UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number
(Exact Name of Registrant as Specified in its Charter)
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(
Registrant’s Telephone Number, Including Area Code
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ |
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Accelerated filer ☐ |
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Smaller reporting company |
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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of November 8, 2024, the registrant had
CYCLERION PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2024
TABLE OF CONTENTS
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33 |
将来の見通しに関する注意事項
この第10-Qフォームの四半期報告書には、連邦証券法の意味で前向きな声明が含まれており、これらの声明には重大なリスクと不確実性が伴います。この報告書における発言は、歴史的事実の発言を除き、将来の出来事、資金調達計画、財務状況、ビジネス戦略、予算、予測コスト、計画および将来の運営のための経営陣の目標に関する発言を含み、ある特定のリスクと不確実性を伴う前向きな声明です。「可能性がある」「かもしれない」「するだろう」「するべきである」「信じている」「見積もり」「プロジェクト」「潜在的」「期待する」「計画する」「目指す」「意図する」「目的とする」「評価する」「追求する」「予測する」「ターゲット」「見通し」「取り組み」「目的」「設計された」「優先事項」「目標」といった言葉の使用またはこれらの言葉の否定または他の類似の表現は、現在の可能性のある将来の出来事についての我々の見解を示す前向きな声明を特定する可能性がありますが、これらの言葉の不在は必ずしもその発言が前向きではないことを意味しません。
将来を見据えた声明は、当社のビジネス、経済、およびその他の将来の状況に関する現在の期待と仮定に基づいています。将来を見据えた声明は未来に関係するため、その性質上、予測しにくい固有の不確実性、リスク、および環境の変化の影響を受けます。その結果、当社の実際の結果は、将来を見据えた声明で考慮されているものと実質的に異なる可能性があります。実際の結果が将来を見据えた声明と異なる要因には、地域別、国内、またはグローバルな政治、経済、ビジネス、競争、市場、規制状況が含まれ、以下の通りです。
3
2023年12月31日に終了した決算年度の年次報告書フォーム10-kの第I部、項目1Aの「リスク要因」セクションを参照してください。これらおよびその他の要因の詳細な説明については、2024年3月5日に証券取引委員会に提出されたものを参照してください。また、上記で言及されているリスク、不確実性、およびその他の要素についての注意事項として、あなたにとって重要な全リスク、不確実性、およびその他の要素が含まれていないかもしれないことをお知らせいたします。さらに、私たちは、期待または予期する結果、利益、または展開を達成すること、または実質的に達成されたとしても、それが予想される結果や当社または当社のビジネスに影響を及ぼす保証はできません。当社が今後のビジネスに影響を与える可能性のある全要素を適切に測定または特定しているか、これらの要因の影響の程度を正しく識別しているか（i）、この分析が基づいているこれら要因に関する利用可能な情報が完全または正確であるか（ii）、この分析が正しいか（iii）、および当社の戦略、これに部分的に基づいている戦略が成功するかどうか（iv）の保証はありません。この報告書の将来を見据えた発言は、この報告書の日付、またはその発言が行われた日付に適用されます。該当法により義務づけられる場合を除き、新しい情報、将来の展開、その他の理由により、将来を見据えた発言を公に更新する義務はありません。
4
サイクリオン・セラピューティクス株式会社
コンデンスドコンソリダ縮小されたバランスシート
（千を除く株式数と株式価格のデータ）
（未確定）
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9月30日, |
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12月31日、 |
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資産 |
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流動資産: |
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現金及び現金同等物 |
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$ |
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売掛金 |
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前払費用 |
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その他の流動資産 |
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流動資産合計 |
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その他の投資 |
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総資産 |
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$ |
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$ |
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負債及び純資産 |
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流動負債： |
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支払い予定の勘定 |
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$ |
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研究開発費用の償却 |
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未払費用およびその他の流動負債 |
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合計流動負債 |
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約束事項および不確定事項（注8） |
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株主資本 |
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优先股、 |
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普通株式、授権株式数$帳簿価額 |
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資本金 |
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累積欠損 |
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その他の総合損失 |
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株主資本合計 |
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負債及び株主資本の合計 |
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$ |
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付随する注記は、これらの簡潔な連結財務諸表の不可欠な部分です。
5
サイクリリオンセラピューティクス株式会社
株主の資本に関する連結財務諸表業務及び包括的損失
（千ドル単位、1株当たりのデータを除く）
（未確定）
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終了した3ヶ月 |
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九ヶ月の終了 |
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2024 |
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2023 |
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2024 |
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2023 |
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収益： |
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ライセンス収益のオプション |
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$ |
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$ |
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$ |
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売上高合計 |
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費用と支出: |
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研究開発 |
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一般管理費 |
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減損損失 |
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費用総額および経費 |
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営業損失 |
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その他の収益、当期純利益 |
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利息収入 |
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支払口座の決済利益 |
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その他の総収益 |
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継続する事業からの当期純損失 |
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中止された業務: |
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廃止事業からの利益 |
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損益の純利益（損失） |
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$ |
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$ |
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一株当たりの純利益（損失）- 基本: |
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継続する事業からの一株当たりの純損失 - 基本 |
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$ |
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$ |
( |
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$ |
( |
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$ |
( |
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中断した事業からの一株当たりの純利益（損失）- 基本 |
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1株当たりの基本純利益（損失） |
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$ |
( |
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$ |
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$ |
( |
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$ |
( |
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1株当たりの純利益（損失）- 基本と希薄化後 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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中断された業務からの1株当たりの純利益 |
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希薄化後1株当たりの純利益（損失） |
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$ |
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$ |
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$ |
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計算に使用される加重平均株数： |
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基本株式数 |
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(Unaudited) |
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その他の包括的損失: |
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損益の純利益（損失） |
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( |
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$ |
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$ |
( |
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$ |
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その他の包括的損失: |
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外貨翻訳調整による利益（損失） |
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包括損失 |
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$ |
( |
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$ |
( |
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$ |
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付随する注記は、これらの簡潔な連結財務諸表の不可欠な部分です。
6
サイクリリオン・セラピューティクス社
総合損益計算書株主資本の要素
（株式データを除く千ドル単位）
（未確定）
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普通株式 |
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优先股 |
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出資済み |
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蓄積 |
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蓄積 |
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合計 |
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株式 |
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金額 |
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株式 |
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金額 |
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資本 |
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赤字 |
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損失 |
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エクイティ |
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2022年12月31日の残高 |
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$ |
— |
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— |
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$ |
— |
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$ |
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$ |
( |
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$ |
( |
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$ |
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純損失 |
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— |
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— |
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— |
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— |
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オプション、RSU、従業員株式購入計画の行使による普通株式の発行 |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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株式オプションとRSU、従業員株式購入計画に関連する株式ベースの報酬費用 |
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— |
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— |
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— |
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— |
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— |
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— |
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外国通貨換算調整 |
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— |
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— |
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— |
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— |
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— |
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— |
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2023年3月31日の残高 |
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$ |
— |
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— |
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$ |
— |
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$ |
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$ |
( |
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純損失 |
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— |
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— |
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( |
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— |
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普通株式の発行 |
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— |
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— |
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— |
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優先株式の発行 |
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— |
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— |
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— |
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— |
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オプション、RSU、従業員株式購入プランの行使に伴う普通株式の発行 |
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— |
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— |
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— |
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— |
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— |
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オプションやRSU、従業員株式購入プランの発行に関連する株式報酬費用 |
