Financial Data and Key Metrics Changes - The company reported a net loss of approximately $9.4 million or $0.21 per basic and diluted share for the three months ended June 30, 2025, compared to a net loss of $8.3 million or $0.23 per share for the same period in 2024, indicating an increase in net loss primarily due to higher net interest expenses [19][20] - Research and development expenses decreased to $4.2 million for the three months ended June 30, 2025, from $4.5 million for the same period in 2024, attributed to lower personnel costs [19] - General administrative expenses were $3.4 million for the three months ended June 30, 2025, down from $4.2 million in the same period last year, primarily due to lower personnel costs and professional fees [20] - The cash balance as of June 30, 2025, was $31.9 million, compared to $41.7 million as of December 31, 2024 [21] Business Line Data and Key Metrics Changes - The VERSAL three phase three clinical trial is ongoing, evaluating PDS0101 in HPV16 positive recurrent and/or metastatic head and neck cancer, with enrollment complete and 22 patients being followed for survival [6][12] - The VERSAL two trial presented positive updated data, demonstrating durable clinical benefits, with median overall survival remaining steady at 30 months over the last 1.5 years [11][12] - The colorectal cancer cohort of the phase two clinical trial with PDS-one ADC met criteria for expansion to stage two following positive stage one results, with a promising response rate observed [15] Market Data and Key Metrics Changes - Over 50% of head and neck cancer cases in the United States are HPV16 positive, representing a significant unmet medical need as there are currently no targeted therapies for this population [7][9] - HPV16 positive oropharyngeal cancer is projected to become the most prevalent type of head and neck cancer in the United States and Europe by the mid-2030s [9] Company Strategy and Development Direction - The company is focused on advancing its VERSAL three registrational trial specifically targeting HPV16 positive head and neck cancer, which is the first phase three clinical trial in this area [40] - The company aims to leverage the strong results from the VERSAL two trial and its Fast Track designation to enhance the potential of PDS0101 in head and neck cancer [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the combination of PDS0101 and pembrolizumab to significantly improve outcomes for patients with recurrent and/or metastatic HPV16 positive head and neck cancer [13] - The management highlighted the importance of tolerability and ease of administration of their therapies, which are critical factors for oncologists when considering treatment options [27][36] Other Important Information - The company announced preclinical efficacy and immune response data for a novel universal flu vaccine, which was presented at the American Association of Immunologists Annual Meeting [17][18] - Collaborations with leading clinical institutions such as the National Cancer Institute and MD Anderson Cancer Center are ongoing to support the development of the company's pipeline [18] Q&A Session Summary Question: Follow-up on VERSAL two ASCO data and its impact on enrollment - Management anticipates final data readout for the VERSAL two trial to be presented or published by the end of this calendar year or early next year, which is expected to drive enrollment in the VERSAL three trial [24][25] Question: Competing trials and Mayo Clinic study update - There are fewer competing trials now, with only one major trial by BioNTech in the same space, and the Mayo Clinic study remains important for future study designs [31][32] Question: Specificity of HPV16 positive therapy - The specificity of the trial for HPV16 positive patients is a significant advantage, and the management emphasized the importance of safety and tolerability in treatment options [36][37]

