は、適用される特許使用料の期限が満了したときに、候補者毎および国/地域ごとに満了するか、または合意の下で適用されるすべての支払義務が満了した後にすべて満了する。

当社は，“小野合意”，“小野書簡協定”，“小野修正案”(総称して“小野手配”と呼ぶ)がASC 808の範囲に属すると認定し，この等の指針に適用している.同社の結論は、Ono手配中のある会計部門、特にある知的財産権に研究許可証及び研究と臨床前開発の業績は顧客関係を代表し、ASC 606の関連指導を応用してこれらの会計部門の適切な会計処理を評価することである。このガイドラインによると、同社は、小野への研究許可証の付与、ある条件下での小野の特定の知的財産権の付与、研究および臨床前開発サービスの実施、共同指導委員会への参加を含む承諾された製品およびサービスを決定した。同社は，小野に何らかの知的財産権を付与した研究許可証は，研究や臨床前開発サービスや共同指導委員会への参加と変わらないことを確認した。そのため、当社は、研究許可証、研究と臨床前開発サービス及び開発オプション期間中に共同指導委員会に参加することは総合業績義務とみなされ、しかもこの総合業績義務は研究と臨床前開発サービスの期待期間内に移転することを決定した。同社はまた、ASC 606の指導の下、行使していることを確認した

12

 

候補国2の開発代替案は、開発および商業化活動とは異なり、ASC 808によって計算された分離することができる。候補者1に関する“小野協定”を終了することはこの評価に影響を与えない。

ASC 606によれば、同社は、Ono手配下の研究および臨床前開発の初期取引価格が#ドルであると決定した48.0百万ドル、前払い、払い戻し不可、貸切不可の#ドルを含みます10.0百万ドルです。研究と臨床前開発費用の総額は#ドルだと思います38.0百万ドルです。同社はまた、マイルストーン費用は$であると結論した10.0小野社は候補2のさらなる研究と臨床前開発のために同社に100万ドルを支払っており，これまで制限されていた可変対価格である。この二つの前金はすべて$です10.0百万ドルと候補者2マイルストーン費用$10.0実際のコストが予想される研究および臨床前開発サービスの予想総コストを占める割合に基づいて、当社は一定期間内に研究および臨床前開発サービスを行う際に、実際のコストで予想総コストの割合を占め、繰延収入であることを確認した。同社は$を記録した5.0初年度研究と臨床前開発費用を繰延収入とし，研究や臨床前開発サービスを提供する際にそのなどの費用を収入として確認した。

同社が確認した収入は#ドル3.1百万ドルとドル11.8小野の手配によると、それぞれ2024年9月30日までの3カ月と9カ月。このような収入には $の3.1 ミルライオンは$を含んでいます1.42024年の小野改正案に関連する100万人、およびd $6.8 mi2024年9月30日までの3カ月と9カ月の研究と臨床前開発サービスに関するLion、と$5.0年内に臨床発展のマイルストーンの実現に関連した百万ドル2024年9月30日までの9カ月。2023年9月30日までの3ヶ月と9ヶ月以内に会社が確認した収入は$1.9百万ドルとドル9.5それぞれ100万ドルですこれらの収入は研究や臨床前開発サービスと関係があります2023年9月30日までの3ヶ月と9ヶ月。

会社は逆研究と開発費#ドルを確認した1.7百万ドルとドル3.6小野手配による共同開発候補2に関する百万ドルそれぞれ2024年9月30日までの3カ月と9カ月。2023年9月30日までの3ヶ月と9ヶ月以内に，会社が確認した逆研究と開発費用は$2.1百万ドルとドル5.9 それぞれ 100 万ドル。

会社が小野手配を締結した直接の結果として、会社が発生した費用総額は#ドルです9.0既存許可側に対する再許可対価格は100万ポンドであった。同社は$を確認した1.2100万ドルの支出は2024年9月30日までの9ヶ月間それは.会社は認識していますいいえこの費用は2024年9月30日までの3カ月と、2023年9月30日までの3カ月と9カ月。

Janssen連携とオプションプロトコル

2020年4月2日(ヤンソン協定発効日)に、当社はジョンソン所属ヤンソン製薬会社傘下のヤンソン生物科学技術有限公司(ヤンソン)と協力及びオプション協定(ヤンソン合意)を締結した。また、ヤンソン協定発効日に、当社はジョンソン·イノベーション社と株式購入協定(株購入協定)を締結した。2023年1月3日、当社はヤンソンからヤンソン合意終了の通知を受けました。終了は2023年4月3日に発効し，2023年3月31日までの3カ月間，ヤンソン合意によるすべての候補連携製品の開発停止を含む段階的に終了した活動を行った。同社はすべての清算活動の補償を受けた。

ヤンソン協定及び株式購入協定の合併条項によると、当社は$を受け取りました100.0 100 万ドルのうち50.0100万ドルは前払いの現金と50.0百万ドルはJJDCの株式投資の形です。当社はJJDCが購入した普通株の割増価格を#ドルと決定した9.931株当たり、または$16.0合計百万ドル(持分割増)、残りは$34.0株主権益における普通株の発行に100万ドルを計上する。また、株式購入協定に基づいて、会社はJJDCに総額#ドルの株を購入することを要求する権利を行使する50.0投資家が公募株で支払った1株当たり価格と同じ価格で、私募方式で発行された百万株。2020年6月JJDCが購入しました1.8百万株会社普通株、価格は$28.31一株ずつです。また，会社はヤンソン合意によるすべての研究，臨床前開発，研究性新薬応用(IND)の活動に全額資金を獲得した。

同社が確認した収入は#ドル52.3ヤンソン協定によると2023年9月30日までの9ヶ月間その中で$は41.22022年12月31日まで、100万ドルは延期された。この収入には$が含まれています11.1研究開発サービスに関連する百万ドルは31.2前払い費用と持分流出に関する百万ドルと10.0 商業オプションの行使に関連した 100 万ドル いいえ 収益は当時認識された ヤンセン協定に基づき 2023 年 9 月 30 日までの 3 ヶ月間。

ヤンセン協定に関連して、当社は $17.1 既存のライセンサーに 100 万ドルを支払っていますThe $17.1 サブライセンスの対価は、 ASC 340 に基づく資産であり、ヤンセン契約に基づく当社の収益認識に比例して研究開発費用に償却されました。中間 2023年9月30日までの9ヶ月間、会社は$を確認しました7.2 100 万ドルの費用です いいえ このような費用は 2023 年 9 月 30 日までの 3 ヶ月間。2024 年 9 月 30 日現在、ヤンセン協定契約資産の残高はありませんでした。

13

 

スローン·キャトリンがんセンター許可協定を記念して

2018年5月15日、当社はMSKCCと改訂および再予約された独占ライセンス契約(改訂されたMSKCC許可)を締結した。改訂されたMSKCCライセンスは、2016年8月19日に当社とMSKCCが締結した独占的許可プロトコルを改訂し、再確認し、これにより、当社とMSKCCは、キメラ抗原受容体(CARS)工学によるIPSCからのt細胞およびNK細胞を含むIPSC由来の細胞免疫療法の組成物および方法をカバーする権利について独占的許可プロトコルを締結する。

当社は改正されたMSKCCライセンスの条項に基づいて何らかのライセンス権利に再ライセンスを付与する権利があり、この場合、当社はMSKCCに会社が受け取ったある再ライセンス収入の一定割合を支払う義務がある。

当社は契約期間内にMSKCCに年間ライセンス維持費を支払うことを義務付け，ライセンス製品が指定された臨床，規制，ビジネスマイルストーンに達したときのマイルストーン支払いと，ライセンス製品の純売上高の特許権使用料の支払いを要求している。

許可された製品が指定された臨床マイルストーンに達した場合、MSKCCは合計$まで取得する資格があります75.0会社の普通株価格を基礎とし、MSKCCを借りた金額は会社の普通株価格が臨床マイルストーンに達した日後のある上昇幅に依存する。これらの支払いは普通株価格倍数を基礎とし、分子は会社の普通株の10取引日の過去平均終値の公正価値であり、分母は会社の普通株が改訂されたMSKCC許可証の発効日の10取引日の過去平均終値であり、任意の株式分割、現金配当、株式配当、その他の分配、合併、資本再編或いは類似事件に基づいて調整を行う。改訂されたMSKCCライセンス条項によると、会社制御権が変更された場合、会社はコントロール権変更に関連する会社普通株価格に基づいてMSKCCに一部のお金を支払う必要がある場合がある。

下表は、合意条項下の普通株式倍数と株価増価マイルストーン支払いをまとめた

 

普通株倍数

 

5.0x

 

 

10.0x

 

 

15.0x

 

10取引日の平均普通株価格

 

$

50.18

 

 

$

100.36

 

 

$

150.54

 

株価上昇一里塚払い(単位：百万)

 

$

20.0

 

 

$

30.0

 

 

$

25.0

 

 

2021年7月、同社は改訂されたMSKCCライセンスの下でライセンス製品の指定臨床マイルストーンを実現し、会社の10取引日の過去最高平均普通株式価格は最初の予め指定されたハードルを超えた。そのため、同社は最初の記念碑的な支払い#ドルを送金した20.0MSKCCには2021年12月31日までの年間で100万ドルが支払われた。

残りの株価増加マイルストーンの推定公正価値を決定するために、会社はモンテカルロシミュレーション方法を用いて、現在の株価といくつかの重要な変数に基づいて未来の会社の普通株価格をモデル化した。株価増価マイルストーンの推定公正価値を計算する際には，以下の変数が格納されている2024年9月30日：

 

 

 

9 月 30 日現在、

 

 

12 月 31 日現在、

 

 

 

2024

 

 

2023

 

リスクフリー金利

 

 

4.0

%

 

 

4.0

%

予想ボラティリティ

 

 

85.0

%

 

 

84.0

%

見積もり期限(年)

 

 

14.3

 

 

 

15.0

 

再評価日現在の終値株価

 

$

3.50

 

 

$

3.74

 

 

株価上昇マイルストーンの公正価値を決定するためのモンテカルロシミュレーションの重要なインプットには、測定日時点での当社の株価、最終有効特許請求日の一部に基づいた推定期間、再測定日時点での当社の通常株式の過去のボラティリティを用いて推定された当社の普通株式の予想ボラティリティが含まれます。そして、決定された推定期間における米国財務利回りに基づくリスクフリー金利です。公正価値の測定は、これらの入力の変化に非常に敏感であり、重要な変化は公正価値の大幅な上昇または低下と結果として生じる費用または利益をもたらす可能性があります。

当社は、各貸借対照表日において、株価上昇マイルストーンの公正価値を再測定し、その公正価値の変更を未監査連結営業計算書においてその他の利益 （ 費用 ） の構成要素として認識し、

14

 

総合損失。金額は、個々の潜在的な支払に関連する推定タイムラインに基づいて、経常債務または非経常債務に含まれます。2024 年 9 月 30 日に終了した 3 ヶ月間の 9 ヶ月間， 当社は $の費用を記録しました。0.1 100 万ドルとその他の収入0.1 株価上昇マイルストーンの公正価値の変化に関連していますD2023 年 9 月 30 日に終了した 3 ヶ月 9 ヶ月間その他収益は $。1.0百万ドルとドル3.2 株価上昇マイルストーンの公正価値の変化に関連しています【 As of 2024 年 9 月 30 日及び 2023 年 12 月 31 日、当社は負債を計上しました。y の $1.2 百万 そして $1.3 ミリオン、 RE具体的には、修正 MSKCC ライセンスの株価上昇マイルストーンに関連しています。

3.カリフォルニア州再生医学研究所賞

FT 819 CIRM賞

2024年2月に同社はドルを獲得しました7.92024年4月、同社はカリフォルニア再生医学研究所(CIRM)と授与協定(FT 819 CIRM賞)に署名し、同社による全身性エリテマトーデス患者のFT 819の第1段階研究を支援した。FT 819 CIRM賞の条項によると、同社はCIRMから5つの異なる金額の支払いを受ける資格があり、その中の1件は奨励を実行する時に受け取るべきであり、4筆はある発展マイルストーンに基づいて奨励期間全体が完成した後に受け取るべきであり、2024年4月1日から2028年3月31日まで(奨励期間)と推定される。FT 819 CIRM賞によると、会社には一定の共同出資義務があり、全入賞期間内にCIRM進展と財務更新報告を提供することが求められている。

奨励期限が終わった後、会社は自分でFT 819 CIRMを奨励ローンまたは贈与と見なす権利があります。もし会社が受賞日から10年以内にFT 819 CIRM賞をローンとして扱うことを選択しなければ、この賞は贈与とみなされ、会社はFT 819商業販売の低い桁の特許権使用料をCIRMに四半期ごとに支払い、支払う特許権使用料の総額がFT 819 CIRM賞が会社に授与された総金額の9倍になるまで支払う義務がある。

当社はその選択時にFT 819 CIRM賞の一部または全部を返済する可能性があるため、当社は選択時までにこの奨励金を負債として会計処理しています。2024年5月、当社はFT 819 CIRM賞の最初の支払いを受け取りました。金額は#ドルです1.9百万ドル、この金額は添付の合併貸借対照表に負債と記載されており、次の潜在的な対応金額に基づいて流動又は非流動に分類される12現在の貸借対照表の月数。自分から2024年9月30日全体の残高は当社と同様に非流動に分類されるいいえI don‘私は次の12ヶ月以内に何の支払いも期待していない。

FT 516 CIRM賞

2018年4月、会社はCIRMとライセンス契約を締結し、この合意に基づき、CIRMは会社に$を授与しました4.0会社のFT 516候補製品を末期固形腫瘍を治療する初のヒト臨床試験(FT 516 CIRM賞)に推進した。FT 516 CIRM賞によると，同社には一定の共同出資義務があり，CIRM進展と財務更新報告の提供が求められている。

FT 516 CIRM賞の条項によると、当社はFT 516 CIRM賞を融資または贈与と見なすことを自ら決定する権利がある。2023年第1四半期に、会社はFT 516 CIRM賞を贈与とすることを選択した。そのため，FT 516 CIRM賞に関する負債がキャンセルされ，2023年9月30日までの9カ月間に他の収入として記録されていることが確認された.

4. 投資

当社は、余剰現金の一部を、米国国債、商業紙、非米国政府債、市政有価証券、および期間の法人債券に投資しています。 三つ トゥ 36 か月 購入日から。これらの投資は、販売可能有価証券として計上され、各有価証券の契約満期日に基づいて、付属連結貸借対照表において短期および長期投資に分類されます。

15

 

下表は、当社が発行済有価証券として計上した投資額を、当年現在にまとめたものです。 2024 年 9 月 30 日および 2023 年 12 月 31 日 （ 満期年を除く千単位 ） ：

 

 

 

成熟性
(単位：年)

 

償却する
費用

 

 

未実現
損

 

 

未実現
ゲイン

 

 

推定数
公正価値

 

2024年9月30日

 

 

 

 

 

 

 

 

 

 

 

 

 

 

流動資産の分類 ：

 

 

 

 

 

 

 

 

 

 

 

 

 

 

マネーマーケット · ファンド

 

1 未満

 

$

11,273

 

 

$

—

 

 

$

—

 

 

$

11,273

 

アメリカ合衆国国債

 

1 以下

 

 

43,963

 

 

 

—

 

 

 

164

 

 

 

44,127

 

非米国政府債券

 

1 以下

 

 

3,965

 

 

 

—

 

 

 

5

 

 

 

3,970

 

市政証券

 

1 以下

 

 

5,965

 

 

 

(2

)

 

 

4

 

 

 

5,967

 

会社債務証券

 

1 以下

 

 

149,461

 

 

 

(7

)

 

 

457

 

 

 

149,911

 

商業手形

 

1 以下

 

 

54,993

 

 

 

(3

)

 

 

49

 

 

 

55,039

 

短期投資総額

 

 

 

$

269,620

 

 

$

(12

)

 

$

679

 

 

$

270,287

 

非流動資産の分類 ：

 

 

 

 

 

 

 

 

 

 

 

 

 

 

会社債務証券

 

1 より大きい

 

$

33,439

 

 

$

(14

)

 

$

182

 

 

$

33,607

 

長期投資総額

 

 

 

$

33,439

 

 

$

(14

)

 

$

182

 

 

$

33,607

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2023 年 12 月 31 日

 

 

 

 

 

 

 

 

 

 

 

 

 

 

経常資産の分類 ：

 

 

 

 

 

 

 

 

 

 

 

 

 

 

マネーマーケットファンド

 

1 以下

 

$

35,273

 

 

$

—

 

 

$

—

 

 

$

35,273

 

アメリカ合衆国国債

 

1 以下

 

 

82,811

 

 

 

(34

)

 

 

27

 

 

 

82,804

 

非米国政府債券

 

1 以下

 

 

999

 

 

 

—

 

 

 

—

 

 

 

999

 

市政証券

 

1 未満

 

 

5,000

 

 

 

(3

)

 

 

—

 

 

 

4,997

 

会社債務証券

 

1 以下

 

 

47,144

 

 

 

(51

)

 

 

14

 

 

 

47,107

 

商業手形

 

1 未満

 

 

137,339

 

 

 

(62

)

 

 

121

 

 

 

137,398

 

短期投資総額

 

 

 

$

308,566

 

 

$

(150

)

 

$

162

 

 

$

308,578

 

非流動資産の分類 ：

 

 

 

 

 

 

 

 

 

 

 

 

 

 

社債証券

 

1 より大きい

 

$

977

 

 

$

—

 

 

$

3

 

 

$

980

 

長期投資総額

 

 

 

$

977

 

 

$

—

 

 

$

3

 

 

$

980

 

 

2024 年 9 月 30 日および 2023 年 12 月 31 日現在、当社は $あった1.9 百万 そして $0.9百万人 未監査連結貸借対照表上の前払い費用およびその他の資産に計上された投資の未払利子です

16

 

5. 公正価値測定

以下の表は、当会社の財務資産及び負債を公正価額で計量したものです。 2024年9月30日と2023年12月31日(単位：千)：

 

 

 

 

 

 

公正価値に応じて計量する
報告日利用

 

 

 

合計

 

 

オファー
活動状態にある
市場：
雷同
資産
(レベル1)

 

 

意味が重大である
その他
観察できるのは
入力量
(レベル2)

 

 

意味が重大である
見えない
入力量
(レベル3)

 

2024 年 9 月 30 日現在

 

 

 

 

 

 

 

 

 

 

 

 

金融資産：

 

 

 

 

 

 

 

 

 

 

 

 

貨幣市場基金

 

$

34,469

 

 

$

34,469

 

 

$

—

 

 

$

—

 

アメリカ合衆国国債

 

 

44,127

 

 

 

44,127

 

 

 

—

 

 

 

—

 

非米国政府債券

 

 

3,970

 

 

 

—

 

 

 

3,970

 

 

 

—

 

市政証券

 

 

5,967

 

 

 

—

 

 

 

5,967

 

 

 

—

 

会社債務証券

 

 

183,518

 

 

 

—

 

 

 

183,518

 

 

 

—

 

商業手形

 

 

55,039

 

 

 

—

 

 

 

55,039

 

 

 

—

 

経常公正価値で計量された金融資産総額

 

$

327,090

 

 

$

78,596

 

 

$

248,494

 

 

$

—

 

 

 

 

 

 

 

 

 

 

 

 

 

 

財務負債：

 

 

 

 

 

 

 

 

 

 

 

 

株価上昇のマイルストーン

 

$

1,197

 

 

$

—

 

 

$

—

 

 

$

1,197

 

経常的な公正価値で計量された財務負債総額

 

$

1,197

 

 

$

—

 

 

$

—

 

 

$

1,197

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2023年12月31日まで

 

 

 

 

 

 

 

 

 

 

 

 

金融資産 ：

 

 

 

 

 

 

 

 

 

 

 

 

貨幣市場基金

 

$

35,273

 

 

$

35,273

 

 

$

—

 

 

$

—

 

アメリカ合衆国国債

 

 

82,804

 

 

 

82,804

 

 

 

—

 

 

 

—

 

非米国政府債券

 

 

999

 

 

 

—

 

 

 

999

 

 

 

—

 

市政証券

 

 

4,997

 

 

 

—

 

 

 

4,997

 

 

 

—

 

会社債務証券

 

 

48,087

 

 

 

—

 

 

 

48,087

 

 

 

—

 

商業手形

 

 

137,398

 

 

 

—

 

 

 

137,398

 

 

 

—

 

公正な価値に応じて恒常的に計量された総資産

 

$

309,558

 

 

$

118,077

 

 

$

191,481

 

 

$

—

 

 

 

 

 

 

 

 

 

 

 

 

 

 

財務負債：

 

 

 

 

 

 

 

 

 

 

 

 

株価上昇のマイルストーン

 

$

1,346

 

 

$

—

 

 

$

—

 

 

$

1,346

 

公正な価値に応じて恒常的に計量された金融負債総額

 

$

1,346

 

 

$

—

 

 

$

—

 

 

$

1,346

 

 

一級資産は貨幣市場基金とアメリカ国庫券を含み、会社の投資マネージャーが提供した活発な市場オファーによって公正な価値によって計量される。

 

二次資産は、会社債務証券、商業手形、市政証券および非アメリカ政府証券を含み、報告された取引、ブローカー/取引業者のオファーおよび入札および/または要約を含む標準的な観察可能な投入を使用して価値計量を公正に許容する。当社は、投資マネージャーの当社ポートフォリオ残高に対する公正価値の評価と、独立ソースから得られた当社ポートフォリオ残高の公正価値を比較することにより、その投資マネージャーが提供する市場オファーを検証する。

同社は2024年9月30日現在、3級資産を保有していない。

 

レベル3負債には、改訂されたMSKCCライセンスに関する株価増加マイルストーンが含まれており、詳細は付記2を参照されたい。

17

 

次の表は、当会社のレベル 3 株価上昇マイルストーン負債の公正価値の推移を示します。 2024年9月30日までの9ヶ月(単位：千)：

 

2023年12月31日の残高

 

$

1,346

 

株価上昇の公正価値の変動マイルストーン負債

 

 

1,394

 

2024 年 3 月 31 日現在の残高

 

$

2,740

 

株価上昇の公正価値の変化マイルストーン負債

 

 

(1,556

)

2024年6月30日の残高

 

$

1,184

 

株価上昇の公正価値の変動マイルストーン負債

 

 

13

 

2024 年 9 月 30 日の残高

 

$

1,197

 

 

次の表は、 2023 年 9 月 30 日に終了した 9 ヶ月間の当社レベル 3 株価上昇マイルストーン負債の公正価値の推移 （ 千単位 ） を示します。

 

2022年12月31日の残高

 

$

3,861

 

株価上昇の公正価値の変化マイルストーン負債

 

 

(1,718

)

2023年3月31日の残高

 

$

2,143

 

株価上昇の公正価値の変化マイルストーン負債

 

 

(393

)

2023年6月30日の残高

 

$

1,750

 

株価上昇の公正価値の変動マイルストーン負債

 

 

(1,049

)

2023年9月30日の残高

 

$

701

 

 

6. 経費発生

費用を計算する

現在発生する経費は、以下のとおり （ 千単位 ） 。

 

 

 

九月三十日
2024

 

 

十二月三十一日
2023

 

賃金とその他の従業員の福祉を計算しなければならない

 

$

7,697

 

 

$

10,563

 

臨床試験関連費用の発生

 

 

5,385

 

 

 

8,833

 

その他の措置を講じる

 

 

10,498

 

 

 

8,118

 

経常経費総計

 

$

23,580

 

 

$

27,514

 

 

7.賃貸証書

当社はオフィス、実験室、製造空間の賃貸プロトコルを持っており、これらの空間は監査されていない簡素化総合貸借対照表で経営賃貸に分類されているこれらのレンタル契約の条項は一から約までです16年更新オプションは最大で可能です10年そして、オプションを事前に終了します。会社が選択権の延長および終了を行使すると合理的に決定した場合、その選択権は総レンタル期間に含まれる。賃貸契約には、公共地域維持、財産税、財産保険、その他の可変コストが含まれる追加の可変費用が必要です。このような費用の可変的な性質を考慮して、それらは発生した費用として確認された。また、当社の一部のレンタル契約には若干の固定料金がかかりますが、当社はこの等の費用を非レンタル部分と決定しています。当社は、将来の賃貸支払い総額を決定するために、レンタルと非レンタル構成要素を統合し、単一賃貸構成要素として計算することを選択した。

2024年9月30日まで、将来割引ミニはございません会社のレンタル項目でのMU契約支払いは#ドルです152.0百万は、残りの加重平均レンタル期間内に支払います10.1何年もです。経営賃貸負債の加重平均割引率は8.4%すなわち、当社のリース開始時の逓増借款金利であり、これは、リース契約に隠されている割引率が容易に決定できないためである。

18

 

 

当社の営業リース契約に基づく将来の割引なしの最低賃料 2024 年 9 月 30 日は以下の通り （ 千単位 ） 。

 

 

 

運営中です
リース支払い

 

残り 2025 年

 

$

3,690

 

2025

 

 

15,087

 

2026

 

 

15,540

 

2027

 

 

16,006

 

2028

 

 

15,057

 

2029

 

 

10,602

 

その後…

 

 

75,978

 

未割引賃貸支払総額

 

$

151,960

 

差し引く：推定利息

 

 

(52,982

)

リース総負債

 

$

98,978

 

 

2023 年 4 月、当社は、約 18,913 2023 年 4 月にサブリース契約が開始され、 2028 年 12 月に満了し、サブリース期間を延長する選択肢はありません。サブリース契約の下では、家賃は予定されている年次増額の対象となり、サブテナントはサブリース期間中一定の運営費と税金を負担します。サブリース収入はその他の収入に計上されます。

 

 

8.転換可能な優先株式および株主資本

転換可能優先株

2016年11月、当社は自社の転換可能な優先株と普通株を購入した株式指向増発を完了し、投資家は当社の取締役や上級管理職に関連する投資家を含めて自社の転換可能な優先株と普通株を購入した(2016年11月配給)。その会社は発行した2,819,549Aクラス転換可能優先株株、$0.0011株当たり額面(A類優先株)、1株$13.30それぞれの株は5人普通株は、2016年11月22日にデラウェア州国務長官に提出されたA類優先株の指定優先、権利および制限証明書(COD)で定義されているいくつかの条件下での普通株式であるA類優先株はレドマイヤーグループ有限責任会社(総称してレドマイヤーと呼ぶ)の付属実体が独占的に購入する。Codの条項は，レドマイヤーがA類優先株を会社普通株に変換することを禁止しており，変換の結果，レドマイヤーとその関連会社が上回ることになる9.99会社が当時発行され、発行された普通株式の%(レドマイヤーパーセンテージ制限)であって、この割合は、レドマイヤーが会社に61日通知した後、(I)以下の任意の他の数字以下に変更することができる19.99%または(Ii)ナスダックグローバル市場規則に従って会社の株主によって承認された後、いずれかを超える19.99%です。2017年5月2日、当社の株主承認発行総額は最大14,097,745普通株A類優先株転換後の普通株。レドマイヤーはレドマイヤーの割合を以下のパーセントを超えるように制限する権利があります19.99その選挙で。その会社はまた発行した7,236,837普通株価格は$2.662016年11月の配給の一部として。はい2023年4月、会社はデラウェア州州務卿室にA類転換可能優先株の指定優先株、権利、制限証明書修正案を提出し、利益所有権制限の定義を修正した14.99当社の株式数のパーセント変換通知により普通株式を発行した直後に発行された発行済み普通株2023 年 4 月、 33,441 当社の株式’s クラス A 優先が変換されました 167,205 会社の株式共同の株式です。

クラス A 優先株は無議決権株で、同社の普通株式 5 株に換算価格で換算できます。2.66 1 株当たり、クラス A 優先権の発行日における当社普通株式の公正価値です。クラス A 優先株の保有者は、当社普通株式の保有者と同等の配当権を有します。さらに、クラス A 優先の清算優先順位は 平価通行証 当社の普通株式の保有者およびクラス A 優先権の保有者の間で、各保有者の保有株式数に比例して （ この目的では、クラス A 優先権が普通株式に転換されたものとして扱われる ） 。

資金調達済みワラント

2021 年 1 月、株式公開に伴い、特定投資家に対して普通株式に代わる事前資金付きワラントを発行し、以下のように購入しました。 257,310 株式 当社の普通株式 （ 2021 年前資金調達令状 ） について購入価格

19

 

THE 2021年の事前計画権証明書$85.4991株当たりの事前資金権証は、普通株1株当たりの公開発行価格から$を引くことに相当する0.001このような事前資金調達権証の行使価格。2021年の事前融資承認株式証が会社自身の普通株とリンクしていること(その他の面で株式に分類される要求を満たす)であることから、当社は会社が監査されていない簡明総合貸借対照表に承認持分証を発行して受け取った代償を追加実収資本として会社の監査されていない簡明総合貸借対照表に記録している。

2024年3月，公開と同時に，会社は普通株の代わりに私募方式である投資家にあらかじめ出資した引受権証を発行した3,636,364当社普通株株式(2024年予融資権証、2021年予融資権証、予融資権証と合計)。2024年の事前資金調達権証の購入価格は$5.4991株当たりの事前資金権証は、2024年3月に公開発行された普通株の1株当たり公開発行価格に等しく、$を引く0.001このような事前資金調達権証の行使価格。2024年の事前融資承認株式証が会社自身の普通株とリンクしていること(その他の面で株式に分類される要求を満たす)であることから、当社は会社が監査されていない簡明総合貸借対照表に承認株式証を発行して受け取った対価格を追加実収資本として会社の監査されていない簡明総合貸借対照表に記録している。

前払い資金株式承認証は発行日後のいつでも行使することができる。事前出資株式証所有者は事前出資株式証を行使してはならず，当該所有者及びその関連会社が実益を超えて所有することを前提としている9.99この権力を行使した後、直ちに発行された会社普通株式数の%である。事前融資権証の保有者はこのパーセントを増加または減少させることができるが，超えてはならない19.99最小61日間の事前通知を当社に提供する.

