What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2026-03-26 compared with 2025-03-27 · 261 added, 188 removed, 722 unchanged (38% of the section changed)

42 unchanged sentences

Cash and cash equivalents

Marketable securities

Prepaid expenses and other current assets

2 unchanged sentences

Property and equipment, net

Internal-use software

Internal-use software, net

Operating lease right-of-use assets

2 unchanged sentences

Total noncurrent assets

Liabilities and stockholder's equity

Liabilities and stockholders' equity

Current liabilities:

Accounts payable

Operating lease liability - current

Operating lease liabilities - current

Other current liabilities

4 unchanged sentences

Defined benefit pension plan

Operating lease liability - noncurrent

Operating lease liabilities - noncurrent

Deferred grant income - noncurrent

10 unchanged sentences

Additional paid-in capital

Accumulated other comprehensive (loss) income

Accumulated other comprehensive income (loss)

Accumulated deficit

9 unchanged sentences

Year Ended December 31,

Collaboration revenues

Total revenues

Operating expenses:

13 unchanged sentences

Interest income, net

Foreign exchange gain (loss), net

Foreign exchange (loss) gain, net

Loss before income tax

15 unchanged sentences

Foreign currency translation

Other comprehensive (loss) income, net of tax

Other comprehensive income (loss), net of tax

Comprehensive loss

7 unchanged sentences

( 60,783,717 )

Issuance of shares in at-the-market (ATM) offering (Note 14)

Issuance of shares and warrants in public offering and private placement (Note 14)

Stock-based compensation (Note 15)

2 unchanged sentences

Net unrealized gain on available-for-sale securities (Note 5)

Issuance of shares in at-the-market (ATM) offering (Note 14)

Issuance of shares and warrants in public offering and private placement (Note 14)

( 20,411,191 )

2 unchanged sentences

( 81,194,908 )

Issuance of shares in ATM offering (Note 14)

Issuance of shares and warrants in public offering (Note 14)

Stock-based compensation (Note 15)

Exercise of warrants (Note 14)

Exercise of stock options (Note 15)

RSU vesting (Note 15)

Changes in defined benefit pension plan obligation (Note 11)

Foreign currency translation

Net unrealized gain on available-for-sale securities (Note 5)

Issuance of shares in ATM offering (Note 14)

Issuance of shares and warrants in public offering and private placement (Note 14)

( 20,161,099 )

20 unchanged sentences

( 1,006,512 )

( 1,080,389 )

Cash used in operating activities

2 unchanged sentences

Cash flows from investing activities:

Purchase of property and equipment and internal-use of software

Purchases of marketable securities

( 1,956,350 )

Purchase of property and equipment and internal-use software

Maturities of marketable securities

1 unchanged sentence

Cash flow from financing activities:

Net proceeds from issuance of shares in ATM offering (Note 14)

Net proceeds from issuance of shares and warrants in public offering (Note 14)

Net proceeds from issuance of shares in 2024 ATM Program (Note 14)

Net proceeds from issuance of shares in public offering (Note 14)

Net proceeds from the exercise of warrants (Note 14)

4 unchanged sentences

Effect of exchange rate changes

Net (decrease)/increase in cash, cash equivalents and restricted cash

Net increase (decrease) in cash, cash equivalents and restricted cash

( 1,411,412 )

7 unchanged sentences

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.

(and together with its subsidiaries, 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.

4 unchanged sentences

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.

In a Phase 1 first-in-human study (n = 72), GT-02287 was safe and generally well tolerated up to and including the highest planned dose level, enabling further development in GBA1 Parkinson’s patients.

Additional corroborating safety data for GT-02287 has been gathered through evaluation of different oral formulations in a bioavailability study (n=24).

As of December 31, 2025, two clinical studies of GT-02287 have been completed, and one is ongoing.

GT-02287 was initially characterized in a first-in-human Phase 1a clinical study to assess the safety, tolerability, pharmacokinetics, and food effect of GT-02287 in healthy participants.

The study design included a single ascending dose part during which the study participants received one dose of GT-02287 at different dose levels, and a multiple ascending dose part during which the study participants received one daily dose of GT-02287 for 14 days at different dose levels.

The Phase 1a study started in September 2023 and was completed in July 2024 and the quality assurance audited interim report was finalized in the third quarter of 2024.

