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 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 ...

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of approximately $8.5 million, or about $0.21 per share, compared to a net loss of $10.6 million, or $0.30 per share, in Q1 2024, reflecting a decrease due to increased tax benefits and lower operating expenses [12][13] - Research and development expenses were $5.8 million for Q1 2025, down from $6.7 million in the prior year, primarily due to lower clinical trial expenses [12] - General and administrative expenses were $3.3 million for Q1 2025, compared to $3.4 million in the prior year [13] - Total operating expenses decreased to $9.1 million in Q1 2025 from approximately $10.1 million in Q1 2024 [13] - Cash balance as of March 31, 2025, was $40 million, down from $41.7 million as of December 31, 2024 [13] Business Line Data and Key Metrics Changes - The company initiated the VERSAL-three registrational trial for Versamune HPV plus pembrolizumab, targeting recurrent or metastatic HPV16 positive head and neck cancer, which is projected to become the most prevalent type of head and neck cancer by the mid-2030s [6][8] - The VERSAL-three trial design includes approximately 350 patients, with a two-arm design approved by the FDA [7] Market Data and Key Metrics Changes - The company highlighted the growing population in need of targeted therapies for HPV16 positive head and neck cancer, which is difficult to treat and represents a significant market opportunity [5][6] Company Strategy and Development Direction - The company is focused on advancing its clinical programs, particularly the VERSAL-three trial, which is the first phase three trial in the high-risk HPV16 population [8][54] - The company aims to leverage its strong relationship with the National Cancer Institute to progress its MUC1 program, which is part of a collaborative research agreement [11][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Versamune HPV and pembrolizumab combination to significantly improve patient outcomes, citing encouraging clinical responses and survival data from previous trials [8][27] - The management team emphasized the importance of durability in treatment responses, noting that patients in the VERSAL-two trial had a median overall survival of 30 months compared to the standard of care's 12 months [27][28] Other Important Information - The company raised approximately $11 million through a securities purchase agreement and completed a refinancing of its debt, extending the term to 36 months [14][15] - The company plans to present updated results from the VERSAL-two study at the upcoming ASCO Annual Meeting [54] Q&A Session Summary Question: Impact of Keytruda head and neck neoadjuvant data on enrollment expectations for Phase III - Management clarified that the KEYNOTE-689 trial focused mainly on HPV negative patients and should not affect enrollment in the VERSAL-three trial, as very few HPV positive patients are eligible for surgery [22][23] Question: Insights on durability from the upcoming ASCO presentation - Management indicated that the upcoming ASCO presentation will provide additional data on durability and survival, highlighting the long-term responses observed in the VERSAL-two trial [24][27] Question: Enrollment status for the VERSAL-three trial - Management stated that enrollment details have not been publicly disclosed yet, as the activation of sites and patient screening processes are ongoing [48][49] Question: Future operating expenses expectations - Management noted that while they do not provide specific financial guidance, they expect a relatively stable trial spend going forward, with higher initial expenses typical in the early stages of a trial [51]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of approximately $8.5 million, or about $0.21 per share, compared to a net loss of $10.6 million, or $0.30 per share, in Q1 2024, reflecting improved tax benefits and lower operating expenses [12][14] - Research and development expenses decreased to $5.8 million from $6.7 million year-over-year, primarily due to lower clinical trial expenses [12] - General and administrative expenses were $3.3 million, slightly down from $3.4 million in the prior year [12] - Total operating expenses for the quarter were $9.1 million, down from approximately $10.1 million in the previous year [12] - Cash balance as of March 31, 2025, was $40 million, compared to $41.7 million as of December 31, 2024 [13] Business Line Data and Key Metrics Changes - The company is advancing its clinical programs, particularly the Versamune HPV plus pembrolizumab treatment for HPV16 positive head and neck cancer, with the initiation of the VERSAL-three registrational trial [5][8] - The VERSAL-three trial design includes approximately 350 patients and has received FDA approval [6][8] Market Data and Key Metrics Changes - The company anticipates that by the mid-2030s, HPV16 positive head and neck cancer will become the most prevalent type of head and neck cancer in the U.S. and Europe [5] - The VERSAL-three trial is the first phase three trial targeting the high-risk HPV16 population [8] Company Strategy and Development Direction - The company is focused on the potential of Versamune HPV in improving outcomes for patients with recurrent and metastatic HPV16 positive head and neck cancer [5][8] - There is a strong emphasis on collaboration with institutions like the Mayo Clinic and the National Cancer Institute to enhance research and development efforts [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Versamune HPV and pembrolizumab combination to significantly improve patient outcomes, citing encouraging clinical response durability [7][28] - The management team highlighted the importance of maintaining long-term clinical responses, with a median overall survival of 30 months observed in the VERSAL-two trial compared to the standard of care's 12 months [28][29] Other Important Information - The company raised approximately $11 million through a securities purchase agreement and completed a refinancing of its debt, extending the term to 36 months [14] - The upcoming ASCO Annual Meeting will feature presentations on the VERSAL-two trial and other studies, which are expected to provide further insights into the company's clinical advancements [9][54] Q&A Session Summary Question: Impact of Keytruda head and neck neoadjuvant data on enrollment expectations for VERSAL-three - Management clarified that the KEYNOTE-689 trial primarily involved HPV negative patients, and thus, it should not affect enrollment in the VERSAL-three trial, which focuses on HPV positive patients [22][23] Question: Insights on durability from the upcoming ASCO presentation - Management indicated that the ASCO presentation will provide updates on the durability of responses observed in the VERSAL-two trial, emphasizing the long-term survival benefits compared to standard treatments [24][30] Question: Enrollment status for VERSAL-three and operational expenses outlook - Management stated that enrollment details have not been publicly disclosed yet, and they expect a steady recruitment state as more sites are activated [47][50]