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— |
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— |
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— |
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— |
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— |
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— |
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外国通貨換算調整 |
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— |
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— |
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— |
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— |
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— |
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— |
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単位未満株の発行 |
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( |
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— |
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— |
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— |
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— |
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— |
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— |
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2023年6月30日の残高 |
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$ |
— |
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$ |
— |
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$ |
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$ |
( |
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$ |
( |
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$ |
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純利益 |
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— |
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— |
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— |
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RSUの確定に伴う普通株式の発行 |
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— |
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— |
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— |
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— |
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— |
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株式オプションおよびRSU、従業員株式購入計画に関連する株式報酬費用 |
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— |
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外国通貨換算調整 |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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2023年9月30日の残高 |
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$ |
— |
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$ |
— |
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$ |
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$ |
( |
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$ |
( |
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$ |
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7
サイクリオン・セラピューティクス株式会社
総合損益計算書及び包括損益計算書の概要
（千ドル単位、1株当たりのデータを除く）
（未確定）
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普通株式 |
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优先股 |
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出資済み |
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蓄積 |
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蓄積 |
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合計 |
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株式 |
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金額 |
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株式 |
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金額 |
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資本 |
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赤字 |
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損失 |
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エクイティ |
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2023年12月31日の残高 |
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$ |
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$ |
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$ |
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$ |
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純損失 |
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— |
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株式オプション及び制限付き株式賞の発行に関連するシェアベースの報酬費用 |
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外国通貨換算調整 |
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2024年3月31日の残高 |
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$ |
— |
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$ |
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$ |
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純損失 |
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オプションおよび制限付き株式賞の発行に関するシェアベースの報酬費用 |
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— |
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外国通貨換算調整 |
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— |
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子会社の清算時における外国currency換算調整の解放 |
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— |
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2024年6月30日の残高 |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
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純損失 |
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— |
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オプションおよび制限付き株式賞の発行に関するシェアベースの報酬費用 |
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— |
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— |
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外国通貨換算調整 |
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— |
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2024年9月30日の残高 |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
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$ |
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付随する注記は、これらの簡潔な連結財務諸表の不可欠な部分です。
8
サイクリリオン・セラピューティクス社
簡単にまとめた連結決算報告書 キャッシュフロー計算書
(千単位で)
（未確定）
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9月30日終了の9ヶ月 |
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2024 |
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2023 |
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営業活動からのキャッシュ・フロー: |
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純損失 |
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$ |
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$ |
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営業活動からの純キャッシュ流入に調整するための調整： |
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廃止する事業の売却益 |
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支払口座の決済利益 |
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減損損失 |
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シェアベースの報酬費用 |
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営業資産および負債の変動: |
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売掛金 |
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前払費用 |
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その他の流動資産 |
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オペレーティングリース資産 |
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その他の資産 |
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支払い予定の勘定 |
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研究開発費用の償却 |
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未払費用およびその他の流動負債 |
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営業によるキャッシュフローの純流出 |
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投資活動からのキャッシュフロー: |
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中止された事業の処分からの純収益 |
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投資活動からの純現金流入 |
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財務活動からのキャッシュフロー: |
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株式購入契約からの収益 |
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株式オプションおよびESPPの行使からの収益 |
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財務活動による純現金流入額 |
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為替レート変動の現金および現金同等物への影響 |
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現金及び現金同等物の純減少分 |
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現金及び現金同等物期首残高 |
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期末現金及び現金同等物 |
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$ |
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$ |
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補足的なキャッシュフロー開示： |
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非現金の廃止事業の処分による利益 |
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$ |
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$ |
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付随する注記は、これらの簡潔な連結財務諸表の不可欠な部分です。
9
サイクリリオン・セラピューティクス社
縮小連結の注記 財務諸表
（未確定）
1.事業の性質
会社の結果は、次のエリアのビジネスセグメントで報告されます - ビジネス保険、債務不履行リスク保険、個人保険。 これらのセグメントは、顧客タイプ、ビジネスのマーケティング方法、リスク引受の方法に基づく製品やサービスの集約を反映し、現在管理されている方法を反映しています。 会社の操作の性質に関する詳細は、Travelersの2023年度報告書の注記1の「操作の性質」セクションを参照してください。
サイクリリオン・セラピューティクス社（「サイクリリオン」、当社または「私たち」）は、アイアンウッド・ファーマシューティカルズ社がその新しい可溶性グアニル酸シクラーゼ（"sGC"）ビジネスを税制上の特典を用いて分社化した後、2019年4月1日に独立した上場企業となりました。この分社化を本書では「セパレーション」と呼びます。2024年9月30日現在、サイクリリオンには1人の従業員がいます。
設立当初、サイクリリオンは中枢神経系（"CNS"）および末梢におけるsGC刺激剤を使用した重篤な疾患の治療に焦点を当てたバイオ医薬品会社でした。一酸化窒素（"NO"）sGCサイクリックグアノシン一リン酸（"cGMP"）シグナル伝達経路は、体全体の生理学の重要な側面を正確に制御する基本的なメカニズムです。NO-sGC-cGMP経路は、CNSおよび末梢における多様で重要な生物学的機能を調整しており、いくつかの医薬品によって成功裏に標的化されています。
プラリシグアットは、経口投与される1日1回の全身sGC刺激剤です。2021年6月3日、サイクリリオンはアケビラ・セラピューティクス社（「アケビラ」）と、プラリシグアットおよびその関連製品を含む医薬品の開発、製造、医療関連業務および商業化に関する会社の権利に関する独占的な世界規模のライセンス契約に署名しました。サイクリリオンは最大で$
オリンシグアットは、サイクリリオンが強力な心血管および/または心肺能力を持つ企業にライセンス供与することを意図している第2相の経口投与される1日1回の血管sGC刺激剤です。
ザゴシグアットは、臨床段階のCNS浸透sGC刺激剤であり、臨床研究において脳血流、機能的脳接続、視覚刺激に対する脳の反応、認知パフォーマンス、ミトコンドリア機能および炎症に関連するバイオマーカーの急速な改善を示しました。CY3018は、中枢神経系をターゲットとしたsGC刺激剤で、脳に優先的に局在し、神経精神病的疾患や障害の治療の可能性を示唆する薬理学的プロファイルを持っています。2023年7月28日、当社はザゴシグアットおよびCY3018を、これらの開発に注力する新しい私企業であるティセンター・セラピューティクス社（「ティセンター」）に売却しました。
Cyclerionは株主価値を向上させることを目的としたその他の活動を積極的に評価しており、これはコラボレーション、ライセンス、合併、買収及びその他の特定の投資を含む可能性があります。
同社は、新しいポートフォリオを構築するために、中枢神経系治療領域内で非sGC刺激剤資産を特定する戦略に移行しました。同社が適切な新しい資産を特定、取得またはライセンスした場合、同社は新しい資産を開発し、これらの特定の目的のために契約研究、開発及び製造組織を保持することを目指します。さらに、Cyclerionは新しい資産に関連するさらなる研究開発活動のための資金を調達することを計画しています。同社の目標は、資本、能力及び取引の最適な組み合わせを見つけることで、同社が取得する可能性のある現在及び将来の資産の進展を可能にし、株主価値を最大化することです。
Cyclerion GmbHは、2019年5月3日にスイスのツークに設立された完全子会社です。機能通貨はswiss francです。Cyclerion GmbHの清算プロセスは完了し、子会社は2024年5月に登録抹消されました。
10
Cyclerion Securities Corporation, a wholly owned subsidiary, was incorporated in Massachusetts on November 15, 2019 and was granted securities corporation status in Massachusetts for the 2019 tax year. Cyclerion Securities Corporation has
Stock Purchase Agreement
In March 2023, the Company entered into a stock purchase agreement with the Company's former Chief Executive Officer (the “Former CEO”) pursuant to which he invested $
Asset Purchase Agreement
On May 11, 2023, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with an investor group that included the Former CEO, JW Celtics Investment Corp and JW Cycle Inc. which subsequently changed their names to Tisento Therapeutics Holdings Inc. (“Tisento Parent”) and Tisento. Upon the closing on July 28, 2023, of the transactions contemplated by the Asset Purchase Agreement, the Company sold to Tisento specified assets relating to the Company’s zagociguat and CY3018 programs (the "Transferred Assets") and Tisento assumed certain liabilities relating thereto, including, but not limited to (i) liabilities, costs and expenses arising after the date of the Asset Purchase Agreement relating to the employment of certain Cyclerion employees and the conduct of certain preclinical and clinical trial activities prior to the closing of the transactions contemplated by the Asset Purchase Agreement, and (ii) liabilities relating to such assets to the extent relating to the period after the closing of the transaction. In consideration for such sale and assumption, at such closing the Company received proceeds of $8.0 million as cash consideration, $2.4 million as reimbursement for certain operating expenses related to such assets for the period between signing and closing of the Asset Purchase Agreement, and shares of common stock of Tisento Parent comprising 10% of the then issued and outstanding equity securities of Tisento Parent immediately following such closing, subject to certain protections against dilution.
