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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2025
CALIDI BIOTHERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40789 | 86-2967193 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
|
4475 Executive Drive, Suite 200, San Diego, California |
92121 | |
| (Address of principal executive offices) | (Zip Code) |
(858) 794-9600
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered | ||
| Common stock, par value $0.0001 per share | CLDI | NYSE American LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 13, 2025, Calidi Biotherapeutics, Inc. (the “Company”) issued a press release announcing certain financial results for the third quarter ended September 30, 2025, and certain recent corporate developments. A copy of the press release is incorporated herein by reference and is furnished as Exhibit 99.1.
The information under this Item 2.02 is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
The information under Item 2.02 above is incorporated herein by reference.
By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD. The information in this Item 7.01 disclosure, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section. In addition, the information in this Item 7.01 disclosure, including Exhibits 99.1, shall not be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit | Exhibit Description | |
| 99.1 | Press release dated November 13, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CALIDI BIOTHERAPEUTICS, INC. | ||
| Dated: November 13, 2025 | ||
| By: | /s/ Andrew Jackson | |
| Name: | Andrew Jackson | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Calidi Biotherapeutics Reports Third Quarter 2025 Financial Results and Recent Operational Highlights
| ● | Presented new data at the Society of Immunotherapy for Cancer (SITC) annual meeting on CLD-401 protection from immune clearance after systemic administration; data also demonstrates that the platform can effectively express genetic medicines at the tumor site | |
| ● | Established new Scientific Advisory Board to support development of CLD-401 and advance RedTail platform for the systemic delivery of targeted genetic medicine | |
| ● | Continued expansion of RedTail platform capabilities with multiple additional payloads and programable membrane targeting, further advancing virotherapy in cancer and beyond oncology | |
| ● | Raised $6.9 million gross proceeds through an underwritten public offering with new and existing investors that further strengthens the company’s balance sheet and extends its runway |
SAN DIEGO, November 13, 2025 — (Business Wire) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today reported its third quarter 2025 operating and financial results and reviewed recent business highlights.
“We are extremely excited about the continued progress at Calidi,” said Eric Poma, PhD, CEO of Calidi Biotherapeutics. “In our preclinical models, the RedTail platform continues to demonstrate its ability to potently and specifically deliver genetic payloads to metastatic tumor sites. CLD-401, the first lead from our RedTail platform, is advancing to clinical trials, and Calidi has built a world-class scientific advisory board to aid those efforts.”
Third Quarter 2025 and Recent Corporate Developments
| ● | Presented new preclinical data surrounding CLD-401, the first lead compound from Calidi’s proprietary RedTail platform, at the Society of Immunotherapy for Cancer (SITC) on November 7th in National Harbor, MD., demonstrating that in syngeneic murine models, the RedTail platform is protected from immune clearance after systemic administration and can find and specifically replicate in tumor cells at metastatic sites. The data also demonstrate that the platform can effectively express genetic medicines at the tumor site in concentrations that are similar to what is achievable with localized dosing while avoiding systemic exposure. | |
| ● | Established Scientific Advisory Board with internationally esteemed advisors to support development of CLD-401 and advance the RedTail platform for the systemic delivery of targeted genetic medicine. |
The founding members of Calidi’s new SAB are:
| ● | Mace L. Rothenberg, MD, FACP, former Chief Medical Officer of Pfizer, a physician executive with more than 30 years of experience in drug development, translational research, and risk benefit assessment; |
| ● | Dmitriy Zamarin MD, PhD, a medical oncologist and Section Head of Gynecologic Medical Oncology and Co-Director of the Center of Excellence for Gynecologic Cancer and a world leader in virotherapy for cancer; | |
| ● | John Wrangle, MD, MPH, a thoracic oncologist and scientist and and expert in translational immunotherapy with extensive experience around IL-15-based treatment in metastatic cancer; and | |
| ● | David T. Curiel, MD, PhD, a world leader in cancer immunotherapy and cancer virotherapy. |
| ● |
Continued to expand the functionality of the RedTail platform; presented at the SITC meeting. The RedTail technology can now allow for “programmable membranes” in which targeting proteins are expressed in the viral envelope. Calidi is also exploring additional cell types outside of oncology that the platform is active in (i.e., activated immune cells) and is exploring additional payloads. |
|
| ● |
Raised $6.9 million in gross proceeds from an underwritten public offering with new and existing investors, extending Calidi’s runway and increasing the total gross proceeds raised in all offerings in 2025 to $23.0 million. |
Third Quarter 2025 Financial Results
The company reported a net loss $5.2 million for the three months ended September 30, 2025, compared to a net loss of $5.1 million for the same period in 2024. In 2025, a non-cash charge for deemed dividend on warrants increased net loss attributable to shareholders to $10.8 million. There was no such charge in the same period in 2024.
