Atlanta-based pharmaceutical company Inhibikase Therapeutics Inc. is planning to raise $18 million in an initial public stock offering.
Inhibikase is a clinical stage pharmaceutical company developing therapeutics for Parkinson’s Disease, or PD, and related disorders. PD is the second most prevalent neurodegenerative disease of the central nervous system, with 7 million to 10 million cases worldwide, the company says in a July 23 filing with the U.S. Securities and Exchange Commission.
The company is led by President and CEO Milton H. Werner, who founded its predecessor, Inhibikase Therapeutics LLC, in 2008 as an entrepreneurial start-up in Atlanta with initial financial support from the Georgia Research Alliance. It has received economic development grants and loans through the Georgia Research Alliance totaling $455,550.
Inhibikase says it filed two Investigational New Drug applications with the U.S. Food and Drug Administration in the first quarter of 2019 for a drug it calls IkT-148009. One proposed use is for the treatment of Parkinson’s Disease, while the second is for treatment of gastrointestinal complications that arise as early symptoms of PD in patients. The company last year launched clinical development of IkT-148009 for the treatment of PD. First dosing of patients for treatment of PD is expected to commence shortly after the conclusion of the stock sale, it says.
“In our opinion, the multi-decade failures in the treatment of neurodegenerative diseases such as PD result from a lack of understanding of the biochemistry of the disease processes involved,” Inhibikase says in its filing.
“We believe we are different,” the company says. “We identified the proteins that become dysfunctional in a disease pathway and sought to understand how a dysfunctional protein causes disease. We believe our approach to PD and other neurological diseases has identified the underlying cause of disease and led to an understanding of how individual proteins are linked together to define the disease process. Using this strategy, we believe we have discovered at least one enzyme that plays a pivotal role in the disease process for PD… which we believe can alter the disease course for PD.”
In the 12 months following the stock sale, the company says it anticipates completing safety and tolerability studies in elderly healthy volunteers, chronic toxicology studies in rats and monkeys for IkT-148009 to treat Parkinson’s Disease and its gastrointestinal complications and advance the drug into proof-of-concept trials.
If the IPO is successful, Inhibikase plans to use approximately $4 million to fund the costs of Phase 1 clinical trial for IkT-148009 in elderly healthy volunteers; approximately $4 million to fund toxicology studies of IkT-148009 to meet regulatory requirements for Phase 2 studies; and approximately $1.5 million to complete manufacturing of IkT-001Pro and other purposes.
As of June 2020 Inhibikase only had two full-time employees and five contractors. More than 90% of the company’s total revenue to date has been received from private, state and federal granting agencies, including the National Institutes of Health, the Department of Defense and the Michael J. Fox Foundation.