Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 29, 2024 | Jun. 30, 2023 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 001-40237 | ||
Entity Registrant Name | GAIN THERAPEUTICS, INC | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 85-1726310 | ||
Entity Address, Address Line One | 4800 Montgomery Lane | ||
Entity Address, Adress Line Two | Suite 220 | ||
Entity Address, City or Town | Bethesda | ||
Entity Address State Or Province | MD | ||
Entity Address, Postal Zip Code | 20814 | ||
City Area Code | 301 | ||
Local Phone Number | 500-1556 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | GANX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 56.6 | ||
Entity Common Stock, Shares Outstanding | 16,219,709 | ||
Entity Central Index Key | 0001819411 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | Ernst & Young AG | ||
Auditor Firm ID | 1460 | ||
Auditor Location | Lugano, Switzerland |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 11,794,949 | $ 7,311,611 |
Marketable securities - current | 4,999,704 | 12,826,954 |
Tax credits | 242,577 | 103,877 |
Prepaid expenses and other current assets | 741,638 | 848,854 |
Total current assets | 17,778,868 | 21,091,296 |
Non-current assets: | ||
Marketable securities - non current | 1,941,488 | |
Property and equipment, net | 125,962 | 144,379 |
Internal-use software | 193,375 | 213,967 |
Operating lease - right of use assets | 459,215 | 659,933 |
Restricted cash | 34,021 | 30,818 |
Long-term deposits and other non-current assets | 17,890 | 17,506 |
Total non-current assets | 830,463 | 3,008,091 |
Total assets | 18,609,331 | 24,099,387 |
Current liabilities: | ||
Accounts payable | 1,318,965 | 1,626,100 |
Operating lease liability - current | 229,693 | 229,080 |
Other current liabilities | 2,160,366 | 2,106,756 |
Deferred income - current | 1,122,138 | 55,180 |
Loans - current | 118,797 | 108,135 |
Total current liabilities | 4,949,959 | 4,125,251 |
Non-current liabilities: | ||
Defined benefit pension plan | 307,454 | 157,580 |
Operating lease liability - non-current | 229,855 | 441,784 |
Deferred income - non-current | 94,786 | |
Loans - non-current | 449,053 | 495,258 |
Total non-current liabilities | 1,081,148 | 1,094,622 |
Total liabilities | 6,031,107 | 5,219,873 |
Stockholders' equity | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; nil shares issued and outstanding as of December 31, 2023 and 2022 | ||
Common stock, $0.0001 par value: 50,000,000 shares authorized; 16,206,680 shares issued and outstanding as of December 31, 2023 and 11,883,368 shares issued and outstanding as of December 31, 2022 | 1,621 | 1,189 |
Additional paid-in capital | 73,113,079 | 57,358,895 |
Accumulated other comprehensive income | 247,241 | 35,627 |
Accumulated deficit | (38,516,197) | (20,925,459) |
Loss of the period | (22,267,520) | (17,590,738) |
Total stockholders' equity | 12,578,224 | 18,879,514 |
Total liabilities and stockholders' equity | $ 18,609,331 | $ 24,099,387 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Consolidated Balance Sheets | ||
Preferred stock, Par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares, issued | 16,206,680 | 11,883,368 |
Common stock, shares, outstanding | 16,206,680 | 11,883,368 |
Consolidated Statement of Opera
Consolidated Statement of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenues: | ||
Collaboration revenues | $ 55,180 | $ 132,640 |
Other income | 7,468 | |
Total revenues | 55,180 | 140,108 |
Operating expenses: | ||
Research and development | (11,520,613) | (8,377,290) |
General and administrative | (10,787,700) | (9,539,863) |
Total operating expenses | (22,308,313) | (17,917,153) |
Loss from operations | (22,253,133) | (17,777,045) |
Other income (expense): | ||
Interest income, net | 494,234 | 375,357 |
Foreign exchange loss, net | (429,346) | (96,074) |
Loss before income tax | (22,188,245) | (17,497,762) |
Income tax | (79,275) | (92,976) |
Net loss | $ (22,267,520) | $ (17,590,738) |
Net loss per shares: | ||
Net loss per share attributable to common stockholders - Basic | $ (1.71) | $ (1.48) |
Net loss per share attributable to common stockholders - Diluted | $ (1.71) | $ (1.48) |
Weighted average common stock - Basic | 13,011,361 | 11,883,368 |
Weighted average common stock - Diluted | 13,011,361 | 11,883,368 |
Consolidated Statement of Compr
Consolidated Statement of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Consolidated Statement of Comprehensive Loss | ||
Net Income (Loss) | $ (22,267,520) | $ (17,590,738) |
Unrealized gain / (loss) on available-for-sale marketable securities | 89,304 | (94,279) |
Defined benefit pension plan | (127,601) | 227,131 |
Foreign currency translation | 249,911 | (6,580) |
Other comprehensive income | 211,614 | 126,272 |
Comprehensive loss | $ (22,055,906) | $ (17,464,466) |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders' Equity - USD ($) | Common Stock Common Stock | APIC | AOCI | Accumulated Deficit | Total |
Balance, beginning of period at Dec. 31, 2021 | $ 1,189 | $ 55,832,461 | $ (90,645) | $ (20,925,459) | $ 34,817,546 |
Balance, beginning of period (in shares) at Dec. 31, 2021 | 11,883,368 | ||||
Stock-based compensation (Note 15) | 1,526,434 | 1,526,434 | |||
Defined benefit pension plan | 227,131 | 227,131 | |||
Foreign currency translation | (6,580) | (6,580) | |||
Net unrealized gain on available for sale securities | (94,279) | (94,279) | |||
Net Income (Loss) | (17,590,738) | (17,590,738) | |||
Balance, end of period at Dec. 31, 2022 | $ 1,189 | 57,358,895 | 35,627 | (38,516,197) | 18,879,514 |
Balance, end of period (in shares) at Dec. 31, 2022 | 11,883,368 | ||||
Stock-based compensation (Note 15) | $ 16 | 3,305,056 | 3,305,072 | ||
Stock-based compensation (Note 15) (in shares) | 171,751 | ||||
Defined benefit pension plan | (127,601) | (127,601) | |||
Foreign currency translation | 249,911 | 249,911 | |||
Net unrealized gain on available for sale securities | 89,304 | 89,304 | |||
Issuance of shares in at-the-market (ATM) offering | $ 86 | 3,544,790 | 3,544,876 | ||
Issuance of shares in at-the-market (ATM) offering (Shares) | 862,535 | ||||
Issuance of shares and warrants in public offering and private placement | $ 330 | 8,904,338 | 8,904,668 | ||
Issuance of shares and warrants in public offering and private placement (Shares) | 3,289,026 | ||||
Net Income (Loss) | (22,267,520) | (22,267,520) | |||
Balance, end of period at Dec. 31, 2023 | $ 1,621 | $ 73,113,079 | $ 247,241 | $ (60,783,717) | $ 12,578,224 |
Balance, end of period (in shares) at Dec. 31, 2023 | 16,206,680 |
Consolidated Statement of Cash
Consolidated Statement of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities: | ||
Net loss | $ (22,267,520) | $ (17,590,738) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 83,579 | 64,168 |
Stock based compensation expense | 3,259,026 | 1,526,434 |
Other non cash items | (383,188) | (206,861) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other currents assets | 184,446 | (114,005) |
VAT credits | (130,068) | 3,631 |
Long term deposit and other non current assets | (10,057) | (2,901) |
Accounts payable | (643,164) | 1,066,707 |
Other current liabilities | (50,534) | 711,073 |
Defined benefit pension plan | 6,313 | 58,696 |
Deferred income | 1,085,294 | (208,343) |
Total changes in operating assets and liabilities | 442,230 | 1,514,858 |
Net cash used in operating activities | (18,865,873) | (14,692,139) |
Cash flows from investing activities: | ||
Purchase of property and equipment and internal-use of software | (15,358) | (118,953) |
Purchases of marketable securities | (1,956,350) | (17,735,355) |
