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PRINCETON, N.J., March 24, 2026 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that the Company will host a conference call and webcast to report financial results for the quarter and year ended December 31, 2025, and will provide a clinical programs and corporate update, on Monday, March 30, 2026 at 8:00 am Eastern Time. Conference C ...

Core Viewpoint - PDS Biotechnology Corporation has amended its Phase 3 VERSATILE-003 clinical trial protocol to include progression-free survival (PFS) as an interim primary endpoint, which may facilitate an accelerated approval pathway for PDS0101 in treating HPV16-positive recurrent and/or metastatic head and neck cancer [1][2]. Group 1: Clinical Trial Details - The amendment allows for a potentially shorter duration of the VERSATILE-003 trial and aims to accelerate the timeline for regulatory submission while enhancing cost efficiency [2]. - The primary endpoint for full approval remains median overall survival (mOS), consistent with prior communications with the U.S. Food and Drug Administration (FDA) [1]. - The FDA did not object to the amended protocol during the standard 30-day wait period following the filing of the Investigational New Drug (IND) Application [1]. Group 2: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative cancer treatments, particularly targeting how the immune system can effectively kill cancer cells [3]. - The company's lead investigational product, PDS0101 (Versamune® HPV), is being developed in combination with a standard immune checkpoint inhibitor and a triple combination that includes PDS01ADC, an IL-12 fused antibody drug conjugate [3].

Core Insights - The study led by the National Cancer Institute (NCI) demonstrated a median progression-free survival (PFS) of 9.6 months for the investigational drug PDS01ADC in patients with metastatic castration-resistant prostate cancer (mCRPC) [1][2] - The combination therapy showed a median PSA decline of 40%, with 6 out of 16 patients achieving more than a 50% decline [2] - PDS Biotech aims to advance PDS01ADC as a key component of its immuno-oncology pipeline, reinforcing its potential to enhance existing therapies across various solid tumor types [3] Company Overview - PDS Biotechnology Corporation is a late-stage immunotherapy company focused on transforming immune responses to cancer [4] - The company has initiated a pivotal clinical trial for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers [4] - PDS Biotech's lead investigational therapy, PDS0101 (Versamune HPV), is being developed in combination with standard immune checkpoint inhibitors and PDS01ADC [4]

Core Viewpoint - PDS Biotechnology Corporation has received a Notice of Allowance for its lead asset PDS0101, enhancing its intellectual property estate and providing significant market protections for over 20 years due to the new patent and anticipated biologics exclusivity [1][3]. Intellectual Property and Patent Details - The new patent (U.S. Application No. 16/210,750) is titled "Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes" and will grant broad composition and method of use claims [2]. - This patent strengthens the company's existing intellectual property portfolio, which includes patents granted in major markets such as the U.S., Europe, Japan, China, Australia, Canada, Israel, Mexico, and Hong Kong [2]. Clinical Development and Market Position - PDS0101 is currently in the Phase 3 VERSATILE-003 clinical trial for HPV16-positive head and neck cancers, with a protocol amendment submitted to the FDA to change the progression-free survival endpoint to a primary endpoint for earlier evaluation [3]. - The company is well-positioned to advance its immunotherapy, with the potential for approximately twenty years of market exclusivity for PDS0101 [3]. Company Overview - PDS Biotechnology is focused on transforming cancer treatment through immunotherapy, specifically targeting HPV16-positive head and neck squamous cell cancers [4]. - The lead investigational product PDS0101 (Versamune HPV) is being developed in combination with standard-of-care immune checkpoint inhibitors and other therapies [4].

