根據424(b)(5)規定提交

註冊 編號333-282456

招股書補充資料

(到2024年10月10日的招股說明書)

Calidi Biotherapeutics，Inc。

2,050,000擁有的Common Stock股份

Calidi生物醫藥公司（「公司」或「我們」或「我們的」或「我們」）正在提供（「發行」）205萬股（「股票」）公司的普通股，每股面值$0.0001（「普通股」），根據本招股說明書和隨附的招股意向書。根據2024年10月23日簽署的證券購買協議，我們與簽署頁上列出的購買者之間的證券購買協議，“購買價格爲每股1.00美元。

在同時的定向增發中，我們向這些購買人發行了隨附的E系列普通股認購權證，可購買高達205萬股普通股（「E系列普通認購權證」），以及可購買高達205萬股普通股的F系列普通股認購權證（「F系列普通認購權證」），加上E系列普通認購權證一起，統稱爲「普通認購權證」。E系列普通認購權證可在發行日期後六（6）個月內行使，行使期爲自首次行使日起一（1）年，並且行使價格爲每股1.13美元，而F系列普通認購權證可在發行日期後六（6）個月內行使，行使期爲自首次行使日起五（5）年，並且行使價格爲每股1.13美元。普通認購權證和普通認購權證行使後可發行的普通股（「普通認購權證股份」）未在1933年修訂版《證券法案》（「證券法案」）下進行註冊，並且不是根據本招股說明書補充和隨附招股說明書進行的提供。普通認購權證和普通認購權證股份是根據《證券法》第4(a)(2)條規定的豁免和根據該規定製定的D部門規定提供的。

我們的普通股股票在紐交所美國股票交易所（「紐交所美國」）上以「CLDI」標的進行交易。2024年10月22日，在紐交所美國報告的最後成交價爲每股$1.13。普通認股權證沒有確立的交易市場，我們不打算將普通認股權證列入任何證券交易所或國家認可的交易系統。

我們是根據美國聯邦證券法定義的「新興成長型公司」和「較小報告公司」，並受到減少的上市公司報告要求的約束。有關「招股說明書摘要—成爲較小報告公司和新興成長型公司的影響」請參閱隨附的招股說明書第3頁。

截至本招股說明書補充的日期，我們未向附屬方出售的未發行普通股的總市值約爲12.22981億美元，按照每股1.22美元的價格計算，在2024年10月18日我們普通股的最後報價，基於11,427,919股未流通普通股，包括（i）9,627,919股有表決權的普通股和（ii）1,800,000股無表決權的普通股，目前由第三方託管，其中10,024,436股未流通普通股中，有10,024,436股爲附屬方持有。根據S-3表格第I.b.6條的一般規定，我們將不會在12個月內通過公開首次發行的證券價值超過我們未向附屬方出售的普通股總市值的三分之一，只要我們未向附屬方出售的未發行普通股總市值維持在7500萬美元以下。在截至本招股說明書補充日期的十二個日曆月內（不包括本次發行），我們沒有根據S-3表格第I.b.6條提供和／或銷售任何普通股。

投資我們的證券涉及高度風險。您應仔細審閱本招股說明書補充的S-8頁開始描述的風險和不確定因素，以及附屬基本招股說明書和其他被參考並納入本招股說明書補充和附屬基本招股說明書中類似標題下的文件中描述的風險。

都不是 美國證券交易委員會或任何州證券委員會已批准或不批准這些證券或通過了 視本招股說明書補充文件或隨附的基本招股說明書的充分性或準確性而定。任何與此相反的陳述都是 刑事犯罪。

我們聘請 Ladenberg Thalmann & Co., Inc. 作爲我們此次發行中的獨家配售代理。配售代理已同意盡最大努力安排出售本補充招股說明書及隨附招股說明書提供的證券。配售代理無義務購買我們發行的任何證券，也無需安排購買或出售任何特定數量或金額的證券。 我們已同意根據下表支付給配售代理列明的配售代理費用，假設我們全部出售本補充招股說明書提供的證券。由於我們將在投資者資金到位後交付本次發行的證券，因此並無設立資金進入代管、信託或類似安排。在此次發行的結束並無任何最低發行要求作爲結束條件。此外，我們出售證券所得的任何收益將可立即用於我們，儘管有關我們是否能夠有效利用這些資金實施我們的業務計劃存在不確定性。更多信息請參見名爲「風險因素」的章節。我們將承擔所有與發行相關的成本。有關這些安排的更多信息，請參閱本招股說明書中第S-15頁起的「分銷計劃」部分。

根據本補充招股說明書及隨附招股說明書提供的普通股的交付預計將在2024年10月24日前後進行，視特定常規閉市條件是否滿足。

獨家 配售代理

拉登堡 塔爾曼

本拓書補充的日期爲2024年10月23日

目錄

招股書補充資料

招股說明書

關於本招股說明書補充

本招股說明書補充和隨附的基礎招股說明書是我們根據表格S-3（註冊編號333-282456）向美國證券交易委員會（SEC）提交的註冊聲明的一部分，利用「貨架」註冊流程。

每次我們根據隨附基本招股說明書進行證券賣出，我們將提供一份招股說明書補充，其中包含有關該出售的條款的具體信息，包括價格、提供的證券數量和分銷計劃。 延續註冊聲明已於2024年10月1日向SEC提交，經過2024年10月7日修訂，並於2024年10月10日被SEC宣佈生效。 此註冊聲明自本招股說明書補充書日期起生效。本招股說明書補充書描述了有關此次發行的具體細節，並可能添加、更新或更改包含在隨附基本招股說明書中的信息。 隨附的基本招股說明書提供了關於我們及我們的證券的一般信息，其中一些信息（例如標題爲「分銷計劃」的部分）可能不適用於此次發行。

本招股說明書補充和隨附的基本招股說明書僅提供出售此處所提供的證券的要約，但只限於法律允許的情況和司法管轄區。我們並非在任何未經授權或未取得資格的司法管轄區提出出售要約或購買我們的普通股的邀約。本文件分爲兩部分。第一部分是本招股說明書補充，描述了這次普通股發行的具體條款，並補充並更新了隨附的基本招股說明書以及參考資料中包含的信息。第二部分是隨附的基本招股說明書，提供更一般的信息。通常情況下，當我們提到本招股說明書時，指的是本文件兩部分合並在一起的內容。在本招股說明書補充中所包含的信息與隨附的基本招股說明書中或在本招股說明書補充日期之前提交的任何文件中包含的信息之間存在衝突時，您應依賴本招股說明書中的信息；但如果其中一份文件中的聲明與另一份文件中的聲明存在不一致，而後一份文件的日期較晚—例如，作爲隨附基本招股說明書中參考的文件—日期較晚的文件中的聲明修改或取代先前的聲明。

如果本招股說明書補充中的信息與隨附的基本招股說明書或參照較早日期引入的信息不一致，您應依賴本招股說明書補充。本招股說明書補充連同隨附的基本招股說明書，以及被引入本招股說明書補充和隨附的基本招股說明書中的文件，以及我們授權用於與本次發行有關的任何自由撰寫招股說明書，包括與本次發行相關的所有重要信息。我們和配售代理商未授權任何人向您提供不同或額外的信息，您不得依賴任何未經授權的信息或聲明。

您應當假定出現在本招股說明書補充、隨附的基本招股說明書、本招股說明書補充中引用的文件以及隨附的基本招股說明書和我們授權用於與本次交易相關的任何自由書寫招股說明書的信息僅準確截至這些文件的各自日期。自那些日期以來，我們的業務、財務狀況、經營業績和前景可能發生了變化。在作出投資決定之前，您應仔細閱讀本招股說明書補充、隨附的基本招股說明書以及此處和那裏引入的信息和文件，以及我們授權用於與本次交易相關的任何自由書寫招股說明書。 參見本招股說明書補充和隨附的基本招股說明書中的「參考文件納入」和「您可以找到更多信息的地方」。

本招股說明書補充資料及附屬基本招股說明書中概述了一些本文所述文件中包含的條款，但完整信息請參閱實際文件。所有概述都受到實際文件的完整文本的限制，並且其中一些已被歸檔或將被歸檔並納入本文。請參閱本招股說明書補充資料中的「更多資料可從何處獲取」。我們進一步指出，在任何作爲附件提交的協議中我們所作出的陳述、擔保和契約僅爲該協議各方，包括在某些情況下爲對於將風險分攤給協議各方的目的，而並不應被視爲對您的陳述、擔保或契約。此外，這些陳述、擔保或契約僅作爲其作出時的準確陳述。因此，不應依賴這些陳述、擔保和契約來準確代表我們當前情況。

本招股說明書補充文件和配套基本招股說明書包含並通過引用特定市場數據和行業統計數據及預測，這些數據和預測基於獨立的行業出版物和其他公開可獲得的信息。儘管我們相信這些來源是可靠的，但涉及到預測的估計涉及許多假設，存在風險和不確定性，並基於各種因素而變化，包括本招股說明書補充文件中討論的「風險因素」和配套基本招股說明書中類似標題下的文件以及這裏和那裏引用的文件。因此，投資者不應過於依賴這些信息。

除非另有規定或上下文另有要求，在本招股說明書補充中提到的所有指公司、我們、我們的、CLDI 均指加州生物療法公司，一家特拉華州公司。"您"指潛在投資者。

招股說明書摘要

該摘要突出了本招股說明書、附屬基本招股說明書和參考文獻中包含的信息。該摘要並不包含您在決定投資於我們證券之前應考慮的所有信息。在做出投資決定之前，您應仔細閱讀本招股說明書和附屬基本招股說明書，包括從第S-8頁開始的「風險因素」部分以及我們的合併財務報表和相關附註以及其他在本招股說明書和附屬基本招股說明書中被引用的信息。

我們是一家持有公司，自身沒有實質性的業務。我們通過我們在中國的子公司開展業務。

我們是一家臨床階段的免疫腫瘤學公司，正在開發創新的幹細胞基因和包裹平台，遞送和增強溶瘤病毒療法以治療癌症。我們的產品線包括現貨候選品，旨在保護溶瘤病毒免受患者免疫系統迅速失活，並靶向腫瘤部位。一旦得到FDA批准，這種改進的遞送方式，無論是局部還是全身，以及增強的效力，將使我們能夠開發針對癌症不同階段的各種類型的治療方法。我們的目標是創建治療任何腫瘤的療法，不受其基因型的影響（通用治療）。除了直接靶向殺死癌細胞外，我們的溶瘤病毒療法已顯示出改變腫瘤免疫環境以誘導強烈的抗腫瘤免疫力並可能導致更好的癌症治療並預防腫瘤復發的跡象。

