Inhibikase Therapeutics Announces Q1 2024 Financial Results and Recent Activities

Inhibikase Therapeutics, Inc., a clinical-stage pharmaceutical company, has announced its financial results for the first quarter ending March 31, 2024, along with key recent advancements. Dr. Milton H. Werner, President and CEO, highlighted the company's progress in both clinical and regulatory fronts, marking 2024 as a pivotal year.

The Phase 2 trial of Risvodetinib (risvo), aimed at treating untreated Parkinson's disease, is nearing completion with 83% of participants enrolled as of May 10, 2024. The final participant is expected to be enrolled in June, with results of biomarker and functional assessments to be disclosed in the latter half of the year. On the regulatory side, Inhibikase has had favorable interactions with the FDA regarding IkT-001Pro for cancers and cardiopulmonary diseases. Dr. Werner expressed optimism about continuing the development of these therapies to provide transformative treatments for patients.

Key Recent Developments and Milestones:

1. Pre-NDA Meeting for IkT-001Pro in Oncology: On February 12, 2024, Inhibikase received final minutes from the FDA's Division of Hematologic Malignancies, outlining requirements for a 505(b)(2) NDA submission for IkT-001Pro in up to 11 cancer indications. The company is considering a 1200 mg dose study to achieve exposure levels equivalent to 800 mg of imatinib and plans additional analysis of gut absorption. Milestone-based meetings with the FDA will be requested to maintain alignment throughout the NDA submission process.

2. Pre-IND Meeting for IkT-001Pro in Pulmonary Arterial Hypertension: On April 5, 2024, the company had a Pre-IND meeting with the FDA's Division of Cardiology and Nephrology. The meeting confirmed that IkT-001Pro would be classified as a novel chemical entity, eligible for exclusivity designations, and could be approved under the 505(b)(2) statute. The FDA supported the initial Phase 2/3 design, requesting a pre-clinical hERG study, expected to be completed this quarter.

3. 201 Trial of Risvodetinib: Enrollment for the 201 trial of Risvodetinib is expected to complete in the second quarter of 2024. As of May 10, 2024, 99 participants have been enrolled, with several more in screening. The company aims to report topline data in the second half of 2024, including novel biomarker data on alpha-synuclein aggregates and risvo's impact on Parkinson’s disease pathology. Post-completion of the double-blinded phase, an end-of-Phase 2 meeting with the FDA will be requested. Additionally, Inhibikase plans to initiate a 12-month extension study of risvo in 2024, subject to resources.

First Quarter Financial Results:

- Net Loss: The net loss for the quarter ended March 31, 2024, was $4.6 million, or $0.73 per share, compared to $4.5 million, or $0.98 per share, in the same quarter of 2023.
- R&D Expenses: Research and development expenses were $2.8 million, slightly down from $2.9 million in the previous year due to a decrease in IkT-001 Pro expenses, partially offset by increased Risvodetinib expenses.
- SG&A Expenses: Selling, general, and administrative expenses were $2.0 million, a slight increase from $1.9 million, mainly due to increased legal and consulting fees.
- Cash Position: As of March 31, 2024, cash, cash equivalents, and marketable securities stood at $9.7 million, with sufficient funds expected to support operations through November 2024.

Inhibikase plans to host a conference call on Thursday, May 16, 2024, at 8:00 a.m. ET to discuss these results and developments. Participants can join via specified phone lines, and a live webcast will be accessible through the company's website. The call will be archived for 90 days for later access.

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