Inhibikase Therapeutics, Inc. Q3 FY2022 earnings call

• FDA issued clinical hold on IkT-148009-201 program in PD and use in MSA; official letter to be issued within 30 days.
• Observed only two mild adverse events in Phase 2a 201 trial, no serious adverse events; planning blinded safety assessment.
• Phase 1/1b study of IkT-148009 showed safety, well-tolerated over 7 days with CNS penetration.
• Preclinical efforts advancing IkT-001Pro towards clinic by end of year; FDA cleared IND for IkT-001Pro.
• IkT-001Pro is prodrug formulation of imatinib to improve safety for CML; aiming for single ascending dose 501 bio-equivalence study.
• As of 9/30/2022, had ~$26.5M in cash, etc.; net loss $4.5M; cash expected to fund ops through Feb 2024.

No distinct product segments with revenue contribution details provided; focus is on specific drug programs like IkT-148009 and IkT-001Pro.

• Existing cash, etc. will fund normal operations and capital expenditures through February 2024, subject to FDA discussions on 148009 program.
• Expect to initiate 501 bioequivalence study for IkT-001Pro by end of 2022.

• FDA clinical hold on IkT-148009 programs in PD and MSA; need to resolve FDA concerns.
• Uncertainties in restarting the study once clinical hold is lifted and discussions with FDA occur.

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