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 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]

Core Viewpoint - PDS Biotechnology Corporation is set to host a conference call on November 13, 2025, to report its financial results for Q3 2025 and provide updates on its clinical programs [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3]. - The company has initiated a pivotal clinical trial for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers [3]. - PDS0101 (Versamune HPV), the company's lead investigational targeted immunotherapy, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC and a standard immune checkpoint inhibitor [3]. - PDS01ADC, an IL-12 fused antibody drug conjugate, is currently being evaluated in multiple phase 2 trials across various cancer indications [3]. Conference Call Details - The conference call is scheduled for November 13, 2025, at 8:00 a.m. Eastern Time [2]. - Dial-in numbers are provided for both domestic and international participants [2]. - The event will be archived on the company's website for six months following the live webcast [2]. Contact Information - Investor contact is Mike Moyer from LifeSci Advisors, reachable at +1 (617) 308-4306 [7]. - Media contact is David Schull from Russo Partners, reachable at +1 (858) 717-2310 [7].

Core Insights - PDS Biotechnology Corporation announced that its combination therapy of PDS0101 (Versamune HPV) and Keytruda (pembrolizumab) achieved a median overall survival (mOS) of 29.5 months in patients with low PD-L1 expression (CPS 1-19), significantly outperforming Keytruda alone (10.8 months) and Keytruda plus chemotherapy (12.3 months) [1][7] Group 1: Clinical Trial Results - The VERSATILE-002 Phase 2 clinical trial evaluated the efficacy of PDS0101 in combination with Keytruda for patients with HPV16-positive recurrent and/or metastatic head and neck squamous cell cancer [1][4] - Approximately 60% of the patients enrolled in the trial had low PD-L1 expression, indicating a challenging subset of the overall patient population [3] - The full study population reported an mOS of 39.3 months, with detailed data expected to be published later this year [3] Group 2: Expert Commentary - Prof. Kevin Harrington highlighted the significance of the results, noting the potential for a well-tolerated treatment option without chemotherapy for patients [2] - Dr. Kirk Shepard emphasized that the findings suggest PDS0101 may enhance survival outcomes for patients who typically have limited treatment options and poor prognosis [3] Group 3: Company Overview - PDS Biotechnology is focused on developing immunotherapy treatments that enhance the immune system's ability to target and kill cancer cells, with a pivotal clinical trial underway for advanced HPV16-positive head and neck squamous cell cancers [5] - The company is also exploring a triple combination therapy involving PDS01ADC, an IL-12 fused antibody drug conjugate, alongside standard immune checkpoint inhibitors [5]

Core Insights - PDS Biotechnology Corporation is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3] - The company will participate in the 27th Annual H.C. Wainwright Global Investment Conference from September 8-10, 2025, in New York and virtually, with key executives available for one-on-one meetings with investors [1][2] Company Overview - PDS Biotechnology is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [3] - The lead investigational targeted immunotherapy, PDS0101 (Versamune HPV), is being developed in combination with the immune checkpoint inhibitor pembrolizumab [3] Investor Relations - Investors interested in engaging with the management team are encouraged to contact their H.C. Wainwright representative [2]

Core Insights - PDS Biotechnology Corporation announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial, showing a median overall survival (mOS) of 39.3 months in patients with CPS ≥ 1, significantly outperforming the best published result of 17.9 months with standard care pembrolizumab or pembrolizumab + chemotherapy [1][2][7] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to cancer, particularly through its lead investigational product PDS0101 (Versamune HPV) [5] - The company is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers, with ongoing pivotal clinical trials [5] Clinical Trial Details - The VERSATILE-002 trial is an open-label, multi-center Phase 2 study evaluating the safety and efficacy of PDS0101 in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive head and neck squamous cell cancer [4] - The trial enrolled 53 patients, with PDS0101 administered via subcutaneous injection alongside IV infusion of pembrolizumab during the first four treatment cycles [7] Survival Data and Efficacy - The mOS of 39.3 months was achieved in patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [7] - The durable patient survival is attributed to high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101, consistent across various patient demographics and clinical characteristics [7] Market Position and Future Outlook - PDS Biotech is positioned for leadership in the rapidly growing segment of HPV16-positive head and neck cancer, addressing a significant unmet medical need [3] - The combination therapy of PDS0101 and pembrolizumab is reported to be well tolerated, with no patients discontinuing due to treatment-related adverse events [3]

Core Insights - PDS Biotechnology Corporation reported a net loss of $9.4 million for Q2 2025, an increase from $8.3 million in Q2 2024, primarily due to higher net interest expenses [5][8] - The company is advancing its VERSATILE-003 Phase 3 clinical trial for PDS0101 (Versamune HPV) targeting HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma [3][11] - PDS Biotech presented three abstracts at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showcasing positive data from the VERSATILE-002 trial [10] Financial Performance - The reported net loss for Q2 2025 was $9.4 million, or $0.21 per share, compared to a loss of $8.3 million, or $0.23 per share, in Q2 2024 [5][16] - Research and development expenses decreased to $4.2 million in Q2 2025 from $4.5 million in Q2 2024, attributed to lower personnel costs [6] - General and administrative expenses also fell to $3.4 million in Q2 2025 from $4.2 million in Q2 2024, mainly due to reduced personnel costs and professional fees [7] Cash Position and Debt - As of June 30, 2025, the company's cash balance was $31.9 million, down from $41.7 million at the end of 2024 [8][15] - Long-term debt increased to $12.9 million as of June 30, 2025, compared to $9.2 million at the end of 2024 [15] Clinical Trials and Developments - The VERSATILE-003 trial is the only registrational stage trial specifically targeting HPV16-positive head and neck cancer patients [3][11] - The colorectal cancer cohort in the Phase 2 clinical trial with PDS01ADC met criteria for expansion to Stage 2 following positive Stage 1 results [10] - The company plans to publish the full data set for the VERSATILE-002 trial later this year [3]