PDS Biotechnology Corp
NASDAQ:PDSB
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PDS Biotechnology Corp
NASDAQ:PDSB
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PDS Biotechnology Corp
PDS Biotechnology Corp. engages in the development of clinical-stage immunotherapies to treat various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. The company is headquartered in Florham Park, New Jersey and currently employs 22 full-time employees. The company went IPO on 2015-10-01. The firm is engaged in the developing a pipeline of molecularly targeted immunotherapies. The firm owns the T-cell activating platforms designed to train the immune system to attack and destroy disease; Versamune, for treatments in oncology and Infectimune, for treatments in infectious disease. Infectimune is also designed to promote the induction of disease-specific neutralizing antibodies. Its immuno-oncology product candidates are of potential interest for use as a component of combination product candidates to provide treatments across a range of advanced and/or refractory cancers. The company develops targeted product candidates to treat several cancers, including Human Papillomavirus (HPV) associated cancers, melanoma, colorectal, lung, breast and prostate cancers. Its infectious disease candidates are of potential interest as vaccines to prevent COVID-19 and universal influenza.
PDS Biotechnology Corp. engages in the development of clinical-stage immunotherapies to treat various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. The company is headquartered in Florham Park, New Jersey and currently employs 22 full-time employees. The company went IPO on 2015-10-01. The firm is engaged in the developing a pipeline of molecularly targeted immunotherapies. The firm owns the T-cell activating platforms designed to train the immune system to attack and destroy disease; Versamune, for treatments in oncology and Infectimune, for treatments in infectious disease. Infectimune is also designed to promote the induction of disease-specific neutralizing antibodies. Its immuno-oncology product candidates are of potential interest for use as a component of combination product candidates to provide treatments across a range of advanced and/or refractory cancers. The company develops targeted product candidates to treat several cancers, including Human Papillomavirus (HPV) associated cancers, melanoma, colorectal, lung, breast and prostate cancers. Its infectious disease candidates are of potential interest as vaccines to prevent COVID-19 and universal influenza.
Protocol change: PDS Biotech said FDA raised no objections to its amended VERSATILE-003 design, which shifts progression-free survival to an earlier interim primary endpoint and is intended to shorten the trial and speed a potential regulatory filing.
Clinical momentum: Management highlighted final VERSATILE-002 data showing median overall survival of 39.3 months in patients with PD-L1 CPS of at least 1, which they said supports the new Phase III approach.
Pipeline update: Early data from the NCI-led PDS01ADC prostate cancer study showed a median PFS of 9.6 months and a median PSA decline of 40%, reinforcing confidence in the broader immuno-oncology pipeline.
Financials: Full-year 2025 net loss narrowed to $34.5 million from $37.6 million, helped by lower operating expenses, while cash ended the year at $26.7 million.
IP expansion: The company said new U.S. and Japan patents, plus expected biologics exclusivity, extend PDS0101 protection into the 2040s.
Enrollment outlook: Management said the revised VERSATILE-003 trial should be smaller and faster, with brisk site reactivation and improved recruitment now that there is less competition in the space.
