Calidi Biotherapeutics, Inc.

What they do

Calidi develops targeted genetic medicines built on its RedTail platform, an engineered enveloped oncolytic virus designed for systemic delivery to metastatic tumor sites. RedTail uses proprietary modifications including engineered CD55 expression to avoid immune clearance, replicate only in tumor cells, and deliver genetic payloads such as IL-15 superagonist to the tumor microenvironment. The company also has legacy SuperNova and NeuroNova stem-cell-encapsulated oncolytic virus platforms. Lead candidates include CLD-401 (RedTail/IL-15 superagonist), CLD-201 (SuperNova, Fast Track Designation for soft tissue sarcoma in July 2025), and CLD-501/CLD-502 in situ T-cell engagers.

Revenue drivers

• Product sales — No products are approved for commercial sale and the company reports it has generated no revenue from product sales.
• RedTail platform (CLD-401, CLD-501, CLD-502) — Preclinical-stage pipeline; CLD-401 has received positive pre-IND FDA feedback and is targeted for first patient dosing in Q1 2027. CLD-501 is a TROP-2-targeted in situ T-cell engager plus IL-15 superagonist; CLD-502 is EpCAM-targeted.
• SuperNova (CLD-201) — Has an open IND for a Phase 1 trial and received FDA Fast Track Designation in July 2025 for soft tissue sarcoma; no revenue.
• NeuroNova — In a Phase 1 investigator-initiated trial run and funded by partner City of Hope; no revenue to Calidi.

Recent performance

For Q2 2026, Calidi reported a net loss attributable to common stockholders of $4.2 million, or $2.94 per share, versus a $5.7 million loss, or $31.75 per share, in Q2 2025 (prior periods adjusted for a 1-for-16 reverse split completed in July 2026). Research and development expenses were $2.6 million, flat year over year, while general and administrative expenses fell to $1.6 million from $3.1 million, a reduction of $1.5 million or 48%. Cash was $4.1 million with $0.2 million restricted cash as of June 30, 2026, down from $5.6 million cash and $0.2 million restricted cash at December 31, 2025. The company's latest balance sheet shows total assets of $7.2 million, total liabilities of $4.1 million and shareholder equity of $3.1 million as of June 30, 2026. Full-year net losses were $22.1 million in 2024 and $19.9 million in 2025, with operating cash outflow of $21.3 million in 2025.

Strategy

Calidi's stated priority is advancing CLD-401, the lead RedTail candidate, into a first-in-human study following positive pre-IND feedback from the FDA, with first patient dosing targeted for Q1 2027. The company is also expanding the RedTail platform into in situ T-cell engagers, presenting CLD-501 preclinical data at the 2026 ASCO Annual Meeting and advancing the EpCAM-targeted CLD-502 program. It continues to support the partnered NeuroNova Phase 1 trial and holds an open IND for CLD-201. Management has emphasized tight expense management, including a 48% year-over-year reduction in Q2 2026 G&A, to conserve capital. Calidi added Corsee Sanders, Ph.D., formerly of Genentech/Roche and Celgene, to its Board of Directors.

Risks

• No revenue and no approved products — The company has never generated product revenue and has incurred significant operating losses since inception, with net losses of $22.1 million in 2024 and $19.9 million in 2025.
• Need for substantial additional funding — Management states that without additional capital when needed it would be forced to delay, reduce or eliminate product development programs or cease operations, and cash stood at just $4.1 million as of June 30, 2026.
• Early-stage clinical and regulatory risk — CLD-401, CLD-501 and CLD-502 remain preclinical, and the company expects CLD-401 to enter the clinic only in Q1 2027, subject to FDA and trial execution risk.
• Stock listing and dilution risk — The company identifies maintaining its NYSE American listing as a risk, and it completed a 1-for-16 reverse stock split in July 2026 while noting that issuing a substantial number of shares in a financing could adversely affect its stock price.

Outlook

Management says it anticipates CLD-401 entering the clinic during the first quarter of 2027, based on positive pre-IND Type B feedback in which the FDA and Calidi agreed on key CMC and non-clinical aspects and the overall first-in-human study design. The company plans to continue advancing its in situ T-cell engager programs (CLD-501 and CLD-502) and to maintain tight expense management to preserve capital for pipeline advancement. It also continues to rely on partner City of Hope to run and fund the NeuroNova Phase 1 trial.