In the second quarter of 2025, a Phase 1 relative bioavailability study in healthy volunteers was initiated.

The purpose of this study was to compare two oral formulations of GT-02287.

This study was completed in the third quarter of 2025.

In March 2025, the Company enrolled the first participant with Parkinson’s disease in its two-part Phase 1b safety and tolerability study to further evaluate the safety, tolerability and biomarker evidence of activity for GT-02287.

In Part 1 of this study, participants dose daily with GT-02287 for 90 days.

In August 2025, the Company amended the Phase 1b clinical study to include an additional nine (9) months of daily oral administration of GT-02287 in the optional Part 2 of the Phase 1b.

Participants enrolled in the Phase 1b are also followed for clinical signs of worsening or improvement.

Through September 2025 a total of 21 patients were enrolled in the Phase 1b.

Samples of cerebrospinal fluid were taken at the initiation of dosing and at day 90 following completion of Part 1, and blood samples were taken at multiple timepoints.

In November 2025 a total of 19 patients had completed Part 1 of the Phase 1b and the Company will be presenting the full analysis of Part 1 throughout 2026.

Of the 19 patients who completed Part 1 of the Phase 1b, a total of 16 patients elected to continue on daily oral administration of GT-02287.

The Company expects to complete Part 2 of the Phase 1b study in September 2026.

Risks and Uncertainties

1 unchanged sentence

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.

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.

5 unchanged sentences

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, 2024, 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, 2025, the results of its operations and its statements of stockholders’ equity and its statements of cash flows for the years ended December 31, 2025 and 2024.

All amounts in the

consolidated financial statements are expressed in U.S.

All amounts in the consolidated financial statements are expressed in U.S.

dollars and disclosed within these explanatory notes in U.S.

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.

The results for the years ended December 31, 2025 and 2024 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, 2024, and the notes thereto, which are included in the Annual Report.

As of December 31, 2024, the Company’s significant accounting policies and estimates, which are detailed herein, have not changed.

Going Concern

8 unchanged sentences

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.

In accordance with ASC 205-40, "Presentation of Financial Statements – 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 $ 20.8 million as of December 31, 2025 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.

will need to obtain additional capital and/or other funding in order to continue operations beyond the first quarter of 2027.

Management plans to raise additional capital primarily through private and/or public equity financings and/or convertible debt financings.

2 unchanged sentences

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.

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 first quarter of 2027, including raising additional capital through either private or public equity, debt financing, or additional program collaborations.

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.

19 unchanged sentences

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).

1 unchanged sentence

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.

As of December 31, 2025 and 2024, accumulated currency translation adjustments recorded in accumulated other comprehensive loss amounted to $ 888,451 and $ 41,247 , respectively.

For the years ended December 31, 2025 and 2024, the unrealized foreign exchange loss from foreign currency transactions was $ 619,800 and the unrealized foreign exchange gain from foreign currency transactions was $ 12,045 , respectively, which is reflected in other non-cash items within cash flows from operating activities.

Use of Estimates

1 unchanged sentence

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.

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, stock-based compensation, warrants 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.

15 unchanged sentences

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.

Issuance Costs

The Company capitalizes certain legal, professional accounting, and other third-party fees that are directly associated with equity financings as issuance costs.

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 issuance costs will be expensed immediately as a charge to operating expenses in the Consolidated Statements of Operations.

Property and Equipment

20 unchanged sentences

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.

Amortization expense for the years ended December 31, 2025 and 2024 was $ 49 thousand and $ 47 thousand, respectively.

Impairment of Long-lived Assets

36 unchanged sentences

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.

Stock-based Compensation

The Company issues stock-based compensation awards with service-based vesting conditions.

The Company applies the fair value method of measuring equity-based compensation, 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.

6 unchanged sentences

therefore, the expected dividend yield is assumed to be nil .

The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.

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.

The Company accounts for warrants to purchase shares of its common stock as equity instruments.

The Company evaluates each warrant at issuance to determine the appropriate classification.

Warrants that are indexed to its common stock and meet the criteria for equity classification are recorded at fair value as of the issuance date within stockholders' equity and are not subsequently remeasured.

The Black-Scholes option pricing model is used for the warrants issued, using consistent inputs and methodology to quantify such inputs, as described above in relation to stock-based compensation.

The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.

Research Grants

2 unchanged sentences

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.