2024年9月30日までにエル3,893,674未返済の前払い資金は持分証を承認する。

株式オプションと制限株式単位奨励

この期間までのすべての持分計画項における株式オプション活動および関連資料を表にまとめる2024年9月30日：

 

 

 

量
オプション

 

 

重み付け —
平均価格

 

2023年12月31日の残高

 

 

9,850,841

 

 

$

13.71

 

付与

 

 

4,210,625

 

 

 

6.46

 

鍛えられた

 

 

(45,438

)

 

 

6.57

 

キャンセルします

 

 

(2,777,641

)

 

 

13.42

 

2024 年 9 月 30 日の残高

 

 

11,238,387

 

 

$

11.09

 

 

すべての株式およびストックオプション計画における制限付き株式の活動の概要は以下の通りです。

 

 

 

数量
限定株単位

 

 

重み付け —
平均付与日 1 株当たりの公正価値

 

2023 年 12 月 31 日の残高

 

 

3,065,087

 

 

$

37.96

 

付与

 

 

4,396,874

 

 

 

5.72

 

既得

 

 

(666,916

)

 

 

33.44

 

キャンセル済み

 

 

(587,471

)

 

 

37.62

 

2024 年 9 月 30 日の残高

 

 

6,207,574

 

 

$

15.62

 

2024 年 9 月 30 日までの 3 ヶ月間、当社は 300,000 付与日の公正価値の合計は約 $のパフォーマンスベースの制限付き株式ユニット1.6 100 万ドル2024 年 9 月 30 日現在、 1,062,607 PRSU は優れていた。これまでのところ、未払いの PRSU に対する費用は認識されていない。

すべての株式報酬に対する株式報酬の配分は以下のとおりです （ 千単位 ） 。

 

 

 

3か月まで
九月三十日

 

 

9か月で終わる
9 月 30 日

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

研究 · 開発

 

$

5,295

 

 

$

4,783

 

 

$

16,248

 

 

$

16,690

 

一般と行政

 

 

6,470

 

 

 

5,321

 

 

 

16,128

 

 

 

17,294

 

合計

 

$

11,765

 

 

$

10,104

 

 

$

32,376

 

 

$

33,984

 

 

20

 

2024 年 9 月 30 日現在、未承認補償未払いのオプションに関連するコストは $18.7 費用として計上され、加重平均期間にわたって計上される見込みです。 1.8 何年もです。

2024 年 9 月 30 日現在制限付き株式 （ 未達成の業績ベース条件を除く ） に関連する未認識補償コストは $38.3 費用として計上される見込みの加重平均は約 100 万ドルです 1.9 何年もです。

従業員および非従業員の株式オプション付与の公正価値を決定するために、ブラック · ショールズオプション価格モデルで使用された加重平均の仮定は以下の通りでした。

 

 

9か月で終わる
9 月 30 日

 

 

 

2024

 

 

2023

 

リスクフリー金利

 

 

3.9

%

 

 

3.8

%

予想ボラティリティ

 

 

87.1

%

 

 

89.6

%

予想期限(年単位)

 

 

6.4

 

 

 

6.4

 

期待配当収益率

 

 

0.0

%

 

 

0.0

%

連結株主持分勘定の調整

以下の表は、当会社の株主持分勘定の推移をまとめたものです。 2024 年 9 月 30 日に終了した 3 ヶ月間と 9 ヶ月間 （ シェアデータを除く千単位 ） ：

 

 

オープンカー
優先株

 

 

ごく普通である
在庫品

 

 

その他の内容
支払い済み

 

 

積算
他にも
全面的に

 

 

累積

 

 

株主合計

 

 

株

 

 

金額

 

 

株

 

 

金額

 

 

資本

 

 

(損を)得る

 

 

赤字.赤字

 

 

株式会社

 

2023 年 12 月 31 日の残高

 

2,761,108

 

 

$

3

 

 

 

98,627,076

 

 

$

99

 

 

$

1,580,032

 

 

$

15

 

 

$

(1,211,732

)

 

$

368,417

 

株式オプションの行使 （ 発行コストを差し引いたもの ）

 

—

 

 

 

—

 

 

 

45,438

 

 

 

—

 

 

 

299

 

 

 

—

 

 

 

—

 

 

 

299

 

帰属制限株式単位の場合に普通株式を発行する

 

—

 

 

 

—

 

 

 

580,974

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

株式報酬

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

10,981

 

 

 

—

 

 

 

—

 

 

 

10,981

 

発行原価を差し引いた普通株式の公募

 

—

 

 

 

—

 

 

 

14,545,454

 

 

 

15

 

 

 

74,620

 

 

 

—

 

 

 

—

 

 

 

74,635

 

発行コストを差し引いた事前資金付きワラントのプライベート · プレイスメント

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

19,996

 

 

 

—

 

 

 

—

 

 

 

19,996

 

投資が未実現損失

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(209

)

 

 

—

 

 

 

(209

)

純損失

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(48,004

)

 

 

(48,004

)

2024 年 3 月 31 日現在の残高

 

2,761,108

 

 

$

3

 

 

 

113,798,942

 

 

$

114

 

 

$

1,685,928

 

 

$

(194

)

 

$

(1,259,736

)

 

$

426,115

 

株式オプションの行使 （ 発行コストを差し引いたもの ）

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(4

)

 

 

—

 

 

 

—

 

 

 

(4

)

帰属制限株式単位の場合に普通株式を発行する

 

—

 

 

 

—

 

 

 

50,615

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

株式報酬

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

9,630

 

 

 

—

 

 

 

—

 

 

 

9,630

 

発行原価を差し引いた普通株式の公募

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(104

)

 

 

—

 

 

 

—

 

 

 

(104

)

投資の未実現損失

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(228

)

 

 

—

 

 

 

(228

)

純損失

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(38,427

)

 

 

(38,427

)

2024年6月30日の残高

 

2,761,108

 

 

$

3

 

 

 

113,849,557

 

 

$

114

 

 

$

1,695,450

 

 

$

(422

)

 

$

(1,298,163

)

 

$

396,982

 

制限付き株式の付与による普通株式の発行

 

—

 

 

 

—

 

 

 

35,327

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

株式報酬

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

11,765

 

 

 

—

 

 

 

—

 

 

 

11,765

 

投資が収益を実現していない

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

1,257

 

 

 

—

 

 

 

1,257

 

純損失

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(47,678

)

 

 

(47,678

)

2024 年 9 月 30 日の残高

 

2,761,108

 

 

$

3

 

 

 

113,884,884

 

 

$

114

 

 

$

1,707,215

 

 

$

835

 

 

$

(1,345,841

)

 

$

362,326

 

 

21

 

以下の表は、 2023 年 9 月 30 日に終了した 3 ヶ月間および 9 ヶ月間の当社の株主持分勘定の推移 （ 株価データを除く千単位 ） をまとめたものです。

 

 

オープンカー
優先株

 

 

ごく普通である
在庫品

 

 

その他の内容
支払い済み

 

 

積算
他にも
全面的に

 

 

積算

 

 

株主合計

 

 

株

 

 

金額

 

 

株

 

 

金額

 

 

資本

 

 

(損を)得る

 

 

赤字.赤字

 

 

株式会社

 

2022年12月31日の残高

 

2,794,549

 

 

$

3

 

 

 

97,294,917

 

 

$

97

 

 

$

1,536,497

 

 

$

(1,854

)

 

$

(1,050,804

)

 

$

483,939

 

株式オプションの行使 （ 発行コストを差し引いたもの ）

 

—

 

 

 

—

 

 

 

68,847

 

 

 

—

 

 

 

222

 

 

 

—

 

 

 

—

 

 

 

222

 

帰属制限株式単位の場合に普通株式を発行する

 

—

 

 

 

—

 

 

 

827,251

 

 

 

1

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

1

 

株式報酬

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

10,983

 

 

 

—

 

 

 

—

 

 

 

10,983

 

投資が収益を実現していない

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

1,208

 

 

 

—

 

 

 

1,208

 

純損失

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(18,881

)

 

 

(18,881

)

2023年3月31日の残高

 

2,794,549

 

 

$

3

 

 

 

98,191,015

 

 

$

98

 

 

$

1,547,702

 

 

$

(646

)

 

$

(1,069,685

)

 

$

477,472

 

株式オプションの行使 （ 発行コストを差し引いたもの ）

 

—

 

 

 

—

 

 

 

24,940

 

 

 

—

 

 

 

81

 

 

 

—

 

 

 

—

 

 

 

81

 

制限付き株式の付与による普通株式の発行

 

—

 

 

 

—

 

 

 

139,558

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

優先株を普通株に転換する

 

(33,441

)

 

 

—

 

 

 

167,205

 

 

 

1

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

1

 

株式報酬

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

12,897

 

 

 

—

 

 

 

—

 

 

 

12,897

 

投資の未実現利益

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

59

 

 

 

—

 

 

 

59

 

純損失

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(52,755

)

 

 

(52,755

)

2023年6月30日の残高

 

2,761,108

 

 

$

3

 

 

 

98,522,718

 

 

$

99

 

 

$

1,560,680

 

 

$

(587

)

 

$

(1,122,440

)

 

$

437,755

 

制限付き株式の付与による普通株式の発行

 

—

 

 

 

—

 

 

 

63,032

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

株式報酬

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

10,104

 

 

 

—

 

 

 

—

 

 

 

10,104

 

投資の未実現利益

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

88

 

 

 

—

 

 

 

88

 

純損失

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(45,170

)

 

 

(45,170

)

2023年9月30日の残高

 

2,761,108

 

 

$

3

 

 

 

98,585,750

 

 

$

99

 

 

$

1,570,784

 

 

$

(499

)

 

$

(1,167,610

)

 

$

402,777

 

 

9. その後のイベント

トレイ · パインズリース終了

2024 年 10 月 28 日、当社はトリー · パインズの営業リースの早期終了権を行使しました。このような演習に関連して、当社は $2.5 家主に 100 万ドルです以前は 2028 年 12 月 31 日まで延長されていたリースの終了は、 2025 年 10 月 31 日に発効します。 当社は、 2024 年第 4 四半期において、本取引をリース契約の修正として計上し、 ROU 資産およびそれに伴うリース負債残高を削減する予定です。

 

22

 

項目 2 。 経営陣の議論と分析 財務状況及び業績

以下の議論と分析は、本フォーム 10—Q の四半期報告書および 2023 年 12 月 31 日に終了した会計年度における財務諸表および付随の注記、および関連する経営陣の財務状況および営業結果に関する議論と分析と併せて読まれる必要があります。2024 年 2 月 26 日に証券取引委員会に提出されたフォーム 10—k の年次報告書に記載されています。

このForm 10-Q四半期報告書には、証券法第27 A節と改正された“1934年証券取引法”(“取引法”)第21 E節で指摘された“前向き陳述”が含まれている。このような展望性陳述は私たちの意図、信念或いは現在の予想を代表し、リスク、不確定要素及びその他の要素に関連し、実際の結果とある事件の時間はこのような展望性陳述の明示或いは暗示の未来の結果とは大きく異なる可能性がある。場合によっては、前向きな陳述は、“可能性”、“予想”、“推定”、“計画”、“計画”、“予測”、“潜在”、“信じる”、“すべき”などの用語によって識別されることができる。結果の差異をもたらすか、または促進する可能性のある要因は、以下の第2の部分1 Aの項の“リスク要因”の項に列挙された要因を含むが、これらに限定されない。法的に別の要求がない限り、私たちは、本報告日後のイベントまたは状況を反映したり、実際の結果を反映するために、これらの前向きな陳述を更新する義務がありません。

概要

当社は、がんおよび自己免疫疾患の患者にプログラムされた細胞免疫療法のファーストクラスのパイプラインを提供することに専念する臨床段階のバイオ医薬品企業です。当社のプログラム細胞免疫療法の開発は、より良い細胞治療はより良い細胞から始まるというシンプルな概念に基づいています。

より良い細胞治療を創出するために、私たちは一般に細胞プログラミングと呼ばれる治療アプローチを開拓してきました。細胞機能の新規な合成制御を取り込むヒト誘導多能性幹細胞の創出とエンジニアリング、再生可能な細胞製造源として使用するためのクローンマスター iPSC ラインの生成、クローンマスター iPSC ラインの運命を導いて細胞治療製品候補の生産を行っています。モノクローナル抗体などのバイオ医薬品の製造に使用されるマスター細胞株と同様に、クローナルマスター iPSC 株は、組成がよく定義され均一であり、市販のために在庫に保管でき、他の治療法と組み合わせて投与でき、より広い患者リーチを持つマルチプレックスエンジニアリングされた細胞免疫療法を大量生産するために使用できると考えています。

当社は独自の iPSC 製品プラットフォームを活用し、細胞機能の新規な合成制御を組み込むように選択的に設計された、既製の多重化設計されたナチュラルキラー （ NK ） および t 細胞製品候補を開発しており、がんおよび自己免疫疾患の治療のために患者に複数の治療メカニズムを提供することを目的としています。当社は、 iPSC 由来のキメラ抗原受容体を標的とした Nk および t 細胞製品候補の豊富なパイプラインを有しており、現在複数の臨床試験が進行中です。さらに、当社は、ミネソタ大学のリージェントス、メモリアルスローン · ケッタリング · がんセンターなど、 iPSC 製品プラットフォームおよび市販の製品候補の開発を支援するため、学術機関と研究協力およびライセンス契約を締結しています。

また、製薬会社とのコラボレーションにより、がん治療のための既製の多重化工学的 iPSC 由来の Nk および T 細胞製品候補の研究、開発、商業化を行ってきました。2018 年 9 月、小野製薬株式会社とコラボレーション · オプション契約 （ 小野契約 ） を締結しました。現在、 iPSC 由来の CAR Nk および CAR t 細胞製品候補を、固形腫瘍治療のための研究 · 開発を行っています。2020 年 4 月、ヤンセンバイオテック株式会社とコラボレーション · オプション契約 （ ヤンセン契約 ） を締結しました。ジョンソン · アンド · ジョンソンのヤンセン製薬会社の一部であるヤンセン （ ヤンセン ） は、がん治療のための iPSC 由来の CAR Nk および CAR t 細胞製品候補の研究、開発、商業化を行っています。当社は、 2023 年 1 月 3 日、ヤンセンからヤンセン協定の終了通知を受け取り、 2023 年 4 月 3 日付で発効しました。

当社は 2007 年にデラウェア州で設立され、カリフォルニア州サンディエゴに本社を置いています。2007 年の創業以来、私たちは、セルプログラミングアプローチと製品候補の研究開発、関連する知的財産の作成、ライセンス、保護、およびこれらの活動の一般的および管理的サポートの提供に実質的にすべてのリソースを費やしてきました。これまでの運営資金は、普通株式の公的 · 非公的売却、優先株式 · 可換証券の非公開発行、商業銀行の負債、協力活動 · 助成金による収益を主として行ってきました。

創業以来、毎年純損失を計上しており、収益を計上したことがない。当社の純損失の実質的なすべては、研究開発プログラムに関連して発生した費用および事業に関連する一般および管理費用によるものです。少なくとも当面は営業損失を計上し続けると予想しています。当社の純損失は、四半期ごとに、前年ごとに大きく変動する可能性があります。現在および計画されている活動に関連して、以下のような費用は引き続き多額のものと予想します。

23

 

•
米国外の試験を含む特定の臨床試験の実施および管理のために臨床研究機関と締結する取決めに関連するより高い臨床試験費用を含む可能性のある、当社の製品候補の進行中および計画されている前臨床試験および臨床試験を実施すること。
•
iPSC 由来の細胞製品候補の製造に必要な活動の一部または全部、製品候補の製造のためのプロセスおよびスケールアップ開発および技術移転活動の実施について、契約製造組織 （ CMO ） を利用することを含め、グッドマニュファクチャリングプラクティス （ GMP ） 生産を実施する。臨床試験中および IND （ 治験新薬出願 ） を可能にする前臨床開発を含む。
•
procure laboratory equipment, materials and supplies for the manufacture of our product candidates and the conduct of our research activities;
•
conduct preclinical and clinical research to investigate the therapeutic activity of our product candidates;
•
continue our research, development and manufacturing activities, including under our sponsored research and collaboration agreement with Ono;
•
maintain, prosecute, protect, expand and enforce our intellectual property portfolio;
•
engage with regulatory authorities for the development of, and seek regulatory approvals for, our product candidates;
•
continue our business operations at our corporate headquarters, including maintaining internal GMP production capabilities; and
•
continue operating as a public company and support our operations.

We do not expect to generate any meaningful revenues from product sales, royalties, or sales milestones unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which we expect will take a number of years. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we will seek to fund our operations through public or private equity or debt financings, collaboration arrangements, or other sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative effect on our financial condition and ability to develop our product candidates.

Financial Operations Overview

We conduct substantially all of our activities through Fate Therapeutics, Inc., a Delaware corporation, at our facilities headquartered in San Diego, California. Our results of operations include the operations of the Company and its subsidiaries. To date, the aggregate operations of our subsidiaries have not been significant, and all intercompany transactions and balances have been eliminated in consolidation.

Collaboration Revenue

To date, we have not generated any revenues from therapeutic product sales or royalties. Our revenues have been derived from collaboration agreements and government grants.

Agreement with Ono Pharmaceutical Co., Ltd.

On September 14, 2018, we entered into the Ono Agreement for the joint development and commercialization of two iPSC-derived CAR T-cell product candidates (Candidate 1 and Candidate 2). Pursuant to the terms of the Ono Agreement, we received an upfront, non-refundable and non-creditable payment of $10.0 million. Additionally, we are entitled to receive funding for the conduct of research and preclinical development under a joint research plan, which fees were estimated to be $20.0 million in aggregate.

In December 2020, we entered into a letter agreement with Ono (the Ono Letter Agreement) pursuant to which Ono delivered proprietary antigen binding domains targeting an antigen expressed on certain solid tumors for incorporation into Candidate 2 and paid the Company a milestone fee of $10.0 million for further research and preclinical development of Candidate 2. In addition, Ono terminated all further research and preclinical development with respect to Candidate 1, and we retained all rights to research, develop and commercialize Candidate 1 throughout the world without any obligation to Ono.

In June 2022, we entered into an amendment with Ono to the Ono Agreement (the 2022 Ono Amendment). Pursuant to the 2022 Ono Amendment, the companies agreed to designate an additional antigen expressed on certain solid tumors for research and preclinical development, and Ono agreed to contribute proprietary antigen binding domains targeting such additional solid tumor antigen (Candidate 3). In addition, for both Candidate 2 and Candidate 3, the companies expanded the scope of the collaboration to

24

 

include the research and preclinical development of iPSC-derived CAR NK cell product candidates (in addition to iPSC-derived CAR T-cell product candidates) targeting the designated solid tumor antigens. Similar to Candidate 2, we granted to Ono, during a specified period of time, a preclinical option (Candidate 3 Development Option) to obtain an exclusive license under certain intellectual property rights, subject to payment of an option exercise fee to us by Ono, to further develop and commercialize Candidate 3 in all territories of the world, where we retain rights to co-develop and co-commercialize Candidate 3 in the United States and Europe under a joint arrangement with Ono pursuant to which we are eligible to share at least 50% of the profits and losses. The Candidate 3 Development Option represents an option with no material right. Under the 2022 Ono Amendment, aggregate estimated research and preclinical development fees have been increased by approximately $9.3 million, for a total estimated $29.3 million in aggregate research and preclinical development fees over the course of the joint research plan.

In November 2022, Ono exercised its option to obtain a license to develop and commercialize Candidate 2 (the Candidate 2 Development Option), and we exercised our option to co-develop and co-commercialize Candidate 2 in the United States and Europe. As a result, we received and recognized an option exercise fee of $12.5 million from Ono during the year ended December 31, 2022. We and Ono are proceeding under a joint development plan for the ongoing development of Candidate 2, and, as such, we have initiated clinical studies for Candidate 2. The costs of this joint development plan are accounted for in accordance with ASC 808, and cost sharing payments to us from Ono are recorded as contra-research and development expenses.

In November 2023, we entered into an amendment with Ono to the Ono Agreement (the 2023 Ono Amendment). Under the 2023 Ono Amendment, aggregate estimated research and preclinical development fees payable to us by Ono for Candidate 3 have been increased by approximately $1.4 million, for a total estimated $30.7 million in aggregate research and preclinical development fees over the course of the joint research plan.

In May 2024, following Ono’s exercise of the Candidate 2 Development Option and grant of the development and commercialization license, we achieved a $5.0 million clinical development milestone for Candidate 2. We determined that we had completed our performance obligation with respect to such milestone in the nine months ended September 30, 2024, and accordingly, recognized such amount as revenue during the period.

In August 2024, we entered into an amendment with Ono to the Ono Agreement (the 2024 Ono Amendment and collectively with the 2023 Ono Amendment and 2022 Ono Amendment, the Ono Amendments). Under the 2024 Ono Amendment, aggregate estimated research and preclinical development fees payable to us by Ono for Candidate 3 have been increased by approximately $7.3 million, for a total estimated $38.0 million in aggregate research and preclinical development fees over the course of the joint research plan. We will continue to receive committed funding from Ono through June 2025. The Candidate 3 Development Option expires upon the earlier of: (a) June 30, 2025 or (b) the achievement of the pre-defined preclinical milestone under the joint research plan for Candidate 3. Subject to payment of an extension fee by Ono, Ono may choose to defer its decision to exercise the Candidate 3 Development Option until no later than June 2026.

We account for the Ono Agreement, Ono Letter Agreement, and Ono Amendments (collectively, the Ono Arrangement) as a revenue contract under ASC 606. The initial transaction price under the Ono Arrangement was determined to be $48.0 million, consisting of the upfront, non-refundable and non-creditable payment of $10.0 million, the aggregate estimated research and preclinical development fees of $38.0 million. We also concluded that the Candidate 2 milestone fee of $10.0 million for further research and preclinical development of Candidate 2 represented a variable consideration that was previously constrained. We identified our promised goods and services under the Ono Arrangement to include our grant to Ono of a research license to certain of our intellectual property subject to certain conditions, our conduct of research and preclinical development services, and our participation in a joint steering committee. We determined that the promised goods and services should be accounted for as one combined performance obligation. We recognize revenue for the combined performance obligation over time as the research and preclinical development services are performed.

During the three and nine months ended September 30, 2024, we recognized $3.1 million, which includes $1.4 million associated with the 2024 Ono Amendment, and $11.8 million of collaboration revenue, respectively, and $1.7 million and $3.6 million of contra-research and development expense, respectively, under the Ono Arrangement. During the nine months ended September 30, 2024, we achieved a clinical development milestone under the Ono Arrangement and received a cash payment of $5.0 million. The milestone payment is included as revenue during the nine months ended September 30, 2024. During the three and nine months ended September 30, 2023, we recognized $1.9 million and $9.5 million of collaboration revenue, respectively, and $2.1 million and $5.9 million of contra-research and development expense, respectively, under the Ono Arrangement.

Agreement with Janssen Biotech, Inc.

On April 2, 2020 (the Janssen Agreement Effective Date), we entered into the Janssen Agreement. Additionally, on the Janssen Agreement Effective Date, we entered into a Stock Purchase Agreement (the Stock Purchase Agreement) with Johnson & Johnson Innovation - JJDC, Inc. (JJDC). Under the terms of the Janssen Agreement and the Stock Purchase Agreement taken together, we received $100.0 million, of which $50.0 million was an upfront cash payment and $50.0 million was in the form of an equity

25

 

investment by JJDC. Additionally, we are entitled to receive fees for the conduct of all research, preclinical development and IND-enabling activities performed by us under the Janssen Agreement.

We determined the common stock purchase by JJDC represented a premium of $9.93 per share, or $16.0 million in aggregate (the Equity Premium), and the remaining $34.0 million was recorded as issuance of common stock in shareholders’ equity.

On January 3, 2023, we received notice of termination from Janssen of the Janssen Agreement. The termination took effect on April 3, 2023, and during the three months ending March 31, 2023, we performed wind-down activities, including discontinuing development of all collaboration product candidates under the Janssen Agreement. We were reimbursed for all wind-down activities associated with the termination of the Janssen Agreement during the second quarter of 2023.

During the nine months ended September 30, 2023, we recognized $52.3 million of collaboration revenue under the Janssen Agreement, of which $41.2 million was deferred as of December 31, 2022. No revenue was recognized during the three months ended September 30, 2023 under the Janssen Agreement.

Research and Development Expenses

Research and development expenses consist of costs associated with the research, preclinical development, process and scale-up development, manufacture and clinical development of our product candidates, the research and development of our cell programming technology including our iPSC product platform, and the performance of research and development activities under our collaboration agreements. These costs are expensed as incurred and include:

•
salaries and employee-related costs, including stock-based compensation;
•
costs incurred under clinical trial agreements with investigative sites;
•
costs to acquire, develop and manufacture preclinical study and clinical trial materials, including our product candidates;
•
costs associated with conducting our preclinical, process and scale-up development, manufacturing, clinical and regulatory activities, including fees paid to third-party professional consultants, service providers and suppliers;
•
costs incurred for our research, development and manufacturing activities, including under our collaboration agreements;
•
costs for laboratory equipment, materials and supplies for the manufacture of our product candidates and the conduct of our research activities;
•
costs incurred to license and maintain intellectual property; and
•
facilities, depreciation and other expenses including allocated expenses for rent and maintenance of facilities.

We plan to continue to significantly invest in our current level of research and development activities for the foreseeable future as we continue the clinical and preclinical development and manufacture of our product candidates, research and develop our iPSC product platform, and perform our obligations under collaboration agreements including under our agreements with Ono, University of Minnesota and MSKCC. Our current planned research and development activities over the next twelve months consist primarily of the following:

•
conducting clinical trials of our product candidates, including through the engagement of CROs to manage various aspects of our clinical trials;
•
conducting GMP production, including through the use of CMOs for the conduct of some or all of the activities required for manufacturing our iPSC-derived cell product candidates, process and scale-up development and technology transfer activities for the manufacture of our product candidates, including those undergoing clinical investigation and IND-enabling preclinical development;
•
procuring laboratory equipment, materials and supplies for the manufacture of our product candidates and the conduct of our research activities;
•
conducting preclinical and clinical research to investigate the therapeutic activity of our product candidates; and
•
conducting research, development and manufacturing activities, including under our sponsored research and collaboration agreement with Ono.

26

 

Due to the inherently unpredictable nature of preclinical and clinical development and manufacture, and given our novel therapeutic approach and the current stage of development of our product candidates, we cannot determine and are unable to estimate with certainty the timelines we will require and the costs we will incur for the development and manufacture of our product candidates. Clinical and preclinical development and manufacturing timelines and costs, and the potential of development and manufacturing success, can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development and manufacturing plans and capital requirements. We cannot predict the effects of the impact of global economic and market conditions, a continued and prolonged public health emergency such as the COVID-19 pandemic, and global geopolitical tensions, including wars and other armed conflicts, on our business and operations, and our expenditures may be increased by delays or disruptions due to these or other factors, including as a result of actions we take in the near term to ensure business continuity and protect against possible supply chain shortages.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for our employees in executive, operational, finance and human resource functions; professional fees for accounting, legal and tax services; costs for obtaining, prosecuting, maintaining, and enforcing our intellectual property; and other costs and fees, including director and officer insurance premiums, to support our operations as a public company. We anticipate that our general and administrative expenses will remain significant in the future as we maintain our focus on innovation, and research and development activities, maintain compliance with exchange listing and SEC requirements, protect and enforce our intellectual property, and continue to operate as a public company.

Other Income

Other income consists of changes in the fair value of stock price appreciation milestones associated with the Amended MSKCC License with MSKCC, interest income earned on cash, cash equivalents and investments (including the amortization of discounts and premiums).

California Institute for Regenerative Medicine Awards

FT819 CIRM Award

In February 2024, we were awarded $7.9 million from the California Institute for Regenerative Medicine (CIRM) to support the conduct of the Company’s Phase 1 study of FT819 in patients with systemic lupus erythematosus and, in April 2024, we executed an award agreement with CIRM (the FT819 CIRM Award). Pursuant to the terms of the FT819 CIRM Award, we are eligible to receive five disbursements in varying amounts from CIRM, with one disbursement receivable upon the execution of the award and four disbursements receivable based upon the completion of certain development milestones throughout the period of the award, which is estimated to be from April 1, 2024 to March 31, 2028 (the Award Period). Under the FT819 CIRM Award, we have certain obligations of co-funding and are required to provide CIRM progress and financial update reports throughout the Award Period.

Following the conclusion of the Award Period, we, in our sole discretion, have the option to treat the FT819 CIRM Award either as a loan or as a grant. If we do not elect to treat the FT819 CIRM Award as a loan within 10 years of the award date, the award will be considered a grant and we will be obligated to pay CIRM, on a quarterly basis, a low single-digit royalty on commercial sales of FT819 until such aggregate royalty payments equal nine times the total amount awarded to us under the FT819 CIRM Award.

Since we may, at our election, repay some or all of the FT819 CIRM Award, we account for the award as a liability until the time of election. In May 2024, we received the first disbursement under the award in the amount of $1.9 million, which amount is recorded as a liability on the accompanying consolidated balance sheets and classified as current or non-current based on the potential amount payable within 12 months of the current balance sheet. As of September 30, 2024, the entire balance is classified as non-current as we do not expect any amount to be payable within the next 12 months.

