Inhibikase Therapeutics, Inc. develops clinical-stage protein kinase inhibitor therapeutics for cardiopulmonary disease, with IKT-001, an oral prodrug of imatinib mesylate, as its lead program for pulmonary arterial hypertension. Company news centers on the IMPROVE-PAH clinical program, FDA interactions, clinical-development milestones, and PAH biology involving Abelson tyrosine kinase, platelet-derived growth factor receptors and c-KIT.
Recurring updates also cover operating results, development spending, equity compensation under Nasdaq rules, common-stock and warrant financing activity, and leadership or commercial-planning changes tied to the PAH program.
Inhibikase Therapeutics (IKT) reported Q3 2024 financial results and secured transformative financing of up to $275 million from healthcare investors. The company received a Study May Proceed letter for IkT-001Pro in Pulmonary Arterial Hypertension (PAH) and added four new board members. Q3 net loss was $5.8 million ($0.65/share), with R&D expenses at $4.2 million and SG&A at $1.6 million. Cash position was $3.2 million as of September 30, excluding the recent $110 million private placement. The company expects topline data from the Phase 2 201 Trial of risvodetinib in Parkinson's disease in Q4 2024.
Inhibikase Therapeutics (Nasdaq: IKT) has closed a private placement of approximately $110 Million with potential aggregate financing of up to $275 Million. The funds will support the Phase 2b '702' trial of IkT-001Pro in Pulmonary Arterial Hypertension (PAH). IkT-001Pro, containing imatinib, is being developed as a New Molecular Entity and the first oral, potentially disease-modifying treatment for PAH, a rapidly fatal disease primarily affecting women aged 30-60.
The company has appointed four new Board members: Roberto Bellini (Independent Chairperson), Amit Munshi, Arvind Kush, and David Canner. This investment from top-tier healthcare funds recognizes IkT-001Pro's potential to improve PAH patients' lives by potentially addressing the safety and tolerability issues that prevented imatinib's approval over a decade ago.
Inhibikase Therapeutics (Nasdaq: IKT) has announced the pricing of a $110 million private placement to advance IkT-001Pro, an optimized prodrug of Imatinib, into a late-stage trial for Pulmonary Arterial Hypertension (PAH). The financing, led by Soleus Capital, involves selling 58,310,000 shares of common stock and pre-funded warrants for 21,985,000 shares, along with accompanying Series A-1 and B-1 warrants. The purchase price is $1.37 per share.
The company plans to use the proceeds to initiate a Phase 2b trial in PAH. The private placement is expected to close on October 21, 2024. Additionally, four new directors will join the company's board, including Roberto Bellini as Independent Chairperson.
Inhibikase Therapeutics (Nasdaq: IKT) reported Q2 2024 financial results and recent developments. Key highlights include:
1. Completed enrollment for Phase 2 '201' trial of risvodetinib in untreated Parkinson's disease, with topline data expected in November 2024.
2. Advanced IkT-001Pro for Pulmonary Arterial Hypertension (PAH), submitting an IND to the FDA.
3. Scaled manufacturing of IkT-001Pro to support late-stage clinical development and NDA requirements.
4. Raised $4 million in a registered direct offering and private placement.
5. Q2 2024 net loss of $5.0 million ($0.66 per share), compared to $5.8 million ($0.94 per share) in Q2 2023.
6. R&D expenses decreased to $3.1 million from $4.5 million year-over-year.
7. Cash position of $7.9 million as of June 30, 2024, expected to fund operations into December 2024.
Inhibikase Therapeutics (Nasdaq: IKT), a clinical-stage pharmaceutical company focusing on protein kinase inhibitor therapeutics for Parkinson's disease and related disorders, has announced its schedule for reporting second quarter 2024 financial results. The company will release its financial report on August 14, 2024, after U.S. markets close. Following this, Inhibikase will host a conference call and webcast on August 15, 2024, at 8:00 a.m. ET to provide a corporate update and review the financial results.
Investors and interested parties can access the conference call by dialing 1-877-407-0789 (U.S.) or 1-201-689-8562 (International). A live webcast will also be available through a link on the company's website. The webcast will be archived on Inhibikase's website for approximately 90 days after the call.
Inhibikase Therapeutics (Nasdaq: IKT) announced the completion of enrollment in its Phase 2 '201' trial of risvodetinib (risvo), a selective c-Abl inhibitor, for untreated Parkinson's disease patients. The 12-week, randomized, double-blind, placebo-controlled trial involves 120 participants across 32 U.S. sites, with the company expecting to report results in Q4 2024. Out of the enrolled participants, 69 have completed the dosing period. To date, 32 mild and 5 moderate adverse events possibly related to the treatment have been reported, with four participants withdrawing early from the study.
Inhibikase Therapeutics (Nasdaq: IKT) is expanding its therapeutic pipeline and updating its R&D programs. The company is positioning multiple assets for late-stage development, particularly for Parkinson's disease (PD) and related disorders. The 201 Trial for untreated PD is 94% enrolled, with completion expected by mid-June 2024. Inhibikase is also seeking grant funding for its 202 Trial in Multiple System Atrophy (MSA) through NINDS. Additionally, following a pre-IND meeting with the FDA, the company will redirect IkT-001Pro towards cardiopulmonary disease, specifically Pulmonary Arterial Hypertension (PAH). The company will submit an IND application for IkT-001Pro for PAH early in Q3 2024. Inhibikase is also scaling manufacturing of IkT-001Pro to support late-stage development and NDA requirements. Lastly, the company will discontinue antiviral development for PML to focus on late-stage assets in neurodegeneration, cancer, and cardiopulmonary disease.
Inhibikase Therapeutics announced a registered direct offering and warrant inducement, totaling gross proceeds of $4.0 million. The agreement includes 1,672,452 shares of common stock or pre-funded warrants, and corresponding Series A and B warrants for the same amount, all priced at $1.68 per share. Additionally, the company has amended the exercise price for outstanding warrants from January 2023 to $1.68, resulting in the immediate exercise of 708,500 shares and issuance of new Series C and D warrants. The proceeds are before placement agent fees and are expected to close by May 22, 2024.
Inhibikase Therapeutics reported its Q1 2024 financial results and recent developments. The net loss for Q1 2024 was $4.6 million ($0.73 per share), slightly higher than Q1 2023's $4.5 million ($0.98 per share). R&D expenses decreased to $2.8 million from $2.9 million, primarily due to reduced costs for IkT-001Pro, while SG&A expenses increased to $2.0 million from $1.9 million.
The Phase 2 trial for Risvodetinib in Parkinson's disease is 83% enrolled, with final enrollment expected in June 2024. The company completed Pre-NDA and Pre-IND meetings with the FDA for IkT-001Pro, targeting oncology and pulmonary arterial hypertension. Cash reserves stand at $9.7 million, projected to fund operations through November 2024.
Inhibikase will host a conference call on May 16, 2024, at 8:00 a.m. ET to discuss these results.
Inhibikase Therapeutics announced the withdrawal of its Registration Statement on Form S-1, initially filed with the SEC on April 19, 2024. The company confirmed that the S-1 had not yet been declared effective and that no securities were sold related to this filing. This action reflects a strategic decision not to proceed with the offering at this time. The press release clarifies that this announcement does not constitute an offer to sell or solicit offers to buy any securities of the company.