Reverse Stock Split
On May 15, 2023, the Company filed Articles of Amendment to the Company's Restated Articles of Organization with the Secretary of Commonwealth of Massachusetts to effect a 1-for-20 reverse stock split of the Company's issued and outstanding shares of common stock. The reverse stock split was reflected on the Nasdaq Capital Market beginning with the opening of trading on May 16, 2023. All share amounts and per share amounts disclosed in this Quarterly Report on Form 10-Q have been adjusted retroactively to reflect the reverse stock split for all periods presented.
At-the-Market Offering
On July 24, 2020, the Company filed a Registration Statement on Form S-3 (the “Shelf”). On September 3, 2020, the Company entered into a Sales Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) with respect to an at-the-market offering (the “ATM Offering”) under the Shelf. Under the ATM Offering, the Company could offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $
11
Basis of Presentation
The condensed consolidated financial statements and the related disclosures are unaudited and have been prepared in accordance with accounting principles generally accepted in the U.S. Additionally, certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and Exchange Commission on March 5, 2024.
In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all normal recurring adjustments considered necessary for a fair presentation of the Company’s financial position and the results of its operations for the interim periods presented. The results of operations for the three and nine months ended September 30, 2024 and 2023 are not necessarily indicative of the results that may be expected for the full year or any other subsequent interim period.
The condensed consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries, Cyclerion GmbH (prior to its deregistration), and Cyclerion Securities Corporation. All significant intercompany accounts and transactions have been eliminated in the preparation of the accompanying condensed consolidated financial statements.
Going Concern
At each reporting period, in accordance with Accounting Standards Codification ("ASC") 205-40, Going Concern, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs and comparing those needs to the current cash and cash equivalent balances. The Company is required to make certain additional disclosures if it concludes substantial doubt exists and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern.
This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future partnerships, license payments, equity or debt issuances, certain cost reduction measures and the achievement of potential milestone payments from Akebia cannot be considered probable at this time because these plans are not entirely within the Company’s control and/or have not been approved by the Board of Directors as of the date of these condensed consolidated financial statements.
The Company expects that its cash and cash equivalents as of September 30, 2024, will be sufficient to fund operations through mid-2025, however the Company will need to obtain additional funding to sustain operations as it expects to continue to generate operating losses for the foreseeable future. The Company's expectation to generate negative operating cash flows in the future and the need for additional funding to support its planned operations, raise substantial doubt regarding the Company’s ability to continue as a going concern. Management's plans to alleviate the conditions that raise substantial doubt include reduced spending, and the pursuit of additional capital. Management has concluded the likelihood that its plan to successfully obtain sufficient funding, or adequately reduce expenditures, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared on a going concern basis, which contemplates the
12
realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
2. Summary of Significant Accounting Policies
The accounting policies of the Company are set forth in Note 2. Summary of Significant Accounting Policies to the consolidated financial statements contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Except as discussed elsewhere in the notes to the consolidated financial statements, the Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2024 that had a material effect on its condensed consolidated financial statements.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for annual reporting periods beginning after December 15, 2023, and for interim reporting periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the impact that adoption of ASU 2023-07 will have on the Company's consolidated financial statement disclosures.
In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses. This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. As a smaller reporting company, ASU 2016-13 will become effective for the Company for fiscal years beginning after December 15, 2022, and early adoption is permitted. The Company adopted ASU 2016-13 in the first quarter of 2023, and the adoption of this standard did not have any impact on the Company's financial position or results of operations.
No other accounting standards known by the Company to be applicable to it that have been issued by the FASB or other standard-setting bodies and that do not require adoption until a future date are expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption.
3. Fair Value of Financial Instruments
The Company’s cash equivalents are generally classified within Level 1 of the fair value hierarchy. The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values as of September 30, 2024 and December 31, 2023 (in thousands):
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Fair Value Measurements as of September 30, 2024: |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
— |
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$ |
— |
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$ |
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Cash equivalents |
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$ |
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$ |
— |
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$ |
— |
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$ |
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Fair Value Measurements as of December 31, 2023: |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
— |
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$ |
— |
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$ |
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Cash equivalents |
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$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
13
During the nine months ended September 30, 2024 and 2023, there were no transfers between levels. The fair value of the Company’s cash equivalents, consisting of money market funds, is based on quoted market prices in active markets with no valuation adjustment.
The Company believes the carrying amounts of its prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their fair value due to the short-term nature of these amounts.
