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SAN DIEGO - Calidi Biotherapeutics, Inc. (NYSE American:CLDI), currently trading at $0.55 per share with a market capitalization of approximately $20 million, announced Tuesday that its cancer therapy candidate CLD-201 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of soft tissue sarcoma. According to InvestingPro data, the stock has experienced significant volatility, falling 21% in the past week alone.
The designation, which aims to expedite development and review of drugs that address serious conditions with unmet medical needs, will provide Calidi with more frequent FDA interactions and potential eligibility for priority review and accelerated approval.
CLD-201, also known as SuperNova, is an allogeneic adipose stem-cell loaded oncolytic virus therapy. The FDA previously cleared the Investigational New Drug application for CLD-201 on April 17, 2025.
"FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201," said Guy Travis Clifton, Chief Medical Officer of Calidi, in a press release statement. "This designation underscores the unmet medical need in sarcoma and provides scientific and regulatory validation of CLD-201."
The company plans to initiate a Phase 1 trial as a first-in-human, open-label, multicenter study evaluating the safety, tolerability and efficacy of CLD-201 in patients with sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.
CLD-201 utilizes adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus. According to the company, this stem-cell loading approach helps protect the virus from immune clearance while allowing virus amplification within the stem cell, potentially enhancing efficacy as demonstrated in pre-clinical animal models.
Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies designed to deliver genetic medicines to disease sites.
In other recent news, Calidi Biotherapeutics has announced a significant financial development. The company has entered into a definitive agreement for the immediate exercise of certain outstanding warrants, which allows for the purchase of up to 6,595,000 shares of common stock at a reduced exercise price of $0.70. This transaction is expected to generate approximately $4.6 million in gross proceeds for Calidi Biotherapeutics, prior to deducting placement agent fees and offering expenses. Ladenburg Thalmann & Co, Inc. is acting as the exclusive placement agent for this offering. These recent developments highlight the company’s efforts to strengthen its financial position.
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