Gain Therapeutics, Inc. 10-K

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA INDEX TO FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA ​ Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 1460 ) ​ 84 Consolidated Balance Sheets ​ 85 Consolidated Statements of Operations ​ 86 Consolidated Statements of Comprehensive Loss ​ 87 Consolidated Statements of Changes in Stockholders’ Equity ​ 88 Consolidated Statements of Cash Flows ​ 89 Notes to Consolidated Financial Statements ​ 90 ​ ​ 83 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Gain Therapeutics, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Gain Therapeutics, Inc. (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles. The Company’s Ability to Continue as a Going Concern The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from operations since inception and has stated that substantial doubt exists about the Company’s ability to continue as a going concern. Management's evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. ​ /s/ Ernst & Young AG ​ We have served as the Company’s auditor since 2020. Lugano, Switzerland March 27, 2025 ​ 84 Table of Contents Gain Therapeutics, Inc Consolidated Balance Sheets ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ ​ ​ 2024 ​ 2023 Assets ​ ​ Current assets: ​ ​ Cash and cash equivalents ​ $ 10,385,863 ​ $ 11,794,949 Marketable securities ​ ​ ​ — ​ ​ 4,999,704 Tax credits ​ ​ ​ 271,079 ​ ​ 242,577 Prepaid expenses and other current assets ​ 945,536 ​ 741,638 Total current assets ​ ​ 11,602,478 ​ ​ 17,778,868 ​ ​ ​ ​ ​ ​ ​ ​ Noncurrent assets: ​ ​ Property and equipment, net ​ 103,619 ​ 125,962 Internal-use software ​ ​ ​ 134,268 ​ ​ 193,375 Operating lease right-of-use assets ​ 219,715 ​ 459,215 Restricted cash ​ 31,695 ​ 34,021 Long-term deposits and other noncurrent assets ​ 32,109 ​ 17,890 Total noncurrent assets ​ ​ 521,406 ​ ​ 830,463 Total assets ​ $ 12,123,884 ​ $ 18,609,331 ​ ​ ​ ​ ​ ​ ​ ​ Liabilities and stockholder's equity ​ ​ ​ ​ ​ ​ ​ Current liabilities: ​ ​ Accounts payable ​ $ 946,259 ​ $ 1,318,965 Operating lease liability - current ​ 160,913 ​ 229,693 Other current liabilities ​ 2,441,761 ​ 2,160,366 Deferred grant income - current ​ 252,211 ​ 1,122,138 Loans - current ​ ​ 110,177 ​ ​ 118,797 Total current liabilities ​ ​ 3,911,321 ​ ​ 4,949,959 ​ ​ ​ ​ ​ ​ ​ ​ Noncurrent liabilities: ​ ​ Defined benefit pension plan ​ ​ 443,623 ​ ​ 307,454 Operating lease liability - noncurrent ​ 53,598 ​ 229,855 Deferred grant income - noncurrent ​ ​ ​ 47,441 ​ ​ 94,786 Loans - noncurrent ​ ​ 328,327 ​ ​ 449,053 Total noncurrent liabilities ​ ​ ​ 872,989 ​ ​ 1,081,148 Total liabilities ​ $ 4,784,310 ​ $ 6,031,107 ​ ​ ​ ​ ​ ​ ​ ​ Stockholders’ equity ​ ​ Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized; nil shares issued and outstanding as of December 31, 2024 and 2023 ​ ​ $ — ​ $ — Common stock, $ 0.0001 par value: 50,000,000 shares authorized; 27,132,588 and 16,206,680 shares issued and outstanding as of December 31, 2024 and 2023, respectively ​ 2,713 ​ 1,621 Additional paid-in capital ​ 88,779,318 ​ 73,113,079 Accumulated other comprehensive (loss) income ​ ( 247,549 ) ​ 247,241 Accumulated deficit ​ ( 60,783,717 ) ​ ( 38,516,197 ) Loss of the period ​ ( 20,411,191 ) ​ ( 22,267,520 ) Total stockholders’ equity ​ ​ 7,339,574 ​ ​ 12,578,224 Total liabilities and stockholders’ equity ​ $ 12,123,884 ​ $ 18,609,331 ​ ​ 85 Table of Contents Gain Therapeutics, Inc Consolidated Statements of Operations ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 Revenues: ​ ​ ​ Collaboration revenues ​ $ — ​ $ 55,180 Other income ​ ​ — ​ — Total revenues ​ ​ — ​ ​ 55,180 ​ ​ ​ ​ ​ ​ ​ Operating expenses: ​ ​ Research and development ​ ( 10,791,058 ) ​ ( 11,520,613 ) General and administrative ​ ( 9,559,534 ) ​ ( 10,787,700 ) Total operating expenses ​ ​ ( 20,350,592 ) ​ ​ ( 22,308,313 ) ​ ​ ​ ​ ​ ​ ​ Loss from operations ​ ​ ( 20,350,592 ) ​ ​ ( 22,253,133 ) ​ ​ ​ ​ ​ ​ ​ Other income (expense): ​ ​ Interest income, net ​ 357,096 ​ 494,234 Foreign exchange gain (loss), net ​ 119,120 ​ ( 429,346 ) Loss before income tax ​ ​ ( 19,874,376 ) ​ ​ ( 22,188,245 ) ​ ​ ​ ​ ​ ​ ​ Income tax ​ ( 536,815 ) ​ ( 79,275 ) ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 20,411,191 ) ​ $ ( 22,267,520 ) ​ ​ ​ ​ ​ ​ ​ Net loss per shares: ​ ​ Net loss per share attributable to common stockholders - basic and diluted ​ $ ( 0.89 ) ​ $ ( 1.71 ) Weighted average common stock - basic and diluted ​ 22,881,415 ​ 13,011,361 ​ ​ ​ 86 Table of Contents Gain Therapeutics, Inc Consolidated Statements of Comprehensive Loss ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 Net loss ​ $ ( 20,411,191 ) ​ $ ( 22,267,520 ) Components of other comprehensive (loss) income ​ ​ ​ ​ ​ ​ Unrealized gain on available-for-sale marketable securities ​ ​ 4,974 ​ ​ 89,304 Changes in defined benefit pension plan obligation, net of tax ​ ​ ( 132,524 ) ​ ​ ( 127,601 ) Foreign currency translation ​ ( 367,240 ) ​ 249,911 Other comprehensive (loss) income, net of tax ​ ​ ( 494,790 ) ​ ​ 211,614 Comprehensive loss ​ $ ( 20,905,981 ) ​ $ ( 22,055,906 ) ​ ​ 87 Table of Contents Gain Therapeutics, Inc Consolidated Statements of Changes in Stockholders’ Equity ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Additional Paid-in ​ Accumulated Other Comprehensive ​ Accumulated ​ ​ ​ ​ Shares Amounts Capital Income (Loss) Deficit Total Balance as of December 31, 2022 ​ 11,883,368 ​ $ 1,189 ​ $ 57,358,895 ​ $ 35,627 ​ $ ( 38,516,197 ) ​ $ 18,879,514 Stock-based compensation (Note 15) ​ 171,751 ​ 16 ​ 3,305,056 ​ — ​ — ​ 3,305,072 Changes in defined benefit pension plan obligation (Note 11) ​ — ​ — ​ — ​ ( 127,601 ) ​ — ​ ( 127,601 ) Foreign currency translation ​ — ​ — ​ — ​ 249,911 ​ — ​ 249,911 Net unrealized gain on available-for-sale securities (Note 5) ​ — ​ ​ — ​ ​ — ​ ​ 89,304 ​ ​ — ​ ​ 89,304 Issuance of shares in at-the-market (ATM) offering (Note 14) ​ 862,535 ​ ​ 86 ​ ​ 3,544,790 ​ ​ — ​ ​ — ​ ​ 3,544,876 Issuance of shares and warrants in public offering and private placement (Note 14) ​ 3,289,026 ​ ​ 330 ​ ​ 8,904,338 ​ ​ — ​ ​ — ​ ​ 8,904,668 Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 22,267,520 ) ​ ​ ( 22,267,520 ) Balance as of December 31, 2023 ​ 16,206,680 ​ $ 1,621 ​ $ 73,113,079 ​ $ 247,241 ​ $ ( 60,783,717 ) ​ $ 12,578,224 Stock-based compensation (Note 15) ​ 77,777 ​ 7 ​ 2,341,213 ​ — ​ — ​ 2,341,220 Changes in defined benefit pension plan obligation (Note 11) ​ — ​ — ​ — ​ ( 132,524 ) ​ — ​ ( 132,524 ) Foreign currency translation ​ — ​ — ​ — ​ ( 367,240 ) ​ — ​ ( 367,240 ) Net unrealized gain on available-for-sale securities (Note 5) ​ — ​ ​ — ​ ​ — ​ ​ 4,974 ​ ​ — ​ ​ 4,974 Issuance of shares in ATM offering (Note 14) ​ 1,597,128 ​ ​ 159 ​ ​ 2,950,974 ​ ​ — ​ ​ — ​ ​ 2,951,133 Issuance of shares and warrants in public offering and private placement (Note 14) ​ 9,251,003 ​ ​ 926 ​ ​ 10,374,052 ​ ​ — ​ ​ — ​ ​ 10,374,978 Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 20,411,191 ) ​ ​ ( 20,411,191 ) Balance as of December 31, 2024 ​ 27,132,588 ​ $ 2,713 ​ $ 88,779,318 ​ $ ( 247,549 ) ​ $ ( 81,194,908 ) ​ $ 7,339,574 ​ ​ ​ 88 Table of Contents Gain Therapeutics, Inc Consolidated Statements of Cash Flows ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ ​ ​ ​ ​ Operating activities: ​ ​ Net loss ​ $ ( 20,411,191 ) ​ $ ( 22,267,520 ) ​ ​ ​ ​ ​ ​ Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ Depreciation and amortization ​ 84,071 ​ 83,579 Stock based compensation expense ​ 2,390,159 ​ 3,259,026 Other non cash items ​ ​ 143,523 ​ ​ ( 383,188 ) ​ ​ ​ ​ ​ ​ ​ Changes in operating assets and liabilities: ​ ​ ​ ​ Prepaid expenses and other current assets ​ ​ ( 356,650 ) ​ ​ 54,378 Long term deposit and other noncurrent assets ​ ( 21,000 ) ​ ( 10,057 ) Accounts payable and other current liabilities ​ 274,889 ​ ( 693,698 ) Defined benefit pension plan ​ ​ ( 122,915 ) ​ ​ 6,313 Deferred grant income ​ ( 854,713 ) ​ 1,085,294 Total changes in operating assets and liabilities ​ ​ ( 1,080,389 ) ​ ​ 442,230 Cash used in operating activities ​ ​ ( 18,873,827 ) ​ ​ ( 18,865,873 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from investing activities: ​ ​ ​ Purchase of property and equipment and internal-use of software ​ ( 22,493 ) ​ ( 15,358 ) Purchases of marketable securities ​ ​ — ​ ​ ( 1,956,350 ) Maturities of marketable securities ​ ​ 5,000,000 ​ ​ 12,194,375 Cash provided by investing activities ​ ​ 4,977,507 ​ ​ 10,222,667 ​ ​ ​ ​ ​ ​ ​ Cash flow from financing activities: ​ ​ ​ Net proceeds from issuance of shares in ATM offering (Note 14) ​ 2,951,133 ​ 3,544,876 Net proceeds from issuance of shares and warrants in public offering (Note 14) ​ 10,261,178 ​ 9,185,534 Net proceeds from the exercise of warrants (Note 14) ​ ​ 113,800 ​ ​ — Net proceeds from the exercise of stock options (Note 15) ​ ​ 57,711 ​ ​ — Payments of offering costs (Note 14) ​ ​ ( 280,867 ) ​ ​ — Payments of current portion of long-term debt (Note 12) ​ ​ ( 90,879 ) ​ ​ ( 89,067 ) Cash provided by financing activities ​ ​ 13,012,076 ​ ​ 12,641,343 Effect of exchange rate changes ​ ​ ( 527,168 ) ​ ​ 488,404 Net (decrease)/increase in cash, cash equivalents and restricted cash ​ ​ ( 1,411,412 ) ​ ​ 4,486,541 Cash, cash equivalents and restricted cash at beginning of period ​ 11,828,970 ​ 7,342,429 Cash, cash equivalents and restricted cash at end of period ​ $ 10,417,558 ​ $ 11,828,970 ​ ​ ​ ​ ​ ​ ​ Supplemental Data: ​ ​ ​ ​ ​ ​ Income taxes paid ​ $ 86,309 ​ $ 134,962 ​ ​ ​ 89 Table of Contents Notes to the Consolidated Financial Statements 1. Nature of the Business and Basis of Presentation Operations and Business Gain Therapeutics, Inc. (and together with its subsidiary, the “Company”), was incorporated under the laws of the state of Delaware (U.S.) on June 26, 2020. Gain Therapeutics has been a publicly traded company since the Initial Public Offering (“IPO”) completed in March of 2021. The shares trade on the Nasdaq Global Market under the ticker symbol “GANX”. The Company is 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. The Company’s clinical stage product candidate, GT-02287, is being developed for the treatment of Parkinson’s disease with and without GBA1 mutations. The Company generated an extensive preclinical data package providing evidence of the mechanism of action, in vivo pharmacology, 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, reduce endoplasmic reticulum stress, improve mitochondrial health and overall survival of dopaminergic neurons, increasing dopamine levels, restoring locomotor and cognitive function, and reducing plasma-based neurodegeneration maker, neurofilament light chain (NfL), back to the level of control animals. The Company uses the Magellan™ drug discovery platform to identify novel allosteric sites and small molecules for all its pipeline programs. The Company plans to continue to advance its existing research programs and initiate additional programs targeting allosteric binding sites identified with the Magellan™ platform in various therapeutic areas through academic partnerships, co-development, and licensing arrangements. Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, risks associated with completion and success of preclinical studies and clinical testing, dependence on key personnel, protection of proprietary technology, compliance with applicable governmental regulations, development by competitors of new technological innovations, protection of proprietary technology and the ability to secure additional capital to fund operations. Drug candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and prior to regulatory approval and commercialization. These efforts require significant amounts of additional capital, adequate personnel, infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. Basis of Presentation The accompanying audited annual consolidated financial statements (the “annual financial statements”) reflect the accounts of Gain Therapeutics, Inc., Gain Therapeutics Australia PTY LTD, GT Gain Therapeutics SA and its wholly owned branch, Gain Therapeutics Sucursal en España. All intercompany transactions and balances have been eliminated in the preparation of the consolidated financial statements. The annual financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The annual financial statements have been prepared on the same basis as applied for the audited annual consolidated financial statements as of and for the year ended December 31, 2023, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of December 31, 2024, the results of its operations and its statements of stockholders’ equity and its statements of cash flows for the years ended December 31, 2024 and 2023. All amounts in the 90 Table of Contents consolidated financial statements are expressed in U.S. dollars and disclosed within these explanatory notes in U.S. dollars. The results for the years ended December 31, 2024 and 2023 are not necessarily indicative of the results to be expected for any future year or period. These annual financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2023, and the notes thereto, which are included in the Annual Report. These accompanying annual financial statements reflect the application of significant accounting policies as described below and elsewhere in these notes to the audited consolidated financial statements. As of December 31, 2024, the Company’s significant accounting policies and estimates, which are detailed herein, have not changed. Going Concern At each reporting period, the Company evaluates whether there are relevant conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company has incurred recurring losses and negative cash flows from operations since its inception and has primarily funded these losses through the completion of its IPO in March 2021, other equity financings and research grants. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in development. Substantial additional capital will be needed by the Company to fund its operations and to develop its product candidates. The Company’s activities have consisted primarily of performing research and conducting preclinical and clinical studies, organizing and staffing the Company, expanding its operations, securing financing, developing and securing its in-licensed technology. The Company faces risks associated with early-stage biotechnology companies whose product candidates are in development. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing, establishing manufacturing capacity and obtaining regulatory approval prior to commercialization. These efforts require significant amounts of additional capital for the Company to complete its research and development activities, achieve its research and development objectives, defend its intellectual property rights, and recruit and retain skilled personnel, and key members of management. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. In accordance with ASU No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”, the Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company assessed that its existing cash and cash equivalents of $ 10.4 million as of December 31, 2024 will not be sufficient to fund its estimated operating and capital expenditures for a period of at least 12 months from the date these financial statements are issued. Because of the current liquidity situation and lack of expected revenues in the foreseeable future, substantial doubt exists about its ability to continue as going concern. The Company will need to obtain additional capital and/or other funding in order to continue operations beyond the third quarter of 2025. Management plans to raise additional capital primarily through private and/or public equity financings and/or convertible debt financings. As an additional action, management is currently reviewing the cost structure throughout the organization, looking for opportunities to optimize expenditures and create efficiencies with the objective of improving the Company’s overall cash burn rate, optimizing the research and development expenses and reducing general and administrative expenses. Furthermore, management is actively seeking opportunities for strategic collaborations, licensing agreements and grant fundings, among other strategic opportunities. The Company may not be successful in its efforts to raise additional funds or achieve profitable operations. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations beyond the third quarter of 2025, including raising additional capital through either private or public equity, debt financing, or additional program collaborations. 91 Table of Contents If the Company is unable to obtain additional funding to support its current or proposed activities and operations, it may not be able to continue its operations as currently anticipated, which may require it to suspend or terminate any ongoing development activities, modify its business plan, curtail various aspects of its operations, cease operations, or seek relief under applicable bankruptcy laws. In such event, the Company’s stockholders may lose a substantial portion or even all of their investment. Because of the actions that management is taking to secure future financial resources, the accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as going concern. Segment Information Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s Chief Executive Officer is the Company’s CODM. The CODM reviews financial information presented on a consolidated basis for purposes of making operating decisions, allocating resources, and evaluating financial performance. As such, the Company has determined that it operates as one operating segment, which is research and development in the pharmaceutical sector with a focus on developing novel therapeutics to treat diseases caused by protein misfolding. The Company has concluded that consolidated net income (loss) is the measure of segment profitability. The CODM assesses performance for the Company, monitors budget versus actual results, and determines how to allocate resources based on consolidated net income (loss) as reported in the Consolidated Statements of Operations. There are no other expense categories regularly provided to the CODM that are not already included in the primary financial statements herein. ​ The Company has operations in four (4) geographic locations: Switzerland, Spain, the United States, and Australia. Product candidates currently under development require significant additional research and development efforts, including extensive preclinical and clinical testing, establishing manufacturing capacity and obtaining regulatory approval prior to commercialization, as such no revenue has been generated and therefore no additional disclosures of revenue information from products and services and information on major customers are required. The following table details the Company’s long-lived assets by geographic location, with the exception of Australia where there are no long-lived assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Long-lived assets by geographic location ​ ​ ​ ​ ​ ​ Switzerland ​ $ 282,185 ​ $ 445,507 Spain ​ ​ 164,847 ​ ​ 274,855 United States ​ ​ 10,570 ​ ​ 58,190 Total ​ $ 457,602 ​ $ 778,552 ​ ​ 2. Summary of Significant Accounting Policies Foreign Currency Transactions The Company is incorporated in the United States of America and has operations in Switzerland, Spain and Australia. The Company’s reporting currency is U.S. dollars (“USD”). The functional currencies of the Company’s operations are the local currencies (USD in the United States, Swiss franc in Switzerland, euro in Spain and Australian dollar in Australia). Assets and liabilities reported in the Consolidated Balance Sheets are translated into USD (the currency in which these financial statements are presented) at the exchange rates applicable at the balance sheet dates and for the Consolidated Statements of Operations at the average exchange rates for the periods presented. Items representing the share capital and additional paid-in capital are presented at historical exchange rates. Adjustments resulting from the translation of the financial statements of the Company’s foreign operations into USD are excluded from the determination of net income and are recorded in accumulated other comprehensive income/(loss), a separate component of shareholders’ equity. The Company has not utilized any foreign currency hedging strategies to mitigate the effect of its foreign currency exposure. As of December 31, 2024 and December 31, 2023, accumulated currency translation adjustments recorded in accumulated other comprehensive loss amounted to $ 41,247 and $ 408,487 , respectively. 92 Table of Contents Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. On an ongoing basis, the Company evaluates its estimates, judgments and assumptions including those related to going concern assessment, recognition of accrued expenses, defined benefit pension liability, share-based compensation, and recognition of research grants. