Gain Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Gain Therapeutics, Inc. has filed its 2023 10-K annual report detailing financial data and corporate events.</b>

AI Summary

Gain Therapeutics, Inc. (GANX) filed a Annual Report (10-K) with the SEC on March 26, 2024. Gain Therapeutics, Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The company's principal business address is 4800 Hampden Lane, Suite 200, Bethesda, MD 20814. The filing includes data related to various warrant types, including Public Warrants, Private Warrants, and Placement Agent Warrants. Key dates mentioned include July 20, 2020, for an unspecified event, and November 1-30, 2023, for a private placement involving accredited investors. The report details equity components such as Retained Earnings, Additional Paid-In Capital, and Accumulated Other Comprehensive Income for fiscal years 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking Gain Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Gain Therapeutics' financial health and operational activities for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The inclusion of detailed information on warrants, equity components, and specific dates of transactions offers insights into the company's capital structure and financing activities, important for understanding shareholder value and dilution.

Risk Assessment

Risk Level: medium — Gain Therapeutics, Inc. shows moderate risk based on this filing. The filing is a standard 10-K, which typically contains a broad range of financial and operational information. However, without specific financial performance metrics like revenue or net income provided in the initial data, a definitive risk assessment is limited, suggesting a medium risk profile due to the inherent uncertainties in biopharmaceutical companies.

Analyst Insight

Investors should review the full 10-K filing to understand Gain Therapeutics' financial position, strategic initiatives, and risk factors in detail.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-26 — Filing Date (Filed as of date)
• 118 — Public Document Count (Number of documents in the filing)
• 2020-07-20 — Key Event Date (An unspecified event date)
• 2023-11-01 — Private Placement Start Date (Accredited Investors Private Placement)

Key Players & Entities

• Gain Therapeutics, Inc. (company) — Filer name
• 2023-12-31 (date) — Conformed period of report
• 2024-03-26 (date) — Filed as of date
• 4800 Hampden Lane, Suite 200, Bethesda, MD 20814 (address) — Business address
• 2834 (sic_code) — Standard Industrial Classification
• 001-40237 (filing_number) — SEC file number
• 2020-07-20 (date) — Key date mentioned
• 2023-11-01 (date) — Start date of private placement

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-26: Filing Date — Date the 10-K was officially submitted to the SEC.
• 2020-07-20: Unspecified Event — A key date referenced in the filing, context not provided in snippet.
• 2023-11-01: Private Placement Start — Beginning of a private placement involving accredited investors.

Key Financial Figures

• $0.0001 — ich Registered Common Stock, par value $0.0001 per share GANX Nasdaq Global Market
• $4.48 — arter), based upon the closing price of $4.48 of the Registrant's common stock as rep

Filing Documents

• ganx-20231231x10k.htm (10-K) — 2428KB
• ganx-20231231xex4d1.htm (EX-4.1) — 46KB
• ganx-20231231xex23d1.htm (EX-23.1) — 6KB
• ganx-20231231xex31d1.htm (EX-31.1) — 11KB
• ganx-20231231xex31d2.htm (EX-31.2) — 10KB
• ganx-20231231xex32d1.htm (EX-32.1) — 10KB
• ganx-20231231xex97d1.htm (EX-97.1) — 39KB
• ganx-20231231x10k001.jpg (GRAPHIC) — 36KB
• ganx-20231231x10k002.jpg (GRAPHIC) — 47KB
• ganx-20231231x10k003.jpg (GRAPHIC) — 67KB
• ganx-20231231x10k004.jpg (GRAPHIC) — 32KB
• ganx-20231231x10k005.jpg (GRAPHIC) — 44KB
• ganx-20231231x10k006.jpg (GRAPHIC) — 45KB
• ganx-20231231x10k007.jpg (GRAPHIC) — 37KB
• 0001558370-24-003943.txt (&nbsp;) — 11753KB
• ganx-20231231.xsd (EX-101.SCH) — 72KB
• ganx-20231231_cal.xml (EX-101.CAL) — 73KB
• ganx-20231231_def.xml (EX-101.DEF) — 262KB
• ganx-20231231_lab.xml (EX-101.LAB) — 639KB
• ganx-20231231_pre.xml (EX-101.PRE) — 508KB
• ganx-20231231x10k_htm.xml (XML) — 1978KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 33 Item 1B. Unresolved Staff Comments 73 Item 1C. Cybersecurity 73 Item 2.

