Calidi Biotherapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 27, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 27, 2026
CLDI$0.70+3.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-31.
0001641172-25-001810
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-27.
0001493152-26-013242
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 196 previous paragraphs and 111 current paragraphs.
46 unchanged; 34 reworded; 31 added; 115 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 9 previous and 16 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (31)
Current report
We are a publicly traded biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. Our proprietary RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations. We expect to file an IND for a Phase I trial by the end of 2026 with CLD-401, the first compound from the RedTail platform, delivering IL-15 superagonist to the tumor microenvironment (“TME”).
Current report
Our RedTail platform is the culmination of over a decade of work around genetic engineering of viruses and allows for the systemic administration of a proprietarily-modified oncolytic virus that can:
Current report
Our legacy SuperNova and NeuroNova platforms are designed to:
Current report
Oncolytic viruses have been pursued as therapeutic platforms in oncology because of their ability to preferentially infect and replicate within cancer cells, resulting in both direct lysis of the tumor cells as well as activation of an antitumor immune response, while leaving normal, healthy cells unharmed. Despite the promises of oncolytic viruses, a major obstacle against their therapeutic use has been their rapid elimination by the patient’s immune system; this has meant that oncolytic viruses have been largely relegated to being used for local delivery to tumors but have not been successful in patients with extensive metastatic disease. The only approved oncolytic virus therapy is T-VEC (Imlygic®), a modified herpes simplex virus (HSV) for the treatment of patients with melanoma given intratumorally.
Current report
We have been working on protecting oncolytic viruses from immune clearance for over a decade. Our NeuroNova investigational drug candidate is currently in a Phase 1 trial being run and funded by our partner, City of Hope, in an investigator-initiated trial and we have an open IND for a Phase 1 trial for our SuperNova investigational drug candidate (CLD-201). In July 2025 we were granted Fast Track Designation to CLD-201 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcoma. The platforms used in NeuroNova and SuperNova use oncolytic viruses embedded in stem cells to avoid immune clearance and facilitate initial viral amplification and expansion at the tumor sites. This approach has shown substantial benefit over unprotected virus in preclinical studies of intratumoral delivery, but stem cell encapsulation does not allow for systemic delivery of virus to tumor metastases in animal models. The size of the stem cells prohibited efficient dissemination into metastatic sites.
Current report
More recently, we used the learnings from NeuroNova and SuperNova to create RedTail, a novel oncolytic viral platform for systemic delivery. The virus used in RedTail has been proprietarily engineered to avoid immune clearance and to specifically replicate in tumor tissue where the virus also has the ability to deliver genetic medicines to the tumor microenvironment. RedTail utilizes a proprietary form of enveloped virus with genetic modifications, including engineered expression of CD55 on the enveloped virus, to avoid immune clearance. Because the virus is not encapsulated in stem cells, it is thousands of times smaller than the NeuroNova or SuperNova products and disseminates efficiently into metastatic sites in syngeneic animal models. In addition, the virus can be engineered to express genetic medicines while replicating in the tumor.
Current report
CLD-401, the first lead derived from the RedTail platform. CLD-401 is enveloped and overexpressed CD55 on its outer membrane. It is tropic for tumor cells and, when replicating, expresses IL-15 superagonist at high concentrations in the tumor microenvironment. In animal models, CLD-401 can be given systemically and clear metastatic sites in syngeneic tumor mouse models with demonstrated enhanced biological efficacy. The combination of the RedTail virus with its genetic payload drives complete tumor eradication in the tumor models compared to the RedTail virus alone. We believe that RedTail, given its systemic administration and targeting to metastatic sites and its delivery of genetic medicines, represents a major advancement in the space of oncolytic virus in oncology. The company is developing additional leads from the RedTail platform including compounds that simultaneously express a bispecific T-cell engager (TCE) and a T-cell activator as well as compounds for use outside of oncology.
Current report
Recent Developments
Current report
On July 24, 2025, the Compensation Committee of Calidi approved the elimination of the position of President, Medical and Scientific Affairs, held by Dr. Boris Minev. As a result, Dr. Minev ceased to serve as an executive officer and a Section 16 officer of Calidi, effective July 29, 2025. On August 8, 2025, we executed a General Release of Claims and Separation Agreement with Dr. Minev effective on August 15, 2025. Pursuant to the terms of the Agreement, we are obligated to pay Dr. Minev, (i) $0.1 million in relation to a negotiated bonus for the NNV1 and SNV1 IND approvals within 10 days following the Revocation Period (which is seven business days from August 8, 2025, and excluding such date), and (ii) $0.2 million separation pay in the form of compensation continuation over six months pursuant to our regular and customary payroll schedule, less all regular and customary payroll withholdings and shall pay Dr. Minev’s COBRA premiums for six months, commencing August 2025, upon timely election.
Current report
On August 20, 2025, we entered into an underwriting agreement with Ladenburg Thalmann & Co. Inc., as representative of the various underwriters, in connection with the issuance and public sale offering of various securities (the “August Public Offering”), including: (i) 1,922,764 common stock units (“Common Stock Unit”), which includes the 450,000 Common Stock Units purchased pursuant to the exercise, in full, of the Over-Allotment Option and (ii) 1,528,000 pre-funded warrant units, resulting in gross proceeds of approximately $6.9 million, before deducting underwriting discounts and commissions and other estimated offering expenses. The August Public Offering closed on August 21, 2025. For additional discussion of this Warrant Inducement Offer, see the section below and further disclosures in the section titled “Liquidity and Capital Resources – Financing Activities” included herein.
Current report
On September 16, 2025, the Board approved the elimination of the position of Chief Legal Officer and, as a result, the termination of the employment agreement with Ms. Wendy Pizarro Campbell (the “Employment Agreement”), effective as of October 17, 2025 (“Effective Date”). Per the terms of the Employment Agreement, Ms. Campbell was given a 30-day written notice of termination. On the Effective Date, and as a result of the termination of the Employment Agreement, Ms. Campbell ceased to serve as an executive officer and Section 16 officer of Calidi. On September 17, 2025, we executed a General Release of Claims and Separation Agreement (“Agreement”) with Ms. Campbell effective on September 24, 2025 (the “Effective Date”). Pursuant to the terms of the Agreement, on the Effective Date, we are obligated to pay i) a bonus in the amount of $0.1 million, upon the successful and effective corporate spin-off, out-licensing, or similar transaction relating to Nova Cell, Inc. (“Nova Cell”) prior to October 31, 2025, and (ii) $0.2 million severance pay in the form of compensation continuation over six months pursuant to our regular and customary payroll schedule, less all regular and customary payroll withholdings and shall pay Ms. Campbell’s COBRA premiums for six months, commencing October 2025, upon timely election. As of December 31, 2025, we paid the bonus of $0.1 million in connection with the sale of the investment in Nova Cell.
