- Announced partnership with Australian CRO to accelerate initiation of CLD-401 clinical trial
- The Company has received feedback from the FDA through Type D interactions, and the Company believes its manufacturing and analytical approaches for CLD-401 are in alignment with FDA guidance; Calidi expects to file an IND by end of 2026
- Partnered with
Matica Bio around the GMP manufacturing of CLD-401 - Presented new data on in situ T-cell engagers (TCEs) at 2026 AACR-IO conference
- Raised
$6.5 million in public offering and ATM sales
“We are extremely excited about the continued progress at Calidi,” said
Fourth Quarter 2025 and Recent Corporate Developments
- Partnered with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in
Australia . The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 inAustralia . CLD-401, the Company’s lead asset, is a systemically delivered oncolytic virus that replicates only in tumor cells. CLD-401 induces high concentrations of IL-15 superagonist (IL15 SA ) expression in the tumor microenvironment while limiting peripheral exposure. - In parallel, Calidi is pursuing an IND filing with the FDA by the end of 2026. Calidi has interacted with the FDA around the Company’s manufacturing and analytical approaches through its Type D meeting request process. The feedback it has received from the agency supports the use of this process for the clinical development of CLD-401.
- Partnered with
Matica Bio , a leading CDMO in the field of oncolytic virus manufacturing, for the GMP manufacturing of CLD-401. Matica has successfully executed multiple oncolytic virus programs at its state-of-the-art, purpose-built GMP facility inCollege Station, Texas . That facility was designed specifically to support complex viral vector modalities like CLD-401. - Presented data demonstrating the expression of an in situ T-cell engagers (TCEs) for solid tumors and the simultaneous expression of a T-cell activating agent (e.g.,
IL-15 SA ) through its systemically delivered RedTail platform at the AACR Immuno-Oncology (AACR-IO) conference. High expression of in situ TCE coincident with expression of a T-cell activator in the TME may overcome the traditional limitations of TCEs in solid tumor. - Raised
$6.0 million in gross proceeds from an underwritten public offering with new and existing investors in Q1-2026 and$0.5 million in gross proceeds from the sale of stock under our ATM in Q4-2025, strengthening the balance sheet and extending Calidi’s cash runway.
Fourth Quarter 2025 Financial Results
The company reported a net loss attributable to common stockholders of
Research and development expenses were
General and administrative expenses were
Full Year 2025 Financial Results
The company reported a net loss attributable to common stockholders of
Research and development expenses were
General and administrative expenses were
The company had approximately
About
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.
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
Contacts:
For Investors and Media:
1-407-644-4256
CLDI@redchip.com
CONSOLIDATED BALANCE SHEETS (In thousands, except for par value data) | ||||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 5,600 | $ | 9,591 | ||||
| Prepaid expenses and other current assets | 656 | 636 | ||||||
| Total current assets | 6,256 | 10,227 | ||||||
| NONCURRENT ASSETS | ||||||||
| Machinery and equipment, net | 781 | 869 | ||||||
| Operating lease right-of-use assets, net | 1,682 | 2,934 | ||||||
| Other noncurrent assets | 138 | 152 | ||||||
| TOTAL ASSETS | $ | 8,857 | $ | 14,182 | ||||
| LIABILITIES AND TOTAL EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 595 | $ | 2,072 | ||||
| Related party accounts payable | 18 | 2 | ||||||
| Accrued expenses and other current liabilities | 1,276 | 1,858 | ||||||
| Related party accrued expenses and other current liabilities | 530 | 480 | ||||||
| Term notes payable, net of discount, including accrued interest | — | 251 | ||||||
| Related party term notes payable, net of discount, including accrued interest | — | 2,702 | ||||||
| Related party bridge loan payable, including accrued interest | — | 223 | ||||||
| Related party other current liability | — | 638 | ||||||
| Finance lease liability, current | 111 | 66 | ||||||
| Operating lease right-of-use liability, current | 1,405 | 1,204 | ||||||
| Total current liabilities | 3,935 | 9,496 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Operating lease right-of-use liability, noncurrent | 277 | 1,845 | ||||||
| Finance lease liability, noncurrent | 171 | 145 | ||||||
| Promissory note | 600 | 600 | ||||||
| Warrant liability | 107 | 119 | ||||||
| Related party warrant liability | 8 | 9 | ||||||
| TOTAL LIABILITIES | 5,098 | 12,214 | ||||||
| TOTAL EQUITY | 3,759 | 1,968 | ||||||
| TOTAL LIABILITIES AND TOTAL EQUITY | $ | 8,857 | $ | 14,182 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) | ||||||||
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | (9,737 | ) | $ | (8,878 | ) | ||
| General and administrative | (10,503 | ) | (12,898 | ) | ||||
| Total operating expense | (20,240 | ) | (21,776 | ) | ||||
| Loss from operations | (20,240 | ) | (21,776 | ) | ||||
| OTHER INCOME (EXPENSES), NET | ||||||||
| Interest expense | (131 | ) | (372 | ) | ||||
| Interest expense – related party | (76 | ) | (561 | ) | ||||
| Change in fair value of other liabilities and derivatives | 1 | 285 | ||||||
| Change in fair value of other liabilities and derivatives – related party | 1 | 39 | ||||||
| Grant income | 50 | 181 | ||||||
| Gain on sale of investment in | 244 | — | ||||||
| Other income, net | 103 | 9 | ||||||
| Total other income (expenses), net | 192 | (419 | ) | |||||
| LOSS BEFORE INCOME TAXES | (20,048 | ) | (22,195 | ) | ||||
| Income tax provision | (15 | ) | (14 | ) | ||||
| NET LOSS | $ | (20,063 | ) | $ | (22,209 | ) | ||
| Net loss attributable to noncontrolling interest | (157 | ) | (66 | ) | ||||
| NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST | (19,906 | ) | (22,143 | ) | ||||
| Deemed dividend on warrants | (5,673 | ) | (1,671 | ) | ||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | (25,579 | ) | (23,814 | ) | ||||
| Net loss per share; basic and diluted | $ | (5.95 | ) | $ | (35.70 | ) | ||
| Weighted average common stock shares outstanding; basic and diluted | 4,302 | 667 | ||||||