CLD-101（NeuroNova™平台）用於新診斷的高級別膠質瘤("HGG")（也稱爲「NNV1」指示）。 CLD-101是我們的產品候選人，利用我們的NeuroNova™平台針對HGG。在與西北大學的授權協議之前，在對新診斷的高級別膠質瘤患者進行開放標籤、調查員贊助、1期、劑量遞增的NNV1臨床試驗進行了完成。該臨床試驗表明，在新診斷的HGG患者中，單次給予CLD-101是良好耐受的。將與西北大學合作在2025年第一季度開始NNV1的10億期臨床試驗。此試驗將探索NNV1的最終劑量方案，包括在新診斷的HGG中重複劑量的可行性。將對腫瘤活檢和血樣進行廣泛的生物標誌物分析，以確定病毒分佈、特異性腫瘤靶向和抗腫瘤免疫的誘導。

CLD-101 對於複發性高級神經膠質瘤（也稱爲「NNV2」，針對複發性高級神經膠質瘤指示），擁有一個許可的專利家族和一個待批准的申請，其中包括針對使用含有溶瘤病毒的特定神經幹細胞株進行腫瘤治療組合治療方法的權利要求。一項評估向複發性高級神經膠質瘤患者腦內重複給予CLD-101劑量的安全性和可行性的1期研究於2023年5月開始治療。這項研究由我們的合作伙伴City of Hope進行，於2024年1月開始招募第4組患者。計劃使用CLD-101重複劑量治療複發性高級神經膠質瘤患者的臨床數據來支持開始一項新診斷高級神經膠質瘤重複劑量試驗的啓動。

CLD-201 （SuperNova™）用於高級實體腫瘤（三陰性乳腺癌（「TNBC」），頭頸部鱗狀細胞癌（「HNSCC」）和先進軟組織肉瘤（也稱爲「SNV1」）。 SNV1是我們首個內部開發的臨床前產品候選者，利用我們的SuperNova™運載平台。基於我們的臨床前研究，我們認爲SNV1在治療頭頸癌，三陰性乳腺癌和黑色素瘤等多種實體腫瘤方面具有治療潛力。我們已經與FDA舉行了一次臨床前IND會議，討論了提交CLD-201的IND申請進行臨床開發的事宜。我們預計將在2025年上半年開始SNV1的I期臨床試驗。

CLD-301 （AAA）適用於多種適應症。我們還在進行早期發現研究，涉及成人異體脂肪源性（「AAA」）幹細胞在不同適應症和治療方面的使用。這些AAA幹細胞在理論上是多能的，能夠沿着脂肪細胞、軟骨細胞、肌肉細胞、神經細胞和成骨細胞分化，並且可以在其他方面發揮作用，例如提供造血支持和基因轉移，具有修復和再生急性和慢性受損組織的潛力。需要進行毒性和療效預臨床研究，並提交IND申請以便FDA審批。

我們的 子公司Nova Cell, Inc.（「Nova Cell」）成立，是一家開發基於創新幹細胞的技術服務提供商 使用我們的蜂窩製造工藝的產品。通過Nova Cell，我們預計將潛在用途從腫瘤學擴展到其他領域 需要再生醫療應用，例如化妝品、骨科、自身免疫性疾病和其他各種療法。

CLD-400（RTNova）用於肺癌和轉移性實體腫瘤，我們的臨床前項目涉及外膜溶瘤病毒（發現階段），借鑑了我們使用細胞保護、增強和傳遞病毒治療的經驗。CLD-400項目源自先前臨床前CLD-202項目的研究。RTNova由工程化天花病毒包裹的細胞膜組成，由於其在血液中存活能力增強，潛在地能夠瞄準肺癌和愛文思控股的晚期轉移性疾病。轉移性實體腫瘤涉及癌細胞脫離首次形成的位置（原發性癌症），通過血液或淋巴系統傳播到身體其他部位形成新的腫瘤，稱爲轉移性腫瘤。在臨床前研究中，RTNova顯示出對人類體液免疫的抗性和靶向多個遙遠和多樣化腫瘤的能力，改變它們的微環境，導致其消除。此外，該項目顯示出與其他免疫療法（包括細胞療法）潛在的協同效應，用於打擊和消滅分散的實體腫瘤。

自成立以來，我們的運營主要集中在組織和人員配備、業務規劃、籌集資本、收購和開發我們的技術、建立知識產權組合、確定潛在產品候選者並進行臨床前研究和製造。我們沒有獲得銷售批准的任何產品，也沒有從產品銷售中產生任何營業收入。我們主要通過普通股、可轉換優先股、有條件轉換和可轉換本票、期債、授信額度、未來股權簡約協議（「SAFE」）以及各種銀行貸款來資助我們的業務。這些投資包括並由各種相關方，包括我們最大的投資者兼董事會首席執行官。

自成立以來，我們已經經歷了重大的營運虧損。截止2024年6月30日，我們在過去3個月與6個月中分別虧損了580萬美元和1300萬美元。截止2024年6月30日，我們累計的虧損達到了1.126億元美元。我們預計在可預見的未來將繼續承擔大量的開支和營運虧損，因爲我們推進當前和未來的產品候選者進行臨床前和臨床試驗、製造藥品和藥品供應、尋求對我們當前和未來的產品候選者進行監管批准、維護和擴大我們的知識產權組合、僱用更多研發和業務人員和運營成爲一家公開上市公司。

經濟狀況的變化，包括利率期貨的上漲，公共衛生問題，包括COVID-19大流行及其後果，消費者信心降低，股票資本市場波動大，持續的供應鏈中斷以及地緣政治衝突的影響，也可能影響我們的業務。

除非我們成功完成臨床開發並獲得產品候選人的監管批准，否則我們不會從產品銷售中獲得營業收入。此外，如果我們獲得產品候選人的監管批准並且沒有進入第三方商業化夥伴關係，我們預計將承擔與開發我們的商業能力以支持產品銷售、市場營銷、製造和分銷活動相關的重大費用。

因此，我們需要大量的額外資金來支持我們的業務，並推進我們的增長策略。在我們能夠從產品銷售中獲得顯著營業收入之前（如果有的話），我們預計通過公開或私募股權募集和債務融資或其他來源（如潛在的合作協議、戰略聯盟和許可安排）來爲我們的業務融資。我們可能無法按可接受的條款或根本無法籌集到額外的資金或進入這些其他協議或安排。我們無法在需要時籌集資本或達成這些協議可能會對我們的業務、運營結果和財務狀況產生重大不利影響。

根據我們的經營計劃，我們認爲我們手頭現金不足以在從未經審計的截至2024年6月30日的簡明綜合財務報表發行之日起的至少一年內支持當前運營。我們得出結論，這種情況對我們作爲持續經營實體的能力構成重大疑慮。請參閱我們的簡明綜合財務報表附註1。此外，我們將需要通過發行股權證券籌集額外資本以支持我們的運營，這將對我們當前的股東產生所有權和經濟稀釋效應，他們以高於我們當前交易價格的價格購買了普通股股票，而這樣的資本籌集可能會對我們的普通股股票價格造成不利影響。此外，根據向SEC提交的另一份註冊聲明，由於我們有限的交易量，某些特定的出售證券持有人出售的大量普通股，以及由於我們的有限交易量，將會對我們未來融資的股價以及未來融資中我們可能獲得的股價產生不利影響，可能會影響我們開展和完成今後的融資。

FLAG併購及相關交易

2023年9月12日，FLAG完成了一系列交易，導致FLAG Merger Sub Inc.（一家內華達州公司，FLAG的全資子公司）和Calidi根據於2023年1月9日修訂的《合併協議和計劃書》進行合併。根據合併協議的條款，業務組合是通過Merger Sub與Calidi的合併實現的，Calidi作爲FLAG的全資子公司生存。根據約0.042的換股比率，已基於該比率逐年回溯重新披露了Calidi的歷史普通股金額。完成業務組合後，FLAG更名爲「Calidi生物技術公司」。

由於業務組合，Calidi所有未結算的股票都被取消，以換取新發行的普通股（也稱爲「新Calidi普通股」），每股面值0.0001美元，並承擔了所有未結算的購買Calidi股票的期權。根據併購協議所規定的交易完成時，Calidi證券持有人所接受的總對價爲新發行的普通股和可轉換或可交換爲新發行的普通股的證券，總價值爲2.5億美元，再加上根據「b輪融資」的淨債務調整條款所作出的2.38百萬美元的調整。因此，Calidi證券持有人作爲併購考慮，收到了2737560股普通股。

作爲額外考慮，每個Calidi股東都有權按比例獲得最多180萬份Escalation股份。在Escalation期間，如果Common Stock的交易價格在任何30連續交易日內的任何20天達到120.00美元、140.00美元、160.00美元和180.00美元的每個股價障礙，Calidi股東可能有權獲得最多1,800,000股Escalation股份，每達到一個股價障礙就釋放450,000股。Escalation股份已被置於託管帳戶，並且在完成交易之後即可用/流通，但如果未達到適用的價格目標，則可能被取消。股份在託管期間將不享有投票權。

未贖回其FLAG A類普通股的持有人將獲得按比例分配的8,585股未贖回繼續股份作爲補償。在交割時，Calidi安防-半導體持有人大約擁有新Calidi普通股的76%。

近期發展

貸款協議

2024年7月1日，我們與第三方貸方（「貸方」）簽訂了貸款協議。根據貸款協議，貸方同意根據2024年7月1日發給貸方的本票條款向Calidi借出60萬美元的本金（「本票」）。根據本票條款，貸方同意於2024年7月2日提供60萬美元的本金。

該票據按照年息15.0%的利率計息，並在付款日後的第三個日曆年到期（「到期日」），除非根據票據條款發生違約事件而提前到期。Calidi同意在付款日後的每個日曆年支付應計利息的年度付款，直到到期日任何未償還的利息全部支付完畢。

股票拆分

2024年7月10日，公司向特拉華州州務卿提交了首次修正證書，以實施公司普通股每股面值0.0001美元的1比10股票合併，生效日期爲2024年7月15日（「反向股票分割」）。由於反向股票分割，每十股已發行和未流通的普通股（表決權和非表決權）自動合併爲一股發行和未流通的普通股，每股面值不變。不會因爲反向股票分割而發行碎股，任何因反向股票分割而產生的碎股都將四捨五入至最接近的整數。公司第二次修正證書所授權的普通股股數，經修正後，保持不變。

所有板塊 未經審計的彙編財務報表中，所有期間涉及的股份和每股金額的參考均進行了追溯性重組以反映此變更的股票拆分。

認購協議

2024年7月26日，Calidi董事會批准了2024年7月28日的認購協議（「協議」），與一位認可的投資者（「投資者」）——一位關聯方——簽訂。根據協議，Calidi將以1.431美元每股的價格（相當於2024年7月22日美國紐約證券交易所上公司普通股收盤價的90%）向投資者出售，投資者購買了（i）698,812股普通股；和（ii）以1.90美元的行權價格行使購買600,000股Calidi普通股的認股權證（相當於2024年7月22日公司普通股在美國紐約證券交易所上的收盤價的120%），總購買價格爲100萬美元（「定向增發」）。

