Core Insights - PDS Biotechnology Corporation has completed patient recruitment for Stage 1 of a clinical trial for its PDS01ADC therapeutic in combination with floxuridine for metastatic colorectal cancer, leading to an expansion into Stage 2 of the study [1][2] Group 1: Clinical Trial Details - The trial is an open-label, single-center, non-randomized Phase 2 study with three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer [2] - The colorectal cancer cohort achieved the milestone of at least 6 out of 9 participants showing an objective response, allowing enrollment to continue up to 22 participants [2] - The study is conducted under a collaborative research and development agreement with the National Cancer Institute (NCI) [2] Group 2: Product Information - PDS01ADC is a fused antibody drug conjugate that targets tumor necrosis by binding to exposed DNA [3] - The investigational approach aims to minimize systemic exposure to IL-12, potentially reducing treatment-limiting toxicities [4] Group 3: Market Context - Colorectal cancer is a significant health issue, with over 930,000 deaths globally in 2020, highlighting the need for more effective treatments [4] - In the U.S., over 150,000 new cases of colorectal cancer are diagnosed annually, with 20% already metastatic at diagnosis [4]

Median overall survival data in first-line recurrent/metastatic (1L r/m) HNSCC remains durable at 30.0 months with additional follow-up of ~4.5 months beyond the initial abstract HPV16-positive is the most rapidly increasing HNSCC in the US VERSATILE-003 is the only ongoing Phase 3 clinical trial exclusively addressing 1L r/m HPV16-positive HNSCC PRINCETON, N.J., June 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy compan ...

Summary of PDS Biotechnology (PDSB) Update - May 23, 2025 Company Overview - **Company**: PDS Biotechnology (PDSB) - **Event**: Update on ASCO 2025 presentations related to Versamune HPV Key Industry Insights - **Focus Area**: Head and neck cancer, specifically HPV16 positive cases - **Current Trends**: Shift in incidence rates from predominantly HPV negative to HPV16 positive head and neck cancers - **Market Research**: A survey indicated that approximately 59% of head and neck cancers in the U.S. are HPV16 positive, aligning with expert feedback suggesting rates between 60% and 70% [10][11] Core Points and Arguments 1. **Clinical Trials**: PDS Biotech is conducting the only ongoing registrational trial (VERSAL-three) specifically targeting HPV16 positive head and neck cancer, which is a significant and growing medical problem [17][44] 2. **Prognosis**: HPV16 positive patients have a worse prognosis compared to P16 positive patients, with studies indicating that HPV16 positive patients may have survival rates similar to HPV negative patients [16][30] 3. **Survival Data**: The VERSAL-two trial reported a median overall survival (MOS) of 30 months for HPV16 positive patients, which is significantly better than the published results for other treatments [19][20] 4. **Treatment Mechanism**: Versamune HPV is designed to generate T cells that specifically target E6 and E7 proteins of HPV16, which are integrated into tumor DNA, providing a robust treatment approach for this patient population [32] 5. **Regulatory Considerations**: The FDA has requested a companion diagnostic to confirm HPV16 positive patients for enrollment in the VERSAL-three trial, emphasizing the need for accurate patient identification [23][32] Additional Important Insights - **Confusion in Terminology**: There is ongoing confusion between P16 positive and HPV16 positive classifications, which complicates treatment discussions and patient management [52][54] - **Competitive Landscape**: Other ongoing trials have shown better responses in HPV negative patients compared to HPV positive patients, highlighting the challenges in treating HPV16 positive cases [54] - **Recruitment Strategy**: The specificity of the HPV16 positive population has aided in the recruitment of clinical sites for the VERSAL-three trial, with oncologists expressing a preference for enrolling HPV16 positive patients in this study [41][48] Conclusion - PDS Biotech is positioned to address a significant unmet need in the treatment of HPV16 positive head and neck cancer through its innovative immunotherapy approach, with promising clinical data supporting its efficacy and ongoing trials aimed at improving patient outcomes [57][58]

Core Insights - PDS Biotechnology Corporation is advancing its lead immunotherapy program, Versamune HPV, in combination with pembrolizumab for the treatment of recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) [2][8] Group 1: Clinical Trial Results - In Phase 2 trials, the median overall survival (mOS) for patients with a Combined Positive Score (CPS) ≥20 is reported at 39.3 months, while for CPS ≥1, it is 30.0 months [1][6] - The ongoing Phase 3 trial (VERSATILE-003) is currently enrolling patients, with a total of 351 patients expected to be accrued [5][6] - The VERSATILE-002 trial shows promising results, with a median follow-up of 18.4 months, indicating one of the longest follow-up periods for this patient population [6] Group 2: Presentation and Publication - Three abstracts summarizing Versamune HPV studies will be presented at the 2025 ASCO Annual Meeting, scheduled for May 30-June 3, 2025 [2][4] - The VERSATILE-002 trial results will be presented by Dr. Jared Weiss, while Dr. Katharine Price will present the ongoing VERSATILE-003 trial details [6] Group 3: Company Overview - PDS Biotechnology is focused on transforming cancer treatment through immunotherapy, particularly targeting HPV16-positive cancers [8] - The company is also developing a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, alongside standard immune checkpoint inhibitors [8]