Press Release Header & Executive Summary [Q2 2025 Announcement & CEO Commentary](index=1&type=section&id=Q2%202025%20Announcement%20%26%20CEO%20Commentary) PDS Biotech announced its Q2 2025 financial results and provided a business update, highlighting significant progress in its VERSATILE-003 Phase 3 clinical trial for HPV16-positive HNSCC and positive data from the VERSATILE-002 trial, which CEO Frank Bedu-Addo believes demonstrates PDS0101's potential for durable clinical benefit - PDS Biotech reported **Q2 2025 financial results** and a business update on August 13, 2025[2](index=2&type=chunk) - CEO highlighted continued progress in **VERSATILE-003 Phase 3 clinical trial** for PDS0101 (Versamune® HPV) in HPV16-positive R/M HNSCC[3](index=3&type=chunk) - Announcement and presentation of data from **VERSATILE-002 trial**, demonstrating potential durable clinical benefit of PDS0101[3](index=3&type=chunk) Clinical and Corporate Update [Clinical Program Progress](index=1&type=section&id=Clinical%20Program%20Progress) The company announced that the colorectal cancer cohort of its Phase 2 clinical trial with PDS01ADC met criteria for expansion to Stage 2 following positive Stage 1 results, showing a promising response rate. The VERSATILE-003 trial for PDS0101 continues as the only registrational stage trial specifically targeting HPV16-positive HNSCC patients - Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC met criteria for expansion to Stage 2 following positive Stage 1 results[4](index=4&type=chunk) - Metastatic colorectal cancer cohort demonstrated **promising response rate (≥6 of 9 confirmed objective responses by RECIST v1.1)**, triggering enrollment expansion[4](index=4&type=chunk) - VERSATILE-003 trial is the only registrational stage trial specifically targeting HPV16-positive HNSCC patients[3](index=3&type=chunk) [Scientific Presentations & Preclinical Data](index=1&type=section&id=Scientific%20Presentations%20%26%20Preclinical%20Data) PDS Biotech presented three abstracts on PDS0101 at the 2025 ASCO annual meeting, featuring updated positive data from the VERSATILE-002 trial and other trials for head and neck cancers. Additionally, preclinical immune response data for a novel Infectimune® based universal flu vaccine was presented at IMMUNOLOGY2025™ - Three abstracts on PDS0101 (Versamune® HPV) were presented at the **2025 American Society of Clinical Oncology (ASCO) annual meeting**, highlighting updated positive data from the VERSATILE-002 trial[4](index=4&type=chunk) - Preclinical immune response data with a novel Infectimune® based universal flu vaccine were featured in two presentations at the American Association of Immunologists' **IMMUNOLOGY2025™ Annual Meeting**[4](index=4&type=chunk) Second Quarter 2025 Financial Results [Consolidated Financial Performance](index=2&type=section&id=Consolidated%20Financial%20Performance) PDS Biotech reported a net loss of $9.4 million, or $0.21 per basic and diluted share, for Q2 2025, an increase from $8.3 million, or $0.23 per share, in Q2 2024. This increase in net loss was primarily driven by higher net interest expenses, partially offset by lower personnel costs Net Loss and EPS (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | | :--------------------------------- | :---------- | :---------- | | Net Loss | $(9.4) million | $(8.3) million | | Net Loss per Share (basic & diluted) | $(0.21) | $(0.23) | - The increase in net loss was primarily due to higher net interest expenses, partially offset by lower personnel costs[5](index=5&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Total operating expenses decreased to $7.6 million in Q2 2025 from $8.7 million in Q2 2024. This reduction was primarily due to lower personnel costs in both research and development ($4.2M vs $4.5M) and general and administrative expenses ($3.4M vs $4.2M), with G&A also benefiting from lower professional fees Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 | Q2 2024 | | :-------------------------- | :---------- | :---------- | | Research and development | $4.2 million | $4.5 million | | General and administrative | $3.4 million | $4.2 million | | Total operating expenses | $7.6 million | $8.7 million | - Research and development expenses decreased primarily due to lower personnel costs, partially offset by higher manufacturing costs[6](index=6&type=chunk) - General and administrative expenses decreased primarily due to lower personnel costs and lower professional fees[7](index=7&type=chunk) [Net Interest Expenses](index=2&type=section&id=Net%20Interest%20Expenses) Net interest expenses significantly increased to $1.8 million in Q2 2025, up from $0.5 million in Q2 2024, primarily attributable to debt repayment costs Net Interest Expenses (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | | :------------------ | :---------- | :---------- | | Net interest expenses | $1.8 million | $0.5 million | - The increase in net interest expenses was primarily due to debt repayment costs[8](index=8&type=chunk) [Cash and Liquidity](index=2&type=section&id=Cash%20and%20Liquidity) The company's cash balance as of June 30, 2025, was $31.9 million, a decrease from $41.7 million as of December 31, 2024 Cash Balance | Date | Amount | | :-------------------- | :----------- | | June 30, 2025 | $31.9 million | | December 31, 2024 | $41.7 million | Company Overview & Conference Call [About PDS Biotechnology](index=2&type=section&id=About%20PDS%20Biotechnology) PDS Biotechnology is a late-stage immunotherapy company focused on transforming cancer treatment by targeting the immune system. Its lead program, PDS0101 (Versamune® HPV), is in a pivotal clinical trial for advanced HPV16-positive HNSCC, developed in combination with immune checkpoint inhibitors and PDS01ADC - PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers[10](index=10&type=chunk) - The Company has initiated a pivotal clinical trial to advance its lead program **PDS0101 (Versamune® HPV)** in advanced HPV16-positive head and neck squamous cell cancers[10](index=10&type=chunk) - PDS0101 is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC[10](index=10&type=chunk) [Conference Call Details](index=2&type=section&id=Conference%20Call%20Details) PDS Biotech hosted a conference call and webcast on August 13, 2025, at 8:00 a.m. Eastern Time to discuss the second quarter financial results and provide clinical program updates - Conference call date: **August 13, 2025**[10](index=10&type=chunk) - Conference call time: **8:00 a.m. Eastern Time**[10](index=10&type=chunk) - Dial-in and webcast registration details were provided[10](index=10&type=chunk) Forward-Looking Statements [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section contains a standard disclaimer regarding forward-looking statements, emphasizing that they are subject to various risks and uncertainties. These include the company's ability to protect intellectual property, capital requirements, dependence on additional financing, limited operating history, and the timing, success, and cost of clinical trials - Forward-looking statements are predictive in nature and depend upon or refer to future events or conditions, subject to risks and uncertainties[12](index=12&type=chunk) - Risks include the Company's ability to protect its intellectual property rights, anticipated capital requirements, dependence on additional financing, limited operating history, and the timing, success, and cost of clinical trials[12](index=12&type=chunk) - The Company undertakes no obligation to revise or update any forward-looking statement[12](index=12&type=chunk) Financial Tables [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This table provides the unaudited condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024, detailing operating expenses, interest income/expense, net loss, and per share information Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development expenses (USD) | $4,212,918 | $4,527,698 | $10,043,918 | $11,231,862 | | General and administrative expenses (USD) | $3,410,433 | $4,156,606 | $6,685,191 | $7,550,069 | | Total operating expenses (USD) | $7,623,351 | $8,684,304 | $16,729,109 | $18,781,931 | | Net interest income (expense) (USD) | $(1,810,857) | $(512,762) | $(2,363,886) | $(1,018,612) | | Net loss and comprehensive loss (USD) | $(9,434,208) | $(8,327,897) | $(17,923,175) | $(18,931,374) | | Net loss per share, basic and diluted (USD) | $(0.21) | $(0.23) | $(0.41) | $(0.53) | | Weighted average common shares outstanding (Shares) | 45,902,502 | 36,693,561 | 43,226,618 | 35,754,715 | [Selected Balance Sheet Data](index=6&type=section&id=Selected%20Balance%20Sheet%20Data) This table presents key unaudited balance sheet figures as of June 30, 2025, and December 31, 2024, including cash and cash equivalents, working capital, total assets, long-term debt, accumulated deficit, and total stockholders' equity Selected Balance Sheet Data | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Cash and cash equivalents (USD) | $31,873,495 | $41,689,591 | | Working capital (USD) | $22,116,593 | $27,967,242 | | Total assets (USD) | $40,476,065 | $45,358,657 | | Long term debt (USD) | $12,943,656 | $9,204,755 | | Accumulated deficit (USD) | $(200,034,174) | $(182,110,999) | | Total stockholders' equity (USD) | $15,959,784 | $19,004,848 | Contact Information [Investor & Media Contacts](index=4&type=section&id=Investor%20%26%20Media%20Contacts) This section provides the contact details for investor relations and media inquiries for PDS Biotechnology - Investor Contact: Mike Moyer, LifeSci Advisors, Phone **+1 (617) 308-4306**, Email: mmoyer@lifesciadvisors.com[13](index=13&type=chunk) - Media Contact: David Schull, Russo Partners, Phone **+1 (858) 717-2310**, Email: david.schull@russopartnersllc.com[13](index=13&type=chunk)

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]

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]