Core Viewpoint - PDS Biotechnology Corporation has submitted an amended protocol for its Phase 3 VERSATILE-003 trial, aiming for accelerated approval of its immunotherapy PDS0101 by changing the primary endpoint to progression-free survival (PFS) [1][2][3] Group 1: Clinical Trial Updates - The amendment to the VERSATILE-003 trial allows for an earlier evaluation of PFS with significant statistical power, which could support accelerated approval [1][2] - Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by the FDA [1] - The submission follows a constructive Type C meeting with the FDA in December 2025, discussing the accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer [2] Group 2: Company Insights - PDS Biotechnology is focused on transforming how the immune system targets and kills cancers, with a pivotal clinical trial for advanced HPV16-positive head and neck squamous cell cancers [4] - The lead investigational targeted immunotherapy, PDS0101 (Versamune HPV), is being developed in combination with a standard-of-care immune checkpoint inhibitor and a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate [4] - The company expresses confidence in the potential to accelerate regulatory submission based on discussions with the FDA [3]

Core Viewpoint - PDS Biotechnology Corporation has received a new patent in Japan for PDS0101, enhancing its intellectual property portfolio and providing market exclusivity for the product into the 2040s [2][4]. Group 1: Patent and Intellectual Property - The Japan Patent Office has issued Patent No. 7783866 for PDS0101, granting broad composition of matter and methods of use claims [2]. - This new patent expands previously granted patents in Japan and adds to the company's existing patents in the United States, China, Australia, and Hong Kong [2]. - The company has additional patent applications pending in several other countries, reinforcing its global intellectual property position [4][5]. Group 2: Market Context and Product Development - The incidence of HPV16-related cancers is rapidly increasing in the US and Europe, which highlights the potential market for PDS0101 [3]. - PDS0101 is currently being studied in a Phase 3 trial in combination with pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer [3][6]. - The company aims to advance broad intellectual property protections for PDS0101 and its other investigational agents in development [5].

Core Viewpoint - PDS Biotechnology (PDSB) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in a company's earnings picture, with the Zacks Consensus Estimate reflecting EPS estimates from sell-side analysts [1][2]. - There is a strong correlation between earnings estimate revisions and near-term stock price movements, influenced by institutional investors who adjust their valuations based on these estimates [4][6]. Company Performance and Outlook - The upgrade for PDS Biotechnology suggests an improvement in the company's underlying business, which could lead to an increase in stock price as investors respond positively to this trend [5][10]. - For the fiscal year ending December 2025, PDS Biotechnology is expected to earn -$0.77 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 9.4% over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of performance, particularly for Zacks Rank 1 stocks which have generated an average annual return of +25% since 1988 [7][9]. - PDS Biotechnology's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Viewpoint - PDS Biotechnology Corporation is seeking an accelerated approval pathway for its investigational treatment PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer, following positive results from the VERSATILE-002 trial [2][3] Group 1: FDA Meeting and Approval Pathway - The FDA has accepted PDS Biotechnology's request for a Type C Meeting to discuss the proposed accelerated approval pathway for PDS0101 [1] - The proposed amendment to the VERSATILE-003 Phase 3 trial aims to change the progression-free survival (PFS) endpoint to a surrogate primary endpoint, allowing for earlier evaluation with significant statistical power [2] - Median overall survival (mOS) will remain the primary endpoint for full approval as originally recommended by the FDA [2] Group 2: Clinical Trial Insights - The VERSATILE-002 trial demonstrated promising median overall survival and durable progression-free survival in patients with CPS ≥ 1 [2] - The company believes that the positive PFS data from VERSATILE-002 presents an opportunity to shorten the duration to a primary endpoint and potentially accelerate regulatory submission [3] Group 3: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to cancer [4] - The lead investigational treatment, PDS0101 (Versamune HPV), is being developed in combination with a standard-of-care immune checkpoint inhibitor and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate [4]

Group 1 - B. Riley has lowered the price target on PDS Biotechnology (PDSB) to $3 from $5 while maintaining a Buy rating on the shares [1] - The shares are considered attractively valued with near-zero enterprise value (EV) that does not reflect the impact of the recent strategic pivot on enrollment size, efficacy endpoint durations, and an enriched p16+ve population with limited competing trials [1]