Inhibikase Therapeutics, Inc. Q4 FY2023 earnings call

• Introduced new Chief Financial Officer Garth Lees-Rolfe and thanked outgoing CFO Joe Frattaroli. - 2023 was a year of execution with advancements across the clinical pipeline, including a pre-NDA meeting with the FDA for IkT-001Pro and rapid enrollment in the 201 Trial for Risvodetinib. - Risvodetinib 201 Trial: ~61% enrolled as of March 22, 73 participants, 34 completed 12-week dosing, plan to report top line results in H2 2024; need additional financing for extension study. - Published Phase I/Ib data for Risvodetinib in the Journal of Parkinson Disease, highlighting safety, tolerability, and pharmacokinetics. - IkT-001Pro: Pre-NDA meeting with FDA, FDA review team feedback, plan to evaluate 1200-milligram dose, initiate preclinical test for gut absorption.

Net loss for the year ended December 31, 2023 was $19.0 million or $3.57 per share, compared to a net loss of $18.1 million, or $4.28 per share for the year ended December 31, 2022. Research and development expenses for the full year ended December 31, 2023 was $13.6 million compared to $12.0 million for the full year 2022. Selling, general and administrative expenses for the full year 2023 was $6.7 million compared to $6.2 million for the same period in 2022. As of December 31, 2023, there was $13.3 million in cash, cash equivalents and marketable securities.

• Existing cash and cash equivalents expected to fund operations into the first quarter of 2025. - Plan to report top line results from the 201 Trial in the second half of 2024. - Need additional financing to begin enrolling participants into the extension study of Risvodetinib. - Plan to build the first NDA package for IkT-001Pro and seek milestone meetings with the FDA.

• Need for additional financing to start enrollment in the Risvodetinib extension study. - Regulatory uncertainties in the NDA submission process for IkT-001Pro. - Potential delays in clinical trials due to various factors.

Q: Assuming positive data in Parkinson's in the second half, what are the next steps towards approval and timing?

A: Approval is a 2-3 year process. Need to assess benefit at doses, possibly seek accelerated approval, plan Phase III trials, manufacturing is ahead, tablet formulation tested in extension trial.

Q: For IkT-001Pro, comment on big-picture strategy and potential partnering?

A: 001Pro is a novel molecule, composition of matter protection. Seeking partner for non-inferiority/superiority trial. Upcoming FDA meeting on non-oncology indications.