鑑於投資者的定向增發，卡里迪董事會批准了投資者的任命，一位傑出的醫生和幹細胞療法專家，加入卡里迪的科學和醫學顧問委員會（「SMAB」）。此任命是根據2024年7月28日簽署的SMAB諮詢協議（「諮詢協議」）進行的。作爲諮詢協議的一部分，投資者將被授予5,000股期權，標準的四年分期歸屬期。

轉讓知識產權給Nova Cell

2024年7月26日，卡里迪董事會和審計委員會批准了200萬美元左右的戰略投資，由關聯方投資者投資到nova電芯。預計該投資將導致向投資者發行750萬股nova電芯普通股，佔nova電芯當前全面攤薄的資本結構的25%。

與此投資同時，董事會批准根據2024年7月28日簽訂的《知識產權轉讓協議》，將某些知識產權轉讓給nova電芯。

普通股權證的練習

根據2024年7月15日實施的反向股票拆分，截至2024年7月22日，A、B、C、B-1和C-1系列權證的行權價格已重置爲每股1.52美元。

2024年7月和8月期間，以每股1.52美元的行使價格，行使了購買375,000股普通股的A系列權證、購買375,000股普通股的B系列權證和購買637,500股普通股的C系列權證。根據權證行使發行的普通股，Calidi獲得了約210萬美元的總收益。

2024年7月和8月，通過行使指定份額的B系列和C系列認股權證，Calidi發行了B-1認股權證，用於購買375,000股普通股，併發行了C-1認股權證，用於購買637,500股普通股。隨後行使了購買75,000股普通股的B-1認股權證和購買325,000股普通股的C-1認股權證，行使價格爲每股$1.52。根據該認股權證行使，Calidi收到了約60萬美元的募集淨收益。

Calidi Cure LLC 解散

Calidi Cure LLC（「Calidi Cure」），成立於2023年6月的特殊目的實體有限責任公司，由公司的首席執行官兼董事會主席Allan J. Camaisa獨家管理和運營。Calidi Cure專門爲支持Calidi的B輪可轉換優先股融資安排而成立，沒有其他經營活動，並於2024年7月解散。

對某些票據和延期薪酬的修正

2024年8月12日，指定2021年期票據的利率爲$700,000，2022年期票據的利率爲$200,000，2023年期票據的利率爲$1,500,000，以及延期總計爲$600,000的報酬，被修改將年利率從24%降低至14%。所有其他條款和條件基本保持不變。

減少董事會規模和董事辭職

2024年8月16日，董事會前成員George Ng先生通知董事會，爲了專注於增加公司外的專業承諾，他打算讓他在董事會的董事職位的任期到期，到期日定於公司2024年年度股東大會的日期，即2024年9月20日。儘管他的董事任期到期，公司和Ng先生同意保持他與公司的戰略諮詢和諮詢關係。與Ng先生的決定相關，自2024年9月20日起，董事會將董事會規模從六名減少到五名董事。

可轉換票據

2024年9月30日，債務人將200萬美元可轉換票據中的本金和利息總額轉換爲184,810股普通股。

市場價格 發行

2024年10月11日，我們與Ladenburg Thalmann\u0026 Co. Inc.（「Ladenburg」）簽訂了一項市場交易協議（「銷售協議」），根據銷售協議，公司可能會隨時自行決定通過Ladenburg（作爲代理人或負責人）發行和賣出公司的普通股股份，總髮行價高達510萬美元。

2024年10月11日，公司向證券交易委員會（「SEC」）提交了一份招股說明書，涉及根據銷售協議出售公司普通股的發行。截至本招股說明書日期，尚未根據銷售協議出售任何公司普通股。

我們公開交易的權證即將退市 公告

2024年10月17日，我們收到了紐交所美國工作人員的通知，稱我們公開交易的權證交易將立即停止。紐交所監管人員確定公司的權證不再適合根據紐交所美國公司指南第1001條的規定列入交易，原因是該等權證的交易價格過低。

我們有權要求紐交所監管人員的決定交易所董事會上市資格審查委員會對公司認股權證進行復審。紐約證券交易所將在完成所有適用程序，包括公司對紐交所監管人員決定的任何上訴後，申請刪除公司的認股權證。

公司信息

我們的首席執行辦公室位於加利福尼亞州聖地亞哥市92121號4475號行政大道200號套房。我們的電話號碼是（858）794-9600。我們的網站地址是 www.calidibio.com。本招股說明書中關於我們網站的引用均爲不活動文本引用。我們網站上的信息既不被引入本招股說明書，也不意在與本次發行有關聯。我們在本招股說明書中包含了我們的網站地址，僅作爲不活動文本引用，而不是作爲活動超鏈接。

發行

Except as otherwise indicated, the information in this prospectus supplement assumes, no release of the Non-Voting Escalation Shares, no exercise of any outstanding options or exercise of any outstanding warrants or conversion of the convertible debt, and assumes no exercise of the Common Warrants issued pursuant to the concurrent private placement described in this prospectus supplement, or by the placement agent of the Placement Agent Warrants.

RISK FACTORS

An investment in our Common Stock involves a high degree of risk. Before making an investment decision, in addition to the risks set forth below, you should consider the “Risk Factors” included under Item 1A of our most recent Annual Report on Form 10-K, as may be updated in our subsequent Quarterly Reports on Form 10-Q, and other reports and documents that are incorporated by reference into this prospectus supplement and the accompanying base prospectus, before deciding whether to purchase any of our Common Stock in this offering. . The market or trading price of our Common Stock could decline due to any of these risks. In addition, please read “Forward-Looking Statements” in this prospectus, where we describe additional uncertainties associated with our business and the forward-looking statements included or incorporated by reference in this prospectus. Please note that additional risks not currently known to us or that we currently deem immaterial may also impair our business and operations. If any of the risks or uncertainties described in our SEC filings or any additional risks and uncertainties actually occur, our business, financial condition, results of operations and cash flow could be materially and adversely affected. In that case, the market value and/or trading price, as applicable, of our securities could decline, and you might lose all or part of your investment.

Our management will have broad discretion over the use of the net proceeds from this offering, you may not agree with how we use the proceeds, and the proceeds may not be invested successfully.

Our management will have broad discretion in the application of the net proceeds from this offering, and our stockholders will not have the opportunity as part of their investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. The failure by our management to apply these funds effectively could harm our business. See “Use of Proceeds” on page S-12 of this prospectus supplement for a description of our proposed use of proceeds from this offering.

Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in our Annual Report on Form 10-K for the Fiscal year ended December 31, 2023.

The report from our independent registered public accounting firm for the year ended December 31, 2023, includes an explanatory paragraph stating that we have significant working capital deficiency, and have incurred significant losses and need to raise additional funds to meet our obligations and sustain our operations. These conditions raise substantial doubt about our ability to continue as a going concern. As of June 30, 2024, we had approximately $0.8 million in cash and restricted cash of $0.2 million, an accumulated deficit of approximately $112.6 million and working capital deficit of approximately $11.4 million. We believe that our existing cash and cash equivalents as of June 30, 2024, and our anticipated expenditures and commitments for the next twelve months, will not enable us to fund our operating expenses and capital expenditure requirements for the twelve months from June 30, 2024. Our recurring losses from operations since inception and required additional funding to finance our operations raise substantial doubt about our ability to continue as a going concern. These conditions could materially limit our ability to raise additional funds through the issuance of new debt or equity securities or otherwise. There is no assurance that sufficient financing will be available when needed, or at all, to allow us to continue as a going concern. The perception that we may not be able to continue as a going concern may also make it more difficult to operate our business due to concerns about our ability to meet our contractual obligations. Our ability to continue as a going concern is contingent upon, among other factors, the sale of our securities. There is no assurance that sufficient financing will be available when needed, or at all, to allow us to continue as a going concern.

If we are unable to secure additional capital, we may be required to curtail our clinical and research and development initiatives and take additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. These measures could cause significant delays in our clinical and regulatory efforts, which is critical to the realization of our business plan. The consolidated financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern. It is not possible for us to predict at this time the potential success of our business. The revenue and income potential of our proposed business and operations are currently unknown. If we cannot continue as a viable entity, you may lose some or all of your investment.

If you purchase securities sold in this offering, you may experience immediate dilution as a result of this offering.

You may incur immediate and substantial dilution as a result of this offering. After giving effect to the sale by us of up to 2,050,000 shares offered in this offering at an offering price of $1.00 per Share, and after deducting placement agent fees and offering expenses payable by us. Based on the effective offering price of $1.00 per share of Common Stock and our pro forma net tangible book value as of June 30, 2024, of $(1.72) per share, if you purchase securities in this offering you will suffer immediate and substantial dilution of approximately $1.27 per share. We have a significant number of stock options and warrants outstanding, and, in order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock at prices that may not be the same as the price per share in this offering. In the event that the outstanding options and/or warrants are exercised, or that we make additional issuances of common stock or other convertible or exchangeable securities, you could experience additional dilution. We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders, including investors who purchase shares of common stock in this offering. The price per share at which we sell additional shares of our common stock or securities convertible into common stock in future transactions, may be higher or lower than the price per share in this offering. As a result, purchasers of the shares we sell, as well as our existing stockholders, will experience significant dilution if we sell at prices significantly below the price at which they invested. See the section entitled “Dilution” below for a more detailed illustration of the dilution you would incur if you participate in this offering.

Sales of a significant number of shares of our Common Stock in the public markets or significant short sales of our Common Stock, or the perception that such sales could occur, could depress the market price of our Common Stock and impair our ability to raise capital.

Sales of a substantial number of shares of our Common Stock or other equity-related securities in the public markets, could depress the market price of our Common Stock. This offering may contribute to a depressed market price of our Common Stock. If there are significant short sales of our Common Stock, the price decline that could result from this activity may cause the share price to decline more so, which, in turn, may cause long holders of the Common Stock to sell their shares, thereby contributing to sales of Common Stock in the market. Such sales also may impair our ability to raise capital through the sale of additional equity securities in the future at a time and price that our management deems acceptable, if at all.

There is a limited trading market for our Common Stock, which could make it difficult to liquidate an investment in our Common Stock, in a timely manner.

Our Common Stock is currently traded on the NYSE American. Because there is a limited public market for our Common Stock, investors may not be able to liquidate their investment whenever desired. We cannot assure that there will be an active trading market for our Common Stock and the lack of an active public trading market could mean that investors may be exposed to increased risk. In addition, if we failed to meet the criteria set forth in SEC regulations, various requirements would be imposed by law on broker-dealers who sell our securities to persons other than established customers and accredited investors. Consequently, such regulations may deter broker-dealers from recommending or selling our Common Stock, which may further affect its liquidity.

There is no established public trading market for the Common Warrants being offered in this Offering, and we do not expect a market to develop for the Common Warrants.