Maturities of marketable securities | 12,194,375 | 3,079,495 |
Net cash provided/(used) by/in investing activities | 10,222,667 | (14,774,813) |
Cash flow from financing activities: | ||
Net proceeds from issuance of shares in at-the-market (ATM) offering | 3,544,876 | |
Net proceeds from issuance of shares and warrants in public offering and private placement | 9,185,534 | |
Payments of current portion of long-term debt | (89,067) | (78,774) |
Net cash provided/(used) by/in financing activities | 12,641,343 | (78,774) |
Effect of exchange rate changes | 488,404 | (23,797) |
Net increase / (decrease) in cash, cash equivalents and restricted cash | 4,486,541 | (29,569,523) |
Cash, cash equivalents and restricted cash at beginning of period | 7,342,429 | 36,911,952 |
Cash, cash equivalents and restricted cash at end of period | 11,828,970 | 7,342,429 |
Supplemental Data: | ||
Income taxes paid | $ 134,962 | $ 2,740 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Nature of the Business and Basis of Presentation | |
Nature of the Business and Basis of Presentation | 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. On July 20, 2020, the Company consummated a corporate reorganization, pursuant to which all of the issued and outstanding common and preferred stock of GT Gain Therapeutics SA, a Swiss company formed in 2017, were exchanged for common stock or preferred stock, as applicable, of Gain Therapeutics, Inc., reflecting a 10:1 stock split. The corporate reorganization was accounted for as a recapitalization for accounting purposes, with GT Gain Therapeutics SA resulting in the predecessor entity of the Company. As a result of the corporate reorganization, GT Gain Therapeutics SA became a wholly-owned subsidiary of Gain Therapeutics, Inc. On March 17, 2021, the Company’s registration statement on Form S-1 related to its Initial Public Offering (“IPO”) was declared effective by the Securities and Exchange Commission (“SEC”). 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 uses its computational target and drug discovery platform Magellan™ to discover novel allosteric binding sites on proteins implicated in a disease and to identify proprietary small molecules that bind these sites to modulate protein function and treat the underlying cause of the disease. 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, and 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. Going concern At each reporting period, the Company evaluates whether there are conditions or events 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 organizing and staffing the Company, expanding its operations, securing financing, developing and securing its in-licensed technology, performing research and conducting preclinical studies. 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 Accounting Standard Update (“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, cash equivalents and marketable securities of $16.8 million 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 first 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 and reducing the research and development expenses and 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 first quarter of 2025, including raising additional capital through either private or public equity or debt financing, or additional program collaborations or non-dilutive funding. 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. Basis of presentation The consolidated financial statements reflect the accounts of the 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 consolidated financial statements as of December 31, 2023, represented by the Consolidated Balance Sheet, the Consolidated Statement of Operations, the Consolidated Statements of Changes in Shareholders’ Equity, the Consolidated Statement of Comprehensive Loss, the Consolidated Statements of Cash Flows and the accompanying Notes, have been prepared in accordance with accounting principles generally accepted in the United States of America (“US 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 of the Financial Accounting Standards Board (“FASB”). All amounts in the consolidated financial statements are expressed in United States Dollars (USD/$) and disclosed within these explanatory notes in United States Dollars (USD/$). The consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements as of and for the year ended December 31, 2022, 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, 2023 and 2022, and the results of its operations, its statements of stockholders’ equity and its statements of cash flows for the years then ended. Segment information Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company’s chief operating decision-maker, the Chief Executive Officer, oversees the Company’s operations and manages the business as a single 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, such as rare genetic diseases and neurological disorders. Geographically, the research and development activities are mainly performed in Australia, Switzerland and Spain. The Company does not consider these geographies to be separate segments. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of significant accounting policies Foreign currency translation The holding company is incorporated in the United States of America and has operations in Switzerland, Spain and Australia. The Company’s reporting currency is USD and the functional currencies of the Company’s operations are the local currencies (US Dollars 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 U.S. dollars (the currency in which these financial statements are presented) at the exchange rates applicable at the balance sheet dates and for the consolidated statement of operations at the average exchange rates for the periods presented. Items representing the share capital and additional paid-in capital are presented at the historical exchange rates. Adjustments resulting from the translation of the financial statements of the Company’s foreign operations into U.S. dollars 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, 2023 and 2022, accumulated currency translation adjustment recorded in the accumulated other comprehensive loss amounted to $408,487 and $158,576, respectively. Use of Estimates The preparation of our consolidated financial statements in conformity with US 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, we evaluate our estimates judgments and, assumptions including those related to the assessment of going concern, recognition of accrued expenses, defined benefit pension liability, share-based compensation, recognition of research grants. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable 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 reports cash on hand and held at banks, and all highly liquid investments in money market, certificates of deposit, time deposit, and other short-term liquid securities with original maturities of less than 90 day, 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. 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 gains/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) are accounted for in the Company’s statements of operations as financial income (or expense). Marketable securities are classified in the Company’s balance sheet 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 reporting date are classified as “current assets”. Marketable securities with a maturity date over 12 months from reporting date are classified as “non-current 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 has 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 issuances are consummated. After consummation of the equity issuance, 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. 