Current report
On October 27, 2025, we entered into a Stock Repurchase Agreement (the “SRA”) and Material Purchase Agreement (the “MPA” and together with the SRA the “Agreements”), with, a then majority owned subsidiary, Nova Cell. In accordance with the Agreements, we sold and transferred all 22,500,000 of our shares of common stock in Nova Cell (the “Repurchased Shares”), representing an ownership interest of 75%, back to Nova Cell, for a purchase price of $6.0 million (the “Purchase Price”). The Purchase Price for the Repurchased Shares was or shall be satisfied (A) in part by cancellation of indebtedness under the September 17, 2024, promissory note, net of specified offsets (including a $50 thousand cash offset), resulting in an Indebtedness Cancellation Amount of $1.2 million, and (B) the balance, by Deferred Consideration of $4.8 million payable after closing, as more fully described in the SRA. As of December 31, 2025, no Deferred Consideration has been recognized, and the full amount remains constrained until underlying uncertainties are resolved. After the Deferred Consideration is fully satisfied, the SRA also provides for an ongoing royalty at a fixed percentage of Covered Gross Revenue attributable to or derivative of the materials listed on Schedule A to the MPA ending on the tenth anniversary of Nova Cell’s first product sale. Furthermore, as part of the Agreements, we sold and transferred certain materials to Nova Cell as listed on Schedule 1 to the MPA. Following the closing of the Agreements, Nova Cell is no longer our subsidiary.
Current report
On November 7, 2025, we presented new data on our first therapeutic candidate from our RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (“SITC”) Annual Meeting.
Current report
On March 5, 2026, the Company entered into an Amendment to Common Stock Purchase Warrants Agreement (the “Warrant Amendment”) with certain investors that participated in the March Offering described below, in connection with the terms of certain of the Company’s outstanding common warrants to purchase shares of Common Stock (the “Existing Warrants”). As originally issued, the Existing Warrants provided for the purchase of:
Current report
Per the Warrant Amendment, the exercise price for each of such Existing Warrants was reduced to $0.50 per share, subject to further adjustment as set forth in the Existing Warrants and any other document governing the terms thereunder. All other terms and conditions of the Existing Warrants remain unchanged and in full force and effect.
Current report
Other Income (Expenses), Net
Current report
Income Tax Provision
Current report
Our ability to continue as a going concern is dependent upon our ability to raise additional funding. We plan to raise additional capital through public or private equity or debt financings to fulfill our operating and capital requirements for at least 12 months from the date of the issuance of the financial statements. However, we may not be able to secure such financing in a timely manner or on favorable terms, if at all. Thus, we estimate that based on our current liquidity resources, there is substantial doubt about our ability to continue as a going concern within 12 months from the date of issuance of these financial statements.
Current report
On March 6, 2026, we entered into an underwriting agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co. Inc., as sole underwriter (“Underwriter”), in connection with the issuance and sale (the “Offering”) of: (i) 2,278,731 common stock units (“Common Stock Units”), which includes 1,575,000 Common Stock Units purchased pursuant to the exercise, in full, of the Over-Allotment Option, sold to the public at a price of $0.50 per Common Stock Unit, and (ii) 9,815,900 pre-funded warrant units (“Pre-Funded Units”), sold to the public at a price of $0.499 per Pre-Funded Unit, resulting in gross proceeds of approximately $6.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses. In connection with the Offering, we also issued to the Underwriter (or its designees) a warrant (the “Underwriter’s Warrant”) to purchase up to 604,732 shares of Common Stock of Calidi, par value $0.0001. The Underwriter’s Warrant has an exercise price of $0.625, is exercisable on or after the date of issuance, and will expire on March 9, 2031.
Current report
Each Common Stock Unit consisted of (i) one share of Common Stock, (ii) one Series J common stock warrant (“Series J Warrants”) to purchase one share of Common Stock (or pre-funded warrants to purchase one share of Common Stock in lieu thereof), (iii) one Series K common stock warrant (“Series K Warrants”) to purchase one share of Common Stock (or pre-funded warrants to purchase one share of Common Stock in lieu thereof), and (iv) one Series L common stock warrant (“Series L Warrants” and together with the Series J Warrants and the Series K Warrants, the “Common Warrants”) to purchase one share of Common Stock (or pre-funded warrants to purchase one share of Common Stock in lieu thereof). Each Pre-Funded Unit consisted of (i) one pre-funded warrant (the “Pre-Funded Warrants”), (ii) one Series J Warrant, (iii) one Series K Warrant, and (iv) one Series L Warrant. The Common Warrants included in the Pre-Funded Units are identical to the Common Warrants included in the Common Stock Units.
Current report
The Series J Warrants have an initial exercise price of $0.50 per share. The Series J Warrants are exercisable immediately, subject to certain limitations described herein. The Series J Warrants expire five (5) years from the date of issuance. The Series K Warrants have an initial exercise price of $0.50 per share. The Series K Warrants are exercisable immediately, subject to certain limitations described herein. The Series K Warrants will expire one (1) year from the date of issuance. The Series L Warrants have an initial exercise price of $0.50 per share. The Series L Warrants are exercisable immediately, subject to certain limitations described herein. The Series L Warrants expire six (6) months from the date of issuance.
Current report
The Common Stock Units, the Pre-Funded Units, the shares of Common Stock comprising the Common Stock Units, the Common Warrants, the Pre-Funded Warrants, the shares of Common Stock issuable upon exercise of the Common Warrants, and the Pre-Funded Warrants were offered by Calidi pursuant to a shelf registration statement on Form S-3 (File No. 333-284229), that was filed with the Securities Exchange Commission (“SEC”) on January 10, 2025 and declared effective on February 7, 2025, including the prospectus forming a part of the registration statement, a final prospectus supplement thereto, which was filed with the SEC on March 9, 2026, pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the “Securities Act”), and the related registration statement filed with the SEC on March 5, 2026 under Rule 462(b) of the Securities Act, which became automatically effective upon filing. The Offering closed on March 9, 2026 (the “Closing Date”).
Current report
On March 6, 2026, we also entered into a warrant agency agreement (the “Warrant Agency Agreement”) with Equiniti Trust Company, LLC, as warrant agent (the “Warrant Agent”).
Current report
Since the closing of the Offering, 2,291,000 Pre-Funded Warrants have been exercised.