4. Discontinued Operations
On May 11, 2023, the Company entered into the Asset Purchase Agreement for Tisento’s acquisition of substantially all of the assets comprising the Company’s zagociguat and CY3018 programs, in exchange for consideration at closing of $
The operations of the Transferred Assets are presented as discontinued for all periods presented. The transaction closed on July 28, 2023.
|
|
Three Months Ended |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue from grants |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total cost and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Gain on disposal of discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net gain from discontinued operations |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table presents the significant non-cash item for the discontinued operations that are included in the accompanying consolidated statements of cash flows (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
5. Other Investment
On July 28, 2023, the Company closed the transactions contemplated by the Asset Purchase Agreement receiving proceeds of $
14
The Company has determined that the Company’s investment in Tisento Parent is an equity security, whereby such investment does not give the Company a controlling financial interest or significant influence over the investee. Further, the Company assessed the accounting for its investment in Tisento Parent in accordance with ASC 810-10, Consolidation—Overall. After determining that no scope exception applies under the guidance of ASC 810-10-15-12 and ASC 810-10-15-17, the Company concluded that it has a variable interest in Tisento Parent through its investment in Tisento Parent common stock. Tisento Parent does not have sufficient equity to finance its activities without additional subordinated financial support as Tisento Parent is a startup entity in its early stages of raising funds and will require significant capital to advance its programs to commercial stage. Therefore, the Company concluded that its investment in Tisento Parent is a variable interest entity (“VIE”) in accordance with ASC 810-10-15-14(a) and is subject to potential consolidation under the VIE model. However, all activities that most significantly impact Tisento Parent and its subsidiary’s economic performance are directed by the Tisento Parent board and the board approves decisions by a simple majority. Based on the board composition, the Company determined that no one party has control over the Tisento Parent board and power is not shared because the activities that most significantly affect Tisento Parent and its subsidiary’s economic performance do not require the consent of all of the parties. Rather, all decisions are made by a simple majority vote of the Tisento Parent board. Therefore, because the Company controls no director of Tisento Parent, the Company cannot unilaterally direct any of the activities that most significantly impact Tisento Parent and its subsidiary’s economic performance. Accordingly, the Company does not hold a controlling financial interest in Tisento Parent. Because both criteria (a) and (b) above have to be met for the application of the guidance in ASC 810-10-25-44B and criteria (a) has not been met, the Company concluded that it should not consolidate Tisento under the VIE model.
Accordingly, the Company has accounted for the investment as a financial instrument without a readily determinable fair value. Such investment is recorded using the measurement alternative for investments without readily determinable fair values, whereby the investment is measured at cost less any impairment recorded or adjustments for observable price changes. An impairment loss is recognized in the consolidated statements of operations and comprehensive loss equal to the amount by which the carrying value exceeds the fair value of the investment. As of September 30, 2024,
The initial fair value of the investment in Tisento Parent was determined by reference to the risk-adjusted net assets value using the discounted cash flow method. The estimated net assets value of Tisento Parent includes the cash generated/used from the operations and the proceeds from equity financing. Valuations were derived by reference to observable valuation measures for comparable companies or transactions, including weighted average cost of capital (
6. Property and Equipment
Property and equipment, net consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Software |
|
$ |
|
|
$ |
|
||
Property and equipment, gross |
|
|
|
|
|
|
||
Less: accumulated depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
During the nine months ended September 30, 2024 and 2023, the Company did
15
7. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Salaries |
|
$ |
|
|
$ |
|
||
Professional fees |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Accrued expenses and other current liabilities |
|
$ |
|
|
$ |
|
||
8. Commitments and Contingencies
Other Funding Commitments
In the normal course of business, the Company enters into contracts with clinical research organizations and other third parties for clinical and preclinical research studies and other services and products for operating purposes. These contracts are generally cancellable, with notice, at the Company’s option and do not have any significant cancellation penalties.
Indemnification Obligations
On September 6, 2018, Cyclerion was incorporated in Massachusetts and its officers and directors are indemnified for certain events or occurrences while they are serving in such capacity.
The Company enters into certain agreements with other parties in the ordinary course of business that contain indemnification provisions. These typically include agreements with directors and officers, business partners, contractors, clinical sites and customers. Under these provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of the Company’s activities. These indemnification provisions generally survive termination of the underlying agreements. The maximum potential amount of future payments the Company could be required to make under these indemnification provisions is unlimited. However, to date the Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of these obligations is minimal. Accordingly, the Company did not have any liabilities recorded for these obligations as of September 30, 2024 and December 31, 2023.
Separation Benefits
As part of the separation benefit of the former Chief Financial Officer, the Company paid $
9. Leases
In May 2021, the Company signed a
On September 15, 2020, the Company entered into a Sublease Termination Agreement (the "Sublease Termination Agreement") to terminate its sublease of
16
termination. The Company gained access to the licensed rooms and services beginning in the third quarter of 2021. The letter of credit security deposit related to the sublease was released.
The Company determined that the Sublease Termination Agreement constituted a non-monetary exchange under ASC 845 Nonmonetary Transactions ("ASC 845") where, in return for the free rooms and the services, the Company agreed to terminate its rights and obligations under the sublease agreement. In accordance with ASC 845, the Company determined that the accounting for the transaction should be based on the fair value of assets or services involved. The Company estimated the fair value of the rooms and services to be approximately $
The Company determined that the licensed rooms represent a lease under ASC Topic 842, Leases. The Company obtained control of the rooms in the third quarter of 2021 and the prepaid rooms balance of approximately $
After the closing of the Asset Purchase Agreement, the Company had no plans in the foreseeable future to use the licensed rooms and the Company is restricted from subleasing the rooms. In August 2023, the ROU asset and other assets were fully impaired.
10. Share-based Compensation Plans
In 2019, Cyclerion adopted share-based compensation plans. Specifically, Cyclerion adopted the 2019 Employee Stock Purchase Plan (“2019 ESPP”) and the 2019 Equity Incentive Plan (“2019 Equity Plan”). Under the 2019 ESPP, eligible employees may use payroll deductions to purchase shares of stock in offerings under the plan, and thereby acquire an interest in the future of the Company. The 2019 Equity Plan provides for stock options, restricted stock awards ("RSAs") and restricted stock units (“RSUs”).
Cyclerion also mirrored two of Ironwood Pharmaceuticals, Inc. ("Ironwood") existing plans, the Amended and Restated 2005 Stock Incentive Plan (“2005 Equity Plan”) and the Amended and Restated 2010 Employee, Director and Consultant Equity Incentive Plan (“2010 Equity Plan"). These mirror plans were adopted to facilitate the exchange of Ironwood equity awards for Cyclerion equity awards upon the Separation as part of the equity conversion. As a result of the Separation and in accordance with the EMA, employees of both companies retained their existing Ironwood vested options and received a pro-rata share of Cyclerion options, regardless of which company employed them post-Separation. For employees that were ultimately employed by Cyclerion, unvested Ironwood options and RSUs were converted to unvested Cyclerion options and RSUs.
The following table provides share-based compensation reflected in the Company’s condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023 (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Research and development |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Stock Options
17
Stock options granted under the Company’s equity plans generally have a ten-year term and vest over a period of four years, provided the individual continues to serve at the Company through the vesting dates. Options granted under all equity plans are exercisable at a price per share not less than the fair market value of the underlying common stock on the date of grant. The estimated fair value of options, including the effect of estimated forfeitures, is recognized over the requisite service period, which is typically the vesting period of each option.
A summary of stock option activity (excluding market-based stock options) for the nine months ended September 30, 2024, is as follows:
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
||||
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Average |
|
||||
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Intrinsic |
|
||||
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Value (in |
|
||||
|
|
of Options |
|
|
Price |
|
|
Term (Years) |
|
|
thousands) |
|
||||
Outstanding as of December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Exercised |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Cancelled or forfeited |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding as of September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
During the three and nine months ended September 30, 2024, the Company granted stock options to purchase an aggregate of
The Company has granted certain employees performance-based options to purchase shares of common stock. These options are subject to performance-based milestone vesting. During the three and nine months ended September 30, 2024 and 2023, there were
Market-based Stock Options
The Company has previously granted to certain employees stock options containing market conditions that vest upon the achievement of specified price targets of the Company’s share price for a period through December 31, 2024. Vesting is measured based upon the average closing price of the Company’s share price for any
Restricted Stock Awards
The Company granted
18
grant. Compensation expense, including the effect of estimated forfeitures, is recognized over the applicable service period.