Under the Australian government’s Research and Development Tax Incentive (“R&DTI”) program, the Company is eligible to obtain certain research and development tax credits for eligible research and development expenditures incurred by its wholly owned subsidiary, Gain Therapeutics Australia.

The tax credits are available on the basis of specific criteria with which the Company must comply, including conducting qualifying research and development activities in Australia.

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.

The tax credits are based on a percentage of eligible research and development activities under the program and are recorded 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 when collectability is reasonably assured.

The Company records the research and development tax credit as an offset to income tax payable with any remainder recorded in other receivables.

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.

Research and development expenses include salaries and other related costs, materials and supplies preclinical expenses, manufacturing expenses, contract services, other third-party expenses, and overhead allocations consisting of various support and facilities-related expenses, which include rent, utilities and maintenance of our facilities, depreciation, travel and conference expenses.

General and Administrative Expenses

4 unchanged sentences

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.

The Company accounts for any taxes associated with Global Intangible Low-Taxed Income ("GILTI") as a period cost.

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.

10 unchanged sentences

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.

The tables below provide the accumulated balances for each classification of accumulated other comprehensive loss, as reflected in the Consolidated Balance Sheets.

Unrealized Gain / (Loss) on Available-for-sale Marketable Securities

Defined Benefit Pension Obligation

Foreign Currency Translation

Balance as of December 31, 2023

Other comprehensive income (loss) before reclassifications

Amounts reclassified from accumulated other comprehensive loss

Net period other comprehensive income (loss), net of tax

Balance as of December 31, 2024

Other comprehensive income (loss) before reclassifications

Amounts reclassified from accumulated other comprehensive loss

Net period other comprehensive income (loss), net of tax

Balance as of December 31, 2025

Net Loss per Share

1 unchanged sentence

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.

As of December 31, 2025 and 2024, common stock equivalents consisted of stock options, RSUs, 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.

1 unchanged sentence

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.

Except as noted below, the Company believes that the

impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements and disclosures.

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.

1 unchanged sentence

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.

2023-09 primarily requires disaggregated information about a Company's effective tax rate reconciliation as well as information on income taxes paid.

2023-09 is effective on a prospective basis for annual periods beginning after December 15, 2024.

The Company adopted ASU No.

2023-09 on a prospective basis for annual disclosures for the year ended December 31, 2025.

The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

Recently issued accounting pronouncements not yet adopted

In November 2024, the FASB issued ASU No.

2 unchanged sentences

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.

Adoption of ASU No.

2024-03 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.

2024-03 will likely result in the required additional disclosures being included in the Company’s consolidated financial statements, once adopted.

2024-03 relates to disclosures only, there will be no impact to the Company’s consolidated results of operations and financial condition.

In September 2025, the FASB issued ASU No.

2025-06, Intangibles–Goodwill and Other– Internal-Use Software (Subtopic 350-40).

2025-06 modernizes the accounting for software development by removing all references to prescriptive and sequential software development stages in favor of a probable-to-completion recognition threshold.

The probable-to-completion recognition threshold requires two criteria be met for entities to begin capitalizing software costs:

(i) management, with the relevant authority, implicitly or explicitly authorizes and commits to funding a computer software project and (ii) it is probable that the project will be completed and the software will be used to perform the function intended.

2025-06 is effective for annual periods beginning after December 15, 2027, and interim periods within fiscal years beginning after December 15, 2027.

Adoption of ASU No.

2025-06 can either be applied prospectively, retrospectively, or via a modified prospective transition method.

The modified prospective transition approach would allow entities to account for an in-process project that, before the transition date, met the capitalization requirements but would no longer meet the requirements for capitalization under ASU No.

2025-06 by derecognizing the capitalized costs for that in-process project through a cumulative-effect adjustment to the opening balance of retained earnings.

The Company is evaluating this new standard, but does not expect it to have material impact on its consolidated results of operations and financial condition.

In December 2025, the FASB issued ASU No.

2025-10, Government Grants (Topic 832):

Accounting for Government Grants Received by Business Entities, which establishes authoritative guidance on the recognition, measurement, presentation, and disclosure of government grants.

Under ASU No.

2025-10, government grants are recognized when it is probable that the entity will both comply with the conditions of the grant and the grant will be received.

2025-10 provides specific accounting models for grants related to assets and grants related to income, including options to recognize government grants as deferred income or as a reduction of the asset’s cost basis.

