Precision Drilling on Track for Highest Close Since August 2024 — Data Talk

Investing.com -- PDS Biotechnology Corp (NASDAQ:PDSB) stock dropped 2.8% on Tuesday following the company’s announcement of a registered direct offering that will raise approximately $5.3 million in gross proceeds.

The late-stage immunotherapy company, which focuses on cancer treatment, disclosed that it has entered into a securities purchase agreement for 5,800,000 shares of common stock (or pre-funded warrants) at $0.91 per share. The offering also includes accompanying warrants to purchase up to an additional 5,800,000 shares with an exercise price of $1.00 per share.

The warrants will become exercisable six months after issuance and will expire five years from the initial exercise date. Craig-Hallum is serving as the exclusive placement agent for the offering, which is expected to close around November 12, 2025.

PDS Biotech plans to use the proceeds to continue its ongoing VERSATILE-003 Phase 3 clinical trial following planned discussions with the FDA regarding protocol amendments that could allow for an expedited approval pathway for its PDS0101 product. Remaining funds will support other research and development expenses and general corporate purposes.

The company reported approximately $26.2 million in cash and cash equivalents for the quarter ended September 30, 2025, according to preliminary financial data subject to final adjustments.

Additionally, PDS Biotech agreed to amend certain existing warrants issued in February 2025, reducing their exercise price from $1.50 to $1.00 per share, with the amended warrants becoming exercisable six months after the closing of the current offering.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Investing.com -- PDS Biotechnology Corp (NASDAQ:PDSB) stock surged 13.3% Wednesday after the company announced it has requested a meeting with the FDA to explore an expedited approval pathway for its cancer immunotherapy drug PDS0101.

The late-stage immunotherapy company is seeking to amend its VERSATILE-003 Phase 3 trial protocol to include progression-free survival (PFS) as an earlier primary endpoint, which could potentially allow for an accelerated approval submission. The company has temporarily paused the trial while the amendment undergoes FDA review.

PDS Biotech’s request follows final results from its VERSATILE-002 trial for HPV16-positive Head and Neck Cancer, which showed a median overall survival of nearly 40 months. According to the company, this represents the first time a trial in recurrent/metastatic Head and Neck Cancer has reported such extended survival outcomes.

"Based on the increasing incidence of HPV16-positive head and neck cancer, our goal is to seek the fastest and most cost-effective regulatory pathway to approval," said Dr. Kirk Shepard, Chief Medical Officer at PDS Biotech.

The proposed amendment would reduce the number of patients while maintaining statistical power, and add PFS as a primary endpoint alongside median overall survival. The company noted that treatment will continue for patients currently enrolled in the VERSATILE-003 trial during the temporary pause.

PDS Biotech focuses on developing immunotherapies that transform how the immune system targets and kills cancers, with particular emphasis on HPV-associated cancers.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.