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PRINCETON, N.J. - PDS Biotechnology Corporation (NASDAQ:PDSB), a late-stage immunotherapy company with a current market capitalization of $59.85 million, announced today that it is set to initiate its VERSATILE-003 Phase 3 clinical trial following FDA clearance of the amended trial design. The trial will evaluate Versamune® HPV in combination with pembrolizumab as a first-line treatment for recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC). According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 2.84, indicating robust short-term financial stability.
The updated clinical protocol was submitted on November 15, 2024, and the FDA’s window for comments has closed, allowing the company to proceed with site activation expected within the first quarter of 2025. The trial has been granted Fast Track designation, which is intended to expedite the review of drugs that treat serious conditions and fill an unmet medical need. While the stock has experienced significant volatility with a beta of 1.88, analysts maintain optimistic price targets ranging from $4.50 to $21.00, according to InvestingPro data.
Dr. Frank Bedu-Addo, President and CEO of PDS Biotech, expressed readiness for the trial’s initiation, emphasizing the potential for improved patient outcomes. Dr. Kirk Shepard, PDS Biotech’s Chief Medical (TASE:PMCN) Officer, highlighted the significance of the companion diagnostic test that will be used to confirm HPV16-positive status in patients, marking its first investigational use in a Phase 3 HNSCC clinical trial.
HPV16-positive patients represent a growing subgroup in need of targeted therapies, and the company aims to address this with its Versamune® HPV immunotherapy. The treatment has been developed to stimulate T-cells in combination with pembrolizumab, an immune checkpoint inhibitor, and is also being considered in a triple combination therapy including PDS01ADC, an IL-12 fused antibody drug conjugate. InvestingPro analysis reveals that while the company holds more cash than debt on its balance sheet, it’s currently experiencing rapid cash burn - a critical factor for investors monitoring clinical-stage biotech companies. For deeper insights into PDS Biotech’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
PDS Biotechnology has emphasized that the forward-looking statements in their press release are based on current beliefs and assumptions and are subject to risks and uncertainties. The company’s progress in clinical trials and future financial requirements are among the factors that could impact actual results.
This announcement is based on a press release statement from PDS Biotechnology. For more detailed information on the VERSATILE-003 trial, interested parties can refer to ClinicalTrials.gov with the identifier NCT06790966.
In other recent news, PDS Biotech has reported notable progress in its clinical trials for HPV-related cancers, as announced during its Third Quarter 2024 Earnings Call. The company highlighted significant advancements in the VERSATILE-003 Phase 3 trial for HPV16-positive head and neck cancer, set to commence in early 2025. In parallel, preliminary results from the IMMUNOCERV Phase 2 trial for cervical cancer have shown encouraging activity and safety of the Versamune HPV treatment. Despite a reported net loss of $10.7 million for the quarter, PDS Biotech maintains a robust cash reserve of $50 million, supporting its intensified research and development efforts.
The VERSATILE-003 trial, in combination with pembrolizumab, is poised for FDA protocol clearance by mid-December 2024, with site initiation projected for the first quarter of 2025. The company is also forming a strategic advisory board to assess cervical cancer product data and determine future steps. PDS Biotech plans to fund the initial phase of the VERSATILE-003 trial with existing resources, with expansion anticipated as more capital is secured.
CEO Dr. Frank Bedu-Addo confirmed the FDA’s agreement on a two-arm study for the VERSATILE-003 trial, with concurrent optimization of a third arm. Further updates on the VERSATILE-003 trial are expected as developments unfold. These recent developments underscore PDS Biotech’s commitment to advancing its HPV-related cancer trials, despite the financial challenges faced in the third quarter of 2024.
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