2025-10 also requires enhanced disclosures regarding the nature of government grants, significant terms and conditions, accounting policies applied, and amounts recognized in the financial statements.

2025-10 is effective for fiscal years beginning after December 15, 2028, including interim periods within those fiscal years, with early adoption permitted.

2025-10 can be applied prospectively, modified prospectively, or retrospectively.

The Company is currently evaluating the impact of adopting ASU No.

2025-10 on its operating results, financial position, and cash flows.

Research Grants

4 unchanged sentences

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 June 2025, the grant was terminated due to the dissolution of the consortium.

The Company repaid the remaining unused portion of the grant awarded of $ 0.21 million during the year ended December 31, 2025.

In May 2023, the Company’s wholly owned subsidiary, GT Gain Therapeutics 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 connection with the grants announced in March 2023 and May 2023 the Company recorded a reduction to research and development expenses of $ 0.8 million and $ 0.9 million during the years ended December 31, 2025 and 2024, respectively.

The Company recorded deferred grant income of nil and $ 0.3 million during the years ended December 31, 2025 and 2024, respectively, and grant-related receivables of $ 0.4 million and nil as of December 31, 2025 and 2024, respectively.

The receivable was recorded within Other Current Assets (see Note 6).

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 R&DTI program provides for a cash refund, net of income taxes payable, 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 $ 1.0 million and $ 1.3 million during the years ended December 31, 2025 and 2024, respectively, related to the R&DTI program.

The corresponding receivable was recorded within Other Current Assets (see Note 6).

1 unchanged sentence

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 cash and cash equivalents include short-term highly liquid investments which are readily convertible into cash and relate to money market securities which are reported at fair value.

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.

4 unchanged sentences

Restricted cash

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.

Restricted cash refers to an amount required under the Company’s office lease agreement in Lugano, Switzerland and is deposited into a restricted bank account as a guarantee.

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.

Marketable securities are comprised of United States Treasury Securities (“USTS”).

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

Allowance for

Estimated Fair

Amortized Cost

Credit Losses

Marketable securities available for sale

Debt Securities - U.S.

government treasury securities

The Company had no marketable securities as of December 31, 2025 and 2024.

For the years ended December 31, 2025 and 2024, the Company recorded interest income on available-for-sale debt securities of nil and $ 38 thousand, respectively.

The USTS in the portfolio reached their final maturity in April 2024.

Tax Credits, Prepaid Expenses and Other Current Assets

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Prepaid and deferred expenses

Prepaid research and development service agreements

Prepaid directors and officers (D&O) insurance costs

Research and development grant receivable

Research and development grant receivable, net

Total prepaid expenses and other current assets

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.

Tax credits consist 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 and deferred expenses refers to pre-payments made to the Company’s vendors for future services.

Prepaid research and development service agreements 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.

The research and development grant receivable, net of income tax payable, relates to a tax credit for eligible research and development costs incurred under the R&DTI program and a receivable related to the research grant awarded by Innosuisse under the Swiss Accelerator program.

Refer to Note 3 for further discussion.

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Property and equipment, net

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.

No disposals or impairments occurred during the years ended December 31, 2025 and 2024.

Depreciation has been calculated based on the assets’ estimated economic lives by taking into consideration the use, purpose and financial-technical duration of the assets.

Depreciation expense for the years ended December 31, 2025 and 2024 was $ 45 thousand and $ 38 thousand, respectively.

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 current lease portfolio consists of leases with remaining terms ranging from less than one year to five years .

Certain of the Company’s leases include options to extend or terminate the lease.

Renewal options are included in the calculation of ROU assets and lease liabilities when the Company is reasonably certain that renewal options will be exercised.

Periods subject to termination options are included in the lease term only when the Company is reasonably certain not to exercise the termination option.

The Company’s lease agreements do not contain residual value guarantees or material restrictive covenants.

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Operating lease right-of-use assets

Operating lease liability - current

Operating lease liability - noncurrent

Operating lease liabilities - current

Operating lease liabilities - noncurrent

Weighted average remaining lease term - years

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Total operating lease costs

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.

In the years ended December 31, 2025 and 2024, the Company incurred short-term lease expense of $ 71 thousand and $ 18 thousand, respectively.

These expense were recognized on a straight-line basis and reported within general and administrative costs.

