On May 17, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported financial results for the first quarter ended March 31, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAY 17, 2021, View Source [SID1234580126]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Key Business and Clinical Highlights
Accelerated timelines for Phase 1 Study of IkT-148009 for the treatment of PD and associated GI Disorders: In February, 2021 Inhibikase commenced patient dosing in its Phase 1 study evaluating the safety, tolerability and pharmacokinetics of IkT-148009, the Company’s novel brain penetrant Abelson tyrosine kinase (c-Abl) inhibitor with the potential to modify Parkinson’s disease and its gastrointestinal complications. In April, 2021, the Company announced that it had accelerated the timeline for completion of the study based on early data that provided the opportunity to seek regulatory approval to commence dosing of PD patients in the third quarter of 2021, much earlier than previously anticipated.
Advancing chronic toxicology studies of IkT-148009 to permit long-term dosing in patients: In January, 2021 Inhibikase initiated 3- and 6-month long-term toxicology studies of IkT-148009 in mice and 3- and 9-month long-term toxicology studies of IkT-148009 in primates as required to obtain regulatory approval for chronic administration of IkT-148009 in patients. The Company has completed 3-month toxicology studies and is presently completing its histopathology analysis in preparation for submission of the data for regulatory review early in the third quarter of 2021. The Company expects to complete 6- and 9-month toxicology studies in the fourth quarter of 2021.
Initiated clinical batch manufacturing and pill formulation of IkT-001Pro. In February, 2021, Inhibikase initiated clinical batch manufacturing and final product formulation of IkT-001Pro, the Company’s prodrug formulation of Imatinib, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). Inhibikase expects to file an Investigational New Drug (IND) application in the third quarter of 2021, with initiation of clinical development as soon as practicable after the filing, subject to FDA acceptance of the IND.
"We are proud of the milestones we have achieved in the first quarter of 2021. The acceleration of our Phase 1 study for our lead candidate, IkT-148009 should allow us to move into evaluation of the safety, tolerability and pharmacokinetics in Parkinson’s patients early in the third quarter of 2021. Concurrently, we are advancing two long term toxicology studies in animals, which will allow for chronic administration of IKT-148009 in patients following FDA review and acceptance," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "In the third quarter of 2021, we plan to file our IND application for IKT-001Pro, which holds the potential to be a safer and better tolerated treatment for cancers such as CML, and expect to initiate clinical development as soon as practicable following the submission of the IND application. We look forward to making 2021 a success as we work to advance our early stage programs forward."
First Quarter Financial Review
Net Loss: Net loss for the quarter ended March 31, 2021, was $2.6 million, or $0.26 per share, compared to a net loss of $0.5 million, or $0.07 per share for the first quarter in 2020.
R&D Expenses: Research and development expenses were $2.4 million for the quarter ended March 31, 2021 compared to $0.3 million for the first quarter in 2020. The increase was driven by an increase in grant related research expenditures and non-grant related research. The non-grant related research was expended primarily in connection with the Company’s Phase 1 clinical trials.
SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2021 were $1.6 million compared to $0.5 million for the first quarter in 2020. The increase was primarily the result of increased non-cash stock compensation expense, increased directors and officer’s liability insurance related to the Company’s initial public offering in December 2020, increased legal fees, board fees, investor relations and consulting fees relating to operating as a public company registrant since December 2020, and an increase in other normal operating expenses.
Cash Position: Cash and cash equivalents were $9.6 million as of March 31, 2021.