There is no established public trading market for the Common Warrants being offered and sold in this Offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the Common Warrants on any national securities exchange or other nationally recognized trading system. Without an active market, the liquidity of the Common Warrants will be limited. Further, the existence of the Common Warrants may act to reduce both the trading volume and the trading price of our Common Stock.

The Common Warrants are speculative in nature.

Except as otherwise provided in the Common Warrants, until holders of the Common Warrants acquire our Common Stock upon exercise of the Common Warrants, holders of such Common Warrants will have no rights with respect to our Common Stock underlying such Common Warrants. Upon exercise of the Common Warrants, the holders will be entitled to exercise the rights of a stockholder of our Common Stock only as to matters for which the record date occurs after the exercise date.

Moreover, following this offering, the market value of the Common Warrants is uncertain. There can be no assurance that the market price of our Common Stock will ever equal or exceed the price of the Common Warrants, and, consequently, whether it will ever be profitable for investors to exercise their Common Warrants.

Holders of the Common Warrants purchased in this offering will have no rights as holders of Common Stock until such holders exercise their Common Warrants and acquire our Common Stock.

Holders of the Common Warrants acquire our Common Stock upon exercise of such Common Warrants, holders of the Common Warrants will have no rights with respect to our Common Stock underlying such Common Warrants. Upon exercise of the Common Warrants, the holders will be entitled to exercise the rights of a holder of Common Stock only as to matters for which the record date occurs after the exercise date.

Significant holders or beneficial holders of shares of our Common Stock may not be permitted to exercise the Common Warrants that they hold.

A holder of the Common Warrants will not be entitled to exercise any portion of any Common Warrant that, upon giving effect to such exercise, would cause: (i) the aggregate number of shares of our Common Stock beneficially owned by such holder (together with its affiliates) to exceed 4.99% (or 9.99%, 14.99%, or 19.99%, at the election of the holder) of the number of shares of our Common Stock immediately after giving effect to the exercise; or (ii) the combined voting power of our securities beneficially owned by such holder (together with its affiliates) to exceed 4.99% (or 9.99%, 14.99%, or 19.99%, at the election of the holder) of the combined voting power of all of our securities outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Common Warrants. As a result, you may not be able to exercise your Common Warrants for shares of our Common Stock at a time when it would be financially beneficial for you to do so. In such a circumstance, you could seek to sell your Common Warrants to realize value, but you may be unable to do so in the absence of an established trading market and due to applicable transfer restrictions.

This is a best efforts offering, no minimum number of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans.

The placement agent has agreed to use its reasonable best efforts to solicit offers to purchase the Shares, in this Offering. The placement agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. There is no required minimum number of securities or amount of proceeds that must be sold as a condition to completion of this Offering. Because there is no minimum number of securities or amount of proceeds required as a condition to the closing of this Offering, the actual offering amount, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth above. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell all of the securities offered in this Offering. Thus, we may not raise the amount of capital we believe is required for our operations in the short term and may need to raise additional funds, which may not be available or available on terms acceptable to us.

You may experience future dilution as a result of future equity offerings.

In order to raise additional capital, we may in the future offer additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock at prices that may not be the same as the price per share paid by any investor in this offering. We may sell shares or other securities in any other offering at a price per share that is less than the price per share paid by any investor in this offering, and investors purchasing shares or other securities in the future could have rights superior to you. The price per share at which we sell additional shares of our Common Stock, or securities convertible or exchangeable into shares of Common Stock, in future transactions may be higher or lower than the price per share paid by any investor in this offering.

We do not intend to pay dividends on our Common Stock in the foreseeable future.

We have never paid cash dividends on our Common Stock. We currently intend to invest our future earnings, if any, to fund our growth and not to pay any cash dividends on our Common Stock. Because we do not intend to pay dividends, your ability to receive a return on your investment will depend on any future appreciation in the market price of our Common Stock. We cannot be certain that our Common Stock will appreciate in price.

CAUTIONARY NOTE FORWARD-LOOKING STATEMENTS

This prospectus supplement, the accompanying base prospectus, the documents that we incorporate by reference herein or therein and any free writing prospectuses that we may authorize for use in connection with this offering contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or words of similar import. Similarly, statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects are also forward-looking statements. Discussions containing these forward-looking statements may be found, among other places, in the “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections incorporated by reference from our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q for the quarterly periods ended subsequent to our filing of such Annual Report on Form 10-K, as well as any amendments thereto reflected in subsequent filings with the SEC.

These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. The risks and uncertainties include, among others, those noted in “Risk Factors” above and in any applicable prospectus supplement or free writing prospectus, and those included in the documents that we incorporate by reference herein and therein.

In addition, past financial and/or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to publicly revise our forward-looking statements to reflect events or circumstances that arise after the filing of this prospectus supplement or any supplement or free writing prospectus, or documents incorporated by reference herein and therein, that include forward-looking statements.

USE OF PROCEEDS

We estimate that our net proceeds from this Offering will be approximately $1.7 million, after deducting the placement agent fees and estimated offering expenses payable by us. The net proceed estimates exclude proceeds, if any, from the concurrent private placement.

Currently, we intend to use the net proceeds from this offering for working capital and for general corporate purposes and preclinical and clinical trials. This represents our best estimate of the manner in which we will use the net proceeds we receive from this offering based upon the current status of our business, but we have not reserved or allocated amounts for specific purposes and we cannot specify with certainty how or when we will use any of the net proceeds. Amounts and timing of our actual expenditures will depend on numerous factors. We will retain broad discretion in the allocation and use of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of the proceeds of this offering.

We believe that the net proceeds from this offering, together with our existing cash and cash equivalents, will meet our capital needs for the next one month under our current business plan.

Pending application of the net proceeds as described above, we intend to invest the proceeds to us in investment-grade, interest-bearing securities such as money market funds, certificates of deposit, or direct or guaranteed obligations of the U.S. government, or hold as cash. We cannot predict whether the proceeds invested will yield a favorable, or any, return.

DIVIDEND POLICY

We have never declared or paid any cash dividends on our capital stock, and we do not currently intend to pay any cash dividends on our Common Stock for the foreseeable future. We expect to retain future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends on our Common Stock will be at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements and any contractual restrictions.

DILUTION

If you purchase Shares in this offering, your ownership interest will be diluted to the extent of the difference between the public offering price per share of our Common Stock and the as adjusted net tangible book value (deficit) per share of our Common Stock after giving effect to this Offering. We calculate net tangible book value (deficit) per share by dividing the net tangible book value (deficit), which is total tangible assets, less total liabilities, by the number of outstanding shares of our Common Stock. Dilution represents the difference between the price per Share paid by purchasers in this offering and the as adjusted net tangible book value per share of our Common Stock immediately after giving effect to this offering.

Our net tangible book value (deficit) as of June 30, 2024, was approximately $(11.1) million, or $(1.72) per share. “Net tangible book value (deficit)” is total assets minus the sum of liabilities and intangible assets.

After giving effect to equity issuances and financing proceeds between June 30, 2024 and October 22, 2024, our pro forma net tangible book value as of October 22, 2024 would have been approximately $(4.8) million or approximately $(0.50) per share.

After giving further effect to the sale by us in this offering of 2,050,000 shares of Common Stock, at an offering price of $1.00 per share, (assuming no exercise of the Common Warrants issued in the concurrent private placement), and after deducting the placement agent fees and estimated offering expenses payable by us, our as adjusted net tangible book value as of June 30, 2024, would have been approximately $ (3.1) million or approximately $(0.27) per share of Common Stock. This represents an immediate increase in net tangible book value of approximately $0.23 per share of Common Stock to our existing security holders and an immediate dilution in as adjusted net tangible book value of approximately $1.27 per share to purchasers of our securities in this offering, as illustrated by the following table:

The number of shares of Common Stock to be outstanding after this offering is based on based on 9,627,919 shares outstanding as of October 22, 2024, and excludes:

Except as otherwise indicated, the information in this prospectus supplement assumes, no release of the Non-Voting Escalation Shares, no exercise of any outstanding options or exercise of any outstanding warrants or conversion of the convertible debt, and assumes no exercise of the Common Warrants issued pursuant to the concurrent private placement described in this prospectus supplement, or by the placement agent of the Placement Agent Warrants.

To the extent that options or warrants are exercised, or the debt is converted, you may experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

DESCRIPTION OF SECURITIES WE ARE OFFERING

We are offering 2,050,000 shares of Common Stock at an offering price of $1.00 per share of Common Stock.

Common Stock

The shares of our Common Stock are registered under Section 12 of the Exchange Act and are traded on NYSE American under the symbol “CLDI”. The material terms and provisions of our Common Stock and each other class of our securities that qualifies or limits our Common Stock are described in the section entitled “Description of Capital Stock”, beginning on page 4 of the accompanying prospectus.

CONCURRENT PRIVATE PLACEMENT

Concurrently with this offering, we are also selling to the purchasers in this offering (i) Series E Common Warrants to purchase up to 2,050,000 shares of Common Stock (“Series E Common Warrant Shares”), with an exercise price of $1.13 per Series E Common Warrant Share, subject to certain adjustments, and exercisable on the date that is six (6) months from the date of issuance for a term of one (1) year from the initial exercise date, or (ii) Series F Common Warrants to purchase up to 2,050,000 shares of Common Stock (“Series F Common Warrant Shares”), with an exercise price of $1.13 per Series F Common Warrant Share, subject to certain adjustments, and exercisable on the date that is six (6) months from the date of issuance for a term of five (5) years from the initial exercise date. The Series E Common Warrant Shares and the Series F Common Warrant Shares are together referred to as the “Common Warrant Shares”, and the Series E Common Warrants and Series F Common Warrants are together referred to as the “Common Warrants”.

The Common Warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and, at any time a registration statement registering the issuance of the Common Stock underlying the Common Warrants under the Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of Common Stock purchased upon such exercise.

A holder of Common Warrants will have the right to exercise the Common Warrants on a “cashless” basis if there is no effective registration statement registering the resale of the Common Warrant Shares underlying the Common Warrants. Subject to limited exceptions, a holder of Common Warrants will not have the right to exercise any portion of its Common Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise, provided that the holder may, at its option, increase the beneficial ownership limitation up to 9.99%, 14.99% or 19.99%.

We have agreed to prepare and file with the SEC a registration statement to register for resale all of the Common Warrant Shares underlying the Common Warrants. Except as otherwise provided in the Common Warrants or by virtue of such holder’s ownership of Common Warrant Shares, the holders of the Common Warrants do not have the rights or privileges of holders of our shares of Common Stock, including any voting rights, until they exercise their Common Warrants.

The Common Warrants and the Common Warrant Shares issuable upon the exercise of the Common Warrants are being offered pursuant to the exemptions provided in Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D promulgated thereunder, and they are not being offered pursuant to this prospectus supplement and the accompanying prospectus.

