Calidi Biotherapeutics (NYSE: CLDI) Q1 2026 loss narrows as cash rises
Rhea-AI Filing Summary
Calidi Biotherapeutics reported first quarter 2026 results showing a net loss attributable to common stockholders of $4.4 million, or $0.43 per share, compared with a net loss of $5.0 million, or $2.21 per share, a year earlier.
Research and development expenses were $2.6 million, slightly higher than in 2025, while general and administrative expenses declined to $1.6 million from $2.6 million, reducing overall operating costs. Total other income turned modestly positive, helping narrow the loss.
The company ended March 31, 2026 with $6.6 million in cash and $0.2 million in restricted cash, up from $5.6 million and $0.2 million at year-end 2025. Calidi continues advancing its RedTail platform, including lead candidate CLD-401 in IND-enabling studies, and plans to submit an IND application by the end of 2026.
Positive
- None.
Negative
- None.
Insights
Loss narrows as G&A falls, cash balance improves modestly.
Calidi Biotherapeutics reported a Q1 2026 net loss attributable to common stockholders of $4.4 million, slightly better than $5.0 million in Q1 2025. Operating expenses fell as lower general and administrative costs more than offset higher R&D spending.
Research and development expenses rose to $2.6 million, reflecting ongoing investment in the RedTail platform and lead candidate CLD-401. General and administrative expenses declined to $1.6 million from $2.6 million, easing the operating loss.
Cash increased to $6.6 million at March 31, 2026, from $5.6 million at December 31, 2025, while total equity improved to $4.9 million. Future company filings may provide more detail on funding plans to support the planned IND submission by the end of 2026 and subsequent clinical activities.
8-K Event Classification
Key Figures
Key Terms
RedTail platform medical
enveloped oncolytic virus medical
Investigational New Drug regulatory
warrant liability financial
operating lease right-of-use assets financial
non-small cell lung cancer medical
Earnings Snapshot
The company plans to submit an IND application for CLD-401 by the end of 2026.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
(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 | ||
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 May 14, 2026, Calidi Biotherapeutics, Inc. (the “Company”) issued a press release announcing certain financial results for the first quarter ended March 31, 2026, and certain other 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 May 14, 2026 | |
| 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: May 14, 2026 | ||
| By: | /s/ Andrew Jackson | |
| Name: | Andrew Jackson | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Calidi Biotherapeutics Reports First Quarter 2026 Financial Results and Recent Operational Highlights
| - | Presented new data on CLD-401 at the AACR conference in San Diego, CA, detailing the profound immune changes in the tumor microenvironment induced by CLD-401; IND filing for CLD-401 expected by end of 2026 |
| - | Presented new data on RedTail at the AACR conference in San Diego, CA detailing the use of the RedTail platform to create in vivo T-cell engagers that simultaneously express both a T-cell engager and a T-cell activator at high levels exclusively in the tumor microenvironment; presented new data on CLD-501, a TROP-2 in vivo T-cell engager |
| - | Demonstrated $1 million reduction in general and administrative expenses from Q1-2025 to Q1-2026 |
| - | Speaker presentation at ASGCT conference in Boston, MA highlighting IL15-SA expression may dramatically expand the therapeutic window of IL-15-mediated treatment |
| - | Speaker presentation at IOVC conference showcasing the ability of the RedTail extracellular enveloped and CD55-overexpressing virus (EEV) to avoid immune clearance |
| - | Strategic partnership with TransferAI to drive efficiencies in IND submission process for CLD-401 |
SAN DIEGO, May 14, 2026 — (GLOBE NEWSWIRE) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today reported its first quarter 2026 operating and financial results and reviewed recent business highlights.
“We are excited about the continued progress at Calidi,” said Eric Poma, PhD, Calidi Biotherapeutics CEO. “We continue to advance CLD-401, the first lead from our RedTail platform, towards the clinic and have built a world-class scientific advisory board to aid those efforts. We have also expanded what the RedTail platform can do with our new approach of in situ T-cell engagers.”
First Quarter 2026 and Recent Corporate Developments
| - | On April 21, 2026, presented new data at the American Association of Cancer Research (AACR) annual meeting in San Diego, California. Data at AACR detailed the profound immune changes in the tumor microenvironment induced by CLD-401 including the recruitment and activation of T, NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in the immunocompetent animal models. Immune activation of cell types that do not require antigen expression or HLA positivity represents a potential new mechanism of immune response that could drive efficacy in patients that have progressed or were refractory to current immune therapy |
| - | On April 19, 2026, Calidi presented data at the AACR meeting that showcased RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. Localized expression of a T-cell engager and a T-cell activator may overcome the key challenges seen with T-cell engagers in solid tumors. The Company presented data on its first in situ T-cell engager, CLD-501, a T-cell engager targeting TROP2 |
| - | Recorded a $1.0 million reduction in general and administrative expenses from Q1-2025 to Q1-2026, demonstrating the Company’s commitment to efficient use of capital. The reduction was primarily due to reduced headcount, consulting, and rent expenses |
| - | On May 14, 2026, presented as a featured speaker at the American Society for Gene and Cell Therapy (ASGCT) conference in Boston, Massachusetts, highlighting that the ability of CLD-401 to induce high levels of IL15-SA expression in the tumor microenvironment while maintaining low circulating levels may dramatically expand the therapeutic window of IL-15-mediated treatment |
| - | On April 28, 2026, presented data at the Internation Oncolytic Virus Conference (IOVC) in Reykjavik, Iceland, showcasing the ability of the RedTail extracellular enveloped and CD55-overexpressing virus (EEV) to avoid immune clearance, replicate only in target cells, and deliver high concentrations of genetic medicine to sites of disease |
| - | In April 2026, entered a collaboration with TransferAI to drive efficiencies in Calidi’s IND submission for CLD-401 by using TransferAI’s proprietary agentic artificial intelligence platform, SofieTM, including pre-built and customizable orchestrations for biopharma. TransferAI’s Sofie platform will work alongside Calidi’s teams, helping orchestrate complex regulatory workflows while preserving the rigor required for IND submissions, providing support for Calidi to achieves its goal of submitting the CLD-401 IND by year end |
First Quarter 2026 Financial Results
The Company reported a net loss attributable to common stockholders of $4.4 million, or $0.43 per share, for the three months ended March 31, 2026, compared to a net loss attributable to common stockholders of $5.0 million, or $2.21 per share, for the same period in 2025.