A summary of RSA activity for the nine months ended September 30, 2024 is as follows:
|
|
|
|
|
Weighted Average |
|
||
|
|
Number |
|
|
Grant Date |
|
||
|
|
of Shares |
|
|
Fair Value |
|
||
Unvested as of December 31, 2023 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
|
|
|
|
||
Unvested as of September 30, 2024 |
|
|
|
|
$ |
|
||
As of September 30, 2024, the unrecognized share-based compensation expense, net of estimated forfeitures, related to all unvested RSAs is $
11. Loss per share
Basic and diluted net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period as follows:
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss from continuing operations (in thousands) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
Net gain (loss) from discontinued operations (in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total net gain (loss) (in thousands) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average shares used in calculating net loss per share — basic (in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average shares used in calculating net loss per share — diluted (in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net gain (loss) per share — basic |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share from continuing operations |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
Net (gain) loss per share from discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total (gain) loss per share |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net gain (loss) per share — diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share from continuing operations |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
Net (gain) loss per share from discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total gain (loss) per share |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
The Company excludes shares of common stock related to Preferred Stock, stock options, RSAs and RSUs from the calculation of diluted net loss per share since the inclusion of such shares would be anti-dilutive.
19
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock Options |
|
|
|
|
|
|
|
|
|
|
|
|
||||
RSAs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
12. Workforce Reductions
On October 6, 2022, the Company began a reduction of its current workforce by
The Company had further reductions of workforce in 2023 in connection with the sale of the Transferred Assets to Tisento and change to the Company’s strategy. The Company recorded total costs of approximately $
All the accrued liabilities were paid off as of December 31, 2023 and no activities occurred during the three and nine months ended September 30, 2024.
|
|
Amounts |
|
|
Charges |
|
|
Amount |
|
|
Adjustments |
|
|
Amounts |
|
|||||
Workforce reductions |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||
Total |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||
13. Option/License Agreement
Option Agreement
On July 22, 2024, the Company entered into an Option to License Agreement (the “Option Agreement”) with a third party (the “Optionee”), pursuant to which the optionee has an option (the “Option”), to enter into an exclusive license to olinciguat for human therapeutics, subject to certain carveouts. Under the terms of the Option Agreement, the Optionee paid the Company an Option fee of $
Akebia License Agreement
On June 3, 2021, the Company and Akebia entered into a License Agreement (the “Akebia License Agreement”) relating to the exclusive worldwide license by the Company to Akebia of the Company's rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing the pharmaceutical compound known as praliciguat and other related products and forms thereof enumerated in the
20
License Agreement (collectively, the “Products”). Pursuant to the Akebia License Agreement, Akebia will be responsible for all future research, development, regulatory, and commercialization activities for the Products.
Akebia paid a $
Pursuant to the Akebia License Agreement, the Company determined the Akebia License Agreement represents a service arrangement under the scope of ASC 606. Given the reversion of the rights under the Akebia License Agreement represents a penalty in substance for a termination by Akebia, the contract term would be the stated term of the License Agreement.
The Company determined that the grant of license to its patents and trademarks, know how transfer, the assignment of regulatory submissions and trademarks and additional knowledge transfer assistance obligations represent a single promise and performance obligation to be transferred to Akebia over time due to the nature of the promises in the contract. The provision of development materials on hand was identified as a separate performance obligation. However, it is immaterial in the context of the contract as the development materials are low value and do not have an alternative use to the Company.
The consideration related to sales-based milestone payments, including royalties, will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license. The Company will re-evaluate the probability of achievement of the milestones and any related constraints each reporting period.
Akebia Supply Agreement
On August 3, 2021, the Company and Akebia entered into a Supply Agreement (the “Supply Agreement”) relating to the manufacturing by the Company of the Initial Supply of the Drug Product and placebo ("Initial Supply") for Akebia's use pursuant to the Akebia License Agreement. Akebia will pay the Company for the manufacturing costs at mutually agreed upon rates.
The Company determined the Supply Agreement has stand-alone value under the scope of ASC 606 and should not be combined with the Akebia License Agreement. Given that the Supply Agreement can be terminated at any time without cause with 30 days’ notice, the Company deemed the Supply Agreement to be a month-to-month contract. The manufacturing of the Initial Supply by the Company represents a single performance obligation and consideration related to the manufacturing costs will be recognized over time as costs are incurred. There was
14. Subsequent Events
The Company has evaluated all events and transactions that occurred after the balance sheet date through the date the consolidated financial statements were issued and determined that there were no such events requiring recognition or disclosure in the consolidated financial statements.
21
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Information
The following discussion of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the corresponding notes included in this Quarterly Report on Form 10-Q, as well as the audited condensed consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. This discussion contains forward-looking statements that involve significant risks and uncertainties. As a result of many factors, such as those referenced or set forth under “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements.
Overview
We operate in one reportable business segment—human therapeutics.
At inception, Cyclerion was a biopharmaceutical company focused on the treatment of serious diseases with novel soluble guanylate cyclase (“sGC”) stimulators in both the central nervous system (“CNS”) and the periphery. The nitric oxide (“NO”) sGC cyclic guanosine monophosphate (“cGMP”) signaling pathway is a fundamental mechanism that precisely controls key aspects of physiology throughout the body. The NO-sGC-cGMP pathway regulates diverse and critical biological functions in both the CNS and the periphery and has been successfully targeted with several drugs. Prior to the sale of two assets to Tisento (see below), Cyclerion’s portfolio included novel sGC stimulators that modulate signaling networks in both the CNS and the periphery.
On July 28, 2023, we sold two of our CNS assets (zagociguat and CY3018, or the “Transferred Assets”) to Tisento in exchange for $8.0 million in cash consideration, $2.4 million as reimbursement for certain operating expenses related to zagociguat and CY3018 for the period between signing and closing of the transaction, and 10% of all of Tisento's Parent's outstanding equity securities. The Cyclerion assets that were retained are olinciguat and praliciguat which are not CNS focused and are either currently out-licensed (praliciguat) or management is seeking to out-license (olinciguat).
We have shifted our strategy to identify non-sGC stimulator assets, mainly within the CNS therapeutic area, to build a new portfolio. If the Company identifies suitable new assets, the Company will seek to develop the new assets and retain contract research and development and seek to outsource to manufacturing organizations for these specific purposes, as well as seek to raise funds for further research and development activities. The Company’s goal is to find the best combination of capital, capabilities, and transactions that will enable the advancement of current and any future assets the Company may acquire for patients in a way that maximizes shareholder value.
Financial Overview
Research and Development Expense. Research and development expenses are incurred in connection with the discovery and development of our product candidates. These expenses consist primarily of the following costs: compensation, benefits and other employee-related expenses, research and development related facilities, third-party contracts relating to manufacturing, nonclinical studies and clinical trial activities. All research and development expenses are charged to operations as incurred.
