Inhibikase Therapeutics, Inc. Q1 FY2023 earnings call

• Continued validating lead IkT-148009 program in Parkinson's disease, with first patient enrolled in Phase 2 '201' trial and up to 14 sites to screen patients by end of May. • Enhanced 201 trial with implementation of state-of-the-art biomarker analyses in skin and spinal fluid. • Advanced 501 bioequivalence study of IkT-001Pro for Stable-Phase CML, completed dose escalation phase and commenced confirmatory analysis phase. • Preclinical development of 148009 in Multiple System Atrophy, with preliminary results from animal model studies presented in March 2023 Research and Development Day. • 148009 designed to have low toxicity profile, cross blood-brain barrier, and accumulate in brain for functional recovery in Parkinson's and related disorders.

For the first quarter of 2023, Inhibikase reported a net loss of approximately $4.5 million or $0.16 per share, compared to a net loss of $4.6 million or $0.18 per share in the same quarter of 2022. Research and development expenses were $2.9 million for the quarter ended March 31, 2023, down from $3 million in the quarter ended March 31, 2022. Selling, general and administrative expenses were $1.9 million for the quarter ended March 31, 2023, up from $1.7 million in the quarter ended March 31, 2022. As of March 31, 2023, the company had approximately $25.7 million in cash, cash equivalents and marketable securities, including net proceeds from the $10 million January 2023 concurrent registered direct offering and private placement.

• Existing cash, cash equivalents, and marketable securities expected to fund operations into the fourth quarter of 2024. • Target to enroll all 120 patients in the 201 trial in the 2023 calendar year. • Anticipate advancing confirmatory analysis in the 501 bioequivalence study for 001Pro in July and completing the trial by end of the second quarter.

• Actual results could differ materially from forward-looking statements due to risks and uncertainties associated with the company's business, as set forth in recent public filings with the SEC.

Q: Good morning. Thanks for taking my questions. So congratulations on getting the first patient dosed in the 201 trial. I know it's very early, but I'm just wondering, if you can give us your thoughts on how long do you think the enrollment for the whole 120 patients is going to take?

A: In our 2023 Research and Development Day, and that presentation is on our website under the Presentations tab, we had guided that we plan to have the trial enrolled in this calendar year. So that's our target. It's premature to know whether the rate of enrollment is leading that target. That will depend on how we get all the sites running and the screening activities, et cetera.

Q: Okay. Thanks, Milton. And just a question on 001Pro, when do you expect to schedule a meeting with the FDA to discuss the path forward and have you -- had any partner interest in the product?

A: Well, partner interest in the product, so I'll answer that question first, it's going to be dependent on showing a differentiation between imatinib mesylate standard-of-care and it’s a prodrug. This study is planned was there to establish what bioequivalence was. We have two types of mechanisms that we are contemplating to demonstrate the improvement over standard of care, one is, the potential for an added cohort at the end of the 501 study, where we'll look at high dose imatinib at steady-state, because we've begun to see a separation in the safety profile of 001Pro more favorably than for imatinib mesylate 400 milligram, we can amplify that difference by looking at a common dose that's used in the clinic, which is 600 milligram imatinib and do a steady-state cohort in healthy subjects for that. Once the bioequivalence pharmacokinetic analysis completes, which we think will occur this month, we'll submit that data and the request to the FDA for them to sign-off on adding that cohort because high dose imatinib could carry a number of side effects for healthy subjects and the FDA has to weigh in before we execute on that component. The other path, which is really a path for future work with a potential partner is to do a formal safety superiority study in the target population, which we've previously disclosed would be a roughly year-long study at 98 a stable phase CML patients. And that trial is outlined in our corporate presentations that you can find on our website. We have not yet reached out to partners because we need to see the full pharmacokinetic profile and have the equivalent dose and then put the package together and we'll start marketing it. So that will -- that process will begin within this month and we should be able to go out and begin talking to potential partners beginning in June.

Q: Okay. Thank you, Milton. And Joe, just a couple of questions for you. R&D was down sequentially. You mentioned the reasons why, now that the study is up and running, you're enrolling patients in the 201 trial. I just wanted to get your thoughts on how we should think about the progression of R&D expenses this year?

A: Thanks, Ed. Great question. Yeah. I mean really R&D was down slightly. But the composition really was that the prior year's quarter, the PD represented about a little over 83% of the total R&D in the current year quarter, down to 61%. I think that through the end of the year, Parkinson's will again be above 80% to 85% of all the R&D expenses.