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Inhibikase Therapeutics(IKT) - 2024 Q2 - Earnings Call Transcript
IKTInhibikase Therapeutics(IKT)2024-08-15 22:13
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Financial Data and Key Metrics Changes - The net loss for Q2 2024 was 5.0millionor5.0 million or 0.66 per share, compared to a net loss of 5.8millionor5.8 million or 0.94 per share for Q2 2023, indicating an improvement in financial performance [12] - Research and development expenses decreased to 3.1millionfrom3.1 million from 4.5 million in the same period last year, primarily due to reduced expenses related to IkT-001Pro [13] - Selling, general and administrative expenses increased to 2.0millionfrom2.0 million from 1.8 million, driven by higher legal and consulting fees [13] - As of June 30, 2024, the company had 7.9millionincash,cashequivalents,andmarketablesecurities,expectedtofundoperationsintoDecember2024[14]BusinessLineDataandKeyMetricsChanges−ThecompanycompletedenrollmentforitsPhase2201trialforrisvodetinibinParkinson′sdisease,withtop−linedataexpectedinNovember2024[5][7]−SignificantprogresswasmadeinthedevelopmentofIkT−001Proforpulmonaryarterialhypertension(PAH),withanINDfiledonAugust9,2024[9][12]MarketDataandKeyMetricsChanges−Theglobalmarketforpulmonaryarterialhypertensionisvaluedat7.9 million in cash, cash equivalents, and marketable securities, expected to fund operations into December 2024 [14] Business Line Data and Key Metrics Changes - The company completed enrollment for its Phase 2 201 trial for risvodetinib in Parkinson's disease, with top-line data expected in November 2024 [5][7] - Significant progress was made in the development of IkT-001Pro for pulmonary arterial hypertension (PAH), with an IND filed on August 9, 2024 [9][12] Market Data and Key Metrics Changes - The global market for pulmonary arterial hypertension is valued at 7.7 billion annually, presenting a significant opportunity for IkT-001Pro [8] Company Strategy and Development Direction - The company aims to differentiate its pipeline of neurological and cardiopulmonary assets, with multiple near-term milestones expected in the second half of 2024 [15] - The strategy includes advancing risvodetinib as a potential disease-modifying treatment for Parkinson's disease and IkT-001Pro for PAH, leveraging FDA discussions to align on trial designs [9][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical progress made in the first half of 2024 and the potential for upcoming data to support further development [4][15] - The company is optimistic about the safety and tolerability of risvodetinib, with expectations for a robust Phase 3 trial following the upcoming data release [21] Other Important Information - The company is exploring alternative financing opportunities for its Multiple System Atrophy program and developing new antibody diagnostic tools for Parkinson's disease [10][11] Q&A Session Summary Question: Update on the risvo Phase 2 study and open-label extension - Management confirmed that 89 patients have completed the trial, with plans to launch the open-label extension study soon, despite some patients potentially opting for symptomatic treatment [16] Question: Details on the Phase 3 program for risvodetinib - Management indicated that the Phase 3 program would likely involve 300 to 400 patients across two trials, focusing on untreated Parkinson's disease [20] Question: Expectations for IND clearance for IkT-001Pro - Management expects IND clearance to proceed without major gating factors, with trial initiation anticipated in approximately 9 to 12 months [22]