- Trial Phase
- Preclinical
- Time to Market
- Unknown; CLD-501 is preclinical with no IND filed. Even under an accelerated timeline, clinical trials typically take 5-10+ years from this stage. The company's financial constraints (going concern warning, ~$4M cash) make advancement highly uncertain.
- Why 2/10
- CLD-501 is a preclinical secondary program with no hard dated catalyst (PDUFA, pivotal readout, or IND filing) scheduled in the next ~12 months. The ASCO 2026 abstracts have already been published. The company's near-term focus is on lead candidate CLD-401, not CLD-501. With a ~$4M market cap, going-concern warning, and limited cash, CLD-501 is unlikely to drive a meaningful share-price move in the foreseeable future.
CLD-501 has no hard dated catalyst in the next 12 months; the next meaningful event for the company is CLD-401's IND submission (targeted by end of 2026) and first-in-human study (Q1 2027). For CLD-501 specifically, investors should watch for any pipeline prioritization updates and whether the company can secure financing to survive long enough to advance preclinical programs into the clinic.
Price Chart
Executive Summary
CLD-501 is a preclinical-stage systemic oncolytic virotherapy from Calidi Biotherapeutics (CLDI), part of the company's RedTail platform that delivers a T-cell engager payload directly into tumors. It is a secondary program behind the lead candidate CLD-401 (IL-15 superagonist), which itself is still in IND-enabling studies. Two preclinical abstracts on the RedTail platform (including CLD-501) were accepted for the 2026 ASCO Annual Meeting, but no human clinical data exist. Calidi has a ~$4M market cap, only $4.1M cash, a going-concern warning, and no approved products — making CLD-501 a very early, high-risk, long-duration option with no near-term catalyst.
How It Works
CLD-501 is a genetically modified virus (oncolytic virotherapy) designed to be injected into the bloodstream, travel to tumors, and selectively infect cancer cells. Once inside the tumor, it produces a T-cell engager — a protein that acts like a bridge, grabbing immune cells (T-cells) and pulling them directly to cancer cells so the immune system can kill them. This is part of Calidi's RedTail platform, which uses a virus as a delivery vehicle to produce therapeutic proteins inside tumors.
Trial Status
CLD-501 is in preclinical development as part of Calidi's RedTail platform. Two preclinical abstracts on the platform (covering CLD-401 and CLD-501) were accepted for online publication at the 2026 ASCO Annual Meeting (May 29 – June 2, 2026). No IND has been filed, and no human trials have been initiated. The company's lead candidate CLD-401 is in IND-enabling studies with a target IND submission by end of 2026 and first-in-human dosing in Q1 2027; CLD-501 is further behind.
The Two-Sided Case
Upcoming Catalysts
- No hard dated catalyst for CLD-501 in the next ~12 months
- CLD-401 IND submission targeted by end of 2026 (lead program, not CLD-501)
- CLD-401 first-in-human study targeted Q1 2027 (lead program, not CLD-501)
- H.C. Wainwright 28th Annual Global Investment Conference (Sept 14-16, 2026) — potential pipeline update
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Calidi Biotherapeutics, Inc. 8-K CLDI ·Originating report