Research and development expenses were $2.6 million for the three months ended March 31, 2026, compared to $2.4 million for the comparable period in 2025.
General and administrative expenses were $1.6 million for the three months ended March 31, 2026, compared to $2.6 million for the comparable period in 2025.
The Company had approximately $6.6 million in cash and $0.2 million in restricted cash as of March 31, 2026, compared to $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025.
About Calidi Biotherapeutics
Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology 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 genetic medicine(s) to metastatic locations.
CLD-401, the lead candidate from the RedTail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform including its novel approach to incorporate in situ T-cell engagers in solid tumors.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here.
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, the Company’s plans strategies, priorities and key operational initiatives for fiscal year 2026, including the Company’s plan to submit an Investigational New Drug (“IND”) application by the end of 2026, 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; and, with respect to the Company’s fiscal year 2026 initiatives, including the timing and ability to submit an IND application by the end of 2026, the risk that actual results may differ materially due to, among other things, the timing, cost and results of research and development activities and preclinical studies; interactions with, and the timing and substance of feedback from, regulatory authorities (including that any preliminary interactions with the FDA may not be indicative of future outcomes or regulatory success); changes in applicable laws or regulations; manufacturing and supply chain matters; the availability of capital and other resources; and changes in business, market, economic or competitive conditions. 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 27, 2026, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
Contacts:
For Investors:
IR@calidibio.com
For Media:
PR@calidibio.com
CALIDI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except for par value data)
March 31, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 6,631 | $ | 5,600 | ||||
| Prepaid expenses and other current assets | 722 | 656 | ||||||
| Total current assets | 7,353 | 6,256 | ||||||
| NONCURRENT ASSETS | ||||||||
| Machinery and equipment, net | 758 | 781 | ||||||
| Operating lease right-of-use assets, net | 1,342 | 1,682 | ||||||
| Other noncurrent assets | 138 | 138 | ||||||
| TOTAL ASSETS | $ | 9,591 | $ | 8,857 | ||||
| LIABILITIES AND TOTAL EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 849 | $ | 595 | ||||
| Related party accounts payable | 51 | 18 | ||||||
| Accrued expenses and other current liabilities | 1,313 | 1,276 | ||||||
| Related party accrued expenses and other current liabilities | 119 | 530 | ||||||
| Finance lease liability, current | 154 | 111 | ||||||
| Operating lease right-of-use liability, current | 1,350 | 1,405 | ||||||
| Total current liabilities | 3,836 | 3,935 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Operating lease right-of-use liability, noncurrent | 6 | 277 | ||||||
| Finance lease liability, noncurrent | 147 | 171 | ||||||
| Promissory note | 600 | 600 | ||||||
| Warrant liability | 62 | 107 | ||||||
| Related party warrant liability | 5 | 8 | ||||||
| TOTAL LIABILITIES | 4,656 | 5,098 | ||||||
| TOTAL EQUITY | 4,935 | 3,759 | ||||||
| TOTAL LIABILITIES AND TOTAL EQUITY | $ | 9,591 | $ | 8,857 | ||||
CALIDI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| (Unaudited) | ||||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | (2,587 | ) | $ | (2,425 | ) | ||
| General and administrative | (1,600 | ) | (2,637 | ) | ||||
| Total operating expense | (4,187 | ) | (5,062 | ) | ||||
| Loss from operations | (4,187 | ) | (5,062 | ) | ||||
| OTHER INCOME, NET | ||||||||
| Interest expense | (33 | ) | (34 | ) | ||||
| Interest expense – related party | (5 | ) | (38 | ) | ||||
| Change in fair value of other liabilities and derivatives | 45 | 32 | ||||||
| Change in fair value of other liabilities and derivatives – related party | 3 | 3 | ||||||
| Grant income | — | 50 | ||||||
| Other income (expense), net | 73 | (10 | ) | |||||
| Total other income, net | 83 | 3 | ||||||
| LOSS BEFORE INCOME TAXES | (4,104 | ) | (5,059 | ) | ||||
| Income tax provision | (4 | ) | (3 | ) | ||||
| NET LOSS | $ | (4,108 | ) | $ | (5,062 | ) | ||
| Net loss attributable to noncontrolling interest | — | (76 | ) | |||||
| NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST | (4,108 | ) | (4,986 | ) | ||||
| Deemed dividend on warrants | (309 | ) | — | |||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | (4,417 | ) | (4,986 | ) | ||||
| Net loss per share; basic and diluted | $ | (0.43 | ) | $ | (2.21 | ) | ||
| Weighted average common shares outstanding; basic and diluted | 10,308 | 2,257 | ||||||