PDS Biotechnology Corporation has amended the protocol for its Phase 3 VERSATILE‑003 trial, adding progression‑free survival (PFS) as an interim primary endpoint while retaining overall survival (OS) as the primary endpoint for full regulatory approval.
The amendment was reviewed by the FDA during its standard 30‑day review period and no objections were raised, allowing the company to pursue an accelerated approval pathway based on the new interim endpoint.
Frank Bedu‑Addo, PDS’s president and CEO, said the addition of PFS “provides a potential pathway to shorten the duration of VERSATILE‑003 and accelerate the timeline to regulatory submission, as well as making the trial more cost efficient.” He added that “survival and safety will continue to anchor full approval, and we remain confident in the path we've outlined and in our commitment to advancing a promising targeted immunotherapy for the rapidly growing population of patients with HPV16‑positive recurrent and/or metastatic head and neck cancer.”
PDS’s financial position underscores the urgency of the accelerated pathway. The company reported a negative free cash flow of $32 million and a cash balance of $26.2 million as of Q3 2025, with a current ratio of 2.09. The cash burn highlights the need for a timely regulatory outcome to support future development and potential commercialization.
Analysts have issued a “Strong Buy” consensus with an average price target of $9.00, but some have cautioned that the company’s weak financial performance and high cash burn may temper enthusiasm. The stock trades near its 52‑week low of $0.66, down 54% over the past year, and a market capitalization of $36 million. Technical indicators as of February 18, 2026 suggest a downward trend, indicating that investors are weighing the potential upside of accelerated approval against the company’s financial headwinds.
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