ATLANTA, May 17, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. 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, today reported financial results for the first quarter ended March 31, 2021 and highlighted recent developments.
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.
About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. IKT is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program for IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, intends to treat Parkinson's disease inside and outside the brain. Inhibikase is currently performing its Phase I, randomized single ascending dose and multiple ascending dose, study to determine the safety, tolerability and pharmacokinetics of IkT-148009 in older and healthy subjects. The Company is also advancing a novel drug delivery platform to treat certain forms of cancer at the same time as it is developing novel drugs for the treatment of neurodegenerative disease. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.
Social Media Disclaimer
Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use Twitter, Facebook, LinkedIn and YouTube as a means of disclosing information about the company, its services and other matters and for complying with its disclosure obligations under Regulation FD.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. One such uncertainty is that positive results from early clinical studies of our product candidates are not necessarily predictive of the results of later clinical studies and any current and future clinical trials of our product candidates. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth from time to time in Inhibikase's filings with the SEC, including its annual report on Form 10-K filed on March 31, 2021, including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
Inhibikase Therapeutics, Inc. | ||||||||
March 31, 2021 | December 31, 2020 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 9,609,631 | $ | 13,953,513 | ||||
Accounts receivable | 332,774 | — | ||||||
Prepaid research and development | 712,674 | 774,356 | ||||||
Prepaid expenses and other current assets | 1,216,173 | 54,837 | ||||||
Total | 11,871,252 | 14,782,706 | ||||||
Deferred offering costs | 2,783 | — | ||||||
Total assets | $ | 11,874,035 | $ | 14,782,706 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 715,016 | $ | 1,720,680 | ||||
Accrued expenses and other current liabilities | 627,399 | 632,934 | ||||||
Deferred revenue | 1,251,349 | 2,325,741 | ||||||
Notes payable | 994,789 | 42,534 | ||||||
Total | 3,588,553 | 4,721,889 | ||||||
Notes payable, net of current portion | 248,911 | 276,461 | ||||||
Total liabilities | 3,837,464 | 4,998,350 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at | — | — | ||||||
Common stock, $0.001 par value; 100,000,000 and 30,000,000 | 10,060 | 10,051 | ||||||
Additional paid-in capital | 25,695,203 | 24,805,929 | ||||||
Accumulated deficit | (17,668,692) | (15,031,624) | ||||||
Total | 8,036,571 | 9,784,356 | ||||||
Total liabilities and stockholders' equity | $ | 11,874,035 | $ | 14,782,706 | ||||
Inhibikase Therapeutics, Inc. | ||||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Revenue: | ||||||||
Grant revenue | $ | 1,407,165 | $ | 270,787 | ||||
Total revenue | 1,407,165 | 270,787 | ||||||
Costs and expenses: | ||||||||
Research and development | 2,431,860 | 283,114 | ||||||
Selling, general and administrative | 1,600,576 | 527,688 | ||||||
Total costs and expenses | 4,032,436 | 810,802 | ||||||
Loss from operations | (2,625,271) | (540,015) | ||||||
Interest expense | (11,797) | (7,425) | ||||||
Net loss | $ | (2,637,068) | $ | (547,440) | ||||
Net loss per share – basic and diluted | $ | (0.26) | $ | (0.07) | ||||
Weighted-average number of common shares – basic and diluted | 10,053,949 | 8,181,734 | ||||||
SOURCE Inhibikase Therapeutics, Inc.
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