FT516 CIRM Award

In April 2018, we executed an award agreement with CIRM pursuant to which CIRM awarded us $4.0 million to advance our FT516 product candidate into a first-in-human clinical trial for the treatment of subjects with advanced solid tumors (the FT516 CIRM Award). Under the FT516 CIRM Award, we have certain obligations of co-funding and are required to provide CIRM with progress and financial update reports.

Pursuant to the terms of the FT516 CIRM Award, we, in our sole discretion, have the option to treat the FT516 CIRM Award either as a loan or as a grant. During the first quarter of 2023, we elected to treat the FT516 CIRM Award as a grant. As such, the liability associated with the FT516 CIRM Award was reversed and such amount was recorded as other income during the first quarter of 2023.

27

 

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations are based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to the fair value of the stock price appreciation milestones for the Amended MSKCC License, contracts containing leases, accrued expenses, stock-based compensation, and the estimated total costs expected to be incurred under our collaboration agreements. We base our estimates on historical experience, known trends and events, financial models, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

The estimates and judgments involved in our accounting policies, as described in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023, continue to be our critical accounting policies and there have been no other material changes to our critical accounting policies during the nine months ended September 30, 2024.

See Note 1 to the unaudited condensed consolidated financial statements for a summary of critical accounting policies and information related to recent accounting pronouncements.

Results of Operations

Comparison of the Three Months Ended September 30, 2024 and 2023

The following table summarizes the results of our operations for the three months ended September 30, 2024 and 2023 (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Increase/

 

 

 

2024

 

 

2023

 

 

(Decrease)

 

Collaboration revenue

 

$

3,074

 

 

$

1,944

 

 

$

1,130

 

Research and development expense

 

 

34,650

 

 

 

34,275

 

 

 

375

 

General and administrative expense

 

 

20,801

 

 

 

18,948

 

 

 

1,853

 

Total other income

 

 

4,699

 

 

 

6,109

 

 

 

(1,410

)

 

Collaboration Revenue. During the three months ended September 30, 2024 and 2023, we recognized revenue of $3.1 million and $1.9 million, respectively, under our collaboration agreement with Ono. The increase was primarily driven by an increase in research and preclinical development fees payable by Ono under the 2024 Ono Amendment.

Research and development expenses. Research and development expenses were $34.7 million for the three months ended September 30, 2024, compared to $34.3 million for the three months ended September 30, 2023. The increase in research and development expenses was attributable primarily to the following:

•
$1.0 million increase in laboratory materials and supplies relating to the manufacture of our product candidates; and
•
$0.5 million increase in employee stock-based compensation expense; offset by a $1.0 million decrease in employee compensation and benefits expense.

General and administrative expenses. General and administrative expenses were $20.8 million for the three months ended September 30, 2024, compared to $18.9 million for the three months ended September 30, 2023. The increase in general and administrative expenses was attributable primarily to a $1.5 million increase in legal expense and a $1.1 million increase in employee stock-based compensation expense, partially offset by a $0.8 million decrease in employee compensation and benefits expense.

Other income. Other income was $4.7 million and $6.1 million for the three months ended September 30, 2024 and 2023, respectively. Other income for the three months ended September 30, 2024 primarily consisted of interest income earned on cash, cash equivalents and investments (including the amortization of discounts and premiums).

During the three months ended September 30, 2023, we recorded other income of $1.0 million attributable to the change in fair value of the stock price appreciation milestones under the Amended MSKCC License. Other income for the three months ended September 30, 2023 also consisted of interest income earned on cash, cash equivalents and investments (including the amortization of discounts and premiums).

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Comparison of the Nine Months Ended September 30, 2024 and 2023

The following table summarizes the results of our operations for the nine months ended September 30, 2024 and 2023 (in thousands):

 

 

Nine Months Ended September 30,

 

 

Increase/

 

 

 

2024

 

 

2023

 

 

(Decrease)

 

Collaboration revenue

 

$

11,771

 

 

$

61,857

 

 

$

(50,086

)

Research and development expense

 

 

101,392

 

 

 

140,780

 

 

 

(39,388

)

General and administrative expense

 

 

58,907

 

 

 

63,513

 

 

 

(4,606

)

Total other income

 

 

14,419

 

 

 

25,630

 

 

 

(11,211

)

 

Collaboration Revenue. During the nine months ended September 30, 2024 and 2023, we recognized revenue of $11.8 million and $61.9 million, respectively, under our collaboration agreements with Janssen and Ono. The decrease in collaboration revenue was primarily attributable to the termination of the Janssen collaboration in 2023. The following table summarizes the revenue recognized with respect to each collaboration partner for the nine months ended September 30, 2024 and 2023:

 

 

 

Nine Months Ended
September 30,

 

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Janssen Biotech, Inc.

 

$

—

 

 

$

52,312

 

Ono Pharmaceutical Co., Ltd.

 

 

11,771

 

 

 

9,545

 

Total collaboration revenue

 

$

11,771

 

 

$

61,857

 

Research and development expenses. Research and development expenses were $101.4 million for the nine months ended September 30, 2024, compared to $140.8 million for the nine months ended September 30, 2023. The decrease in research and development expenses was attributable primarily to the following:

•
$17.7 million decrease in third-party professional consultant and clinical trial related expense;
•
$16.4 million decrease in employee compensation and benefits expense; and
•
$5.9 million decrease in sublicense consideration owed to existing licensors.

General and administrative expenses. General and administrative expenses were $58.9 million for the nine months ended September 30, 2024, compared to $63.5 million for the nine months ended September 30, 2023. The decrease in general and administrative expenses was attributable primarily to a $4.7 million decrease in employee compensation and benefits expense, including a $1.2 million decrease in employee stock-based compensation expense and a $1.6 million decrease in third-party professional consultant expense.

Other income. Other income was $14.4 million and $25.6 million for the nine months ended September 30, 2024 and 2023, respectively. Other income for the nine months ended September 30, 2024 primarily consisted of interest income earned on cash, cash equivalents and investments (including the amortization of discounts and premiums).

During the nine months ended September 30, 2023, we recorded other income of $4.0 million attributable to the FT516 CIRM Award, $5.1 million attributable to the ERC, and $3.2 million attributable to the change in fair value of the stock price appreciation milestones under the Amended MSKCC License. Other income for the nine months ended September 30, 2023 also consisted of interest income earned on cash, cash equivalents and investments (including the amortization of discounts and premiums).

Liquidity and Capital Resources

We have incurred losses and negative cash flows from operations since inception. As of September 30, 2024, we had an accumulated deficit of $1.3 billion and we anticipate that we will continue to incur net losses for the foreseeable future.

Operating Activities

During the nine months ended September 30, 2024, cash used in operating activities was $95.1 million compared to cash used in operating activities of $95.6 million during the nine months ended September 30, 2023. The primary drivers of this change in cash used in operating activities was our increase of $17.3 million in net loss primarily due to the termination of the Janssen agreement.

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Investing Activities

During the nine months ended September 30, 2024, investing activities used cash of $10.6 million compared to cash provided by investing activities of $67.3 million during the nine months ended September 30, 2023. The change was primarily attributable to a decrease in the maturities of investments of $269.8 million during the nine months ended September 30, 2024 compared to the maturities of investments of $382.1 million during the nine months ended September 30, 2023. All other investing activities for the periods presented were attributable to the purchases of investments and purchases of property and equipment.

Financing Activities

For the nine months ended September 30, 2024, financing activities provided cash of $96.8 million, which primarily consisted of (i) the issuance of 14,545,454 shares of common stock at a purchase price of $5.50 per share in an underwritten offering of common stock in March 2024, (ii) the issuance of pre-funded warrants to purchase an aggregate of 3,636,364 shares of common stock at a purchase price of $5.499 per pre-funded warrant, which represents the offering price per share of common stock in the underwritten offering less the $0.001 exercise price per share of each pre-funded warrant, in a private placement concurrent with the underwritten offering, and (iii) the issuance of common stock from equity incentive plans pursuant to the exercise of employee stock options.

For the nine months ended September 30, 2023, financing activities provided cash of $0.3 million, which consisted of the issuance of common stock from equity incentive plans pursuant to the exercise of employee stock options.

From our inception through September 30, 2024, we have funded our consolidated operations primarily through the public and private sale of common stock, the issuance of warrants, the private placement of preferred stock and convertible notes, commercial bank debt and revenues from collaboration activities and grants. As of September 30, 2024, we had aggregate cash and cash equivalents and investments of $330.5 million.

Offerings Pursuant to Registration Statement on Form S-3 and Private Placement of Pre-Funded Warrants

In November 2023, the SEC declared effective a shelf registration statement on Form S-3 filed by us in November 2023 (File No. 333-275402). The shelf registration statement allows us to issue certain securities, including shares of our common stock, from time to time. The specific terms of any offering under the shelf registration statement are established at the time of such offering. We were initially eligible to issue an aggregate of $300.0 million in securities under the shelf registration statement. Additionally, we entered into a sales agreement with Jefferies LLC (Jefferies) with respect to an at-the-market offering program, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (which is included in the $300.0 million registered under the shelf registration statement) through Jefferies as the sales agent.

In March 2024, we entered into an underwriting agreement with BofA Securities, Inc., Jefferies, and Leerink Partners LLC with respect to an underwritten offering, under which we sold 14,545,454 shares of our common stock at a purchase price of $5.50 per share pursuant to the shelf registration statement. To date, we have not sold any securities pursuant to the sales agreement with Jefferies and are eligible to issue an aggregate of approximately $220.0 million under the shelf registration statement (including the $100.0 million issuable pursuant to the sales agreement with Jefferies).

In March 2024, concurrent with the underwritten offering, we entered into a securities purchase agreement with a fund affiliated with Redmile Group, LLC under which we sold pre-funded warrants to purchase up to 3,636,364 shares of our common stock, at a purchase price of $5.499 per pre-funded warrant, in a private placement exempt from the registration requirements pursuant to Section 4(a)(2) of the Securities Act of 1933 (the Securities Act), as amended. Pursuant to the terms of the purchase agreement, we agreed to register for resale the shares of common stock issuable upon the exercise of the pre-funded warrants (Warrant Shares). On April 18, 2024, we filed a resale registration statement on Form S-3 (File No. 333-278792), registering the Warrant Shares. The resale registration statement on Form S-3 was declared effective on April 29, 2024.

Operating Capital Requirements

We anticipate that we will continue to incur losses for the foreseeable future, and we expect the losses to remain significant as we continue the research, manufacture and development of, and seek regulatory approvals for, our product candidates and conduct additional research, manufacturing and development activities pursuant to our collaboration agreement with Ono. Our product candidates have not yet achieved regulatory approval and we may not be successful in achieving commercialization of our product candidates.

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We believe our existing cash and cash equivalents and investments as of September 30, 2024 and as of the date of filing of this Quarterly Report on Form 10-Q will be sufficient to fund our projected operating requirements for at least the next twelve months. However, we are subject to all the risks and uncertainties incident in the research, manufacture and development of therapeutic products, and cell therapy product candidates in particular. For example, the FDA or other regulatory authorities may require us to generate additional data or conduct additional preclinical studies, manufacturing activities, or clinical trials, or may impose other requirements beyond those that we currently anticipate. Additionally, it is possible for a product candidate to show promising results in preclinical studies or in clinical trials, but fail to establish sufficient safety and efficacy data necessary to obtain regulatory approvals. As a result of these and other risks and uncertainties and the probability of success, the duration and the cost of our research, manufacturing and development activities required to advance a product candidate cannot be accurately estimated and are subject to considerable variation. We may encounter difficulties, complications, delays and other unknown factors and unforeseen expenses in the course of our research, manufacturing and development activities, any of which may significantly increase our capital requirements and could adversely affect our liquidity.

We will require additional capital for the research, manufacture and development of our product candidates and to perform our obligations under our collaboration agreements, and we may need to seek additional funds sooner than expected due to any changes in our business, operations, financial condition or prospects, including any impacts of inflation rates and global economic conditions, and wars and other armed conflicts. We expect to finance our capital requirements in the foreseeable future through the sale of public or private equity, debt securities, or through existing or future potential collaborations. However, additional capital may not be available to us on reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the research, manufacture or development of one or more of our product candidates. If we do raise additional funds through the issuance of additional equity or debt securities, it could result in dilution to our existing stockholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our common stock. Additionally, if we incur indebtedness, we may become subject to financial or other covenants that could adversely restrict, impair or affect our ability to conduct our business, such as requiring us to relinquish rights to certain of our product candidates or technologies or limiting our ability to acquire, sell or license intellectual property rights or incur additional debt. Any of these events could significantly harm our business, operations, financial condition and prospects. In addition, the full impact of rising inflation rates, global political and economic instability, a continued and prolonged public health emergency such as the COVID-19 pandemic, and wars and other armed conflicts on our business, operations, financial condition and prospects, and on the global economy, are currently unknown and difficult to predict, and these events could materially and adversely affect our ability to raise capital through equity or debt financings in the future.

Our forecast of the period of time through which our existing cash and cash equivalents and investments will be adequate to support our operations is a forward-looking statement and involves significant risks and uncertainties. We have based this forecast on assumptions that may prove to be wrong, and actual results could vary materially from our expectations, which may adversely affect our capital resources and liquidity. We could utilize our available capital resources sooner than we currently expect. The amount and timing of future funding requirements, both near- and long-term, will depend on many factors, including, but not limited to:

•
the initiation, timing, progress, size, duration, costs and results of our clinical trials and preclinical studies for our product candidates, including the timing and costs of manufacturing activities to support such clinical trials and preclinical studies;
•
the number and the nature of product candidates that we pursue;
•
the time to and cost of establishing and maintaining internal GMP production capabilities to support the clinical and potential commercial manufacture of our product candidates at our corporate headquarters;
•
the cost of GMP production, process and scale-up development and technology transfer activities for the manufacture of our product candidates, including the cost of laboratory equipment, materials and supplies to support these activities;
•
the time, cost and outcome of seeking and obtaining regulatory approvals;
•
the extent to which we are required to pay milestone or other payments under our existing in-license agreements and any in-license agreements that we may enter into in the future, and the timing of such payments, including payments owed to MSKCC in connection with the stock price appreciation milestones;
•
the extent to which milestones are achieved under our collaboration agreement with Ono, and any other strategic partnership or collaboration agreements that we may enter into in the future, and the time to achievement of such milestones and our receipt of any associated milestone payments;
•
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights, including in our ongoing lawsuits against Shoreline Biosciences, Inc. and Dr. Dan S. Kaufman, and the cost of enforcing any of our other contractual rights;
•
the cost of our research and development activities, including our need and ability to hire additional employees and procure additional equipment, materials and supplies;

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•
the establishment and continuation of collaborations and strategic alliances;
•
the timing and terms of future in-licensing and out-licensing transactions; and
•
the cost of establishing sales, marketing, manufacturing and distribution capabilities for, and the pricing and reimbursement of, any products for which we may receive regulatory approval.

In addition, we are closely monitoring inflation rates and global political and economic conditions, including ongoing and emerging global geopolitical tensions, including wars and other armed conflicts, and evaluating adjustments to our business and operations, which may negatively impact our financial condition and prospects and our operating results. We will continue to assess our operating capital requirements and may make adjustments to our business and operations if circumstances warrant. If we cannot continue or expand our research, manufacturing and development operations, or otherwise capitalize on our business opportunities, because we lack sufficient capital, our business, operations, financial condition and prospects could be materially adversely affected.

Contractual Obligations and Commitments

We lease certain office, laboratory, and manufacturing space under non-cancelable operating leases. In addition to rent, our leases are subject to certain fixed amenities fees. These leases are also subject to additional variable charges for common area maintenance, property taxes, property insurance and other variable costs. See Note 7 to the unaudited condensed consolidated financial statements for additional detail.

We entered into a license agreement with MSKCC under which we obtained rights relating to compositions and methods covering iPSC-derived cellular immunotherapy, including T-cells and NK-cells derived from iPSCs engineered with CARs. In the event a licensed product achieves a specified clinical milestone, MSKCC is then eligible to receive certain milestone payments totaling up to $75.0 million based on the price of our common stock, where the amount of such payments owed to MSKCC are contingent upon certain increases in the price of our common stock following the date of achievement of such clinical milestone. In July 2021, we achieved the specified clinical milestone for a licensed product under the Amended MSKCC License and our ten-trading day trailing average common stock price exceeded the first, pre-specified threshold. As a result, we remitted payment to MSKCC for the first milestone payment of $20.0 million. See Note 2 to the unaudited condensed consolidated financial statements for additional detail surrounding our stock price appreciation milestone obligations.

We have no material contractual obligations not fully recorded on our unaudited condensed consolidated balance sheets or fully disclosed in the notes to the financial statements.

Inflation

We do not believe that inflation has had a material impact on our financial position or results of operations to date; however, we may experience some effect if there is an elevated rate of inflation in the near future. Inflationary factors, such as increases in the prices of material, interest rates and costs of labor, may adversely affect our operating results.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Not required for smaller reporting companies.

 

Item 4. Controls and Procedures

Disclosure Controls and Procedures

We carried out an evaluation, under the supervision and with the participation of our management, including the individual who is our chief executive officer and chief financial officer, who serves as both our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this Quarterly Report on Form 10-Q. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, the individual serving as our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2024.

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Changes in Internal Control over Financial Reporting

There were no changes in our internal controls over financial reporting that occurred during our latest fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

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PART II. OTHER INFORMATION

During the reporting period, we pursued claims in two lawsuits that we filed in 2022 against Shoreline Biosciences, Inc. (Shoreline) and certain of its founders and officers (collectively, the Shoreline litigations). The first suit, filed on May 13, 2022, was pending in San Diego Superior Court against Shoreline and four of its founders, Drs. Dan S. Kaufman (Kaufman), Kleanthis G. Xanthopoulos, and Messrs. William Sandborn and Steven Holtzman. Our claims included actions for breach of contract, breach of implied covenant of good faith and fair dealing, fraud and deceit, tortious interference, restitution and unfair competition. On August 9, 2024, the court denied the defendants’ motions for summary judgment preserving for trial all of Fate’s claims against the defendants, with the exception of defendants’ motions with respect to certain theories under Fate’s tortious interference claim (which claim by Fate was otherwise preserved for trial). On September 19, 2024, the court denied defendants’ motion for reconsideration of its summary judgment ruling. Trial began on October 21, 2024, with a jury selected on October 24, 2024. On October 28, 2024, the parties entered a settlement agreement resolving the litigation on terms agreeable to all parties, pursuant to which we filed a request for dismissal with prejudice of all claims on October 31, 2024.

In the second of the Shoreline litigations, also filed on May 13, 2022, we and Whitehead Institute for Biomedical Research (Whitehead) filed a lawsuit in the U.S. District Court for the Southern District of California against Shoreline and Kaufman seeking monetary damages for the defendants’ infringement of U.S. Patent Nos. 8,071,369, 8,932,856, 8,951,797, 8,940,536, 9,169,490, 10,457,917, and 10,017,744. On June 7, 2023, we and Whitehead filed a motion to dismiss our patent infringement claims against Kaufman in his personal capacity; that motion was granted on June 9, 2023. On August 30, 2023, the court granted Shoreline’s motion for summary judgment and denied our motion for partial summary judgment as moot. Judgment in favor of Shoreline was entered on August 31, 2023. On September 27, 2023, we and Whitehead filed a Notice of Appeal with the Court of Appeals for the Federal Circuit challenging the trial court’s claim construction and grant of summary judgment in favor of the defendants; the defendants cross-appealed challenging the district court’s earlier denial of a motion to dismiss and partial motion for summary judgment on other grounds. The Federal Circuit docketed the case on October 5, 2023, and briefing was completed on June 26, 2024. On October 28, 2024, the parties entered a settlement agreement resolving the litigation on terms agreeable to all parties, pursuant to which the parties filed a joint notice of dismissal of the appeal and cross-appeal on October 31, 2024.

On January 20, 2023, a purported stockholder of the Company filed a securities class action lawsuit against the Company and certain of its officers captioned Hadian v. Fate Therapeutics, Inc. et al. in the U.S. District Court for the Southern District of California (the Securities Action). On May 4, 2023, the court appointed a different purported stockholder of the Company to serve as lead plaintiff in the Securities Action. On July 24, 2023, the lead plaintiff filed an amended complaint. The amended complaint alleged that the Company violated the federal securities laws by making allegedly false and/or misleading statements and/or omissions in its public disclosures dating back to August 2020 relating to our collaboration agreement with Janssen Biotech, Inc. (the Janssen Agreement), potential product candidates subject to the Janssen Agreement, and the termination of the Janssen Agreement. On September 22, 2023, we filed a motion to dismiss the amended complaint. On September 19, 2024, the court granted our motion to dismiss the amended complaint, with leave for plaintiff to file a second amended complaint. On October 18, 2024, the lead plaintiff filed a second amended complaint alleging substantially similar facts and claims as in the prior amended complaint. Our motion to dismiss the second amended complaint is due on November 18, 2024, with briefing due to be completed by January 21, 2025. We intend to continue to vigorously defend against this action.

On June 2, 2023, a derivative complaint, captioned Guarino v. Wolchko, et al., was filed by a purported stockholder of the Company in the U.S. District Court for the Southern District of California (the Guarino Action). On June 12, 2024, an additional derivative complaint, captioned Horrobin v. Wolchko, et al., was filed by a purported stockholder of the Company in the same district (the Horrobin Action, and together with the Guarino Action, the Derivative Actions). The Derivative Actions both name members of our board of directors and certain officers as defendants. The Company is also named as a nominal defendant in both cases. The plaintiffs in the Derivative Actions assert derivative claims arising out of substantially the same alleged facts and circumstances as the Securities Action. The Guarino complaint asserts claims for breach of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement, waste of corporate assets, and violation of federal securities laws. The Horrobin complaint asserts substantially similar claims in addition to a claim of breach of fiduciary duty for insider trading. On August 14, 2023, the court stayed the Guarino Action pending the court’s decision on our motion to dismiss in the Securities Action. On August 7, 2024, the court stayed the Horrobin Action pending the court’s decision on our motion to dismiss in the Securities Action. The stays in the Derivative Actions automatically expired on September 19, 2024, when the decision dismissing the amended complaint in the Securities Action was issued. On November 4, 2024, the plaintiffs in the Derivative Actions filed a joint motion to consolidate the Derivative Actions, for the court to appoint counsel in the Derivative Actions as co-lead counsel, and for the court to stay the consolidated case pending the resolution of our anticipated motion to dismiss the second amended complaint in the Securities Action. The court’s ruling on the motion is pending. We intend to vigorously defend against the Derivative Actions.

From time to time, we may be subject to various other legal proceedings and claims that arise in the ordinary course of our business activities.

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Item 1A. Risk Factors

 

RISK FACTORS

You should carefully consider the following risk factors, as well as the other information in this Quarterly Report on Form 10-Q, and in our other public filings. The occurrence of any of these risks could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time. You should consider all of the risk factors described in our public filings when evaluating our business.

Risks Related to the Discovery, Development and Regulation of Our Product Candidates

If we fail to complete the preclinical or clinical development of, or to obtain regulatory approval for, our product candidates, our business would be significantly harmed.

All of our product candidates are currently in research or early clinical development. We have not completed clinical development of or obtained regulatory approval for any of our product candidates. Only a small percentage of research and development programs ultimately result in commercially successful products, and we cannot assure you that any of our product candidates will demonstrate the safety, purity and potency, or efficacy profiles necessary to support further preclinical study, clinical development or regulatory approval. In addition, we have historically focused on the development of cell therapies for cancer. We have limited prior experience in developing treatments for autoimmune diseases, and there are no cell therapies approved in the United States to treat autoimmune diseases.

We may experience delays in, or cancel our ongoing and planned clinical development activities or research and development activities for any of our product candidates for a variety of reasons, including:

•
difficulties in optimizing the right dose and dosing schedule for our product candidates, which might result in a determination that a product candidate is ineffective, causes harmful side effects, or otherwise presents unacceptable safety risks during clinical trials or has an unfavorable toxicity profile in preclinical studies or early clinical trials to support initiating or continuing clinical investigation;
•
difficulties in manufacturing or distributing a product candidate, including the inability to manufacture and distribute a product candidate in a sufficient quantity, suitable form, or in a cost-effective manner, or under protocols and processes and with materials and facilities acceptable to the U.S. Food and Drug Administration (FDA) or comparable foreign regulatory authorities for the conduct of clinical trials or for marketing approval;
•
our prioritization of certain of our product candidates for advancement or the emergence of competing product candidates developed by others, including a decision to cease research and development of any existing product candidate due to the potential obsolescence of our product candidate by a competing product or product candidate or our determination that another of our existing or future product candidates has greater potential for clinical development, regulatory approval, or commercialization, including potentially greater therapeutic benefit, a more favorable safety or efficacy profile, a more consistent or more cost effective manufacturing process, or a more favorable commercial profile, including greater market acceptance or commercial potential, or more advantageous intellectual property position;
•
challenges and delays in trial execution which may result from our testing of multiple product candidates in the same indication in different clinical trials, as well as competition from biotechnology and pharmaceutical companies, universities, and other research institutions for patients, qualified investigators and clinical trial sites;
•
the proprietary rights of third parties, which may preclude us from developing, manufacturing or commercializing a product candidate;
•
determining that a product candidate may be uneconomical to develop, manufacture, or commercialize, or may fail to achieve market acceptance or an adequate pricing and reimbursement profile;
•
our inability to secure or maintain relationships with strategic partners that may be necessary for advancement of a product candidate into or through clinical development, regulatory approval and commercialization in any particular indication(s) or geographic territory(ies); and
•
difficulty establishing predictive preclinical models for demonstration of safety and efficacy of a product candidate in one or more potential therapeutic areas for clinical development.

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For example, in January 2023, we announced the discontinuation of our FT516, FT596, FT538, and FT536 NK cell programs to focus our resources on advancing our most innovative and differentiated programs. We also announced the termination of the Collaboration and Option Agreement we entered into with Janssen Biotech, Inc. (Janssen) on April 20, 2020 (the Janssen Agreement), which termination took effect on April 3, 2023. As a result of the termination, we discontinued the development of two product candidates that had been expected to enter the clinic in 2023.

Additionally, we will only be able to obtain regulatory approval to market a product candidate if we can demonstrate, to the satisfaction of the FDA or comparable foreign regulatory authorities, in well-designed and conducted clinical trials that such product candidate is manufactured in accordance with applicable regulatory requirements, is safe, pure and potent, or effective, and otherwise meets the appropriate standards required for approval for a particular indication. Our ability to obtain regulatory approval of our product candidates depends on, among other things, completion of additional preclinical studies, process development and manufacturing activities, and clinical trials, whether our clinical trials demonstrate statistically significant efficacy with safety profiles that do not potentially outweigh the therapeutic benefit, and whether regulatory agencies agree that the data from our clinical trials and our manufacturing operations are sufficient to support approval. In addition, the approval by the FDA of new products in the same indications that we are studying may change the standard of care, and this may result in the FDA or other regulatory agencies requesting that we conduct additional studies to show that our product candidate is superior to the new standard of care. Securing regulatory approval also requires the submission of information about product manufacturing operations to, and inspection of manufacturing facilities by, the relevant regulatory authority. The results of our current and future clinical trials may not meet the FDA’s or other regulatory agencies’ requirements to approve a product candidate for marketing, and the regulatory agencies may otherwise determine that our manufacturing operations are insufficient to support approval. We may need to conduct preclinical studies and clinical trials that we currently do not anticipate, including as a result of changes in the standard of care. If we fail to complete preclinical or clinical development of, or obtain regulatory approval for, our product candidates, we will not be able to generate any revenues from product sales and our ability to receive milestone or other payments under any collaboration agreements may be impaired, which will harm our business, prospects, financial condition and results of operations.

We may face delays in initiating, conducting or completing our clinical trials, and we may not be able to initiate, conduct or complete them at all.