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 financial 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. As of December 31, 2023 and 2022, internal-use software amount to $193,375 and $213,967, respectively, and refer to the external and internal labor costs incurred in the development of the Company’s enterprise resource planning system. 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 and for the years ended December 31, 2023 and 2022 was $45,507 and $37,536, respectively. The accumulated amortization as of December 31, 2023 and 2022 was $91,262 and $39,021, respectively. Impairment of long-lived assets In accordance with ASC Topic 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. 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. 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. 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 statement 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 our 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 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. 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, performance-based and market-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 on the grant date using the Black-Scholes option pricing model. The Company determines the volatility and the expected term for awards granted based on an analysis of reported data for a peer group of similar biopharmaceutical companies. 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 (or RSUs) based on their fair market value, determined as the closing price on 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 market or performance -based vesting conditions (or PRSUs), the fair value at grant date is calculated using an option-pricing model (Monte Carlo Simulation) or based on management’s assessment of the likelihood of concurrence of the underlying performance, respectively. 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 The Company derives limited revenue from its collaboration and licensing agreements. The Company recognizes revenue related to these agreements in accordance with ASC 606, “Revenues from Contracts with Customers” 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 we fulfill our 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) we satisfy 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 fulfil 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. Research grants Under the terms of the research and development grants awarded, the Company is entitled to receive reimbursement of its allowable direct expenses and payroll costs. Contributions from research and development activities under the grants 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 statement of operations as a reduction to research and development expenses. 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 statement of operations. Fair value measurements 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. ● 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, we utilize 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, defined benefit obligation adjustments and unrealized income/(loss) 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 antidilutive. As of December 31, 2023 and 2022, 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 Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. There were no new accounting pronouncements effective in 2023 with a material impact on the Company’s consolidated financial statements. |
Research Grants
Research Grants | 12 Months Ended |
Dec. 31, 2023 | |
Research Grants | |
Research Grants | 3. Research Grants During the course of its business, the Company applies for research grants with public or private organization to funds is research projects. Under the terms of these grants , the Company is entitled to receive reimbursement of its allowable direct research expenses. In July 2019, the Company’s wholly owned subsidiary, GT Gain Therapeutics SA, announced that, in a consortium with the Institute for Research in Biomedicine, Bellinzone (Switzerland) and Neuro-Sys SAS in Gardanne (France), it obtained a three-years research grant to support the development of the drugs portfolio for the treatment of Gaucher Disease, GM1 Gangliosidosis, Mucopolysaccharidosis type 1 and Krabbe.The grant was approved by the Eurostars-2 joint programme, with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. In connection with this grant, during the year ended December 31, 2022, the Company recorded a reduction to research and development expenses of $82 thousand. The research grant is concluded and no reduction to research and development expenses has been recorded for the year ended December 31, 2023. 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 connection with the grants announced in March 2023 and May 2023 the Company recorded, during the year ended December 31, 2023, a reduction to research and development expenses of $0.6 million and reports deferred income of $1.2 million. |
Cash, cash equivalents and rest
Cash, cash equivalents and restricted cash | 12 Months Ended |
Dec. 31, 2023 | |
Cash, cash equivalents and restricted cash | |
Cash, cash equivalents and restricted cash | 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. These investments relate to money market securities with maturities of three months or less when acquired. 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 (see Note 13). Given their short-term maturities and the underlying being represented by cash equivalents, their face value amount approximate 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, 2023 2022 Cash 5,027,658 2,910,446 Money Market 6,767,291 4,401,165 Total cash and cash equivalents $ 11,794,949 $ 7,311,611 Restricted cash $ 34,021 $ 30,818 Restricted cash refers to an amount required under the Company’s office lease agreement in Lugano and deposited into a restricted bank account as a guarantee. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2023 | |
Marketable Securities | |
Marketable Securities | 5. Marketable Securities As of December 31, 2023 the Company reports $5 million of marketable securities, related to United States Treasury Securities (“USTS”), within current assets. The USTS purchased have maturity dates going from January 2024 to April 2024, on a monthly basis, in tranches of USD 1,000 thousand each month. 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. The following table summarizes the Company’s investment in available-for-sale marketable securities with the detail of the unrealized gains / (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, current 5,004,679 — — (4,975) 4,999,704 Totals $ 5,004,679 $ — $ — $ (4,975) $ 4,999,704 As of December 31, 2023, the Company did not intend to sell any of the debt securities included in the table above, and it is not more likely than not that the Company will be required to sell any of these securities before recovery of the unrealized losses, which will be at maturity. Unrealized losses on available-for-sale debt securities as of December 31, 2023 were primarily due to changes in interest rates. Accordingly, as of December 31, 2023, the Company has not recorded an allowance for credit losses related to its available-for-sale debt securities. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: December 31, December 31, 2023 2022 Tax Credits 242,577 103,877 Prepaid and deferred expenses 608,638 552,882 Other receivable — 87,430 Prepaid D&O Insurance 133,000 208,542 Total Prepaid expenses and other current assets $ 741,638 $ 848,854 Tax credit consist of a value added tax (“VAT”) 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. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2023 | |