Properties

Properties 74 Item 3.

Legal Proceedings

Legal Proceedings 74 Item 4. Mine Safety Disclosures 74 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 74 Item 6.

Selected Financial Data

Selected Financial Data 75 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 75 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 85 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 86 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 117 Item 9A.

Controls and Procedures

Controls and Procedures 117 Item 9B. Other information 117 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 117 Part III Item 10. Directors, Executive Officers and Corporate Governance 118 Item 11.

Executive Compensation

Executive Compensation 118 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 118 Item 13. Certain Relationships and Related Transactions and Director Independence 118 Item 14. Principal Accountant Fees and Services 118 Part IV Item 15. Exhibits and Financial Statement Schedules 119 Item 16. Form 10-K Summary 120 2 Table of Contents Unless the context suggests otherwise, references in this Annual Report on Form 10-K, or the Annual Report, to "Gain," the "Company," "we," "us," and "our" refer to Gain Therapeutics, Inc. and, where appropriate, its wholly owned subsidiaries. Magellan is our trademark. All other brand names and service marks, trademarks and other trade names appearing in this Annual Report are the property of their respective owners. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and are often characterized by the use of words such as "aim", "believe," "can," "could," "potential," "plan," "predict," "goals," "seek," "should," "may," "may have," "would," "estimate," "continue," "anticipate," "intend," "expect" or the negative of these terms, other comparable terminology or by discussions of strategy, plans or intentions. These include, but are not limited to, statements about: our ability to continue as a going concern and our needs for additional financing; our ability to accurately estimate anticipated operating losses, expenses, future revenues, capital requirements, including our anticipated cash runway; the success of our efforts, and those of our advisors, in exploring, and

BUSINESS

ITEM 1. BUSINESS Overview We are a biotechnology company developing novel small molecule therapeutics to treat diseases across several therapeutic areas, including, central nervous system ("CNS") disorders, lysosomal storage disorders ("LSDs"), metabolic disorders, and other diseases that can be targeted through protein degradation, such as oncology. GT-02287 - our lead product candidate: for the treatment of GBA1 Parkinson's disease and other synucleinopathies Our clinical stage product candidate, GT-02287, is being developed for the treatment of GBA1 Parkinson's disease. We have generated an extensive preclinical data package providing evidence of the mechanism of action and safety of GT-02287. In preclinical models of GBA1 Parkinson's disease, GT-02287 has been shown to restore glucocerebrosidase, or GCase, function in the lysosome, reduce toxic lipid substrates and toxic forms of alpha-synuclein, improve survival of dopaminergic neurons, increase dopamine levels, completely restore locomotor function, and reduce plasma-based neurodegeneration maker, neurofilament light chain, or NfL, back to the level of healthy animals. In September 2023, we initiated in Australia the first-in-human Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics, and food effect of GT-02287 in healthy participants. The study design includes a single ascending dose part during which the study participants receive one dose of GT-02287 at different dose levels, and a multiple ascending dose part during which the study participants receive one daily dose of GT-02287 for 14 days at different dose levels. In February 2024, we initiated the multiple ascending dose part of this Phase 1 clinical trial, which we anticipate completing in the second quarter of 2024, with the availability of the quality assurance audited interim report in the third quarter of 2024. We are planning to expand the scope of this Phase 1 clinical trial by amending the study protocol to include

View Full Filing

View this 10-K filing on SEC EDGAR