We are heavily dependent on our ability to complete the clinical development of, and obtain regulatory approval for, our product candidates. We have not completed the clinical trials necessary to support an application for approval to market any of our product candidates. We, or any investigators who initiate or conduct clinical trials of our product candidates, may experience delays in our current or future clinical trials, and we do not know whether we or our investigators will be able to initiate, enroll patients in, or complete, clinical trials of our product candidates on time, if at all. Current and future clinical trials of our product candidates may be delayed, unsuccessful or terminated, or not initiated at all, as a result of many factors, including factors related to:

•
difficulties in identifying eligible patients for participation in clinical trials of our product candidates;
•
difficulties enrolling a sufficient number of suitable patients to conduct clinical trials of our product candidates, including difficulties resulting from patients enrolling in studies of therapeutic product candidates sponsored by us or our competitors and difficulties resulting from patient availability as a result of any measures taken by governmental authorities, hospitals, or clinical trial sites in response to any future public health crises or other serious disasters or similar events;
•
difficulties determining suitable doses and schedules of our novel cell product candidates for evaluation in clinical trials;
•
difficulties in obtaining agreement from regulatory authorities on study endpoints and/or study duration, achieving study endpoints, the amount and sufficiency of data demonstrating efficacy and safety, and completing data analysis in clinical trials for any of our product candidates;
•
delays in filing an Investigational New Drug Application (IND) or IND amendment with the FDA to initiate or amend clinical trials of our current product candidates and any other product candidates that we may identify;
•
difficulties in obtaining agreement with regulatory authorities on the preclinical safety and efficacy data, the manufacturing requirements, and the clinical trial design and parameters necessary for an IND application to go into effect to initiate and conduct clinical trials for any of our current product candidates and any other product candidates that we may develop;
•
the occurrence of unexpected safety issues or adverse events in any ongoing or future clinical trials of our product candidates, including in trials of our product candidates conducted by investigator-sponsors;
•
securing and maintaining the support of clinical investigators and investigational sites, including investigators and sites who may conduct clinical trials under an investigator-sponsored IND with our financial support, and obtaining institutional review board (IRB) approval at each site for the conduct of our clinical trials;

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•
reaching agreement on acceptable terms with third-party service providers and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different service providers and clinical trial sites;
•
failure to manufacture certain of our product candidates consistently, and at acceptable quality levels and costs, in accordance with our protocol-specified manufacturing requirements and applicable regulatory requirements;
•
failure or delays in obtaining sufficient quantities of suitable raw materials, components, and equipment necessary for the conduct of our clinical trials or the manufacture of any product candidate, including any inability to obtain materials as a result of supply chain issues related to any future public health crises or other serious disasters or ongoing or emerging global geopolitical tensions, including wars and other armed conflicts, or other factors;
•
failure or delays by us or by our clinical sites to obtain sufficient quantities of components and supplies necessary for the conduct of our clinical trials, including any inability to obtain agents such as cyclophosphamide or fludarabine which may be required to condition patients for treatment with our product candidates, or certain monoclonal antibodies which are intended for administration to patients in combination with many of our product candidates in certain of our clinical trials;
•
challenges in distributing our product candidates to clinical trial sites, or failure to establish effective protocols for the supply and transport of our product candidates;
•
the costs of conducting clinical trials or manufacturing of our product candidates being greater than we anticipate, including due to rising inflation rates, or the timelines for these activities being longer than we anticipate;
•
our failure, or the failure of investigators, third-party service providers, or clinical trial sites, to ensure the proper and timely conduct of and analysis of data from clinical trials of our product candidates;
•
inability to reach agreement on clinical trial design and parameters with regulatory authorities, investigators, and IRBs;
•
imposition of a temporary or permanent clinical hold by data monitoring committees or regulatory agencies for a number of reasons, including after review of an IND submission or amendment, a new safety finding that presents unreasonable risk to clinical trial participants, a negative finding from an inspection of our clinical trial operations or trial sites, developments in trials conducted by us or our competitors that raise concerns about the safety risk to patients of novel therapeutics derived from pluripotent or genome edited therapies and/or negative public perception of the same, or if the FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;
•
the serious, life-threatening diseases of the patients in our oncology clinical trials, who may die or suffer adverse medical events during the course of the trials for reasons that may not be related to our product candidates;
•
failure of patients to complete clinical trials or adhere to study protocols due to safety issues, side effects, disruptions in study conduct, or other reasons;
•
approval of competitive agents or changes in the standard of care or treatment landscape on which a clinical development plan was based, which may require new or additional trials, or render our product candidates or clinical trial designs obsolete;
•
clinical trials of our product candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials or abandon product development programs;
•
governmental or regulatory delays, including any delays due to limitations on the availability of governmental and regulatory agency personnel to review regulatory filings, conduct site inspections or engage in discussions with us as a result of the change in administration following the 2024 U.S. presidential election, any future public health crisis or other serious disaster or similar events, failure to obtain regulatory approval, or uncertainty or changes in U.S. or foreign regulatory requirements, policy or guidelines; and
•
limitations on clinical trial conduct at our clinical trial sites resulting from prioritization of hospital and other medical resources toward other efforts, such as any future public health crisis or other serious disaster or similar events, policies and procedures implemented at clinical sites with respect to the conduct of clinical trials including those relating to site initiation, study monitoring, and data collection and analysis, and other precautionary measures taken in treating patients or in practicing medicine in response to various public health concerns.

If there are delays in initiating or conducting any clinical trials of our product candidates or any of these clinical trials are terminated before completion, the commercial prospects of our product candidates will be harmed. In addition, any delays in initiating, conducting or completing our clinical trials or adjustments to certain of our study protocols and procedures, including as a result of any shortage of materials or agents necessary to conduct our studies or as a result of any future public health crisis or other public health concerns or other factors, will increase our costs, slow down our product candidate development and regulatory approval process, and jeopardize our ability to gain regulatory approval, commence product sales and generate revenues. Furthermore, many of

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the factors that cause, or lead to, a delay in the initiation, conduct or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. Any of these occurrences would significantly harm our business, prospects, financial condition, results of operations, and market price of shares of our common stock.

The manufacture and distribution of our cell product candidates, particularly our induced pluripotent stem cell (iPSC)-derived cell product candidates, is complex and subject to a multitude of risks. These risks could substantially increase our costs and limit the clinical and commercial supply of our product candidates, and the development and commercialization of our product candidates could be substantially delayed or restricted if the FDA or other regulatory authorities impose additional requirements on our manufacturing operations or if we are required to change our manufacturing operations to comply with regulatory requirements.

The manufacture and supply of our cell product candidates involves novel processes that are more complex than those required for most small molecule drugs and other cellular immunotherapies, and accordingly present significant challenges and are subject to multiple risks. For our iPSC-derived product candidates, these complex processes include reprogramming human fibroblasts to obtain iPSCs, in some cases genetically engineering these iPSCs, and differentiating the iPSCs to obtain the desired cell product candidate. As a result of the complexities in manufacturing biologics and distributing cell therapies, the cost to manufacture and distribute biologics and cell therapies in general, and our cell product candidates in particular, is generally higher than for traditional small molecule chemical compounds. In addition, our cost of goods development is at an early stage. The actual cost to manufacture and process our product candidates could be greater than we expect and could materially and adversely affect the commercial viability of our product candidates.

We have limited experience in the manufacture of cell-based therapies. We are still developing optimized and reproducible manufacturing processes for clinical and commercial-scale manufacturing of our product candidates, and none of our manufacturing processes have been validated for commercial production of our product candidates. We may face multiple challenges as we scale our manufacturing for large-scale clinical trials or commercial-scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with good manufacturing practices, lot consistency and timely availability of raw materials. In addition, we are continuing to optimize our protocols for the supply and transport of our product candidates for distribution to clinical trial sites. Although we are working to develop reproducible and commercially viable manufacturing processes for our product candidates, and effective protocols for the supply and transport of our product candidates, doing so is a difficult and uncertain task.

We may make changes or be required by the FDA or other regulatory authorities to make changes to our manufacturing processes, including materials and equipment used in manufacturing our product candidates, as we continue to develop and refine the manufacturing and distribution processes for our product candidates for advanced clinical trials and commercialization, and we cannot be sure that even minor changes in these processes, materials, and equipment will not cause our product candidates to perform differently and affect the results of our ongoing and planned clinical trials or the performance of the product once commercialized. In some circumstances, changes in our manufacturing operations, including to our protocols, processes, materials or facilities used, may require us to perform additional preclinical or comparability studies, or to collect additional clinical data from patients prior to undertaking additional clinical studies or filing for regulatory approval for a product candidate. These requirements may lead to delays in our clinical development and commercialization plans for our product candidates, and may increase our development costs substantially.

The manufacturing processes for any products that we may develop are subject to FDA and foreign regulatory authority approval requirements, and we and any contract manufacturing organizations (CMOs) or other third-party manufacturers that we may engage for manufacturing our product candidates will need to meet all applicable FDA and foreign regulatory authority requirements on an ongoing basis. Our existing product candidates are currently manufactured by us and our current manufacturing operations, including protocols, processes, materials, and facilities, may not support regulatory approval of our existing product candidates. We may be required to identify alternative protocols, processes, materials or facilities for the manufacture of any of these product candidates in compliance with applicable regulatory requirements. In addition, we may be required to make changes to our protocols for the supply and transport of our product candidates to enable effective distribution of our product candidates. Any modifications to our manufacturing and supply protocols, processes, materials or facilities, and any delays in, or inability to, establish acceptable manufacturing and supply operations for our product candidates could require us to incur additional development costs or result in delays to our clinical development. If we or any CMOs or other third-party manufacturers that we may engage for manufacturing our product candidates are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, we may not obtain or maintain the regulatory approvals we need to commercialize such products. Even if we obtain regulatory approval for any of our product candidates, there is no assurance that either we or any CMOs or other third-party manufacturers that we may engage for manufacturing our product candidates will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities and on the requisite timelines to meet the requirements for the potential launch of the product, or to meet potential future demand. Additionally, changes in regulatory requirements may require us or any third-party manufacturers that we may engage for manufacturing our product candidates to perform additional studies or to modify protocols, processes, materials or facilities for the manufacture of our product candidates or any components thereof. Any of

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these challenges could delay initiation or completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and prospects.

A disruption to our manufacturing operations, or the inability by us or our third-party suppliers or manufacturers to manufacture sufficient quantities of our product candidates at acceptable quality levels or costs, or at all, would materially and adversely affect our business.

Developing manufacturing processes to support clinical studies and commercialization requirements is a difficult and uncertain task, and there are risks associated with scaling to the level required for clinical trials or commercialization, including, among others, cost overruns, potential problems with process scale-out, process reproducibility, stability and purity issues, lot consistency, and timely availability of acceptable reagents and raw materials. If we are unable to scale to the level required for the conduct of clinical trials or commercialization, we may not be able to produce our product candidates in a sufficient quantity to conduct our ongoing and planned clinical trials, or to meet demand if any product candidates are approved for commercialization. We have not yet caused any of our product candidates to be manufactured or processed on a commercial scale and may not be able to do so for any of our product candidates.

We are substantially dependent on our own internal manufacturing facilities in San Diego, California for the production of our product candidates, and we rely, and expect to continue to rely, on third parties for the manufacture of certain components to manufacture our product candidates for use in conducting clinical trials. The facilities used to manufacture our product candidates, including our own facilities, must be evaluated by the FDA or other foreign regulatory agencies pursuant to inspections that will be conducted after we submit an application to the FDA or other foreign regulatory agencies. If the FDA or a comparable foreign regulatory authority finds deficiencies with or does not approve these facilities for the manufacture of our product candidates or if it later finds deficiencies or withdraws any such approval in the future, we may not be able to locate additional or replacement facilities to produce such product candidates or materials in a timely manner and on commercially reasonable terms, or at all. This would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

Because we rely on our own manufacturing facilities to produce our product candidates and on third parties for the manufacture of certain components, we are required to transfer certain manufacturing process know-how and certain intermediates to third parties, including larger-scale facilities operated by a CMO or by us, to facilitate manufacture of our product candidates for clinical trials and commercialization. Transferring manufacturing testing and processes and know-how is complex and involves review and incorporation of both documented and undocumented processes that may have evolved over time. In addition, transferring production to different facilities may require utilization of new or different processes to meet the specific requirements of a given facility. We and any CMOs or third parties that we engage to manufacture our product candidates will need to conduct significant development work to transfer these processes and manufacture each of our product candidates for clinical trials and commercialization. In addition, we may be required to demonstrate the comparability of material generated by any CMO or third parties that we engage for manufacturing our product candidates with material previously produced and used in testing. Any inability to manufacture comparable drug product by us or any CMOs or third parties that we engage to manufacture our product candidates could delay the continued development of our product candidates.

In addition to relying on third parties for the manufacture of certain components for the manufacture of our product candidates, we manufacture our product candidates ourselves, and intend to manufacture some or all of the clinical supply of our iPSC-derived NK-cell and T-cell product candidates for our ongoing and planned clinical trials. To do so, we will need to scale up our own manufacturing operations, as we do not currently have the infrastructure or capability internally to manufacture sufficient quantities of each of our product candidates to support the conduct of each of our clinical trials or commercialization of each of our product candidates, if approved. Accordingly, we will be required to make significant investments to maintain and expand our existing Good Manufacturing Practice (GMP) manufacturing capabilities and facilities, establish additional GMP manufacturing facilities, conduct GMP production, and process and scale up development and technology transfer activities for the manufacture of our product candidates, and our efforts to scale our own manufacturing operations may not succeed.

Even if we are successful in developing manufacturing capabilities sufficient for clinical and commercial supply, problems with our manufacturing operations or those of the third-party manufacturers upon which we rely, including difficulties with production costs and yields, quality control, stability of the product, quality assurance testing, operator error, shortages of qualified personnel, shortages of materials and supplies, facility shutdowns, global pandemics or other public health concerns, global geopolitical tensions, including wars and other armed conflicts, natural disasters (including due to the effects of climate change) or other reasons, as well as compliance with strictly enforced federal, state and foreign regulations, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims or insufficient supplies of our product candidates for our ongoing and planned clinical trials or eventual commercialization. Further, delays in regulatory inspections, commissioning and receiving regulatory approvals for our manufacturing capabilities or facilities, including any new facilities could delay our development plans,

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including the initiation and conduct of our ongoing and planned clinical trials. In addition, we and our third-party manufacturers may have limited manufacturing capacity for certain product candidates or components used in manufacturing our product candidates, and we may fail to locate suitable additional or replacement manufacturing capacity, including for the manufacture of our product candidates in compliance with current GMP (cGMP) or current Good Tissue Practice (cGTP), on a reasonable basis or at all. Any such failure could be the basis for the FDA or other regulatory authorities to issue a warning letter, withdraw approvals for product candidates previously granted to us, or take other regulatory or legal action, including recall or seizure of outside supplies of the product candidate, total or partial suspension of production, suspension of ongoing clinical trials, refusal to approve pending applications or supplemental applications, detention of product, refusal to permit the import or export of products, injunction or imposing civil and criminal penalties.

Furthermore, certain of the components currently used in manufacturing our product candidates are research-grade only, and we may encounter problems obtaining or achieving adequate quantities and quality of clinical grade materials that meet FDA, European Medicines Agency, or other standards or specifications applicable in the United States or in other countries with consistent and acceptable production yields and costs. In addition, if contaminants are discovered in our supply of product candidates or in our manufacturing facilities or those of our third-party suppliers and manufacturers, such manufacturing facilities may be closed for an extended period of time to investigate and remedy the contamination. Any such events could delay or prevent our ability to obtain regulatory approval for or commercialize our product candidates, which would adversely affect our business, prospects, financial condition and results of operations.

Because our approach to the development of product candidates is based on novel and unproven technologies, it is subject to a substantial degree of technological uncertainty and we may not succeed in developing any of our product candidates.

All of our current product candidates are based on our novel iPSC platform, and some of our product candidates utilize novel genome editing technologies. To date, no iPSC-derived therapeutic product candidates have been approved in the United States or worldwide, and there have been only a limited number of regulatory approvals of genome edited therapeutics, and similarly a limited number of clinical trials involving the use of a therapeutic product candidate manufactured using a master iPSC line or genome edited cells. The development of such complex cell therapies is a relatively new and emerging field, and the scientific research that forms the basis of our efforts to discover and develop iPSC-derived and genome edited cellular immunotherapies is ongoing; this is particularly true in relation to the development of cell therapies for the treatment of autoimmune diseases where there is limited clinical data available and where we have limited prior experience. We may determine to incorporate information learned from this research into the design of our ongoing Phase 1 clinical trials of our iPSC product candidates, as well as our planned future clinical trials, which could delay or impair our clinical development activities. We may ultimately discover that our product candidates do not possess certain properties required for therapeutic effectiveness or protection from toxicity in our target patient populations, or they may exhibit undesirable side effects as more patient data become available. In addition, our product candidates may demonstrate different chemical and pharmacological properties in patients than they do in laboratory studies. It may take many years before we develop a full understanding of the pharmacological properties of our product candidates, and we may never know precisely how they function in vivo. As with any new biologic or product developed using novel technologies, our product candidates have an unknown immunogenicity profile. As a result, our cellular immunotherapy product candidates may trigger immune responses that inhibit their therapeutic effects or cause adverse side effects. In addition, one or more of our product candidates may:

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be found ineffective or cause harmful side effects during preclinical studies or clinical trials;
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fail to receive necessary regulatory approvals on a timely basis or at all;
•
be precluded from commercialization by proprietary rights of third parties;
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be difficult to manufacture on a large scale; or
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be uneconomical to commercialize or fail to achieve market acceptance.

Any such problems that affect one of our product candidates may have an unfavorable impact on all of our product candidates. As a result, we may never succeed in developing a marketable product and we may never become profitable, which would have an adverse effect on our business, prospects, financial condition, results of operations, and market price of shares of our common stock.

We anticipate that our current product candidates and any future product candidates may be used in combination with third-party drugs or biologics, some of which may still be in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics.

Certain of our product candidates are being developed for use in combination with one or more other cancer therapies, such as monoclonal antibodies, and other current or future product candidates may be used in combination with other biologics or drugs, both approved and unapproved, such as fludarabine. Our ability to develop and ultimately commercialize our current product candidates

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and any future product candidates used in combination with another drug or biologic will depend on our ability, or the ability of third-party clinical trial sites on which we rely, to access such drugs or biologics on commercially reasonable terms for the clinical trials and their availability for use with the commercialized product, if approved. We cannot be certain that we, or third-party clinical trial sites on which we rely, will be able to secure a steady supply of such drugs or biologics on commercially reasonable terms or at all.

Any failure by us, or by third-party clinical trial sites on which we rely, to secure a steady supply of such drugs or biologics may delay our development timelines, increase our costs and jeopardize our ability to develop our current product candidates and any future product candidates as commercially viable therapies. If any of these occur, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

Moreover, the development of product candidates for use in combination with another product or product candidate may present challenges that are not faced for single agent product candidates. For example, the FDA or comparable foreign regulatory authorities may require us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed effects. It is possible that the results of such trials could show that any positive previous trial results are attributable to the combination therapy and not our current product candidates or any of our future product candidates. Moreover, following product approval, the FDA or comparable foreign regulatory authorities may require that products used in conjunction with each other be cross labeled for combined use. To the extent that we do not have rights to the other product, this may require us to work with a third party to satisfy such a requirement. Moreover, developments related to the other product may impact our clinical trials for the combination as well as our commercial prospects should we receive marketing approval. Such developments may include changes to the other product’s safety or efficacy profile, changes to the availability of the approved product, quality, manufacturing and supply issues, and changes to the standard of care.

In the event that any collaborator or supplier cannot continue to supply their products on commercially reasonable terms, we would need to identify alternatives for accessing such products. Additionally, should the supply of products from any collaborator or supplier be interrupted, delayed or otherwise be unavailable, our clinical trials may be delayed. In the event we are unable to source an alternative supply or are unable to do so on commercially reasonable terms, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

In addition, to the extent a third-party clinical trial site on which we rely sources a combination therapy itself and does not submit the costs of such therapy to government programs or patients’ insurance, the costs of such therapy may be passed on to us, which could harm our business, financial condition, results of operations, stock price and prospects.

If we encounter difficulties enrolling patients in our clinical trials, including as a result of challenges in identifying and recruiting eligible patients to participate in our trials or competition for patients, our clinical development activities could be delayed or otherwise adversely affected.

We are required to identify and enroll a sufficient number of patients with the disease under investigation for each of our ongoing and planned clinical trials of our product candidates, and we may not be able to identify and enroll a sufficient number of patients, or those with required or desired characteristics and who meet certain criteria, in a timely manner. In addition, we will be competing with other clinical trials of product candidates being developed by our competitors in the same therapeutic areas, and potential patients who might be eligible for enrollment in one of our clinical trials may instead choose to enroll in a trial being conducted by one of our competitors. We may also face an unwillingness of sites to participate in our clinical trials. A number of cell therapy companies have recently commenced clinical trials for the treatment of autoimmune diseases, which has increased competition for investigators and for patients for our ongoing and any future clinical trials that we may initiate for the treatment of autoimmune diseases.

Our ability, and the ability of investigators, to enroll patients in our ongoing and planned clinical trials of our product candidates is affected by factors including:

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our ability to identify clinical trial sites and recruit clinical trial investigators with the appropriate capabilities, competencies and experience;
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our ability to open clinical trial sites;
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the ability to identify, solicit and recruit a sufficient number of patients;
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severity of the disease under investigation;
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the design of the clinical trial and whether the FDA agrees to the design and implementation of the trial;
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the relatively small size and nature of the patient populations for certain of our clinical trials;

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•
eligibility criteria for the clinical trials in question;
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clinicians’ and patients’ perceptions as to the potential risks and benefits of the product candidate under study, including any perceived risks associated with our iPSC-derived product candidates, which we believe are the first ever iPSC-derived cell therapies cleared by the FDA for clinical investigation in the United States, or with our chimeric antigen receptor (CAR) T-cell therapies broadly following FDA’s investigation into reports of T-cell malignancies for B-cell maturation antigen (BCMA)- and CD19-directed autologous CAR T cell therapies, and perceived risks associated with the novel use of cell therapies for the treatment of autoimmune diseases, where there are no FDA-approved cell therapies and limited clinical precedent;
•
changing medical practice patterns or guidelines related to the indications we are investigating;
•
the availability of competing therapies and clinical trials;
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efforts to facilitate timely enrollment in clinical trials;
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the availability of time and resources at the limited number of institutions at which our clinical trials are or will be conducted, including any constraints on resources, or policies and procedures implemented, at hospitals and clinical trial sites as a result of any public health crisis;
•
the availability of cells suitable for the manufacture of our clinical product candidates from eligible and qualified donors for certain of our product candidates;
•
the availability of components and agents necessary to enroll and treat prospective patients in our clinical trials, including agents which may be required to condition patients or monoclonal antibodies which are intended for administration to patients in combination with our product candidates, in certain of our clinical trials;
•
the ability to monitor patients adequately during and after treatment, including through remote monitoring if required as a result of precautionary changes implemented at clinical trial sites as a result of any public health crisis; and
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the proximity and availability of clinical trial sites for prospective patients.

Moreover, development of certain of our product candidates as treatment for autoimmune diseases represents a novel approach, and no cell therapies have been approved for commercial use for the treatment of autoimmune diseases. As a consequence, use of cell therapies such as our product candidates for the treatment of autoimmune diseases may not gain the acceptance of the public or medical community. Our ability to enroll patients in our clinical trials for treatment of autoimmune diseases will depend upon the treatment practices of physicians who specialize in the treatment of autoimmune diseases targeted by our product candidates, and enrollment in our clinical trials may be impaired if physicians are reluctant to enroll patients into our clinical trials in lieu of, or in addition to, using existing treatments with which they are more familiar and for which more clinical data may be available. In addition, patient populations targeted for autoimmune diseases by our product candidates are typically not at risk of near-term death, even if they may suffer life-threatening symptoms, so these patients will need to deem the potential benefits of our cell therapy product candidates to be worth the risk of unknown potential adverse side effects. Furthermore, autoimmune disease patients and their physicians may choose to use conventional therapies, such as corticosteroids or systemic immunosuppressive medications, rather than participate in our clinical trials.

In addition, certain of our clinical trial sites at times have delayed or paused patient enrollment in clinical trials as a result of the COVID-19 pandemic and supply chain shortages, and may do so again in the future for a variety of reasons. The extent and duration of such delays and disruptions, and the overall impact on the timing and conduct of our clinical trials, are uncertain. If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay or terminate ongoing or planned clinical trials, either of which would have an adverse effect on our business, prospects, financial condition, results of operations, and market price of shares of our common stock.

The clinical development of our product candidates could be substantially delayed if we are required to conduct unanticipated studies, including preclinical studies or clinical trials, or if the FDA imposes other requirements or restrictions including on the manufacture, of our product candidates.

The FDA may require us to generate additional preclinical, product, manufacturing, or clinical data as a condition to continuing our current clinical trials, or initiating and conducting any future clinical trials of our current product candidates or other cell product candidates that we may identify. Additionally, the FDA may in the future have comments, or impose requirements, on the conduct of our clinical trials or the initiation of clinical trials or any of our other iPSC-derived cell product candidates, including the protocols, processes, materials and facilities we use to manufacture our product candidates and potential future product candidates in support of clinical trials. Any requirements to generate additional data, or redesign or modify our protocols, processes, materials or facilities, or other additional comments, requirements or impositions by the FDA, may cause delays in the initiation or conduct of the current or

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future clinical trials for our product candidates and subsequent development activities for our product candidates, and could require us to incur additional development or manufacturing costs and resources, seek funding for these increased costs or resources or delay our timeline for, or cease, our preclinical or clinical development activities for our product candidates, or could create uncertainty and additional complexity in our ability to obtain regulatory approval for our product candidates.

Further, if the results of our clinical trials are inconclusive, or if there are safety concerns or adverse events associated with our existing product candidates or any other product candidates we may identify, we may:

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be delayed in obtaining, or unable to obtain, regulatory approval for such product candidates;
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be required to amend the protocols for our clinical trials, perform additional nonclinical studies or clinical trials to support approval or be subject to additional post-marketing testing requirements;
•
obtain approval for indications or patient populations that are not as broad as intended or desired;
•
obtain approval with labeling that includes significant use or distribution restrictions or safety warnings or contraindications; or
•
in the event a product candidate is approved, have regulatory authorities withdraw their approval of the product or impose restrictions on its use.

Even if our current and planned clinical trials are successful, we will need to conduct additional clinical trials, which may include registrational trials, trials in additional patient populations or under different treatment conditions, and trials using different manufacturing protocols, processes, materials or facilities or under different manufacturing conditions, before we are able to seek approvals for our product candidates from the FDA and regulatory authorities outside the United States to market and sell these product candidates. In addition, changes in regulatory policies or the administration as a result of the 2024 U.S. presidential election may result in delays in the regulatory review and approval process and cause uncertainty regarding approval pathways. If we fail to meet the requirements to support continued clinical development, our clinical development activities for any of our product candidates are delayed or suspended, or we fail to obtain or maintain regulatory approvals with an acceptable scope, our business, prospects, financial condition and results of operations will be harmed.

We are pursuing multiple programs and product candidates in our novel cell therapy development pipeline using an approach that is designed to enable rapid incorporation of new product features. If we elect to incorporate these new features into next-generation product candidates, this may render our existing product candidates obsolete, and we may devote our limited resources in pursuit of a particular program for which there is a greater potential for success and fail to capitalize on development opportunities or product candidates including those which may be more advanced in development.

We focus on the development of programmed cellular immunotherapies for patients with cancer and autoimmune diseases, including off-the-shelf NK- and T-cell product candidates derived from clonal master engineered iPSC lines. Because our iPSC product platform is designed to enable rapid incorporation of novel functional product features in an evolving clinical setting, we may elect to incorporate these discoveries into next-generation product candidates that render our existing product candidates, including product candidates under clinical development, obsolete. Additionally, because we have limited financial and personnel resources, we may elect or be required to abandon or delay the pursuit of opportunities with existing or future product candidates, including those that may be more advanced in development than those we ultimately elect to pursue. For example, in January 2023, we announced the discontinuation of our FT516, FT596, FT538, and FT536 NK cell programs to focus our resources on advancing our most innovative and differentiated programs. We have also expanded our research and development efforts into areas outside of our initial focus in oncology, such as autoimmune diseases, where we have limited or no experience. Due to these factors, our spending on current and future research and development programs and product candidates and the scientific innovation arising from these expenditures, may not yield commercially viable product candidates.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.

During the conduct of clinical trials, patients may report changes in their health, including illnesses, injuries and discomforts, to their doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions. Regulatory authorities may draw different conclusions and may require us to pause our clinical trials or require additional testing to confirm these determinations, if they occur. Drug-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims.

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In addition, it is possible that as we test our product candidates in larger, longer and more extensive clinical trials, or as use of these product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events that were not observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, may be reported by subjects or patients. Many times, drug-related side effects are only detectable after investigational products are tested in large-scale pivotal trials or, in some cases, after they are made available to patients on a commercial scale after approval. Furthermore, because certain autoimmune diseases we seek to treat may be less serious than the later stage cancers traditionally being treated with cell therapies or other immunotherapy products, we believe the FDA and other regulatory authorities will apply a different benefit-risk threshold such that any potential harmful side effects may outweigh the benefits of our product candidates and require us to cease clinical trials or result in denial of regulatory approval of our product candidates in autoimmune disease indications. Tolerance for adverse events in the autoimmune disease patient populations being pursued with cell-based therapies, such as in SLE patients in our FT819 clinical trial, is expected to be lower than it is in oncology, and the risks of negative impacts from these toxicities may therefore be greater for our autoimmune programs than for our oncology programs or the oncology programs of others. If any of our product candidates cause undesirable side effects or have unfavorable benefit-risk profiles, this may cause us or regulatory authorities to interrupt, delay, or halt clinical trials, and the development of the product candidate may fail or be delayed. If the product candidate receives regulatory approval, such undesirable side effects could result in a more restrictive label than anticipated or in the regulatory approval being revoked. Any such delay or failure as a result of undesirable side effects would harm our business, financial condition, results of operations and prospects.

Certain of our product candidates are being developed for the treatment of patient populations with significant comorbidities, particularly in the case of oncology patients, that may result in deaths or serious adverse events or unacceptable side effects and require us to abandon or limit our clinical development activities.

Patients treated with our current product candidates, particularly in our clinical trials in oncology indications, may also receive chemotherapy, radiation, and/or other high dose or myeloablative treatments in the course of treatment of their disease, and may therefore experience side effects or adverse events, including death, that are unrelated to our product candidates. While these side effects or adverse events may be unrelated to our product candidates, they may still affect the success of our clinical studies. In particular, the oncology diseases we are studying have complex comorbidities and the patients enrolled in those studies are often critically ill. The inclusion of critically ill patients in our clinical studies may result in deaths or other adverse medical events due to underlying disease or to other therapies or medications that such patients may receive. Any of these events could prevent us from advancing our product candidates through clinical development, and from obtaining regulatory approval, and would impair our ability to commercialize our product candidates. Any inability to advance our existing product candidates or any other product candidate through clinical development would have a material adverse effect on our business, and the value of our common stock would decline.

