Inhibikase Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Highlights Recent Period Activity
Inhibikase Therapeutics (IKT) reported financial results for Q4 and the full year 2020, noting a net loss of $1.21 million in Q4, improving from $0.43 million in Q4 2019. For the full year, the net loss was $2.85 million, down from $5.72 million in 2019. The company completed its IPO in December 2020, raising approximately $14.60 million. In early 2021, it commenced patient dosing for IkT-148009, aimed at treating Parkinson's disease, and initiated chronic toxicology studies. Cash reserves stood at $13.95 million as of year-end 2020, supporting ongoing research initiatives.
- Completed IPO raising approximately $14.60 million in net proceeds.
- Initiated Phase 1 study for IkT-148009, with timeline reduced by 6 months.
- Commenced chronic toxicology studies for long-term patient dosing.
- Cash position of $13.95 million to support research.
- Net loss increased to $1.21 million in Q4 2020 from $0.43 million in Q4 2019.
- Total net loss for 2020 was $2.85 million compared to $5.72 million in 2019, indicating ongoing financial challenges.
ATLANTA, April 1, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease (PD) and related disorders inside and outside of the brain, today reported financial results for the fourth quarter and full year ended December 31, 2020 and highlighted recent developments.
Key Business and Clinical Highlights
- Completed Initial Public Offering: In December 2020, Inhibikase successfully completed its initial public offering (IPO) of 1,800,000 shares of common stock at a public offering price of
$10.00 per share. The Company received aggregate net proceeds of approximately$14.60 million after deducting offering costs, underwriting discounts and commissions. - Commenced Dosing of Patients in Phase 1 Study of IkT-148009 for the treatment of PD and associated GI Disorders: In February 2021, Inhibikase commenced patient dosing in older and elderly healthy volunteers in a Phase 1 randomized single ascending dose and multiple ascending dose study to determine the safety, tolerability and pharmacokinetics of IkT-148009. IkT-148009 is a novel brain penetrant Abelson tyrosine kinase, or c-Abl, inhibitor intended to be used to modify Parkinson's disease and its gastrointestinal complications.
- Accelerated timelines for completion of the Phase 1 trial and initiation of dosing in PD patients. Early data from this study have led to a reduction in the timelines for completion of the study by 6 or more months, providing the opportunity to obtain regulatory approval to commence dosing of PD patients much earlier than previously anticipated.
- Commenced chronic toxicology studies of IkT-148009 to permit long-term dosing in patients. In January, 2021 Inhibikase commenced 3 month and 6 month long-term toxicology studies of IkT-148009 in rats and 3 month and 9 month long-term toxicology studies of IkT-148009 in monkeys as required to obtain regulatory approval for chronic administration of IkT-148009 in patients. These studies are expected to be completed in the fourth quarter of 2021.
- Commenced clinical batch manufacturing and pill formulation of IkT-001Pro in preparation for an Investigational New Drug application filing in the second quarter of 2021. In February, 2021 Inhibikase commenced clinical batch manufacturing and final product formulation of IkT-001Pro as a film-coated tablet in preparation for regulatory filing with the Food and Drug Administration to initiate clinical development. This regulatory filing is anticipated to be completed near the end of the second quarter of 2021, with initiation of clinical development 30 days after the filing, subject to FDA agreement and issuance of a Study May Proceed notification.
"2020 was a transformative year for Inhibikase, as we successfully completed our IPO and worked diligently to advance our novel programs to treat neurodegenerative diseases towards the clinic," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "Just recently, we were pleased to announce the advancement of our lead candidate, IkT-148009, into a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics in elderly volunteers. Early data from this study has been encouraging and we are shortening the timeline to completion by six or more months, with an expectation to move into early patient studies this year. We believe that IKT-148009 could be a transformative therapy for millions of Parkinson's patients worldwide. Simultaneously, we have advanced our oncology clinical candidate, IkT-001Pro, into manufacturing and expect to initiate clinical development early in the third quarter. Our highly dedicated team has exceeded all of our internal expectations to move these clinical programs forward for the benefit of patients."