Net loss per share, basic and diluted, was $2.21 for the three months ended September 30, 2025, compared to $7.75 for the comparable period in 2024.
Research and development expenses were $2.4 million for the three months ended September 30, 2025, compared to $2.2 million for the comparable period in 2024.
General and administrative expenses were $2.7 million for the three months ended September 30, 2025, compared to $3.1 million for the comparable period in 2024.
The company had approximately $10.4 million in cash and $0.2 million in restricted cash as of September 30, 2025, compared to $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024.
About Calidi Biotherapeutics
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s 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 gene therapies to metastatic locations.
The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing protected virotherapies, in clinical-stage, for intratumoral and localized administration, focusing on a subset of injectable cancer indications.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.
Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 31, 2025, as may be amended or supplemented by other reports we file with the SEC from time to time.
Contacts:
For Investors and Media:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com
CALIDI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for par value data)
|
September 30, 2025 |
December 31, 2024 |
|||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 10,375 | $ | 9,591 | ||||
| Prepaid expenses and other current assets | 653 | 636 | ||||||
| Total current assets | 11,028 | 10,227 | ||||||
| NONCURRENT ASSETS | ||||||||
| Machinery and equipment, net | 849 | 869 | ||||||
| Operating lease right-of-use assets, net | 2,012 | 2,934 | ||||||
| Other noncurrent assets | 140 | 152 | ||||||
| TOTAL ASSETS | $ | 14,029 | $ | 14,182 | ||||
| LIABILITIES AND TOTAL EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 1,143 | $ | 2,072 | ||||
| Related party accounts payable | 5 | 2 | ||||||
| Accrued expenses and other current liabilities | 1,396 | 1,858 | ||||||
| Related party accrued expenses and other current liabilities | 778 | 480 | ||||||
| Term notes payable, net of discount, including accrued interest | — | 251 | ||||||
| Related party term notes payable, net of discount, including accrued interest | 405 | 2,702 | ||||||
| Related party bridge loan payable, including accrued interest | — | 223 | ||||||
| Related party other current liability | — | 638 | ||||||
| Finance lease liability, current | 112 | 66 | ||||||
| Operating lease right-of-use liability, current | 1,354 | 1,204 | ||||||
| Total current liabilities | 5,193 | 9,496 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Operating lease right-of-use liability, noncurrent | 640 | 1,845 | ||||||
| Finance lease liability, noncurrent | 197 | 145 | ||||||
| Promissory note | 600 | 600 | ||||||
| Warrant liability | 186 | 119 | ||||||
| Related party warrant liability | 15 | 9 | ||||||
| TOTAL LIABILITIES | 6,831 | 12,214 | ||||||
| TOTAL EQUITY | 7,198 | 1,968 | ||||||
| TOTAL LIABILITIES AND TOTAL EQUITY | $ | 14,029 | $ | 14,182 | ||||
CALIDI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
| Three Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | (2,361 | ) | $ | (2,153 | ) | ||
| General and administrative | (2,687 | ) | (3,073 | ) | ||||
| Total operating expense | (5,048 | ) | (5,226 | ) | ||||
| Loss from operations | (5,048 | ) | (5,226 | ) | ||||
| OTHER INCOME (EXPENSES), NET | ||||||||
| Interest expense | (31 | ) | (98 | ) | ||||
| Interest expense – related party | (10 | ) | (134 | ) | ||||
| Change in fair value of other liabilities and derivatives | (93 | ) | 352 | |||||
| Change in fair value of other liabilities and derivatives – related party | (7 | ) | 28 | |||||
| Other expense, net | 18 | 8 | ||||||
| Total other income (expenses), net | (123 | ) | 156 | |||||
| LOSS BEFORE INCOME TAXES | $ | (5,171 | ) | $ | (5,070 | ) | ||
| Income tax provision | (10 | ) | 1 | |||||
| NET LOSS | $ | (5,181 | ) | $ | (5,069 | ) | ||
| Net loss attributable to noncontrolling interest | (32 | ) | (15 | ) | ||||
| NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST | (5,149 | ) | (5,054 | ) | ||||
| Deemed dividend on warrants | (5,673 | ) | — | |||||
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
(10,822 | ) | (5,054 | ) | ||||
| Net loss per share; basic and diluted | $ | (2.21 | ) | $ | (7.75 | ) | ||
| Weighted average common shares outstanding; basic and diluted | 4,907 | 652 | ||||||