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) 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.
Calidi Biotherapeutics (NYSE American: CLDI) will present new preclinical data from its RedTail systemically delivered virotherapy platform at ASGCT on May 14, 2026 in Boston. Data will show targeted tumor delivery, immune-evasion EEV design, and high intratumoral expression of therapeutic payloads. The lead candidate, CLD-401, expresses IL-15 superagonist in the tumor microenvironment and an IND filing is expected by end of 2026. Calidi is also advancing in situ T-cell engager expression and pursuing strategic partnerships to accelerate clinical development.
Calidi Biotherapeutics (NYSE American: CLDI) will present new preclinical data on its lead candidate CLD-401 at the American Association for Cancer Research (AACR) annual meeting, April 17-22, 2026 in San Diego.
The data will describe tumor-restricted expression of an IL-15 superagonist (IL-15 SA) by CLD-401 and resulting immune changes in the tumor microenvironment; Calidi expects to file an IND for CLD-401 by the end of 2026.
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.