On August 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 Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the second quarter ended June 30, 2024 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 14, 2024, View Source [SID1234645920]).

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"The first half of 2024 has showcased the strength of our pipeline through the continued execution of key milestones for both risvodetinib (risvo) and IkT-001Pro," said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "We completed enrollment of The 201 Trial evaluating risvo in untreated Parkinson’s disease, and anticipate the last patient exiting the study in September, 2024. We anticipate reporting topline data in November, 2024. Additionally, 001Pro has advanced as a potential treatment for Pulmonary Arterial Hypertension (PAH). We have filed our IND and we intend to ramp up the 702 trial following IND clearance. Finally, the manufacturing requirements for 001Pro necessary for potential approval is advancing with the on-going development of a scalable process."

Recent Developments and Upcoming Milestones:

Completed enrollment of the Phase 2 ‘201’ trial evaluating risvodetinib in untreated Parkinson’s disease: On June 17, 2024, Inhibikase announced that the final participant had been enrolled in The 201 Trial evaluating the safety and tolerability of risvodetinib as a treatment in untreated Parkinson’s patients. The trial has enrolled and randomized 126 patients total. The last patient will exit the trial in September, 2024. As of July 29, 2024, 84 participants have completed the 12-week dosing period. There have been 41 mild and 8 moderate adverse events observed that may be related to risvo treatment. Six people withdrew from the trial without completing 12 weeks of treatment. Forty-six people have agreed to participate in biomarker studies of the change in synuclein aggregate deposition in the skin and seven have agreed to biomarker studies of the status of synuclein aggregate in the spinal fluid.
Expanded Pipeline with advancement of IkT-001Pro as a therapy in Pulmonary Arterial Hypertension: Following receipt of final meeting minutes from Inhibikase’s pre-IND meeting with the FDA in May 2024, the Company submitted its IND to the FDA and plans to begin ramp-up of the Phase 2 702 trial to evaluate IkT-001Pro as a treatment for PAH, subject to receipt of the Study May Proceed letter from the FDA. In the final meeting minutes, the FDA stated that Inhibikase had built a bridge between imatinib’s use in blood and gastrointestinal cancers and PAH and that the Company’s Phase 2 design, to be known as the 702 trial, was reasonable. The Company has completed the requested pre-clinical hERG safety study showing that IkT-001Pro does not inhibit hERG and therefore is unlikely to induce QTcF prolongation in treated patients. Imatinib has previously been shown to induce QTcF prolongation in some patients.
The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that 001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication. If approved, IkT-001Pro could be a branded product with all the value drivers of a novel treatment for an indication with high unmet need valued at $7.66 billion in 2023 according to global sales data from Evaluate Pharma.
Scaled manufacturing of IkT-001Pro: Following the Company’s pre-NDA meeting with the U.S. FDA in January 2024, Inhibikase scaled its process development efforts for IkT-001Pro to support late-stage clinical development and NDA batch requirements. 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.
Successfully raised $4.0 Million in a registered direct offering and concurrent private placement: In May 2024, Inhibikase raised $4 million in aggregate gross proceeds from its registered direct offering and concurrent private placement. The Company is using the net proceeds from the offering to progress risvodetinib towards its planned Phase 3 trials in 2025 and completed pre-clinical studies requested by the FDA that enabled the IND filing for 001Pro in PAH.
Second Quarter Financial Results

Net Loss: Net loss for the quarter ended June 30, 2024, was $5.0 million, or $0.66 per share, compared to a net loss of $5.8 million, or $0.94 per share in the quarter ended June 30, 2023. The net loss per share for the three and six months ended June 30, 2023, was adjusted to show an improvement from ($1.11) to ($0.94) and from ($2.09) to ($1.74), respectively.

R&D Expenses: Research and development expenses were $3.1 million for the quarter ended June 30, 2024 compared to $4.5 million in the quarter ended June 30, 2023. The $1.5 million decrease in research and development expenses was due to a decrease of $1.4 million in IkT-001Pro expenses due to the completion of the three-part dose finding/dose equivalence study in 2023 and a net decrease of $0.1 million in other research and development expenses.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2024 were $2.0 million compared to $1.8 million for the quarter ended June 30, 2023. The $0.2 million increase was primarily driven by a $0.4 million increase legal and consulting fees partially offset by a $0.1 million decrease in D&O insurance and a $0.1 million net decrease in all other normal selling, general and administrative expenses.

Cash Position: Cash, cash equivalents and marketable securities were $7.9 million as of June 30, 2024. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into December, 2024.

Conference Call Information
The conference call is scheduled to begin at 8:00am ET on August 15, 2024. Participants should dial 1-877-407-0789 (United States) or 1-201-689-8562 (International). A live webcast may be accessed using the link HERE or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.