Praliciguat is an orally administered, once-daily systemic sGC stimulator. On June 3, 2021, we entered into a license agreement with Akebia relating to the exclusive worldwide license to Akebia of our rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing praliciguat and other related products and forms thereof enumerated in such agreement. Cyclerion is eligible to receive up to $585 million in total potential future development, regulatory, and commercialization milestone payments. Cyclerion is also eligible to receive tiered, sales-based royalties ranging from single-digit to high-teen percentages and subject to reduction upon expiration of patent rights or the launch of a generic product.
22
Olinciguat is a Phase 2 orally administered, once-daily, vascular sGC stimulator that Cyclerion intends to out-license to an entity with strong cardiovascular and/or cardiopulmonary capabilities. On July 22, 2024, we entered into an Option to License Agreement (the “Option Agreement”) with a third party (the “Optionee”), pursuant to which the Optionee has an option (the “Option”) to enter into an exclusive license to olinciguat for human therapeutics, subject to certain carveouts. Under the terms of the Option Agreement, the Optionee paid the Company an Option fee of $150,000 in August 2024. The Optionee may exercise the Option on or before February 22, 2025, which may be extended for an additional two-month period for an additional fee of $25,000. If the Optionee exercises the Option during the Option Period, the Parties shall promptly commence negotiations of the definitive license agreement. The terms of the license agreement will be negotiated in good faith within a period not to exceed 90 days after the date of exercise of the Option. If the parties cannot reach agreement, all rights revert to the Company. In addition, the Optionee has agreed to reimburse the Company for certain patent expenses incurred during the Option period.
Zagociguat and CY3018 are orally administered CNS-penetrant sGC stimulators. On July 28, 2023, Tisento purchased zagociguat and CY3018 in exchange for $8.0 million in cash consideration, $2.4 million as reimbursement for certain operating expenses related to zagociguat and CY3018 for the period between signing and closing of the transaction, and 10% of all of Tisento Parent's outstanding equity securities at the time of closing.
Cyclerion continues to evaluate other activities aimed at enhancing shareholder value, which may potentially include collaborations, licenses, mergers, acquisitions, and/or other targeted investments.
The following table summarizes our research and development expenses, employee and facility related costs allocated to research and development expense, and discovery and pre-clinical phase programs, for the three and nine months ended September 30, 2024 and 2023. The product pipeline expenses relate primarily to external costs associated with nonclinical studies and clinical trial costs.
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
(in thousands) |
|
|
(in thousands) |
|
||||||||||
Product pipeline external costs |
|
$ |
— |
|
|
$ |
58 |
|
|
$ |
— |
|
|
$ |
88 |
|
Personnel and related internal costs |
|
|
25 |
|
|
|
304 |
|
|
|
86 |
|
|
|
555 |
|
Facilities and other |
|
|
56 |
|
|
|
218 |
|
|
|
144 |
|
|
|
848 |
|
Total research and development expenses |
|
$ |
81 |
|
|
$ |
580 |
|
|
$ |
230 |
|
|
$ |
1,491 |
|
Securing regulatory approvals for new drugs is a lengthy and costly process. Any failure by us or our partners to obtain, or any delay in obtaining, regulatory approvals would materially adversely affect our product candidate development efforts and our business overall.
Given the inherent uncertainties of pharmaceutical product development, we cannot estimate with any degree of certainty how our programs will evolve, and therefore the amount of time or money that would be required to obtain regulatory approval to market them. As a result of these uncertainties surrounding the timing and outcome of any approvals, we are currently unable to estimate precisely when, if ever, our discovery and development candidates will be approved.
The successful development of any current or potential future product candidates is highly uncertain and subject to a number of risks. Please refer to Item 1A, Risk Factors, in this Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
We are unable to determine the duration and costs to complete current or future nonclinical and clinical stages of any current or potential future product candidates, including as licensed to third parties, or when, or to what extent, we may generate revenues from the commercialization and sale of any current or potential future product candidates. Development timelines, probability of success and development costs vary widely. We anticipate that we will make determinations as to which additional programs to pursue and how much funding to direct to each program on an ongoing basis in response to the data from the studies of each product candidate, the competitive landscape and ongoing assessments of such product candidate’s commercial potential.
23
General and Administrative Expense. General and administrative expenses consist primarily of compensation, benefits and other employee-related expenses for personnel in our administrative, finance, legal, information technology, business development, and human resource functions. Other costs include the legal costs of pursuing patent protection of our intellectual property, general and administrative related facility costs, insurance costs and professional fees for accounting and legal services. We record all general and administrative expenses as incurred.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements prepared in accordance with GAAP. The preparation of these financial statements requires us to make certain estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the amounts of expenses during the reported periods. We base our estimates on our historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from our estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
We believe that our application of accounting policies requires significant judgments and estimates on the part of management and is the most critical to aid in fully understanding and evaluating our reported financial results. Our significant accounting policies are more fully described in Note 2, Summary of Significant Accounting Policies, of the consolidated financial statements elsewhere in Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
All research and development expenses are expensed as incurred. We defer and capitalize nonrefundable advance payments we make for research and development activities until the related goods are received or the related services are performed. A discussion of our critical accounting policies and estimates may be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 in Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations under the heading Critical Accounting Policies and Estimates.
Results of Operations
The revenue and expenses reflected in the consolidated financial statements may not be indicative of revenue and expenses that will be incurred by us in the future. The following discussion summarizes the key factors we believe are necessary for an understanding of our consolidated financial statements.