Property and Equipment, net | |
Property and Equipment, net | 7. Property and Equipment, net Property and equipment, net, consists of the following : December 31, December 31, 2023 2022 Computer $ 83,894 $ 71,774 Furniture and fixtures 62,825 57,603 Leasehold improvements 33,992 31,437 Laboratory instruments 38,048 36,894 Total property and equipment $ 218,759 $ 197,708 Less: accumulated depreciation (92,797) (53,329) Property and equipment, net $ 125,962 $ 144,379 No disposals, nor impairments occurred during the periods. 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, 2023 and 2022 was $34,875 and $26,632, respectively. |
Operating Lease, Right of Use (
Operating Lease, Right of Use ("ROU") Assets | 12 Months Ended |
Dec. 31, 2023 | |
Operating Lease; Right of Use ("ROU") Assets | |
Operating Lease; Right of Use ("ROU") Assets | 8. Operating lease; Right of use (“ROU”) assets The Company’s leased assets include offices in Bethesda, Maryland, Lugano, Switzerland and Barcelona, Spain and a lab in Barcelona, Spain. The current lease portfolio consists of leases with remaining terms ranging from one 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, 2023 2022 Operating lease- right of use assets $ 459,215 $ 659,933 Operating lease liability - current $ 229,693 $ 229,080 Operating lease liability - non current $ 229,855 $ 441,784 Weighted average remaining lease term - years 2.25 3.05 Weighted average discount rate 1.51 1.53 The amounts related to lease costs included in the consolidated statements of operations were as follows: Year Ended December 31 2023 2022 Research and development 141,591 134,210 General and administrative 104,574 94,529 Total operating lease costs $ 246,165 $ 228,739 The future minimum lease payments for the Company’s operating leases as of December 31, 2023, are as follows: Fiscal Year Operating Leases 2024 234,576 2025 174,585 2026 57,889 Total future minimum lease payments 467,050 Less amount representing interest or imputed interest 7,502 Present value of lease liabilities $ 459,548 |
Accounts Payable
Accounts Payable | 12 Months Ended |
Dec. 31, 2023 | |
Accounts Payable | |
Accounts Payable | 9. Accounts Payable Accounts payable are reported at their nominal value. Accounts payable refer to amounts due to third parties on outstanding invoices received for services already provided. As of December 31, 2023 and December 31, 2022, accounts payable amounted to $1.3 million and $1.6 million, respectively. All accounts payable are due in less than 12 months. |
Other Current Liabilities and D
Other Current Liabilities and Deferred Income | 12 Months Ended |
Dec. 31, 2023 | |
Other Current Liabilities and Deferred Income | |
Other Current Liabilities and Deferred Income | 10. Other current liabilities and deferred income Other current liabilities and deferred income consist of the following as of December 31, 2023 and 2022: December 31, December 31, 2023 2022 Payable for social security $ 368,345 $ 256,798 Accrued payroll 726,474 660,556 Accrued expenses 1,016,582 1,082,091 Tax provision 48,965 107,311 Total Other Current Liabilities $ 2,160,366 $ 2,106,756 Deferred income 1,216,924 55,180 Total Other Current Liabilities and Deferred Income $ 3,377,290 $ 2,161,936 Deferred income refers to the portion of grants cashed in and not yet recognized as a reduction of R&D expenses in the statement of operations. Accrued payroll refers to accruals for year-end bonuses, accrued vacations and overtime to be paid to employees. Accrued expenses refer 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. |
Pension Obligations
Pension Obligations | 12 Months Ended |
Dec. 31, 2023 | |
Pension obligations | |
Pension obligations | 11. Pension obligations Net pension obligations related to the Company’s defined pension plan refer only to Swiss employees and as of December 31, 2023 and 2022 can be summarized as follows: December 31, December 31, 2023 2022 End of year funded status: Fair value of plan assets $ 822,763 $ 675,127 (Projected benefit obligation) (1,130,217) (832,707) Funded status $ (307,454) $ (157,580) Accumulated benefit obligation 1,076,742 785,478 Reconciliation of funded status: Funded status beginning of year $ (157,580) $ (329,458) Expense (149,309) (179,924) Employer contribution 143,599 123,193 Translation differences (16,563) 1,478 Change in AOCI over the year (127,601) 227,131 Funded status at end of year $ (307,454) $ (157,580) Component of net periodic pension costs: Service cost $ 144,565 $ 169,709 Interest cost 19,264 3,376 Expected return on plan assets (11,786) (9,000) Amortization of (gain)/losses — 16,753 Amortization of prior service cost (2,734) (914) Total $ 149,309 $ 179,924 Service cost is reported in general and administrative expenses. All other components of net period costs are reported in interest income, net in the consolidated statement of operations Reconciliation of projected benefit obligation: Projected benefit obligation at January 1 $ 832,707 $ 1,272,483 Services cost 144,565 169,709 Employee contribution 96,099 83,731 Interest Cost 19,264 3,376 Benefit payments (119,897) (413,780) (Gain) / loss on financial assumptions 132,781 (242,607) (Gain) / loss on demographic assumptions 2,730 — (Gain) / loss on experience (61,208) (715) Translation differences 91,689 (25,130) Plan Amendment (8,513) (14,360) $ 1,130,217 $ 832,707 December 31, December 31, 2023 2022 Reconciliation of fair value of plan assets: Fair value at January 1 $ 675,127 $ 943,025 Expected return on plan assets 11,786 9,000 Gain/(loss) on plan assets (59,077) (46,390) Employer contributions 143,599 123,193 Employee contributions 96,099 83,731 Benefit payments (119,897) (413,780) Translation differences 75,126 (23,652) Fair value at December 31 $ 822,763 $ 675,127 December 31, December 31, 2023 2022 Change in net (gain)/loss: (Gain)/loss at beginning of year $ 49,541 $ 263,226 (Gain)/loss on PBO during the year 74,303 (243,322) (Gain)/loss on assets during the year 59,077 46,390 Amortization of gain/(loss) — (16,753) (Gain)/loss at end of year $ 182,921 $ 49,541 December 31, December 31, 2023 2022 Change in accumulated other comprehensive income (AOCI): AOCI at beginning of year $ 28,670 $ 255,801 Net gain/(loss) amortized — (16,753) (Gain)/loss on PBO during the year 74,303 (243,322) (Gain)/loss on assets during the year 59,077 46,390 Prior Service Cost/(credit) occurring over the year (8,513) (14,360) Net prior service (cost)/credit amortized 2,734 914 Total AOCI at end of year $ 156,271 $ 28,670 The assumptions used in the determination of the benefit obligation and the plan assets for the pension plans and the pension obligation were as follows: December 31, December 31, 2023 2022 Financial Assumptions (%pa): Discount rate 1.40% 2.30% Interest credit rate / ERoA 1.25% 1.50% 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 65/64 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 December 31, December 31, 2023 2022 Expected benefit payments: Year 1 $ 43,703 $ 38,493 Year 2 50,060 44,884 Year 3 55,679 50,459 Year 4 60,285 55,444 Year 5 64,215 59,369 Next 5 years $ 482,594 $ 450,981 Other disclosure items: Next year's expected employer contribution $ 156,395 $ 128,746 The actuarial losses in 2023 were primarily due to a decrease in discount and interest rates applied against future expected benefit payments and resulted in a 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. We maintain a 401(k) saving Plan, which is available to all U.S. employees. Participants may make voluntary contributions. We make matching contributions according to the 401(k) Saving Plan’s matching formula. All matching contributions and participant contribution vest immediately. The expense related to our 401(k) Savings Plan consist of our matching contributions. Expenses related to our 401(k) Savings Plan totaled $19,938 and $15,875 for the years ended December 31, 2023 and 2022. Our UK employees are eligible to participate to our 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 expense related to our pension scheme consist of our matching contributions and totaled $16,753 and $5,165 for the years ended December 31, 2023 and 2022. |