In the event of any fundamental transaction, as described in the Common Warrants and generally including any merger with or into another entity, sale of all or substantially all of our assets, tender offer or exchange offer, or reclassification of our shares of Common Stock, subject to certain exceptions, then upon any subsequent exercise of a Common Warrant, the holder will have the right to receive as alternative consideration, for each Common Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of Common Stock of the successor or acquiring corporation of our company, if it is the surviving corporation, and any additional consideration receivable upon or as a result of such transaction by a holder of the number of Common Warrant Shares for which the Common Warrant is exercisable immediately prior to such event. Notwithstanding the foregoing, in the event of a fundamental transaction, the holders of the Common Warrants have the right to require us or a successor entity to redeem the Common Warrants for cash in the amount of the Black Scholes Value (as defined in each Common Warrant) of the unexercised portion of the Common Warrants concurrently with or within 30 days following the consummation of a fundamental transaction. However, in the event of a fundamental transaction which is not in our control, including a fundamental transaction not approved by our board of directors, the holders of the Common Warrants will only be entitled to receive from us or our successor entity, as of the date of consummation of such fundamental transaction the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of the Common Warrants, that is being offered and paid to the holders of our common shares in connection with the fundamental transaction, whether that consideration is in the form of cash, shares or any combination of cash and shares, or whether the holders of our common shares are given the choice to receive alternative forms of consideration in connection with the fundamental transaction, provided, further, that if holders of Common Stock of the Company are not offered or paid any consideration in such fundamental transaction, such holders of Common Stock will be deemed to have received common stock of the successor entity (which entity may be the Company following such Fundamental Transaction) in such fundamental transaction.

In accordance with its terms and subject to applicable laws, a Common Warrant may be transferred at the option of the holder upon surrender of the Common Warrant to us together with the appropriate instruments of transfer and payment of funds sufficient to pay any transfer taxes (if applicable).

Except as otherwise provided in the Common Warrants or by virtue of such holder’s ownership of our Common Stock, the holder of a Common Warrant does not have the rights or privileges of a holder of our Common Stock, including any voting rights, until the holder exercises the Common Warrant.

There is no established public trading market for the Common Warrants, and we do not expect a market to develop. In addition, we do not intend to list the Common Warrants on NYSE American, any other national securities exchange or any other nationally recognized trading system.

PLAN OF DISTRIBUTION

Ladenburg Thalmann & Co. Inc. (the “placement agent”), has agreed to act as our exclusive placement agent in connection with this offering, subject to the terms and conditions of the Placement Agency Agreement, dated October 23, 2024. The placement agent is not purchasing or selling any of the securities offered by this prospectus supplement, nor is it required to arrange the purchase or sale of any specific number or dollar amount of securities but has agreed to use its reasonable best efforts to arrange for the sale of all of the securities offered hereby. We may not sell the entire amount of securities offered pursuant to this prospectus.

In connection with this offering, we entered into a securities purchase agreement with each purchaser. This agreement includes representations and warranties by us and the purchaser.

We will deliver the securities being issued to the purchasers upon receipt of such purchaser’s funds for the purchase of the securities offered pursuant to this prospectus supplement. We expect to deliver the shares of our Common Stock being offered pursuant to this prospectus supplement on or about October 24, 2024, subject to the satisfaction of customary closing conditions.

We have agreed to indemnify the placement agent against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the placement agent may be required to make in respect thereof.

Fees and Expenses

We have engaged the placement agent as our exclusive placement agent in connection with this offering. This offering was conducted on a “reasonable best efforts” basis and the placement agent had no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of securities. We have agreed to pay the placement agent a fee based on the aggregate proceeds as set forth in the table below.

1. We have agreed to pay the placement agent cash fee equal to 8% of the gross proceeds raised in this offering. We have also agreed to reimburse the placement agent for certain of its offering-related expenses, including a management fee of 1.0% of the gross proceeds raised in this offering from the sale of the Securities at the Closing and to reimburse the placement agent for its legal fees and expenses and other out-of-pocket expenses in an amount up to $125,000.

2. The amount of the offering proceeds to us, presented in this table, does not give effect to the proceeds from the exercise of any of the Common Warrants, or any of the Placement Agent Warrants.

Placement Agent Warrants

In addition, we have agreed to issue to the placement agent or its designees warrants (“Placement Agent Warrants”) to purchase 102,500 shares of Common Stock (which represents 5% of the aggregate number of Shares issued in this offering) with an exercise price of $1.25 per share (representing 125% of the offering price) and exercisable from time to time, in whole or in part, during a period commencing six (6) months from the date of issuance and expiring five years from the date of this offering. The Placement Agent Warrants will have substantially the same terms as the Common Warrants described above. The Placement Agent Warrants and underlying shares of common stock are not registered on the registration statement of which this prospectus is a part. The Placement Agent Warrants have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to Rule 5110(e) of FINRA. The placement agent (or permitted assignees) will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities underlying these warrants, nor will they engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the warrants or the underlying securities for a period of 180 days following the commencement of sales of the securities issued in this offering.

We estimate the total expenses of this offering payable by us, excluding the placement agent fee and management fee, will be approximately $200,000.

Tail

We have also agreed to pay the placement agent a tail fee equal to the cash and warrant compensation in this offering, if any investor, who was contacted or introduced to us by the placement agent during the term of its engagement, provides us with capital in any public or private offering or other financing or capital raising transaction during the nine (9) month period following expiration or termination of our engagement agreement with the placement agent dated October 16, 2024, provided, however, that the Company has the right to terminate its engagement of the placement agent for cause in compliance with FINRA Rule 5110(g)(5)(B)(i), which termination for cause eliminates the Company’s obligations with respect to the tail.

Lock-up Agreements and other restrictions

We and each of our officers and directors have agreed with the placement agent to be subject to a lock-up period of thirty (30) days, and ninety (90) days, respectively, following the date of closing of the offering pursuant to this prospectus supplement. This means that, during the applicable lock-up period, such persons may not offer for sale, contract to sell, sell, distribute, grant any option, right or warrant to purchase, pledge, hypothecate or otherwise dispose of, directly or indirectly, any of our shares of common stock or any securities convertible into, or exercisable or exchangeable for, shares of common stock, subject to customary exceptions. Notwithstanding, our Chief Executive Officer, after forty-five (45) days and until the end of the lock-up period, may, to address personal tax planning strategies, sell no more than 10,000 shares of common stock. The placement agent may waive the terms of these lock-up agreements in its sole discretion and without notice.

In addition, pursuant to the placement agency agreement, we have agreed with the placement agent not to: (i) enter into variable rate financings for a period of six (6) months following the closing of the offering, subject to certain exceptions; and (ii) for twenty (20) days from closing of the offering (a) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or securities convertible in common stock, or (b) file any registration statement or any amendment or supplement thereto, in each case other than a prospectus related to this offering or the filing a registration statement on Form S-8 in connection with any employee compensation plan, subject to certain exceptions.

Regulation M

The placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the resale of the securities sold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. As an underwriter, the placement agent would be required to comply with the requirements of the Securities Act and the Exchange Act, including, without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of our securities by the placement agent acting as principal. Under these rules and regulations, the placement agent (i) may not engage in any stabilization activity in connection with our securities and (ii) may not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until it has completed its participation in the distribution.

Indemnification

We have agreed to indemnify the placement agent against certain liabilities, including certain liabilities arising under the Securities Act and to contribute to payments that the placement agent may be required to make for these liabilities.

Determination of Offering Price

The offering price of the securities we are offering has been negotiated between us and the investors in the offering based on the trading of our shares of common stock prior to the offering, among other things. Other factors considered in determining the public offering price of the securities we are offering include our history and prospects, the stage of development of our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management, the general conditions of the securities markets at the time of the offering and such other factors as were deemed relevant.

Electronic Offer, Sale and Distribution of Securities

A prospectus in electronic format may be made available on the websites maintained by the placement agent, if any, participating in this offering and the placement agent may distribute prospectuses electronically. Other than the prospectus in electronic format, the information on the websites is not part of this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us or the placement agent, and should not be relied upon by investors.

Other Relationships

The placement agent and certain of its affiliates are full service financial institutions engaged in various activities, which may include securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment, hedging, financing and brokerage activities. The placement agent and certain of its affiliates have, from time to time, performed, and may in the future perform, various commercial and investment banking and financial advisory services for us and our affiliates, for which they received or will receive customary fees and expenses.

In the ordinary course of their various business activities, the placement agent and certain of its affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involve securities and/or instruments issued by us and our affiliates. If the placement agent or its affiliates have a lending relationship with us, they routinely hedge their credit exposure to us consistent with their customary risk management policies. The placement agent and its affiliates may hedge such exposure by entering into transactions that consist of either the purchase of credit default swaps or the creation of short positions in our securities or the securities of our affiliates, including potentially the securities offered hereby. Any such short positions could adversely affect future trading prices of the securities offered hereby. The placement agent and certain of its affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or express independent research views in respect of such securities or instruments and may at any time hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.

In addition to the services provided in connection with this offering, the placement agent has in the past also:

(a) entered into a market offering agreement, or sales agreement dated October 11, 2024 with us, for an at-market-offering, pursuant to which we filed the Prior Prospectus with the SEC on October 11, 2024. If and when any sales are made pursuant to such sales agreement, the placement agent will be entitled to compensation at a commission rate of 3.0% of the gross sales price per share sold under such agreement.

(b) the placement agent also acted as the placement agent for the offering that closed in June 2024, for which the placement agent was engaged to provide exclusive financial services in connection with the transactions, and was paid a fee equal to 8.0% of the aggregate gross proceeds received, certain accountable expenses, a 1% management fee of the gross proceeds; and was issued placement agent warrants to purchase 534,900 shares of Common Stock, or 5.0% of the aggregate number of shares of Common Stock underlying such warrants.

(c) the placement agent also acted as the placement agent for the offering that closed in April 2024, for which the placement agent was engaged to provide exclusive financial services in connection with the transactions, and was paid a fee equal to 8.0% of the aggregate gross proceeds received, certain accountable expenses, a 1% management fee of the gross proceeds; and was issued placement agent warrants to purchase 759,875 shares of Common Stock, or 5.0% of the aggregate number of shares of Common Stock underlying such warrants.

LEGAL MATTERS

The validity of the securities offered by this prospectus supplement will be passed upon for us by Sichenzia Ross Ference Carmel LLP, New York, New York. Certain legal matters in connection with this offer will be passed upon for the placement agent by Sheppard, Mullin, Richter & Hampton LLP, New York, New York.

EXPERTS

The consolidated financial statements of Calidi Biotherapeutics, Inc., as of December 31, 2023 and 2022 and for each of the two years in the period ended December 31, 2023, included in Calidi Biotherapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2023 have been audited by Marcum LLP, independent registered public accounting firm, as set forth in their report thereon, which includes an explanatory paragraph as to the Company’s ability to continue as a going concern, included therein, and incorporated herein by reference. Such consolidated financial statements are incorporated herein by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing.