Summary of PDS Biotechnology (PDSB) FY Conference Call Company Overview - **Company**: PDS Biotechnology (PDSB) - **Focus**: Developing targeted immunotherapies for cancer, specifically their lead product, Versamune HPV, which is in a Phase III clinical trial for recurrent or metastatic HPV16 positive head and neck cancers [1][5][29] Industry Context - **Market Opportunity**: The market for HPV16 positive head and neck cancers is estimated to be between $4 billion to $5 billion in the United States and Europe [7] - **Epidemic Status**: Head and neck cancer is described as a "silent epidemic," with projections indicating a 30% annual increase in incidence by 2030 [5][6] Core Product Insights - **Versamune HPV**: - Targeting HPV16 positive cancers, which are expected to dominate head and neck cancer cases by the 2030s [6] - Fast track designation granted by the FDA based on Phase II trial data [7] Clinical Trial Data - **Phase II VERSATILE 002 Trial**: - Median overall survival of 30 months compared to 12-13 months for standard therapies [14][15] - 100% elimination of circulating tumor HPV16 DNA in patients treated with Versamune HPV plus standard care, versus 50% reduction in those receiving only standard care [11] - 92% two-year recurrence-free survival for patients with no detectable circulating tumor DNA [11] - **Phase III VERSATILE 003 Trial**: - Designed to have median overall survival as the primary endpoint, with a two-to-one randomization [17][18] - Anticipated interim data readouts to facilitate early discussions with the FDA [18] Competitive Advantages - **Immunotherapy vs. Traditional Treatments**: - Current treatments like chemotherapy and EGFR inhibitors have limited effectiveness in long-term survival [9] - Versamune HPV aims to train the immune system to target specific cancer markers, potentially improving outcomes [10][12][13] Future Developments - **Upcoming ASCO Presentation**: Three abstracts accepted, including updates on VERSATILE 002 and details on the VERSATILE 003 trial [20][21] - **Market Potential**: Beyond head and neck cancers, Versamune HPV may also target other HPV16 positive cancers, potentially leading to a market opportunity exceeding $10 billion [29] Additional Notes - **Collaboration with National Cancer Institute**: Ongoing work on the MAC1 program, focusing on MUC1 sequences for various cancers [25][27] - **Regulatory Updates**: IND approval for new trials is pending, with timelines still to be determined [28] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic focus, clinical advancements, and market potential.

Core Viewpoint - PDS Biotechnology Corporation is participating in the A.G.P. Virtual Annual Healthcare Company Showcase, highlighting its focus on immunotherapy for cancer treatment [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company dedicated to transforming the immune system's ability to target and eliminate cancers [3]. - The company has initiated a pivotal clinical trial for its lead program, which targets advanced HPV16-positive head and neck squamous cell cancers [3]. - The lead investigational therapy, Versamune HPV, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC, an IL-12 fused antibody drug conjugate [3]. Event Details - The A.G.P. Virtual Annual Healthcare Company Showcase is scheduled for May 21, 2025, with a fireside chat featuring the CEO of PDS Biotech from 5:20 to 5:40 p.m. ET [2]. - An archived replay and transcript of the fireside chat will be available on the company's Investor Relations website following the event [2].

PDS Biotechnology (PDSB) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Mike Moyer - Managing DirectorFrank Bedu-Addo - Chief Executive OfficerLars Boesgaard - Chief Financial OfficerMayank Mamtani - Senior Managing Director & Group Head of HealthcareKirk Shepard - Chief Medical Officer Conference Call Participants Joseph Pantginis - MD & Senior Healthcare AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst Operator Greetings, and wel ...

PDS Biotechnology (PDSB) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Speaker0 Greetings, and welcome to the PBS Biotech First Quarter and twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, LifeSci Advisors. Thank you, sir. You may begin. Speaker1 Thank you, operator. Good mor ...

VERSATILE-003 Phase 3 Site Initiations Underway Multiple Abstracts Selected for Presentation at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., May 14, 2025 (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 provided a clinical and corporate update and report ...

Core Insights - PDS Biotechnology Corporation has initiated the VERSATILE-003 Phase 3 clinical trial for its investigational therapy Versamune® HPV targeting recurrent/metastatic HPV16-positive head and neck squamous carcinoma [4][9] - The company reported a net loss of approximately $8.5 million for Q1 2025, a decrease from $10.6 million in Q1 2024, attributed to lower operating expenses and increased tax benefits [6][7] - PDS Biotech's cash balance as of March 31, 2025, was $40 million, down from $41.7 million at the end of 2024 [8][15] Clinical Updates - The VERSATILE-003 trial is designed to include around 350 patients and is a two-arm controlled trial with a 2:1 randomization [6][4] - The primary endpoint of the trial is median overall survival, with interim readouts included in the study design [6][4] - The FDA has granted Fast Track designation for the combination of Versamune® HPV and pembrolizumab in treating recurrent/metastatic HNSCC [6][4] Financial Performance - Research and development expenses for Q1 2025 were $5.8 million, down from $6.7 million in Q1 2024, primarily due to reduced clinical trial expenses [7][6] - General and administrative expenses were slightly lower at $3.3 million for Q1 2025 compared to $3.4 million in Q1 2024 [7][6] - Total operating expenses decreased to $9.1 million in Q1 2025 from approximately $10.1 million in Q1 2024 [8][6] Corporate Developments - Three abstracts on Versamune® HPV were selected for presentation at the 2025 ASCO Annual Meeting scheduled for May 30-June 3, 2025 [6][4] - The company has entered into securities purchase agreements for the sale of 7,330,121 shares of common stock, raising approximately $11 million upon closing [6][4]