Loans
Loans | 12 Months Ended |
Dec. 31, 2023 | |
Loans | |
Loans | 12 . Loans In August 2020, the Company obtained a CHF 638,000 (USD 700,221 at the historical exchange rate) nine-year loan. The loan has zero interest and is due in quarterly installments of CHF 20,000, with payments commencing on December 31, 2021 and ending on September 30, 2029. The loan is 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, and the loan issued under the program does not bear interest and there are no applicable issuance costs. The Company accounts for its loan at face value, which is deemed to approximate the related fair value. The future loan payments are reported in the table below: December, 31 Total 2024 2025 2026 2027 2028 Thereafter Loan $ (567,850) (118,797) (95,038) (95,038) (95,038) (95,038) (68,901) |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2023 | |
Fair value measurement | |
Fair value measurement | 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 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. 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, 2023: Assets Marketable securities available for sale: Debt securities - U.S. government treasury securities, current 4,999,704 — — Debt securities - U.S. government treasury securities, non current — — — 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 and cash equivalents: Money market funds 6,767,291 — — Total cash and cash equivalents $ 6,767,291 $ — $ — Total financial assets $ 11,766,995 $ — $ 822,763 December 31, 2022: Assets Marketable securities available for sale: Debt securities - U.S. government treasury securities, current 12,826,954 — — Debt securities - U.S. government treasury securities, non current 1,941,488 — — Total marketable securities available for sale $ 14,768,442 $ — $ — Defined Benefit Pension Plan: Pension Plan Asset — — 675,127 Total Defined Benefit Pension Plan $ — $ — $ 675,127 Cash and cash equivalents: Money market funds 4,401,165 — — Total cash and cash equivalents $ 4,401,165 $ — $ — Total financial assets $ 19,169,607 $ — $ 675,127 The carrying amounts of prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair value due to their short-term maturities. Please refer to the Note 11 “Pension obligations” for additional details on the valuation of Pension Plan Assets. |
Common Stock, Preferred Stock a
Common Stock, Preferred Stock and Warrants | 12 Months Ended |
Dec. 31, 2023 | |
Common Stock, Preferred Stock and Warrants | |
Common Stock, Preferred Stock and Warrants | 14. Common Stock, Preferred Stock and Warrants As of December 31, 2023 and December 31, 2022, 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, 2023 and December 31, 2022, there were 16,206,680 and 11,883,368 shares of common stock respectively, $0.0001 par value, issued outstanding In July 2020, in connection with a private placement, the Company issued equity-classified warrants to placement agent designees. After a reverse stock split in March 2021, the aggregate number of outstanding warrants totaled 237,249 shares with an exercise price of $5.07 per share, valued in the aggregate at $413,887. The warrants vested immediately upon issuance, provide for a cashless exercise right and are exercisable for a period of five years until July 20, 2025. As of December 31, 2023, 225,387 warrants were outstanding. On May 6, 2021, the Company entered into an investment banking services and financial advisory agreement and issued equity-classified warrants to investment bank designees to purchase an aggregate of 200,000 shares of the Company common stock at an exercise price of $13.75 per share, valued in the aggregate at $1.0 million. The warrants vested immediately upon issuance, do not provide cashless exercise right and are exercisable for a period of four years from May 6, 2021. The fair value of the warrants was fully recognized on a straight-line basis over the service period as general and administrative expense. As of December 31, 2023, no warrants have been exercised. At the market offering In May 2022, the Company entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald, Inc. (“Cantor”), pursuant to which the Company was able to sell from time to time, through the Agent, shares of common stock, having an aggregate offering price of up to $16.0 million (the “ATM Program”). Sales under the ATM Program are made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 issued under the Securities Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Company’s common stock, through a market maker or as otherwise agreed by the Company and Cantor. During the year ended December 31, 2023, we sold an aggregate of 862,535 shares of common stock at an average price of $4.60 per share, raising gross proceeds of $3.9 million, which includes $0.4 million in sales and commissions and other offering expenses. The 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 described below. Public Offering In November 2023, we completed the public offering of 2,545,000 shares of our common stock and warrants to purchase 1,272,500 shares of our common stock (the “Public Warrants”). The warrants have been offered and sold at the rate of one In connection with the public offering we also issued 178,150 warrants to purchase an equal amount of our common stock at an exercise price of $2.75 per share to the Underwriter as a consideration for the services provided (the “Underwriter Warrants”), the warrants vested immediately upon the finalization of the public offering. The “Underwriter Warrants” are equity-classified and are exercisable for a period that goes from May 2024 to November 2028 and provide for cash-less exercise. Private Placement In a private placement that was completed concurrently with the public offering we also issued to accredited investors 744,026 shares of our common stock, 1,756,062 pre-funded warrants to purchase an equal amount of our common stock at the nominal exercise price of $0.0001 and private warrants to purchase 2,500,088 shares of our common stock (the “Private Warrants”). The “Private Warrants” have been offered and 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 warrant to purchase one share of common stock was $2.00 per set of securities sold privately. The “Private Warrants” immediately vested upon the finalization of the private placement, are equity-classified, have an exercise price of $2.75 per share of common stock and are exercisable for a period that goes from May 2024 to November 2028. The pre-funded warrants immediately vested upon the finalization of the private placement, are equity-classified and are exercisable for a period of five years starting from November 2023. In connection with the private placement we also issued 175,006 warrants to purchase an equal amount of our common stock at an exercise price of $2.75 to the Placement Agent as a consideration for the services provided (the “Placement Agent Warrants”), the warrants vested immediately upon the finalization of the private placement. The “Placement Agent Warrants” are equity-classified, are