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable by management under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. Changes in estimates are recorded in the period in which they become known. To the extent that material differences arise between the estimates and actual results, the Company’s future results of operations will be affected. Cash and Cash Equivalents The Company classifies cash on hand and held at banks, and all highly liquid investments in money markets, certificates of deposit, time deposits, and other short-term liquid securities with original maturities of less than 90 days, as cash and cash equivalents. Marketable Securities The Company classifies marketable securities as held-to-maturity or available-for-sale at the time these instruments are purchased, based on the requirements of ASC 320, “Investments – Debt Securities” (“ASC 320”). Marketable securities are classified as available-for-sale since the Company does not have the positive intent and the capacity to hold the marketable securities until the maturity date. Available-for-sale marketable securities are carried out at fair value with the unrealized gain/(loss) excluded from the computation of the earnings of the period and accounted for in other comprehensive income/(loss). The accretion of discounts (or amortization of premiums) is accounted for in the Company’s Consolidated Statements of Operations as interest income or (expense). Marketable securities are classified in the Company’s Consolidated Balance Sheets based on their maturities and the Company’s reasonable expectations with regard to those securities. Marketable securities with a maturity date within 12 months from the reporting date are classified as “Current assets.” Marketable securities with a maturity date over 12 months from reporting date are classified as “Noncurrent assets.” Concentrations of Credit Risk The Company has no significant off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that may expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents which are deposited in accredited financial institutions in excess of federally insured limits. The Company deposits its cash and cash equivalents in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Deferred Issuance Costs The Company capitalizes certain legal, professional accounting, and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such equity transactions are consummated. Subsequently, these costs are recorded as a reduction of the proceeds generated as a result of the offering. Should the planned equity financing be abandoned, the deferred issuance costs will be expensed immediately as a charge to operating expenses in the Consolidated Statements of Operations. 93 Table of Contents Property and Equipment Property and equipment are stated at cost, including any accessory and direct costs that are necessary to make the assets fit for use, and adjusted by the corresponding accumulated depreciation. The depreciation expenses are recorded using the straight-line method in the Consolidated Statements of Operations and have been calculated by taking into consideration the use, purpose and financial-technical duration of the assets, on the basis of their estimated useful economic lives. The Company believes the above criteria to be represented by the following depreciation rates: ​ ​ ​ ​ ​ -  Equipment & furniture 12.5 % -  Electronic office equipment ​ 20 % -  Leasehold improvements ​ based on the terms of the lease ​ -  Laboratory equipment ​ 15 % ​ Ordinary maintenance costs are entirely attributed to the Consolidated Statements of Operations in the year in which they are incurred. Extraordinary maintenance costs, the purpose of which is to extend the useful economic life of the asset, to technologically upgrade it and/or to increase its productivity or safety for the purposes of the economic productivity of the Company, are attributed to the asset to which they refer and depreciated on the basis of its estimated useful economic lives. Amortization of leasehold improvements is computed using the straight-line method based upon the terms of the applicable lease or estimated useful life of the improvements, whichever is lower. Capitalized Software Development Costs The Company capitalizes the costs of software obtained for internal use in accordance with ASC 350-40, “Internal-Use Software”. Capitalized software development costs consist of costs incurred during the development stage and include purchased software licenses, implementation costs, consulting costs, and payroll-related costs for projects that qualify for capitalization. All other costs, primarily related to maintenance and minor software fixes, are expensed as incurred. Internal-use software, net consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ ​ 2024 ​ 2023 Internal-use software ​ $ 264,062 ​ $ 284,637 Less: accumulated amortization ​ ( 129,794 ) ​ ( 91,262 ) Internal-use software, net ​ $ 134,268 ​ $ 193,375 ​ The Company amortizes the capitalized software development costs on a straight-line basis over the estimated useful life of the software, which is generally six years , beginning when the asset is substantially ready for use. The amortization of capitalized software development costs is reflected in general and administrative expenses. Amortization expense for the years ended December 31, 2024 and December 31, 2023 was $ 47 thousand and $ 46 thousand, respectively. Impairment of Long-lived Assets In accordance with ASC 360-10-20, “Property, Plant and Equipment,” the Company performs an impairment test whenever events or circumstances indicate that the carrying value of long-lived assets with finite lives may be impaired. Impairment is measured by comparing the carrying value of the long-lived assets to the estimated undiscounted pre-tax cash flows expected to result from the use of such assets and their ultimate disposition. In circumstances where impairment is determined to exist, the Company will write down the asset to its fair value based on the present value of estimated cash flows. No impairments have been identified by management as of and for any periods presented. Patents Patent-related costs refer to legal fees incurred in connection with filing and prosecuting patent applications and are expensed as incurred due to uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. 94 Table of Contents Leases The Company determines if an arrangement contains a lease at inception based on whether or not the Company has the right to control the asset during the contract period and other facts and circumstances, as per ASC 842, “Leases.” Operating lease right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease, both of which are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date using the Company’s incremental borrowing rate applicable to the lease. The collateralized incremental borrowing rate is based on the information available at the lease commencement date. The Company is typically required to make fixed minimum rent payments and is often required, by the lease, to pay for certain other costs including real estate taxes, insurance, common area maintenance and/or certain other costs, which may be fixed or variable, depending upon the terms of the respective lease agreement. To the extent these payments are fixed, the Company has included them in calculating the lease ROU assets and lease liabilities. Variable lease payments primarily include payments for non-lease components, such as maintenance or utilities. Leases with a term of 12 months or less at inception are expensed on a straight-line basis over the lease term in the Consolidated Statements of Operations. The Company determines the lease term by assuming the exercise of renewal options that are reasonably certain. Accounts Payable Accounts payable are reported at their nominal amounts due to their short-term maturities. Trade accounts payable are recorded net of trade discounts; cash discounts are recorded at the time of payment. Payables for Social Security Charges Social security charges are reported in compliance with rules and laws applicable in the countries where the Company’s employees work. Charges are accrued in accordance with the policies stipulated and in connection with salaries due for the period. Accrued Expenses As part of the process of preparing the Company’s consolidated financial statements, the Company is required to estimate its accrued expenses as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with the Company personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The Company makes estimates of its accrued expenses as of each balance sheet date based on facts and circumstances known at the time of the preparation of its consolidated financial statements. There may be instances in which payments made to the Company’s vendors exceed the level of services provided, and result in a prepayment reported under Other Current Assets, which is subsequently expensed in the Consolidated Statement of Operations when the related activity has been performed. To date, there have been no material differences between the Company’s estimates of accrued expenses reported at each balance sheet date and the amounts actually incurred. Pension Obligations The Company operates defined benefit pension plan and defined contribution pension plans in accordance with local regulations and practices in the countries in which the Company operates. These plans are funded by regular contributions made by the Company and its employees. For the defined benefit pension plan, the liability recognized in the Consolidated Balance Sheets is the present value of the defined benefit obligation at the balance sheet date less the fair value of plan assets. The overfunded or underfunded status of the defined benefit plan is calculated as the difference between plan assets and the projected benefit obligations. Estimates are used in determining the assumptions incorporated in the calculation of the pension obligations, which is supported by input from independent actuaries. Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions are recognized in the Consolidated Statements of Changes in Stockholders’ Equity under accumulated other comprehensive income (loss), and are charged or credited to income over the employees’ expected average remaining service period using the corridor amortization method. The measurement date used for the Company’s employees defined benefit plan is December 31. 95 Table of Contents For defined contribution pension plans, the Company pays contributions to publicly or privately administered pension insurance plans on a mandatory, contractual or voluntary basis. The Company has no further payment obligations once the contributions have been paid. The contributions are recognized as employee benefit expense when they are due. Stock-based Compensation and Warrants The Company issues stock-based compensation with service-based and performance-based vesting conditions. The Company applies the fair value method of measuring equity-based compensation and warrants, which requires an entity to measure the cost of services received in exchange for an award of equity instruments based on the grant-date fair value of the award. The Company recognizes the corresponding expense in the statement of operations over the period the participants are required to render service. Forfeitures are recognized as they occur. The fair value of each stock option award is estimated as of the grant date using the Black-Scholes option pricing model. The Company determines the volatility and the expected term of exercise for awards granted based on the actual volatility of its share price traded on the Nasdaq and the best estimate of the timing of the exercise by the beneficiaries as of the grant date. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company has not paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to be nil . The Company recognizes expenses related to restricted stock units (RSUs) based on their fair market value, determined as the closing price on the Nasdaq of the Company’s common stock as of the grant date, on a straight-line basis over the requisite service period. For restricted stock units with performance-based vesting conditions ( PRSUs), the fair value at grant date is calculated based on management’s assessment of the likelihood of occurrence of the underlying performance. The Black-Scholes option pricing model is also used for the warrants issued, using consistent inputs and methodology to quantify such inputs, as described above in relation to equity-based compensation. The assumptions used in calculating the fair value of share-based awards and warrants represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. Revenue Recognition When the Company derives income from its collaboration and licensing agreements, it recognizes revenue in accordance with ASC 606, “Revenues from Contracts with Customers” (“ASC 606”) and ASC 808, “Collaborative Arrangements”. The terms of these arrangements typically include payment from third-party customers of one or more of the following: non-refundable initiation fee, reimbursement of development costs, future development and regulatory milestone payments, and royalties on net sales of the licensed product. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations, the Company applies the five-step model of ASC 606: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) it satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. If a contract is determined to be within the scope of ASC 606 at inception, the Company assesses the goods or services promised within such contract, determines which of those goods and services are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Costs and revenues associated with collaborative arrangements are reported in the Consolidated Statements of Operations on a gross basis when the counterpart is identified as being a customer, when the performance obligations incurred and rendered to fulfill the agreements are deemed to be in the ordinary course of the Company’s business, or when there is an expectation that the collaborative arrangement will result in a future constant flow of revenues in the form of sales of products, royalties, or licenses. 96 Table of Contents Research Grants Under the terms of the research and development grants awarded, the Company receives upfront payments or is entitled to receive reimbursement of its allowable direct expenses and payroll costs. Contributions from research and development activities under the grants are recorded when there is reasonable assurance of collection and based on management’s best estimate of the periods in which the related expenditures are incurred, and activities performed and are classified in the Consolidated Statements of Operations as a reduction to research and development expenses. Grants received in advance of the specific research and development costs to which they relate are deferred and recognized in the Consolidated Balance Sheets as deferred grant income. The Company is also eligible to obtain certain research and development tax credits. The tax credits are available on the basis of specific criteria with which the Company must comply. The tax credits are administered through the local tax authority and can be realized regardless of whether the Company has generated taxable income in the respective jurisdictions. The Company accounts for the tax credits through offsets to the related research and development as it incurs costs eligible for reimbursement when collectability is reasonably assured and when the applicable conditions under the tax incentive program have been met. ​ Research and Development Expenses The Company expenses all costs incurred in performing research and development activities. Research and development expenses include salaries and other related costs, materials and supplies, preclinical expenses, manufacturing expenses, contract services, and other third-party expenses. General and Administrative Expenses General and administrative expenses consist primarily of salaries, benefits, and other related costs, for personnel and consultants in the Company’s executive, administrative, and finance functions. General and administrative expenses also include professional fees for legal, finance, accounting, intellectual property, auditing, tax and consulting services, travel expenses and facility-related expenses, which include allocated expenses for rent and maintenance of facilities and other operating costs not otherwise included in research and development expenses. Income Taxes The Company accounts for income taxes under the liability method. Under this method deferred income tax liabilities and assets are determined based on the difference between the financial statements carrying amounts of assets and liabilities and the related tax basis using enacted tax rates in effect in the years in which the associated deferred taxes are expected to reverse. A valuation allowance is recorded if it is “more likely than not” that a portion or all of a deferred tax asset will not be realized. As of each reporting date, the Company considers existing evidence, both positive and negative, that could impact its view with regard to future realization of deferred tax assets. In consideration of the start-up status of the Company, a full valuation allowance has been established to offset the deferred tax assets, as the related realization is currently uncertain. In the future, should management conclude that it is more likely than not that the deferred tax assets are partially or fully realizable, the valuation allowance will be reduced to the extent of such expected realization, and the corresponding amount will be recognized as income tax benefit in the Company’s Consolidated Statements of Operations. Fair Value Measurement The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company applies the following fair value hierarchy, which prioritizes the inputs used to measure fair value into three levels based on their observability in the market and degree of judgment involved: ● Level 1 – Quoted prices in active markets for identical assets or liabilities. ● Level 2 – Observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. 97 Table of Contents ● Level 3 – Inputs that are generally unobservable and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and consider counterparty credit risk in their assessment of fair value. Comprehensive Income / (Loss) Comprehensive income / (loss) is composed of net income / (loss) and certain changes in stockholder’s equity that are excluded from the net income / (loss), primarily foreign currency translation adjustments, changes in defined benefit obligation, and unrealized gains / (losses) on available-for-sale securities. Net Loss per Share Basic net loss per share is computed by dividing the reported net loss by the weighted average number of shares of common stock outstanding during the period and shares issuable for little or no cash consideration upon resolution of any applicable contingency. The Company gives consideration to all potentially dilutive impacts, except where the effect of including such securities would be anti-dilutive. As of December 31, 2024 and December 31, 2023, common stock equivalents consisted of stock options, RSUs, PRSUs and warrants. Because the Company has reported net losses since inception, these potential impacts would be anti-dilutive, and therefore common stock equivalents have been excluded from the computation, resulting in basic and diluted net loss per share being the same for all periods presented. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Recently issued accounting pronouncements adopted In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . This ASU primarily requires incremental disclosures of disaggregated expense information about a Company's reportable segments. The Company adopted this ASU for the year-end December 31, 2024, and applied it retrospectively to all prior periods presented (see Note 1). Recently issued accounting pronouncements not yet adopted In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . This ASU primarily requires disaggregated information about a Company's effective tax rate reconciliation as well as information on income taxes paid. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. This ASU will likely result in the required additional disclosures being included in the Company’s consolidated financial statements, once adopted. As this ASU relates to disclosures only, there will be no impact to the Company’s consolidated results of operations and financial condition. In November 2024, the FASB issued ASU No. 2024-03, Disaggregation of Income Statement Expenses (Subtopic 220-40) . The ASU requires new disclosures providing further detail of a company’s income statement expense line items. The ASU is effective for annual periods beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Adoption of this ASU can either be applied prospectively to consolidated financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the consolidated financial statements. This ASU will likely result in the required additional disclosures being included in the Company’s consolidated financial statements, once adopted. As this ASU relates to disclosures only, there will be no impact to the Company’s consolidated results of operations and financial condition. ​ 98 Table of Contents 3. Research Grants During the course of its business, the Company applies for research grants with public or private organization to funds its research projects. Under the terms of these grants, the Company receives an upfront payment or is entitled to receive reimbursement of its allowable direct research expenses. In March 2023, the Company’s wholly owned subsidiary, GT Gain Therapeutics SA, announced that Eurostars and Innosuisse awarded a grant in the aggregated amount of $ 1.3 million to a consortium led by Gain Therapeutics that also includes the Institute for Research in Biomedicine, Newcells Biotech and the University of Helsinki. The grant is intended to support the development of our alpha-1 antitrypsin deficiency program. The portion of the grant that was allocated to the Company was $ 0.45 million. In May 2023, the Company’s wholly owned subsidiary, GT Gain Therapetuics SA, announced that Innosuisse awarded the Company a grant, under the Swiss Accelerator program, in the amount of $ 2.8 million to support the further development activities of Gain Therapeutics’ lead program GBA1 Parkinson’s disease. In December 2024, the parties to the grant entered into an amendment to the funding agreement whereby the grant amount was amended to approximately $ 2.0 million due to changes in project scope. There is no impact to the Consolidated Statements of Operations or Consolidated Balance Sheets due to this amendment. In connection with the grants announced in March 2023 and May 2023 the Company recorded a reduction to research and development expenses of $ 0.9 million and $ 0.6 million and reports deferred grant income of $ 0.3 million and $ 1.2 million during the years