Current report
On March 5, 2026, we entered into an Amendment to Common Stock Purchase Warrants Agreement (the “Warrant Amendment”) with certain investors, that participated in the March 2026 CMPO described above, in connection with the terms of certain of our outstanding common warrants to purchase shares of Common Stock (the “Existing Warrants”). As originally issued, the Existing Warrants provided for the purchase of:
Current report
Per the Warrant Amendment, the exercise price for each of such Existing Warrants was reduced to $0.50 per share, subject to further adjustment as set forth in the Existing Warrants and any other document governing the terms thereunder. All other terms and conditions of the Existing Warrants remain unchanged and in full force and effect.
Current report
Debt Obligations
Current report
Calidi’s outstanding debt obligations as of December 31, 2025, are as follows (in thousands):
Current report
Warrants
Current report
As of December 31, 2025, Calidi had outstanding warrants to purchase up to 5,026,613 shares of Common Stock, consisting of the following:
Current report
On July 1, 2025, StemVac, GmbH entered into a finance lease agreement for laboratory equipment with an initial term that expires on May 31, 2029, with total payments of approximately €0.1 million.
Removed paragraphs (115)
Previous report
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.
Previous report
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. Northwestern University began recruiting for a Phase 1b/2 clinical trial 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.
Previous report
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 supported the start of a trial of repeated doses in newly diagnosed HGG.
Previous report
CLD-201 (SuperNova™) for solid tumors (breast cancer, head & neck squamous cell carcinoma (HNSCC), and 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, breast cancer and sarcoma. We filed our IND application with the FDA for the clinical development of CLD-201 in March 2025 and we anticipate commencing a Phase 1 clinical trial for SNV1 during the first half of 2025.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
The FLAG Merger and Related Transactions
Previous report
On September 12, 2023, FLAG consummated a series of transactions that resulted in the merger of FLAG Merger Sub Inc., a Nevada corporation and a wholly-owned subsidiary of FLAG (“Merger Sub”) and Calidi NV pursuant to the Agreement and Plan of Merger, as amended, dated as of January 9, 2023. Pursuant to the terms of the Merger Agreement, the business combination was effected through the merger of Merger Sub with and into Calidi NV, with Calidi NV surviving such merger as a wholly-owned subsidiary of FLAG. Historical common share amounts of Calidi NV have been retroactively restated based on the conversion ratio of approximately 0.42 (the “Conversion Ratio”). Following the consummation of the business combination, FLAG was renamed “Calidi Biotherapeutics, Inc.”
Previous report
As a result of the Business Combination, all outstanding stock of Calidi NV were cancelled in exchange for the right to receive newly issued shares of Common Stock (also referred to as “Calidi Common Stock”), par value $0.0001 per share, and all outstanding options to purchase Calidi stock were assumed by Calidi. The total consideration received by Calidi Security Holders at the Closing of the transactions contemplated by the Merger Agreement is the newly issued shares of Common Stock and securities convertible or exchangeable for newly issued shares of Common Stock with an aggregate value equal $250.0 million, plus an adjustment of $23.8 million pursuant to the net debt adjustment provisions of the Merger Agreement by reason of the Series B Financing. As a result, the Calidi Security Holders received an aggregate of 2,737,560 shares of Common Stock as Merger Consideration.
Previous report
As additional consideration, each Calidi stockholder was entitled to earn, on a pro rata basis, up to 1,800,000 Escalation Shares. During the Escalation Period, Calidi Stockholders may be entitled to receive up to 1,800,000 Escalation Shares with incremental releases of 450,000 shares upon the achievement of each share price hurdle if the trading price of Common Stock is $120.00, $140.00, $160.00 and $180.00, respectively, for a period of any 20 days within any 30-consecutive-day trading period. The Escalation Shares have been placed in escrow and are outstanding from and after the Closing, subject to cancellation if the applicable price targets are not achieved. While in escrow, the shares will be non-voting.
Previous report
Holders of FLAG Class A Common Stock who did not redeem their shares obtained their pro rata portion of an additional 8,585 Non-Redeeming Continuation Shares issued at Closing. At the Closing, Calidi NV Security Holders own approximately 76% of the outstanding shares of Calidi Common Stock.
Previous report
See the section below titled*“Liquidity and Capital Resources”*included herein for additional disclosures.
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Other Income or Expenses, Net
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At the Closing of the FLAG Merger, all convertible instruments outstanding were converted into Calidi Common Stock immediately prior the closing of the FLAG Merger and are no longer outstanding as of the Closing date.
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Income Taxes
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On January 9, 2025, Calidi entered into a Placement Agency Agreement with Ladenburg Thalmann & Co. Inc. (the “Placement Agent”), pursuant to which Calidi agreed to issue and sell in a public offering 5,000,000 shares of Calidi’s common stock (the “Shares”), par value $0.0001 per share, at a purchase price of $0.85 per Share. The closing of the offering took place on January 10, 2025. The gross proceeds from the offering were $4.3 million, before deducting placement agent fees and other offering expenses payable by Calidi and excluding the net proceeds, if any, from the exercise of the Placement Agent Warrants (as defined below). The common stock shares were offered by Calidi pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities Exchange Commission on October 10, 2024.
Previous report
Shelf Registration Statement
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On January 10, 2025, Calidi filed a Form S-3 shelf registration statement under the Securities Act of 1933, which was declared effective by the SEC on February 7, 2025, providing for the public offer and sale of up to $25.0 million of Calidi’s shares of common stock.
Previous report
Termination of Standby Equity Purchase Agreement
Previous report
On December 10, 2023, we entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, Ltd., a Cayman Island exempt limited partnership (“Yorkville”). Pursuant to the SEPA, we will have the right, but not the obligation, to sell to Yorkville up to $25.0 million of its shares of Common Stock, par value $0.0001 per share, at our request any time during the 36 months following the execution of the SEPA.
Previous report
On January 23, 2025, Calidi delivered to Yorkville, a Notice of Termination of the SEPA, as required under Section 10.01(b) of the SEPA, which notifies Yorkville of Calidi’s election to terminate the SEPA. Termination of the SEPA became effective as of January 23, 2025, as mutually agreed by Calidi and Yorkville.
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At the time of the termination, there were no outstanding borrowings, advance notices or shares of common stock to be issued under the SEPA. In addition, there are no fees due by Calidi or Yorkville in connection with the termination of the SEPA.
