BOSTON and ATLANTA – Inhibikase Therapeutics, Inc. (NASDAQ: IKT), a clinical-stage pharmaceutical company, announced it will engage with the U.S. Food and Drug Administration (FDA) to discuss a potential treatment for Pulmonary Arterial Hypertension (PAH).
The pre-Investigational New Drug (IND) meeting with the FDA's Division of Cardiology and Nephrology is scheduled for April 5, 2024. The goal is to obtain regulatory guidance on a late-stage trial for IkT-001Pro, a kinase inhibitor that may offer a more tolerable treatment option for PAH compared to currently available therapies.
Dr. Milton Werner, President and CEO of Inhibikase, highlighted the need for a safer therapeutic alternative for PAH, a condition that can lead to heart failure and primarily affects women aged 30 to 60. The active ingredient in IkT-001Pro, imatinib, has previously demonstrated potential as a disease-modifying agent for PAH but was not approved due to its adverse event profile. The upcoming FDA meeting will focus on the design of a late-stage trial to assess the efficacy and safety of IkT-001Pro in patients with WHO Class I PAH.
The company's request for this meeting follows a pre-New Drug Application (NDA) discussion with the FDA in January regarding the approval path for IkT-001Pro in various blood and stomach cancers. The discussion with the FDA will also cover regulatory advice on potential exclusivity and approval pathways for IkT-001Pro as a branded product for PAH.
PAH is a rare disease affecting the pulmonary microvasculature, with approximately 30,000 cases in the U.S. The global PAH market was valued at $7.66 billion in 2023, with an estimated growth rate of 5.4% from 2024 to 2030. The recent approval of another treatment, Winrevair®, indicates that disease modification in PAH is achievable. Inhibikase aims to reproduce the efficacy of imatinib with better safety and tolerability through IkT-001Pro.
Inhibikase Therapeutics specializes in developing treatments for Parkinson's disease and related disorders. The company's pipeline focuses on neurodegeneration and diseases arising from Abelson Tyrosine Kinases. The information in this article is based on a press release statement.
InvestingPro Insights
Inhibikase Therapeutics, Inc. (NASDAQ: IKT), while advancing its clinical trials, presents a mixed financial picture according to recent InvestingPro data. The company holds a market capitalization of 13.93 million USD, which is rather modest for the biotech industry. Despite a remarkable revenue growth of 111.03% in the last twelve months as of Q4 2023, it's important to note the company's revenue dropped by 100% in Q4 2023 compared to the previous quarter, indicating potential volatility in their financial performance.
InvestingPro Tips suggest that while Inhibikase holds more cash than debt, providing some financial stability, the company is quickly burning through its cash reserves. Additionally, the firm has been grappling with weak gross profit margins, which have been reported at a staggering negative 5127.75% for the same period. This suggests that the costs of goods sold far exceed the revenue generated from those goods, a situation that may raise concerns about the company's current business model and pricing strategies.
With the company not being profitable over the last twelve months and suffering from a poor free cash flow yield as implied by its valuation, investors should be cautious. However, on a more positive note, liquid assets exceed short term obligations, which could offer some reassurance regarding the company's short-term financial health. It's also noteworthy that the stock has seen a strong return over the last three months, with a price total return of 62.88%, and a large price uptick over the last six months, at 53.57%. Despite this recent uptick in stock price, Inhibikase does not pay a dividend to shareholders, which is a common characteristic of many growth-focused biotech firms.
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