BOSTON and ATLANTA, May 15, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), 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, today reported financial results for the first quarter ended March 31, 2024 and highlighted recent developments.
“2024 is shaping up to be a year of clinical and regulatory execution as we advance our core programs towards important inflection points,” said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. “The Phase 2 201 trial for Risvodetinib (“risvo”) in untreated Parkinson’s disease is 83% enrolled as of May 10, 2024 and we anticipate enrolling the final patient in June with biomarker and functional assessment results to be reported in the second half of the year. On the regulatory front, we had positive interactions with the FDA for IkT-001Pro in gastrointestinal and hematological cancers and cardiopulmonary disease. As we look ahead, we believe our work to date supports the continued development of both risvo and 001Pro, and we are excited to continue on this journey to bring transformative treatments for patients in need.”
Recent Developments and Upcoming Milestones:
First Quarter Financial Results
Net Loss: Net loss for the quarter ended March 31, 2024 was $4.6 million, or $0.73 per share, compared to a net loss of $4.5 million, or $0.98 per share in the quarter ended March 31, 2023.
R&D Expenses: Research and development expenses were $2.8 million for the quarter ended March 31, 2024 compared to $2.9 million in the quarter ended March 31, 2023. The $0.1 million decrease in research and development expenses was due to a decrease of $0.7 million in IkT-001 Pro expenses offset by a $0.6 million increase in Risvodetinib expenses.
SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2024 were $2.0 million compared to $1.9 million for the quarter ended March 31, 2023. The $0.1 million increase was primarily driven by a $0.18 million increase legal and consulting fees, and a $0.08 million net decrease in all other normal selling, general and administrative expenses.
Cash Position: Cash, cash equivalents and marketable securities were $9.7 million as of March 31, 2024. The Company expects that existing cash and cash equivalents will be sufficient to fund operations through November 2024.
Conference Call Information
The conference call is scheduled to begin at 8:00am ET on May 16, 2024. Participants should dial 1-877-407-0789 (United States) or 1-201-689-8562 (International). A live webcast may be accessed using the link here, or by visiting the investors section of the Company's website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase's website for approximately 90 days after the call.
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 has a primary focus on neurodegeneration and its lead program Risvodetinib, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified several follow-on compounds to Risvodetinib that could potentially be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts.
Social Media Disclaimer
Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts. The Company intends to also use X, 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. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to enroll and complete the 201 Trial evaluating Risvodetinib in untreated Parkinson’s disease, to successfully apply for and obtain FDA approval for IkT-001Pro in blood and stomach cancers or other indications, to successfully conduct clinical trials that are statistically significant and whether results from our animal studies may be replicated in humans, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. 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.
Contacts:
Company Contact:
Milton H. Werner, PhD
President & CEO
678-392-3419
This email address is being protected from spambots. You need JavaScript enabled to view it.
Investor Relations:
Alex Lobo
SternIR, Inc.
This email address is being protected from spambots. You need JavaScript enabled to view it.
| Inhibikase Therapeutics, Inc. Condensed Consolidated Balance Sheets | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| (unaudited) | (Note 2) | |||||||
| Assets | | |||||||
| Current assets: | | |||||||
| Cash and cash equivalents | $ | 2,353,346 | $ | 9,165,179 | ||||
| Marketable securities | 7,396,009 | 4,086,873 | ||||||
| Accounts receivable | - | - | ||||||
| Prepaid research and development | 207,422 | 219,817 | ||||||
| Prepaid expenses and other current assets | 851,057 | 739,179 | ||||||
| Total current assets | 10,807,834 | 14,211,048 | ||||||
| Equipment and improvements, net | 66,804 | 73,372 | ||||||
| Right-of-use asset | 193,460 | 222,227 | ||||||
| Total assets | $ | 11,068,098 | $ | 14,506,647 | ||||
| Liabilities and stockholders’ equity | | |||||||
| Current liabilities: | | |||||||
| Accounts payable | $ | 1,293,755 | $ | 646,767 | ||||
| Lease obligation, current | 151,159 | 150,095 | ||||||
| Accrued expenses and other current liabilities | 2,507,589 | 2,259,955 | ||||||
| Insurance premium financing payable | 280,614 | 381,784 | ||||||
| Total current liabilities | 4,233,117 | 3,438,601 | ||||||
| Lease obligation, net of current portion | 58,330 | 90,124 | ||||||
| Total liabilities | 4,291,447 | 3,528,725 | ||||||
| Commitments and contingencies (see Note 13) | | |||||||
| Stockholders’ equity: | | | ||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding at March 31, 2024 and December 31, 2023 | — | — | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 6,476,844 and 6,186,280 shares issued and outstanding at March 31, 2024 and December 31, 2023 | 6,477 | 6,186 | ||||||
| Additional paid-in capital | 78,322,334 | 77,871,584 | ||||||
| Accumulated other comprehensive (loss) income | (1,800 | ) | 877 | |||||
| Accumulated deficit | (71,550,360 | ) | (66,900,725 | ) | ||||
| Total stockholders' equity | 6,776,651 | 10,977,922 | ||||||
| Total liabilities and stockholders’ equity | $ | 11,068,098 | $ | 14,506,647 | ||||
See accompanying notes to condensed consolidated financial statements.
| Inhibikase Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue: | ||||||||
| Grant revenue | $ | — | $ | 64,521 | ||||
| Total revenue | — | 64,521 | ||||||
| Costs and expenses: | ||||||||
| Research and development | 2,751,279 | 2,854,119 | ||||||
| Selling, general and administrative | 2,031,081 | 1,925,351 | ||||||
| Total costs and expenses | 4,782,360 | 4,779,470 | ||||||
| Loss from operations | (4,782,360 | ) | (4,714,949 | ) | ||||
| Interest income | 132,725 | 237,171 | ||||||
| Net loss | (4,649,635 | ) | (4,477,778 | ) | ||||
| Other comprehensive income (loss), net of tax | ||||||||
| Unrealized (loss) gains on marketable securities | (2,677 | ) | 61,104 | |||||
| Comprehensive loss | $ | (4,652,312 | ) | $ | (4,416,674 | ) | ||
| Net loss per share – basic and diluted | $ | (0.73 | ) | $ | (0.98 | ) | ||
| Weighted-average number of common shares – basic and diluted | 6,340,697 | 4,585,013 | ||||||
See accompanying notes to condensed consolidated financial statements.
| Last Trade: | US$2.64 |
| Daily Change: | -0.13 -4.69 |
| Daily Volume: | 85,916 |
| Market Cap: | US$19.690M |
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