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Increase in Maximum Aggregate Offering Amount under the At The Market Offering Agreement
Previous report
On February 4, 2025, Calidi increased the maximum aggregate offering amount of the shares of Calidi’s common stock, par value $0.0001 per share issuable under the At The Market Offering Agreement (the “Sales Agreement”) with Ladenburg Thalmann & Co. Inc., dated October 11, 2024, from $5.1 million to $11.2 million and filed a prospectus supplement (the “Current Prospectus Supplement”) under the Sales Agreement for an aggregate of $6.1 million. Prior to February 4, 2025, Calidi sold shares of common stock having an aggregate sales price of approximately $5.0 million under the Sales Agreement, including $3.2 million in 2024. Subsequent to December 31, 2024, Calidi sold 2,862,911 shares of common stock for gross proceeds of approximately $2.9 million under the Sales Agreement. See Note 12.
Previous report
On March 28, 2025, Calidi entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Purchaser”), pursuant to which Calidi issued to the Purchaser, (i) in a registered offering, 3,325,000 shares of Calidi Common Stock, at a purchase price of $0.65 per share, and at the election of the investor, in lieu of the common stock, pre-funded warrants to purchase up to 2,728,000 shares of Common Stock at a price of $0.649 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant, and (ii) in a concurrent private placement, Series G common stock purchase warrants to purchase up to 6,053,000 shares of Common Stock (the “Series G Common Warrants”).
Previous report
The Pre-funded Warrants are exercisable immediately at an exercise price of $0.001 per share, and shall remain valid and exercisable until all the Pre-funded Warrants are exercised in full. The Series G Common Warrants have an exercise price of $0.6954 per share, will be exercisable six months following the date of issuance, and will have a term of seven and one-half years from the date of exercisability. Such registered direct offering and concurrent private placement are referred to herein as the “Transactions.” Ladenburg Thalmann & Co. Inc. (“Ladenburg”) acted as the placement agent. The securities issued in these Transactions do not contain any variable or priced based resets.
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The closing of the Transactions took place on March 31, 2025. The gross proceeds from the Transactions were approximately $3.9 million before deducting placement agent fees and other offering expenses payable by Calidi. See Note 12.
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Reverse Stock Split
Previous report
On July 10, 2024, we filed a First Certificate of Amendment to Second Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for-10 reverse stock split of the shares of Calidi’s common stock, par value $0.0001 per share, effective on July 15, 2024 (the “Reverse Stock Split”). As a result of the Reverse Stock Split, every ten shares of issued and outstanding our Common Stock was automatically combined into one issued and outstanding share of our Common Stock, without any change in the par value per share. No fractional shares were issued as a result of the Reverse Stock Split, and any fractional shares that would otherwise have resulted from the Reverse Stock Split were rounded up to the next whole number. The number of authorized shares of Common Stock under our Second Amended and Restated Certificate of Incorporation, as amended, remained unchanged.
Previous report
All references to share and per share amounts for all periods presented in the consolidated financial statements have been retrospectively restated to reflect this Reverse Stock Split.
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Public Financing
Previous report
On April 18, 2024, we closed on a public offering of securities pursuant to that certain securities purchase agreement dated April 16, 2024 entered into by and among Calidi and certain purchasers (the “April Public Offering”). In connection with the April public offering, Calidi sold an aggregate of 1,323,250 Common Stock Units and 196,500 Pre-Funded Warrant (“PFW”) Units at an effective combined purchase price of $4.00 per Common Stock Unit or PFW Unit for aggregate gross proceeds of approximately $6.1 million before deducting placement agent fees and offering expenses payable by Calidi. The securities offered and sold in the public offering were registered pursuant to registration statement on Form S-1, as amended, filed with the SEC and declared effective on April 15, 2024.
Previous report
On November 14, 2024, we entered into a Placement Agency Agreement with Ladenburg Thalmann & Co. Inc. (the “Placement Agent”), pursuant to which we agreed to issue and sell in a public offering 4,437,869 shares of Calidi’s common stock (the “Shares”), par value $0.0001 per share, at a purchase price of $1.69 per Share. The closing of the offering took place on November 15, 2024. The gross proceeds from the offering were $7.5 million, before deducting placement agent fees and other offering expenses payable by us and excluding the net proceeds, if any, from the exercise of the Placement Agent Warrants (as defined below). The common stock shares were offered by Calidi pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities Exchange Commission on October 10, 2024.
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Warrant Inducement
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Subscription Agreements
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On July 26, 2024, the Board of Calidi approved the Subscription Agreement dated July 28, 2024 entered with an accredited investor, a related-party. Pursuant to the Agreement, we sold to the Investor and the investor purchased, (i) 698,812 shares of Common Stock at a purchase price of $1.431 per share; and (ii) warrants to purchase 600,000 shares of the Calidi’s common stock at an exercise price of $1.90, for an aggregate purchase price of $1.0 million.
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Strategic Investment into Nova Cell
Previous report
On July 26, 2024, the Board and the Audit Committee of Calidi’s Board approved a strategic investment of approximately $2.0 million by the investor, a related-party, into Nova Cell, in exchange for the issuance of 7,500,000 shares of Nova Cell’s shares of common stock to the investor, representing 25% of Nova Cell’s current fully-diluted capitalization.
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At The Market Offering Agreement
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Reworded paragraphs (34)
Previous wording
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 loans, lines of credit, and Simple Agreements for Future Equity (“SAFE”). 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.
Current wording
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, warrants, convertible promissory notes, term debt, and the issuance of publicly traded securities. These investments have included and have been made by various related parties, including our former chief executive officer and former chairman of the Board of Directors.
Previous wording
Since inception, we have incurred significant operating losses. Our net loss was $22.2 million for the year ended December 31, 2024. As of December 31, 2024, we had an accumulated deficit of $121.7 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.
Current wording
Since inception, we have incurred significant operating losses. Our net loss was $20.1 million for the year ended December 31, 2025. As of December 31, 2025, we had an accumulated deficit of $141.6 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.
Previous wording
Changes in economic conditions, including rising interest rates, public health issues, lower consumer confidence, volatile equity capital markets and ongoing supply chain disruptions and the impacts of geopolitical conflicts, may also affect our business.
Current wording
Changes in economic conditions, including rising interest rates, public health issues, lower consumer confidence, volatile equity capital markets, tariffs, ongoing supply chain disruptions, and the impacts of geopolitical conflicts, may also affect our business.
Previous wording
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 consolidated financial statements as of, and for the year ended December 31, 2024. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern. See Note 1 to our annual 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.
Current wording
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 consolidated financial statements as of and for the year ended December 31, 2025. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern. See Note 1 to our audited 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, adversely affect the share price that we may obtain in future financings, and may adversely affect our ability to conduct and complete future financings.