24
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
||||||||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||||||
|
|
(dollars in thousands) |
|
|
(dollars in thousands) |
|
||||||||||||||||||||||||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Revenue from option agreement |
|
$ |
194 |
|
|
$ |
— |
|
|
$ |
194 |
|
|
|
100 |
% |
|
$ |
194 |
|
|
$ |
— |
|
|
$ |
194 |
|
|
|
100 |
% |
Total revenues |
|
|
194 |
|
|
|
— |
|
|
|
194 |
|
|
|
100 |
% |
|
|
194 |
|
|
|
— |
|
|
|
194 |
|
|
|
100 |
% |
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
|
81 |
|
|
|
580 |
|
|
|
(499 |
) |
|
|
(86 |
)% |
|
|
230 |
|
|
|
1,491 |
|
|
|
(1,261 |
) |
|
|
(85 |
)% |
General and administrative |
|
|
1,241 |
|
|
|
2,131 |
|
|
|
(890 |
) |
|
|
(42 |
)% |
|
|
4,094 |
|
|
|
6,361 |
|
|
|
(2,267 |
) |
|
|
(36 |
)% |
Impairment loss |
|
|
— |
|
|
|
3,304 |
|
|
|
(3,304 |
) |
|
|
(100 |
)% |
|
|
— |
|
|
|
3,304 |
|
|
|
(3,304 |
) |
|
|
(100 |
)% |
Total cost and expenses |
|
|
1,322 |
|
|
|
6,015 |
|
|
|
(4,693 |
) |
|
|
(78 |
)% |
|
|
4,324 |
|
|
|
11,156 |
|
|
|
(6,832 |
) |
|
|
(61 |
)% |
Loss from operations |
|
|
(1,128 |
) |
|
|
(6,015 |
) |
|
|
4,887 |
|
|
|
(81 |
)% |
|
|
(4,130 |
) |
|
|
(11,156 |
) |
|
|
7,026 |
|
|
|
(63 |
)% |
Other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Interest income |
|
|
42 |
|
|
|
107 |
|
|
|
(65 |
) |
|
|
(61 |
)% |
|
|
180 |
|
|
|
257 |
|
|
|
(77 |
) |
|
|
(30 |
)% |
Gain from settlement of account payable |
|
|
363 |
|
|
|
— |
|
|
|
363 |
|
|
|
100 |
% |
|
|
363 |
|
|
|
— |
|
|
|
363 |
|
|
|
100 |
% |
Total other income, net |
|
|
405 |
|
|
|
107 |
|
|
|
298 |
|
|
|
279 |
% |
|
|
543 |
|
|
|
257 |
|
|
|
286 |
|
|
|
111 |
% |
Net loss from continuing operations |
|
|
(723 |
) |
|
|
(5,908 |
) |
|
|
5,185 |
|
|
|
(88 |
)% |
|
|
(3,587 |
) |
|
|
(10,899 |
) |
|
|
7,312 |
|
|
|
(67 |
)% |
Discontinued operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Gain from discontinued operations |
|
|
— |
|
|
|
13,474 |
|
|
|
(13,474 |
) |
|
|
(100 |
)% |
|
|
— |
|
|
|
7,330 |
|
|
|
(7,330 |
) |
|
|
(100 |
)% |
Net gain (loss) |
|
$ |
(723 |
) |
|
$ |
7,566 |
|
|
$ |
(8,289 |
) |
|
|
(110 |
)% |
|
$ |
(3,587 |
) |
|
$ |
(3,569 |
) |
|
$ |
(18 |
) |
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Revenue
Revenue from option agreement. On July 22, 2024, we entered into the Option Agreement with the Optionee, which the Optionee has the Option to enter into an exclusive license to olinciguat for human therapeutics, subject to certain carveouts. We recognized revenue of $0.2 million related to the Option fee payment and expense reimbursement during the three and nine months ended September 30, 2024.
Expenses
Research and development expense. We had further reductions of workforce in 2023 in connection with the sale of the Transferred Assets to Tisento and change to the Company’s strategy. The decrease in research and development expense of approximately $0.5 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 was driven by decreases of approximately $0.3 million in employee-related expenses primarily due to the workforce reduction in 2023 and a decrease of approximated of $0.2 million in other miscellaneous expenses including professional consulting expense, research study costs and outside service fees.
The decrease in research and development expense of approximately $1.3 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was driven by decreases of approximately $0.5 million in employee-related expenses primarily due to the workforce reduction in 2023, approximately $0.2 million in information technology services, approximately $0.1 million in research study costs, approximately $0.1 million in outside service fee, approximately $0.2 million in lab equipment and service and approximately $0.1 million in lab space rent.
General and administrative expense. The decrease in general and administrative expenses of approximately $0.9 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 was primarily driven by decreases of approximately $0.2 million in employee-related expenses primarily due to the workforce reduction in 2023, approximately $0.1 million in board member fees, approximately $0.1 million in outside service fee, approximately $0.4 million in legal services and approximately $0.1 million in audit service.
The decrease in general and administrative expenses of approximately $2.3 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily driven by
25
decreases of approximately $0.3 million in employee-related expenses primarily due to the workforce reduction in 2023, approximately $1.4 million in legal services, approximately $0.2 million in audit and tax services, approximately $0.2 million in outside services, $0.3 million in insurance expenses and approximately $0.3 million in information technology services, offset by an increase of approximately of $0.4 million in professional consulting.
Impairment loss. The impairment loss consists of an impairment loss of operating lease of approximately $3.3 million during the three and nine months ended September 30, 2023. There was no impairment loss recognized during the three and nine months ended September 30, 2024.
Interest income. Interest income decreased by $0.1 million for the three and nine months ended September 30, 2024 compared to the three and nine months ended September 30, 2023, primarily attributable to the decrease of our money market fund balance.
Gain from settlement of account payable. During the three and nine months ended September 30, 2024, we reached a settlement agreement with a vendor for a disputed account payable and recorded a gain of $0.4 million on settlement of account payable.
Gain from discontinued operations. The decrease in gain from discontinued operations of approximately $13.5 million and $7.3 million for the three and nine months ended September 30, 2024 compared to the three and nine months ended September 30, 2023, respectively, was driven by the sale of Transferred Assets in July 2023. After the sale of Transferred Assets, no discontinued operation was recognized in the income statements.
Liquidity and Capital Resources
On July 24, 2020, the Company filed a Registration Statement on Form S-3 (the “Shelf”) with the Securities and Exchange Commission (the “SEC”) in relation to the registration of common stock, preferred stock, debt securities, warrants and units of any combination thereof for an aggregate initial offering price not to exceed $150.0 million. On September 3, 2020, we entered into the Sales Agreement with Jefferies with respect to the ATM Offering under the Shelf. The Shelf expired in July 2023. We did not sell any shares of our common stock under the Shelf from January 1, 2022 to July 2023.
On May 19, 2023, we sold 225,000 shares of our common stock, pursuant to a Common Stock Purchase Agreement, and 351,037 shares of Series A Preferred Stock, to our former CEO, for total gross proceeds of approximately $5 million. There were no material fees or commissions related to the transaction. Such Series A Convertible Preferred Stock is convertible into shares of our common stock on a one-to-one basis. Our shareholders approved such convertibility on July 19, 2023.
On July 28, 2023, we closed the transactions contemplated by the Asset Purchase Agreement receiving proceeds of $8.0 million as cash consideration, approximately $2.4 million as reimbursement for certain operating expenses related to zagociguat and CY3018 programs for the period between signing and closing of the transaction, and 10% of all of Tisento Parent’s outstanding equity securities.
Our ability to continue to fund our operations and meet capital needs in the next twelve months will depend on our ability to generate cash from operations and access to capital markets and other sources of capital, as further described below. We anticipate that our principal uses of cash in the future will be primarily to fund our operations, working capital needs, capital expenditures and other general corporate purposes.
On September 30, 2024, we had approximately $2.9 million of unrestricted cash and cash equivalents. Our cash equivalents include amounts held in U.S. government money market funds. We invest cash in excess of immediate requirements in accordance with our investment policy, which requires all investments held by us to be at least “AAA” rated or equivalent, with a remaining final maturity when purchased of less than twelve months, so as to primarily achieve liquidity and capital preservation.
Going Concern
We evaluated whether there are conditions and events, considered in the aggregate, which raise substantial doubt about our ability to continue as a going concern within one year after the date that these consolidated financial
26
statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of our plans sufficiently alleviates substantial doubt about our ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. In performing our analysis, management excluded certain elements of our operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future partnerships, equity or debt issuances, and the potential milestones from the Akebia agreement cannot be considered probable at this time because these plans are not entirely within our control and/or have not been approved by the Board of Directors as of the date of these consolidated financial statements.