exercisable for a period that goes from May 2024 to November 2028 and provide for cash-less exercise. The public offering and the concurrent private placement resulted in combined gross proceeds of $10.1 million, which includes $1.2 million of underwriting commissions, placement agent’s fees and other expenses connected with the financing round. As of December 31, 2023 $0.9 million of the costs associated with the financing round had already been paid or deducted from the gross proceeds, while the reminder of the amount has been paid in the first quarter of 2024. The fair market value of the “Public Warrants”, “Private Warrants”, and of the “Underwriter Warrants”, “Placement Agent Warrants” (together referred to as “Agent Warrants”) 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 the private investors and the share price of our stock at grant date. Below a table that summarizes the assumptions that have been used in the calculation: Year Ended December 31, 2023 Public Private Pre Funded Agent Warrants Warrants Warrants Warrants Market Price at Grant Date $ 2.16 $ 2.16 $ 2.16 $ 2.16 Volatility 70.30 % 70.30 % — % 70.30 % Expected term (years) 2.50 2.75 — 2.75 Risk-free interest rate 4.73 % 4.73 % — % 4.73 % Expected dividend yield — — — — Grant date fair value per share $ 0.83 $ 0.88 $ 0.16 $ 0.88 The fair values of the shares, public, private and pre funded warrants to purchase shares of our common stock have been recorded in APIC and allocated to the gross proceeds as follows: $6.25 million for the shares issued in the public offering and the private placement (based on the stock price as of transaction date), $0.82 million for the public warrants, $2.69 million for the private warrants and $0.34 million for the pre funded warrants. The agent warrants were recorded within APIC as they represent compensation associated with the financing round, for $0.3 million. As of December 31, 2023 no warrant has expired or has been exercised. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2023 | |
Equity Incentive Plan | |
Equity Incentive Plan | 15. Equity Incentive Plans On September 24, 2020, the Board adopted the 2020 Omnibus Incentive Plan (the “2020 Omnibus Plan”). The 2020 Omnibus Plan provided for the granting of equity-based awards to our named executive officers, other employees, consultants and non-employee directors at a price to be determined by the Company’s Board. The maximum number of shares to be issued under the 2020 Omnibus Plan was 1,153,827. 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. The Company’s 2022 Equity Incentive Plan (the “2022 Plan”) was approved by the Board on May 12, 2022. On June 16, 2022, at the Company’s annual meeting of stockholders, the Company’s stockholders approved the 2022 Plan. The 2022 Plan is the successor to and continuation of the 2020 Omnibus Plan. The number of newly authorized shares reserved for issuance under the 2022 Equity Incentive Plan was 646,173, and the total number of shares initially reserved for issuance under the 2022 Plan (including shares remaining available under the 2020 Omnibus Plan) is 1,800,000. On January 1, 2023, the number of shares of common stock issued under the 2022 Plan, increased automatically by 6% or 713,002, based on the number of shares of common stock issued and outstanding as of December 31, 2022. Following such increase, the number of shares of common stock that may be issued under the 2022 Plan totaled 2,513,002. 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 equity incentive plans. Stock Option Grants The following tables summarize the stock option activity for the year ended December 31, 2023 : Options Weighted Weighted Weighted Average Outstanding Average Average Remaining Aggregate Number of Exercise Price Fair Value Contractual Intrinsic Shares Per Share Per Share Life (in years) Value Options outstanding as of December 31, 2022 1,879,662 $ 4.42 $ 2.94 8.85 $ — Granted 721,850 $ 4.81 $ 3.40 Exercised — $ — $ — Canceled and forfeited (27,213) $ 5.03 $ 3.66 Options outstanding as of December 31, 2023 2,574,299 $ 4.52 $ 3.06 7.70 $ — Vested as of December 31, 2023 1,516,053 $ 4.33 $ 2.77 6.93 $ — Options exercisable as of December 31, 2023 1,516,053 $ 4.33 $ 2.77 6.93 $ — The assumptions that the Company used to determine the grant-date fair value of stock options granted were as follows, presented on a weighted-average basis: Year Ended December 31, 2023 2022 Grant date fair value $ 3.40 $ 2.49 Volatility 77 % 80 % Expected term (years) 6.60 5.24 Risk-free interest rate 3.49 % 3.39 % Expected dividend yield — — Each of these inputs is subjective and generally requires significant judgment to determine. Restricted Stock Units and Performance Restricted Stock Units The following table summarizes the Company’s RSUs and PRSUs activity for the year ended December 31, 2023: Weighted Average Grant Date Fair Numbers of Shares Value per Share Outstanding as of December 31, 2022 303,050 $ 1.18 Granted 362,500 4.41 Vested (171,751) 4.10 Cancelled/forfeited — — Outstanding as of December 31, 2023 493,799 $ 2.54 The fair value of the RSUs is based on the closing price of the Company’s stock on the grant date. The fair value of the RSUs is recognized as an expense over the duration of the vesting period. The weighted average vesting period for the RSUs granted in 2023 is four years (two years for the RSU granted in 2022). In December 2021, the Compensation Committee of the Board approved 200,000 awards of performance-based restricted stock units (“PRSUs”) to an executive officer of the Company, subject to vesting on the achievement of certain services, business development and clinical development performance criteria. The grant date fair value for these PRSUs award was determined to be nil under ASC 718 based upon a determination that as of the grant date, it was not probable that the performance conditions will be achieved. The Company evaluates the performance targets in the context of its business development plan and product candidates’ development pipeline and recognized compensation expense based on the probable number of PRSUs that will ultimately vest. The potential fair value for the PRSU award, based on achieving the maximum level of performance under the award as of the grant date, was calculated to be $1.1 million, using the closing price of the Company’s common stock at grant date. In April 2023, the Compensation Committee of the Board approved 100,000 awards of performance-based restricted stock units (“PRSUs”) to an executive officer of the Company, subject to vesting on the achievement of certain services, financing and business development performance and market criteria. The grant date fair value for the PRSUs with financing and business development performance was determined based on the closing price of the Company’s common stock at grant date and for the PRSUs with market condition, through an option-pricing model (Monte Carlo Simulation). Options, RSUs and PRSUs do not have voting rights and the underlying shares are not considered issued and outstanding. The total stock-based compensation expense for stock options, RSUs and PRSUs, granted to employees and non-employees, has been reported in the Company’s consolidated statements of operations as follows: Year Ended December 31 2023 2022 Research and development 846,571 583,764 General and administrative 2,412,455 942,670 Total stock-based compensation $ 3,259,026 $ 1,526,434 As of December 31, 2023, the total unrecognized compensation cost related to non-vested stock options, RSUs and PRSUs granted was $3.48 million and is expected to be recognized over 3 years. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income taxes | |
