Inhibikase Therapeutics(US:IKT)2024-05-18 01:57Financial Data and Key Metrics Changes - The net loss for the quarter ended March 31, 2024, was $4.6 million, or $0.73 per share, compared to a net loss of $4.5 million, or $0.98 per share for the same period in 2023, indicating a slight increase in loss per share [23] - Cash and cash equivalents and marketable securities as of March 31, 2024, totaled $9.7 million, expected to fund operations through November 2024 [6] Business Line Data and Key Metrics Changes - Research and development expenses for the quarter ended March 31, 2024, were $2.8 million, a decrease from $2.9 million in the same period in 2023, attributed to a decrease in IkT-001Pro expenses offset by an increase in Risvo expenses [48] - Selling, general, and administrative expenses for the quarter were $2 million, up from $1.9 million in the same period in 2023, primarily due to increased legal and consulting fees [35] Market Data and Key Metrics Changes - The global pulmonary arterial hypertension (PAH) market is valued at approximately $7.66 billion, with the potential for IkT-001Pro to deliver improved safety and tolerability compared to imatinib mesylate [22] Company Strategy and Development Direction - The company is focused on advancing its core programs towards important inflection points, particularly in the development of Risvodetinib (Risvo) for Parkinson's disease and IkT-001Pro for PAH [17] - The company aims to position IkT-001Pro as a disease-modifying treatment for PAH, with ongoing discussions with the FDA to confirm its status as a novel chemical entity [18][47] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the rapid enrollment in the Phase 2 trial for Risvo, anticipating the final patient enrollment in June and top-line data in the second half of the year [30][44] - The management highlighted the importance of biomarker developments in tracking treatment effects and emphasized the commitment of trial participants [50][13] Other Important Information - The company is actively seeking partnerships to fund trial work, recognizing the significant commitment required for ongoing clinical trials [11][40] - The company has made progress in discussions with the FDA regarding the protocol for potential Phase 2/3 trials for IkT-001Pro, with a focus on pulmonary vascular resistance as a primary endpoint [38] Q&A Session Summary Question: What are the expectations for Risvo data and next steps? - Management indicated that positive results would lead to further steps towards approval, with a focus on quality of life measures and Parkinson's disease severity [7][37] Question: Any updates on potential partnerships for IkT-001Pro? - Management confirmed ongoing discussions with multiple potential partners, emphasizing the need for regulatory milestones to be achieved before finalizing partnerships [10][40] Question: What does the trial design for IkT-001Pro look like? - The trial design would include a Phase 2 period with a smaller cohort, focusing on pulmonary vascular resistance, with plans to roll patients into Phase 3 if safety profiles are favorable [38]