Because our product candidates are based on novel technologies, it is difficult to predict the regulatory approval process and the time, the cost and our ability to successfully initiate, conduct and complete clinical development, and obtain the necessary regulatory and reimbursement approvals, required for commercialization of our product candidates, if approved.

Our cell programming technology and platform for generating cell therapy products using iPSCs represent novel therapeutic approaches, and to our knowledge there are currently no iPSC-derived cell products approved anywhere in the world for commercial sale. As such, it is difficult to accurately predict the type and scope of challenges we may incur during development of our product candidates, and we face uncertainties associated with the preclinical and clinical development, manufacture and regulatory requirements for the initiation and conduct of clinical trials, regulatory approval, and reimbursement required for successful commercialization of these product candidates. In addition, because our iPSC-derived cell product candidates are all in the early clinical or preclinical stage, we are currently assessing safety in humans and have not yet been able to assess the long-term effects of treatment. Animal models and assays may not accurately predict the safety and efficacy of our product candidates in our target patient populations, and appropriate models and assays may not exist for demonstrating the safety and purity of our product candidates, as required by the FDA and other regulatory authorities for ongoing clinical development and regulatory approval.

The preclinical and clinical development, manufacture, and regulatory requirements for approval of novel product candidates such as ours can be more expensive and take longer than for other more well-known or extensively studied pharmaceutical or biopharmaceutical product candidates due to a lack of prior experiences on the side of both developers and regulatory agencies. Additionally, due to the uncertainties associated with the preclinical and clinical development, manufacture, and regulatory requirements for approval of our product candidates, we may be required to modify or change our preclinical and clinical development plans or our manufacturing activities and plans, or be required to meet stricter regulatory requirements for approval. Any such modifications or changes could delay or prevent our ability to develop, manufacture, obtain regulatory approval or commercialize our product candidates, which would adversely affect our business, financial condition and results of operations.

Cellular immunotherapies, and iPSC-derived cell therapies in particular, represent relatively new therapeutic areas, and the FDA has cautioned consumers about potential safety risks associated with cell therapies. For example, in November 2023, the FDA

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announced that it would be conducting an investigation into reports of T-cell malignancies following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies following reports of T-cell lymphoma in patients receiving these therapies. In January 2024, the FDA determined that new safety information related to T-cell malignancies should be included in the labeling with boxed warning language on these malignancies for all BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. To date, there are relatively few approved cell therapies as treatments for cancer, and no cell-based therapies have been approved for commercial use for the treatment of an autoimmune disease. Currently, all approved CAR T-cell immunotherapies are in oncology indications, and there can be no assurance that the FDA will find the risks of treatment with cell therapy acceptable in other indications, such as autoimmune diseases. The development of any cell therapy may be placed on hold by the FDA upon the detection of any unexpected safety event to evaluate the potential relevance of such novel technology to the occurrence of such safety event, highlighting the technical and regulatory risk of working with new technology. As a result, the regulatory approval process for product candidates such as ours is uncertain and may be more expensive and take longer than the approval process for cell therapy product candidates based on other, better known or more extensively studied technologies and therapeutic approaches.

Regulatory requirements in the United States and in other countries governing the development of cell therapy products and therapeutic products created with gene editing technology have changed frequently and the FDA or other regulatory bodies may change the requirements, or identify different regulatory pathways, for approval for any of our product candidates. For example, as regulatory expectations regarding cell therapy products and products created with gene editing technology continue to evolve, the FDA could require additional testing or new testing of products created with gene editing technology, including our product candidates, and any such additional FDA requirements for approval for any of our product candidates may adversely impact or slow development of our product candidates. The FDA previously established the Office of Tissues and Advanced Therapies (OTAT) within the Center for Biologics Evaluation and Research (CBER) to consolidate the review of cell therapy and related products, and to advise CBER on its review. In September 2022, the FDA announced retitling of OTAT to the Office of Therapeutic Products (OTP) and elevation of OTP to a “Super Office” to meet its growing cell and gene therapy workload and new commitments under the Prescription Drug User Fee Act agreement for fiscal years 2023-2027. It is possible that over time new or different divisions may be established or be granted the responsibility for regulating cell and/or gene therapy products, including iPSC-derived cell products made with gene editing technology, such as ours. The regulatory review divisions and committees, and any new guidelines they promulgate, may lengthen the regulatory review process, require us to perform additional studies or clinical trials, and delay or prevent development, approval, and commercialization of our product candidates. As a result, we may be required to change our regulatory strategy or to modify our applications for regulatory approval, which could delay and impair our ability to complete the preclinical and clinical development and manufacture of, and obtain regulatory approval for, our product candidates. Changes in regulatory authorities and advisory groups, or any new requirements or guidelines they promulgate, may lengthen the regulatory review process, require us to perform additional studies, increase our development and manufacturing costs, lead to changes in regulatory pathways, positions and interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval limitations or restrictions. As we advance our product candidates, we will be required to consult with the FDA and other regulatory authorities, and our product candidates will likely be reviewed by an FDA advisory committee. We also must comply with applicable requirements, and if we fail to do so, we may be required to delay or discontinue development of our product candidates. Delays or unexpected costs in obtaining, or the failure to obtain, the regulatory approval necessary to bring a potential product to market could impair our ability to generate sufficient product revenues to maintain our business.

Preliminary data and interim results we disclose may change as more patient data becomes available or as we make changes to our protocols or manufacturing processes, and such interim results and results from earlier studies may not be predictive of the final results, or of later studies or future clinical trials.

We may from time to time disclose results from preclinical testing or preliminary data or interim results from clinical studies of our product candidates. Such results from preclinical testing, process development and manufacturing activities, and clinical studies, including interim clinical trial results as of specified data cutoff dates and results of earlier clinical studies with similar product candidates, are not necessarily predictive of future results, including later clinical trial results.

The results of our current and future clinical trials may differ from results achieved in earlier preclinical and clinical studies for a variety of reasons, including:

•
we may not demonstrate the potency and efficacy benefits observed in previous studies;
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our efforts to improve, standardize and automate the manufacture and supply of our product candidates and any resulting deviations in the manufacture of our product candidates, may adversely affect the safety, purity, potency, stability, or efficacy of such product candidates;
•
differences in study design, including differences in conditioning regimens, eligibility criteria, and patient populations;
•
advancements in the standard of care may affect our ability to demonstrate efficacy or achieve study endpoints in our current or future clinical trials; and

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•
safety issues or adverse events in patients who enroll in our current or future clinical trials.

Additionally, some of the data from clinical trials of our product candidates performed to date were generated from open-label studies, and these studies are being conducted at a limited number of clinical sites on a limited number of patients. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which treatment regimen patients have received and may interpret the information of the treated group more favorably given this knowledge. Accordingly, the preliminary data from our Phase 1 clinical trials of certain of our product candidates may not be predictive of future clinical trial results for these or other product candidates when studied in a controlled environment or larger patient populations.

From time to time, we also publish interim, “top-line,” or preliminary data from our clinical studies based on a preliminary analysis of then-available data. Preliminary or interim data from clinical trials that we are conducting are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, the duration of treatment increases and more patient data become available. For example, although we have, from time to time, reported positive interim clinical data for certain of our clinical programs, we may encounter dose-limiting toxicities or unacceptable side effects for these product candidates as dose escalation and expansion progresses in our clinical trials and additional patient data become available. Our preliminary or interim results and related conclusions also are subject to change following a more comprehensive review of the data related to the particular study or trial. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Material adverse changes between preliminary, “top-line,” or interim data and final data could significantly harm our business prospects, financial condition and results of operations.

Results of clinical testing of any of our existing or future product candidates may fail to show the necessary safety and efficacy required for regulatory approval.

Before obtaining marketing approval from regulatory authorities for the sale of any of our product candidates, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy in humans of any such product candidates. Clinical testing is expensive, difficult to design and implement, can take many years to complete, and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Our product candidates have a limited history of being evaluated in human clinical trials. Any of our product candidates may fail to show the desired safety and efficacy in later stages of clinical development despite having successfully advanced through initial clinical trials.

There is a high failure rate for drugs and biologics proceeding through clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in later stage clinical trials even after achieving promising results in earlier stage clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit, or prevent regulatory approval. In addition, regulatory delays or rejections may be encountered as a result of many factors, including changes in regulatory policy during the period of product development.

If our product candidates are ultimately not approved for any reason, our business, prospects, results of operations and financial condition would be adversely affected. In addition, the standard of care may change with the approval of new products for the same indications that we are studying.

Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.

Any product candidate for which we obtain marketing approval, along with the manufacturing protocols, processes, materials and facilities, qualification testing, post-approval clinical data, labeling and promotional activities for such product, will be subject to continual and additional requirements of the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information, reports, registration and listing requirements, requirements relating to cGMP, applicable product tracking and tracing requirements, quality control, quality assurance and corresponding maintenance of records and documents, and recordkeeping. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. Additionally, under the Food and Drug

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Omnibus Reform Act of 2022 (FDORA), sponsors of approved drugs and biologics must provide 6 months’ notice to the FDA of any changes in marketing status, such as the withdrawal of a drug, and failure to do so could result in the FDA placing the product on a list of discontinued products, which would revoke the product’s ability to be marketed. The FDA closely regulates the post-approval marketing and promotion of pharmaceutical and biological products to ensure such products are marketed only for the approved indications and in accordance with the provisions of the approved labeling. Later discovery of previously unknown problems with our product candidates, manufacturing operations, or failure to comply with regulatory requirements, may lead to various adverse conditions, including significant delays in bringing our product candidates to market and/or being precluded from manufacturing or selling our product candidates, any of which could significantly harm our business.

We may seek regenerative medicine advanced therapy (RMAT) designation for certain of our product candidates, but such designation may not actually lead to a faster development or regulatory review or approval process and we may be unable to obtain or maintain the benefits associated with such designation.

We may seek RMAT designation from the FDA for certain of our product candidates. A product candidate is eligible for RMAT designation if: (1) it is a cell therapy, therapeutic tissue engineering product, human cell or tissue product, or a combination product using any such therapies or products; (2) it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and (3) there is preliminary clinical evidence that indicates that the product candidate has the potential to address unmet medical needs for such disease or condition. This program is intended to facilitate efficient development and expedite review of RMATs. A Biologics License Application (BLA) for a product candidate with RMAT designation may be eligible for priority review or accelerated approval through (1) surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit or (2) reliance upon data obtained from a meaningful number of sites. Benefits of such designation also include early interactions with the FDA to discuss any potential surrogate or intermediate endpoint to be used to support accelerated approval. A product candidate that has RMAT designation and is subsequently granted accelerated approval and is subject to post-approval requirements may fulfill such requirements through the submission of clinical evidence, clinical studies, patient registries, or other sources of real-world evidence, such as electronic health records; the collection of larger confirmatory data sets; or post-approval monitoring of all patients treated with such therapy prior to its approval. RMAT designation is within the discretion of the FDA. Accordingly, even if we believe one of our product candidates meets the criteria for RMAT designation, the FDA may disagree and instead determine not to grant such designation. In any event, the receipt of RMAT designation for a product candidate may not result in a faster development process, review or approval compared to product candidates considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualifies for RMAT designation, the FDA may later decide that the product candidate no longer meets the conditions for qualification.

We may rely on orphan drug status to develop and commercialize certain of our product candidates, but orphan drug designations may not confer marketing exclusivity or other expected commercial benefits and we may not be able to obtain orphan drug designations for our other product candidates.

We may rely on orphan drug exclusivity for product candidates that we may develop. Orphan drug status confers seven years of marketing exclusivity in the United States under the Federal Food Drug, and Cosmetic Act, and up to ten years of marketing exclusivity in Europe for a particular product in a specified indication, subject to certain conditions. However, we may be unable to obtain orphan drug designations for any of our product candidates that we are currently developing or may pursue. Even if we do obtain orphan drug designations and are the first to obtain marketing approval of our product candidates for the applicable indications, we will not be able to rely on these designations to exclude other companies from manufacturing or selling biological products using the same principal molecular structural features for the same indication beyond these time frames. Furthermore, any marketing exclusivity in Europe can be reduced from ten years to six years if the initial designation criteria have significantly changed since the market authorization of the orphan product.

For any product candidate for which we may be granted orphan drug designation in a particular indication, it is possible that another company also holding orphan drug designation for the same product candidate will receive marketing approval for the same indication before we do. If that were to happen, our applications for that indication may not be approved until the competing company’s period of exclusivity expires. Even if we are the first to obtain marketing authorization for an orphan drug indication in the United States, there are circumstances under which a competing product may be approved for the same indication during the seven-year period of marketing exclusivity, such as if the later product is shown to be clinically superior to our orphan product, or if the later product is deemed a different product than ours. Further, the seven-year marketing exclusivity would not prevent competitors from obtaining approval of the same product candidate as ours for indications other than those in which we have been granted orphan drug designation, or for the use of other types of products in the same indications as our orphan product.

We may seek designation for our cell programming technology as a designated platform technology, but we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.

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We may seek designation for our cell programming technology as designated platform technology. Under FDORA, a platform technology incorporated within or utilized by a drug or biological product is eligible for designation as a designated platform technology if (1) the platform technology is incorporated in, or utilized by, a drug approved under a BLA or New Drug Application (NDA); (2) preliminary evidence submitted by the sponsor of the approved or licensed drug, or a sponsor that has been granted a right of reference to data submitted in the application for such drug, demonstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse effect on quality, manufacturing, or safety; and (3) data or information submitted by the applicable person indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the drug development or manufacturing process and to the review process. A sponsor may request the FDA to designate a platform technology as a designated platform technology concurrently with, or at any time after, submission of an IND application for a drug that incorporates or utilizes the platform technology that is the subject of the request. If so designated, the FDA may expedite the development and review of any subsequent original BLA or NDA for a drug that uses or incorporates the platform technology. Even if we believe our cell programming technology meets the criteria for such designation, the FDA may disagree and instead determine not to grant such designation. In addition, the receipt of such designation for a platform technology does not ensure that a drug will be developed more quickly or lead to a faster FDA review or approval process and does not assure ultimate FDA approval of a drug. Moreover, the FDA may revoke a designation if the FDA determines that a designated platform technology no longer meets the criteria for such designation.

We may seek approval of one or more of our product candidate into real-time oncology review (RTOR). This program may not lead to a faster regulatory review or approval process and does not increase the likelihood that our product candidate(s) will receive marketing approval.

Participation in RTOR is voluntary. Our acceptance into RTOR does not guarantee or influence approval of our application, which is subject to the same statutory and regulatory requirements for approval as applications that are not included in RTOR. Although early approvals have occurred with applications selected for RTOR, this may not be the case for our application even if it is selected for RTOR. If at any time the FDA determines our participation in RTOR, if selected, is no longer appropriate, the FDA may rescind our acceptance and instruct us to follow routine submission procedures for marketing approval.

We may be subject to certain regulations, including federal and state healthcare fraud and abuse laws, physician payment transparency laws, anti-bribery and anti-corruption laws and health information privacy and security laws. Any actual or perceived failure to comply with these regulations could have a material adverse effect on our business and financial condition.

If we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our operations may be subject to various federal and state healthcare laws, including, without limitation, fraud and abuse laws, false claims laws, data privacy and security laws, as well as transparency laws regarding payments or other items of value provided to healthcare providers. These laws may impact, among other things, our proposed sales, marketing and education programs. Additionally, we may be subject to state and foreign equivalents of such healthcare laws and regulations, some of which may be broader in scope and may apply regardless of the payor, as well as patient privacy regulation by both the federal government and the states in which we conduct our business. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge and may not comply under one or more of such laws, regulations, and guidance. Law enforcement authorities are increasingly focused on enforcing fraud and abuse laws, and it is possible that some of our practices may be challenged under these laws. Efforts to ensure that our current and future business arrangements with third parties, and our business generally, will comply with applicable healthcare laws and regulations will involve substantial costs. If our operations, including our arrangements with physicians and other healthcare providers are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs (such as Medicare and Medicaid), and imprisonment, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our financial results. For more information, please see “Business—Government Regulation—Other Healthcare Laws and Compliance Requirements” in our Annual Report on Form 10-K for the year ended December 31, 2023.

The scope and enforcement of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

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The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is prohibited in the European Union. The provision of benefits or advantages to physicians is also governed by the national anti-bribery laws of European Union Member States, such as the UK Bribery Act 2010. Infringement of these laws could result in substantial fines and individual imprisonment.

Payments made to physicians in certain European Union Member States must be publicly disclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory authorities of the individual European Union Member States. These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the European Union Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or individual imprisonment.

A variety of risks associated with conducting research and clinical trials abroad and marketing our product candidates internationally could materially adversely affect our business.

We plan to develop and potentially commercialize our product candidates worldwide. Accordingly, we expect that we will be subject to additional risks related to operating in foreign countries, including:

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differing regulatory requirements in foreign countries;
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unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
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increased difficulties in managing the logistics and transportation of storing and shipping product candidates produced in the United States and shipping the product candidate to the patient abroad;
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import and export requirements and restrictions;
•
economic weakness, including inflation, or political instability in particular foreign economies and markets;
•
compliance with data privacy regulations in foreign countries;
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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foreign taxes, including withholding of payroll taxes;
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foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
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difficulties staffing and managing foreign operations;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price controls;
•
potential liability under the U.S. Foreign Corrupt Practices Act or comparable foreign regulations;
•
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
•
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
•
business interruptions resulting from ongoing and emerging geopolitical tensions, including wars, armed conflicts or acts of terrorism.

These and other risks associated with our potential international operations may materially adversely affect our ability to attain or maintain profitable operations, which could have a material adverse effect on our business and results of operations.

We may decide to conduct clinical trials for our product candidates outside the United States, and the FDA may not accept data from trials conducted in such locations.

To date, we have only conducted clinical trials in the United States. However, we may in the future choose to conduct one or more of our clinical trials or include sites in current or future clinical trials outside the United States.

Although the FDA may accept data from sites or clinical trials outside the United States, acceptance of these data is subject to conditions imposed by the FDA. The FDA will generally not consider the data from a foreign clinical trial not conducted under an

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IND unless (i) the trial was well-designed and well-conducted in accordance with Good Clinical Practice (GCP) requirements, including requirements for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected, and (ii) the FDA is able to validate the data from the trial through an onsite inspection, if necessary. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such as inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering must be met. Many foreign regulatory authorities have similar approval requirements. In addition, while these clinical trials or trial sites are subject to the applicable local laws where the trials are conducted, FDA acceptance of the data will depend on its determination that the trials or trial sites also complied with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept data from trials conducted outside the United States. If the FDA does not accept the data from any trial or trial site outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and would delay or halt our development of the applicable product candidates.

Risks Related to Our Financial Condition

Our ongoing and planned operations, including the development of our product candidates, will require substantial additional funding, without which we will be unable to complete preclinical or clinical development of, or obtain regulatory approval for, or commercialization of our product candidates.

We are currently advancing multiple product candidates through clinical development, and conducting preclinical research and development activities in other programs. Drug development is expensive, and we expect our research and development expenses to remain significant in connection with our ongoing activities, particularly as we advance our current product candidates in clinical trials and seek to initiate clinical development for additional product candidates.

As of September 30, 2024, our cash and cash equivalents and investments were $330.5 million. We intend to use our cash and cash equivalents and investments primarily to fund the advancement and clinical development of our current product candidates and our ongoing preclinical, discovery and research programs, and for working capital and general corporate purposes. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic and licensing arrangements or a combination of these approaches. In any event, we will require additional capital to obtain regulatory approval for, and to commercialize our existing product candidates and any other product candidates we may identify and develop. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations. Our future capital requirements will depend on many factors, including, but not limited to:

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the progress, results, size, timing and costs of our ongoing and planned clinical trials, and any additional clinical trials we may initiate, conduct or support for our product candidates;
•
the progress, results, size, timing and costs of our preclinical, process development and manufacturing studies, and activities necessary to initiate and conduct clinical trials for our product candidates and to establish and maintain manufacturing capabilities necessary to support such trials;
•
continued progress in our research and development programs, including preclinical studies, process development, manufacturing and other research activities that may be necessary in order for an IND application to go into effect for a prospective clinical development candidate, as well as potential future clinical trials of any additional product candidates we may identify for development;
•
the extent to which we are required to pay milestone or other payments under our existing in-license agreements and any in-license agreements that we may enter into in the future, and the timing of such payments, including payments owed to Memorial Sloan Kettering Cancer Center (MSKCC) in connection with the stock price appreciation milestones;
•
our ability and the ability of our investigators to initiate and conduct, and the progress, results, size, timing and costs of, clinical trials of our product candidates that will be necessary to support any application for regulatory approval;
•
our ability to manufacture, or enter into arrangements with third parties for the manufacture of our existing product candidates, as well as potential future clinical development candidates, both for clinical development and commercialization, and the timing and costs associated with such manufacture;

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•
our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, or other costs we may incur, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;
•
the cost of manufacturing, distribution, and commercialization activities and arrangements, including the manufacturing of our product candidates, establishment of effective protocols for the supply and transport of our product candidates, and the establishment of a sales and marketing organization either internally or in partnership with a third party; and
•
our ability to establish and maintain strategic arrangements and alliances with third-party collaborators including our existing collaborations with Ono Pharmaceutical Co., Ltd. (Ono), the University of Minnesota, and MSKCC, to advance the research, development and commercialization of therapeutic products.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness would result in increased fixed payment and interest obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at a different stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects. In addition, while the overall impacts of the ongoing and emerging geopolitical tensions, including wars and other armed conflicts, on the global economy remain unknown and difficult to predict, these events caused significant disruptions and created uncertainties in the global financial markets, and the economic impacts of these and other similar global events could materially and adversely affect our ability to raise capital through equity or debt financings in the future.

If we cannot raise additional capital or obtain adequate funds, we may be required to curtail significantly our research and clinical programs or may not be able to continue our research or clinical development of our product candidates. Our failure to raise additional capital, or obtain adequate funds, will have a material adverse effect on our business, prospects, financial condition, results of operations, and market price of shares of our common stock.

We have a limited operating history, have incurred significant losses since our inception, and anticipate that we will continue to incur significant losses for the foreseeable future.

We are a clinical-stage biopharmaceutical company formed in 2007 with a limited operating history. We have not yet obtained regulatory approval for any of our product candidates or generated any revenues from therapeutic product sales. Since inception, we have incurred significant net losses in each year and, as of September 30, 2024, we had an accumulated deficit of $1.3 billion. We expect to continue to incur losses for the foreseeable future as we continue to fund our ongoing and planned clinical trials of our product candidates and our other ongoing and planned research and development activities. We also expect to incur significant operating and capital expenditures as we continue our research and development of, and seek regulatory approval for, our product candidates, in-license or acquire new product candidates for development, implement additional infrastructure and internal systems, and hire additional scientific, clinical, and administrative personnel. We anticipate that our net losses for the next several years could be significant as we conduct our planned operations.

Because of the numerous risks and uncertainties associated with pharmaceutical, biological, and cell therapy product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. In addition, our expenses could increase if we are required by the FDA, or comparable foreign regulatory authorities, to perform studies or trials in addition to those currently expected, or if there are any delays in completing our clinical trials, preclinical studies, process development, manufacturing activities, or the research and development of any of our product candidates. The amount of our future net losses will depend, in part, on the rate of increase in our expenses, our ability to generate revenues and our ability to raise additional capital. These net losses have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.

We have broad discretion over the use of our cash, cash equivalents, and investments and may not use them effectively.

Our management has broad discretion to use our cash, cash equivalents, investments and any additional funds that we may raise to fund our operations and could spend these funds in ways that do not improve our results of operations or enhance the value of our common stock. The failure by our management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline or delay the development of our product candidates. We may invest our cash and cash equivalents in a manner that does not produce income or that loses value.

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Risks Related to Our Reliance on Third Parties

We are, and expect to continue to be, dependent on third parties to conduct some or all aspects of manufacturing of our product candidates for use in clinical trials and for commercial sale, if approved. Our business could be harmed if those third parties fail to perform satisfactorily.

While we currently manufacture clinical supplies of our iPSC-derived cell product candidates at our cGMP facilities located in San Diego, California, we also rely on third parties to manufacture certain components required for the manufacture of our product candidates, and we may rely on third parties to conduct some or all aspects of manufacturing of our product candidates for use in conducting later stage clinical trials and for commercial sale upon approval of any of our product candidates.

Reliance on third parties for manufacture of our product candidates and components utilized in manufacturing our product candidates entails certain risks, including reliance on the third party for regulatory compliance and quality assurance, the possibility that the third-party manufacturer does not maintain the financial, personnel or other resources to meet its obligations, the possibility that the third party fails to manufacture such components, or our product candidates or any products we may eventually commercialize, in accordance with our specifications, misappropriation of our proprietary information, including our trade secrets and know-how, and the possibility of termination of our manufacturing relationship by the third party, based on its own business priorities, at a time that is costly or damaging to us. In addition, the FDA and other regulatory authorities require that our product candidates and any products that we may eventually commercialize be manufactured according to cGMP, cGTP and similar jurisdictional standards. These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation. The FDA or similar foreign regulatory agencies may also implement new standards at any time, or change their interpretations and enforcement of existing standards for manufacture, packaging or testing of products. We have little control over our manufacturers’ compliance with these regulations and standards.

In some cases, the technical skills required to manufacture our product candidates may be unique or proprietary to a particular CMO, and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier if needed, or we may be unable to transfer such skills at all. In addition, if we are required to change contract manufacturers for any reason, we will be required to verify that the new CMO maintains facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce our product candidate according to the specifications previously submitted to the FDA or another regulatory authority. The delays associated with the verification of a new CMO could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget. In addition, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating the comparability of clinical supplies produced by different manufacturers, which could require the conduct of additional clinical trials.

Further, we depend in some instances on third party suppliers, including sole source suppliers, for the provision of reagents, materials, devices and equipment that are used by us and our third-party contract manufacturers in the production of our product candidates, including certain of our iPSC-derived cell therapy product candidates. Any disruption to or loss of supply from any of these suppliers could delay our clinical development and commercialization efforts, which would adversely affect our business, prospects, results of operations and financial condition.

We depend on strategic partnerships and collaboration arrangements for the development and commercialization of certain of our product candidates in certain indications or geographic territories, and if these arrangements are terminated or are unsuccessful, this could result in delays and other obstacles in the development, manufacture or commercialization of any of our product candidates and materially harm our results of operations.

Our strategy for fully developing and commercializing our product candidates is dependent upon maintaining our current arrangements and establishing new arrangements with research collaborators, corporate collaborators and other third parties. We currently have a corporate collaboration agreement with Ono; our collaboration with Janssen terminated effective April 2023. Our collaboration agreement with Ono provides for, among other things, research funding and significant future payments should certain development, regulatory and commercial milestones be achieved. Under our arrangement with Ono and any future corporate arrangements that we may form, our corporate collaborators may be responsible for:

•
electing to advance product candidates through preclinical and into clinical development;
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conducting clinical development and obtaining required regulatory approvals for product candidates; and
•
commercializing any resulting products.

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As a result, we may not be able to conduct such corporate collaborations in the manner or on the time schedule we currently contemplate, which may negatively impact our business operations.

Our lack of control over the research funding for, and the development and commercialization of, certain of our product candidates being developed under the collaboration and option agreement we entered into with Ono on September 14, 2018 (as amended to date, the Ono Agreement) and any other product candidates that we may develop under a future arrangement could cause delays or other difficulties in the development and commercialization of any of our product candidates, which may prevent completion of research and development activities and intended regulatory filings in a timely fashion, if at all. Because we expect to continue to rely on our current collaborator and to enter into new collaborations in the future, the development and commercialization of any of our product candidates could be substantially delayed, and our ability to receive future funding could be substantially impaired, if one or more of our current or future collaborators:

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shifts its priorities and resources away from our collaborations due to a change in business strategies, or a merger, acquisition, sale or downsizing of its company or business unit;
•
ceases development in therapeutic areas which are the subject of our collaboration;
•
fails to select a product candidate for advancement into preclinical development, clinical development, or subsequent clinical development into a marketed product;
•
changes the success criteria for a particular product candidate, thereby delaying or ceasing development of such product candidate;
•
significantly delays the initiation or conduct of certain activities which could delay our receipt of milestone payments tied to such activities, thereby impacting our ability to fund our own activities;
•
develops a product candidate that competes, either directly or indirectly, with our product candidates;
•
does not obtain the requisite regulatory approval of a product candidate;
•
does not successfully commercialize a product candidate;
•
encounters regulatory, resource or quality issues and is unable to meet demand requirements;
•
exercises its rights under the agreement to terminate the collaboration, as Janssen did in January 2023, or otherwise withdraws support for, or otherwise impairs or delays development under the collaboration;
•
disagrees on the research, development or commercialization of a product candidate resulting in a delay in milestones, royalty payments or termination of such product candidate; and
•
uses our proprietary information or intellectual property in such a way as to jeopardize our rights in such property.

In addition, the termination of the Ono Agreement or any future strategic partnership or collaboration arrangement that we enter into may prevent us from receiving any milestone, royalty payment, sharing of profits, and other benefits under such agreement. Furthermore, disagreements with these parties could require or result in litigation or arbitration, which would be time-consuming and expensive. Any of these events could have a material adverse effect on our ability to develop and commercialize any of our product candidates and may adversely impact our business, prospects, financial condition, and results of operations.

Cell-based therapies depend on the availability of reagents and specialized materials and equipment which in each case are required to be acceptable to the FDA and foreign regulatory agencies, and such reagents, materials, and equipment may not be available to us on acceptable terms or at all. We rely on third-party suppliers for various components, materials and equipment required for the conduct of our clinical trials and the manufacture of our product candidates and do not have supply arrangements for certain of these components.

