PRINCETON, N.J., April 23, 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 three abstracts on Versamune® HPV (PDS0101) have been accepted for presentation at the 2025 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 30-June 3, 2025, in Chicago, Illinois. Details of the presentation are as follow ...

Update on American Association for Cancer Research Annual Meeting 2025 presentation PRINCETON, N.J., April 16, 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 preclinical immune response data with a novel Infectimune based flu vaccine will be featured in a symposium on universal influenza vaccines at the American Association ...

Core Insights - PDS Biotechnology Corporation announced that an abstract on its IL-12 fused antibody drug conjugate, PDS01ADC, has been accepted for presentation at the AACR Annual Meeting 2025 [1][2] - The presentation will focus on alterations in peripheral T stem-like memory cells in patients with advanced solid tumors treated with tumor-targeting IL-12 therapy [2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company aiming to transform immune system responses to cancer [1][2] - The company is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [2] - PDS Biotech's lead investigational targeted immunotherapy, Versamune® HPV, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination including PDS01ADC [2]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) Delaware 26-4231384 (State or other juri ...

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 ...