Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is 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. The company's multi-therapeutic pipeline has a primary focus on neurodegeneration, with its lead program utilizing Risvodetinib (IkT-148009), a selective inhibitor of the non-receptor Abelson Tyrosine Kinases, targeting the treatment of Parkinson's disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases.

Business Overview

In 2021, Inhibikase commenced clinical development of Risvodetinib (IkT-148009), which the company believes can modify the course of Parkinson's disease, including its manifestation in the gastrointestinal tract. In January 2023, the company initiated its Phase 2 program, termed 'the 201 trial' (www.the201trial.com), for Risvodetinib (IkT-148009) as a treatment for Parkinson's disease. As of May 10, 2023, the 201 trial is approximately 83% enrolled, with 99 participants, 15 prospective participants in medical screening, and 22 potential participants being evaluated for suitability to initiate medical screening. Additionally, 44 participants have completed the full 12-week dosing period. To-date, there have been 25 mild and 3 moderate possibly treatment-related adverse events observed across all enrolled patients taking Risvodetinib (IkT-148009). Inhibikase expects to report top-line results from the 201 trial in the second half of 2024.

Inhibikase is also developing IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate, which is intended to treat Stable Phase Chronic Myelogenous Leukemia (SP-CML). In January 2024, the company held a pre-NDA meeting with the FDA to discuss the requirements for potential approval of IkT-001Pro under the 505(b)(2) statute. The FDA provided a roadmap for the NDA submission, including the recommendation to conduct a pre-clinical test to evaluate how IkT-001Pro and imatinib affect certain gut transporters, and to consider evaluating the 1200 milligram dose of IkT-001Pro as a possible equivalent to the approved 800 milligram dose of imatinib mesylate.

In addition, on April 5, 2024, Inhibikase held a pre-IND meeting with the FDA's Division of Cardiology and Nephrology to discuss the potential of IkT-001Pro as a disease-modifying treatment for pulmonary arterial hypertension (PAH). PAH is a rare disease of the pulmonary microvasculature that primarily affects women between the ages of 30 to 60, with approximately 30,000 cases in the U.S. alone. The global PAH market size was valued at approximately $7.66 billion in 2023 and is estimated to grow at a compound annual growth rate of 5.4% between 2024 to 2030. The FDA confirmed that IkT-001Pro would be viewed as a New Molecular Entity (NME) for PAH and that the appropriate path for approval is the 505(b)(2) statute, which opens up the possibility of IkT-001Pro being granted NME and patent exclusivity on approval.

Financials

Inhibikase's financial performance in the first quarter of 2024 was marked by a net loss of $4.6 million, or $0.73 per share, compared to a net loss of $4.5 million, or $0.98 per share, in the same period of 2023. Research and development expenses for the quarter were $2.8 million, down from $2.9 million in the prior year period, while selling, general, and administrative expenses increased to $2 million from $1.9 million. As of March 31, 2024, the company had $9.7 million in cash and cash equivalents and marketable securities, which it expects will be sufficient to fund operations through November 2024.

For the full year 2023, Inhibikase reported annual net income of -$19,028,883, annual revenue of $260,500, annual operating cash flow of -$18,085,043, and annual free cash flow of -$18,099,281. The company has not provided any specific guidance or outlook for the future.

Intellectual Property

Inhibikase's patent portfolio includes nine issued patents and four pending patent applications in the United States, as well as eleven issued foreign patents and four pending foreign patent applications. The patents in this portfolio, and patents that may issue from the applications, will expire between 2033 and 2037, not taking into account any potential patent-term adjustments or extensions that may be available in the future.

Product Pipeline

The company's lead program, Risvodetinib (IkT-148009), is a potent selective inhibitor of c-Abl that is administered once daily and is believed to have the potential to slow or halt the progression of Parkinson's disease. Inhibikase is also developing IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate, which is intended to treat Stable Phase Chronic Myelogenous Leukemia (SP-CML) and potentially pulmonary arterial hypertension (PAH).

In addition to its lead programs, Inhibikase is evaluating a number of research phase molecules (IkT-148x and BIP 4-7) for a variety of neurodegenerative disease indications across its pre-clinical development pipeline. The company believes its approach to neurodegenerative disease, which focuses on understanding the underlying cause of disease and how individual proteins are linked together to define the disease process, is validated by its recent publications and oral presentations at major academic and industry conferences.

Risks and Challenges

Inhibikase faces several risks, including the ability to successfully develop and obtain regulatory approval for its product candidates, the ability to raise additional capital, and the potential impact of the COVID-19 pandemic or other future pandemics on its operations. The company also faces competition from other companies developing therapies for Parkinson's disease, chronic myelogenous leukemia, and other indications.

Conclusion

Overall, Inhibikase Therapeutics is a clinical-stage pharmaceutical company with a promising pipeline of product candidates targeting neurodegenerative diseases and other indications. The company's focus on understanding the underlying causes of disease and developing innovative therapies sets it apart in a field that has historically seen limited success in drug development. Investors will be closely watching the progress of Inhibikase's clinical trials, particularly the results of the 201 trial for Risvodetinib (IkT-148009) in Parkinson's disease, as well as the company's efforts to advance IkT-001Pro through the regulatory process.