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Inhibikase Therapeutics Reports Second Quarter Financial Results and Highlights Recent Period Activity

BOSTON and ATLANTA, Aug. 14, 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 second quarter ended June 30, 2024 and highlighted recent developments.

“The first half of 2024 has showcased the strength of our pipeline through the continued execution of key milestones for both risvodetinib (risvo) and IkT-001Pro,” said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. “We completed enrollment of The 201 Trial evaluating risvo in untreated Parkinson’s disease, and anticipate the last patient exiting the study in September, 2024. We anticipate reporting topline data in November, 2024. Additionally, 001Pro has advanced as a potential treatment for Pulmonary Arterial Hypertension (PAH). We have filed our IND and we intend to ramp up the 702 trial following IND clearance. Finally, the manufacturing requirements for 001Pro necessary for potential approval is advancing with the on-going development of a scalable process.”

Recent Developments and Upcoming Milestones:

Second Quarter Financial Results

Net Loss: Net loss for the quarter ended June 30, 2024, was $5.0 million, or $0.66 per share, compared to a net loss of $5.8 million, or $0.94 per share in the quarter ended June 30, 2023. The net loss per share for the three and six months ended June 30, 2023, was adjusted to show an improvement from ($1.11) to ($0.94) and from ($2.09) to ($1.74), respectively.

R&D Expenses: Research and development expenses were $3.1 million for the quarter ended June 30, 2024 compared to $4.5 million in the quarter ended June 30, 2023. The $1.5 million decrease in research and development expenses was due to a decrease of $1.4 million in IkT-001Pro expenses due to the completion of the three-part dose finding/dose equivalence study in 2023 and a net decrease of $0.1 million in other research and development expenses.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2024 were $2.0 million compared to $1.8 million for the quarter ended June 30, 2023. The $0.2 million increase was primarily driven by a $0.4 million increase legal and consulting fees partially offset by a $0.1 million decrease in D&O insurance and a $0.1 million net decrease in all other normal selling, general and administrative expenses.

Cash Position: Cash, cash equivalents and marketable securities were $7.9 million as of June 30, 2024. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into December, 2024.

Conference Call Information
The conference call is scheduled to begin at 8:00am ET on August 15, 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 for the treatment of certain hematological or gastrointestinal cancers and in cardiopulmonary disease. 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 XFacebookLinkedIn 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
Precision AQ
Alex.lobo@precisionaq.com

Inhibikase Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
    June 30,
2024
    December 31,
2023
    (unaudited)      
Assets        
Current assets:        
Cash and cash equivalents   $ 3,086,455     $ 9,165,179
Marketable securities     4,853,559       4,086,873
Prepaid research and development     306,300       219,817
Prepaid expenses and other current assets     356,487       739,179
Total current assets     8,602,801       14,211,048
Equipment and improvements, net     60,235       73,372
Right-of-use asset     163,762       222,227
Total assets   $ 8,826,798     $ 14,506,647
Liabilities and stockholders’ equity        
Current liabilities:        
Accounts payable   $ 1,340,538     $ 646,767
Lease obligation, current     152,224       150,095
Accrued expenses and other current liabilities     2,034,525       2,259,955
Insurance premium financing payable     177,256       381,784
Total current liabilities     3,704,543       3,438,601
Lease obligation, net of current portion     25,606       90,124
Total liabilities     3,730,149       3,528,725
Commitments and contingencies        
Stockholders’ equity:      
Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2024 and December 31, 2023          
Common stock, $0.001 par value; 100,000,000 shares authorized; 7,216,145 and 6,186,280 shares issued and outstanding at June 30, 2024 and December 31, 2023     7,216       6,186
Additional paid-in capital     81,600,425       77,871,584
Accumulated other comprehensive (loss) income     (1,024 )     877
Accumulated deficit     (76,509,968 )     (66,900,725
Total stockholders’ equity     5,096,649       10,977,922
Total liabilities and stockholders’ equity   $ 8,826,798     $ 14,506,647
           
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
  Three Months Ended June 30,   Six Months Ended June 30,
    2024       2023       2024       2023  
Revenue:              
Grant revenue $   $ 116,410   $   $ 180,931  
Total revenue         116,410             180,931  
Costs and expenses:              
Research and development   3,075,830     4,535,698     5,827,109     7,389,817  
Selling, general and administrative   1,974,705       1,783,113       4,005,786       3,708,464  
Total costs and expenses   5,050,535       6,318,811       9,832,895       11,098,281  
Loss from operations   (5,050,535 )     (6,202,401 )     (9,832,895 )     (10,917,350 )
Interest income (expense)   90,927       424,435       223,652       661,606  
               
Net loss   (4,959,608 )     (5,777,966 )     (9,609,243 )     (10,255,744 )
Other comprehensive income, net of tax              
Unrealized (loss) gains on marketable securities   776       (167,536 )     (1,901 )     (106,432 )
Comprehensive Loss $ (4,958,832 )   $ (5,945,502 )   $ (9,611,144 )   $ (10,362,176 )
Net loss per share – basic and diluted $ (0.66 )   $ (0.94 )   $ (1.38 )   $ (1.74 )
Weighted-average number of common shares – basic and diluted   7,535,667       6,162,280       6,939,779       5,883,895  


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