ended December 31, 2024 and December 31, 2023, respectively. In the second quarter of fiscal year 2023, the Company’s wholly owned subsidiary, Gain Therapeutics Australia started the Phase 1 Clinical Trial for its lead program in Parkinson’s disease in Australia. The Australian government sponsors the Research and Development Tax Incentive (“R&DTI”) program which offers a tax credit for companies conducting eligible research and development activities. The R&DTI program provides for a cash refund based on a percentage of eligible research and development activities undertaken in Australia by Gain Therapeutics Australia. The Company recorded a reduction to research and development expenses of $ 1.3 million during the year ended December 31, 2024 related to the R&DTI program. The corresponding receivable was recorded within Other Current Assets (see Note 6). ​ 4. Cash, Cash Equivalents and Restricted Cash The Company considers all short-term, highly liquid investments, with an original maturity of three months or less, to be cash equivalents. The Company’s cash and cash equivalents include short-term highly liquid investments which are readily convertible into cash and relate to money market securities. The Company’s institutional money market accounts permit daily redemption, and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions, which are considered Level 1 inputs in the fair value hierarchy. Given their short-term maturities and the underlying value being mainly represented by cash equivalents, their face value amount approximates the related fair market value. The Company has not experienced any losses in these accounts and does not believe it is exposed to any significant credit risk on cash and cash equivalents. Cash, cash equivalents and restricted cash are broken down as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Cash ​ $ 5,640,783 ​ $ 5,027,658 Money Market ​ ​ 4,745,080 ​ ​ 6,767,291 Total cash and cash equivalents ​ $ 10,385,863 ​ $ 11,794,949 Restricted cash ​ $ 31,695 ​ $ 34,021 ​ Restricted cash refers to an amount required under the Company’s office lease agreement in Lugano and is deposited into a restricted bank account as a guarantee. ​ ​ ​ ​ 99 Table of Contents 5. Marketable Securities As of December 31, 2024 and December 31, 2023, the Company reported nil and $ 5.0 million of marketable securities, respectively, within current assets, related to United States Treasury Securities (“USTS”). The USTS in the portfolio reached their final maturity in April 2024. ​ The Company classifies the USTS, which are accounted for as available-for-sale, within the Level 1 fair value hierarchy category as the fair value is based on quoted market prices in active markets with a high level of daily trading volume. Unrealized losses on available-for-sale debt securities as of December 31, 2023 were primarily due to changes in interest rates. The following tables summarize the Company’s investment in available-for-sale marketable securities with the detail of the unrealized losses and the estimated fair value as of December 31, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2023 ​ ​ ​ ​ ​ ​ ​ ​ Gross ​ Gross ​ ​ ​ ​ ​ ​ ​ ​ Allowance for ​ Unrealized ​ Unrealized ​ Estimated Fair ​ Amortized Cost Credit Losses Gains Losses Value Marketable securities available for sale ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Debt Securities - U.S. government treasury securities ​ $ 5,004,679 ​ $ — ​ $ — ​ $ ( 4,975 ) ​ $ 4,999,704 Totals ​ $ 5,004,679 ​ $ — ​ $ — ​ $ ( 4,975 ) ​ $ 4,999,704 ​ ​ 6. Tax Credits, Prepaid Expenses and Other Current Assets ​ Tax credits, prepaid expenses and other current assets consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Tax credits ​ $ 271,079 ​ $ 242,577 ​ ​ ​ ​ ​ ​ ​ Prepaid and deferred expenses ​ $ 369,893 ​ $ 608,638 Prepaid directors and officers (D&O) insurance costs ​ ​ 80,959 ​ ​ 133,000 Research and development grant receivable ​ ​ 494,684 ​ ​ — Total prepaid expenses and other current assets ​ $ 945,536 ​ $ 741,638 ​ Tax credits consisted of a value-added tax credit, which is an indirect tax receivable from Swiss and Spanish tax authorities on purchases of goods and services executed in those countries. Prepaid expenses refers to pre-payments made to the Company’s vendors for future services. Deferred expenses mainly refer to research agreements entered into with third parties for research projects that will be recognized as expenses throughout the research period. Prepaid D&O insurance costs relate to an annual insurance premium which will be recognized in the statement of operations on a monthly basis throughout the one year insurance period. The research and development grant receivable relates to a tax credit for eligible research and development costs incurred under the R&DTI program. Refer to Note 3 for further discussion. ​ 100 Table of Contents 7. Property and Equipment, Net Property and equipment, net consisted of the following : ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ 2024 2023 Computer ​ $ 101,087 ​ $ 83,894 Furniture and fixtures ​ 58,573 ​ 62,825 Leasehold improvements ​ 31,616 ​ 33,992 Laboratory instruments ​ 35,700 ​ 38,048 Total property and equipment ​ ​ 226,976 ​ ​ 218,759 Less: accumulated depreciation ​ ( 123,357 ) ​ ( 92,797 ) Property and equipment, net ​ $ 103,619 ​ $ 125,962 ​ No disposals, no r impairments occurred during the years ended December 31, 2024 and 2023. Depreciation has been calculated by taking into consideration the use, purpose and financial-technical duration of the assets based on their estimated economic lives. Depreciation expense for the years ended December 31, 2024 and December 31, 2023 was $ 38 thousand and $ 35 thousand, respectively. ​ 8. Operating Leases The Company leases offices in Bethesda (United States), Lugano (Switzerland), and Barcelona (Spain). The current lease portfolio consists of leases with remaining terms ranging from less than one to two years . Renewal options are included in the calculation of ROU assets and lease liabilities when the Company is reasonably certain that the renewal options will be exercised. The Company’s lease agreements do not contain residual value guarantees or material restrictive covenants. The breakdown of the significant components of ROU assets, lease liabilities and operating lease expense is reported in the table below, together with the discount rate used in order to calculate the net present value of the lease liabilities as of those periods. ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ ​ 2024 ​ 2023 Operating lease ​ ​ Operating lease right-of-use assets ​ $ 219,715 ​ $ 459,215 ​ ​ ​ ​ ​ ​ ​ Operating lease liability - current ​ $ 160,913 ​ $ 229,693 Operating lease liability - noncurrent ​ $ 53,598 ​ $ 229,855 Weighted average remaining lease term - years ​ 1.38 ​ 2.25 Weighted average discount rate ​ 1.53 ​ 1.51 ​ The operating lease expenses are reported as follows: ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Research and development $ 140,577 ​ $ 141,591 General and administrative ​ 88,499 ​ ​ 104,574 Total operating lease costs $ 229,076 ​ $ 246,165 ​ The Company incurred $ 17,636 in costs related to the short term lease in Bethesda in the year ended December 31, 2024. The variable lease costs incurred in the years December 31, 2024 and December 31, 2023 was $ 24,469 and $ 39,948 , respectively. The Company made fixed cash payments related to operating leases of $ 0.2 million in both the years ended December 31, 2024 and December 31, 2023. 101 Table of Contents The future minimum lease payments for the Company’s operating leases as of December 31, 2024, are as follows: ​ ​ ​ ​ ​ Fiscal Year Operating Leases 2025 ​ $ 162,991 2026 ​ ​ 53,973 Total future minimum lease payments ​ ​ 216,964 Less amount representing interest or imputed interest ​ ​ 2,453 Present value of lease liabilities ​ $ 214,511 ​ ​ 9. Accounts Payable Accounts payable refer to amounts due to third parties on outstanding invoices received for services already provided. As of December 31, 2024 and December 31, 2023, accounts payable amounted to $ 0.9 million and $ 1.3 million, respectively. All accounts payable are due in less than 12 months. ​ 10. Other Current Liabilities and Deferred Grant Income Other current liabilities and deferred grant income consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Payable for social security and withholding taxes ​ $ 229,319 ​ $ 368,345 Accrued payroll ​ 1,377,428 ​ 726,474 Accrued research and development ​ 344,138 ​ 588,433 Accrued professional fees ​ ​ 461,966 ​ ​ 399,034 Accrued other ​ ​ 10,417 ​ ​ 29,115 Tax provision ​ ​ 18,493 ​ ​ 48,965 Total other current liabilities ​ ​ 2,441,761 ​ ​ 2,160,366 Deferred grant income ​ 299,652 ​ 1,216,924 Total other current liabilities and deferred income ​ $ 2,741,413 ​ $ 3,377,290 ​ Accrued payroll refers to accruals for year-end bonuses, accrued vacations, overtime and other payroll-related accruals. Accrued other refers to invoices to be received from vendors for services performed and not yet billed. Tax provision refers to a tax payable due to the Spanish tax authorities related to taxable income generated in Spain. Deferred grant income refers to the upfront payment that the Company has received after the successful application regarding research and development grants with Innosuisse. 102 Table of Contents 11. Pension and Other Benefit Programs Net pension obligations related to the Company’s defined pension plan refers only to Swiss employees and as of December 31, 2024 and December 31, 2023 can be summarized as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 End of year funded status: ​ ​ ​ ​ ​ ​ Fair value of plan assets ​ $ 898,853 ​ $ 822,763 Projected benefit obligation ​ ​ ( 1,342,476 ) ​ ​ ( 1,130,217 ) Funded status ​ $ ( 443,623 ) ​ $ ( 307,454 ) ​ ​ ​ ​ ​ ​ ​ Accumulated benefit obligation ​ $ 1,270,787 ​ $ 1,076,742 ​ ​ ​ ​ ​ ​ ​ Reconciliation of funded status: ​ ​ ​ ​ ​ ​ Funded status beginning of year ​ $ ( 307,454 ) ​ $ ( 157,580 ) Expense ​ ​ ( 150,890 ) ​ ​ ( 149,309 ) Employer contributions ​ ​ 122,915 ​ ​ 143,599 Translation differences ​ ​ 24,330 ​ ​ ( 16,563 ) Change in accumulated other comprehensive loss ​ ​ ( 132,524 ) ​ ​ ( 127,601 ) Funded status at end of year ​ $ ( 443,623 ) ​ $ ( 307,454 ) ​ ​ ​ ​ ​ ​ ​ Component of net periodic pension costs: ​ ​ ​ ​ ​ ​ Service cost ​ $ 142,734 ​ $ 144,565 Interest cost ​ ​ 14,836 ​ ​ 19,264 Expected return on plan assets ​ ​ ( 11,133 ) ​ ​ ( 11,786 ) Amortization of losses ​ ​ 8,252 ​ ​ — Amortization of prior service credit ​ ​ ( 3,799 ) ​ ​ ( 2,734 ) Total ​ $ 150,890 ​ $ 149,309 ​ Service cost is reported in general and administrative expenses. Certain other components of net periodic pension costs are reported in interest income, net in the Consolidated Statements of Operations. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ ​ 2024 2023 Reconciliation of projected benefit obligation: ​ ​ ​ ​ ​ ​ Projected benefit obligation at January 1 ​ $ 1,130,217 ​ $ 832,707 Service cost ​ ​ 142,734 ​ ​ 144,565 Employee contributions ​ ​ 81,930 ​ ​ 96,099 Interest cost ​ ​ 14,836 ​ ​ 19,264 Benefit payments ​ ​ ( 40,044 ) ​ ​ ( 119,897 ) Loss on financial assumptions ​ ​ 106,396 ​ ​ 132,781 Loss on demographic assumptions ​ ​ — ​ ​ 2,730 Gain on experience ​ ​ ( 12,990 ) ​ ​ ( 61,208 ) Translation differences ​ ​ ( 87,608 ) ​ ​ 91,689 Plan amendment ​ ​ 7,005 ​ ​ ( 8,513 ) Total ​ $ 1,342,476 ​ $ 1,130,217 ​ 103 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Reconciliation of fair value of plan assets: ​ ​ ​ ​ ​ ​ Fair value at January 1 ​ $ 822,763 ​ $ 675,127 Expected return on plan assets ​ ​ 11,133 ​ ​ 11,786 Loss on plan assets ​ ​ ( 36,566 ) ​ ​ ( 59,077 ) Employer contributions ​ ​ 122,915 ​ ​ 143,599 Employee contributions ​ ​ 81,930 ​ ​ 96,099 Benefit payments ​ ​ ( 40,044 ) ​ ​ ( 119,897 ) Translation differences ​ ​ ( 63,278 ) ​ ​ 75,126 Fair value at December 31 ​ $ 898,853 ​ $ 822,763 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Change in net loss: ​ ​ ​ ​ ​ ​ Loss at beginning of year ​ $ 182,921 ​ $ 49,541 Loss on pension benefit obligation during the year ​ ​ 93,406 ​ ​ 74,303 Loss on assets during the year ​ ​ 36,566 ​ ​ 59,077 Amortization of loss ​ ​ ( 8,252 ) ​ ​ — Loss at end of year ​ $ 304,641 ​ $ 182,921 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Change in accumulated other comprehensive loss: ​ ​ ​ ​ ​ ​ Accumulated other comprehensive income at beginning of year ​ $ 156,271 ​ $ 28,670 Net loss amortized ​ ​ ( 8,252 ) ​ ​ — Loss on pension benefit obligation during the year ​ ​ 93,406 ​ ​ 74,303 Loss on assets during the year ​ ​ 36,566 ​ ​ 59,077 Prior service cost/(credit) occurring over the year ​ ​ 7,005 ​ ​ ( 8,513 ) Net prior service credit amortized ​ ​ 3,799 ​ ​ 2,734 Total accumulated other comprehensive income at end of year ​ $ 288,795 ​ $ 156,271 ​ The assumptions used in the determination of the benefit obligation and the net periodic costs for the pension plans were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Financial assumptions (%pa): ​ ​ ​ ​ Discount rate ​ ​ 0.90 % ​ ​ 1.40 % Interest credit rate / expected return on assets ​ ​ 1.25 % ​ ​ 1.25 % Salary increases ​ ​ 2.50 % ​ ​ 2.50 % Pension increases ​ ​ 0.00 % ​ ​ 0.00 % Inflation ​ ​ 1.50 % ​ ​ 1.50 % Demographic assumptions: ​ ​ ​ ​ ​ ​ Lump-sum option ​ ​ 25 % ​ ​ 25 % Retirement age ​ ​ 65 / 65 ​ ​ 65 / 64 Proportion married ​ ​ BVG 2020 ​ ​ BVG 2020 Allowance for child pensions ​ ​ 5 % loading on risk benefits ​ ​ 5 % loading on risk benefits Mortality base table ​ ​ BVG 2020 ​ ​ BVG 2020 Longevity improvement ​ ​ CMI 2018 ( 1.25 %) ​ ​ CMI 2018 ( 1.25 %) Turnover ​ ​ BVG 2020 ​ ​ BVG 2020 Disability ​ ​ 80 % BVG 2020 ​ ​ 80 % BVG 2020 ​ 104 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ ​ 2024 2023 Expected benefit payments: ​ ​ ​ ​ ​ ​ Year 1 ​ $ 43,568 ​ $ 43,703 Year 2 ​ ​ 48,374 ​ ​ 50,060 Year 3 ​ ​ 52,452 ​ ​ 55,679 Year 4 ​ ​ 56,008 ​ ​ 60,285 Year 5 ​ ​ 60,105 ​ ​ 64,215 Next 5 years ​ ​ 498,129 ​ ​ 482,594 ​ ​ ​ ​ ​ ​ ​ Other disclosure items: ​ ​ ​ ​ ​ ​ Next year's expected employer contribution ​ $ 123,399 ​ $ 156,395 ​ The actuarial losses in 2024 were primarily due to a decrease in discount rate applied against future expected benefit payments and resulted in an increase of the benefit obligation. The increase of the plan assets recorded during the year was mainly related to employer’s and employees’ contributions to the plan. The Company’s investment strategy for its pension plans is to optimize the long-term investment return on plan assets in relation to the liability structure to maintain an acceptable level of risk while minimizing the cost of providing pension benefits and maintaining adequate funding levels in accordance with applicable rules in each jurisdiction. The Company does not manage any assets internally. The insurance contract plan asset relates to mandatory and discretionary contributions made in accordance with Swiss law to a leading pension provider. The capital is insured and provides for a minimum rate of return. The fair value is equal to the employees’ accrued savings and is calculated using total employer and employee contributions plus any accumulated interest credited (which is substantially equivalent to the related cash surrender value). The plan asset has been classified within Level 3 of the fair value hierarchy and the approach is consistent with prior years. The Company maintains a 401(k) savings plan, which is available to all U.S. employees. Participants may make voluntary contributions. The Company makes matching contributions according to the 401(k) savings plan’s matching formula. All matching contributions and participant contribution vest immediately. The expenses related to the Company’s 401(k) savings plan consist of matching contributions. Expenses related to the Company’s 401(k) savings plan totaled $ 36,528 and $ 19,938 for the years ended December 31, 2024 and December 31, 2023. The Company’s United Kingdom (“UK”) employees are eligible to participate in its UK defined contribution pension scheme upon commencement of employment. The employees and the Company will make such contributions in line with the rules of the pension scheme in force. The expenses related to the Company’s pension scheme consist of matching contributions and totaled $ 14,563 and $ 16,753 for the years ended December 31, 2024 and December 31, 2023, respectively. ​ 12. Loans In August 2020, the Company obtained a CHF 638,000 ($ 700,221 at the historical exchange rate) nine-year loan, due in quarterly installments with payments commencing on December 31, 2021, and ending on September 30, 2029. The loan was part of the infrastructure put in place by the Federal Council and Swiss Parliament in view of the economic consequences of the COVID-19 pandemic, bears no interest, and had no issuance costs. The Company accounts for this loan at face value, which is deemed to approximate the related fair value. The future payments under the loan are reported in the table below: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total 2025 2026 2027 2028 2029 Loan ​ $ 438,504 ​ $ 110,177 ​ $ 88,142 ​ $ 88,142 ​ $ 88,142 ​ $ 63,901 ​ ​ 13. Fair Value Measurement Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company’s assessment of the significance of a particular input to 105 Table of Contents the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The carrying amounts of the Company’s cash and cash equivalents, including money market funds, restricted cash and financial liabilities are considered to be representative of their respective fair values because of the short-term nature and the contractual terms of those instruments. The fair values of money market funds are based upon the quoted prices in active markets provided by the holding financial institution, which are considered Level 1 inputs in the fair value hierarchy according to ASC 820, “Fair Value Measurement.” There have been no changes to the valuation methods utilized by the Company, nor were there transfers between levels of the fair value hierarchy. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair value measurement at reporting date using ​ ​ Quoted prices in active market for identical assets ​ Significant other observable inputs ​ Significant unobservable inputs ​ (Level 1) (Level 2) (Level 3) December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ Assets ​ ​ ​ ​ ​ ​ ​ ​ ​ Defined benefit pension plan: ​ ​ ​ ​ ​ ​ ​ ​ ​ Pension plan asset ​ $ — ​ $ — ​ $ 898,853 Total defined benefit pension plan ​ ​ — ​ ​ — ​ ​ 898,853 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents: ​ ​ ​ ​ ​ ​ ​ ​ ​ Money market funds ​ ​ 4,745,080 ​ ​ — ​ ​ — Total cash equivalents ​ ​ 4,745,080 ​ ​ — ​ ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total financial assets ​ $ 4,745,080 ​ $ — ​ $ 898,853 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ Assets ​ ​ ​ ​ ​ ​ ​ ​ ​ Marketable securities available for sale: ​ ​ ​ ​ ​ ​ ​ ​ ​ Debt securities - U.S. government treasury securities, current ​ $ 4,999,704 ​ $ — ​ $ — Total marketable securities available for sale ​ ​ 4,999,704 ​ ​ — ​ ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Defined benefit pension plan: ​ ​ ​ ​ ​ ​ ​ ​ ​ Pension plan asset ​ ​ — ​ ​ — ​ ​ 822,763 Total defined benefit pension plan ​ ​ — ​ ​ — ​ ​ 822,763 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents: ​ ​ ​ ​ ​ ​ ​ ​ ​ Money market funds ​ ​ 6,767,291 ​ ​ — ​ ​ — Total cash equivalents ​ ​ 6,767,291 ​ ​ — ​ ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total financial assets ​ $ 11,766,995 ​ $ — ​ $ 822,763 ​ The carrying amounts of prepaid expenses and other current assets, accounts payable, and accrued expenses approximate fair value due to their short-term maturities. Please refer to Note 11 “Pension Obligations” for additional details on the valuation of pension plan assets. ​ 106 Table of Contents 14. Common Stock, Preferred Stock and Warrants As of December 31, 2024 and December 31, 2023, the authorized capital stock of the Company included 50,000,000 shares of common stock, $ 0.0001 par value and 10,000,000 shares of preferred stock, $ 0.0001 par value. As of December 31, 2024 and December 31, 2023, there were 27,132,588 and 16,206,680 shares of common stock, respectively, $ 0.0001 par value, issued and outstanding . At the market offering In May 2022, the Company entered into a Controlled Equity Offering Sales Agreement (the “Cantor Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), pursuant to which the Company was able to sell from time to time, through the agent, Cantor, shares of common stock, having an aggregate offering price of up to $ 16.0 million (the “ATM Program”). For the year ended December 31, 2023, the Company sold an aggregate of 862,535 shares of common stock under the ATM Program at an average price of $ 4.60 per share for aggregate gross proceeds of $ 3.9 million, which included $ 0.4 million of sales commissions and other offering expenses. The Cantor Sales Agreement was terminated in conjunction with the public offering and concurrent private placement of shares of the Company’s common stock in November 2023 as described below. In September 2024, the Company entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Oppenheimer & Co. Inc., serving as agent (“Oppenheimer”) with respect to an at-the-market (“ATM”) offering program (the “2024 ATM Program”). Under the 2024 ATM Program the Company may offer and sell, from time to time at its sole discretion, shares of common stock having an aggregate offering price of up to $ 50.0 million. The Company will pay Oppenheimer a commission equal to 3.0 % of the gross sales proceeds of any shares sold through Oppenheimer under the Distribution Agreement. During the year ended December 31, 2024, the Company sold an aggregate of 1,597,128 shares of commons stock at an average selling price of $ 1.97 per share under the 2024 ATM Program, raising gross proceeds of $ 3.1 million, which included $ 0.2 million of sales commissions and other offering expenses. Public