Inhibikase Therapeutics Announces Q1 Financial Results and Recent Activity

Inhibikase Therapeutics, Inc., a clinical-stage pharmaceutical company focusing on protein kinase inhibitor therapeutics for Parkinson's disease and related disorders, announced its financial results for the first quarter ending on March 31, 2024, alongside recent progress in its clinical and regulatory endeavors.

Dr. Milton H. Werner, President and CEO of Inhibikase, remarked that 2024 appears to be pivotal for clinical and regulatory advancements. The company's Phase 2 201 trial for Risvodetinib in untreated Parkinson’s disease is nearly fully enrolled, with 83% of participants as of May 10, 2024. The final patient is expected to be enrolled by June, with results on biomarkers and functional assessments anticipated in the latter part of the year. Regulatory discussions with the FDA regarding IkT-001Pro in cancer and cardiopulmonary diseases have also been positive, suggesting continued development of both Risvodetinib and IkT-001Pro.

Key Developments and Expectations:

1. IkT-001Pro in Oncology: Inhibikase conducted a Pre-NDA meeting with the FDA on February 12, 2024, for IkT-001Pro, aimed at treating various blood and stomach cancers. The company's discussions with the FDA outlined the requirements for a 505(b)(2) NDA submission. Subsequently, Inhibikase is evaluating a 1200 mg dose of IkT-001Pro, which is projected to match the exposure levels of 800 mg of imatinib. The company plans to conduct further comparative studies on gut absorption between IkT-001Pro and imatinib mesylate. Milestone-based meetings will be sought to maintain alignment with the FDA throughout the NDA submission process.

2. IkT-001Pro for Pulmonary Arterial Hypertension (PAH): On April 5, 2024, Inhibikase met with the FDA’s Division of Cardiology and Nephrology to discuss using IkT-001Pro for PAH treatment. The FDA's final meeting minutes confirmed that IkT-001Pro is considered a novel chemical entity, qualifying for exclusivity designations despite being eligible for approval under the 505(b)(2) statute. The FDA endorsed the initial Phase 2/3 trial design but requested a pre-clinical hERG study, a 7-day cell culture-based experiment comparing IkT-001Pro with imatinib, expected to be completed in the current quarter.

3. Risvodetinib Phase 2 201 Trial: As of May 10, 2024, Inhibikase had enrolled 99 participants, with additional candidates in various stages of the screening process. Out of the enrolled participants, 44 have completed the 12-week dosing period. The trial has reported 25 mild and three moderate adverse events potentially related to Risvodetinib. The company anticipates reporting topline data, including novel biomarker measurements related to alpha-synuclein aggregates, in the latter half of 2024. Following the completion of the double-blind phase of the 201 trial, an end-of-Phase 2 meeting with the FDA will be requested. Additionally, plans to initiate a 12-month extension study for Risvodetinib in 2024 are contingent on resource availability.

First Quarter Financial Results (Q1 2024):

- Net Loss: The net loss for Q1 2024 was $4.6 million, or $0.73 per share, compared to a $4.5 million loss, or $0.98 per share, for Q1 2023.
- R&D Expenses: Research and development expenses were $2.8 million in Q1 2024, slightly down from $2.9 million in Q1 2023. This decrease was attributed to a reduction of $0.7 million in IkT-001Pro expenses, partially offset by a $0.6 million increase in Risvodetinib-related costs.
- SG&A Expenses: Selling, general, and administrative expenses were $2.0 million, up from $1.9 million in Q1 2023. The increase was mainly due to a $0.18 million rise in legal and consulting fees, counterbalanced by a net decrease of $0.08 million in other SG&A expenses.
- Cash Position: As of March 31, 2024, the company had $9.7 million in cash, cash equivalents, and marketable securities, sufficient to fund operations through November 2024.

Conference Call Information:
Inhibikase will host a conference call on May 16, 2024, at 8:00 a.m. ET to discuss the results. Participants can dial specific numbers for access, and a live webcast will be available on the company's website, with an archived version accessible for 90 days post-call.

Inhibikase Therapeutics continues to advance its pipeline, focusing on treatments that address critical needs in neurodegenerative and other serious diseases.

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