We have incurred recurring losses since our inception, including a net loss of $3.6 million for the nine months ended September 30, 2024. In addition, as of September 30, 2024, we had an accumulated deficit of $268.0 million. We expect that our cash and cash equivalents as of September 30, 2024, will be sufficient to fund operations into mid-2025, however we will need to obtain additional funding to sustain operations as we expect to continue to generate operating losses for the foreseeable future. Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern.
The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
Reverse Stock Split
On May 15, 2023, we filed Articles of Amendment to our Restated Articles of Organization with the Secretary of Commonwealth of Massachusetts to effect a 1-for-20 reverse stock split of our issued and outstanding shares of common stock. The reverse stock split was reflected on the Nasdaq Capital Market beginning with the opening of trading on May 16, 2023. All share amounts and per share amounts disclosed in this Quarterly Report on Form 10-Q have been adjusted retroactively to reflect the reverse stock split for all periods presented.
Cash Flows
The following is a summary of cash flows for the nine months ended September 30, 2024 and 2023:
|
|
Nine Months Ended |
|
|
Change |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
$ |
|
|
% |
|
||||
|
|
(dollars in thousands) |
|
|||||||||||||
Net cash used in operating activities |
|
$ |
(4,693 |
) |
|
$ |
(19,704 |
) |
|
$ |
15,011 |
|
|
|
(76 |
)% |
Net cash provided by investing activities |
|
$ |
— |
|
|
$ |
10,402 |
|
|
$ |
(10,402 |
) |
|
|
— |
|
Net cash provided by financing activities |
|
$ |
— |
|
|
$ |
5,024 |
|
|
$ |
(5,024 |
) |
|
|
— |
|
Cash Flows from Operating Activities
Net cash used in operating activities was $4.7 million for the nine months ended September 30, 2024 was primarily a result of our $3.6 million net loss from operations. The net loss was offset by non-cash stock-based compensation expense of $0.5 million. The net loss was also adjusted by gain from settlement of accounts payable of $0.4 million, an increase in prepaid expense of $0.2 million, a decrease in accounts payable of $0.5 million and a decrease in accrued expenses and other current liabilities of $0.5 million.
Net cash used in operating activities was $19.7 million for the nine months ended September 30, 2023 was primarily a result of our $3.6 million net loss from operations. The net loss was offset by impairment loss of $3.3
27
million, non-cash stock-based compensation expense of $1.0 million, a decrease in account receivable of $0.1 million, a decrease in prepaid expenses of $0.1 million, a decrease in other current assets of $0.1 million, a decrease in operating lease assets of $0.1 million and a decrease in other assets of $0.2 million. The net loss was also adjusted by gain on disposal of discontinued operations of $15.8 million, a decrease in account payable of $2.2 million, a decrease in accrued research and development costs of $1.9 million and a decrease in accrued expenses and other current liabilities of $1.2 million.
Cash Flows from Investing Activities
There was no investing activity incurred in the nine months ended September 30, 2024. Net cash provided by investing activities for the nine months ended September 30, 2023 of $10.4 million was due to cash proceeds received from the disposal of discontinued operations of approximately $10.4 million.
Cash Flows from Financing Activities
There was no financing activity in the nine months ended September 30, 2024. Net cash provided by financing activities for the nine months ended September 30, 2023 of $5.0 million was due to cash received from the May 2023 stock purchase agreement of $5 million.
Funding Requirements
We expect our expenses to fluctuate as we continue to maintain out-license opportunities and seek to broaden our portfolio through in-licensing of assets. We expect that our cash and cash equivalents as of September 30, 2024, will be sufficient to fund operations into mid-2025, however we will need to obtain additional funding to sustain operations as we expect to continue to generate operating losses for the foreseeable future. Failure to obtain necessary capital when needed may delay development of any current or potential future product candidates, or other operations. Additional funding may not be available on acceptable terms, if at all to continue as a going concern and advance our current and any potential future product candidates. Failure to obtain capital when needed may force us to delay, limit or terminate our product development efforts or other operations. Raising additional capital may dilute our existing shareholders, restrict our operations or cause us to relinquish valuable rights.
Because of the many risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount of our working capital requirements. Our expenses will fluctuate, and our future funding requirements will depend on, and could increase or decrease significantly as a result of many factors, including the:
A change in any of these or other variables with respect to the development of any current or potential future product candidates could significantly change the costs and timing of the development of that product candidate.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances
28
or licensing arrangements with third parties, of which there can be no assurance. To the extent that we raise additional capital through the sale of equity or convertible debt securities, outstanding equity ownership may be materially diluted, and the terms of securities sold in such transactions could include liquidation or other preferences that adversely affect the rights of holders of common stock. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, debt financing would result in increased fixed payment obligations.
If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, as to which raise there can be no assurances, we may have to relinquish rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise funds, we may need to cease operations.
Contractual Commitments and Obligations
Tax-related Obligations
We exclude assets, liabilities or obligations pertaining to uncertain tax positions from our summary of contractual commitments and obligations as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities. As of September 30, 2024, we had no uncertain tax positions.
Separation Benefits
As part of the separation benefit of the former Chief Financial Officer, we paid $0.1 million in May 2024 and August 2024, as the former Chief Financial Officer had not secured full-time employment prior to the six-month anniversary and nine-month anniversary of November 15, 2023. We have no further separation benefits obligation as of September 30, 2024.
Off-Balance Sheet Arrangements
We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, that would have been established for the purpose of facilitating off-balance sheet arrangements (as that term is defined in Item 303(a)(4)(ii) of Regulation S-K) or other contractually narrow or limited purposes. As such, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in those types of relationships. We enter into guarantees in the ordinary course of business related to the guarantee of our own performance.
New Accounting Pronouncements
For a discussion of new accounting pronouncements see Note 2, Summary of Significant Accounting Policies, of the consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and are not required to provide the information required under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing
29
similar functions, as appropriate to allow timely decisions regarding required disclosure. Because there are inherent limitations in all control systems, a control system, no matter how well conceived and operated, can provide only reasonable, as opposed to absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective, at the reasonable assurance level, as of the end of the period covered by this report. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this Quarterly Report on Form 10-Q which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II
Item 1. Legal Proceedings
We are not a party to any material legal proceedings at this time. From time to time we may be subject to various legal proceedings and claims, which may have a material adverse effect on our financial position or results of operations.
Item 1A. Risk Factors
Not applicable as we are a “smaller reporting company”. You should carefully review and consider the information regarding certain factors which could materially affect our business, financial condition or future results set forth under the heading “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Item 5. Other Information
During the 2024 second quarter, no director or Section 16 officer
Item 6. Exhibits
See the Exhibit Index on the following page of this Quarterly Report on Form 10-Q.
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EXHIBIT INDEX
Exhibit No. |
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Description |
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101.INS |
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Inline XBRL Instance Document. |
101.SCH |
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Inline XBRL Taxonomy Extension Schema Document. |
104 |
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Cover Page Interactive Data File. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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CYCLERION THERAPEUTICS, INC. |
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By: |
/s/ Regina Graul |
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Name: |
Regina Graul |
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Title: |
President and Chief Executive Officer (Principal Executive Officer) |
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By: |
/s/ Rhonda Chicko |
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Name: |
Rhonda Chicko |
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Title: |
Chief Financial Officer (Principal Financial and Accounting Officer) |
Date: November 14, 2024
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