and private offering November 2023 In November 2023, the Company completed the public offering of 2,545,000 shares of its common stock and warrants to purchase 1,272,500 shares of its common stock (the “Public Warrants”). The warrants have been offered and sold at the rate of one warrant for every two shares of common stock purchased. The public offering price for each set of two shares of common stock and accompanying warrant to purchase one share of common stock was $ 4.01 , yielding an effective price of $ 2.00 per share and $ 0.01 per warrant. In connection with the public offering that occurred in November 2023, the Company also issued 178,150 warrants to purchase an equal amount of its common stock at an exercise price of $ 2.75 per share to the underwriter as consideration for the services provided (the “2023 Underwriter Warrants”). The 2023 Underwriter Warrants provide for cashless exercise. In a private placement that was completed concurrently with the public offering from November 2023 described above, the Company also issued to accredited investors 744,026 shares of its common stock, 1,756,062 pre-funded warrants, to purchase an equal amount of its common stock at the nominal exercise price of $ 0.0001 and private warrants to purchase 2,500,088 shares of its common stock (the “Private Warrants”). The Private Warrants were sold at the rate of one warrant for every share of common stock (or pre-funded warrant in lieu thereof) purchased in the private placement. The private placement price per share (or pre-funded warrant in lieu thereof) and accompanying Private Warrants to purchase one share of common stock was $ 2.00 per set of securities sold privately. In connection with the private placement from November 2023, the Company also issued 175,006 warrants to purchase an equal amount of its common stock at an exercise price of $ 2.75 to the placement agent as consideration for the services provided. These warrants provide for cashless exercise. The public offering and the concurrent private placement that were finalized in the fourth quarter of the year ended December 31, 2023, resulted in combined gross proceeds of $ 10.1 million, which included $ 1.2 million of underwriting commissions, placement agent’s fees and other expenses connected with the financing round. 107 Table of Contents Public offering June 2024: In June 2024, the Company completed the public offering of 7,116,547 shares of its common stock and 1,031,602 pre-funded warrants (the “Pre-Funded Warrants”) to purchase an equal amount of its common stock at the nominal exercise price of $ 0.0001 . The public offering price was $ 1.35 per share while the purchase price of each pre-funded warrant was equal to the public offering price at which a share of common stock was sold less $ 0.0001 . As part of the public offering, the Company granted the underwriter an over-allotment option to purchase up to an additional 1,222,222 shares of its common stock, at the public offering price of $ 1.35 , less underwriting discounts and commissions. In July 2024, the underwriter partially exercised the over-allotment option and purchased an additional 337,076 shares of the Company’s common stock at the offering price mentioned above. The over-allotment option expired as of the end of July 2024. In connection with the public offering, the Company also issued 593,965 warrants to purchase an equal amount of its common stock at an exercise price of $ 1.6875 per share to the underwriter as a consideration for the services provided (the “2024 Underwriter Warrants”). The 2024 Underwriter Warrants provide for cashless exercise. The public offering that was finalized in 2024 resulted in gross proceeds of $ 11.5 million, which include $ 1.2 million of underwriting commissions and other expenses connected with the financing round. The fair value of the shares of common stock issued in the offering has been recorded in additional paid-in capital and the totality of the gross proceeds has been allocated to the shares of common stock issued. The fair market value of the Underwriter Warrants that have been issued in connection with the public offering that occurred in fiscal year 2024 has been calculated using the Black-Scholes option pricing model, while the fair market value of the pre-funded warrants has been determined as the spread between the price paid by investors and the closing price of the Company’s stock at grant date. The 2024 Underwriter Warrants were recorded within additional paid-in capital, as they represent compensation associated with the financing round, for $ 0.3 million. Below is a table that summarizes the assumptions that have been used in the calculation: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, 2024 ​ 2024 Pre-Funded ​ 2024 Underwriter ​ Warrants ​ Warrants Market price at grant date $ 1.32 ​ ​ $ 1.32 ​ Volatility ​ — % ​ ​ 73.47 % Expected term (years) ​ — ​ ​ ​ 2.75 ​ Risk-free interest rate ​ — % ​ ​ 4.28 % Expected dividend yield ​ — ​ ​ ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ Grant date fair value per share $ — ​ ​ $ 0.56 ​ ​ Warrants: Below is a summary of the Company’s issued and outstanding warrants as of December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ Warrants ​ Warrants Expiration Date ​ Exercise Price Outstanding Exercisable May 6, 2025 ​ $ 13.75 ​ 200,000 ​ 200,000 July 20, 2025 ​ $ 5.07 ​ 225,387 ​ 225,387 November 24, 2028 ​ $ 2.75 ​ 4,084,426 ​ 4,084,426 June 17, 2029 ​ $ 1.69 ​ 593,965 ​ 593,965 Pre-funded warrants ​ $ — ​ 1,031,602 ​ 1,031,602 Outstanding as of December 31, 2024 ​ $ 2.63 ​ 6,135,380 ​ 6,135,380 ​ 108 Table of Contents The following table summarizes the Company’s warrants activity for the year ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ Warrants ​ Exercise Price Outstanding as of December 31, 2023 ​ 6,307,193 ​ $ 2.42 Issued: ​ ​ ​ ​ ​ Pre-funded Warrants ​ 1,031,602 ​ $ — 2024 Underwriter Warrants ​ 593,965 ​ $ 1.69 Exercised: ​ ​ ​ ​ ​ Pre-funded Warrants ​ ( 1,756,062 ) ​ $ — Public Warrants ​ ( 41,318 ) ​ $ 2.75 Outstanding as of December 31, 2024 ​ 6,135,380 ​ $ 2.63 ​ ​ ​ 15. Equity Incentive Plan On September 24, 2020, the Company’s Board of Directors (the “Board”) adopted the 2020 Omnibus Incentive Plan (the “2020 Omnibus Plan”). On May 12, 2022, the Board approved the Company’s 2022 Equity Incentive Plan (the “2022 Plan”), which was approved at the Company’s annual meeting of stockholders on June 16, 2022. The 2022 Plan is the successor to, and continuation of, the 2020 Omnibus Plan. The total number of shares reserved for issuance under the 2022 Plan (including shares remaining available under the 2020 Omnibus Plan) is 1,800,000 , which increases automatically by 6 % every year on January 1 based on the number of shares of common stock issued and outstanding as of the previous year-end. No incentive stock options may be granted under the 2022 Plan after May 12, 2032 and the Board may suspend or terminate the 2022 Plan at any time. The Board is responsible for administering the 2022 Plan. In addition to the above, on December 23, 2021, the Board adopted the Inducement Equity Incentive Plan (the “2021 Inducement Equity Incentive Plan”), intended to induce new employees to join the Company for the benefit of individuals who satisfy the standards for inducement grants under Rule 5635(c)(4) of the Nasdaq listing rules. The maximum number of shares reserved for issuance pursuant to awards granted under the 2021 Inducement Equity Incentive Plan is 1,000,000 . Stock options are generally granted with a 10 year term at exercise prices equal to the market price at the date of grant. After one year of service from the date of grant, 25 % of the options become exercisable, with the remainder becoming exercisable monthly over the following three-year period. RSUs generally vest 25 % after one year of service from the date of grant and the remainder vesting quarterly over the following three-year period. Stock Option Grants The following table summarizes the Company’s stock option activity for the year ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ ​ ​ ​ Weighted Average ​ Aggregate ​ ​ ​ ​ ​ Grant Date ​ Weighted Average ​ Remaining Contractual ​ Intrinsic ​ Shares Fair Value Exercise Price Life (in years) Value Options outstanding as of December 31, 2023 ​ 2,574,299 ​ $ 3.06 ​ $ 4.52 ​ ​ 7.70 ​ $ — Options granted ​ 1,402,500 ​ 2.47 ​ ​ 3.98 ​ ​ ​ ​ ​ ​ Options exercised ​ ( 15,983 ) ​ 2.62 ​ ​ 3.61 ​ ​ ​ ​ ​ ​ Options cancelled/forfeited ​ ( 808,371 ) ​ 3.03 ​ ​ 4.34 ​ ​ ​ ​ ​ ​ Options outstanding as of December 31, 2024 ​ ​ 3,152,445 ​ $ 2.80 ​ $ 4.33 ​ ​ 7.99 ​ $ — Vested as of December 31, 2024 ​ ​ 1,907,132 ​ ​ 2.88 ​ ​ 4.46 ​ ​ 7.39 ​ $ — Options exercisable as of December 31, 2024 ​ ​ 1,907,132 ​ $ 2.88 ​ $ 4.46 ​ ​ 7.39 ​ $ — ​ The aggregate intrinsic value of stock options is calculated as the difference between the weighted average exercise price of the underlying stock options and the market price of the Company’s common stock on December 31, 2024. Based on this calculation the intrinsic value of the outstanding stock options as of December 31, 2024 was nil. 109 Table of Contents As of December 31, 2024, unrecognized compensation costs associated with the stock option grants was $ 2.9 million and will be recognized over a period of 3.25 years. The fair value of the options vested was $ 2.1 million for both the years ended December 31, 2024 and December 31, 2023. The assumptions that the Company used to determine the grant-date fair value of stock options granted during the periods ended December 31, 2024 and December 31, 2023 were as follows, presented on a weighted-average basis: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31 ​ 2024 2023 Grant date fair value $ 2.47 ​ ​ $ 3.40 ​ Volatility ​ 66 % ​ ​ 77 % Expected term (years) ​ 5.64 ​ ​ ​ 6.60 ​ Risk-free interest rate ​ 4.23 % ​ ​ 3.49 % Expected dividend yield ​ — ​ ​ ​ — ​ ​ The assumptions that cause the greatest variation in fair value in the Black-Scholes model are the volatility and expected term of exercise. Increases or decreases in either the volatility or expected term of exercise will cause the Black-Scholes option value to increase or decrease, respectively. Each of these inputs is subjective and generally requires significant judgment to determine. ​ Restricted Stock Units The following table summarizes the Company’s RSUs activity for the year ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ ​ ​ ​ Grant Date Fair ​ Numbers of Shares ​ Value per Share Outstanding as of December 31, 2023 493,799 ​ $ 2.54 Granted ​ 25,000 ​ $ 4.37 Vested ​ ( 61,794 ) ​ $ 4.25 Cancelled/forfeited ​ ( 354,303 ) ​ $ 1.91 Outstanding as of December 31, 2024 ​ 102,702 ​ $ 4.12 Total unrecognized expense remaining $ 220,455 ​ ​ ​ Years unrecognized expense expected to be recognized over ​ 2.3 ​ ​ ​ ​ Options and RSUs do not have voting rights and the underlying shares are not considered issued and outstanding. The fair value of the RSUs vested was $ 487 thousand and $ 328 thousand for the years ended