WHERE YOU CAN FIND MORE INFORMATION

As permitted by SEC rules, this prospectus supplement omits certain information that is included in the registration statement of which this prospectus supplement forms a part and its exhibits. Since this prospectus supplement may not contain all of the information that you may find important, we urge you to review the full text of these documents. If we have filed a contract, agreement or other document as an exhibit to the registration statement of which this prospectus supplement forms a part, please read the exhibit for a more complete understanding of the document or matter involved. Each statement in this prospectus supplement, including statements incorporated by reference as discussed above, regarding a contract, agreement or other document is qualified in its entirety by reference to the actual document.

We are subject to the information reporting requirements of the Exchange Act and, in accordance with these requirements, we file annual, quarterly and current reports, proxy statements, information statements, and other information with the SEC. Our SEC filings are available to the public over the Internet at the SEC’s website at www.sec.gov. These documents may also be accessed on our web site at www.calidibio.com. Information contained on our web site is not incorporated by reference into this prospectus supplement and you should not consider information contained on our web site to be part of this prospectus supplement.

INCORPORATION BY REFERENCE

The SEC allows us to “incorporate by reference” into this prospectus the information we file with it, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus. Any statement contained herein or in a document incorporated or deemed to be incorporated by reference into this document will be deemed to be modified or superseded for purposes of the document to the extent that a statement contained in this document or any other subsequently filed document that is deemed to be incorporated by reference into this document modifies or supersedes the statement. We incorporate by reference in this prospectus the following information (other than, in each case, documents or information deemed to have been furnished and not filed in accordance with SEC rules):

In addition, all documents that the Company files pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act, subsequent to the filing of this Registration Statement and prior to the filing of a post-effective amendment which indicates that all securities offered hereby have been sold or which deregisters all securities then remaining unsold, shall be deemed to be incorporated by reference into this Registration Statement and to be a part hereof from the date of filing of such documents, except as to any document or portion of any document that is deemed furnished and not filed. Notwithstanding the foregoing, information furnished under Items 2.02 and 7.01 of any Current Report on Form 8-K, including the related exhibits, is not incorporated by reference in this prospectus supplement.

Pursuant to Rule 412 under the Securities Act, any statement contained in the documents incorporated or deemed to be incorporated by reference in this Registration Statement shall be deemed to be modified, superseded or replaced for purposes of this Registration Statement to the extent that a statement contained herein or in any other subsequently filed document which also is incorporated or deemed to be incorporated by reference in this Registration Statement modifies, supersedes or replaces such statement. Any such statement so modified, superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a part of this Registration Statement.

Upon written or oral request made to us at the address or telephone number below, we will, at no cost to the requester, provide to each person, including any beneficial owner, to whom this prospectus supplement is delivered, a copy of any or all of the information that has been incorporated by reference into this prospectus supplement (other than an exhibit to a filing, unless that exhibit is specifically incorporated by reference into that filing), but not delivered with this prospectus supplement:

Calidi Biotherapeutics, Inc.

4475 Executive Drive, Suite 200

San Diego, California 92121

Attention: Wendy Pizarro

Chief Legal Officer and Secretary

(858) 794-9600.

PROSPECTUS

$25,000,000

Calidi Biotherapeutics, Inc.

Common Stock

Preferred Stock

Warrants

Units

We may from time to time, in one or more offerings at prices and on terms that we will determine at the time of each offering, sell common stock, preferred stock, warrants, or a combination of these securities, or units, up to a total offering price of $25,000,000.

This prospectus describes the general manner in which our securities may be offered using this prospectus. Each time we offer and sell securities, we will provide you with a prospectus supplement that will contain specific information about the terms of that offering. Any prospectus supplement may also add, update, or change information contained in this prospectus. You should carefully read this prospectus and the applicable prospectus supplement as well as the documents incorporated or deemed to be incorporated by reference in this prospectus before you purchase any of the securities offered hereby.

We are an “emerging growth company” under applicable Securities and Exchange Commission rules and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

This prospectus may not be used to offer and sell securities unless accompanied by a prospectus supplement.

Our common stock and certain warrants are currently traded on the NYSE American LLC (“NYSE”) under the symbols “CLDI” and “CLDIWS,” respectively. On September 30, 2024, the last reported sales price for our common stock was $1.14 per share. The applicable prospectus supplement will contain information, where applicable, as to any other listing of the securities on NYSE or any other securities market or exchange covered by the prospectus supplement. Prospective purchasers of our securities are urged to obtain current information as to the market prices of our securities, where applicable.

We may offer the securities directly or through agents or to or through underwriters or dealers. If any agents or underwriters are involved in the sale of the securities their names, and any applicable purchase price, fee, commission or discount arrangement between or among them, will be set forth, or will be calculable from the information set forth, in an accompanying prospectus supplement. We can sell the securities through agents, underwriters or dealers only with delivery of a prospectus supplement describing the method and terms of the offering of such securities. See “Plan of Distribution.”

The aggregate market value of our outstanding common stock held by non-affiliates was approximately $16.71 million which was calculated based on 9,551,760 shares of outstanding common stock held by non-affiliates as of September 27, 2024, and a price per share of $1.75, the closing price of our common stock on August 12, 2024. Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities in a public offering with a value of more than one-third of our public float in any 12-month period, so long as our public float is less than $75,000,000. As of the date of this prospectus, we have not offered and sold any shares of our common stock pursuant to General Instruction I.B.6 to Form S-3 during the prior 12 calendar month period that ends on and includes the date hereof.

Investing in our securities involves significant risks. We strongly recommend that you read carefully the risks we describe in this prospectus and in any accompanying prospectus supplement, as well as the risk factors that are incorporated by reference into this prospectus from our filings made with the Securities and Exchange Commission. See “Risk Factors” beginning on page 3 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

This prospectus is dated October 10, 2024

Table of Contents

You should rely only on the information contained or incorporated by reference in this prospectus or any prospectus supplement. We have not authorized anyone to provide you with information different from that contained or incorporated by reference into this prospectus. If any person does provide you with information that differs from what is contained or incorporated by reference in this prospectus, you should not rely on it. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus. You should assume that the information contained in this prospectus or any prospectus supplement is accurate only as of the date on the front of the document and that any information contained in any document we have incorporated by reference is accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any prospectus supplement or any sale of a security. These documents are not an offer to sell or a solicitation of an offer to buy these securities in any circumstances under which the offer or solicitation is unlawful.

ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission, or SEC, using a “shelf” registration process. Under this shelf registration process, we may sell any combination of the securities described in this prospectus in one of more offerings up to a total dollar amount of proceeds of $25,000,000. This prospectus describes the general manner in which our securities may be offered by this prospectus. Each time we sell securities, we will provide a prospectus supplement that will contain specific information about the terms of that offering. The prospectus supplement may also add, update or change information contained in this prospectus or in documents incorporated by reference in this prospectus. The prospectus supplement that contains specific information about the terms of the securities being offered may also include a discussion of certain U.S. Federal income tax consequences and any risk factors or other special considerations applicable to those securities. To the extent that any statement that we make in a prospectus supplement is inconsistent with statements made in this prospectus or in documents incorporated by reference in this prospectus, you should rely on the information in the prospectus supplement.

You should not assume that the information contained in this prospectus, any applicable prospectus supplement or any related free writing prospectus is accurate on any date subsequent to the date set forth on the front of the document or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus, any applicable prospectus supplement or any related free writing prospectus is delivered, or securities are sold, on a later date. You should carefully read both this prospectus and any prospectus supplement together with the additional information described under “Where You Can Find More Information” before buying any securities in this offering.

The terms “Calidi”, the “Company,” “we,” “our,” or “us,” in this prospectus refer to Calidi Biotherapeutics, Inc. and its wholly-owned subsidiaries, unless the context suggests otherwise.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements made under “Prospectus Summary,” “Use of Proceeds,” and elsewhere in this prospectus, as well as the documents incorporated by reference herein, including in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology.

These forward-looking statements may include, but are not limited to, statements related to our expected business, new product introductions, results of clinical studies, expectations regarding regulatory clearance and the timing of FDA or non-US filings or approvals including meetings with FDA or non-U.S. regulatory bodies, our ability to raise funds for general corporate purposes and operations, including our research activities and clinical trials, procedures and procedure adoption, future results of operations, future financial position, our ability to generate revenues, our financing plans and future capital requirements, anticipated costs of revenue, anticipated expenses, the effect of recent accounting pronouncements, our anticipated cash flows, our ability to finance operations from cash flows or otherwise, and statements based on current expectations, estimates, forecasts, and projections about the economies and markets in which we operate and intend to operate and our beliefs and assumptions regarding these economies and markets.

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate.

Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others, those factors referred to in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which is incorporated by reference herein.

These statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in the documents incorporated by reference herein. You should not rely upon forward-looking statements as predictions of future events.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by law, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this prospectus.

PROSPECTUS SUMMARY

This summary highlights certain information about us and selected information contained in the prospectus. This summary is not complete and does not contain all of the information that may be important to you. For a more complete understanding of the Company, we encourage you to read and consider the more detailed information included or incorporated by reference in this prospectus and our most recent consolidated financial statements and related notes.

Company Overview

We are a clinical-stage immuno-oncology company that is developing innovative stem cell-based and enveloped platforms for the delivery and potentiation of oncolytic virotherapies to treat cancer. Our pipeline includes off-the-shelf product candidates designed to protect oncolytic viruses from being quickly inactivated by the patient’s immune system and target tumor sites. Once approved by the FDA, this improved delivery, both localized and systemic, and increased potency will enable us to develop treatments that target various types of cancer at different stages of progression. Our goal is to create therapies that work on any tumor, regardless of its genetic profile (universal treatments). In addition to direct targeting and killing cancer cells, our oncolytic virotherapies have shown signs of changing the tumor immune environment to induce strong anti-tumor immunity that could lead to better cancer treatment and prevent tumor recurrence.

CLD-101 (NeuroNova™ Platform) for Newly Diagnosed High Grade Glioma (“HGG”) (also referred to as “NNV1” as to the indication). CLD-101 is our product candidate utilizing our NeuroNova™ Platform targeting HGG. Prior to our licensing agreement with Northwestern University, an open-label, investigator sponsored, Phase 1, dose- escalation clinical trial for NNV1 in patients with newly diagnosed high-grade gliomas was completed. This clinical trial demonstrated that single administration of CLD-101 was well tolerated in patients with newly diagnosed HGG. A Phase 1b clinical trial will commence for NNV1 in collaboration with Northwestern University during the first quarter of 2025. This trial will explore the final dosing regimen for NNV1, including the feasibility of repeated dosing in newly diagnosed HGG. Extensive biomarker analysis will be performed on tumor biopsies and blood samples to determine viral distribution, specific tumor targeting and induction of anti-tumor immunity.

