Inhibikase Therapeutics, Inc. Q2 FY2023 earnings call

• Progress in Phase II 201 trial for Parkinson's disease: Screening and enrolling patients across 22 of 35 planned sites, with first patient on 12-week dosing regimen; launched public awareness campaign via 201trial.com with outreach to patient advocacy groups, etc.
• Completion of pivotal phase of 501 trial evaluating bioequivalence between IkT-001Pro and commercial imatinib mesylate; contemplating high-dose bioequivalence cohort to explore safety benefit of IkT-001Pro delivery.
• Preclinical efforts in multiple system atrophy (MSA): Evaluating 2 models for IkT-148009's effect on MSA, with first MSA model study near completion showing functional benefit, and second study ongoing with expected completion by end 2023, forming basis for planned Phase II study in MSA.
• Continued expansion in drug delivery expertise, including improved efficiency of IkT-148009's commercial tablet formulation.

For the second quarter ended June 30, 2023, Inhibikase reported a net loss of $5.8 million or $1.11 per share compared to a net loss of $4.6 million or $1.10 per share in the same quarter of 2022. Research and development expenses were $4.5 million in Q2 2023 compared to $3 million in Q2 2022, primarily due to ongoing Phase II 201 PD clinical trial costs and IkT-001Pro for the CML program. Selling, general and administrative expenses were $1.8 million in Q2 2023 compared to $1.7 million in Q2 2022, driven by a net increase in normal SG&A expenses. As of June 30, 2023, the company had approximately $20.9 million in cash and cash equivalents, with existing funds expected to support operations into Q4 2024.

• Plan to release full data description for pivotal phase of 501 trial in near term; plan to engage FDA to discuss parameters of drug approval under 505(b)(2) pathway.
• Guidance on enrollment rate for Phase II 201 trial to be provided closer to next quarterly report.
• Expect existing cash and cash equivalents to fund operations into Q4 2024.

• Challenges in Parkinson's patient enrollment due to telehealth impact leading to earlier physician treatment decisions for Parkinson's patients.
• Uncertainties in regulatory approvals and the process of engaging the FDA for drug approval pathways.
• Potential variability in clinical trial outcomes and enrollment rates affecting the timeline for data readouts and subsequent steps.

Q: On the Phase II 201 trial, how many sites have enrolled patients so far and is the screening process meeting expectations?

A: Milton Werner mentioned it's a challenging patient population with Parkinson patients now in telehealth, not yet providing enrollment rate guidance and stating they'll provide it closer to the next quarterly report.

Q: On the 501 trial for IkT-001Pro, what are the pros and cons of considering a high-dose bioequivalence cohort?

A: Milton Werner explained that the FDA's norm is Phase I studies in target population for oncology agents, but they have agreement with FDA to do studies in healthy subjects, the 600-milligram dose is widely used but poorly tolerated, and the agency agreed to a design similar to dose escalation phase with 8 subjects, single dose, full PK and safety description.

Q: How should we think of R&D expenses into the second half of the year with patient enrollment in the 201 trial and potential high-dose cohort for 501 trial?

A: Milton Werner stated all current activities are part of existing budget with no concern of burn rate exceeding resources, and Joseph Frattaroli added that budgeted items are contemplated in present cash forecast with outflow dependent in part on enrollment rate which is still being assessed