The variable lease costs incurred in the years ended December 31, 2025 and 2024 was $ 31 thousand and $ 25 thousand, respectively.

The Company made fixed cash payments related to operating leases of $ 0.2 million in both the years ended December 31, 2025 and 2024.

The future minimum lease payments for the Company’s operating leases as of December 31, 2025, are as follows:

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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.

As of December 31, 2025 and 2024, accounts payable amounted to $ 0.8 million and $ 0.9 million, respectively.

All accounts payable are due in less than 12 months.

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Total other current liabilities and deferred income

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.

Accrued payroll refers to accruals for year-end bonuses, accrued vacation, overtime and other payroll-related accruals.

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.

Deferred grant income refers to the upfront payment that the Company has received after the successful application regarding research and development grants.

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:

Net pension obligations related to the Company’s defined pension plan refers only to Swiss employees and as of December 31, 2025 and 2024 can be summarized as follows:

End of year funded status:

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Benefit payments

Loss on financial assumptions

Loss on demographic assumptions

Gain on financial assumptions

Gain on experience

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Loss at beginning of year

Loss on pension benefit obligation during the year

Gain on pension benefit obligation during the year

Loss on assets during the year

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Net loss amortized

Loss on pension benefit obligation during the year

Gain on pension benefit obligation during the year

Loss on assets during the year

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Total accumulated other comprehensive income at end of year

The assumptions used in the determination of the benefit obligation and the net periodic costs for the pension plans were as follows:

The assumptions used in the determination of the benefit obligation and the net periodic costs for the pension plan were as follows:

Financial assumptions (%pa):

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Next year's expected employer contribution

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 increase in projected benefit obligation for the year ended December 31, 2025 was primarily related to foreign exchange currency translation as the Swiss franc strengthened against the U.S.

Excluding the foreign exchange impact, the projected benefit obligation decreased due to the actuarial gains related to an increase in the discount rate and changes in the forecast inflation which were applied against future expected benefit payments.

The increase of the plan assets recorded during the year was mainly related to foreign exchange currency translation as the Swiss franc strengthened against the U.S.

dollar, partially offset by net benefit payments.

The Company’s investment strategy for its pension plan 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.

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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.

Expenses related to the Company’s 401(k) savings plan totaled $ 47 thousand and $ 37 thousand for the years ended December 31, 2025 and 2024, respectively.

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.

The expenses related to the Company’s pension scheme consist of matching contributions and totaled $ 16 thousand and $ 15 thousand for the years ended December 31, 2025 and 2024, respectively.

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 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 there were 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:

The future payments for the Company’s loan as of December 31, 2025 are as follows:

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

the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.

The Company’s assessment of the significance of a particular input to 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.

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Defined benefit pension plan:

Pension plan asset

Pension plan asset (insurance contract)

Total defined benefit pension plan

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December 31, 2024:

Marketable securities available for sale:

Debt securities - U.S.

government treasury securities, current

Total marketable securities available for sale

Defined benefit pension plan:

Pension plan asset

Pension plan asset (insurance contract)

Total defined benefit pension plan

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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.

Please refer to Note 11 “Pension and Other Benefit Programs” for additional details on the valuation of pension plan assets.

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 Company’s annual meeting held on June 24, 2025, the stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase its authorized shares of common stock from 50,000,000 to 100,000,000 .

The amendment did not change any of the current rights and privileges of the Company’s common stock or its par value, and did not affect the number of shares of the Company’s common stock outstanding.

As of December 31, 2025 and 2024, the authorized capital stock of the Company included 100,000,000 shares of common stock, $ 0.0001 par value and 10,000,000 shares of preferred stock, $ 0.0001 par value.

As of December

31, 2025 and 2024, there were 42,073,807 and 27,132,588 shares of common stock, respectively, $ 0.0001 par value, issued and outstanding .

Public offering July 2025

In July 2025, the Company completed the public offering of 4,501,640 shares of its common stock and warrants to purchase 2,250,820 shares of its common stock.

The warrants were offered and sold at a 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 $ 3.11 , yielding an effective price of $ 1.55 per share and $ 0.01 per warrant.

Each warrant has an exercise price of $ 1.65 per share of common stock and was immediately exercisable on the date of issuance.