Income taxes | 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 report a provision for income taxes due to the Spanish tax authorities pertaining to our branch Gain Therapeutics Sucursal en España. For financial reporting purposes, income/(loss) before income taxes provision includes the following components: Year Ended December 31, 2023 2022 Domestic $ (22,477,695) $ (17,341,701) Foreign 289,450 (156,061) Total $ (22,188,245) $ (17,497,762) Following is the breakdown of the components of income tax expense provision for the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 2022 Current: Federal — — State — — Foreign 79,275 92,976 Total $ 79,275 $ 92,976 Deferred: Federal — — State — — Foreign — — Total — — Total income tax expense $ 79,275 $ 92,976 The breakdown of domestic and foreign NOLs and related DTAs are reported in the following table: Year Ended December 31, 2023 2022 NOLs (domestic) $ (27,850,813) $ (22,833,222) NOLs (foreign) (10,932,386) (11,455,938) Total NOLs $ (38,783,199) $ (34,289,160) Deferred tax assets related to: Net operating loss (domestic) 7,662,929 6,283,703 Net operating loss (foreign) 2,001,169 2,140,174 Stock based compensation (domestic) 820,078 399,538 Stock based compensation (foreign) 96,173 41,093 Section 174 - Capitalized R&D 947,754 — Warrant expense 278,198 278,198 Patent expense 103,386 202,149 Other temporary differences 147,245 117,371 Total deferred tax assets $ 12,056,932 $ 9,462,226 Deferred tax liabilities Depreciation and other (15,977) (20,011) Total deferred tax liabilities $ (15,977) $ (20,011) Valuation allowance 12,040,955 9,442,215 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. According to the U.S. Tax Cuts and Jobs Act (“TCJA”) that was signed into law on December 22, 2017, federal net operating losses (“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, 2023 and 2022, 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, 2023 and 2022 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, 2023 2022 Federal income tax at US statutory rate 21.00% 21.00% State income taxes, net of federal benefit 2.41% 6.22% Permanent differences (9.48)% (0.17)% Provision to return (2.80)% (0.13)% Foreign taxes rate differential 0.04% (0.12)% Valuation allowance (11.53)% (27.33)% Effective income tax rate (0.36)% (0.53)% For the year ended December 31, 2023, permanent differences are mainly attributable to tax on global intangible low-tax income (“GILTI”) which was enacted as part of Tax Cuts and Jobs Act (the “Tax Act”) on December 22, 2017. GILTI, in general, is determined annually based on the Company’s aggregate foreign subsidiaries’ income in excess of certain qualified business asset investment return. The Company accounts for taxes on GILTI in the period that it is subject to such taxes. As of December 31, 2023 and 2022, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statement 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. |
Net loss per common share
Net loss per common share | 12 Months Ended |
Dec. 31, 2023 | |
Net loss per common share | |
Net loss per common share | 17. Net loss per common share Basic net loss per common share is computed by dividing the net loss available 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 2023 2022 Options to purchase common stock 2,411,327 1,394,676 RSUs, PRSUs 497,899 235,764 Warrants to purchase common stock 843,613 425,387 The weighted average number of warrants to purchase common stock as per the table above does not include the weighted average effect of 1,756,062 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 Statement of Operations. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2023 | |
Related Parties | |
Related Parties | 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, 2023 and 2022, 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 in expenses for $236 thousand. As of December 31, 2023 there were no receivables |
Other Information
Other Information | 12 Months Ended |
Dec. 31, 2023 | |
Other Information | |
Other Information | 19. Other Information Own Shares The Company does not hold, either directly or indirectly, its own shares and in these periods has not purchased or alienated its own shares. Commitments As of December 31, 2023 and 2022, the Company had research commitments with one year contractual maturity date for $4 million and $1.5 million, respectively. |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2023 | |
Significant events after the balance sheet date | |
Subsequent events | 20. Subsequent Events On February 19, 2024, the Company received notice of the resignation of C. Evan Ballantyne as the Company’s Chief Financial Officer, effective March 1, 2024. The Company has initiated a search to identify its next Chief Financial Officer. In the first quarter of 2024, n. 1,756,062 pre funded warrants have been exercised and converted into common stock. |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Nature of the Business and Basis of Presentation | |
Going Concern | Going concern At each reporting period, the Company evaluates whether there are conditions or events 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 organizing and staffing the Company, expanding its operations, securing financing, developing and securing its in-licensed technology, performing research and conducting preclinical studies. 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 Accounting Standard Update (“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, cash equivalents and marketable securities of $16.8 million 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 first 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 and reducing the research and development expenses and 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 first quarter of 2025, including raising additional capital through either private or public equity or debt financing, or additional program collaborations or non-dilutive funding. 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. |
Basis of Presentation | Basis of presentation The consolidated financial statements reflect the accounts of the 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 consolidated financial statements as of December 31, 2023, represented by the Consolidated Balance Sheet, the Consolidated Statement of Operations, the Consolidated Statements of Changes in Shareholders’ Equity, the Consolidated Statement of Comprehensive Loss, the Consolidated Statements of Cash Flows and the accompanying Notes, have been prepared in accordance with accounting principles generally accepted in the United States of America (“US 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 of the Financial Accounting Standards Board (“FASB”). All amounts in the consolidated financial statements are expressed in United States Dollars (USD/$) and disclosed within these explanatory notes in United States Dollars (USD/$). The consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements as of and for the year ended December 31, 2022, 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, 2023 and 2022, and the results of its operations, its statements of stockholders’ equity and its statements of cash flows for the years then ended. |