CLD-101 for Recurrent HGG (also referred to as “NNV2” as to the recurrent HGG indication). A phase 1 study evaluating the safety and feasibility of administering repeated doses of CLD-101 intracerebrally to patients with recurrent high-grade gliomas began treatment in May 2023. The study is being run by our partner, City of Hope, and started enrolling cohort 4 in January 2024. Clinical data from patients with recurrent HGG treated with repeated doses of CLD-101 is planned to support the start of a trial of repeated doses in newly diagnosed HGG.

CLD-201 (SuperNova™) for Advanced Solid Tumors (triple-negative breast cancer (“TNBC”), head & neck squamous cell carcinoma (HNSCC), and advanced soft tissue sarcoma (also referred to as “SNV1”). SNV1 is our first internally developed pre-clinical product candidate utilizing our SuperNova™ Delivery Platform. Based on our pre-clinical studies, we believe SNV1 has therapeutic potential for the treatment of multiple solid tumors such as head and neck cancer, triple-negative breast cancer and melanoma. We have held a pre-IND meeting with FDA to discuss the filing of our IND application for the clinical development of CLD-201. We anticipate commencing a Phase 1 clinical trial for SNV1 during the first half of 2025.

CLD-301 (AAA) for Multiple Indications. We are also currently engaged in early discovery research involving Adult Allogeneic Adipose-derived (“AAA”) stem cells for various indications and therapies. These AAA stem cells are theoretically multipotent, differentiating along the adipocyte, chondrocyte, myocyte, neuronal, and osteoblast lineages, and may have the ability to serve in other capacities, such as providing hematopoietic support and gene transfer with potential applications for repair and regeneration of acute and chronically damaged tissues. Pre-clinical studies involving toxicity and efficacy will be needed before an IND application may be filed with the FDA.

Our subsidiary Nova Cell, Inc. (“Nova Cell”) was formed to be a technology service provider that develops innovative stem cell-based products using our cellular manufacturing process. Through Nova Cell we anticipate expanding potential uses from oncology to other fields that require regenerative medical applications, such as cosmetics, orthopedics, auto-immune diseases, and various other therapies.

CLD-400 (RTNova) for Lung cancer and Metastatic Solid Tumors, our pre-clinical program involving enveloped oncolytic viruses (discovery phase), builds upon our experience of using cells to protect, potentiate and deliver virotherapies. CLD-400 program is derived from research from prior pre-clinical CLD-202 program. RTNova consists of an engineered vaccinia virus enveloped by a cell membrane, that is potentially capable of targeting lung cancer and advanced metastatic disease due to its increased ability to survive in the bloodstream. Metastatic solid tumors involve cancer cells that break away from where they first formed (primary cancer) and travel through the blood or lymph system to form new tumors, known as metastatic tumors, in other parts of the body. In preclinical studies, RTNova has shown early signs of its resistance to human humoral immunity and capability to target multiple distant and diverse tumors and transform their microenvironments leading to their elimination. In addition, the program has shown potential synergistic effects with other immunotherapies, including cell therapies, to attack and eliminate disseminated solid tumors.

Since inception, our operations have focused on organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through private sales of common stock, convertible preferred stock, contingently convertible and convertible promissory notes, term debt, lines of credit, Simple Agreements for Future Equity (“SAFE”) and various bank loans. These investments have included and have been made by various related parties, including our largest investor and Chief Executive Officer and Chairman of the Board of Directors.

Since inception, we have incurred significant operating losses. Our net loss was $5.8 million and $13.0 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2024, we had an accumulated deficit of $112.6 million. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.

Changes in economic conditions, including rising interest rates, public health issues, including the COVID-19 pandemic and its aftereffects, lower consumer confidence, volatile equity capital markets and ongoing supply chain disruptions and the impacts of geopolitical conflicts, may also affect our business.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our inability to raise capital or enter into such agreements as, and when needed, could have a material adverse effect on our business, results of operations and financial condition.

Based on our operating plan, we believe we do not have sufficient cash on hand to support current operations for at least one year from the date of issuance of our unaudited condensed consolidated financial statements as of, and for the three and six months ended June 30, 2024. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern. See Note 1 to our unaudited condensed consolidated financial statements. In addition, we will be required to raise additional capital through the issuance of our equity securities to support our operations which will have an ownership and economic dilutive effect to our current shareholders who purchased their shares of common stock at prices above our current trading price, and such capital raising may adversely affect the price of our common stock. Further, the sale of or the perception of a sale of a substantial number of our common stock by certain selling securityholders pursuant to another registration statement filed with the SEC will adversely affect the price of our common stock due to our limited trading volume and adversely affect the share price that we may obtain in future financings and may adversely affect our ability to conduct and complete future financings.

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

We qualify as an “emerging growth company” as defined in Section 2(a)(19) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012, or the “JOBS Act.” As such, we take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies for as long as we continue to be an emerging growth company, including (i) the exemption from the auditor attestation requirements with respect to internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), (ii) the exemptions from say-on-pay, say-on-frequency and say-on-golden parachute voting requirements and (iii) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. As a result, our stockholders may not have access to certain information they deem important. We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year (a) following the fifth anniversary of the date of the first sale of the Company’s common stock, (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which Calidi is deemed to be a large accelerated filer, which means the market value of our common stock that are held by non-affiliates exceeds $700 million as of the last business day of our prior second fiscal quarter, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the exemption from complying with new or revised accounting standards provided in Section 7(a)(2)(B) of the Securities Act, as long as it is an emerging growth company. An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies, but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of our financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

Corporate Information

Our principal executive offices are located at 4475 Executive Drive, Suite 200, San Diego, California 92121. Our telephone number is (858) 794-9600. Our website address is www.calidibio.com. The references to our website in this prospectus are inactive textual references only. The information on our website is neither incorporated by reference into this prospectus nor intended to be used in connection with this offering. We have included our website address in this prospectus as an inactive textual reference only and not as an active hyperlink.

RISK FACTORS

Investing in our securities involves a high degree of risk. Before making an investment decision, you should consider carefully the risks, uncertainties and other factors described in our most recent Annual Report on Form 10-K, as supplemented and updated by subsequent quarterly reports on Form 10-Q and current reports on Form 8-K that we have filed or will file with the SEC, which are incorporated by reference into this prospectus.

Our business, affairs, prospects, assets, financial condition, results of operations and cash flows could be materially and adversely affected by these risks. For more information about our SEC filings, please see “Where You Can Find More Information”.

USE OF PROCEEDS

Unless otherwise indicated in a prospectus supplement, we intend to use the net proceeds from the sale of the securities under this prospectus for working capital and general corporate purposes, and pre-clinical and clinical trials.

DESCRIPTION OF CAPITAL STOCK

General

The following description of our capital stock, together with any additional information we include in any applicable prospectus supplement or any related free writing prospectus, summarizes the material terms and provisions of our common stock and the preferred stock that we may offer under this prospectus. While the terms we have summarized below will apply generally to any future common stock or preferred stock that we may offer, we will describe the particular terms of any class or series of these securities in more detail in the applicable prospectus supplement. For the complete terms of our common stock and preferred stock, please refer to our articles of incorporation and our bylaws that are incorporated by reference into the registration statement of which this prospectus is a part. The summary below and that contained in any applicable prospectus supplement or any related free writing prospectus are qualified in their entirety by reference to our articles of incorporation and our bylaws.

Common Stock

We are authorized to issue 330,000,000 shares of common stock, $0.0001 par value per share, of which Three Hundred Twelve Million (312,000,000) are designated as Voting Common Stock (“Common Stock”) and Eighteen Million (18,000,000) are designated as Non-Voting Common Stock (the “Non-Voting Common Stock”). As of September 27, there were 10,925,712 shares of common stock issued and outstanding. The outstanding shares of common stock are validly issued, fully paid and nonassessable.

Voting Power

Holders of Common Stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders, including the election of directors, and do not have cumulative voting rights. Accordingly, the holders of a plurality of votes cast can elect all of the directors standing for election, if they so choose, other than any directors that holders of any preferred stock may issue may be entitled to elect. Subject to supermajority votes for some matters, other matters shall be decided by the affirmative vote of our stockholders having a majority in voting power of the votes cast by the stockholders present or represented and voting on such matter.

The shares of Non-Voting Common Stock shall automatically convert into shares of Common Stock on a one-to-one basis at such time that such shares of Non-Voting Common Stock are released from the escrow account holding such shares in accordance with the Merger Agreement and the escrow agreement governing such escrow account.

Dividends

Subject to applicable law and the rights and preferences, if any, of any holders of any outstanding series of Preferred Stock, holders of Common Stock will be entitled to receive dividends when, as and if declared by the Board, payable either in cash, in property or in shares of capital stock.

Liquidation, Dissolution and Winding Up

Upon our liquidation, dissolution or winding up and after payment in full of all amounts required to be paid to creditors and to any holders of preferred stock having liquidation preferences, if any, the holders of Common Stock will be entitled to receive pro rata our remaining assets available for distribution.

Preemptive or Other Rights

Holders of Common Stock are not be entitled to preemptive rights, and the Common Stock is not subject to conversion, redemption or sinking fund provisions.

Election of Directors

The Charter and the Bylaws establish a classified board of directors that is divided into three classes with staggered three-year terms. Only the directors in one class are subject to election by a plurality of the votes cast at each annual meeting of stockholders, with the directors in the other classes continuing for the remainder of their respective three-year terms. Our Charter does not provide for cumulative voting for the election of directors.

Preferred Stock

We are authorized to issue up to 1,000,000 shares of our Preferred Stock, par value $0.0001 per share, from time to time in one or more series. As of the date of this prospectus, there were no shares of our Preferred Stock issued and outstanding.

Our Charter provides that shares of preferred stock may be issued from time to time in one or more series. The Board is authorized to establish the number of shares to be included in each such series, to fix the designation, vesting, powers (including voting powers), preferences and relative, participating, optional or other rights (and the qualifications, limitations or restrictions thereof) of the shares of each such series and to increase (but not above the total number of authorized shares of the class) or decrease (but not below the number of shares of such series then outstanding) the number of shares of any such series, in each case without further vote or action by the stockholders. The Board is able to, without stockholder approval, issue preferred stock with voting and other rights that could adversely affect the voting power and other rights of the holders of Common Stock and could have anti-takeover effects. The ability of the Board to issue preferred stock, while providing flexibility in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring or preventing a change of control of us or the removal of our existing management.

Issuance of Preferred Stock

A prospectus supplement relating to the issuance of preferred stock being offered will include specific terms relating to the offering. Such prospectus supplement will include:

The terms, if any, on which the preferred stock may be convertible into or exchangeable for our common stock will also be stated in the preferred stock prospectus supplement. The terms will include provisions as to whether conversion or exchange is mandatory, at the option of the holder or at our option, and may include provisions pursuant to which the number of shares of our common stock to be received by the holders of preferred stock would be subject to adjustment.

