false 0001750149 0001750149 2025-03-27 2025-03-27

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 27, 2025

 

 

INHIBIKASE THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-39676   26-3407249

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

3350 Riverwood Parkway SE, Suite 1900  
Atlanta, Georgia   30339
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: (678) 392-3419

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 par value   IKT   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 

 


Item 2.02.

Results of Operations and Financial Condition.

On March 27, 2025, Inhibikase Therapeutics, Inc. announced its financial results for the year ended December 31, 2024 and other corporate updates. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

99.1    Press Release issued by Inhibikase Therapeutics, Inc., dated March 27, 2025, furnished herewith.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: March 27, 2025     INHIBIKASE THERAPEUTICS, INC.
    By:  

/s/ Mark Iwicki

      Mark Iwicki
      Chief Executive Officer

Exhibit 99.1

 

 

LOGO

Inhibikase Therapeutics Announces 2024 Financial Results and Highlights Recent Activity

— New Leadership and Focus on Advancement of IkT-001 into a Late-Stage Clinical Trial Program in Pulmonary Arterial Hypertension —

March 27, 2025 — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company innovating small molecule kinase inhibitor therapeutics to treat pulmonary arterial hypertension (“PAH”), today reported financial results for the year ended December 31, 2024 and highlighted recent developments.

“The financing concluded in October positioned us to focus our clinical development efforts on advancing IkT-001 toward a late-stage clinical trial in PAH,” said Mark Iwicki, Chief Executive Officer of Inhibikase. “To drive the Company toward its next phase of growth, we subsequently added depth to our management team with the additions of Chris Cabell and John Adams, two accomplished scientific leaders with established track records in the PAH space. Additionally, we expect Chris and John will enable us to accelerate the build out of our team as we make preparations to execute on the IkT-001 Phase 2b clinical trial in PAH. We enter 2025 well positioned to aggressively advanced our IkT-001 development plan.”

Recent Developments:

 

   

Closed a private placement with gross proceeds of approximately $110 million in October 2024 in support of advancing IkT-001 into a late-stage clinical trial in PAH. If the warrants issued in such offering are exercised for cash, the aggregate total gross proceeds from the financing may be up to $275 million.

 

   

Announced the appointments of Mark Iwicki as Chief Executive Officer, Chris Cabell, M.D., MHS, FACC, as President and Head of Research & Development, and John Adams, Ph.D., as Chief Scientific Officer.

 

   

Added highly accomplished leaders in biopharmaceutical development to the Board of Directors of the Company (the “Board”):

 

   

Amit Munshi, Chief Executive Officer of Orna Therapeutics and former CEO of Arena Pharmaceuticals; Mr. Munshi has been appointed as the independent Chair of the Board.

 

   

Vince Aurentz, former Executive Vice President and Chief Business Officer at Arena Pharmaceuticals and former member of the Board at Longboard Pharmaceuticals, Inc.

 

   

Roberto Bellini, Managing Partner of BSQUARED Capital and former Chief Executive Officer of BELLUS Health Inc.

 

   

David Canner, Partner at Soleus Capital.

 

   

Mark Iwicki, Chair of the Board of Akero Therapeutics.

 

   

Arvind Kush, Chief Financial Officer and Chief Business Officer of Candid Therapeutics and former CFO of RayzeBio.

 

   

Advancement of IkT-001 as a therapy in Pulmonary Arterial Hypertension:

 

   

The Company received its Study May Proceed letter for the Phase 2b trial in September 2024.

 

   

The active ingredient in IkT-001, imatinib, has previously been shown to be disease-modifying for PAH.


LOGO

 

2024 Financial Results

Net Loss: Net loss for the year ended December 31, 2024, was $27.5 million, or $1.16 per share, compared to a net loss of $19.1 million, or $3.16 per share in the year ended December 31, 2023.

R&D Expenses: Research and development expenses were $17.2 million for the year ended December 31, 2024 compared to $13.6 million in the year ended December 31, 2023.

SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2024 were $11.4 million compared to $6.7 million for the year ended December 31, 2023.

Cash Position: Cash, cash equivalents and marketable securities were $97.5 million as of December 31, 2024.

