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 (CLDI) received a NYSE American notice on September 21, 2026, citing noncompliance with its stockholders’ equity listing standard.
The standard requires at least $4.0 million in stockholders’ equity for a company reporting continuing-operation or net losses in three of its four most recent fiscal years. Calidi is not currently eligible for an exemption under the cited rule. It must submit a plan by October 21, 2026 describing how it will regain compliance by March 21, 2028. If Calidi does not submit a plan or the exchange does not accept it, delisting proceedings will begin. The notice has no immediate effect on trading, but CLDI shares will carry a .BC below-compliance designation.
Calidi Biotherapeutics (CLDI) entered a definitive agreement for a registered direct offering of 1,025,640 common shares at $1.17 per share, with closing expected on or about September 18, 2026, subject to customary conditions.
The transaction is expected to generate approximately $1.2 million in gross proceeds before expenses. Calidi plans to use the net proceeds for working capital and general corporate purposes. The securities are being issued under an effective shelf registration statement on Form S-3, and the offering will be made using a prospectus and prospectus supplement to be filed with the SEC.
Calidi Biotherapeutics (CLDI) plans to participate in the H.C. Wainwright 28th Annual Global Investment Conference, held September 14–16, 2026, at the Lotte New York Palace Hotel in New York.
Chief Executive Officer Eric Poma, Ph.D., will conduct one-on-one investor meetings during the conference dates. A virtual presentation will be available on-demand starting Friday, September 11, 2026, at 7:00 AM ET for registered attendees via the conference platform. Meeting requests and conference registration are available through the event website.
Calidi Biotherapeutics (NYSE American: CLDI) reported second quarter 2026 results, highlighting FDA pre-IND alignment for lead RedTail candidate CLD-401, supporting its development strategy toward a first-in-human study with initial patient dosing targeted for Q1 2027.
The company presented new preclinical data at the 2026 ASCO meeting for CLD-501, its lead in situ T‑cell engager virotherapy, and additional CLD-401 data, demonstrating tumor-targeted delivery and immune activation. Calidi expanded its Board with industry veteran Corsee Sanders, Ph.D.
Calidi reduced Q2 2026 general and administrative expenses by $1.5 million, or 48%, year over year to $1.6 million, while research and development expenses were stable at $2.6 million. Net loss attributable to common stockholders narrowed to $4.2 million, or $2.94 per share, from $5.7 million, or $31.75 per share, in Q2 2025. As of June 30, 2026, Calidi held $4.1 million in cash and $0.2 million in restricted cash, with total assets of $7.2 million and total equity of $3.1 million.
Calidi Biotherapeutics (NYSE American: CLDI) reported that it presented new data on July 23, 2026, at the AACR Drug Discovery and Development Conference in Boston. The presentation covered cytotoxicity and IL-15 SA expression data from its CLD-401 program, which Calidi expects to enter the clinic in the first quarter of 2027, and its in situ T-cell engager (TCE) program, including a new TCE targeting the EpCam receptor.
According to Calidi, CLD-401 is the lead candidate from its RedTail platform, currently in IND-enabling studies for metastatic non-small cell lung cancer, head and neck cancer, and other tumors. The RedTail platform uses an engineered enveloped oncolytic virus designed for systemic delivery to metastatic sites.
Calidi Biotherapeutics (NYSE American: CLDI) issued a mid-year 2026 update highlighting regulatory, pipeline, governance, and cost-cutting progress around its RedTail platform and lead candidate CLD-401.
The company reported a successful pre-IND meeting with the US FDA in June 2026, stating the agency agreed with its overall pharmacology, toxicology, CMC, and phase I protocol strategy for the planned CLD-401 first-in-human trial. Calidi is targeting dosing the first patient in Q1 2027 and anticipates initial patient data in Q2 2027. CLD-401 is currently in IND-enabling studies for metastatic non-small cell lung cancer, head and neck cancer, and other tumors with high unmet need.
Calidi also advanced its RedTail-based in situ T-cell engager (TCE) programs, presenting CLD-501 proof-of-concept data and expanding targets to TROP-2 and EpCAM. The company reduced debt and G&A expenses by about $1 million in Q1 2026 versus Q1 2025 and strengthened its Board with industry veteran Corsee Sanders, Ph.D. Upcoming 2026 catalysts include multiple data presentations at AACR D3, ESMO, and SITC.
Calidi Biotherapeutics (NYSE American: CLDI) has approved a 1-for-16 reverse stock split of its outstanding common shares, with trading on a split-adjusted basis expected to begin on July 31, 2026 under the existing ticker CLDI and new CUSIP 320703 507.
The reverse split, approved by stockholders on June 12, 2026 and set at a 1-for-16 ratio by the board on July 15, 2026, will consolidate every sixteen pre-split shares into one post-split share. Fractional entitlements will be rounded up at the participant level. According to Calidi, the move is intended to optimize market dynamics, broaden investor appeal and accessibility, and align trading conditions with investor interests. The par value, authorized but unissued common shares, and authorized preferred stock will remain unchanged, and proportional adjustments will apply to equity awards, convertible securities, and share reserves under equity plans.
Calidi Biotherapeutics (NYSE American: CLDI) granted an inducement non-qualified stock option to new VP Finance, Controller, Sandra Gurrola. The option covers 100,000 shares at an exercise price of $0.15, the July 6, 2026 closing price, and vests over four years under NYSE American Section 711.
Calidi Biotherapeutics (NYSE American: CLDI) presented new data on its RedTail virotherapy platform and CLD-501, an in situ T-cell engager candidate targeting TROP2, at the T-Cell Engager Therapeutic Summit.
According to Calidi, RedTail enables localized expression of T-cell engagers and IL-15 superagonist within the tumor microenvironment, aiming to remodel solid tumors and limit off-tumor toxicity.
Calidi Biotherapeutics (NYSE American: CLDI) appointed biopharma veteran Corsee Sanders, Ph.D. as an independent member of its Board of Directors, effective June 17, 2026.
Her background includes senior clinical development and operations roles at Genentech/Roche, Juno, Celgene, and Bristol Myers Squibb, plus multiple current biotech board positions.