Previous wording
For additional discussion on our liquidity and the Closing of the FLAG Merger, see the section below and further disclosures in the section titled*“Liquidity and Capital Resources”*included herein.
Current wording
For additional discussion on our liquidity, see the section below and further disclosures in the section titled*“Liquidity and Capital Resources”*included herein.
Previous wording
On May 31, 2024, we entered into an inducement offer letter agreement (the “May Inducement Offer”) with nine (9) holders of the Calidi’s existing Series B unit purchase warrants (“Series B Warrants”) and Series C unit purchase warrants (“Series C Warrants” and together with the Series B Warrants, the “Existing Warrants”), which Existing Warrants were originally issued on April 18, 2024 and had an exercise price of $6.00 (see Note 8). Following the closing of the May Inducement Offer, such warrant holders immediately exercised some or all of their respective outstanding Existing Warrants to purchase up to an aggregate of 1,069,800 shares of Calidi’s common stock, Series B-1 Warrants to purchase up to 267,300 shares of common stock and Series C-1 Warrants to purchase up to 802,500 shares of Common Stock, at a reduced exercise price of $2.00. In consideration for the immediate exercise of some or all of the Existing Warrants for cash, we agreed to issue unregistered new Series D common stock purchase warrants (“Series D Warrants”) to purchase up to 1,069,800 shares of Common Stock (see Note 8). We received gross proceeds of $2.1 million in cash from the exercise of the Existing Warrants pursuant to the May Inducement Offer, prior to deducting placement agent fees and offering expenses.
Current wording
On July 9, 2025, we entered into an inducement offer letter agreement (the “Warrant Inducement Offer”) with seven holders of our existing Series A warrants, Series B-1 warrants, Series C-1 warrants, Series D warrants, Series E warrants, and Series F warrants (together the “Existing Warrants”). Pursuant to the Warrant Inducement Offer, such warrant holders immediately exercised some or all of their respective outstanding Existing Warrants at a reduced exercise price, to purchase an aggregate of 549,596 shares of our common stock. The gross proceeds from the exercise of the induced warrants were $4.6 million, prior to deducting placement agent fees and offering expenses. In consideration for the immediate exercise of some or all of the Existing Warrants for cash, we issued unregistered new Series H common stock warrants (“Series H Warrants”) to purchase up to 549,587 shares of common stock. We filed a resale registration statement on Form S-3 (File No. 333-288784), to register the shares underlying the Series H Warrants, which registration statement was declared effective by the Securities and Exchange Commission (the “SEC”) on July 25, 2025. The Warrant Inducement Offer closed on July 10, 2025. For additional discussion of this Warrant Inducement Offer, see the section below and further disclosures in the section titled*“Liquidity and Capital Resources – Financing Activities”*included herein.
Previous wording
Financing and Financing-Related Transactions During the Year Ended December 31, 2024
Current wording
On March 6, 2026, we entered into an Underwriting Agreement with the Underwriter, in connection with the Offering of: (i) 2,278,731 Common Stock Units, which includes 1,575,000 Common Stock Units purchased pursuant to the exercise, in full, of the Over-Allotment Option, sold to the public at a price of $0.50 per Common Stock Unit, and (ii) 9,815,900 pre-funded warrant units Pre-Funded Units, sold to the public at a price of $0.499 per Pre-Funded Unit, resulting in gross proceeds of approximately $6.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses. For more details in relation to the Offering, see*“Financing and Financing-Related Transactions Subsequent to December 31, 2025”*below.
Previous wording
We track external research and development costs on a program-by-program basis beginning, with respect to each program, upon our internal nomination of a candidate in that program for further preclinical and clinical development. External costs include fees paid to consultants, contractors and vendors, including contract manufacturing organizations (“CMOs”), and clinical research organizations (“CROs”), in connection with our preclinical, clinical and manufacturing activities and license milestone payments related to candidate development.
Current wording
We track external research and development costs on a program-by-program basis beginning, with respect to each program, upon our internal nomination of a candidate in that program for further preclinical and clinical development. External costs include fees paid to consultants, contractors and vendors, including contract development and manufacturing organizations (“CDMOs”), and clinical research organizations (“CROs”), in connection with our preclinical, clinical and manufacturing activities and license milestone payments related to candidate development.
Previous wording
General and administrative expenses include salaries and other compensation-related costs, including stock-based compensation, for personnel in executive, finance and accounting, business development, operations and administrative roles. Other significant costs include professional service and consulting fees including legal fees relating to intellectual property and corporate matters, accounting fees, recruiting costs and costs for consultants utilized to supplement our personnel, insurance costs, travel costs, facility and office-related costs not included in research and development expenses and depreciation and amortization.
Current wording
General and administrative expenses include salaries and other compensation-related costs, including stock-based compensation, for personnel in executive, finance and accounting, operations, and administrative roles. Other significant costs include professional service and consulting fees including legal fees relating to intellectual property and corporate matters, accounting fees, and costs for consultants utilized to supplement our personnel, insurance costs, travel costs, facility and office-related costs not included in research and development expenses and depreciation and amortization.
Previous wording
Other income or expenses, net, primarily includes the changes in fair value of debt instruments, warrants, and derivatives. The changes in the fair value of these instruments are recorded in change in fair value of debt, other liabilities, and derivatives, and change in fair value of debt, other liabilities, and derivatives – related party, included as a component of other income or expenses, net, in the consolidated statements of operations.
Current wording
Other income (expenses), net, primarily includes the changes in fair value of warrants and derivatives. The changes in the fair value of these instruments are recorded in change in fair value of other liabilities and derivatives, and change in fair value of other liabilities, and derivatives – related party, included as a component of other income (expense), net, in the consolidated statements of operations.
Previous wording
Interest expense primarily consists of amortization of discounts on convertible and term notes, including from related parties, and other interest expense incurred from financing leases and other obligations.
Current wording
Interest expense primarily consists of amortization of discounts on term notes, including from related parties, and other interest expense incurred from financing leases and other obligations.
Previous wording
Other income also includes grant income generated from a grant awarded to us by the California Institute for Regenerative Medicine (“CIRM”) in December 2022. Proceeds from the CIRM grant are recognized over the period necessary to match the related research and development expenses when it is probable that we have complied with the CIRM conditions and will receive the proceeds pursuant to the milestones defined in the grant as reimbursement of those expenditures. Any CIRM grant proceeds received in advance of having incurred the related research and development expenses are recorded in accrued expenses and other current liabilities and recognized as other income on our consolidated statements of operations when the related research and developments expenses are incurred.