The public offering resulted in gross proceeds to the Company of $ 7.0 million, which included $ 1.0 million in offering expenses, such as underwriter fees and legal, audit, and advisory costs, for net proceeds to the Company of $ 6.0 million.

As of December 31, 2025, 1,146,821 public warrants were exercised resulting in the issuance of 1,146,821 shares of common stock and net proceeds of $ 1.9 million.

Following completion of the public offering, the underwriter exercised its over-allotment option to purchase an additional 675,246 shares of common stock, and warrants to purchase 337,623 shares of common stock, which resulted in additional gross proceeds of $ 1.1 million, which included $ 0.1 million in offering expenses, such as underwriter fees, for net proceeds of $ 1.0 million.

The fair value of the shares of common stock and investor warrants 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 and investor warrants issued.

In connection with the public offering, the Company issued the underwriter warrants to purchase 362,382 shares of common stock at an exercise price of $ 1.94 per share as consideration for the services provided (the “2025 Underwriter Warrants”).

The 2025 Underwriter Warrants will be exercisable for four and a half years commencing six months after the date of the underwriting agreement.

The 2025 Underwriter Warrants provide for cashless exercise.

The 2025 Underwriter Warrants were recorded within additional paid-in capital, as they represent compensation associated with the financing round, for $ 0.3 million.

The fair market value of the investor warrants and the 2025 Underwriter Warrants issued in connection with the public offering have been calculated using the Black-Scholes option pricing model.

Below is a table that summarizes the assumptions that have been used in the calculation:

2025 Investor Warrants

2025 Underwriter Warrants

July 17, 2025

July 23, 2025

July 17, 2025

July 23, 2025

Market price at grant date

Expected term (years)

Risk-free interest rate

Expected dividend yield

Grant date fair value per share

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.

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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.

For the year ended December 31, 2025, the Company sold an aggregate of 6,850,679 shares of common stock at an average selling price of $ 2.74 per share under the 2024 ATM Program, raising gross proceeds of $ 18.8 million, which included $ 0.7 million of sales commissions and other offering expenses for net proceeds of $ 18.1 million.

As of December 31, 2025, the Company has sold an aggregate of 8,447,807 shares of common stock at an average selling price of $ 2.60 per share under the 2024 ATM Program, raising

gross proceeds of $ 21.9 million, which included $ 0.9 million of sales and commissions and other offering expenses for net proceeds of $ 21.0 million.

Public offering June 2024:

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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 of December 31, 2025, 1,031,602 Pre-Funded Warrants were exercised resulting in the issuance of 1,031,602 shares of common stock.

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.

20 unchanged sentences

Exercise Price

July 20, 2025

November 24, 2028

June 17, 2029

Pre-funded warrants

July 17, 2030

Outstanding as of December 31, 2025

3 unchanged sentences

Outstanding as of December 31, 2024

Pre-funded Warrants

Investor warrants

2025 Underwriter warrants

1 unchanged sentence

( 1,031,602 )

Public Warrants

Investor warrants (a)

( 1,629,111 )

Agent warrants (a)

July 20th warrants (b)

May 6th warrants (c)

Outstanding as of December 31, 2025

(a) In December 2025, 482,290 investor warrants and 240,652 placement agent warrants issued in 2023, in connection with a public and private offering, were exercised and resulted in net proceeds of $ 1.3 million.

In connection with the cashless exercise of the placement agent warrants, 68,356 shares were issued and 172,296 shares were withheld and canceled.

(b) On July 20, 2025, 225,387 warrants issued in 2020 in connection with the Series B Preferred Stock to designees of the placement agent were not exercised within their five year exercisable period and were therefore forfeited.

(c) On May 6, 2025, 200,000 warrants issued in 2021 to an investment bank for banking services and financial advisory were not exercised within their four year exercisable period and were therefore forfeited.

Equity Incentive Plan

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As of December 31, 2025, unrecognized compensation costs associated with the stock option grants was $ 3.1 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:

The fair value of the options vested was $ 1.2 million and $ 2.1 million for the years ended December 31, 2025 and 2024 respectively.

The assumptions that the Company used to determine the grant-date fair value of stock options granted during the periods ended December 31, 2025 and 2024 were as follows, presented on a weighted-average basis:

Year Ended December 31

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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 fair value of the RSUs vested was $ 237 thousand and $ 487 thousand for the years ended December 31, 2025 and 2024, 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:

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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.

