On November 14, 2024 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Cardiopulmonary and Neurodegenerative disease through Abelson Tyrosine Kinase inhibition, reported financial results for the third quarter ended September 30, 2024 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 14, 2024, View Source [SID1234648401]).

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"The financing we concluded in October was a transformational moment for Inhibikase, and positioned us to advance IkT-001Pro into a late-stage clinical trial in Pulmonary Arterial Hypertension (PAH)," said Dr. Milton Werner, President and Chief Executive of Inhibikase. "This investment, with top tier dedicated healthcare investment funds, recognized the potential of IkT-001Pro to improve the lives of patients afflicted with PAH. We believe IkT-001Pro, a prodrug of imatinib, has the potential to ameliorate the safety and tolerability profile that precluded approval of imatinib for the treatment of PAH more than 10 years ago. This investment further validates the Company’s innovative approach to the development of kinase inhibitor therapeutics in the non-oncology setting."

Recent Developments and Upcoming Milestones:

Closed up to $275 million financing in October 2024 in support of advancing IkT-001Pro into a late-stage clinical trial in PAH
Private placement of approximately $110 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants with potential aggregate financing of up to approximately $275 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement fees and offering expenses. The financing will fund execution of the Phase 2b ‘702’ trial in Pulmonary Arterial Hypertension (PAH) and general corporate purposes.
Added three highly accomplished leaders in biopharmaceutical development and a Partner of Soleus Capital to the Board of Directors coincident with the financing:
Roberto Bellini, Managing Partner of BSQUARED Capital and former Chief Executive Officer of BELLUS Health Inc.
Amit Munshi, Chief Executive Officer of Orna Therapeutics and former CEO of Arena Pharmaceuticals,
Arvind Kush, Chief Financial Officer and Chief Business Officer of Candid Therapeutics and former CFO of RayzeBio
David Canner, Partner at Soleus Capital
In addition to joining the Board of Directors, Messers. Bellini, Munshi and Kush each participated in the financing; Mr. Bellini has been appointed Independent Chairperson of the Inhibikase Board.
Advancement of IkT-001Pro as a therapy in Pulmonary Arterial Hypertension:
The Company received its Study May Proceed letter on September 9, 2024.
The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that IkT-001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication.
Following the Company’s pre-NDA meeting with the FDA in January 2024, Inhibikase enhanced its manufacturing process development efforts for IkT-001Pro to support late-stage clinical development. Ongoing activities include development of new dosage forms, a more efficient production process and a high throughput tableting process that will lead to dosage forms for 001Pro tablets that are differentiated from generic imatinib mesylate in alignment with FDA feedback.
The last patient and last visit in the Phase 2 201 Trial evaluating risvodetinib (also known as IkT-148009) in untreated Parkinson’s disease occurred in October, 2024; topline data is expected in the fourth quarter of 2024. The trial randomized 126 patients total, 120 of which completed the 12 week double blind dosing period.
Third Quarter Financial Results

Net Loss: Net loss for the quarter ended September 30, 2024, was $5.8 million, or $0.65 per share, compared to a net loss of $4.6 million, or $0.75 per share in the quarter ended September 30, 2023. The net loss per share does not give effect to the shares issued in the October 2024 financing.

R&D Expenses: Research and development expenses were $4.2 million for the quarter ended September 30, 2024 compared to $3.23 million in the quarter ended September 30, 2023.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2024 were $1.6 million compared to $1.62 million for the quarter ended September 30, 2023.

Cash Position: Cash, cash equivalents and marketable securities were $3.2 million as of September 30, 2024, which does not include the gross proceeds of approximately $110 million from the October 2024 Offering.