Core Viewpoint - PDS Biotechnology Corporation is advancing its clinical programs, particularly the VERSATILE-003 Phase 3 trial for its investigational therapy Versamune® HPV targeting HPV16-positive head and neck squamous carcinoma, while also reporting improved financial results for Q1 2025 compared to the previous year [3][4][6]. Clinical Updates - The VERSATILE-003 Phase 3 clinical trial has been initiated to evaluate Versamune® HPV in recurrent/metastatic HPV16-positive head and neck squamous carcinoma, with site activations progressing, including the addition of Mayo Clinic sites [4]. - The trial is designed to include approximately 350 patients and is a two-arm controlled trial with a 2:1 randomization, focusing on median overall survival as the primary endpoint [6]. - The company received FDA Fast Track designation for the combination of Versamune® HPV and pembrolizumab in recurrent/metastatic head and neck squamous carcinoma [6]. Financial Results - For Q1 2025, the reported net loss was approximately $8.5 million, or $0.21 per share, a decrease from a net loss of $10.6 million, or $0.30 per share, in Q1 2024 [6][7]. - Research and development expenses were $5.8 million in Q1 2025, down from $6.7 million in Q1 2024, primarily due to lower clinical trial expenses [7]. - Total operating expenses for Q1 2025 were $9.1 million, compared to approximately $10.1 million in Q1 2024 [8]. Cash Position - As of March 31, 2025, the company's cash balance was $40 million, a slight decrease from $41.7 million as of December 31, 2024 [8][16]. - The company has entered into securities purchase agreements for the sale of 7,330,121 shares of common stock, raising approximately $11 million upon closing, with potential for an additional $11 million from warrant exercises [6]. Upcoming Events - Three abstracts on Versamune® HPV have been selected for presentation at the 2025 American Society of Clinical Oncology Annual Meeting, scheduled for May 30-June 3, 2025 [6].

Core Insights - PDS Biotechnology Corporation has initiated the VERSATILE-003 Phase 3 clinical trial for its investigational therapy Versamune® HPV targeting recurrent/metastatic HPV16-positive head and neck squamous carcinoma [4][9] - The company reported a net loss of approximately $8.5 million for Q1 2025, a decrease from $10.6 million in Q1 2024, attributed to lower operating expenses and increased tax benefits [6][7] - PDS Biotech's cash balance as of March 31, 2025, was $40 million, down from $41.7 million at the end of 2024 [8][15] Clinical Updates - The VERSATILE-003 trial is designed to include around 350 patients and is a two-arm controlled trial with a 2:1 randomization [6][4] - The primary endpoint of the trial is median overall survival, with interim readouts included in the study design [6][4] - The FDA has granted Fast Track designation for the combination of Versamune® HPV and pembrolizumab in treating recurrent/metastatic HNSCC [6][4] Financial Performance - Research and development expenses for Q1 2025 were $5.8 million, down from $6.7 million in Q1 2024, primarily due to reduced clinical trial expenses [7][6] - General and administrative expenses were slightly lower at $3.3 million for Q1 2025 compared to $3.4 million in Q1 2024 [7][6] - Total operating expenses decreased to $9.1 million in Q1 2025 from approximately $10.1 million in Q1 2024 [8][6] Corporate Developments - Three abstracts on Versamune® HPV were selected for presentation at the 2025 ASCO Annual Meeting scheduled for May 30-June 3, 2025 [6][4] - The company has entered into securities purchase agreements for the sale of 7,330,121 shares of common stock, raising approximately $11 million upon closing [6][4]

Core Insights - PDS Biotechnology Corporation has granted a nonstatutory stock option to an employee in its clinical department as part of its 2019 Inducement Plan, which aims to attract new talent [1][2] - The stock option allows the purchase of 5,000 shares at an exercise price of $1.31, the closing price on the grant date, and vests over a four-year period [2] - PDS Biotechnology is focused on immunotherapy, particularly in developing its lead program, Versamune HPV, for advanced HPV16-positive head and neck squamous cell cancers [3] Company Overview - PDS Biotechnology is a late-stage immunotherapy company aiming to change how the immune system targets and kills cancers [3] - The company is conducting a pivotal clinical trial for its lead investigational targeted immunotherapy, Versamune HPV, in combination with standard immune checkpoint inhibitors and other therapies [3]

Core Insights - PDS Biotechnology Corporation is advancing its investigational flu vaccine, Infectimune, which has shown promising preclinical immune response data at the IMMUNOLOGY2025™ Annual Meeting [1][2] - The vaccine has demonstrated a significantly greater frequency of multifunctional, influenza-specific CD4 T cells compared to current vaccine approaches, indicating its potential effectiveness [2] - Infectimune-based universal flu vaccines have shown excellent breadth of protective immune response against multiple strains of influenza in preclinical studies [3] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to target and kill cancers and infectious diseases [1][5] - The company is currently conducting a pivotal clinical trial for its lead program, Versamune HPV, aimed at treating advanced HPV16-positive head and neck squamous cell cancers [5] - PDS Biotech is leveraging collaborations to enhance its research while focusing resources on its immuno-oncology programs [4]

Core Viewpoint - PDS Biotechnology Corporation is set to report its financial results for Q1 2025 and provide updates on its clinical programs during a conference call on May 14, 2025 [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on enhancing 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 targeted immunotherapy, 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].

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 ...

Core Insights - PDS Biotechnology Corporation announced that preclinical immune response data for a novel Infectimune-based flu vaccine will be presented at the American Association of Immunologists' IMMUNOLOGY2025™ Annual Meeting [1] - The presentation will focus on broadly protective immunity against influenza and opportunities for universal influenza vaccines [2] - PDS Biotech is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [3] Presentation Details - Title of the presentation: Broadly Protective Immunity against Influenza and Opportunities for Universal Influenza Vaccines [2] - Session Type: Guest Symposium at the International Society of Influenza and Other Respiratory Viruses (ISIRIV) Symposium [2] - Date and Time: May 4, 2025, from 8:30 to 10:30 a.m. HST [2] - Presenter: Andrea Sant, Ph.D., Professor of Microbiology and Immunology at the University of Rochester Medical Center [2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune responses to target and kill cancers [3] - The company is developing its lead investigational targeted immunotherapy, Versamune HPV, in combination with standard-of-care immune checkpoint inhibitors [3] - PDS Biotech is also exploring a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, along with standard-of-care immune checkpoint inhibitors [3]

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 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]