The development and manufacturing of our product candidates requires many reagents and other specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production. To date, we and our CMOs have purchased equipment, materials and disposables used for the manufacture of our existing product candidates from third-party suppliers. Some of these suppliers may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs. Reagents and other key materials from these suppliers may have inconsistent attributes and introduce variability into our manufactured product candidates, which may contribute to variable patient outcomes and possible adverse events. We rely on the general commercial availability of materials and equipment required for the manufacture of our product candidates, and do not have supply contracts with many of these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all.

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Even if we are able to enter into such contracts, we may be limited to a sole third-party for the supply of certain required components and equipment.

In addition, the clinical development of our product candidates depends on the availability of certain materials and agents used in our clinical trials. For example, we intend to develop certain of our product candidates as a combination therapy with other cancer therapies, such as monoclonal antibodies, requiring availability and use of these monoclonal antibodies in certain of our clinical trial protocols. Additionally, the FDA recently reported a shortage of certain intravenous solutions which are required for the conduct of our clinical trials. We cannot predict the extent and duration of this shortage of these intravenous solutions, although any failure or delays by us or by our clinical sites to obtain sufficient quantities of materials and agents required under our protocols, or other components and agents necessary for the conduct of our clinical trials, may delay our ability to enroll and treat patients in, or complete, our current or future clinical trials of our product candidates on time, if at all.

As a result of any public health crises, the business and operations of our suppliers and other third parties which produce agents and materials used in our clinical trials or manufacturing of our product candidates may be disrupted or delayed, and we in turn may experience disruptions or delays in our supply chain. A delay or inability to continue to source product or materials from any of these suppliers or third parties, which could be due to the impacts of any public health crises, natural disasters (including due to the effects of climate change), ongoing and emerging global geopolitical tensions, including wars and other armed conflicts, regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands, or quality issues, could adversely affect our ability to manufacture our product candidates and our ability to conduct clinical trials, which could significantly harm our business.

If we are required to change suppliers, or modify the components, equipment, materials or disposables used for the manufacture of our product candidates, we may be required to change our manufacturing operations or clinical trial protocols or to provide additional data to regulatory authorities in order to use any alternative components, equipment, materials or disposables, any of which could set back, delay, or increase the costs required to complete our clinical development and commercialization of our product candidates. Additionally, any such change or modification may adversely affect the safety, efficacy, stability, or potency of our product candidates, and could adversely affect our clinical development of our product candidates and harm our business.

We currently rely on third parties to conduct certain research and development activities and clinical trials of our product candidates. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to timely develop, manufacture, obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.

We rely upon third parties, including medical institutions, clinical investigators, and clinical research organizations (CROs) for the conduct of certain research and preclinical development activities, process development and manufacturing activities, and for the conduct, management, and supervision of clinical trials of our product candidates. We do not have direct control over the activities of these third parties, and may have limited influence over their actual performance. Our reliance on these third parties and CROs does not relieve us of our responsibilities to ensure that our clinical studies are conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards.

We are responsible for complying, and we are responsible for ensuring that our third-party service providers and CROs comply, with applicable GCP for conducting activities for all of our product candidates in clinical development, including conducting our clinical trials, and recording and reporting data from these trials. Regulatory authorities enforce these regulations through periodic inspections of trial sponsors, principal investigators and trial sites. We cannot assure that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with applicable GCP requirements. In addition, our registrational clinical trials must be conducted with product produced under applicable regulatory requirements.

If these third parties and CROs do not successfully carry out their contractual duties or obligations, meet expected deadlines or successfully complete activities as planned, or if the quality or accuracy of the research, preclinical development, process development, manufacturing, or clinical data they obtain is compromised due to the failure to adhere to applicable regulatory and manufacturing requirements or for other reasons, our research, preclinical development, process development and manufacturing activities, and clinical trials, and the development of our product candidates, may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. Further, if our agreements with third parties or CROs are terminated for any reason, the development of our product candidates may be delayed or impaired, and we may be unable to advance our product candidates. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed or impaired.

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If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.

If conflicts arise between our corporate or academic collaborators or strategic partners and us, the other party may act in a manner adverse to us and could limit our ability to implement our strategies. Some of our academic collaborators and strategic partners are conducting multiple product development efforts within each area that is the subject of the collaboration with us. Our collaborators or strategic partners, however, may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations. Competing products, either developed by the collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of our collaborators’ or partners’ support for our product candidates.

Some of our collaborators or strategic partners could also become our competitors in the future. Our collaborators or strategic partners could develop competing products, preclude us from entering into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate their agreements with us prematurely, or fail to devote sufficient resources to the development and commercialization of our product candidates. Any of these developments could harm our product development efforts.

We may also rely on certain third-party vendors located in China or who are owned by or are associated with certain Chinese companies to assist in non-clinical or clinical trials or provide laboratory services. It is unknown how current or future geopolitical relationships with China or specific Chinese-owned or associated vendors may affect our ability to complete our non-clinical or clinical trials.

We currently, and may in the future, do business with one or more companies located in China, or that are owned or operated by Chinese companies to provide non-clinical or clinical trial support services. The process of changing these vendors could have an adverse impact on our current clinical development programs if they were no longer permitted to provide services or products due to geopolitical pressures, including legislative activities or executive orders aimed at prohibiting certain Chinese or Chinese-owned biotechnology companies from engaging in biotechnology or biopharmaceutical research activities. We could experience delays in finding suitable replacement service providers located outside China or not otherwise owned by or associated with Chinese companies, which could have a material adverse effect on our development activities and our business. We are unable to predict whether or when proposed legislative or executive actions would be effective, and whether such changes would materially and adversely affect our liquidity, access to capital and our ability to conduct business. Any failure on our part to comply with changing government regulations and policies could result in the loss of our ability to manufacture and develop our product candidates.

Risks Related to Our Intellectual Property

If we are unable to protect our intellectual property, or obtain and maintain patent protection for our technology and product candidates, other companies could develop products based on our discoveries, which may reduce demand for our products and harm our business.

Our commercial success will depend in part on our ability to obtain and maintain intellectual property protection for our product candidates, the operations used to manufacture them and the methods for using them, and also for our cell programming technology in order to prevent third parties from making, using, selling, offering to sell or importing our product candidates or otherwise exploiting our cell programming approach. The scope of patent protection in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. One aspect of the determination of patentability of our inventions depends on the scope and content of the “prior art,” information that was or is deemed available to a person of skill in the relevant art prior to the priority date of the claimed invention. There may be prior art of which we are not aware that may affect the patentability of our patent claims or, if issued, affect the validity or enforceability of a patent claim. Further, we may not be aware of all third-party intellectual property rights potentially relating to our product candidates or their intended uses, and as a result the impact of such third-party intellectual property rights upon the patentability of our own patents and patent applications, as well as the impact of such third-party intellectual property upon our freedom to operate, is highly uncertain. Because patent applications in the United States and most other countries are confidential for typically a period of 18 months after filing, or may not be published at all, we cannot be certain that we were the first to file any patent application related to our product candidates. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are uncertain. We own and have exclusive licenses to patent portfolios for our product candidates and cell programming technology, although we cannot be certain that our existing patents and patent applications provide adequate protection or that any additional patents will issue to us with claims that provide adequate protection of our other product candidates. Further, we cannot predict the breadth of claims that may be enforced in our patents if we attempt to enforce them or if they are challenged in court or in other proceedings. If we are unable to secure and maintain protection for our product candidates and cell programming technology, or if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our technology could be adversely affected.

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Others have filed, and in the future are likely to file, patent applications covering products and technologies that are similar, identical or competitive to ours or important to our business. Since patent applications in the United States and most other countries are confidential for a period of time after filing, and some remain so until issued, we cannot be certain that any patent application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our licensors will not be involved in interference, opposition, reexamination, review, reissue, post grant review or invalidity proceedings before U.S. or non-U.S. patent offices. The scope, validity or enforceability of our patents or the patents of our licensors may be challenged in such proceedings in either the courts or patent offices in the United States and abroad, and our business may be harmed if the coverage of our patents or the patents of our licensors is narrowed, or if a patent of ours or our licensors is judged invalid or unenforceable, in any such proceedings.

Furthermore, our intellectual property rights may be subject to a reservation of rights by one or more third parties. For example, the research resulting in certain of the patent rights and technology that we own or have licensed was funded in part by the U.S. government. As a result, the government has certain rights, including march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention or to have others use the invention on its behalf. These rights may permit the government to disclose our information to third parties and to exercise march-in rights to use or allow third parties to use our technology. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Any exercise by the government of such rights or by any third party of its reserved rights could harm our competitive position, business, financial condition, results of operations, and prospects.

We depend on our licensors to prosecute and maintain patents and patent applications that are material to our business. Any failure by our licensors to effectively protect these intellectual property rights could adversely affect our business and operations.

Certain rights to our key technologies and product candidates, including intellectual property relating to our iPSC technology, are licensed from third parties. As a licensee of third-party intellectual property, we rely on our licensors to file and prosecute patent applications and maintain patents, and otherwise protect the licensed intellectual property under some of our license agreements. We have not had and do not have primary control over these activities for certain of our licensed patents, patent applications and other intellectual property rights, and we cannot be certain that such activities will result in valid and enforceable patents and other intellectual property rights. Additionally, our licensors may have the right to control enforcement of our licensed patents or defense of any claims asserting the invalidity of these patents and we cannot be certain that our licensors will allocate sufficient resources or prioritize enforcement of such patents or defense of such claims to protect our interests in the licensed patents. Even if we are not a party to these legal actions, an adverse outcome could harm our business because it might prevent us from continuing to license intellectual property that we may need to operate our business.

If we fail to comply with our obligations under our license agreements, we could lose rights to our product candidates or key technologies.

We have obtained rights to develop, market and sell some of our product candidates through intellectual property license agreements with third parties. These license agreements impose various diligence, milestone payment, royalty and other obligations on us. In particular, under our Amended MSKCC License with MSKCC, in the event a licensed product achieves a specified clinical milestone, MSKCC is eligible to receive from us certain milestone payments totaling up to $75.0 million based on the price of our common stock, where the amount of such payments owed to MSKCC is contingent upon certain increases in the price of our common stock following the date of achievement of such clinical milestone. If we fail to comply with our obligations under our license agreements, including any payment obligations, we could lose some or all of our rights to develop, market and sell products covered by these licenses, and our ability to form collaborations or partnerships may be impaired. In addition, disputes may arise under our license agreements with third parties, which could prevent or impair our ability to maintain our current licensing arrangements on acceptable terms and to develop and commercialize the affected product candidates.

We are and may become involved in litigation or other proceedings from time to time relating to the enforcement or defense of patent and other intellectual property rights, which could cause us to divert our resources and could put our intellectual property at risk.

To prevent infringement or unauthorized use of our intellectual property, we have in the past, and may in the future, need to file infringement claims. For example, in May 2022, we filed a patent infringement lawsuit in the Southern District of California against Shoreline Biosciences, Inc. (see “Item 1. Legal Proceedings” for a more detailed description of this matter). When we pursue litigation to stop another party from using the inventions claimed in any patents we own or control, that party has the right to ask the

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court to rule that such patents are invalid or should not be enforced against that third party. In addition to patent infringement lawsuits, we may decide to file interferences, oppositions, ex parte reexaminations, post-grant review, or inter partes review proceedings before the U.S. Patent and Trademark Office (the USPTO) and corresponding foreign patent offices. Litigation and other proceedings relating to intellectual property are unpredictable and expensive and may consume time and resources and divert the attention of managerial and scientific personnel. Such litigations and proceedings could substantially increase our operating losses and reduce the resources available for research, development, and other activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings or may be required to divert such resources from our ongoing and planned research and development activities. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing or misappropriating or successfully challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

There also is a risk that a court or patent office in such proceeding will decide that our patents or the patents of our licensors are not valid or are not enforceable, and that we do not have the right to stop the other party from using the inventions. Additionally, even if the validity of such patents is upheld, the court may refuse to stop the other party on the ground that such other party’s activities do not infringe our rights to such patents. If we are not successful in enforcing or defending our intellectual property, our competitors could develop and market products based on our discoveries and technologies, which may reduce the commercial viability of, and demand for, our product candidates and any future products.

We or our strategic partners may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing, or increase the costs of commercializing, our product candidates.

Our success will depend, in part, on our ability to operate without infringing the proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions, ex parte reexaminations, post-grant review, and inter partes review proceedings before the USPTO and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights or misappropriation of other intellectual property rights of third parties.

We cannot be certain that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our product candidates in any jurisdiction. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products are not covered by a third-party patent or intellectual property rights or may incorrectly predict whether a third-party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products.

We cannot guarantee that the manufacture, use or marketing of our existing product candidates or any other product candidates that we develop, or the use of our cell programming technology, will not infringe third-party patents. There may be third-party patents or patent applications with claims to materials, cell compositions, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Our competitors may have filed, and may in the future file, patent applications covering products and technologies similar to ours. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.

Third parties asserting their patent or other intellectual property rights against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates or force us to cease some of our business operations. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business, cause development delays, and may impact our reputation. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties, or redesign our infringing products, which may be impossible on a cost-effective basis or require substantial time and monetary

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expenditure. In that event, we would be unable to further develop and commercialize our product candidates, which could harm our business significantly. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

We may not be successful in obtaining or maintaining necessary rights to product components and processes for development or manufacture of our product candidates which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.

We own or license from third parties certain intellectual property rights necessary to develop and manufacture our product candidates. The growth of our business will likely depend in part on our ability to acquire or in-license additional proprietary rights, including to advance our research or allow commercialization of our product candidates. In that event, we may be required to expend considerable time and resources to develop or license replacement technology. For example, our programs may involve additional technologies or product candidates that may require the use of additional proprietary rights held by third parties. Furthermore, other pharmaceutical or biotechnology companies and academic institutions may also have filed or may be planning to file patent applications potentially relevant to our business. From time to time, in order to avoid infringing these third-party patents, we may be required to license technology from additional third parties to further develop or commercialize our product candidates. We may be unable to acquire or in-license any relevant third-party intellectual property rights, including any such intellectual property rights required to manufacture, use or sell our product candidates, that we identify as necessary or important to our business operations. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all, and as a result we may be unable to develop or commercialize the affected product candidates, which would harm our business. We may need to cease use of the compositions or methods covered by such third-party intellectual property rights, and may need to seek to develop alternative approaches or technology that do not infringe on such intellectual property rights which may entail additional costs and development delays, even if we were able to develop such alternatives, which may not be feasible. Even if we are able to obtain a license under such intellectual property rights, any such license may be non-exclusive, which may allow our competitors’ access to the same technologies licensed to us.

Additionally, we sometimes collaborate with academic institutions to accelerate our preclinical research or development under written agreements with these institutions. Typically, these institutions provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue our program. If we are unable to successfully obtain rights to required third-party intellectual property or to maintain the existing intellectual property rights we have, we may have to abandon development of such program and our business and financial condition could suffer.

The licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that may be more established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our product candidates. More established companies may have a competitive advantage over us due to their larger size and cash resources or greater clinical development and commercialization capabilities. In addition, it may be more costly for us to secure and maintain the necessary patent protection to block third parties from using our technology than to negotiate out-licenses or similar agreements with these parties to provide them with limited rights to use our technology. There can be no assurance that we will be able to successfully complete any such negotiations and ultimately acquire or maintain, on commercially viable terms, the rights to the intellectual property required for the successful development and commercialization of our product candidates.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

•
others may be able to make product candidates that are similar to ours but that are not covered by the claims of the patents that we own or have exclusively licensed;
•
we or our licensors or future collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed;
•
we or our licensors or future collaborators might not have been the first to file patent applications covering certain of our inventions;
•
others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

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•
it is possible that our pending patent applications will not lead to issued patents;
•
issued patents that we own or have exclusively licensed may be held invalid or unenforceable, as a result of legal challenges by our competitors;
•
our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
•
we may not develop additional proprietary technologies that are patentable;
•
we cannot predict the scope of protection of any patent issuing based on our patent applications, including whether the patent applications that we own or in-license will result in issued patents with claims that cover our product candidates or uses thereof in the United States or in other foreign countries;
•
the claims of any patent issuing based on our patent applications may not provide protection against competitors or any competitive advantages, or may be challenged by third parties;
•
if enforced, a court may not hold that our patents are valid, enforceable and infringed;
•
we have initiated, and may from time to time initiate, litigation or administrative proceedings to enforce and/or defend our patent rights which will be costly whether we win or lose;
•
we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property;
•
we may fail to adequately protect and police our trademarks and trade secrets; and
•
the patents of others may have an adverse effect on our business, including if others obtain patents claiming subject matter similar to or improving that covered by our patents and patent applications.

Should any of these events occur, they could significantly harm our business, results of operations and prospects.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets.

In conducting our business operations, we have obtained confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers or other parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we could lose valuable intellectual property rights or personnel, which could adversely affect our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We may be subject to claims that former employees, collaborators, or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor. If we fail in defending any such claims, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. We may also be subject to monetary damages, and any of these outcomes could have a material adverse impact on our business.

Proprietary information and invention assignment agreements with our employees and third parties may not prevent unauthorized disclosure of our trade secrets and other proprietary information.

In addition to the protection afforded by patents, we also rely upon unpatented trade secrets and improvements, proprietary know-how, and continuing technological innovation to develop and maintain our competitive position, which we seek to protect, in part, through confidentiality agreements with our collaborators, employees and consultants. We also have invention or patent assignment agreements with our employees and some, but not all, of our collaborators and consultants. Because we expect to rely on third parties in the development and manufacture of our product candidates, we must, at times, share trade secrets with them, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

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Trade secrets, however, may be difficult to protect, and any disclosure, either intentional or unintentional, by our employees or third-party consultants and vendors that we engage to perform research, clinical trials or manufacturing activities, or misappropriation by third parties (such as through a cybersecurity breach) of our trade secrets or proprietary information could enable competitors to duplicate or surpass our technological achievements, thus eroding our competitive position in our market. Although we use reasonable efforts to protect our trade secrets, our employees or former employees, consultants, outside scientific advisors, contractors, and collaborators might intentionally or inadvertently disclose our trade secret information to competitors. In addition, competitors may otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third-party, we would have no right to prevent them from using that technology or information to compete with us. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, or misappropriation of our intellectual property by third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results, and financial condition.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with any products that we may develop and commercialize, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology and pharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Changes in the patent law in the United States could diminish the value of patents in general, thereby impairing our ability to protect our product candidates and technology.

As is the case with other biotechnology companies, our success is heavily dependent on intellectual property rights, particularly patents. Obtaining and enforcing patents in the biotechnology industry involve both technological and legal complexity, and therefore obtaining and enforcing biotechnology patents is costly, time-consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

The term of our patents may not be sufficient to effectively protect our market position and products.

Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Even if we obtain patents covering our product candidates, once the patent life has expired for a product, we may be open to competition from other products. If

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the lives of our patents are not sufficient to effectively protect our products and business, our business and results of operations will be adversely affected.

Risks Related to the Commercialization of Our Product Candidates

We do not have experience marketing any product candidates and do not have a sales force or distribution capabilities, and if our products are approved, we may be unable to commercialize them successfully.

We currently have no experience in marketing and selling therapeutic products, including obtaining and maintaining adequate pricing and reimbursements. If any of our product candidates are approved for marketing, we intend to establish marketing and sales capabilities internally or we may selectively seek to enter into partnerships with other entities to utilize their marketing and distribution capabilities. If we are unable to develop adequate marketing and sales capabilities on our own or effectively partner with third parties, our ability to generate product revenues will suffer.

The commercial success of our product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payers and others in the medical community.

The commercial success of our products, if approved for marketing, will depend in part on the medical community, patients and third-party payers accepting our product candidates as effective and safe. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. For example, in November 2023, the FDA announced that it would be conducting an investigation into reports of T-cell malignancies following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies following reports of T-cell lymphoma in patients receiving these therapies. In January 2024, the FDA determined that new safety information related to T-cell malignancies should be included in the labeling with boxed warning language on these malignancies for all BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. FDA’s investigation into CAR T-cell therapies and other similar actions could result in increased government regulation, unfavorable public perception and publicity, stricter labeling requirements for those product candidates that are approved, and a decrease in demand for any such product candidates. The degree of market acceptance of our products, if approved for marketing, will depend on a number of factors, including:

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the safety and efficacy of the products, and advantages over alternative treatments;
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the labeling of any approved product;
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the prevalence and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling;
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the clinical indications for which any product candidate is approved;
•
the emergence, and timing of market introduction, of competitive products;
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the effectiveness of our marketing strategy;
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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
•
obtaining and maintaining adequate pricing and reimbursement; and
•
sufficient third-party insurance coverage or governmental reimbursement, which may depend on our ability to provide compelling evidence that a product meaningfully improves health outcomes to support such insurance coverage or reimbursement.

The patient populations targeted by our autoimmune product candidates are also typically not at risk of near-term death, even if they may suffer life-threatening symptoms, so those patients will need to deem the benefits of cell therapy to be worth the risk of unknown potential adverse side effects. Our success in this space will depend upon physicians who specialize in the treatment of autoimmune diseases targeted by our product candidates prescribing treatments that involve the use of our product candidates in lieu of, or in addition to, existing treatments with which they are more familiar and for which greater clinical data may be available.

Even if a potential product displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be known until after it is launched. Any failure to achieve market acceptance for our product candidates will harm our business, results and financial condition.

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We expect to face uncertainty regarding the pricing of our existing product candidates and any other product candidates that we may develop. If pricing policies for our product candidates are unfavorable, our commercial success will be impaired.

Due to the novel nature of our cellular immunotherapy product candidates, we face significant uncertainty as to the pricing of any such products for which we may receive marketing approval. While we anticipate that pricing for any cellular immunotherapy product candidates that we develop will be relatively high due to their anticipated use in the prevention or treatment of life-threatening diseases where therapeutic options are limited, the biopharmaceutical industry has recently experienced significant pricing pressures. In particular, drug pricing and other healthcare costs continue to be subject to intense political and societal pressures, which we anticipate will continue and escalate on a global basis. These pressures may result in harm to our business and reputation, cause our stock price to decline or experience periods of volatility and adversely affect results of operations and our ability to raise funds.

The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates could limit our product revenues.

Our ability to commercialize any of our product candidates successfully will depend in part on the availability of coverage and reimbursement for these products from third-party payors, including government health administration authorities, private health insurers, and other managed care organizations. The availability and extent of reimbursement by governmental and private payors is essential for most patients who generally rely on third-party payors to reimburse all or part of the costs of their care, including treatments such as cellular immunotherapy. Because our product candidates represent new approaches to the treatment of cancer and autoimmune diseases, there is significant uncertainty as to the insurance coverage and reimbursement status of any product candidates for which we may receive regulatory approval. In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services (CMS), an agency within the U.S. Department of Health and Human Services. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare, and private payors tend to follow CMS determinations to a substantial degree. If reimbursement or insurance coverage is not available for our product candidates, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be sufficient to allow us to establish or maintain pricing to generate income. Factors payors consider in determining reimbursement are based on whether the product is: (i) a covered benefit under its health plan; (ii) safe, effective and medically necessary; (iii) appropriate for the specific patient; (iv) cost-effective; and (v) neither experimental nor investigational. For more information, please see “Business—Government Regulation—Coverage and Reimbursement” in our Annual Report on Form 10-K for the year ended December 31, 2023.

In addition, reimbursement agencies in foreign jurisdictions may be more conservative than those in the United States. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits. Moreover, increasing efforts by governmental and third-party payors, in the United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for our product candidates. Failure to obtain or maintain adequate reimbursement for any products for which we receive marketing approval will adversely affect our ability to achieve commercial success, and could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products, and our overall financial condition.

If the market opportunities for our product candidates are restricted or smaller than we believe they are, our revenues may be adversely affected and our business may suffer. Because the target patient populations of our product candidates may be small and variable, we must be able to successfully identify patients and capture a significant market share to achieve and maintain profitability.

We focus our research and development on product candidates for rare diseases, including cancer and autoimmune diseases. The FDA often approves new therapies initially for use in patients with relapsed or refractory disease. We expect to initially seek approval of our product candidates in these settings. Subsequently, for those products that prove to be sufficiently beneficial, if any, we would expect to seek approval in earlier lines of treatment. There is no guarantee that our product candidates, even if approved, would be approved for earlier lines of therapy, and, prior to any such approvals, we will have to conduct additional clinical trials, including potentially comparative trials against approved therapies. Certain of our product candidates also target similar patient populations as autologous cell therapy product candidates, including approved autologous CAR T products. Our therapies may not be as safe and effective as approved autologous CAR T therapies and as a result, such product candidates may only be approved for patients who are ineligible for autologous CAR T therapy.

Our projections of the number of people who have or will have the diseases we may be targeting, as well as the subset of patients with these cancers in a position to receive second or later lines of therapy and who have the potential to benefit from treatment with our product candidates, may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients in the United States, Europe and elsewhere may turn out to be lower than expected, or the

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potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates, all of which would adversely affect our results of operations and our business. Additionally, because our target patient populations may be small and variable, we may never achieve profitability without capturing a significant market share or obtaining regulatory approval for additional indications for our products.

Healthcare legislative or regulatory reform measures may have a negative impact on our business and results of operations.

In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval. Payors, whether domestic or foreign, or governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably. Additional changes that may affect our business include those governing enrollment in federal healthcare programs, reimbursement changes, rules regarding prescription drug benefits under the health insurance exchanges and fraud and abuse and enforcement. Continued implementation of the Affordable Care Act (ACA) and the passage of additional laws and regulations may result in the expansion of new programs such as Medicare payment for performance initiatives, and may impact existing government healthcare programs, such as by improving the physician quality reporting system and feedback program. For more information regarding the risks related to recently enacted and future legislation please see “Business – Government Regulation – Healthcare Reform and Other Regulatory Changes” in our Annual Report on Form 10-K for the year ended December 31, 2023.

There has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.  Specifically, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, and review the relationship between pricing and manufacturer patient programs.

The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect:

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the demand for any of our product candidates, if approved;
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the ability to set a price that we believe is fair for any of our product candidates, if approved;
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our ability to generate revenues and achieve or maintain profitability;
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the level of taxes that we are required to pay; and
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the availability of capital.

We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare drugs and services, which could result in reduced demand for our drug candidates or additional pricing pressures. Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our drugs or put pressure on our drug pricing, which could negatively affect our business, financial condition, results of operations and prospects.

In addition, the U.S. Supreme Court’s 2024 decision in Loper Bright Enterprises v. Raimondo overruled the Chevron doctrine, which for 40 years required federal courts to defer to permissible agency interpretations of statutes that are silent or ambiguous on a particular topic. In Loper Bright, the Supreme Court held that the U.S. Administrative Procedure Act requires courts to exercise their independent judgment when deciding whether an agency has acted within its statutory authority, and that courts may not defer to an agency interpretation solely because a statute is ambiguous. This landmark Supreme Court decision may invite more companies and other stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, which could undermine the FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions. We cannot predict the full impact of this decision, future judicial challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative

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action. Any such challenges, if successful, could have an impact on our business, and any such impact could be material. In addition to potential changes to regulations and agency guidance as a result of legal challenges, these decisions may result in increased regulatory uncertainty and delays in and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations.

Risks Related to Our Business and Industry

The success of our existing product candidates is substantially dependent on developments within the field of cellular immunotherapy, and specifically developments relating to the use of pluripotent or genome edited cells for the manufacture of cellular therapeutics, the majority of which are beyond our control.

Our product candidates are designed and are being developed as therapeutic entities for use as cellular immunotherapies, and all of our current product candidates are based on our novel iPSC product platform. Additionally, some of our product candidates utilize novel genome editing technologies. To date, there is limited clinical trial experience testing iPSC-derived therapeutic product candidates using genome edited cells. The fields of cellular and genome edited therapies are evolving, and as more therapeutic product candidates derived from pluripotent and genome edited cells are reviewed by regulatory authorities, regulatory authorities may impose additional requirements for approval that were not previously anticipated. There have also been several significant adverse events from gene therapy treatments in the past, including reported cases of leukemia and death. Additionally, in November 2023, the FDA announced that it would be conducting an investigation into reports of T-cell malignancies following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies following reports of T-cell lymphoma in patients receiving these therapies. In January 2024, the FDA determined that new safety information related to T-cell malignancies should be included in the labeling with boxed warning language on these malignancies for all BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. There can be no assurance that any product candidates developed from or related to our iPSC product platform or any of our research programs will not cause severe or undesirable side effects or result in significant delays or unanticipated costs, or that such development problems can be solved. Any adverse developments in the fields of cellular immunotherapy or genome edited therapy, such as FDA’s investigation into CAR T-cell therapies and other similar actions, could negatively affect our ability to develop and commercialize our product candidates.

We face intense competition in an environment of rapid technological and scientific progress from other biotechnology and pharmaceutical companies that are commercializing, have developed or may develop product candidates for the treatment of the diseases that we may target, including companies developing novel therapies and platform technologies. If these companies develop product candidates or platform technologies more rapidly than we do, if their commercialized products or product candidates are more effective, more cost effective, or have fewer side effects, or if they compete in various other aspects of our business, our ability to develop and successfully commercialize product candidates and to execute on our business plans will be adversely affected.

