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PRINCETON, N.J. - PDS Biotechnology (NASDAQ:PDSB) Corporation (NASDAQ:PDSB), a late-stage immunotherapy company, announced plans to commence the Phase 3 VERSATILE-003 clinical trial for its investigational immunotherapy, Versamune® HPV, targeting HPV16-positive head and neck squamous cell carcinoma (HNSCC). The trial is set to begin in Q4 2024 following a productive meeting with the U.S. Food and Drug Administration (FDA).
The planned trial will evaluate the efficacy of Versamune® HPV in combination with pembrolizumab, a standard-of-care immune checkpoint inhibitor. Moreover, the study is designed to include a third arm involving a triple combination therapy that also incorporates PDS01ADC, an antibody-drug conjugate.
The FDA has endorsed the development strategy for both the double and triple combination therapies. The agency requested an additional safety analysis for the PDS01ADC component, which will be conducted separately to prevent delays in the randomized trial. The Versamune® HPV and pembrolizumab combination has been granted Fast Track designation, underscoring the potential urgency and significance of this treatment option.
Dr. Frank Bedu-Addo, President and CEO of PDS Biotech, expressed appreciation for the FDA's support and highlighted the promising results from the VERSATILE-002 study, which have informed the updated statistical endpoints for the VERSATILE-003 trial.
Dr. Kirk Shepard, Chief Medical Officer, noted the support from key opinion leaders and the strong interest from target sites in participating in the upcoming trial, which aims to improve treatment outcomes for patients with HPV16-positive HNSCC.
The company's press release also provided information about the conference call held today to discuss the trial details. PDS Biotechnology specializes in developing therapies that harness the immune system to target and kill cancers and to create vaccines for infectious diseases.
This announcement is based on the press release statement from PDS Biotechnology Corporation.
In other recent news, PDS Biotechnology reported steady survival rates in its ongoing VERSATILE-002 Phase 2 clinical trial for the treatment of HPV16-positive head and neck squamous cell cancer. The company also announced a strategic shift towards a development strategy emphasizing a triplet regimen combining its tumor-activated IL-12 ADC with PDS0101 or Versamune HPV and Keytruda.
In relation to this, B.Riley adjusted the share target for PDS Biotechnology from $11 to $9, while maintaining a buy rating.
In addition, PDS Biotechnology appointed Stephan Toutain as its new Chief Operating Officer, bringing in his extensive experience in the pharmaceutical industry. These developments are part of recent events that underscore PDS Biotechnology's commitment to its clinical strategy and financial management.
The company also reported a net loss of $42.9 million for the year-end 2023, but confirmed a cash balance sufficient to fund operations until Q4 2025. PDS Biotechnology is preparing to initiate a pivotal clinical trial in 2024 for advanced head and neck squamous cell cancers with its lead program. These are the latest developments in the company's journey.
InvestingPro Insights
PDS Biotechnology Corporation (NASDAQ:PDSB) has shown resilience in its financial position, holding more cash than debt on its balance sheet, which could be a strategic advantage as it enters the pivotal Phase 3 VERSATILE-003 clinical trial. The liquidity is further bolstered by the fact that liquid assets exceed short-term obligations, providing the company with a buffer to manage upcoming operational expenses related to the trial.
These financial health indicators are particularly relevant as the company does not anticipate profitability this year and has not been profitable over the last twelve months. This is reflected in the InvestingPro Data, showing a negative EBITDA growth and a significant return on assets of -63.85% for the last twelve months as of Q1 2024.
While the stock has experienced volatility, as evidenced by the 17.49% return over the last month and a contrasting 37.43% decline over the past year, two analysts have revised their earnings upwards for the upcoming period, signaling potential optimism in the company's future performance. This optimism may be in part due to the FDA's support for the company's development strategy and the Fast Track designation awarded to the Versamune® HPV and pembrolizumab combination therapy.
For investors considering PDS Biotechnology as a potential addition to their portfolio, it's noteworthy that the stock price is currently standing at 51.97% of its 52-week high, with a previous close at 3.56 USD. The InvestingPro product features additional tips that might be useful for those looking to make an informed decision; currently, there are 9 additional InvestingPro Tips available for PDS Biotechnology, which can be accessed at https://www.investing.com/pro/PDSB.
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