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]

Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., May 14, 2025 -- 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 and corporate update and reported financial results for the first quarter ended March 31, 2025. "The first quarter of 2025 and recent weeks have been productive for PDS Biotech, highlighted by the initiati ...

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]