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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) reported positive pre-IND feedback from the US FDA for its oncolytic virus candidate CLD-401, providing alignment on IND-enabling preclinical plans and first-in-human trial design.
According to Calidi, IND submission is targeted by end of 2026, with Phase 1 initiation in early 2027 and potential parallel regulatory filing in Australia.
Calidi Biotherapeutics (NYSE American: CLDI) will host an investor webinar on June 9, 2026, at 1:15pm PT. CEO Eric Poma will review the RedTail targeted virotherapy platform, lead candidate CLD-401, recent preclinical data, 2026 IND plans, upcoming development milestones, and key shareholder catalysts.
Calidi Biotherapeutics (NYSE American: CLDI) announced that two abstracts featuring its RedTail systemic virotherapy platform were accepted for online publication at the 2026 ASCO Annual Meeting.
Preclinical data cover lead programs CLD-401 and CLD-501, with an IND filing for CLD-401 expected by end of 2026.
Calidi Biotherapeutics (NYSE American: CLDI) announced that its audited 2025 Financial Statements in the Form 10-K include an audit report containing an explanatory paragraph stating the statements were prepared assuming the company will continue as a going concern. This disclosure is required under NYSE American Section 610(b) and involves no changes to Calidi’s 2025 filings.
Calidi Biotherapeutics (NYSE American: CLDI) reported first quarter 2026 results and R&D updates. Net loss attributable to common stockholders was $4.4 million, or $0.43 per share, versus $5.0 million, or $2.21, a year earlier. Cash and restricted cash totaled $6.8 million at March 31, 2026.
General and administrative expenses fell to $1.6 million from $2.6 million, while research and development expenses rose to $2.6 million from $2.4 million. The company highlighted new CLD-401 and RedTail platform data, a CLD-401 IND target by year-end 2026, and a partnership with TransferAI.
Calidi Biotherapeutics (NYSE American: CLDI) announced that Chief Scientific Officer Dr. Antonio F. Santidrian will present at the ASGCT conference in Boston. He will discuss the company’s RedTail systemic virotherapy platform and new preclinical data for lead programs CLD-401 and CLD-501.
Calidi Biotherapeutics (NYSE American: CLDI) announced a collaboration with TransferAI to use the Sofie agentic AI platform to support and streamline the IND submission for CLD-401. IND-enabling studies are underway and Calidi expects an IND filing by year end. CLD-401 is engineered to express an IL-15 superagonist to activate CD8, gamma delta T-cells, and NK cells.
Calidi will combine TransferAI’s AI orchestration with its clinical, regulatory, and manufacturing teams and is expanding its RedTail platform while pursuing strategic partnerships.
Calidi Biotherapeutics (NYSE:CLDI) presented preclinical data for lead candidate CLD-401 at AACR on April 21, 2026, showing tumor-restricted expression of an IL-15 superagonist and robust immune recruitment in immunocompetent animal models. The Company said it expects to file an IND for CLD-401 by end of 2026 and pursue clinical entry thereafter.
Calidi highlighted the RedTail platform's ability to deliver high intratumoral payloads with low systemic exposure and noted parallel data for CLD-501; strategic partnerships are being pursued to accelerate development.
Calidi Biotherapeutics (NYSE American: CLDI) presented preclinical data at AACR on April 19, 2026, showing its RedTail virotherapy can co-express high levels of an IL-15 superagonist and functional in situ T-cell engagers in the tumor microenvironment. The company named CLD-401 as its lead and expects to file an IND for CLD-401 by end of 2026. Calidi is also developing CLD-501 targeting TROP2 and exploring EGFR, EpCAM, and Nectin-4 targets.
Calidi Biotherapeutics (NYSE American: CLDI) will present data at the Internation Oncolytic Virus Conference in Reykjavík on April 28, 2026 highlighting its RedTail platform and lead candidate CLD-401. The presentation will describe systemic delivery, tumor-selective replication, immune-evasion features, and high local expression of therapeutic payloads in preclinical models.
The company expects to file an IND for CLD-401 by the end of 2026 and is developing CLD-501 to express a TROP2-targeting TCE plus IL-15SA in the tumor microenvironment while pursuing strategic partnerships.