PDS Biotechnology(US:PDSB)2025-08-13 13:00Financial Data and Key Metrics Changes - The company reported a net loss of approximately $9.4 million or $0.21 per basic and diluted share for the three months ended June 30, 2025, compared to a net loss of $8.3 million or $0.23 per share for the same period in 2024, indicating an increase in net loss primarily due to higher net interest expenses [19][20] - Research and development expenses decreased to $4.2 million for the three months ended June 30, 2025, from $4.5 million for the same period in 2024, attributed to lower personnel costs [19] - General administrative expenses were $3.4 million for the three months ended June 30, 2025, down from $4.2 million in the same period last year, primarily due to lower personnel costs and professional fees [20] - The cash balance as of June 30, 2025, was $31.9 million, compared to $41.7 million as of December 31, 2024 [21] Business Line Data and Key Metrics Changes - The VERSAL three phase three clinical trial is ongoing, evaluating PDS0101 in HPV16 positive recurrent and/or metastatic head and neck cancer, with enrollment complete and 22 patients being followed for survival [6][12] - The VERSAL two trial presented positive updated data, demonstrating durable clinical benefits, with median overall survival remaining steady at 30 months over the last 1.5 years [11][12] - The colorectal cancer cohort of the phase two clinical trial with PDS-one ADC met criteria for expansion to stage two following positive stage one results, with a promising response rate observed [15] Market Data and Key Metrics Changes - Over 50% of head and neck cancer cases in the United States are HPV16 positive, representing a significant unmet medical need as there are currently no targeted therapies for this population [7][9] - HPV16 positive oropharyngeal cancer is projected to become the most prevalent type of head and neck cancer in the United States and Europe by the mid-2030s [9] Company Strategy and Development Direction - The company is focused on advancing its VERSAL three registrational trial specifically targeting HPV16 positive head and neck cancer, which is the first phase three clinical trial in this area [40] - The company aims to leverage the strong results from the VERSAL two trial and its Fast Track designation to enhance the potential of PDS0101 in head and neck cancer [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the combination of PDS0101 and pembrolizumab to significantly improve outcomes for patients with recurrent and/or metastatic HPV16 positive head and neck cancer [13] - The management highlighted the importance of tolerability and ease of administration of their therapies, which are critical factors for oncologists when considering treatment options [27][36] Other Important Information - The company announced preclinical efficacy and immune response data for a novel universal flu vaccine, which was presented at the American Association of Immunologists Annual Meeting [17][18] - Collaborations with leading clinical institutions such as the National Cancer Institute and MD Anderson Cancer Center are ongoing to support the development of the company's pipeline [18] Q&A Session Summary Question: Follow-up on VERSAL two ASCO data and its impact on enrollment - Management anticipates final data readout for the VERSAL two trial to be presented or published by the end of this calendar year or early next year, which is expected to drive enrollment in the VERSAL three trial [24][25] Question: Competing trials and Mayo Clinic study update - There are fewer competing trials now, with only one major trial by BioNTech in the same space, and the Mayo Clinic study remains important for future study designs [31][32] Question: Specificity of HPV16 positive therapy - The specificity of the trial for HPV16 positive patients is a significant advantage, and the management emphasized the importance of safety and tolerability in treatment options [36][37]