Inhibikase Therapeutics Reports First Quarter Financial Results and Highlights Recent Period Activity
Inhibikase Therapeutics reported its Q1 2024 financial results and recent developments. The net loss for Q1 2024 was $4.6 million ($0.73 per share), slightly higher than Q1 2023's $4.5 million ($0.98 per share). R&D expenses decreased to $2.8 million from $2.9 million, primarily due to reduced costs for IkT-001Pro, while SG&A expenses increased to $2.0 million from $1.9 million.
The Phase 2 trial for Risvodetinib in Parkinson's disease is 83% enrolled, with final enrollment expected in June 2024. The company completed Pre-NDA and Pre-IND meetings with the FDA for IkT-001Pro, targeting oncology and pulmonary arterial hypertension. Cash reserves stand at $9.7 million, projected to fund operations through November 2024.
Inhibikase will host a conference call on May 16, 2024, at 8:00 a.m. ET to discuss these results.
- Phase 2 201 trial for Risvodetinib is 83% enrolled.
- Pre-NDA meeting with FDA for IkT-001Pro in oncology completed.
- Pre-IND meeting with FDA for IkT-001Pro in pulmonary arterial hypertension completed.
- Net loss per share decreased from $0.98 to $0.73 year-over-year.
- Research and development expenses decreased by $0.1 million.
- Cash position of $9.7 million as of March 31, 2024.
- Net loss increased from $4.5 million to $4.6 million year-over-year.
- Increase in SG&A expenses from $1.9 million to $2.0 million.
- Cash reserves sufficient only through November 2024.
- Reported 25 mild and 3 moderate adverse events in Risvodetinib trial.
Insights
Inhibikase Therapeutics' first quarter financial results present a mixed picture. The net loss for the quarter ended March 31, 2024 was
Inhibikase's progress on its Phase 2 trial for Risvodetinib in untreated Parkinson’s disease is a notable development. The trial is 83% enrolled, with final enrollment expected in June 2024. The use of biomarkers and functional assessments to gauge efficacy provides a robust approach to understanding the drug's impact on disease progression. If positive, this could mark a significant step forward in treating Parkinson’s disease, a market with substantial unmet needs. Moreover, the company's positive interactions with the FDA regarding IkT-001Pro in various oncology and cardiopulmonary indications are encouraging. The classification of IkT-001Pro as a novel chemical entity eligible for exclusivity designations further strengthens its potential market position. However, it is essential to remember that these are still early-stage trials. The success of these trials will be pivotal for long-term growth. The risk of adverse events and trial failures remains, which investors should consider. Positive trial results could lead to significant appreciation in the company's stock, while any negative outcomes could have a substantial downside impact.
The strategic focus of Inhibikase on advancing its core programs towards regulatory milestones reflects a calculated approach to long-term market positioning. The potential NDA submission for IkT-001Pro in up to 11 indications, including blood and stomach cancers, opens a diverse array of market opportunities. The successful completion of a Pre-IND meeting for IkT-001Pro as a treatment for pulmonary arterial hypertension (PAH) further diversifies their pipeline and reduces dependence on a single therapeutic area. This diversified approach could mitigate risk and attract a broader investor base. However, the company's cash runway only extends through November 2024, creating a sense of urgency for achieving these milestones. The company's ability to manage its cash burn rate while advancing its clinical programs will be crucial. Investors should watch for upcoming clinical and regulatory updates, as these will significantly influence market sentiment and stock performance.
Company to host conference call on Thursday, May 16, 2024 at 8:00 a.m. ET
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
Recent Developments and Upcoming Milestones:
- Completed Pre-NDA Meeting with the FDA for IkT-001Pro in oncology: On February 12, 2024, Inhibikase received final Meeting Minutes from the FDA Review Team (“Review Team”) from the Division of Hematologic Malignancies discussing the requirements for a 505(b)(2) NDA submission for IkT-001Pro in up to 11 blood and stomach cancer indications. Following receipt of the meeting minutes, the Company is considering the study of the 1200 mg dose of IkT-001Pro that is expected to lead to exposures equivalent to 800 mg imatinib as well as conduct an additional analysis comparing IkT-001Pro and imatinib mesylate in gut absorption. Inhibikase will request milestone-based meetings as it completes the necessary preclinical, clinical, manufacturing and quality control processes to ensure the Company and the Review Team remain aligned throughout the process of NDA submission.
- Completed Pre-IND meeting with the FDA for IkT-001Pro in Pulmonary Arterial Hypertension: On April 5, 2024, the Company met with the Office of Cardiology, Hematology, Endocrinology and Nephrology in the Division of Cardiology and Nephrology at the FDA for a Pre-IND meeting to discuss the potential of using IkT-001Pro as a treatment for pulmonary arterial hypertension (PAH). Final Meeting Minutes were provided by the FDA on May 3, 2024 and confirmed that IkT-001Pro would be classified as a novel chemical entity and eligible for exclusivity designations even though it could be approved under the 505(b)(2) statute. The FDA supported our initial Phase 2/3 design and has requested that the Company conduct a pre-clinical hERG study in comparison to imatinib prior to submitting the IND. This cell culture-based 7-day experiment is expected to be completed in the current quarter.
- Expect to complete enrollment for the 201 Trial of Risvodetinib in the second quarter 2024: As of May 10, 2024, 99 participants have been enrolled, 15 prospective participants are in medical screening and 22 potential participants are being evaluated for suitability to initiate medical screening across all 32 clinical sites. 44 participants have completed the 12-week dosing period and 25 mild and 3 moderate adverse events that may have been related to risvo have been reported as of May 10, 2024. The Company expects to report topline data results in the second half of 2024, including measurement of novel biomarker data as it relates to alpha-synuclein aggregates and the effect of risvo on the underlying pathology for Parkinson’s disease. Following completion of the double-blinded phase of the 201 trial, Inhibikase will request an end of Phase 2 meeting with the FDA. In addition, the Company hopes to initiate enrollment in its 12-month extension study of risvo in 2024, subject to available resources.
First Quarter Financial Results
Net Loss: Net loss for the quarter ended March 31, 2024 was
R&D Expenses: Research and development expenses were
SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2024 were
Cash Position: Cash, cash equivalents and marketable securities were
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
info@inhibikase.com
Investor Relations:
Alex Lobo
SternIR, Inc.
alex.lobo@sternir.com
| 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, | — | — | ||||||
| Common stock, | 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.
FAQ
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