For financial reporting purposes, loss before income tax provision includes the following components:

6 unchanged sentences

The breakdown of domestic and foreign net operating losses (“NOLs”) and related deferred tax assets are reported in the following table:

NOLs (domestic)

NOLs (domestic federal)

( 44,986,286 )

19 unchanged sentences

Valuation allowance

( 20,690,493 )

( 15,307,461 )

Net deferred tax assets

8 unchanged sentences

The Company has not done an analysis to determine whether or not ownership changes have occurred since inception.

On July 4, 2025, the One Big Beautiful Act ("OBBBA") was signed into law, enacting changes in the wide array of policy areas, including federal tax law.

The impacts of OBBBA are included in the financial statements for the year ended December 31, 2025 and have not been material.

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.

3 unchanged sentences

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, 2025 and 2024 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:

A reconciliation of the provision for income taxes to the amount computed by applying the 21 % statutory U.S.

federal income tax rate to income before income taxes after the adoption of ASU 2023-09, which has been applied prospectively, is as follows:

US federal statutory tax rate

( 4,052,996 )

State and local income taxes, net of federal income tax effect

Nontaxable or nondeductible items

Effects of cross-border tax law, net of related credits

Global intangible low-taxed income

Change in domestic valuation allowance

Provision to return

( 3,446,278 )

Foreign tax effects

Nontaxable grant income

Nondeductible R&D

Other foreign tax effects

Total income tax expense

Provision to return mainly relates to temporary differences associated with capitalized research and development activities which are fully covered by a corresponding valuation allowance, with no impact to the Consolidated Statements of Operations.

A reconciliation of the provision for income taxes to the amount computed by applying the 21 % statutory U.S.

federal income tax rate to income before income taxes for the year prior to the adoption of ASU 2023-09 is as follows:

Federal income tax at U.S.

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Effective income tax rate

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, 2025 and 2024, 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.

2 unchanged sentences

The Company is currently not under examination by any tax authorities.

As of December 31, 2025, the Company has not provided any deferred taxes with respect with respect to the unremitted earnings of its non-U.S.

subsidiaries as the Company considers those earnings to be indefinitely reinvested.

It is not practicable for the Company to determine the amount of unrecognized tax expense on these reinvested international earnings.

The Company paid $ 48 thousand in foreign taxes in Spain for the year ended December 31, 2025.

Net Loss per Common Share

1 unchanged sentence

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.

For purposes of the diluted net loss per share calculation, preferred stock, warrants, stock options, and RSUs 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:

1 unchanged sentence

Options to purchase common stock

RSUs and PRSUs

Warrants to purchase common stock

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.

Related Parties

4 unchanged sentences

● 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.

There were no receivables and payables as of December 31, 2025 and 2024 with Minoryx.

There were no revenues or expenses for the years ended December 31, 2025 and 2024 with Minoryx.

Commitments and Contingencies

1 unchanged sentence

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.

The Company records a liability when it is probable a loss has been incurred and the amount is reasonably estimable, the determination of which requires significant judgment.

When a loss is reasonably possible but not probable, or when the amount of a probable loss cannot be reasonably estimated, the Company discloses the nature of the contingency and, where estimable, the range of possible loss.

The Company does not anticipate, at the present

time, that the ultimate aggregate liability, if any, arising out of such other legal proceedings will have a material adverse effect on the Company’s financial position, result of operations or liquidity.

Resolution of legal matters in a manner inconsistent with management’s expectations could have a material impact on the Company’s financial condition and operating results.

On September 18, 2024, Matthias Alder, the Company’s former Chief Executive Officer, filed litigation against the Company in the Circuit Court of Maryland for Montgomery County.

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.

In connection with the litigation the Company recorded an accrual of $ 0.53 million, reported within payroll related accruals as of December 31, 2024.

Following mediation, the lawsuit was dismissed with prejudice on July 2, 2025.

The amounts accrued by the Company were materially in line with the disbursements required to settle this litigation.

Subsequent Events

From January 1, 2026, through March 13, 2026, the Company has sold an aggregate of 184,662 shares of common stock through the 2024 ATM Program at a weighted-average selling price of $ 2.39 for total gross proceeds of $ 0.4 million.

On March 20, 2025, 454,893 pre-funded warrants were exercised resulting in the issuance of 454,893 shares of common stock.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 8. Financial Statements and Supplementary Data