Inhibikase Therapeutics, Inc. Q3 FY2023 earnings call

• Progress in the Phase II 201 trial for risvodetinib in Parkinson's disease, with 24 participants enrolled, 9 in screening, and 15 in informed consent; 5 participants completed the 12-week regimen. Work ongoing on a 12-month extension study. - Completed 501 bioequivalent study for IkT-001PRo, submitting briefing documents to FDA for 505(b)(2) pathway. - Medicinal chemistry efforts advancing second-generation c-Abl inhibitors for improved brain delivery. - Received orphan drug designation for risvodetinib in multiple system atrophy, working towards Phase II study initiation. - Public unblinded functional data from 11 Parkinson's patients pulled from the 201 trial showed potential benefits with higher doses, though sample size was small.

For the third quarter ended September 30, 2023, research and development expenses were $3.23 million, an increase from $2.98 million in the same quarter of 2022, primarily due to the ongoing Phase II 201 trial in Parkinson's disease. Selling, general and administrative expenses were $1.62 million, up from $1.4 million in Q3 2022, driven by normal operating increases. As of September 30, 2023, cash, cash equivalents, and marketable securities totaled approximately $16.83 million, and existing funds are expected to support operations into Q4 2024.

• Existing cash, cash equivalents, and marketable securities are expected to fund operations into Q4 2024. - Expect to burn an average of $1.2 million to $1.3 million per month through the next year, subject to enrollment rates.

• Actual results could differ materially from forward-looking statements due to risks and uncertainties in the company's business, as outlined in SEC filings. - Risks associated with clinical trial progress, regulatory approvals, and funding for new trials like the multiple system atrophy study.

Q: What is the typical time for patients to go from informed consent to dosing in the Phase II 201 trial?

A: Varies widely, typically between 1 and 2 weeks depending on site and screening processes.

Q: How many more sites do you plan on opening?

A: Currently plan on 32 sites, with some sites winding down and others coming up to meet trial needs.

Q: When is the potential start of the multiple system atrophy trial?

A: Aspirational for 2024, pending funding and discussions with stakeholders.

Q: Any comments on potential partner interest for IkT-001Pro?

A: Interest in CML, GIST, and pulmonary arterial hypertension; seeking partners for 505(b)(2) approvals, with updates expected early next year.

Q: Does cash into Q4 2024 include preparation for the MSA trial?

A: MSA trial not currently funded; normal expenses budgeted but pending additional funding.

Q: Thoughts on R&D spending trends?

A: R&D spending up due to ongoing trials, with variable costs depending on enrollment rates.