Current wording
Other income also includes grant income generated from a grant awarded to us by the California Institute for Regenerative Medicine (“CIRM”) in December 2022. Proceeds from the CIRM grant are recognized over the period necessary to match the related research and development expenses when it is probable that we have complied with the CIRM conditions and will receive the proceeds pursuant to the milestones defined in the grant as reimbursement of those expenditures. Any CIRM grant proceeds received in advance of having incurred the related research and development expenses are recorded in accrued expenses and other current liabilities and recognized as grant income in our consolidated statements of operations when the related research and developments expenses are incurred.
Previous wording
Since inception, we have incurred net operating losses primarily for U.S. federal and state income tax purposes and have not reflected any benefit of such net operating loss carryforwards for any periods presented in this Form 10-K. The income tax provision in the periods presented is entirely attributable to amounts recorded from StemVac operations, our wholly-owned German subsidiary that provides research and development services to us under a cost-plus development agreement.
Current wording
Since inception, we have incurred net operating losses primarily for U.S. federal and state income tax purposes and have not reflected any benefit of such net operating loss carryforwards for any periods presented in this Form 10-K. The income tax provision in the periods presented is entirely attributable to amounts recorded from StemVac, GmbH operations, our wholly-owned German subsidiary that provides research and development services to us under a cost-plus development agreement.
Previous wording
Research and development expenses for the year ended December 31, 2024, and 2023 were $8.9 million and $13.0 million, respectively. The $4.1 million decrease was primarily attributable to decrease in drug manufacturing and preclinical studies of $3.4 million, salaries and benefits of $0.3 million, lab supplies of $0.2 million, consulting costs of $0.1 million, and other expenses of $0.1 million.
Current wording
Research and development expenses for the year ended December 31, 2025, and 2024 were $9.7 million and $8.9 million, respectively. The $0.8 million increase was primarily attributable to increases in consulting costs of $0.5 million, rent expenses of $0.3 million, drug manufacturing and preclinical expenses of $0.2 million, and office expenses of $0.2 million, partially offset by decrease in salaries and benefits of $0.4 million.
Previous wording
General and administrative expenses for the year ended December 31, 2024 and 2023 were $12.9 million and $16.0 million, respectively. The $3.1 million decrease was primarily due to decreases in compensation of $3.0 million arising from lower share based compensation expenses, decrease in headcount and lower separation costs, legal and settlement expenses of $0.9 million, consulting and directors’ expenses of $0.4 million, and other expenses of $0.3 million, partially offset by increases in insurance costs of $0.9 million, marketing and advertising expenses of $0.3 million, and certain other public company expenses of $0.3 million.
Current wording
General and administrative expenses for the year ended December 31, 2025 and 2024 were $10.5 million and $12.9 million, respectively. The $2.4 million decrease was primarily due to decreases in insurance costs of $0.7 million, legal expenses of $0.6 million, salaries and benefits of $0.3 million, accounting expenses of $0.3 million, public company expenses of $0.2 million, investor relations expenses of $0.2 million, and rent expenses of $0.1 million.
Previous wording
Other income (expense), net for the year ended December 31, 2024 and 2023 were $0.4 million and $0.2 million other expense, respectively. The $0.2 million increase in net expenses primarily relates to a decrease in grant income from CIRM of $2.7 million and the net change in fair value of Forward Purchase Agreement Derivative Asset, Public Warrants, and Private Placement Warrants of $0.8 million, partially offset by decreases in Series B Convertible Preferred Stock financing costs of $2.7 million, debt extinguishment losses of $0.5 million, and interest expense of $0.1 million.
Current wording
Other income (expense), net for the year ended December 31, 2025 and 2024 were $0.2 million other income and $0.4 million other expense, respectively. The $0.6 million decrease in net expenses primarily relates to a decrease in interest expense of $0.7 million, increase in other income of $0.2 million, primarily related to the gain on sale of our investment in Nova Cell, partially offset by a net change in fair value of other liabilities and derivatives of $0.3 million.
Previous wording
Since inception, we have funded our operations primarily through sales of common stock, convertible preferred stock, contingently convertible and convertible promissory notes, term loans, lines of credit, and SAFEs. These investments have also been made by and included various related parties.
Current wording
Since inception, we have funded our operations primarily through private sales of common stock, warrants, promissory notes, term debt, and the issuance of publicly traded securities. Certain of these investments were with various related parties.
Previous wording
As of December 31, 2024, we had a cash balance of $9.6 million and restricted cash of $0.2 million. Our debt and liability obligations as of December 31, 2024 include $4.4 million in accounts payable and accrued expenses and other current liabilities, including related party amounts, $3.1 million in operating lease liabilities, $3.0 million in term notes payable, including related party amounts, $0.6 million in promissory notes, $0.6 million in related party other current liabilities, $0.2 million in bridge loan payable, $0.2 million in finance lease liabilities, and $0.1 million in warrant liabilities, including related party amounts. Subsequent to December 31, 2024, principal and interest of $2.8 million were paid.
Current wording
As of December 31, 2025, we had a cash balance of $5.6 million and restricted cash of $0.2 million. Our debt and liability obligations as of December 31, 2025 include $2.4 million in accounts payable and accrued expenses and other current liabilities, including related party amounts, $1.7 million in operating lease liabilities, $0.6 million in promissory notes, $0.3 million in finance lease liabilities, and $0.1 million in warrant liabilities, including related party amounts.
Previous wording
On October 10, 2022, Calidi entered into an Office Lease Agreement (the “San Diego Lease”) that will serve as Calidi’s new principal executive and administrative offices and laboratory facility. To secure and execute the San Diego Lease, Mr. Allan Camaisa provided a personal Guaranty of Lease of up to $0.9 million (the “Guaranty”) to the lessor for Calidi’s future performance under the San Diego Lease agreement. As consideration for the Guaranty, Calidi agreed to pay Mr. Camaisa 10% of the Guaranty amount for the first year of the San Diego Lease, and 5% per annum of the Guaranty amount thereafter through the life of the lease, with all amounts accrued and payable at the termination of the San Diego Lease or release of Mr. Camaisa from the Guaranty by the lessor, whichever occurs first. The San Diego Lease has an initial term of 4 years.
Current wording
On October 10, 2022, Calidi entered into an Office Lease Agreement (the “San Diego Lease”) that serves as Calidi’s principal executive and administrative offices and laboratory facility. To secure and execute the San Diego Lease, Mr. Allan J. Camaisa, former Chief Executive Officer, provided a personal Guaranty of Lease of up to $0.9 million (the “Guaranty”) to the lessor for Calidi’s future performance under the San Diego Lease agreement. As consideration for the Guaranty, Calidi agreed to pay Mr. Camaisa 10% of the Guaranty amount for the first year of the San Diego Lease, and 5% per annum of the Guaranty amount thereafter through the life of the lease, with all amounts accrued and payable at the termination of the San Diego Lease or release of Mr. Camaisa from the Guaranty by the lessor, whichever occurs first. The amount due was partially settled in April 2025. The San Diego Lease has an initial term of 4 years.
