PDS Biotechnology(PDSB)2024-11-14 16:18Financial Data and Key Metrics Changes - The net loss for Q3 2024 was approximately 0.29 per share, compared to a net loss of 0.35 per share in Q3 2023, primarily due to lower operating expenses [25][26] - Research and development expenses increased to approximately 6.4 million in Q3 2023, attributed to higher manufacturing expenses [26] - General administrative expenses decreased to approximately 4.1 million in Q3 2023, mainly due to lower personnel costs and professional fees [27] - Cash and cash equivalents totaled approximately $50 million as of September 30, 2024 [28] Business Line Data and Key Metrics Changes - The VERSATILE-003 trial design was updated to include approximately 350 patients, maintaining statistical power and a 2 to 1 randomization, with median overall survival as the primary endpoint [8][21] - The VERSATILE-002 study showed median overall survival remained at 30 months, with an objective response rate improving from 26% to 36% [10][11] Market Data and Key Metrics Changes - The population of HPV 16-positive patients is increasing significantly, with over 70% of new patients seen by key opinion leaders being HPV 16 positive [16][36] - Most HPV positive patients do not meet the inclusion criteria for the KEYNOTE-689 study, indicating that the potential use of Keytruda in early treatment will not significantly impact the target population for VERSATILE-003 [17][19] Company Strategy and Development Direction - The company aims to be the first to market an HPV-targeted immunotherapy for head and neck cancer, with a focus on the growing population of HPV 16-positive patients [13][21] - The company is exploring the next steps in the development of Versamune HPV for cervical cancer following promising data from the IMMUNOCERV Phase 2 trial [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the updated trial design for VERSATILE-003 and the potential for timely enrollment, with an FDA decision expected by mid-December [8][63] - The company believes that the increasing incidence of HPV 16-positive head and neck cancer presents a significant long-term opportunity [36][64] Other Important Information - The company is conducting an independent survey of oncologists to understand the treatment landscape and the impact of emerging therapies on their target population [15][16] - The company plans to initiate the VERSATILE-003 trial in early 2025, with a focus on a targeted subset of sites financed from existing resources [21][63] Q&A Session Summary Question: When would the company expect an interim look at the VERSATILE-003 data and thoughts on the opportunity given the changing landscape? - Management indicated that the enrollment duration is expected to be around 18 months, with the first interim data readout anticipated about six months after enrollment completion [39][41] Question: Plans for a Phase 3 trial for IMMUNOCERV and positioning against Merus EGFR bispecific? - Management highlighted the impressive data from Merus but emphasized that their focus is specifically on HPV 16-positive head and neck cancer, which is a rapidly growing population [44][45] Question: Status of the VERSATILE-003 trial arm with PDS01ADC? - Management confirmed that the focus is currently on getting VERSATILE-003 up and running, with plans for dose optimization of PDS01ADC to follow [61][62]