By Josh Beckerman
PDS Biotechnology shares declined after it issued an update about a cancer study with a combination of Versamune HPV and pembrolizumab and reported quarterly results.
The stock was down 18%, to $2.25, Thursday and is down about 55% this year.
The company said it made minor modifications to the VERSATILE-003 Phase 3 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion. PDS Biotechnology is evaluating Versamune HPV and pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell cancer.
The company said, since its last update in August, it has been actively engaged with investors and clinicians to discuss its strategy and funding requirements for the trial.
PDS Biotechnology submitted an updated Investigational New Drug application to the Food and Drug Administration this week. It expects the FDA clearance decision by mid-December, allowing it to initiate site activation in the first quarter of 2025.
The company's net loss narrowed to 29 cents a share from 35 cents as operating expenses were lower.
Cash and cash equivalents as of Sept. 30 totaled about $49.8 million.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
November 14, 2024 14:07 ET (19:07 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
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