Previous wording
We further entered into separate license agreements with Northwestern University and City of Hope and the University of Chicago, wherein Calidi may be liable to make certain contingent payments pursuant to the terms and conditions of the license agreements. As of December 31, 2024, we do not believe it probable that we will make these payments.
Current wording
We further entered into separate license agreements with Northwestern University and City of Hope and the University of Chicago, wherein Calidi may be liable to make certain contingent payments, under certain conditions that are in our control, pursuant to the terms and conditions of the license agreements. As of December 31, 2025, we do not believe it probable that we will incur these payments.
Previous wording
Other commitments and contingencies include (i) various operating and financing leases for equipment, office facilities, and other property containing future minimum lease payments totaling $3.7 million, (ii) certain manufacturing and other supplier agreements with vendors principally for manufacturing drug products for clinical trials and continuing the development of the CLD-101 and CLD-201 programs totaling $0.3 million, and (iii) severance costs due on January 1, 2025 totaling $0.4 million. The severance costs were paid in full in January 2025.
Current wording
Other commitments and contingencies include various operating and financing leases for equipment, office facilities, and other property containing future minimum lease payments totaling $2.1 million and certain manufacturing and other supplier agreements with vendors principally for manufacturing drug products for clinical trials and continuing the development of the CLD-101, CLD-201, and CLD-401 programs totaling $0.5 million.
Previous wording
Please see Note 6 to our annual consolidated financial statements for more information on our related party transactions.
Current wording
Please see Note 6 to our consolidated financial statements for more information on our related party transactions.
Previous wording
Net cash used in operating activities was $27.0 million for the year ended December 31, 2023, primarily resulting from our net loss of $29.2 million. Our net loss was reduced by certain non-cash items that included $4.8 million in stock-based compensation, $2.7 million in Series B Preferred Stock financing costs paid with equity, $0.9 million in amortization of right of use assets, $0.5 million in debt extinguishment, $0.4 million in amortization of debt discount and financing costs, and $0.4 million in depreciation expense, partially increased by $6.3 million from the change in our operating assets and liabilities, which includes payment of $6.8 million of FLAG liabilities assumed, and $1.2 million from the change in fair value of debt and other liabilities.
Current wording
Net cash used in operating activities was $21.3 million for the year ended December 31, 2025, primarily resulting from our net loss of $20.1 million. Our net loss was reduced by certain non-cash items that included $2.1 million in stock-based compensation, $1.7 million in depreciation and amortization expense, partially increased by $4.8 million from the change in our operating assets and liabilities, and $0.2 million from the gain on the sale of our investment in Nova Cell.
Previous wording
Net cash used in operating activities was $19.7 million for the year ended December 31, 2024, primarily resulting from our net loss of $22.2 million. Our net loss was reduced by certain non-cash items that included $3.0 million in stock-based compensation, $1.1 million in amortization of right of use assets, and $0.4 million in depreciation expense, partially increased by $1.7 million from the change in our operating assets and liabilities, and $0.3 million from the change in fair value of debt and other liabilities.
Current wording
Net cash used in operating activities was $19.7 million for the year ended December 31, 2024, primarily resulting from our net loss of $22.2 million. Our net loss was reduced by certain non-cash items that included $3.0 million in stock-based compensation, $1.5 million in depreciation and amortization expense, partially increased by $1.7 million from the change in our operating assets and liabilities, and $0.3 million from the change in fair value of debt and other liabilities.
Previous wording
Net cash used in investing activities was $0.5 million for the year ended December 31, 2023, which primarily related to the purchase of certain machinery and equipment of $0.6 million partially offset by proceeds from security deposits, net of $0.1 million.
Current wording
Net cash used in investing activities was $0.2 million for the year ended December 31, 2025, which primarily related to the purchase of certain machinery and equipment and cash disposed of in the sale of our investment in Nova Cell.
Previous wording
Net cash provided by financing activities was $29.0 million for the year ended December 31, 2023, which primarily related to related party proceeds from issuance of Series B Preferred Stock of $24.5 million, proceeds from New Money PIPE Subscription Agreement of $2.8 million, proceeds from SAFEs of $2.8 million, related party proceeds from issuance of term notes payable of $2.0 million, proceeds from issuance of term notes payable of $1.2 million, and proceeds from exercise of stock options of $0.3 million, partially offset by payment of financing costs of $2.2 million, repayment of principal on loan payables of $1.0 million, repayment of related party term notes of $1.0 million, repayment of term note payables of $0.3 million, and repayment of financing lease obligations of $0.1 million.
Current wording
Net cash provided by financing activities was $17.5 million for the year ended December 31, 2025, which primarily related to proceeds from public offerings of our securities of $9.9 million, proceeds from July Inducement Offer of $4.1 million, proceeds from the March Registered Direct Offering and Concurrent Private Placement of $3.5 million , and proceeds of $3.3 million from sales under our At The Market facility, partially offset by repayment of term notes payable of $2.2 million, including related party amounts, payment of financing costs of $0.8 million, repayment of bridge loan payable of $0.2 million and repayment of finance lease obligations of $0.1 million.
Previous wording
Net cash provided by financing activities was $27.4 million for the year ended December 31, 2024, which primarily related to proceeds from the November Public Offering of $6.8 million, proceeds from the April Public Offering of $5.4 million, proceeds from the exercise of common stock and pre-funded warrants of $4.8 million, proceeds from At the Market Offering of $3.1 million, proceeds from issuance of convertible notes payable of $3.0 million, proceeds from the May Inducement Offer of $2.1 million, proceeds from issuance of noncontrolling interest of $2.0 million, proceeds from the October Public Offering of $1.8 million, proceeds from the issuance of common shares and warrants per subscription agreement of $1.0 million, proceeds from issuance of promissory note of $0.6 million, and related party proceeds from issuance of a bridge loan payable of $0.2 million, partially offset by payment of financing costs of $1.5 million, repayment of convertible notes payable of $1.5 million, repayment of term notes payable of $0.3 million, and repayment of finance lease obligations of $0.1 million.
