エドガーで原本を確認する
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): June 25, 2024
| Gain Therapeutics, Inc. | ||
| (Exact Name of the Registrant as Specified in Charter) | ||
| Delaware | 001-40237 | 85-1726310 | ||
| (State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
4800 Montgomery Lane, Suite 220
Bethesda, Maryland 20814
(Address of principal executive offices) (Zip Code)
(301) 500-1556
(Registrant’s telephone number, including area code)
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:
| ¨ | 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 exchange on which registered |
| Common Stock, $0.0001 par value | GANX | 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 x
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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Departures and Appointments of Executive Officers
Matthias Alder
On June 25, 2024, Matthias Alder (“Mr. Alder”), Chief Executive Officer of Gain Therapeutics, Inc. (the “Company”), and the Company mutually agreed that his service as Chief Executive Officer of the Company would terminate so that Mr. Alder can pursue other opportunities. Pursuant to Mr. Alder’s amended and restated employment letter dated September 20, 2022 (the “Employment Agreement”), Mr. Alder automatically resigned from the Board effective June 25, 2024.
In connection with Mr. Alder’s departure, the Company entered into a separation and general release agreement with Mr. Alder on June 27, 2024 (the “Separation Agreement”).
The Separation Agreement provides, among other things, for Mr. Alder to receive the following:
| · | A lump sum payment equal to 12 months of Mr. Alder’s current base salary; and |
| · | COBRA premiums for medical, dental, and vision employee benefit programs, on the same basis as his current coverage election, through the twelve-month anniversary of the effective date of the Separation Agreement. |
In addition, the Separation Agreement contemplates that any outstanding unvested stock options and restricted stock units held by Mr. Alder shall vest to the extent that such stock options and restricted stock units would have vested had Mr. Alder remained employed with the Company through the one-year anniversary of June 25, 2024. The Separation Agreement further provides for mutual general releases and mutual non-disparagement provisions.
Gene Mack
On June 27, 2024, Mr. Gene Mack (“Mr. Mack”), the Company’s current Chief Financial Officer, was appointed to serve as Interim Chief Executive Officer (“Interim CEO”), effective as June 25, 2024, to fill the vacancy created by Mr. Alder’s departure as Chief Executive Officer.
Mr. Mack’s biographical information is set forth in the Proxy Statement and such information is incorporated herein by reference. There are no transactions since the beginning of the Company’s last fiscal year in which the Company is a participant and in which Mr. Mack or any members of his immediate family have any interest that are required to be reported under Item 404(a) of Regulation S-K. No family relationships exist between Mr. Mack and any of the Company’s directors or executive officers. The appointment of Mr. Mack was not pursuant to any arrangement or understanding between him and any person, other than a director or executive officer of the Company acting in his or her official capacity.
No additional compensation will be paid to Mr. Mack in his role as Interim CEO, and Mr. Mack’s compensatory arrangements as the Company’s Chief Financial Officer are disclosed in Proxy Statement and such information is incorporated herein by reference.
Designation of Executive Chairman of the Board of Directors
On June 27, 2024, Dr. Khalid Islam (“Dr. Islam”), the current Chairman of the Board, was appointed to serve as Executive Chairman of the Board, effective June 25, 2024. As Executive Chairman, he will continue to be responsible for the effective performance of the Board and will work closely with Mr. Mack, acting in an advisory capacity to him and other executives.
Dr. Islam’s biographical information is set forth in the Company’s Definitive Proxy Statement (the “Proxy Statement”) filed with the Securities and Exchange Commission (the “SEC”) on April 26, 2024, and such information is incorporated herein by reference. There are no transactions since the beginning of the Company’s last fiscal year in which the Company is a participant and in which Dr. Islam or any members of his immediate family have any interest that are required to be reported under Item 404(a) of Regulation S-K promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) that have not otherwise been reported in the Company’s filings with the SEC. No family relationships exist between Dr. Islam and any of the Company’s directors or executive officers. The appointment of Dr. Islam was not pursuant to any arrangement or understanding between him and any person, other than a director or executive officer of the Company acting in his or her official capacity.
Item 7.01 Regulation FD Disclosure.
On June 27, 2024, the Company issued a press release regarding the above. A copy of the press release is furnished hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1 is being furnished to the SEC and shall not be deemed to be “filed” for the 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, and shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The exhibits listed below are furnished as part of this Current Report on Form 8-K.
| Exhibit No. |
Description | |
| 99.1 | Gain Therapeutics, Inc. Press Release dated June 27, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
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.
| GAIN THERAPEUTICS, INC. | ||
| Date: June 28, 2024 | By: | /s/ Gene Mack |
| Name: | Gene Mack | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Gain Therapeutics, Inc. Appoints Gene Mack as Interim CEO
Mr. Mack is the Company’s Current CFO
Khalid Islam, PhD, Founder and Chairman of the Board, to serve as Executive Chairman
BETHESDA, Md., June 27, 2024 -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that Matthias Alder has departed the Company in order to pursue other opportunities. Upon Mr. Alder’s departure, the Company appointed Gene Mack, the Company’s current Chief Financial Officer, as interim Chief Executive Officer, effective June 25, 2024. Mr. Mack will retain his role as Chief Financial Officer. Khalid Islam, Ph.D., founder and Chairman of the Company’s Board of Directors, will bolster management as Executive Chairman until a permanent CEO is appointed.
“On behalf of Gain, I would like to thank Matthias for his significant contribution to the development of our company, as we advanced our lead candidate, GT-02287, into clinical development. Matthias played an instrumental role building the preclinical dossier for GT-02287 including the most recent positive data presented this week at FENS Forum 2024, in which administration of GT-02287 was associated with significant improvement in cognitive performance and other related activities of daily living in a preclinical model of GBA1 Parkinson’s disease. We look forward to the continued advancement of GT-02287 and the potential positive impact we believe it may have on Parkinson’s Disease patients,” stated Dr. Islam.
About GT-02287
Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease. The orally administered, brain-penetrant small molecule is an allosteric protein modulator that restores the function of the lysosomal protein enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced aggregated α-synuclein, neuroinflammation and neuronal death, increased dopamine levels and improved motor function and cognitive performance. Additionally, GT-02287 significantly reduced plasma neurofilament light chain (NfL) levels, an emerging biomarker for neurodegeneration.
Gain’s lead program in Parkinson’s disease has been awarded funding support from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency.
About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate GT-02287 for the treatment of Parkinson’s disease, is currently being evaluated in a Phase 1 clinical trial.
Leveraging AI-supported structural biology, proprietary algorithms, and supercomputer-powered physics-based models, the company’s Magellan™ drug discovery platform can identify novel allosteric binding sites on disease-implicated proteins, pinpointing pockets that cannot be found or drugged with current technologies. Its AI and machine-learning tools and virtual screening capabilities leverage the emerging on-demand compound libraries covering vast chemical spaces of over five trillion compounds to identify and select suitable small molecule hits for experimental validation.
Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology.
Forward Looking Statements
This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, risks associated with market conditions and the satisfaction of customary closing conditions related to the offering and uncertainties related to the offerings and the use of proceeds from the offerings. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s prospectus supplement to be filed with the SEC, and the documents incorporated by reference therein, including the Company’s Form 10-K for the year ended December 31, 2023 and Form 10-Q for the quarter ended March 31, 2024.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
CORE IR
(516) 222-2560
ir@gaintherapeutics.com
Media Contacts:
Russo Partners
Nic Johnson and Elio Ambrosio
nic.johnson@russopartnersllc.com
elio.ambrosio@russopartnersllc.com
(212) 845-4242