Inhibikase Therapeutics Announces Q2 Financial Results and Recent Activities
Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage pharmaceutical company focusing on protein kinase inhibitor therapeutics for Parkinson’s disease and related conditions, has shared its financial results for Q2 2024, alongside updates on its recent advancements.
Dr. Milton H. Werner, President and CEO of Inhibikase, highlighted the progress made within the first half of the year, emphasizing the advancements of their key programs. "We have successfully completed enrollment for The 201 Trial, which evaluates risvodetinib (risvo) in untreated Parkinson’s disease," stated Dr. Werner. The final patient participating in this trial is expected to complete their involvement by September 2024, with topline data anticipated by November 2024. Additionally, IkT-001Pro, which is being assessed as a potential treatment for Pulmonary Arterial Hypertension (PAH), has shown progress, with the necessary manufacturing processes advancing towards a scalable model.
Key Developments:
1. Completion of Phase 2 '201' Trial Enrollment:
In June 2024, the final participant of the Phase 2 ‘201’ trial for untreated Parkinson’s disease was enrolled. This trial, which included 126 participants, aims to evaluate the safety and tolerability of risvodetinib. As of late July 2024, 84 participants had completed the 12-week dosing period. Notably, the trial observed 41 mild and 8 moderate adverse events potentially related to the treatment, and six participants withdrew before completing the 12 weeks. Additionally, several participants have agreed to partake in biomarker studies related to synuclein aggregate deposition.
2. Advancement of IkT-001Pro for PAH:
Inhibikase took significant steps forward with IkT-001Pro by submitting an Investigational New Drug (IND) application to the FDA following a pre-IND meeting. The FDA has acknowledged that Inhibikase has successfully built a bridge between imatinib’s prior use in cancers and its potential application in PAH. Pre-clinical studies have indicated that IkT-001Pro does not inhibit hERG, suggesting a lower risk of QTcF prolongation compared to imatinib. If approved, IkT-001Pro could provide a safer alternative with fewer side effects and cater to a market estimated at $7.66 billion in 2023.
3. Manufacturing Advancements for IkT-001Pro:
Post a pre-NDA meeting with the FDA in January 2024, the company has significantly advanced its manufacturing processes for IkT-001Pro. Efforts include developing new dosage forms, enhancing production efficiency, and implementing a high throughput tableting process.
4. Financial Highlights:
- Net Loss: The company reported a net loss of $5.0 million for Q2 2024, a reduction from $5.8 million in the corresponding period in 2023.
- R&D Expenses: Research and Development expenses decreased to $3.1 million from $4.5 million in Q2 2023, primarily due to the completion of a dose-finding study for IkT-001Pro.
- SG&A Expenses: Selling, General, and Administrative expenses rose slightly to $2.0 million from $1.8 million in Q2 2023, driven by increased legal and consulting fees.
- Cash Position: As of June 30, 2024, Inhibikase had $7.9 million in cash, cash equivalents, and marketable securities. The company expects this to support operations through December 2024.
5. Fundraising Success:
In May 2024, Inhibikase successfully raised $4 million through a registered direct offering and a concurrent private placement. These funds are earmarked for advancing risvodetinib towards Phase 3 trials and completing pre-clinical studies for IkT-001Pro in PAH.
Inhibikase continues to develop its multi-therapeutic pipeline, focusing primarily on neurodegeneration and conditions associated with Abelson Tyrosine Kinases. Alongside Parkinson’s disease treatments, the company is exploring applications of its lead program in related disorders and advancing drug delivery technologies for kinase inhibitors.
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