Current wording
Net cash provided by financing activities was $27.4 million for the year ended December 31, 2024, which primarily related to proceeds from the November Public Offering of $6.8 million, proceeds from the April Public Offering of $5.4 million, proceeds from the exercise of common stock and pre-funded warrants of $4.8 million, proceeds from the At the Market Offering of $3.1 million, proceeds from issuance of convertible notes payable of $3.0 million, proceeds from the May Inducement Offer of $2.1 million, proceeds from issuance of noncontrolling interest of $2.0 million, proceeds from the October Public Offering of $1.8 million, proceeds from the issuance of common shares and warrants per subscription agreement of $1.0 million, proceeds from issuance of promissory note of $0.6 million, and related party proceeds from issuance of a bridge loan payable of $0.2 million, partially offset by payment of financing costs of $1.5 million, repayment of convertible notes payable of $1.5 million, repayment of term notes payable of $0.3 million, and repayment of finance lease obligations of $0.1 million.
Previous wording
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue our research and development, initiate clinical trials, and seek marketing approval for our current and any of our future product candidates. In addition, if we obtain marketing approval for any of our current or our future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution, which costs we may seek to offset through entry into collaboration agreements with third parties. Furthermore, upon the completion of this offering, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
Current wording
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue our research and development, initiate clinical trials, and seek marketing approval for our current and any of our future product candidates. In addition, if we obtain marketing approval for any of our current or our future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution, which costs we may seek to offset through entry into collaboration agreements with third parties. Furthermore, we expect to continue to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
Previous wording
Based on our current operating plan, available cash and additional access to capital discussed above under the “Liquidity and Capital Resources” section, 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 the consolidated financial statements as of and for the year ended December 31, 2024 appearing elsewhere in this Form 10-K. To finance our operations, we will need to raise substantial additional capital, which cannot be assured. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern for at least one year from the date that our aforementioned consolidated financial statements were issued. See Note 1 to our consolidated financial statements appearing elsewhere in this Form 10-K for additional information on our assessment.
Current wording
Based on our current operating plan, available cash and additional access to capital discussed above under the “Liquidity and Capital Resources” section, 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 the consolidated financial statements as of and for the year ended December 31, 2025 appearing elsewhere in this Form 10-K. To finance our operations, we will need to raise substantial additional capital, which cannot be assured. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern for at least one year from the date that our consolidated financial statements were issued. See Note 1 to our consolidated financial statements appearing elsewhere in this Form 10-K for additional information on our assessment.
Previous wording
Our existing cash will not be sufficient to complete development of CLD-101, CLD-201, and CLD-400. Accordingly, we will be required to obtain further funding to achieve our business objectives.
Current wording
Our existing cash will not be sufficient to complete development of our current product candidates. Accordingly, we will be required to obtain further funding to achieve our business objectives.
Previous wording
Our significant accounting policies and estimates are described in more detail in Note 2 in the notes to consolidated financial statements as of and for the years ended December 31, 2024 and 2023 appearing elsewhere in this Annual Report on Form 10-K.
Current wording
Our significant accounting policies and estimates are described in more detail in Note 2 to the consolidated financial statements as of and for the year ended December 31, 2025 and 2024 appearing elsewhere in this Annual Report on Form 10-K. We determined that none of our significant accounting policies and estimates are deemed to be critical accounting estimates.
Previous wording
We enter into agreements in the normal course of business with vendors for preclinical and clinical studies, preclinical and clinical supply and manufacturing services, professional consultants for expert advice, and other vendors for other services for operating purposes. These contracts do not contain any minimum purchase commitments and are cancellable at any time by us, generally upon 30 days prior written notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.
Current wording
We enter into agreements in the normal course of business with vendors for preclinical and clinical studies, preclinical and clinical supply and manufacturing services, professional consultants for expert advice, and other vendors for other services for operating purposes. We have certain manufacturing and other supplier agreements with vendors principally for manufacturing drug products for clinical trials and continuing the development of our product candidates totaling $0.5 million in future purchase commitments. However, these contracts do not contain any minimum purchase commitments and are cancellable at any time by us, generally upon 30 days prior written notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.
Previous wording
In addition, we have entered into license and royalty agreements for intellectual property with certain parties. Such arrangements require ongoing payments, including payments upon achieving certain development, regulatory and commercial milestones, receipt of sublicense income, as well as royalties on commercial sales. Payments under these arrangements are expensed as incurred and are recorded as research and development expenses. We paid amounts under such agreements at the time of execution and pay annual fees. We have not paid any royalties under these agreements to date. We have not included the annual license fee payments contractual obligations because the license agreements are cancelable by us and therefore, we believe that our non-cancelable obligations under these agreements are not material. We have not included potential royalties or milestone obligations because they are contingent upon the occurrence of future events and the timing and likelihood of such potential obligations are not known with certainty. For further information regarding these agreements and amounts that could become payable in the future under these agreements, please see the sub-section entitled “License Agreements” within the “Item 1. Business” section herein.
Current wording
In addition, we have entered into license and royalty agreements for intellectual property with certain parties. Such arrangements require ongoing payments, including payments upon achieving certain development, regulatory and commercial milestones, receipt of sublicense income, as well as royalties on commercial sales. Payments under these arrangements are expensed as incurred and are recorded as research and development expenses. We may pay amounts under such agreements at the time of execution or annual fees. We have not paid any royalties under these agreements to date. We have not included the annual license fee payments contractual obligations because the license agreements are cancelable by us and therefore, we believe that our non-cancelable obligations under these agreements are not material. We have not included potential royalties or milestone obligations because they are contingent upon the occurrence of future events and the timing and likelihood of such potential obligations are not known with certainty. For further information regarding these agreements and amounts that could become payable in the future under these agreements, please see the sub-section entitled “License Agreements” within the “Item 1. Business” section herein.
Previous wording
We are not currently exposed to significant market risk related to changes in interest rates because we do not have any cash equivalents or interest-bearing investments at this time. Our debt typically contains a fixed interest rate or is issued to certain lenders, including related party lenders, with other equity instruments, such as warrants, in lieu of a stated cash interest rate. However, for debt that we have issued that is variable and fluctuates with changes in interest rates, an immediate one percentage point change in market interest rates would not have a material impact on our financial position or results of operations.
Current wording
We are not currently exposed to significant market risk related to changes in interest rates because we do not have any cash equivalents or interest-bearing investments at this time. Our debt typically contains a fixed interest rate or is issued to certain lenders, including related party lenders, with other equity instruments, such as warrants, in lieu of a stated cash interest rate. We currently do not have debt with an interest rate that is variable and fluctuates with changes in interest rates.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Please see Note 2 to our consolidated financial statements for additional details.