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Calidi Biotherapeutics develops targeted genetic medicines for cancer using systemically delivered virotherapy. Its RedTail platform is designed to selectively target tumors, remodel the tumor microenvironment, and express therapeutic genetic payloads at tumor sites while limiting peripheral exposure.
Recurring CLDI news covers RedTail research presentations, CLD-401 oncology data, IL-15 superagonist payload work, in situ T-cell engager approaches, regulatory preparation, manufacturing and clinical-development partnerships, financing activity, and periodic financial results. Company updates also address pipeline expansion, including RedTail-based programs such as CLD-501 for TROP2-targeted T-cell engagement in solid tumors.
Calidi Biotherapeutics (NYSE American: CLDI) will present new data at AACR April 17–22, 2026 on its RedTail systemically delivered virotherapy platform. Data highlight in situ expression of IL-15 SA and functional T-cell engagers, and a lead TROP2-targeting candidate. The company expects to file an IND for CLD-401 by end of 2026.
Presentations describe confined tumor expression to limit peripheral exposure and address historical challenges of T-cell engagers in solid tumors.
Calidi Biotherapeutics (NYSE: CLDI) reported Q4 and full-year 2025 results and operational updates on March 27, 2026. Key items: partnerships with Avance Clinical and Matica Bio to accelerate CLD-401 clinical start and GMP manufacturing, Type D FDA feedback supporting its approach, AACR-IO data on in situ T-cell engagers, and $6.5 million raised via public offering and ATM sales.
Full-year 2025 net loss was $25.6 million; cash was $5.6 million at year-end. The company expects to file an IND for CLD-401 by end of 2026.
Calidi Biotherapeutics (NYSE: CLDI) announced a partnership with Avance Clinical to expedite Australian regulatory approval and rapidly initiate a first-in-human Phase I trial of CLD-401. The company said it will pursue an IND filing with the FDA in 2026 while conducting IND-enabling studies.
CLD-401 is a tumor-replicating vaccinia engineered to express an IL-15 superagonist, intended as systemic monotherapy for patients with refractory solid tumors.
Calidi Biotherapeutics (NYSE American: CLDI) presented its proprietary, in‑house manufacturing process for CLD-401 at the 9th Annual Bioprocessing Summit in Barcelona on March 12, 2026. The process aims to enable scalable, high‑yield production while preserving the CD55 over‑expressing envelope of the RedTail virus to permit systemic delivery.
Calidi said it has engaged the FDA via a Type D meeting; the agency's feedback supports using this manufacturing and analytical approach for CLD-401’s clinical development. The company expects to submit an IND for CLD-401 by the end of 2026 and is advancing IND‑enabling studies and strategic partnerships.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI) closed an underwritten public offering and the underwriters’ full over-allotment, raising approximately $6.0 million gross proceeds before commissions and expenses.
The company sold 12,094,631 shares (or pre-funded warrants) and issued Series J, K and L warrants exercisable at $0.50 per share with varying terms (5 years, 1 year, 6 months). Warrants include two-step exercise-price reset provisions.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI) priced an underwritten public offering of 10,519,631 units at $0.50 per unit, expected to raise approximately $5.2 million gross before fees. Each unit includes common stock (or a pre-funded warrant) and three warrants (6‑month, 12‑month, 5‑year).
The company granted a 45‑day overallotment option for up to an additional 1,575,000 shares/warrants per series (aggregate up to 4,725,000 shares). Certain existing warrants for 2,973,585 shares will be amended to a reduced exercise price of $0.50 upon closing. Closing expected on or about March 9, 2026.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI) announced a proposed underwritten public offering of units consisting of common stock and, for certain buyers, pre-funded warrants, with accompanying common warrants. The securities comprising the units will separate immediately upon issuance.
The company expects to grant underwriters a 45-day option to purchase up to an additional 15% of the offering. Proceeds are intended for working capital and general corporate purposes. The offering is subject to market and other conditions and may not be completed.
Calidi Biotherapeutics (NYSE American: CLDI) presented preclinical data at the 2026 AACR Immuno-Oncology conference on its systemically delivered RedTail virotherapy platform. Data show RedTail can express a tumor-localized BiTE and high levels of IL-15 superagonist within the tumor microenvironment, potentially enabling T-cell activation in solid tumors. Calidi is conducting IND-enabling studies for CLD-401 and plans to submit an IND by the end of 2026 while pursuing strategic partnerships.
Calidi Biotherapeutics (NYSE American: CLDI) will present a late‑breaking abstract at the AACR Immuno‑Oncology (AACR‑IO) conference in Los Angeles, Feb 18–21, 2026, on its RedTail virotherapy platform and a novel approach to tumor‑localized BiTEs.
Calidi will discuss preclinical data for lead candidate CLD‑401, which expresses an IL‑15 superagonist in the tumor microenvironment, and reports IND‑enabling studies with an expected IND submission by end of 2026. The company is pursuing strategic partnerships to accelerate clinical development.
Calidi Biotherapeutics (NYSE: CLDI) recapped 2025 progress and outlined 2026 value drivers, focusing on its RedTail platform and lead candidate CLD-401. The company plans an IND filing in Q4 2026 for CLD-401 and expects preclinical proof-of-concept data for tumor-localized IL-15 delivery, BiTE co-delivery, and non-oncology payloads.
2025 highlights include ASCO and SITC preclinical presentations, CEO and CMO appointments, advisory board additions, and reductions in term debt and G&A expenses.