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]

Summary of PDS Biotechnology (PDSB) Update / Briefing June 17, 2025 Company and Industry Overview - **Company**: PDS Biotechnology (PDSB) - **Industry**: Oncology, specifically focusing on HPV16 positive recurrent metastatic head and neck squamous cell carcinoma Key Points and Arguments 1. **Clinical Trials and Data Presentation**: - PDSB presented data from the VERSATILE-two trial at the ASCO annual meeting, showing a median overall survival of **30 months** for patients treated with Versamune HPV plus pembrolizumab [3][4][39] - The ongoing VERSATILE-three trial is evaluating the combination of Versamune HPV plus pembrolizumab against pembrolizumab alone in a pivotal Phase III study [4][42] 2. **Unmet Medical Need**: - The incidence of HPV positive head and neck cancers, particularly HPV16, is rising and is projected to remain high for decades, indicating a significant unmet medical need [9][19] - HPV16 positive cancers may have worse prognoses compared to other HPV types, necessitating targeted therapies [15][19] 3. **Patient Demographics and Treatment Response**: - The patient population affected by HPV related head and neck cancer tends to be younger and has fewer comorbidities compared to those with HPV negative cancers [24][25] - The VERSATILE-two trial showed a **35.8% overall response rate** and a **77.4% disease control rate** among participants [39] 4. **Safety and Tolerability**: - The combination therapy was well tolerated, with most adverse events being grade one or two, and no deaths reported during the study [35][39] 5. **Future Directions**: - The VERSATILE-three trial aims to establish the efficacy of the combination therapy as a first-line treatment for HPV16 positive recurrent metastatic head and neck cancer [42] - A companion diagnostic tool is being developed to identify HPV16 positive patients, which will enhance treatment selection [44][65] Additional Important Insights 1. **Vaccination and Public Awareness**: - There is a need for increased public health efforts to promote HPV vaccination, especially among boys, to combat the rising incidence of HPV related cancers [72][74] - Disparities in vaccination rates, particularly in rural areas, contribute to the growing incidence of HPV related head and neck cancers [73] 2. **Competitive Landscape**: - The VERSATILE-three trial is positioned uniquely as it focuses on HPV16 positive patients, while many other ongoing studies primarily target HPV negative populations [51][52] 3. **Mechanistic Insights**: - The combination of Versamune HPV and pembrolizumab is expected to enhance immune response by generating new activated T cells, potentially improving outcomes in patients with low CPS scores [54][56] 4. **Long-term Outlook**: - The overall survival rates for patients in the VERSATILE-two trial are promising, with nearly **40% of patients alive after three years**, indicating the potential for durable responses and long-term management of the disease [38][39] This summary encapsulates the critical insights from the PDS Biotechnology briefing, highlighting the company's focus on addressing the unmet needs in HPV16 positive head and neck cancer through innovative clinical trials and therapies.

Core Viewpoint - PDS Biotechnology Corporation is hosting a virtual event to discuss the evolving treatment landscape for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) in light of the Merck KEYNOTE-689 study and the rising incidence of HPV16-positive HNSCC in the US and Europe [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative treatments that enhance the immune system's ability to target and eliminate cancers [7]. - The company's lead investigational therapy, Versamune® HPV, is currently in a Phase 3 clinical trial in combination with pembrolizumab for first-line treatment of recurrent/metastatic HPV16-positive HNSCC [2][7]. Event Details - The event will feature key opinion leaders, including Kevin Harrington and Katharine A. Price, who will discuss the unmet needs in treating HPV16-positive HNSCC and the distinct characteristics of HPV-positive versus HPV-negative HNSCC [1][2][3]. - A live Q&A session will follow the formal presentations, allowing for direct engagement with the experts [3]. Clinical Trials and Research - Versamune® HPV is being evaluated in multiple clinical trials, including a Phase 3 trial in combination with pembrolizumab and Phase 2 trials for various HPV16-positive cancers [2]. - The event will also address the emerging treatment landscape for first-line recurrent/metastatic HNSCC and the differentiation between HPV-positive and HPV-negative cases [2]. Speakers' Expertise - Kevin Harrington is a leading authority on metastatic head and neck cancer and has significant experience in clinical trials related to HNSCC treatments [4]. - Katharine A. Price specializes in head and neck cancers and is involved in research aimed at improving treatment access and awareness regarding HPV vaccination [5].

Core Insights - The event hosted by PDS Biotechnology Corporation will focus on the changing landscape of recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) in relation to Merck's KEYNOTE-689 study and the rising incidence of HPV16-positive HNSCC in the US and Europe [1][2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company dedicated to transforming how the immune system targets and kills cancers, with a pivotal clinical trial underway for its lead program in advanced HPV16-positive HNSCC [7] Event Details - The virtual key opinion leader event will feature experts Kevin Harrington and Katharine A. Price discussing the unmet needs and treatment landscape for HPV16-positive HNSCC, including the investigational immunotherapy Versamune HPV [1][2][3] - The event is scheduled for June 17, 2025, from 12:00 PM to 1:30 PM ET [4] Treatment Landscape - The event will review the current treatment landscape for recurrent/metastatic HPV16-positive HNSCC, including the evaluation of Versamune HPV in a Phase 3 clinical trial in combination with pembrolizumab [2] - The discussion will highlight the distinction between HPV-positive and HPV-negative HNSCC, emphasizing their different underlying causes and treatment approaches [2]

Core Insights - The median overall survival (mOS) for first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) remains at 30.0 months, indicating durability in clinical responses [1][7] - HPV16-positive HNSCC is identified as a rapidly increasing and severe medical need in the US, with over 50% of HNSCC cases being HPV16-positive [2][3] - PDS Biotechnology's VERSATILE-003 is the only ongoing Phase 3 clinical trial specifically targeting HPV16-positive HNSCC [1][3] Company Overview - PDS Biotechnology Corporation is a late-stage immunotherapy company focused on transforming immune responses to target and kill cancers, particularly HPV16-positive HNSCC [1][11] - The company is developing its lead investigational immunotherapy, Versamune HPV (PDS0101), in combination with standard-of-care immune checkpoint inhibitors [11] Clinical Trial Insights - The VERSATILE-002 trial reported a median overall survival of 30.0 months for patients treated with PDS0101 and pembrolizumab, with a follow-up period of 22.1 months [6][7] - The trial included 53 patients, with a disease control rate of 77.4% and an objective response rate of 35.8% [8] - The lower limit of the 95% confidence interval for mOS improved from 18.4 months in 2023 to 23.9 months, suggesting a positive trend in survival outcomes [7] Comparative Analysis - PDS Biotechnology's approach differs from other ongoing Phase 3 trials by exclusively targeting HPV16-positive HNSCC, while other trials focus on predominantly HPV-negative populations [3][4] - HPV-positive HNSCC is recognized as a distinct disease requiring targeted treatment strategies, as traditional therapies have shown limited efficacy [4][9] Regulatory Insights - The FDA has recommended the development of a companion diagnostic for identifying HPV16-positive patients in the ongoing VERSATILE-003 trial [5]

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 26-4231384 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 303A College Road East, Princeton, NJ 08540 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ...