Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2024, was approximately $37.6 million or $1.03 per basic and diluted share, compared to a net loss of $42.9 million or $1.39 per basic and diluted share for the prior year [21] - Research and development expenses for 2024 were $22.6 million, down from $27.8 million in 2023, primarily due to decreases in clinical costs, personnel costs, and professional fees [22] - General and administrative expenses for 2024 were $13.8 million, compared to $15.3 million in 2023, reflecting a decrease in professional fees and facilities costs [23] - Total operating expenses for 2024 were $36.3 million, compared to $43 million in 2023 [23] - The company's cash balance as of December 31, 2024, was $41.7 million, not including the direct offering concluded in February 2025 [25] Business Line Data and Key Metrics Changes - The VERSATILE-003 Phase 3 clinical trial of Versamune HPV + pembrolizumab has been initiated, targeting HPV16-positive head and neck cancer, a growing population in need of targeted therapies [8][10] - The trial design includes approximately 350 patients, with a primary endpoint of median overall survival [10][12] - The VERSATILE-002 Phase 2 study showed median overall survival of 30 months, with an objective response rate improvement from 26% to 36% [12][13] Market Data and Key Metrics Changes - HPV-16 positive head and neck cancer is projected to become the most prevalent type of head and neck cancer in the U.S. and Europe by the mid-2030s [9] - The best-published median overall survival for pembrolizumab is 17.9 months, indicating the potential competitive advantage of the Versamune HPV combination [13] Company Strategy and Development Direction - The company aims to be the first to market with an HPV-targeted immunotherapy for head and neck cancer, leveraging strong clinical data from the VERSATILE-002 study [16][84] - The focus remains on progressing the VERSATILE-003 trial while collaborating with the National Cancer Institute on other programs [17][60] - The company plans to raise necessary capital in a stepwise manner as it progresses with the Phase 3 trial, balancing funding needs against shareholder dilution [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Versamune HPV combination to improve patient outcomes and enhance standard-of-care [10][16] - The current funding environment is challenging, but the company successfully raised $11 million recently [33] - Management is optimistic about rapid enrollment in the VERSATILE-003 trial due to the familiarity of sites from the Phase 2 trial [30][53] Other Important Information - The company announced FDA clearance for the Investigational New Drug application for the combination of Versamune MUC1 and PDS01ADC to treat metastatic colorectal cancer [16] - The trial design for VERSATILE-003 includes two interim data readouts, allowing for early discussions with the FDA regarding potential accelerated approval [46][47] Q&A Session Summary Question: Enrollment trajectory for Versamune-003 and projected timelines - Management indicated that most sites from the Phase 2 trial are re-engaged, which should expedite enrollment [30] Question: Current funding environment for studies - The company acknowledged the challenging funding environment but expressed satisfaction with recent fundraising efforts [33] Question: Rationale for the reduced patient sample size in VERSATILE-003 - The reduction from over 400 to 350 patients was based on observed durability of responses and retained statistical power [44] Question: Timeline for MUC1 candidate and TARP program - The MUC1 trial is led by the National Cancer Institute, and timelines will depend on their progress [75] - No guidance has been provided for the TARP program at this time [79]

Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2024, was approximately $37.6 million or $1.03 per basic and diluted share, compared to a net loss of $42.9 million or $1.39 per basic and diluted share for the prior year [21] - Research and development expenses for 2024 were $22.6 million, down from $27.8 million in 2023, primarily due to decreases in clinical costs, personnel costs, and professional fees [22] - General and administrative expenses for 2024 were $13.8 million, compared to $15.3 million in 2023, reflecting a decrease in professional fees and facilities costs [23] - Total operating expenses for 2024 were $36.3 million, compared to $43 million in 2023 [23] - The company's cash balance as of December 31, 2024, was $41.7 million, not including the direct offering concluded in February 2025 [25] Business Line Data and Key Metrics Changes - The VERSATILE-003 Phase 3 clinical trial of Versamune HPV + pembrolizumab has been initiated, targeting HPV16-positive head and neck cancer, a growing population in need of targeted therapies [8][10] - The trial design includes approximately 350 patients, with a primary endpoint of median overall survival [10][12] - The VERSATILE-002 Phase 2 study showed median overall survival at 30 months, with an objective response rate improvement from 26% to 36% [12][13] Market Data and Key Metrics Changes - HPV-16 positive head and neck cancer is projected to become the most prevalent type of head and neck cancer in the U.S. and Europe by the mid-2030s [9] - The best-published median overall survival for pembrolizumab is 17.9 months, while the disease control rate improved from 70% to 77% in the VERSATILE-002 study [13][14] Company Strategy and Development Direction - The company aims to be the first to market an HPV-targeted immunotherapy for head and neck cancer, leveraging the promising results from the VERSATILE-002 study [16][84] - The company is focusing on progressing the VERSATILE-003 trial while maintaining strong relationships with the National Cancer Institute for other clinical trials [17][56] - Future plans include exploring non-dilutive funding options and potential partnerships to support pipeline development [35][38] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging funding environment but expressed confidence in their ability to raise necessary capital in a stepwise manner as the Phase 3 trial progresses [34][35] - The company is optimistic about the potential for accelerated approval discussions with the FDA based on interim data readouts from the VERSATILE-003 trial [47][49] - Management emphasized the importance of rapid patient enrollment in the trial, aided by the familiarity of sites involved in the previous Phase 2 study [51][53] Other Important Information - The company announced FDA clearance for the Investigational New Drug application for the combination of Versamune MUC1 and PDS01ADC to treat metastatic colorectal cancer [16] - The company is also exploring the potential of a triple combination therapy involving IL-12, pending the success of the doublet therapy [61][70] Q&A Session Summary Question: Enrollment trajectory for Versamune-003 and projected timelines - Management indicated that most sites from the Phase 2 trial are re-engaged, which should expedite enrollment [29][30] Question: Current funding environment for studies - Management acknowledged the challenging funding environment but expressed satisfaction with recent fundraising efforts [33][34] Question: Rationale for the reduced patient sample size in VERSATILE-003 - The trial size was reduced from over 400 to 350 patients based on improved confidence in clinical outcomes from the Phase 2 study [44] Question: Timeline for MUC1 candidate and TARP program - The MUC1 trial is led by the National Cancer Institute, and timelines will depend on their progress [75][79]

Financial Performance - For the year ended December 31, 2024, the net loss was approximately $37.6 million, or $1.03 per basic and diluted share, a decrease from a net loss of $42.9 million, or $1.39 per share in 2023[5] - The accumulated deficit as of December 31, 2024, was $(182.1) million, compared to $(144.5) million in 2023[19] Expenses - Research and development expenses for 2024 were $22.6 million, down from $27.8 million in 2023, primarily due to a $4.1 million decrease in clinical costs[6] - General and administrative expenses decreased to $13.8 million in 2024 from $15.3 million in 2023, reflecting a reduction in professional fees and facilities costs[7] - Total operating expenses for 2024 were $36.3 million, compared to $43.0 million in 2023, indicating a significant reduction in overall costs[7] - The company reported a net interest expense of $2.2 million for 2024, an increase from $1.3 million in 2023 due to higher debt interest[8] Cash Position - The cash balance as of December 31, 2024, was $41.7 million, down from $56.6 million in 2023[11][19] Clinical Trials and Designations - The company initiated the VERSATILE-003 Phase 3 clinical trial for Versamune® HPV in HPV16-positive head and neck cancer, with approximately 350 patients expected to be enrolled[4] - The FDA granted Fast Track designation for the combination of Versamune® HPV and pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma[4] Fundraising Activities - In March 2025, the company announced an up to $22 million registered direct offering, with $11 million in upfront gross proceeds[10]

Initiated VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., March 27, 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 programs update and reported financial results for the full year ended Dece ...

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 present at the 2025 Cancer Advocacy Group of Louisiana NeauxCancer Conference, highlighting its advancements in cancer treatment [1][2] Company Overview - PDS Biotechnology is developing its lead investigational targeted immunotherapy, Versamune® HPV, in pivotal clinical trials for advanced HPV16-positive head and neck squamous cell cancers [3] - The therapy is being tested 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 presentation at the 2025 CAGLA NeauxCancer Conference is scheduled for March 28, 2025, at 11:00 AM CT, focusing on innovative cancer treatment approaches [2]

PRINCETON, N.J., March 18, 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 announced that the Company will host a conference call to report financial results for the year ended December 31, 2024, and provide a clinical programs update on Thursday, March 27, 2025, at 8:00 a.m. Eastern Time. Conference Call Details Date: March 27, 2025Time: 8 ...

Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer Institute Second Versamune® platform candidate targets MUC1-positive solid tumors U.S. Patent #12,201,685 covering methods of using combinations of the Versamune® platform and various immunocytokines, including PDS01ADC recently issued PRINCETON, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused ...

Core Viewpoint - PDS Biotechnology Corporation has initiated the VERSATILE-003 Phase 3 clinical trial for its investigational immunotherapy Versamune HPV, aimed at treating recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers [4]. - The company is advancing its lead program in advanced HPV16-positive HNSCC through pivotal clinical trials [4]. Clinical Trial Details - The VERSATILE-003 trial is a global, multi-center, randomized, controlled, and open-label Phase 3 trial designed to evaluate the safety and efficacy of Versamune HPV in combination with pembrolizumab as a first-line treatment [2]. - Approximately 350 patients will be enrolled in a 2:1 ratio between the investigational arm and the control arm receiving pembrolizumab alone [2]. - The primary endpoint of the trial is overall survival, with secondary endpoints including objective response rate, progression-free survival, disease control rate, and duration of response [2]. Leadership and Expertise - Frank Bedu-Addo, PhD, serves as the President and CEO of PDS Biotech, expressing confidence in the potential of the combination therapy to improve patient outcomes [2]. - Kirk Shepard, M.D., the Chief Medical Officer, highlighted the significance of advancing into Phase 3 for improving treatment options for patients with HPV16-positive HNSCC [3]. Product Information - Versamune HPV is an HPV-specific T cell stimulating immunotherapy that has shown potential in stimulating high levels of HPV16-specific CD8+ and CD4+ T cells [3]. - The U.S. Food and Drug Administration granted Versamune HPV Fast Track designation based on data from the previous VERSATILE-002 Phase 2 trial [3].

Core Viewpoint - PDS Biotechnology Corporation has announced a registered direct offering of 7,330,121 shares of common stock and warrants, aiming to raise approximately $11 million for research and development and general corporate purposes [1][2]. Group 1: Offering Details - The offering includes 7,330,121 shares priced at $1.50 for institutional investors and $1.66 for certain directors, with warrants exercisable at $1.50 per share [1]. - The gross proceeds from the offering are expected to be around $11 million, with an additional potential $11 million from the exercise of warrants [2]. - The closing of the offering is anticipated on or about February 28, 2025, pending customary closing conditions [2]. Group 2: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [5]. - The company plans to initiate a pivotal clinical trial for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers [5]. - The lead investigational immunotherapy, Versamune® HPV, is being developed in combination with a standard immune checkpoint inhibitor and a triple combination including PDS01ADC [5].

Core Insights - Versamune HPV shows potential as a broadly effective treatment for HPV16-associated cancers, with a Phase 3 trial for HPV16-positive head and neck squamous cell carcinoma (HNSCC) planned for Q1 2025 [1][2][3] Group 1: Clinical Trial Results - The trial demonstrated that Versamune HPV combined with chemoradiation (CRT) led to greater and earlier clearance of HPV16-positive cancer cells from the bloodstream in patients with locally advanced cervical cancer [2][3] - 100% of patients with locally advanced HPV16 cervical cancer treated with Versamune HPV + CRT had no detectable HPV16 circulating tumor DNA (ctDNA) at 3-4 months, compared to 50% of patients receiving standard CRT [1][4] - Undetectable HPV ctDNA at 3-4 months was associated with improved 2-year recurrence-free survival (RFS) of 93% versus only 30% in patients with detectable HPV ctDNA [1][4] Group 2: Patient Outcomes - The median follow-up period was 23 months, with a strong correlation between HPV ctDNA clearance at 3-4 months and better 2-year RFS (92.9% vs. 30%, P = 0.0067) [4] - The strongest predictor of RFS was HPV ctDNA clearance at 3-4 months, achieving a concordance index score of 0.83 [4] - The 36-month overall survival (OS) rate was reported as 100% for 8 patients who received 5 doses of Versamune HPV + CRT, and an 84.4% OS rate for 17 patients who received at least 2 doses of Versamune HPV + CRT [5] Group 3: Future Plans and Regulatory Pathway - The company plans to initiate discussions with the U.S. Food and Drug Administration regarding the potential for an accelerated regulatory pathway, such as Breakthrough Therapy designation in cervical cancer [3] - The findings suggest that the reduction of ctDNA levels may also apply to other HPV16-positive cancers like HNSCC, which is included in the VERSATILE-003 Phase 3 clinical trial [3]