The biotechnology and pharmaceutical industries are intensely competitive and characterized by rapid and significant innovation, particularly in the areas of immune-oncology and the development and commercialization of cell therapies. We compete with a variety of large pharmaceutical companies, multinational biopharmaceutical companies, other biopharmaceutical companies and specialized biotechnology companies, as well as technology and/or therapeutics being developed at universities and other research institutions. Many of our competitors have greater financial and other resources, such as larger research and development staff, more experienced manufacturing organizations and facilities and greater sales and marketing organizations. Third parties are commercializing, have developed, are developing or may develop product candidates, platform technologies and processes that compete with ours. Competitive therapeutic treatments include those that have already been approved and accepted by the medical community, as well as novel treatments that are currently in preclinical or clinical development or may otherwise enter the market. We believe that a significant number of product candidates are currently under development, including various cellular immunotherapies as well as multifunctional targeted antibodies, such as bi-specific and tri-specific T-cell engagers, which may become commercially available in the future for the treatment of indications, including a variety of cancers, for which we are developing or may try to develop our product candidates. Additionally, several companies with experience and knowledge in the development of CAR T-cell therapies for oncology indications have now commenced the development of cell therapies for the treatment of autoimmune diseases where B cells may play a role in initiating or maintaining disease affected populations, and the product candidates these companies develop may be competitive with product candidates that we are developing for autoimmune diseases. Should one or more of these competing product candidates or other competing product candidates of which we are not aware receive regulatory approval or otherwise achieve clinical or commercial success, our regulatory strategy could be impaired, our ability to obtain regulatory approval could be delayed or prevented, or the market for our products may be reduced or eliminated, thereby harming or preventing our commercial success.

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Even if we successfully obtain approval for any product candidate, we will face competition based on many different factors, including the relative safety and efficacy of our product candidates, the actual or perceived quality of patient life while undergoing treatment with our product candidates, the ease with which our product candidates can be administered, the timing and scope of regulatory approvals for these product candidates, the availability and cost of manufacturing, marketing and sales capabilities, pricing, reimbursement coverage and patent positions, and the relative prioritization of our product candidates by physicians and healthcare providers among available therapies. Competing products and product candidates could present superior treatment alternatives, including by being more effective, safer, less expensive or marketed and sold more effectively than any products we may develop. Competitive products and product candidates may also make any product we develop obsolete or noncompetitive before we recover the expense of developing and commercializing such product. We could also face competition from other companies for collaboration partners, employees, advisors and service providers, which could negatively impact our ability to execute our business plans.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Our competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive or more commercially viable than any products that we may develop. Furthermore, currently approved products could be discovered to have application for treatment of our targeted disease indications or similar indications, which could give such products significant regulatory and market timing advantages over our product candidates. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours and may obtain orphan product exclusivity from the FDA for indications that we are targeting, which could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, products or technologies developed by our competitors may render our product candidates uneconomical or obsolete and we may not be successful in marketing those product candidates, once approved, against competitors.

Our ability to compete effectively with other biotechnology and pharmaceutical companies depends on our ability to distinguish our company and our product candidates from our competitors and their product candidates.

Some of our competitors may have, and new competitors or alliances may emerge that have, greater name and brand recognition, greater market share, a larger customer base, more widely adopted proprietary technologies, greater marketing expertise, larger sales forces, and/or significantly greater resources than we do and may be able to offer solutions competitive with ours at a more attractive price. Further, our current or potential competitors may be acquired by third parties with greater available resources. As a result, our competitors may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements and may have the ability to initiate or withstand substantial price competition. In addition, our competitors may in the future establish cooperative relationships with vendors of complementary products, technologies or services to increase the availability of their solutions in the marketplace. Our competitors could also be better positioned to serve certain segments of our market, which could create additional price pressure. In light of these factors, even if any products that we may develop are more effective than those of our competitors, current or potential customers may accept competitive products in lieu of purchasing our products. If we are unable to successfully compete, our business, financial condition, and results of operations could be materially and adversely affected.

The loss of any member of our senior management team or our inability to attract and retain key personnel and consultants could adversely affect our business.

We may not be able to retain or attract qualified management, finance, scientific and clinical personnel and consultants due to the intense competition for a limited number of qualified personnel and consultants among biotechnology, pharmaceutical and other businesses. The loss of any members of our senior management team, including the resignation of our former chief financial officer effective in June 2024, could adversely impact our operations if we experience difficulties in recruiting and hiring qualified successors. We may also experience difficulties in attracting or retaining personnel with sufficient experience and skills in the complex and emerging field of cellular therapeutic development and manufacture to support our ongoing and planned clinical development activities. We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants. There can be no assurance that the services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. We may also be subject to penalties or other liabilities if we misclassify employees as consultants. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonable terms, or at all.

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Many of the biotechnology and pharmaceutical companies that we compete against for qualified personnel have greater financial and other resources and different risk profiles than we do. We may be required to provide compensation in excess of historical levels in order to recruit and retain personnel in the current market. If we are not able to retain and attract necessary personnel and consultants to perform the requisite operational roles and accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.

If we engage in an acquisition, reorganization or business combination, we will incur a variety of risks that could adversely affect our business operations or our stockholders.

From time to time, we have considered, and we will consider in the future, strategic business initiatives intended to further the expansion and development of our business. These initiatives may include acquiring businesses, technologies or products or entering into business combinations with other companies. If we pursue such a strategy, we could, among other things:

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issue equity securities that would dilute our current stockholders’ percentage ownership;
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incur substantial debt that may place strains on our operations;
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spend substantial operational, financial and management resources to integrate new businesses, technologies and products;
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assume substantial actual or contingent liabilities;
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reprioritize our development programs and even cease development and commercialization of our product candidates; or
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merge with, or otherwise enter into a business combination with, another company in which our stockholders would receive cash or shares of the other company on terms that certain of our stockholders may not deem desirable.

Although we intend to evaluate and consider acquisitions, reorganizations and business combinations in the future, we have no agreements or understandings with respect to any acquisition, reorganization or business combination at this time.

We face potential product liability exposure far in excess of our limited insurance coverage.

The use of our product candidates in clinical trials, and the sale of any products for which we obtain marketing approval, exposes us to the risk of product liability claims. Product liability claims might be brought against us by participants in clinical trials, hospitals, medical centers, healthcare providers, pharmaceutical companies, and consumers, or by others selling, manufacturing or otherwise coming into contact with our product candidates. We carry product liability insurance and we believe our product liability insurance coverage is sufficient in light of our current clinical programs. In addition, if and when we obtain marketing approval for product candidates, we intend to expand our insurance coverage to include the sale of commercial products; however, we may be unable to obtain insurance coverage for any approved products on commercially reasonable terms or in sufficient amounts to protect us against losses due to liability.

On occasion, large judgments have been awarded in class action lawsuits based on drugs or medical treatments that had unanticipated adverse effects. In addition, under some of our agreements with clinical trial sites, we are required to indemnify the sites and their personnel against product liability and other claims. A successful product liability claim, or a series of claims, brought against us or any third parties whom we are required to indemnify could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business.

Patients with the diseases targeted by our product candidates are often already in severe and advanced stages of disease and have both known and unknown significant pre-existing and potentially life-threatening health risks. During the course of treatment, patients may suffer adverse events, including death, for a variety of reasons. Such events, whether or not resulting from our product candidates, could subject us to costly litigation, require us to pay substantial amounts of money to injured patients, delay, negatively affect or end our opportunity to receive or maintain regulatory approval to market our products, or require us to suspend or abandon our commercialization efforts. Even in a circumstance in which we do not believe that an adverse event is related to our products, the investigation into the circumstance may be time-consuming or inconclusive. These investigations may interrupt our development and commercialization efforts, delay our regulatory approval process, or impact and limit the type of regulatory approvals our product candidates receive or maintain. As a result of these factors, a product liability claim, even if successfully defended, could have a material adverse effect on our business, financial condition or results of operations.

Our insurance policies are expensive and protect us from only some risks, which leaves us exposed to significant uninsured liabilities.

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We do not carry insurance for all categories of risk to which our business is or may be exposed. Some of the policies we maintain include general liability, product liability, property, employee benefits liability, employment practices, workers’ compensation, cybersecurity, directors’ and officers’ insurance, and umbrella. We do not know, however, if we will be able to maintain insurance coverage at a reasonable cost or in sufficient amounts or scope to protect us against losses. Even if we obtain insurance, a claim could exceed the amount of our insurance coverage or it may be excluded from coverage under the terms of the policy. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations.

Our employees or third party service providers may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.

We are exposed to the risk of employee or third party service provider fraud or other misconduct. Misconduct by employees or third party service providers could include intentional failures to comply with the regulations of the FDA or foreign regulators, to provide accurate information to the FDA or foreign regulators, to comply with healthcare fraud and abuse laws and regulations in the United States and abroad, to report financial information or data accurately or to disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. Employee or third party service provider misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. If any actions alleging such conduct are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant effect on our business, including the imposition of significant fines or other sanctions.

Our business could be negatively affected by cyberattacks or a deficiency in our cybersecurity system and infrastructure.

A cyberattack or similar incident could occur and result in information theft, data corruption, operational disruption, damage to our reputation, or financial loss. We are increasingly dependent on information technology systems and infrastructure, including mobile technologies, to operate our business. Our technologies, systems, networks, or other proprietary information, and those of our vendors, suppliers and other business partners, may become the target of cyberattacks or information security breaches that could result in the unauthorized release, gathering, monitoring, misuse, loss, or destruction of proprietary and other information, or could otherwise lead to the disruption of our business operations. The risk of a security breach or disruption, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. Moreover, certain cyber incidents, such as surveillance, may remain undetected for an extended period and could lead to disruptions in critical systems or the unauthorized release of confidential or otherwise protected information. These events could lead to financial loss due to remedial actions, loss of business, disruption of operations, damage to our reputation, or potential liability. Our systems and insurance coverage for protecting against cybersecurity risks may not be sufficient. Furthermore, as cyberattacks continue to evolve, we may be required to expend significant additional resources to continue to modify or enhance our protective measures or to investigate and remediate any vulnerability to cyberattacks.

We face risks of potential liability related to the privacy of personal information, including health information we utilize in the development of our products, as well as information we obtain from clinical trials sponsored by us from research institutions and directly from individuals.

We and our partners and vendors may be subject to various federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators, including the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) and privacy and security requirements under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH). Depending on the facts and circumstances, we could be subject to civil, criminal, and administrative penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. There is no certainty that all of our employees, agents, suppliers, manufacturers, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Even when HIPAA does not apply, failing to take appropriate steps to keep consumers’ personal information secure may constitute a violation of the Federal Trade Commission Act. In addition, certain of the materials we use as starting material in our iPSC-derived product candidates are derived from human sources, which potentially contain sensitive identifiable personal information regarding the donor. In addition, in conducting our clinical trials, we may maintain sensitive identifiable personal information, including health information, that we receive throughout the clinical trial process, in the course of

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our research collaborations, and directly from individuals (or their healthcare providers) who enroll in our clinical trials. As such, we may become subject to further obligations under HIPAA. Our collection of personal information generally (e.g., of employees currently and/or of patients in the future) may subject us to state data privacy laws governing the processing of personal information and requiring notification of affected individuals and state regulators in the event of a breach of such personal information. These state laws include the California Consumer Privacy Act, as amended by the California Privacy Rights Act (the CCPA), which establish data privacy rights for residents of the State of California, with corresponding obligations on businesses related to transparency, deletion rights, and opt-out of the selling or sharing of personal information, and grants a private right of action for individuals in the event of certain security breaches. Similar laws relating to data privacy and security have passed in several other states, which may have potentially conflicting requirements that would make compliance challenging, require us to expend significant resources to come into compliance, and restrict our ability to process certain personal information.

Certain state laws may be more stringent or broader in scope than the CCPA, or offer greater individual rights, with respect to confidential, sensitive and personal information than federal, international or other state laws, and such laws may differ from each other, which may complicate compliance efforts.

An increasing number of foreign data protection laws, regulations and industry standards may also apply to personal information we obtain from individuals outside of the United States. For example, the European Union’s General Data Protection Regulation (EU GDPR) and the United Kingdom’s General Data Protection Regulation (UK GDPR) impose strict requirements for processing the personal data of individuals within the EEA and UK, including health-related data, and on the transfer of personal data out of the European Economic Area (EEA) and United Kingdom (UK) to non-adequate territories such as the United States; any inability to transfer personal data from the EEA and UK to the United States in compliance with data protection laws may impede our ability to conduct trials and may adversely affect our business and financial position. Failure to comply with the requirements of the EU GDPR may result in potential fines for companies of up to the greater of €20 million (£17.5 million for the UK GDPR) or 4% of annual global revenue and other administrative penalties. In addition, under the EU GDPR and UK GDPR, companies may face private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to protect their interests. Although the EU GDPR and the UK GDPR currently impose substantially similar obligations, it is possible that over time the UK GDPR could become less aligned with the EU GDPR, particularly with the introduction of the new Data Reform Bill into the UK legislative process. In addition, EEA Member States have adopted national laws to supplement the EU GDPR, which may partially deviate from the EU GDPR, and the competent authorities in the EEA Member States may interpret EU GDPR obligations slightly differently from country to country, such that we do not expect to operate in a uniform legal landscape in the EEA and UK with respect to data protection regulations. The potential of the respective provisions and enforcement of the EU GDPR and UK GDPR further diverging in the future creates additional regulatory challenges and uncertainties for us. The lack of clarity on future UK laws and regulations and their interaction with EU laws and regulations could add legal risk, uncertainty, complexity and compliance cost to the handling of European personal data and our privacy and data security compliance, and could require us to amend our processes and procedures to implement different compliance measures for the UK and the EEA.

We are likely to be required to expend significant capital and other resources to ensure ongoing compliance with applicable data privacy and security laws. Claims that we have violated individuals’ privacy rights or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend, and could result in adverse publicity that could harm our business. Moreover, even if we take all necessary action to comply with legal and regulatory requirements, we could be subject to a data breach or other unauthorized access of personal information, which could subject us to fines and penalties, as well as litigation and reputational damage. If we fail to keep apprised of and comply with applicable international, federal, state, or local regulatory requirements, we could be subject to a range of regulatory actions that could affect our or any collaborators’ ability to seek to commercialize our clinical candidates. Any threatened or actual government enforcement action or litigation could also generate adverse publicity, damage our reputation, result in liabilities, fines and loss of business, and require that we devote substantial resources that could otherwise be used in other aspects of our business.

We make public statements about our use and disclosure of personal information through our privacy policy information provided on our internet platform and press statements. Although we endeavor to comply with our public statements and documentation, we may at times fail to do so or be alleged to have failed to do so. Moreover, despite our efforts, we may not be successful in achieving compliance if our employees or contractual partners fail to comply with our published policies, certifications and documentation. The publication of our privacy policy and other statements that provide promises and assurances about data privacy and security can subject us to potential government or legal action if they are found to be deceptive, unfair or misrepresentative of our actual practices. Any failure, real or perceived, by us to comply with our posted privacy policies or with any legal or regulatory requirements, standards, certifications or orders or other privacy or consumer protection-related laws and regulations applicable to us could cause our prospective customers to reduce their use of our products and could materially and adversely affect our business, financial condition and results of operations. In many jurisdictions, enforcement actions and consequences for non-compliance can be significant and are rising. In addition, from time to time, concerns may be expressed about whether our products or processes compromise the privacy of customers and others. Concerns about our practices with regard to the

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collection, use, retention, security, disclosure, transfer and other processing of personal information or other privacy-related matters, even if unfounded, could damage our reputation and materially and adversely affect our business, financial condition and results of operations.

Many statutory requirements, both in the United States and abroad, include obligations for companies to notify individuals of security breaches involving certain personal information, which could result from breaches experienced by us or our third-party service providers. For example, laws in all 50 U.S. states and the District of Columbia require businesses to provide notice to consumers whose personal information has been disclosed as a result of a data breach. These laws are not consistent, and compliance in the event of a widespread data breach is difficult and may be costly. We also may be contractually required to notify customers or other counterparties of a security breach. Although we may have contractual protections with our third-party service providers, contractors and consultants, any actual or perceived security breach could harm our reputation and brand, expose us to potential liability or require us to expend significant resources on data security and in responding to any such actual or perceived breach or security incident. Any contractual protections we may have from our third-party service providers, contractors or consultants may not be sufficient to adequately protect us from any such liabilities and losses, and we may be unable to enforce any such contractual protections.

In addition to the possibility of fines, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded in a manner that requires changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively impact our business. Complying with these various laws could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. Any inability to adequately address data privacy or security-related concerns, even if unfounded, or to comply with applicable laws, regulations, standards and other obligations relating to data privacy and security, could result in additional cost and liability to us, harm our reputation and brand, damage our relationships with contract partners and the physician and patient community and have a material and adverse impact on our business.

Our internal computer systems, or those used by our third-party research institution collaborators, CROs or other contractors or consultants, may fail or suffer security breaches.

Despite the implementation of security measures, our internal computer systems and those of our CROs and other contractors, vendors, and consultants may be vulnerable to damage from cybersecurity risks, including attempts to gain unauthorized access to and to harm sensitive or confidential information and networks, insider threats, and ransomware. These vulnerabilities may be heightened as a result of flexible work arrangements, including hybrid or remote work policies implemented by us and our third-party contractors, that were first adopted in response to the COVID-19 pandemic and have continued by many businesses in an effort to attract and retain talent.

We have from time to time experienced, and may continue to experience in the future, cyber-attacks on our information technology systems despite our best efforts to prevent them. Although such incidents have been immaterial to our business to date, investigations into and remedial efforts in connection with any security incidents, even those with immaterial impact, can be costly and time-consuming, and any future incidents could be material, or cause significant disruption, to our business. For example, the loss of clinical trial data from completed, ongoing or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on third parties for research and development, the manufacture and supply of drug product and drug substance and to conduct clinical trials. We depend on these third parties to implement adequate controls and safeguards to protect against and report cybersecurity incidents. If they fail to do so, we may suffer financial and other harm, including to our information, operations, performance, and reputation. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or systems, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed.

Cybersecurity threats, both on premises and in the cloud, are evolving and include, but are not limited to: malicious software, destructive malware, ransomware, attempts to gain unauthorized access to systems or data, disruption to operations, critical systems or denial of service attacks; unauthorized release of confidential, personal or otherwise protected information; corruption of data, networks or systems; harm to individuals; and loss of assets. In addition, we could be impacted by cybersecurity threats or other disruptions or vulnerabilities found in products or services we use that are provided to us by third-parties. The techniques used by criminal elements to attack computer systems are sophisticated, change frequently and may originate from less regulated and remote areas of the world. As a result, we may not be able to address these techniques proactively or implement adequate preventative measures. These events, if not prevented or effectively mitigated, could damage our reputation, require remedial actions and lead to loss of business, regulatory actions, potential liability and other financial losses.

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特定のデータ侵害は、 HITECH 、その他の米国連邦法および州法によって改正された HIPAA の規定、および欧州連合データ保護指令を含む米国以外の管轄区域の要件に基づき、影響を受けた個人および様々な政府および / または規制機関、および場合によってはメディアにも報告する必要があり、金銭的罰則も適用される場合があります。

当社の保険契約は、当社のインフラの侵害、故障または中断、壊滅的な事象および災害などによって生じる潜在的な損失を補償するのに十分でない場合があります。また、かかる保険は、将来的に経済的に合理的な条件で、または全く利用できない場合があります。さらに、当社の保険は当社に対して提出されたすべての請求をカバーしない可能性があり、訴訟のメリットにかかわらず、訴訟を弁護することは費用がかかり、経営陣の注意をそらす可能性があります。

FDA 、証券取引委員会 （ SEC ） およびその他の政府機関に対する資金不足は、政府の閉鎖、またはこれらの機関の業務の他の混乱によるものを含め、主要な指導者やその他の要員を雇用し維持する能力を妨げる可能性があります。新製品のタイムリーな開発または商業化を妨げるか、その他の方法でそれらの代理店が業務の運営を担う通常の業務機能を遂行することを妨げる。事業に悪影響を及ぼす可能性があります

FDA が新製品を審査 · 承認する能力は、政府の予算や資金レベル、主要要員を雇用 · 維持し、ユーザー料の支払いを受け付ける能力、法定 · 規制 · 政策の変更など、さまざまな要因によって影響を受ける可能性があります。これらの要因の結果、近年、機関における平均審査時間は変動しています。また、 FDA やその他の機関での混乱は、新製品候補が必要な政府機関による審査および / または承認に必要な時間を遅らせ、当社の事業に悪影響を及ぼす可能性があります。さらに、 SEC や研究開発活動に資金を供給する政府機関を含む当社の事業が依存するその他の政府機関に対する政府資金は、本質的に流動的で予測不可能な政治的プロセスの対象となります。

また、 FDA やその他の機関での混乱は、新製品候補が必要な政府機関による審査および / または承認に必要な時間を遅らせ、当社の事業に悪影響を及ぼす可能性があります。例えば、過去数年間にわたって米国政府は何度か閉鎖され、 FDA や SEC などの特定の規制機関は、重要な FDA 、 SEC およびその他の政府職員を休暇を与え、重要な活動を停止しなければなりませんでした。長期にわたる政府閉鎖が発生した場合、 FDA の規制提出をタイムリーに審査 · 処理する能力に大きな影響を与える可能性があります。さらに、将来の政府閉鎖は、当社の公的市場へのアクセスや適切な資本調達と事業継続に必要な資本調達に影響を与える可能性があります。

私たちの普通株式所有権に関連するリスク

当社の株価は、業績に関係なく、変動または下落する可能性があります。

当社の普通株式の市場価格は、過去に変動しており、本項に記載されている多くのリスクおよびその他の当社のコントロールを超えたリスクの結果、将来的に大きく変動する可能性があります。

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現在および計画されている臨床試験および前臨床試験の開始時期および進捗状況
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当社の臨床試験および前臨床試験の結果、および当社と同様の製品候補または適応症に関する他者による臨床試験および前臨床試験の結果。
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FDA または細胞免疫療法全般に適用される規制、特に当社の製品候補に関連する進展 （ 規制経路および承認のための臨床試験要件を含むがこれらに限定されない ） 。
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当社または競合他社による重要な買収、戦略的パートナーシップ、ジョイントベンチャー、コラボレーションまたは資本コミットメントの発表 （ 2023 年 1 月のヤンセンとのコラボレーション終了の発表など ） 。
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特許、訴訟問題、当社の技術に対する特許保護を得る能力を含む所有権に関する進展。
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主要な管理職や科学者の増員や離職
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当社の研究開発活動および競合他社との関係を含む事業見通しの実際または予想される変化
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免疫療法の分野における当社の技術革新や新しい治療製品の開発
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追加の株式または債務ファイナンス努力の発表または期待
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当社または当社のインサイダーまたはその他の株主による普通株式の販売

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株価と出来高の変動は、私たちの株の出来高水準が一致しないことに起因する
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証券アナリストのコメント
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業績の変動 （ 業績報酬からの株式報酬に関する変更を含む ） 。
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acts of war or periods of widespread civil unrest, including the increasingly volatile global economic conditions resulting from the ongoing global geopolitical tensions, including wars and other armed conflicts; and
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general economic and market conditions, including inflationary pressures and stock market volatility.

These and other market and industry factors, including the effects of any future public health crises or other public health concerns, wars or other armed conflicts, the outcome of the 2024 presidential election in the United States or similar events, and global economic conditions, may cause the market price and demand for our common stock to fluctuate substantially regardless of our actual operating performance, which may limit or prevent investors from readily selling their shares of common stock and may otherwise negatively affect the liquidity of our common stock.

Changes in our stock price may also trigger financial obligations under our licensing arrangements. For example, pursuant to the terms of the Amended MSKCC License, MSKCC is eligible to receive from us certain milestone payments totaling up to $75.0 million based on the price of our common stock, where the amount of such payments owed to MSKCC is contingent upon certain increases in the price of our common stock following the date of achievement of a specified clinical milestone. In July 2021, we achieved the specified clinical milestone for a licensed product under the Amended MSKCC License and our ten-trading day trailing average common stock price exceeded the first, pre-specified threshold. Accordingly, MSKCC received the first milestone payment of $20.0 million in November 2021; however, uncertainty of the price of our common stock results in an inability to ascertain the precise timing of any remaining future milestone payments in advance.

Additionally, a decrease in our stock price may cause our common stock to no longer satisfy the continued listing standards of Nasdaq. If we are not able to maintain the requirements for listing on Nasdaq, our common stock could be delisted, which could have a materially adverse effect on our ability to raise additional funds as well as the price and liquidity of our common stock.

Our principal stockholders and management own a significant percentage of our stock and may be able to exercise significant control over our company.

As of November 5, 2024, our executive officers, directors and entities affiliated with our five percent stockholders beneficially own, in the aggregate, shares representing approximately 44.0% of our outstanding voting stock. If, in accordance with the CoD (as such term is defined in Note 8 of the notes to the consolidated financial statements herewith) relating to the Class A Convertible Preferred Stock, Redmile (as such term is defined in Note 8 of the notes to the consolidated financial statements herewith) elects to remove certain limitations on the percentage of our outstanding common stock that it may own such that the 2,761,108 shares of Class A Convertible Preferred Stock currently held by Redmile become fully convertible at Redmile’s option into 13,805,540 shares of common stock, the beneficial ownership of our executive officers, directors and entities affiliated with our five percent stockholders would increase to 47.9%. Although we are not aware of any voting arrangements in place among these stockholders, if these stockholders were to choose to act together, as a result of their stock ownership, they would be able to influence our management and affairs and control all matters submitted to our stockholders for approval, including the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This concentration of ownership may have the effect of delaying or preventing a change in control of our company that our other stockholders may believe are in their best interests, or adversely affecting the liquidity, volatility, and market price of our common stock. For example, if any of our directors, executive officers or other entities affiliated with our five percent stockholders elect to sell, transfer or otherwise dispose of a significant amount of shares of our common stock, this could result in a decrease in our stock price. Furthermore, any transferees or successors of all or a significant portion of our existing stockholders’ ownership in us will be able to exert a similar amount of control over us through their ownership position.

We may sell additional equity or debt securities or enter into other arrangements to fund our operations, which may result in dilution to our stockholders and impose restrictions or limitations on our business.

We expect that significant additional capital will be needed in the future to continue our planned operations, and we may seek additional funding through a combination of equity offerings, debt financings, state or government grants, strategic alliances, licensing and collaboration arrangements, or other third-party business arrangements. These financing activities may have an adverse effect on our stockholders’ rights, the market price of our common stock and on our operations and may require us to relinquish rights to some of our technologies, intellectual property or product candidates, issue additional equity or debt securities, or otherwise agree to terms

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unfavorable to us. Further, in November 2023, we filed a registration statement on Form S-3 pursuant to which we were initially eligible to issue and sell up to $300.0 million in common stock, preferred stock, debt securities, warrants and/or units, in one or more series or classes, including up to $100.0 million in shares of common stock that may be issued in sales deemed to be an “at the market offering” as defined by the Securities Act of 1933, as amended (the Securities Act). In March 2024, we issued and sold 14,545,454 shares of our common stock at a purchase price of $5.50 per share in an underwritten offering pursuant to the shelf registration statement for aggregate gross proceeds of approximately $80.0 million. Accordingly, we are currently eligible to issue an aggregate of approximately $220.0 million under the shelf registration statement (including the $100.0 million issuable in “at the market offerings”). Any sale or issuance of securities pursuant to a registration statement or otherwise may result in dilution to our stockholders and may cause the market price of our stock to decline, and new investors could gain rights superior to our existing stockholders. In addition, any debt financings that we may enter into in the future may subject us to unfavorable repayment terms, including increased interest rates, impose restrictive covenants or otherwise adversely affect the holdings or the rights of our stockholders, and any additional equity financings will be dilutive to our stockholders. Furthermore, additional equity or debt financing might not be available to us on reasonable terms, if at all.

A significant portion of our total outstanding shares may be sold into the market in the near future, which could cause the market price of our common stock to drop significantly.

Sales of a substantial number of shares of our common stock in the public market could occur at any time. A significant portion of our outstanding shares of common stock are held by a small number of stockholders, including our directors, officers and significant stockholders. Sales by our stockholders of a substantial number of shares, or the expectation that such sales may occur, could significantly reduce the market price of our common stock.

For example, we registered all of the 5,250,000 shares of common stock issued by us in our August 2016 private placement transaction for resale on a Form S-3, which was declared effective by the SEC in September 2016. We also registered all of the 6,766,915 shares of common stock issued by us and all 14,097,745 shares of common stock issuable upon the conversion of an aggregate of 2,819,549 shares of Class A Convertible Preferred Stock issued by us in our November 2016 private placement transaction for resale on a Form S-3, which was declared effective by the SEC in January 2017. Additionally, we have registered the shares of common stock issued to Johnson & Johnson Innovation – JJDC, Inc. under the stock purchase agreement entered into in June 2020 in connection with the Janssen Agreement pursuant to a registration statement on Form S-3. Moreover, we registered all of the 5,380,117 shares of common stock issued by us and all of the 257,310 prefunded warrants to purchase common stock in our public offering in January 2021. We registered all of the 14,545,454 shares of common stock issued by us in our underwritten offering in March 2024. In addition, we registered for resale all of the 3,636,364 shares of common stock issuable upon exercise of the pre-funded warrants sold in the concurrent private placement in March 2024.

We have also registered or intend to register all shares of our common stock subject to options, restricted stock units or other equity awards issued or reserved for future issuance under our equity incentive plans. As a result, these shares will be available for sale in the public market subject to vesting arrangements and exercise of options, and restrictions under applicable securities laws. In addition, certain of our executive officers, directors, employees and affiliates have established and may in the future establish programmed selling plans under Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the Exchange Act), for the purpose of effecting sales of our common stock. If any of these events cause a large number of our shares to be sold in the public market, the sales could reduce the trading price of our common stock and impede our ability to raise future capital.

