PDS Biotechnology(PDSB)2023-05-15 14:33Financial Data and Key Metrics Changes - The net loss for Q1 2023 was approximately 0.32 per share, compared to a net loss of 0.32 per share for the same period in 2022, attributed to increased personnel costs, clinical studies costs, and medical affairs expenses [20][21]. - Total operating expenses for Q1 2023 were approximately 8.5 million in Q1 2022 [21]. - The company ended the quarter with approximately 5 million payment to Merck KGaA for the in-license of PDS0301 [22]. Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2023 increased to approximately 5.2 million in Q1 2022, primarily due to increased clinical studies and personnel costs [43]. - General and administrative expenses for Q1 2023 increased slightly to approximately 3.3 million in Q1 2022, mainly due to higher personnel costs [97]. Market Data and Key Metrics Changes - The company is preparing to initiate the Phase 3 VERSATILE-003 trial, which will study PDS0101 in combination with KEYTRUDA against KEYTRUDA monotherapy in HPV-positive cancers [5][39]. - The Phase 2 results of PDS0101 have shown consistent anti-tumor activity across various HPV-positive cancers, with substantial biomarker data indicating the induction of HPV16-specific killer T cells [38]. Company Strategy and Development Direction - The company aims to commercialize PDS0101 for first-line treatment of recurrent or metastatic HPV-positive head and neck cancer, addressing a significant unmet medical need [14]. - The strategic focus includes the development of a triple combination therapy involving PDS0101, PDS0301, and a commercial immune checkpoint inhibitor, with promising results in both ICI naive and refractory cancers [17][55]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, emphasizing the potential of PDS0101 to revolutionize cancer treatment and the importance of upcoming milestones [14][87]. - The company is awaiting feedback from the FDA regarding the VERSATILE-003 trial design and anticipates that initial data from the refractory arm of the VERSATILE-002 study will inform the registrational study design [40][77]. Other Important Information - The company has monetized its net operating loss carryforwards in New Jersey, receiving 1.4 million as part of a tax benefits program [44]. - The company plans to present updated interim results for the Phase 2 VERSATILE-002 trial at the ASCO conference, which has been accepted for a poster presentation [37][72]. Q&A Session Summary Question: Can you provide more thoughts on the expert panel reviewing the VERSATILE-002 study at ASCO? - Management indicated that the expert panel will assess the data presented, including interim data points for progression-free survival (PFS) and overall survival (OS) [23][26]. Question: What are the expectations for interim analysis in the VERSATILE-003 trial? - Management stated that interim analysis criteria will be established in alignment with the FDA, and they are designing the trial based on observed enrollment rates from VERSATILE-002 [46][68]. Question: Can you discuss the partnership environment and ongoing discussions? - Management confirmed that partnership discussions are ongoing and are facilitated by the progress into Phase 3 trials, which potential partners find attractive [82]. Question: What is the anticipated cash burn for the remainder of the year? - Management projected a cash burn ramp-up to approximately 12 million to $13 million per quarter, primarily driven by R&D expenses [94]. Question: What CMC-related work is still needed before filing an amended IND? - Management highlighted the need for proper characterization of the manufacturing and release processes, as well as stability program requirements before filing the IND in Q3 [73][74].