December 31, 2024 and December 31, 2023, respectively. The total stock-based compensation expense for stock options and RSUs, granted to employees and non-employees, has been reported in the Company’s Consolidated Statements of Operations as follows: ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31 ​ 2024 2023 Research and development $ 1,020,994 ​ $ 846,571 General and administrative 1,369,165 ​ ​ 2,412,455 Total stock-based compensation $ 2,390,159 ​ $ 3,259,026 ​ ​ ​ 16. Income Taxes The Company is subject to taxation in the U.S., Switzerland, Spain and Australia. Taxes are recorded on an accrual basis and represent the allowances for taxes paid or to be paid for the year, calculated according to the current enacted rates and applicable laws. The Company has accumulated net tax losses since inception in Switzerland and in the U.S. The Company reports a provision for income taxes due to the Spanish and Australian tax authorities pertaining to our subsidiaries Gain Therapeutics Sucursal en España and Gain Therapeutics Australia PTY LTD. 110 Table of Contents For financial reporting purposes, loss before income tax provision includes the following components: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2024 2023 Domestic ​ $ ( 22,388,925 ) ​ $ ( 22,477,695 ) Foreign ​ 2,514,549 ​ ​ 289,450 Total ​ $ ( 19,874,376 ) ​ $ ( 22,188,245 ) ​ The following is the breakdown of the components of income tax expense provision for the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2024 ​ 2023 Current: ​ ​ ​ ​ ​ ​ Federal ​ $ — ​ $ — State ​ ​ — ​ ​ — Foreign ​ ​ 536,815 ​ ​ 79,275 Total ​ $ 536,815 ​ $ 79,275 Deferred: ​ ​ ​ ​ ​ ​ Federal ​ $ — ​ $ — State ​ ​ — ​ ​ — Foreign ​ ​ — ​ ​ — Total ​ ​ — ​ ​ — Total income tax expense ​ $ 536,815 ​ $ 79,275 ​ The breakdown of domestic and foreign net operating losses (“NOLs”) and related deferred tax assets are reported in the following table: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2024 2023 NOLs (domestic) ​ $ ( 37,839,738 ) ​ $ ( 27,850,813 ) NOLs (foreign) ​ ​ ( 9,612,067 ) ​ ​ ( 10,932,386 ) Total NOLs ​ $ ( 47,451,805 ) ​ $ ( 38,783,199 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Deferred tax assets related to: ​ ​ ​ ​ ​ ​ Net operating loss (domestic) ​ $ 10,411,842 ​ $ 7,662,929 Net operating loss (foreign) ​ ​ 1,730,172 ​ ​ 2,001,169 Stock based compensation (domestic) ​ ​ 932,770 ​ ​ 820,078 Stock based compensation (foreign) ​ ​ 120,497 ​ ​ 96,173 Section 174 - Capitalized R&D ​ ​ 1,573,082 ​ ​ 947,754 Warrant expense ​ ​ 278,198 ​ ​ 278,198 Patent expense ​ ​ 95,885 ​ ​ 103,386 Other temporary differences ​ ​ 167,889 ​ ​ 147,245 Total deferred tax assets ​ $ 15,310,335 ​ $ 12,056,932 Deferred tax liabilities ​ ​ ​ ​ ​ ​ Depreciation and other ​ $ ( 2,874 ) ​ $ ( 15,977 ) Total deferred tax liabilities ​ $ ( 2,874 ) ​ $ ( 15,977 ) ​ ​ ​ ​ ​ ​ ​ Valuation allowance ​ $ 15,307,461 ​ $ 12,040,955 Net deferred tax assets ​ $ — ​ $ — ​ Foreign NOLs refer to the Company’s Swiss subsidiary and according to Swiss tax law such NOLs can be carried forward for seven years and will begin to expire commencing from 2025 for the NOLs generated in 2017. 111 Table of Contents According to the U.S. Tax Cuts and Jobs Act (“TCJA”) that was signed into law on December 22, 2017, federal NOLs incurred after December 31, 2017 can be carried forward indefinitely and are limited to 80% of taxable income in any tax period. The NOLs and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOLs and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50 percent, as defined under Sections 382 and 383 of the Internal Revenue Code, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has not done an analysis to determine whether or not ownership changes have occurred since inception. Deferred tax assets require an assessment of both positive and negative evidence when determining whether it is more likely than not that they can be recovered. Such assessment is made on a jurisdiction-by-jurisdiction basis. The Company’s assessment includes an evaluation of cumulative losses, future sources of taxable income and risks and uncertainties related to our business. As of December 31, 2024 and 2023, the Company has determined that there is not sufficient evidence that the Company will be able to realize the benefits of the domestic and foreign deferred tax assets. Accordingly, due to uncertainty regarding their realization, the Company continues to maintain a full valuation allowance on the Company’s domestic and foreign deferred tax assets as of December 31, 2024 and 2023 and until sufficient positive evidence will exist to support the reversal of the valuation allowance. A reconciliation of income tax expense computed at the statutory federal income tax rate to the Company’s effective tax rate as reflected in the consolidated financial statements is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ December 31, ​ ​ ​ 2024 ​ 2023 Federal income tax at U.S. statutory rate ​ ​ 21.00 % ​ 21.00 % State income taxes, net of federal benefit ​ ​ 4.76 % ​ 2.41 % Permanent differences ​ ​ ( 11.91 ) % ​ ( 9.48 ) % Provision to return ​ ​ 0.00 % ​ ( 2.80 ) % Foreign taxes rate differential ​ ​ ( 0.29 ) % ​ 0.04 % Valuation allowance ​ ​ ( 16.26 ) % ​ ( 11.53 ) % Effective income tax rate ​ ​ ( 2.70 ) % ​ ( 0.36 ) % ​ For the year ended December 31, 2024, permanent differences are mainly attributable to tax on global intangible low-tax income (“GILTI”) which was enacted as part of the TCJA. GILTI, in general, is determined annually based on the Company’s aggregate foreign subsidiaries’ income in excess of certain qualified business asset investment returns. The Company accounts for taxes on GILTI in the period that it is subject to such taxes. As of December 31, 2024 and 2023, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s Consolidated Statements of Operations. There are no changes expected to occur in the next 12 months with respect to the status of the Company’s uncertain tax positions. The Company files income tax returns in the U.S., Switzerland, Spain and Australia. Tax returns from fiscal year 2017 and onwards remain subject to examination by the taxing jurisdictions. The NOL and tax carryforwards remain subject to review until utilized. The Company is currently not under examination by any tax authorities. ​ 112 Table of Contents 17. Net Loss per Common Share Basic net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities outstanding during the period. For purposes of the diluted net loss per share calculation, preferred stock, warrants, stock options, RSUs, and PRSUs are considered to be potentially dilutive securities, but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and, therefore, basic and diluted net loss per share are the same for all periods presented. The following table sets forth the outstanding weighted-average potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would have resulted in anti-dilutive impacts: ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31 ​ 2024 ​ 2023 Options to purchase common stock ​ 3,125,122 ​ 2,411,327 RSUs and PRSUs ​ 252,250 ​ 497,899 Warrants to purchase common stock 4,836,427 ​ 843,613 ​ ​ The weighted-average number of warrants to purchase common stock as per the table above does not include the weighted-average effect of 1,031,602 pre-funded warrants for which the exercise price is less than or equal to $ 0.0001 per share. The weighted-average effect of the pre-funded warrants has been included in the computation of the net loss per share attributable to common stockholders – basic and diluted in the Consolidated Statements of Operations. ​ 18. Related Parties Dr. Khalid Islam, the Chairman of the Company’s Board, shareholder and founder of the Company, is currently the Chairman of the Board of Directors of Minoryx Therapeutics SL (“Minoryx”), and, therefore, Minoryx is considered a related party of the Company. In December 2017, the Company entered into an exclusive worldwide, royalty-bearing, assignable, transferable license agreement with Minoryx to use and exploit Minoryx’s intellectual property and into an exclusive worldwide, royalty-bearing, assignable, transferable sublicense agreement with Universitat de Barcelona and Institucio Catalana Recerca Estudis Avancats in order to be able to develop its business, directly or indirectly, through sub-licensing to third parties or any other way of operation. According to the terms and conditions of the Minoryx License Agreement, the Company shall pay to Minoryx as royalties: ● an amount equal to 8 % of (i) net revenues with regard to products that would infringe (a) at least one composition of matter claim or (b) Minoryx molecules and (ii) sublicensing revenues; and ● an amount equal to 3 % of net revenues with regard to products that would infringe at least (a) one method of claim or (b) Minoryx know-how (as such term is defined in the agreement). ​ As of December 31, 2024 and December 31, 2023, there were no receivables and payables, revenues or expenses with Minoryx. ​ On September 20, 2022 the Company entered into a consulting agreement with Mr. Eric Richman, who previously served as the Company’s CEO and is currently a member of the Board of Directors of the Company. As per the consulting agreement Mr Richman agreed to provide consulting services as a special advisor to the Company and its Board of Directors at the request of the Chairman of the Board or another member of the Board of the Company. The consulting agreement terminated on September 20, 2023. In connection with this consulting agreement during the year ended December 31, 2023 the Company incurred expenses of $ 236 thousand. As of December 31, 2024 and December 31, 2023, there were no receivables or payables connected with the consulting agreement with Mr. Richman. ​ ​ 113 Table of Contents 19. Commitments and Contingencies Commitments: As of December 31, 2024, the Company had research commitments for $ 4.2 million for activities that will be performed within one year. Contingencies: The Company records a provision for its contingent obligations when it is probable that a loss will be incurred, and the amount of the loss can be reasonably estimated. On September 18, 2024, Matthias Alder (“Alder”), the Company’s former Chief Executive Officer, filed litigation against the Company in the Circuit Court of Maryland for Montgomery County. Mr. Alder’s employment was terminated on June 25, 2024. In connection with the litigation, as of December 31, 2024, the Company has made an accrual of $ 0.53 million, reported within payroll related accruals. ​ ​ ​ 20. Subsequent Events From January 1, 2025, through March 24, 2025, the Company has sold an aggregate of 1,062,804 shares of common stock through the “2024 ATM Program” at a weighted-average selling price of $ 2.28 for total gross proceeds of $ 2.4 million. On March 20, 2025, 454,893 pre-funded warrants were exercised resulting in the issuance of 454,893 shares of common stock. ​ 114 Table of Contents ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. ​