Fourth Quarter and Full Year 2020 Financial Review
Net Loss: Net loss for the fourth quarter ended December 31, 2020, was
R&D Expenses: Research and development expenses were
SG&A Expenses: Selling, general and administrative expenses for the fourth quarter 2020 were
Cash Position: Cash and cash equivalents were
About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (NASDAQ: 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.
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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.
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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. | ||||||||
December 31, 2020 | December 31, 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 13,953,513 | $ | 18,457 | ||||
Prepaid research and development | 774,356 | — | ||||||
Prepaid expenses and other current assets | 54,837 | 16,924 | ||||||
Total | 14,782,706 | 35,381 | ||||||
Deferred initial public offering costs | — | 2,873 | ||||||
Total assets | $ | 14,782,706 | $ | 38,254 | ||||
Liabilities and stockholders' deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,720,680 | $ | 1,001,699 | ||||
Accrued expenses and other current liabilities | 632,934 | 1,724,141 | ||||||
Deferred revenue | 2,325,741 | 1,428,636 | ||||||
Notes payable | 42,534 | 98,419 | ||||||
Total | 4,721,889 | 4,252,895 | ||||||
Notes payable, net of current portion | 276,461 | 275,375 | ||||||
Total liabilities | 4,998,350 | 4,528,270 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity (deficit): | ||||||||
Preferred stock, | — | — | ||||||
Common stock, | 10,051 | 8,181 | ||||||
Additional paid-in capital | 24,805,929 | 7,685,533 | ||||||
Accumulated deficit | (15,031,624) | (12,183,730) | ||||||
Total | 9,784,356 | (4,490,016) | ||||||
Total liabilities and stockholders' equity (deficit) | $ | 14,782,706 | $ | 38,254 | ||||
Inhibikase Therapeutics, Inc. | ||||||||
Year ended December 31, | ||||||||
2020 | 2019 | |||||||
Revenue: | ||||||||
Grant revenue | $ | 698,468 | $ | 1,122,740 | ||||
Total revenue | 698,468 | 1,122,740 | ||||||
Costs and expenses: | ||||||||
Research and development | 893,802 | 2,552,711 | ||||||
Selling, general and administrative | 2,623,158 | 4,268,177 | ||||||
Total costs and expenses | 3,516,960 | 6,820,888 | ||||||
Loss from operations | (2,818,492) | (5,698,148) | ||||||
Interest expense | (29,402) | (24,835) | ||||||
Net loss | $ | (2,847,894) | $ | (5,722,983) | ||||
Net loss per share – basic and diluted | $ | (0.35) | $ | (0.70) | ||||
Weighted-average number of common shares – basic and diluted | 8,212,581 | 8,180,937 | ||||||
Inhibikase Therapeutics, Inc. | ||||||||
Quarter ended December 31, | ||||||||
2020 | 2019 | |||||||
Revenue: | ||||||||
Grant revenue | $ | 170,416 | $ | 240,276 | ||||
Total revenue | 170,416 | 240,276 | ||||||
Costs and expenses: | ||||||||
Research and development | 226,944 | 267,915 | ||||||
Selling, general and administrative | 1,144,319 | 394,624 | ||||||
Total costs and expenses | 1,371,263 | 662,539 | ||||||
Loss from operations | (1,200,847) | (422,263) | ||||||
Interest expense | (7,139) | (7,747) | ||||||
Net loss | $ | (1,207,986) | $ | (430,010) | ||||
Net loss per share – basic and diluted | $ | (0.15) | $ | (0.05) | ||||
Weighted-average number of common shares – basic and diluted | 8,286,886 | 8,180,937 | ||||||
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SOURCE Inhibikase Therapeutics, Inc.
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