Provisions of Delaware law or our charter documents could delay or prevent an acquisition of our company, and could make it more difficult for you to change management.

Provisions of Delaware law, our amended and restated certificate of incorporation, and our amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions may also prevent or delay attempts by stockholders to replace or remove our current management or members of our board of directors. These provisions include:

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a classified board of directors with limitations on the removal of directors;
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advance notice requirements for stockholder proposals and nominations;
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the inability of stockholders to act by written consent or to call special meetings;
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the ability of our board of directors to make, alter or repeal our amended and restated bylaws; and
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the authority of our board of directors to issue preferred stock with such terms as our board of directors may determine.

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In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which limits the ability of stockholders owning in excess of 15% of our outstanding voting stock to merge or combine with us. Any provision of our amended and restated certificate of incorporation or amended and restated bylaws or Delaware law that has the effect of delaying or discouraging a potential acquisition proposal or tender offer could limit the opportunity for our stockholders to achieve liquidity for their shares of our common stock, even if the acquisition proposal or tender offer is at a premium over the then-current market price for our common stock, and could also affect the price that some investors are willing to pay for our common stock.

Our amended and restated bylaws designate the Court of Chancery of the State of Delaware and the U.S. federal district courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to litigate disputes with us in a different judicial forum.

Pursuant to our amended and restated bylaws, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of our directors, officers, or employees to us or our stockholders; (iii) any action asserting a claim against us arising pursuant to any provision of the General Corporation Law of the State of Delaware, our amended and restated certificate of incorporation or our amended and restated bylaws; or (iv) any action asserting a claim governed by the internal affairs doctrine. This exclusive forum provision will not apply to any causes of action arising under the Securities Act. Unless we consent in writing to the selection of an alternate forum, the U.S. federal district courts shall be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. The forum selection clause in our amended and restated bylaws may limit our stockholders’ ability to litigate disputes with us in a different judicial forum. While the Delaware courts have determined that these types of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we may incur significant additional costs associated with resolving the dispute in other jurisdictions, and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

We currently qualify as a “smaller reporting company” and a “non-accelerated filer,” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to such companies could make our common shares less attractive to investors.

As a result of our public float (the market value of our common shares held by non-affiliates) as of June 30, 2024, we qualify as a “smaller reporting company,” as defined under the Exchange Act. In addition, we are a “non-accelerated filer” as defined under the Exchange Act. For as long as we continue to be a smaller reporting company or a non-accelerated filer, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies that are not smaller reporting companies or non-accelerated filers, as applicable, including, but not limited to, an exemption from the requirement that our independent registered public accounting firm attest to the design and operating effectiveness of our internal controls over financial reporting under Section 404(b) of the Sarbanes-Oxley Act.

If we choose to rely on any of these reporting and disclosure exemptions, the information we provide stockholders will be different than the information that is available with respect to many other public companies. Moreover, if some investors find our common stock less attractive as a result of any choices to reduce future disclosure or have an independent review and attestation of our internal control over financial reporting, there may be a less active trading market for our common stock and the market price of our common stock may be more volatile.

Our ability to use our net operating loss carryforwards and certain other tax benefits may be limited and, as a result, our future tax liability may increase.

As of December 31, 2023, we had federal and California net operating loss carryforwards of $526.4 million and $522.1 million, respectively, some of which begin to expire in various amounts in 2027 and 2028, respectively. As of December 31, 2023, we also had federal and California research and development tax credit carryforwards of $40.3 million and $34.7 million, respectively. The federal research and development tax credit carryforwards will begin to expire in 2035 unless previously utilized, while the California carryforwards will carry forward indefinitely. These net operating loss and tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities. In addition, in general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses (NOLs) or tax credits, or NOLs or credits, to offset future taxable income or taxes. Generally, a change of more than 50 percentage points in the ownership of a corporation’s stock, by value, over a three-year period constitutes an ownership change for U.S. federal income tax purposes. We have determined that we triggered an ownership change limitation in November 2009 and again in May 2015. We have determined that we do not believe there were any ownership changes from May 2015 through

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December 2023. We have not analyzed periods subsequent to December 2023. We may experience additional ownership changes as a result of shifts in our stock ownership in the future. Limits on our ability to use our pre-change NOLs or credits to offset U.S. federal taxable income could potentially result in increased future tax liability to us if we earn net taxable income in the future. The amount of NOLs generated in taxable periods beginning after December 31, 2023, that we are permitted to deduct in any taxable year is limited to 80% of our taxable income in such year, where taxable income is determined without regard to the NOL deduction itself. U.S. federal and certain state NOLs generated in taxable years beginning after December 31, 2017 are not subject to expiration.

General Risk Factors

We are and could be further subject to securities class action litigation and other types of stockholder litigation.

The stock market in general, and the Nasdaq Global Market and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. For example, in January 2023, a purported stockholder filed a lawsuit against us and certain of our officers captioned Hadian v. Fate Therapeutics, Inc. et al. in the U.S. District Court for the Southern District of California and two derivative actions were filed in the same court in June 2023 and June 2024, respectively (see “Item 1. Legal Proceedings” for a more detailed description of this matter). We could also be subject to other types of litigation, which may involve claims of breach of fiduciary duties by our directors or officers for misuse/mismanagement of company assets/resources or conflicts of interest. Any such litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results, or financial condition. Additionally, the dramatic increase in the cost of directors’ and officers’ liability insurance may cause us to opt for lower overall policy limits or to forgo insurance that we may otherwise rely on to cover significant defense costs, settlements, and damages awarded to plaintiffs.

Our business operations may subject us to disputes, claims and lawsuits, which may be costly and time-consuming and could materially and adversely impact our financial position and results of operations.

From time to time, we may become involved in disputes, claims and lawsuits relating to our business operations. For example, we have in the past and we may, from time to time, face or initiate claims related to intellectual property matters, employment matters, or commercial disputes. Any dispute, claim or lawsuit may divert management’s attention away from our business, we may incur significant expenses in addressing or defending any dispute, claim or lawsuit, and we may be required to pay damage awards or settlements or become subject to equitable remedies that could adversely affect our operations and financial results. Litigation related to these disputes may be costly and time-consuming and could materially and adversely impact our financial position and results of operations if resolved against us. In addition, the uncertainty associated with litigation could lead to increased volatility in our stock price.

Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.

Our ability to invest in and expand our business and meet our financial obligations, to attract and retain third-party contractors and collaboration partners and to raise additional capital depends on our operating and financial performance, which, in turn, is subject to numerous factors, including the prevailing economic and political conditions and financial, business, regulatory and other factors beyond our control, such as the rate of unemployment, rate of inflation, the number of uninsured persons in the United States, political influences and inflationary pressures, and fluctuations in costs, particularly due to changes in labor costs and material costs. For example, an overall decrease in or loss of insurance coverage among individuals in the United States due to high levels of unemployment, underemployment or the repeal of certain provisions of the ACA may decrease the demand for healthcare services and pharmaceuticals. If fewer patients are seeking medical care because they do not have insurance coverage or are unable to obtain medical care for their conditions due to resource constraints on the healthcare system, we may experience difficulties in any eventual commercialization of our product candidates and our business, results of operations, financial condition and cash flows could be adversely affected. In addition, if we are unable to manage cost fluctuations and inflationary pressures, including prices of materials, costs of labor, it may adversely impact our operating performance, expenses and results.

In addition, our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets upon which pharmaceutical and biopharmaceutical companies such as us are dependent for sources of capital. In the past, global financial crises have caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn, ongoing and emerging global geopolitical tensions, including wars or other armed conflicts, interest rate fluctuations, rising inflation rates or recession, could result in a variety of risks to our business, including a reduced ability to raise additional capital when needed on acceptable terms, if at all, and weakened demand for our product candidates. A weak or declining

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economy, and rising inflation could also strain our suppliers, possibly resulting in supply disruption. Additionally, the outcome of the 2024 U.S. Presidential election and resulting changes to the administration or governmental policies could cause additional legal, political and economic uncertainty. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which ongoing wars and other armed conflicts, current economic climate and financial market conditions could adversely impact our business.

Volatility in capital markets and lower market prices for our securities may affect our ability to access new capital through sales of shares of our common stock or issuance of indebtedness, which may harm our liquidity, limit our ability to grow our business, pursue acquisitions or improve our operating infrastructure and restrict our ability to compete in our markets.

Our operations consume substantial amounts of cash, and we intend to continue to make significant investments to support our business growth, respond to business challenges or opportunities, develop new product candidates, retain or expand our current levels of personnel, improve our existing products, enhance our operating infrastructure, and potentially acquire complementary businesses and technologies. Our future capital requirements may be significantly different from our current estimates and will depend on many factors, including the need to:

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finance unanticipated working capital requirements;
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continue the research and development or our existing product candidates and develop or enhance our technological infrastructure;
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pursue acquisitions, in-licenses or other strategic relationships; and
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respond to competitive pressures.

Accordingly, we may need to pursue equity or debt financings to meet our capital needs. With uncertainty in the capital markets and other factors, such financing may not be available on terms favorable to us or at all. If we raise additional funds through further issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences, and privileges superior to those of holders of our common stock. Any debt financing secured by us in the future could involve additional restrictive covenants relating to our capital-raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions. If we are unable to obtain adequate financing or financing on terms satisfactory to us, we could face significant limitations on our ability to invest in our operations and otherwise suffer harm to our business.

Recent volatility in interest rates could affect our ability to obtain working capital through borrowings such as bank credit lines and public or private sales of debt securities, which may result in lower liquidity, reduced working capital and other adverse impacts on our business.

To meet our liquidity needs, we have previously relied, in part, on borrowed funds, and may do so again in the future. Continued volatility in interest rates will impact the cost of new indebtedness and could materially and adversely affect our results of operations, financial condition, liquidity and cash flows.

Increasing scrutiny and changing expectations from governments and third-parties relating to environmental, social and governance (ESG) policies and practices may cause us to incur additional costs or expose us to additional risks.

In recent years, there has been increasing public focus and scrutiny from certain investors, employees and other stakeholders concerning corporate responsibility, specifically related to ESG factors. Third-party providers of ESG ratings and reports on companies have increased in number, resulting in varied and, in some cases, inconsistent standards and frameworks. Topics taken into account in such assessments include, among others, our efforts and impacts with respect to climate change and the role of our board of directors in supervising various sustainability issues.

Some investors may use third-party ESG ratings and reports to guide their investment strategies and, in some cases, may choose not to invest in us if they believe our ESG practices are inadequate. At the same time, anti-ESG sentiment has gained some momentum across the United States, with several states having enacted or proposed “anti-ESG” policies or legislation, which may conflict with other laws or regulations. The criteria by which companies’ ESG practices are assessed are evolving, which could result in greater expectations of us and cause us to undertake costly initiatives to satisfy such new criteria. Alternatively, if we elect not to or are unable to satisfy new criteria or do not meet the criteria of a specific third-party provider, some investors may conclude that our policies with respect to ESG are inadequate and choose not to invest in us.

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当社の事業慣行が ESG に関する投資家、政府機関、その他のステークホルダーの期待や基準を満たさない場合、当社の評判、従業員を引き付けまたは維持する能力、および当社の証券の市場価格に悪影響を及ぼす可能性があります。新しい政府規制により、新たな指令や ESG 監督 · 開示の新規またはより厳格な形態が生じ、サステナビリティイニシアチブへの支出が増加し、当社の事業、財務状況、キャッシュフローおよび業績に重大な悪影響を及ぼし、当社の普通株式の時価が低下する可能性があります。

金融機関や取引相手方による流動性、デフォルト、業績不振などの実際の出来事や懸念など、金融サービス業界に影響を及ぼす悪影響は、当社の現在および予想される事業運営、財務状況および業績に悪影響を及ぼす可能性があります。

Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (SVB) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. Similarly, on March 12, 2023, Signature Bank and Silvergate Capital Corp. were each swept into receivership. In these cases borrowers under credit agreements, letters of credit and certain other financial instruments with SVB, Signature Bank or any other financial institution that is placed into receivership by the FDIC may be unable to access undrawn amounts thereunder. We currently use deposit accounts to fund our operations and other financial instruments such as cash-collateralized letters of credit associated with our facilities leases. Our excess cash is invested according to a restrictive investment policy within custodial accounts at various financial institutions. If any of the financial institutions that hold our deposit accounts were to be placed into receivership, we may be unable to access the funds in those accounts, which could result in liquidity constraints or failures. In addition, if any of our collaboration partners, suppliers or other parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments to us could be adversely affected. In this regard, counterparties to SVB credit agreements and arrangements, and third parties such as beneficiaries of letters of credit (among others), may experience direct impacts from the closure of SVB, or the sale of its assets, and uncertainty remains over liquidity concerns in the broader financial services industry. Similar impacts have occurred in the past, such as during the 2008-2010 financial crisis.

インフレと金利の急速な上昇は、これまでに発行された国債の取引価値を低下させた。米国財務省、連邦預金保険会社、連邦準備委員会は、このようなツールの売却による潜在的損失のリスクを低減するために、金融機関が保有するいくつかのこのような政府証券を保証する金融機関に250億ドルまでの融資を提供する計画を発表しているが、金融機関の顧客引き出しの広範な需要や金融機関の即時流動性の他の需要は、このような計画の能力を超える可能性がある。また、米国財務省、連邦預金保険会社、連邦準備委員会が将来他の銀行や金融機関が閉鎖された場合に未保険資金のルートを提供すること、あるいはタイムリーにそうすることは保証されない。

私たちは、私たちの銀行と他の業務関係が必要または適切であることを評価しているにもかかわらず、私たちが現在および予想されている将来の業務運営に資金または資本化を提供するのに十分な資金源および他の信用手配の金額を得ることは、私たちと直接信用協定や手配を持っている金融機関または金融サービス業全体または全体経済に影響を与える深刻な損害を受ける可能性がある。これらの要因には、流動性制限または失敗、様々な金融、信用または流動性合意または手配に従って義務を履行する能力、金融サービス業または金融市場の中断または不安定、または金融サービス会社の将来性への懸念または負の予想などの他の要因が含まれる可能性がある。これらの要因は、我々と金融や業務関係にある金融機関に関与する可能性があるが、金融市場や一般金融サービス業に関連する要因も含まれている可能性がある。

1つまたは複数のこれらの要因に関連するイベントまたは懸念の結果には、現在および予想されているビジネス運営、ならびに私たちの財務状況および運営結果に生じる様々な重大かつ悪影響が含まれている可能性がある。これらは、以下を含むことができるが、これらに限定されない

•
預金その他の金融資産へのアクセスの遅延、または預金その他の金融資産の無保険損失。
•
運転資本源の下で利用可能な借入金の遅延またはアクセスの喪失、または削減、および / または払い戻し、ロールオーバーまたは満期延長、または新しい運転資本源への参入の能力の遅延、不具合または減少。

さらに、米国や国際金融システムに関する投資家の懸念は、金利やコストの引き上げ、財務 · 運営契約の厳格化、信用 · 流動性源へのアクセスのシステミックな制限など、商用ファイナンスの条件が不利になり、許容可能な条件でのファイナンスの取得が困難になる可能性があります。減少は

76

 

利用可能な資金調達または当社の現金および流動性リソースへのアクセスは、その他のリスクの中でも、当社の営業費用、財務義務またはその他の義務を履行する当社の能力に悪影響を及ぼし、当社の財務および / または契約上の義務の違反、または連邦または州の賃金および時間法の違反をもたらす可能性があります。

これらの影響、または上記の要因、または上記に記載されていないその他の関連または類似の要因に起因するその他の影響は、当社の流動性、現在および / または予想される事業運営および財務状況および業績に重大な悪影響を及ぼす可能性があります。

また、マクロ経済や金融サービス業の更なる悪化は、当社の協力パートナー、サプライヤー、その他の取引先による損失またはデフォルトにつながり、その結果、当社の現在および / または見通しの事業運営、業績および財務状況に重大な悪影響を及ぼす可能性があります。当社が取引を行っている協力パートナー、サプライヤーまたはその他の当事者の破産または倒産、または当該当事者が支払期限に支払いを怠ったこと、または当該当事者による違反またはデフォルト、または重要な商業関係の喪失は、当社に重大な損失をもたらし、当社の事業に重大な悪影響を及ぼす可能性があります。

現在進行中の戦争や武力紛争に関連する地政学的リスクは、当社の事業、財務状況、臨床試験を含む事業結果に悪影響を及ぼす可能性があります。

戦争や他の武力衝突を含む持続的かつ新たな地政学的緊張は，衝突がこれまで我々の業務にほとんど直接影響を与えていなかったにもかかわらず，これらの衝突による不確実性や連鎖反応が未知の間接的影響を与える可能性がある.例えば、持続的な衝突は、ある株、債務、通貨市場の大幅な変動、いくつかの商品価格の大幅な上昇、および経済的不確実性を招く。私たちは、長期的な衝突がインフレを含むミクロ経済状況に悪影響を及ぼす可能性があるにもかかわらず、これらの紛争のより広範またはより長期的な結果を予測することができない；ネットワーク攻撃、身代金攻撃またはサイバーセキュリティ侵入を含む、私たちのグローバル技術インフラの中断、国際貿易政策と関係の不利な変化、グローバルサプライチェーンの中断；私たちは外国為替変動の影響を受け、資本市場の制約、変動または中断を含み、これらは私たちの業務、財務業績、および財務状況に負の影響を与える可能性がある。米国、カナダ、EU、および他の国が持続的な衝突に対応するために実施した制裁およびそのような制裁に対する潜在的な反応は、私たちの臨床試験、金融市場、および世界経済を含む私たちの業務に悪影響を及ぼす可能性もある。

当社は、戦争の勃発及びその後の米国その他の国による制裁措置が世界経済全般、当社の事業及び事業、並びに当社のサプライヤー及び取引を行う第三者の事業及び事業に及ぼす悪影響を監視し続けます。

当社または当社が依存する第三者は、地震、火災、停電、または公衆衛生危機を含むその他の自然災害によって悪影響を受ける可能性があり、当社の事業継続および災害復旧計画は深刻な災害から当社を十分に保護しない可能性があります。

地震、火災、停電、または他の自然災害(気候変動または任意の公衆衛生危機の影響を含む)は、私たちの運営または私たちが依存している第三者の運営を深刻に混乱させ、私たちの業務、運営結果、財務状況、および見通しに重大な悪影響を及ぼす可能性がある。自然災害、停電、または他の事件が発生した場合、本社の全部または大部分を使用することができなくなり、当社の製造施設やCMOの製造施設のような重要なインフラを破損したり、他の方法で運営を中断したりすることは困難かもしれませんし、場合によっては、長い間私たちの業務を継続することはできません。例えば、候補NKおよびT細胞治療製品の臨床供給、およびこれらの候補製品を生産するための作業細胞バンクおよび主細胞バンクは、私たちの製造施設および第三者生物倉庫の冷凍庫に保存されている。もしこれらの材料が私たちの施設や私たちの第三者ストレージの施設で破損した場合、停電や自然災害を含めて、私たちの候補製品の臨床供給が影響を受ける可能性があり、私たちの臨床試験は遅れる可能性があります。さらに、政府当局または企業が任意の公衆衛生危機に対応するために講じた任意の措置、例えば、隔離、在宅命令、旅行制限などは、私たちの臨床試験および研究開発活動を行う能力を制限し、私たちと私たちの第三者メーカーが製品を生産する能力を制限し、依存する施設や施設を一時的に閉鎖させることで、私たちの業務、運営、財務状況、将来性、または運営結果に悪影響を及ぼす可能性がある。私たちと私たちの第三者バイオバンクが現在実施している災害復旧·事業継続計画は限られている可能性があり、公衆衛生危機や他の深刻な災害や同様の事件によって当社の業務が中断された場合に私たちの業務を保護し、継続するのに十分ではないかもしれません。私たちの災害復旧と業務連続計画の性質が限られているため、大量の費用が発生する可能性があり、地震保険の不足に加えて、私たちの業務に実質的な悪影響を及ぼす可能性があります。

77

 

開示管理、手続および内部統制の効果的なシステムを維持しなければ、正確な財務諸表を作成したり、適用される規制を遵守したりする能力が低下する可能性があります。

上場企業として、当社は、 2002 年のサーベネス · オックスリー法 （ 改正版 ） 、および SEC の関連規則、開示要件の拡大、報告要件の加速、およびより複雑な会計ルールを遵守することが求められています。サーベネス · オックスリー法によって要求される会社の責任には、財務報告および開示管理および手順に関する企業監督と適切な内部統制の確立および維持が含まれます。信頼できる財務報告書を作成するためには効果的な内部統制が必要であり、財務詐欺の防止に役立ちます。

財務報告に関する内部統制に重大な弱点や重大な欠陥がないことは保証できません。財務報告に関する内部統制における重大な弱点または重大な欠陥を正常に是正し、または存在する可能性のある重大な弱点または重大な欠陥を特定できない場合、財務報告の正確性およびタイミングが悪影響を受ける可能性があります。当社は、適用される証券取引所の上場に加えて、定期報告書の適時提出に関する証券法の要件を遵守できない場合があります。要求により株価が大幅に下落する可能性があります

有害物質の取扱い、保管または廃棄に関する規制を含む環境、健康、安全法令を遵守しない場合、罰金または罰金、または事業に害を及ぼす可能性のある費用が発生する可能性があります。

当社は、実験室の手順、有害物質および廃棄物の取扱い、使用、保管、処理、廃棄を管理するものを含む、多くの環境、健康、安全法規制の対象となります。当社の業務には、化学物質、生物物質、感染剤などの有害物質の使用が含まれます。また、有害廃棄物の生成も発生します。当社は一般的に、これらの材料や廃棄物の廃棄について第三者と契約します。当社は、これらの材料からの汚染または怪我のリスクを排除することはできません。危険物質の使用に起因する汚染または傷害が発生した場合、当社はその損害について責任を負う可能性があり、その責任は当社の能力を超える可能性があります。また、そのような法律規制を遵守しなかった場合、民事または刑事罰金および罰金に関連する多額のコストが発生する可能性があります。

当社は、有害物質の使用によって従業員が傷害した際に発生する費用や経費をカバーするために、労働者補償保険を保有していますが、この保険は潜在的な責任に対して適切な補償を提供していない場合があります。当社は、生物物質または有害物質の保管または廃棄に関連して当社に対して主張される可能性のある環境責任または毒性不法行為の請求に対する保険を維持しません。

さらに、現在または将来の環境、健康、安全に関する法律および規制を遵守するために多額のコストが発生する場合があります。これらの現行または将来の法令は、当社の研究、開発または生産努力を損なう可能性があります。これらの法令を遵守しない場合、多額の罰金、罰則またはその他の制裁も生じます。

税法の変更は、当社や投資家に悪影響を及ぼす可能性があります。

米国連邦、州、地方所得税に関する規則は立法過程に参加する人員および米国国税局(IRS)と米国財務省の審査を受け続けている。税法の変化(これらの変化は追跡力を持つ可能性がある)は、私たちまたは私たちの普通株の所有者に悪影響を及ぼすかもしれない。近年、このような変化は多く発生しており、未来も変化し続けるかもしれない。例えば、“減税·雇用法案”は2017年に公布され、会社税率を最高限界税率の35%から21%の統一税率に引き下げ、純利息支出控除を調整後の課税所得額の30%(一部の小企業を除く)に制限し、純営業損失控除を今年度の課税所得額の80%に制限し、純営業赤字の繰越を廃止する(いずれの場合もこのような純営業損失は無期限に繰り越す可能性があるにもかかわらず)、多くの業務控除や相殺を改正または廃止するなど、会社税を大きく改革している。また、改正された1986年国内収入法第174条によると、2021年12月31日以降の納税年度には、米国で発生した研究開発費が資本化·償却され、我々のキャッシュフローに悪影響を及ぼす可能性がある。税務法律、法規、および裁決がいつ、どのような形で、またはどのような日に公布、公布または発行されるかどうかを予測することはできません。それにより、私たちまたは私たちの株主の納税責任を増加させるか、または税法変化のいかなる悪影響を最大限に減少または軽減するために、運営方式を変更することを要求する可能性があります。

 

78

 

項目 2 。 アンレギス銀行による持分証券の売却および運用得た金

当社は、このレポートの対象となる四半期中に、フォーム 8—k に開示されていない有価証券の未登録販売を行っていません。

項目 3 。 Upo デフォルトN高級証券

ない。

項目 4 。 鉱山サFYY開示

該当しない。

項目5.その他の情報

a ） なし。

b ） なし。

c) フォーム 10—Q の四半期報告書の対象期間中、当社の取締役または役員は 養子。 物質的 型を変えるあるいは、あるいは終了しました取引法に基づく規則 10 b 5 — 1 （ c ） の肯定的な防衛条件を満たすことを意図した、または規則 10 b 5 — 1 以外の取り決めの会社の有価証券の売買のための契約、指示、または書面による計画。


 

 

79

 

第六項です展示品

 

展示品

番号をつける

 

展示品名

 

表

 

書類番号.

 

展示会

 

提出日

 

 

 

 

 

 

 

 

 

 

 

3.1

 

登録者登録成立証明書の改訂と再予約

 

S-1/A

 

333-190608

 

3.2

 

2013 年 08 月 29 日

 

 

 

 

 

 

 

 

 

 

 

3.2

 

現在有効な登録者の改正および再記載の設立証明書の修正証明書

 

8-K

 

001-36076

 

3.1

 

2021 年 06 月 7 日

 

 

 

 

 

 

 

 

 

 

 

3.3

 

クラス A 転換優先株式の優先権 · 権利 · 制限指定証明書

 

8-K

 

001-36076

 

3.1

 

2016 年 11 月 29 日

 

 

 

 

 

 

 

 

 

 

 

3.4

 

現在効力のある登録者の定款の修正および改定

 

10-K

 

001-36076

 

3.3

 

2021 年 2 月 24 日

 

 

 

 

 

 

 

 

 

 

 

3.5

 

株式会社フェイトセラプティクス第 A 級転換優先株式の優先権 · 権利 · 制限指定証明書の修正証明書

 

8-K

 

001-36076

 

3.1

 

2023年4月19日

 

 

 

 

 

 

 

 

 

 

 

3.6

 

現在有効な登録者の改正および再記載の設立証明書の修正証明書

 

8-K

 

001-36076

 

3.1

 

2024年6月10日

 

 

 

 

 

 

 

 

 

 

 

4.1

 

普通株式証明書サンプル

 

S-1/A

 

333-190608

 

4.1

 

2013 年 8 月 29 日

 

 

 

 

 

 

 

 

 

 

 

4.2

 

あらかじめ出資して株式証の書式を承認する

 

8-K

 

001-36076

 

4.1

 

2021年1月8日

 

 

 

 

 

 

 

 

 

 

 

4.3

 

前資金調達令状の形態

 

8-K

 

001-36076

 

4.1

 

2024年3月21日

 

 

 

 

 

 

 

 

 

 

 

4.4

 

証券説明書

 

10-Q

 

001-36076

 

4.3

 

2023年11月8日

 

 

 

 

 

 

 

 

 

 

 

10.1

 

補償契約の修正 · 改定

 

8-K

 

001-36076

 

10.1

 

2024年8月30日

 

 

 

 

 

 

 

 

 

 

 

10.2†

 

登録者及び大野製薬株式会社との間の協力 · オプション契約の改正第 4 号2024 年 8 月 28 日付

 

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同封アーカイブ

 

 

 

 

 

 

 

 

 

 

31.1

 

1934 年の証券取引法 （ 改正 ） に基づき公布された規則 13 a—14 および 15 d—14 に基づく最高経営責任者および最高財務責任者の認定、 2002 年のサーベネス · オックスリー法第 302 条に基づいて採択された。

 

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Filed herewith

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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32.1*

 

18 U. S.C. に基づく最高経営責任者および最高財務責任者の認定。2002 年のサーベネス · オックスリー法第 906 条に基づき採択された第 1350 条。

 

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同封アーカイブ

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

XBRLインスタンスドキュメントを連結する– インスタンスドキュメントは、その XBRL タグがインライン XBRL ドキュメント内に埋め込まれているため、 Interactive Data File には表示されません。

 

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Filed herewith

101.書院

 

イントラネットXBRL分類拡張アーキテクチャ文書

 

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Filed herewith

101.カール

 

インラインXBRL分類拡張計算リンクライブラリ文書

 

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Filed herewith

101.def

 

インラインXBRL分類拡張Linkbase文書を定義する

 

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Filed herewith

101.介護会

 

XBRL分類拡張ラベルLinkbase文書を連結する

 

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Filed herewith

101.Pre

 

インラインXBRL分類拡張プレゼンテーションLinkbaseドキュメント

 

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同封アーカイブ

104

 

表紙インタラクティブデータファイル （ インライン XBRL としてフォーマットされ、資料 101 に記載 ） 。

 

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同封アーカイブ

* この資料は、取引法第 18 条の目的のために「提出」されたものとみなされず、その条項の責任の対象となり、証券法または取引法に基づくいかなる提出にも参照によって組み込まれているものとみなされません。

 

† 本資料の一部は、機密情報として省略されています。


 

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登録する解決策

1934年の証券取引法の要求によると、登録者はすでに正式に本報告を正式に許可した署名者がそれを代表して署名することを促した。

 

 

Fate Therapeutics 株式会社

 

 

 

日時 ： 2024 年 11 月 12 日

投稿者：

/J · スコット · ウォルチコ

 

 

J. スコット · ウォルチコ

 

 

社長、最高経営責任者、最高財務責任者、取締役

 

 

（ 最高執行役員、最高財務責任者、最高会計責任者 ）

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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