Grant of Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

The Board approved the grant of non-statutory stock options to each of Mr. Adams and Mr. Cabell to purchase an aggregate of 2,250,000 and 2,810,000 shares of common stock, respectively, as an inducement material to the employees’ acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $2.97 per share, which is equal to the closing price of the Company’s common stock on February 21, 2025, the effective date of grant. The options have a ten year term, vesting annually over three years, commencing on the one-year anniversary of the employee’s date of hire. The options are subject to the employee’s continued service with the Company on each such vesting date and the terms and conditions of an award agreement.

About Inhibikase (www.inhibikase.com)

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary disease. Inhibikase’s cardiopulmonary disease portfolio is led by IkT-001, a prodrug of imatinib mesylate, for PAH. 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 include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the initiation of the Company’s Phase 2b trial of IkT-001 in PAH, the Company’s future activities, or future events or conditions; and expectations regarding the


LOGO

 

anticipated contribution of Dr. Cabell and Dr. Adams to our operations and progress. 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 commence and execute a Phase 2b ‘702’ trial to evaluate IkT-001 as a treatment for PAH, 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:

Investor Relations:

Michael Moyer

LifeSci Advisors

mmoyer@lifesciadvisors.com

—tables to follow—


Inhibikase Therapeutics, Inc.

Consolidated Balance Sheets

(Unaudited)

 

     December 31,
2024
    December 31,
2023
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 56,490,579     $ 9,165,179  

Marketable securities

     41,052,949       4,086,873  

Prepaid research and development

     81,308       219,817  

Prepaid expenses and other current assets

     826,473       739,179  
  

 

 

   

 

 

 

Total current assets

     98,451,309       14,211,048  

Equipment and improvements, net

     47,100       73,372  

Right-of-use asset

     101,437       222,227  
  

 

 

   

 

 

 

Total assets

   $ 98,599,846     $ 14,506,647  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 943,019     $ 646,767  

Lease obligation, current

     110,517       150,095  

Accrued expenses and other current liabilities

     2,680,030       2,259,955  

Insurance premium financing payable

     —        381,784  
  

 

 

   

 

 

 

Total current liabilities

     3,733,566       3,438,601  

Lease obligation, net of current portion

     —        90,124  
  

 

 

   

 

 

 

Total liabilities

     3,733,566       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 December 31, 2024 and December 31, 2023

     —        —   

Common stock, $0.001 par value; 100,000,000 shares authorized; 69,362,439 and 6,186,280 shares issued and outstanding at December 31, 2024 and December 31, 2023

     69,362       6,186  

Additional paid-in capital

     189,254,777       77,871,584  

Accumulated other comprehensive (loss) income

     (37,248     877  

Accumulated deficit

     (94,420,611     (66,900,725
  

 

 

   

 

 

 

Total stockholders’ equity

     94,866,280       10,977,922  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 98,599,846     $ 14,506,647  
  

 

 

   

 

 

 


LOGO

 

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

     Year ended December 31,  
     2024     2023  

Revenue:

    

Grant revenue

   $ —      $ 260,501  
  

 

 

   

 

 

 

Total revenue

     —        260,501  
  

 

 

   

 

 

 

Costs and expenses:

    

Research and development

     17,210,548       13,618,348  

Selling, general and administrative

     11,378,520       6,731,945  
  

 

 

   

 

 

 

Total costs and expenses

     28,589,068       20,350,293  
  

 

 

   

 

 

 

Loss from operations

     (28,589,068     (20,089,792

Interest income

     1,069,182       1,060,909  
  

 

 

   

 

 

 

Net loss

     (27,519,886     (19,028,883

Other comprehensive loss, net of tax

    

Unrealized loss on marketable securities

     (38,125     (103,841
  

 

 

   

 

 

 

Comprehensive loss

   $ (27,558,011   $ (19,132,724
  

 

 

   

 

 

 

Net loss per share – basic and diluted

   $ (1.16   $ (3.16
  

 

 

   

 

 

 

Weighted-average number of common shares – basic and diluted

     23,712,220       6,028,210  
  

 

 

   

 

 

 
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Mar. 27, 2025
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Entity Registrant Name INHIBIKASE THERAPEUTICS, INC.
Entity Incorporation State Country Code DE
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Entity Tax Identification Number 26-3407249
Entity Address, Address Line One 3350 Riverwood Parkway SE
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