DESCRIPTION OF WARRANTS

We may issue warrants for the purchase of preferred stock or common stock. Warrants may be issued independently or together with any preferred stock or common stock, and may be attached to or separate from any offered securities. Each series of warrants will be issued under a separate warrant agreement to be entered into between a warrant agent specified in the agreement and us. The warrant agent will act solely as our agent in connection with the warrants of that series and will not assume any obligation or relationship of agency or trust for or with any holders or beneficial owners of warrants. This summary of some provisions of the securities warrants is not complete. You should refer to the securities warrant agreement, including the forms of securities warrant certificate representing the securities warrants, relating to the specific securities warrants being offered for the complete terms of the securities warrant agreement and the securities warrants. The securities warrant agreement, together with the terms of the securities warrant certificate and securities warrants, will be filed with the SEC in connection with the offering of the specific warrants.

The applicable prospectus supplement will describe the following terms, where applicable, of the warrants in respect of which this prospectus is being delivered:

Warrants for the purchase of common stock or preferred stock will be offered and exercisable for U.S. dollars only. Warrants will be issued in registered form only.

Upon receipt of payment and the warrant certificate properly completed and duly executed at the corporate trust office of the warrant agent or any other office indicated in the applicable prospectus supplement, we will, as soon as practicable, forward the purchased securities. If less than all of the warrants represented by the warrant certificate are exercised, a new warrant certificate will be issued for the remaining warrants.

Prior to the exercise of any securities warrants to purchase preferred stock or common stock, holders of the warrants will not have any of the rights of holders of the common stock or preferred stock purchasable upon exercise, including in the case of securities warrants for the purchase of common stock or preferred stock, the right to vote or to receive any payments of dividends on the preferred stock or common stock purchasable upon exercise.

DESCRIPTION OF UNITS

As specified in the applicable prospectus supplement, we may issue units consisting of shares of common stock, shares of preferred stock or warrants or any combination of such securities.

The applicable prospectus supplement will specify the following terms of any units in respect of which this prospectus is being delivered:

Transfer Agent and Registrar

The transfer agent for our common stock is Equiniti Trust Company, LLC. The transfer agent’s address is 6201 15^th Avenue, Brooklyn, NY 11219.

Listing

Our common stock is currently traded on the NYSE American LLC under the symbol “CLDI”, and certain of our publicly traded warrants are also listed on the NYSE American LLC under the symbol “CLDIWS”.

PLAN OF DISTRIBUTION

We may sell the securities offered through this prospectus (i) to or through underwriters or dealers, (ii) directly to purchasers, including our affiliates, (iii) through agents, or (iv) through a combination of any these methods. The securities may be distributed at a fixed price or prices, which may be changed, market prices prevailing at the time of sale, prices related to the prevailing market prices, or negotiated prices. The prospectus supplement will include the following information:

Sale Through Underwriters or Dealers

Only underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.

If underwriters are used in the sale, the underwriters will acquire the securities for their own account, including through underwriting, purchase, security lending or repurchase agreements with us. The underwriters may resell the securities from time to time in one or more transactions, including negotiated transactions. Underwriters may sell the securities in order to facilitate transactions in any of our other securities (described in this prospectus or otherwise), including other public or private transactions and short sales. Underwriters may offer securities to the public either through underwriting syndicates represented by one or more managing underwriters or directly by one or more firms acting as underwriters. Unless otherwise indicated in the prospectus supplement, the obligations of the underwriters to purchase the securities will be subject to certain conditions, and the underwriters will be obligated to purchase all the offered securities if they purchase any of them. The underwriters may change from time to time any initial public offering price and any discounts or concessions allowed or reallowed or paid to dealers.

If dealers are used in the sale of securities offered through this prospectus, we will sell the securities to them as principals. They may then resell those securities to the public at varying prices determined by the dealers at the time of resale. The prospectus supplement will include the names of the dealers and the terms of the transaction.

Direct Sales and Sales Through Agents

We may sell the securities offered through this prospectus directly. In this case, no underwriters or agents would be involved. Such securities may also be sold through agents designated from time to time. The prospectus supplement will name any agent involved in the offer or sale of the offered securities and will describe any commissions payable to the agent. Unless otherwise indicated in the prospectus supplement, any agent will agree to use its reasonable best efforts to solicit purchases for the period of its appointment.

We may sell the securities directly to institutional investors or others who may be deemed to be underwriters within the meaning of the Securities Act with respect to any sale of those securities. The terms of any such sales will be described in the prospectus supplement.

Delayed Delivery Contracts

If the prospectus supplement indicates, we may authorize agents, underwriters or dealers to solicit offers from certain types of institutions to purchase securities at the public offering price under delayed delivery contracts. These contracts would provide for payment and delivery on a specified date in the future. The contracts would be subject only to those conditions described in the prospectus supplement. The applicable prospectus supplement will describe the commission payable for solicitation of those contracts.

Continuous Offering Program

Without limiting the generality of the foregoing, we may enter into a continuous offering program equity distribution agreement with a broker-dealer, under which we may offer and sell shares of our common stock from time to time through a broker-dealer as our sales agent. If we enter into such a program, sales of the shares of common stock, if any, will be made by means of ordinary brokers’ transactions on the NYSE at market prices, block transactions and such other transactions as agreed upon by us and the broker-dealer. Under the terms of such a program, we also may sell shares of common stock to the broker-dealer, as principal for its own account at a price agreed upon at the time of sale. If we sell shares of common stock to such broker-dealer as principal, we will enter into a separate terms agreement with such broker-dealer, and we will describe this agreement in a separate prospectus supplement or pricing supplement.

Market Making, Stabilization and Other Transactions

Unless the applicable prospectus supplement states otherwise, other than our common stock all securities we offer under this prospectus will be a new issue and will have no established trading market. We may elect to list offered securities on an exchange or in the over-the-counter market. Any underwriters that we use in the sale of offered securities may make a market in such securities, but may discontinue such market making at any time without notice. Therefore, we cannot assure you that the securities will have a liquid trading market.

Any underwriter may also engage in stabilizing transactions, syndicate covering transactions and penalty bids in accordance with Rule 104 under the Securities Exchange Act of 1934 (the “Exchange Act”). Stabilizing transactions involve bids to purchase the underlying security in the open market for the purpose of pegging, fixing or maintaining the price of the securities. Syndicate covering transactions involve purchases of the securities in the open market after the distribution has been completed in order to cover syndicate short positions.

Penalty bids permit the underwriters to reclaim a selling concession from a syndicate member when the securities originally sold by the syndicate member are purchased in a syndicate covering transaction to cover syndicate short positions. Stabilizing transactions, syndicate covering transactions and penalty bids may cause the price of the securities to be higher than it would be in the absence of the transactions. The underwriters may, if they commence these transactions, discontinue them at any time.

General Information

Agents, underwriters, and dealers may be entitled, under agreements entered into with us, to indemnification by us against certain liabilities, including liabilities under the Securities Act. Our agents, underwriters, and dealers, or their affiliates, may be customers of, engage in transactions with or perform services for us, in the ordinary course of business.

Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities in a public offering with a value exceeding more than one-third of our public float in any 12-calendar month period so long as our public float remains below $75,000,000.

LEGAL MATTERS

The validity of the issuance of the securities offered by this prospectus will be passed upon for us by Sichenzia Ross Ference Carmel LLP, New York, New York.

EXPERTS

The consolidated financial statements of Calidi Biotherapeutics, Inc., as of December 31, 2023 and 2022 and for each of the two years in the period ended December 31, 2023, included in Calidi Biotherapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2023 have been audited by Marcum LLP, independent registered public accounting firm, as set forth in their report thereon, which includes an explanatory paragraph as to the Company’s ability to continue as a going concern, included therein, and incorporated herein by reference. Such consolidated financial statements are incorporated herein by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing.

WHERE YOU CAN FIND MORE INFORMATION

We have filed our registration statement on Form S-3 with the SEC under the Securities Act, as may be amended. We also file annual, quarterly and current reports, proxy statements and other information with the SEC. You may read and copy any document that we file with the SEC, including the registration statement and the exhibits to the registration statement, at the SEC’s Public Reference Room located at 100 F Street, N.E., Washington D.C. 20549. You may obtain further information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. Our SEC filings are also available to the public at the SEC’s web site at www.sec.gov. These documents may also be accessed on our web site at www.calidibio.com. Information contained on our web site is not incorporated by reference into this prospectus and you should not consider information contained on our web site to be part of this prospectus.

This prospectus and any prospectus supplement are part of a registration statement filed with the SEC and do not contain all of the information in the registration statement. The full registration statement may be obtained from the SEC or us as indicated above. Other documents establishing the terms of the offered securities are filed as exhibits to the registration statement or will be filed through an amendment to our registration statement on Form S-3 or under cover of a Current Report on Form 8-K and incorporated into this prospectus by reference.

INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE

The SEC allows us to “incorporate by reference” into this prospectus the information we file with it, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus. Any statement contained herein or in a document incorporated or deemed to be incorporated by reference into this document will be deemed to be modified or superseded for purposes of the document to the extent that a statement contained in this document or any other subsequently filed document that is deemed to be incorporated by reference into this document modifies or supersedes the statement. We incorporate by reference in this prospectus the following information (other than, in each case, documents or information deemed to have been furnished and not filed in accordance with SEC rules):

We also incorporate by reference any future filings (other than information furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits furnished on such form that are related to such items unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, including those made after the date of the initial filing of the registration statement of which this prospectus is a part and prior to effectiveness of such registration statement, until we file a post-effective amendment that indicates the termination of the offering of the common stock made by this prospectus and will become a part of this prospectus from the date that such documents are filed with the SEC. Information in such future filings updates and supplements the information provided in this prospectus. Any statements in any such future filings will automatically be deemed to modify and supersede any information in any document we previously filed with the SEC that is incorporated or deemed to be incorporated herein by reference to the extent that statements in the later filed document modify or replace such earlier statements.

Notwithstanding the foregoing, information furnished under Items 2.02 and 7.01 of any Current Report on Form 8-K, including the related exhibits, is not incorporated by reference in this prospectus.

The information about us contained in this prospectus should be read together with the information in the documents incorporated by reference. You may request a copy of any or all of these filings, at no cost, by writing to, or calling us, at: Calidi Biotherapeutics, Inc., 4475 Executive Drive, Suite 200, San Diego, California 92121, Attention: Wendy Pizarro, Chief Legal Officer and Secretary, telephone number (858) 794-9600.

Calidi Biotherapeutics, Inc.

2,050,000 SHARES OF COMMON STOCK

PROSPECTUS SUPPLEMENT

Exclusive Placement Agent

Ladenburg Thalmann

October 23, 2024