Gain Therapeutics Files 8-K
Ticker: GANX · Form: 8-K · Filed: Dec 23, 2024 · CIK: 1819411
| Field | Detail |
|---|---|
| Company | Gain Therapeutics, Inc. (GANX) |
| Form Type | 8-K |
| Filed Date | Dec 23, 2024 |
| Risk Level | low |
| Pages | 3 |
| Reading Time | 3 min |
| Key Dollar Amounts | $0.0001 |
| Sentiment | neutral |
Sentiment: neutral
Topics: disclosure, regulatory-filing, financials
TL;DR
Gain Therapeutics dropped an 8-K on 12/23 - check for updates.
AI Summary
Gain Therapeutics, Inc. filed an 8-K on December 23, 2024, reporting on events including Regulation FD disclosures, other events, and financial statements. The company, incorporated in Delaware with its principal executive offices in Bethesda, Maryland, operates in the Pharmaceutical Preparations industry.
Why It Matters
This filing provides important updates and disclosures from Gain Therapeutics, Inc. to investors and the public regarding company events and financial status.
Risk Assessment
Risk Level: low — This filing is a routine 8-K disclosure and does not appear to contain significant new risks.
Key Numbers
- 001-40237 — SEC File Number (Identifies the company's filing history with the SEC.)
- 85-1726310 — IRS Employer Identification No. (Company's tax identification number.)
Key Players & Entities
- Gain Therapeutics, Inc. (company) — Registrant
- December 23, 2024 (date) — Date of earliest event reported
- Delaware (jurisdiction) — State of incorporation
- Bethesda, Maryland (location) — Address of principal executive offices
- 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations
FAQ
What specific events are being disclosed in this 8-K filing?
The filing indicates disclosures related to Regulation FD, other events, and financial statements and exhibits.
When was the earliest event reported in this Form 8-K?
The earliest event reported was on December 23, 2024.
Where are Gain Therapeutics, Inc.'s principal executive offices located?
The principal executive offices are located at 4800 Montgomery Lane, Suite 220, Bethesda, Maryland 20814.
What is the Standard Industrial Classification code for Gain Therapeutics, Inc.?
The SIC code is 2834, which corresponds to Pharmaceutical Preparations.
What is the SEC file number for Gain Therapeutics, Inc.?
The SEC file number is 001-40237.
Filing Stats: 780 words · 3 min read · ~3 pages · Grade level 11.3 · Accepted 2024-12-23 08:30:32
Key Financial Figures
- $0.0001 — ch registered Common Stock, par value $0.0001 GANX The Nasdaq Stock Market LLC It
Filing Documents
- tm2431811d1_8k.htm (8-K) — 28KB
- tm2431811d1_ex99-1.htm (EX-99.1) — 17KB
- tm2431811d1_ex99-1img001.jpg (GRAPHIC) — 4KB
- 0001104659-24-131084.txt ( ) — 229KB
- ganx-20241223.xsd (EX-101.SCH) — 3KB
- ganx-20241223_lab.xml (EX-101.LAB) — 33KB
- ganx-20241223_pre.xml (EX-101.PRE) — 22KB
- tm2431811d1_8k_htm.xml (XML) — 4KB
01. Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure. On December 23, 2024, Gain Therapeutics, Inc. (the "Company") issued a press release announcing it has received approval in Australia to initiate a Phase 1b clinical trial. 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 of 1933 or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
01 Other Information
Item 8.01 Other Information On December 23, 2024, the Company issued a press release announcing that it has received approval in Australia to initiate a Phase 1b clinical trial. The Company will be working with local Parkinson's disease ("PD") advocacy groups to support enrollment, and expects enrollment to complete in the spring of 2025 with data from the study expected mid-2025. GT-02287 is the Company's lead allosteric small molecule in clinical development for the treatment of PD with or without a GBA1 mutation. The primary goal of the Phase 1b trial is to assess the safety and tolerability of GT-02287 in people with PD. The Phase 1b trial will follow the Company's Phase 1 study in healthy volunteers completed during the third quarter of 2024, in which GT-02287 demonstrated a favorable safety and tolerability profile as well as plasma and CNS exposures in the projected therapeutic range. The Phase 1 study also showed significant target engagement of GT-02287 demonstrated by a statistically significant increase in glucocerebrosidase (GCase) activity that was more than 50%. The Phase 1b clinical trial of GT-02287 will be conducted at seven sites covering the major metropolitan areas in Australia, all of which have experience with PD trials. The Phase 1b open-label trial will assess the safety and tolerability of 13.5 mg/kg/day of GT-02287 for three months in patients with GBA1-PD or idiopathic PD. Secondary endpoints include pharmacokinetics, GCase modulation, levels of GCase substrates, and other biomarkers in plasma and cerebrospinal fluid. Data from the Phase 1b trial is anticipated mid-2025.
01 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1* Press Release dated December 23, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). * Exhibit is being furnished as part of this Current Report on Form 8-K 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. Dated: December 23, 2024 By: /s/ Gene Mack Name: Gene Mack Title: Chief Financial Officer and Interim Chief Executive Officer