Inovio Pharmaceuticals(INO) - 2023 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for Q2 2023 was $226,000, down from $784,000 in Q2 2022, indicating a significant decline in revenue [5] - Net loss for Q2 2023 was $35.5 million or $0.13 per share, compared to a net loss of $108.5 million or $0.46 per share in Q2 2022, representing a 67% year-over-year reduction in net loss [5] - General and administrative (G&A) expenses for Q2 2023 were $13.5 million, a 72% decrease from $48.5 million in Q2 2022, primarily due to one-time costs related to litigation settlements in 2022 [4] Business Line Data and Key Metrics Changes - The company announced the cessation of further development of VGX-3100 for cervical HSIL in the U.S. due to FDA requirements for additional trials [2] - INO-3107, targeting recurrent respiratory papillomatosis (RRP), is progressing towards a Phase 3 trial, with patient dosing expected to start in Q1 2024 [38][64] - The company is also advancing VGX-3100 for anal HSIL and other oncology candidates, including INO-3112 and INO-5401 [40][68] Market Data and Key Metrics Changes - The anal HSIL disease affects an estimated 210,000 to over 1 million people in the U.S., with a similar estimate for Europe, highlighting a significant market opportunity [66] - The company is focusing on global markets for VGX-3100, particularly in China, where a Phase 3 trial is ongoing without the use of the novel biomarker [46] Company Strategy and Development Direction - The company is undergoing a strategic overhaul to focus on pipeline candidates closest to market with the highest likelihood of success [29] - A workforce reduction of approximately 30% has been implemented to align resources with current pipeline needs, aiming to fund operations into Q3 2025 [41][60] - The company is actively pursuing strategic partnerships and funding opportunities to support the development of its late-stage candidates [68] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline and the potential of DNA medicines to address unmet medical needs [8] - The company is optimistic about the progress of INO-3107 and other candidates, with plans to provide updates in future quarterly calls [68] - Management acknowledged the challenging funding environment for pre-commercial biotech companies and emphasized the importance of resource allocation [53] Other Important Information - The company reported a total operating expense of $37.3 million for Q2 2023, down 64% from Q2 2022 [61] - Research and development expenses for Q2 2023 were $23.7 million, a 58% reduction from the same period in 2022, primarily due to lower drug manufacturing and clinical trial costs [62] Q&A Session Summary Question: What is the status of the 3107 program and FDA discussions? - Management confirmed positive interactions with the FDA regarding the trial design and is preparing to open clinical trial sites for 3107 [83] Question: Will the patient population criteria change for the Phase 3 trial? - Management indicated that they have not provided specific details on patient recruitment but are optimistic about the clinical need and timely recruitment [18][77] Question: What updates are available for INO-5401 and discussions with Regeneron? - Management stated that the study is wrapping up, and discussions with Regeneron are ongoing regarding the next steps for INO-5401 [86] Question: When can further updates on INO-4201 be expected? - Management mentioned that updates on INO-4201 will be provided in due course as discussions with regulators and collaborators are ongoing [90]