Segment information | Segment information Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company’s chief operating decision-maker, the Chief Executive Officer, oversees the Company’s operations and manages the business as a single 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, such as rare genetic diseases and neurological disorders. Geographically, the research and development activities are mainly performed in Australia, Switzerland and Spain. The Company does not consider these geographies to be separate segments. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Foreign Currency Transactions | Foreign currency translation The holding company is incorporated in the United States of America and has operations in Switzerland, Spain and Australia. The Company’s reporting currency is USD and the functional currencies of the Company’s operations are the local currencies (US Dollars 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 U.S. dollars (the currency in which these financial statements are presented) at the exchange rates applicable at the balance sheet dates and for the consolidated statement of operations at the average exchange rates for the periods presented. Items representing the share capital and additional paid-in capital are presented at the historical exchange rates. Adjustments resulting from the translation of the financial statements of the Company’s foreign operations into U.S. dollars 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, 2023 and 2022, accumulated currency translation adjustment recorded in the accumulated other comprehensive loss amounted to $408,487 and $158,576, respectively. |
Use of Estimates | Use of Estimates The preparation of our consolidated financial statements in conformity with US 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, we evaluate our estimates judgments and, assumptions including those related to the assessment of going concern, recognition of accrued expenses, defined benefit pension liability, share-based compensation, recognition of research grants. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable 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 | Cash and cash equivalents The Company reports cash on hand and held at banks, and all highly liquid investments in money market, certificates of deposit, time deposit, and other short-term liquid securities with original maturities of less than 90 day, as cash and cash equivalents. |
Marketable Securities | 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. 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 gains/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) are accounted for in the Company’s statements of operations as financial income (or expense). Marketable securities are classified in the Company’s balance sheet 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 reporting date are classified as “current assets”. Marketable securities with a maturity date over 12 months from reporting date are classified as “non-current assets”. |
Concentrations of Credit Risk | 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 has 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 | 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 issuances are consummated. After consummation of the equity issuance, 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. |
Property and Equipment | 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 financial 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 | 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. As of December 31, 2023 and 2022, internal-use software amount to $193,375 and $213,967, respectively, and refer to the external and internal labor costs incurred in the development of the Company’s enterprise resource planning system. 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 and for the years ended December 31, 2023 and 2022 was $45,507 and $37,536, respectively. The accumulated amortization as of December 31, 2023 and 2022 was $91,262 and $39,021, respectively. |
Impairment of Long-lived Assets | Impairment of long-lived assets In accordance with ASC Topic 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 | 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. |
Leases | 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. 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. 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 statement of operations. The Company determines the lease term by assuming the exercise of renewal options that are reasonably certain. |
Accounts Payable | 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 Securities Charges | Payables for Social Security Charges Social Security charges are reported in compliance with rules and laws applicable in the countries where our employees work. Charges are accrued in accordance with the policies stipulated and in connection with salaries due for the period. |
Accrued Expenses | 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 | 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 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. 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 | Stock-based Compensation and Warrants The Company issues stock-based compensation with service-based, performance-based and market-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 on the grant date using the Black-Scholes option pricing model. The Company determines the volatility and the expected term for awards granted based on an analysis of reported data for a peer group of similar biopharmaceutical companies. 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 (or RSUs) based on their fair market value, determined as the closing price on 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 market or performance -based vesting conditions (or PRSUs), the fair value at grant date is calculated using an option-pricing model (Monte Carlo Simulation) or based on management’s assessment of the likelihood of concurrence of the underlying performance, respectively. 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 | Revenue Recognition The Company derives limited revenue from its collaboration and licensing agreements. The Company recognizes revenue related to these agreements in accordance with ASC 606, “Revenues from Contracts with Customers” 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 we fulfill our 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) we satisfy 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 fulfil 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. |
Research grants | Research grants Under the terms of the research and development grants awarded, the Company is entitled to receive reimbursement of its allowable direct expenses and payroll costs. Contributions from research and development activities under the grants 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 statement of operations as a reduction to research and development expenses. |
Research and Development Expenses | 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 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 | 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 statement of operations. |
Fair value measurement | Fair value measurements 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. ● 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, we utilize 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) 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, defined benefit obligation adjustments and unrealized income/(loss) on available for sale securities. |
Net Loss per Share | 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 antidilutive. As of December 31, 2023 and 2022, 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 | Recently issued accounting pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. There were no new accounting pronouncements effective in 2023 with a material impact on the Company’s consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Schedule of depreciation rates | - Equipment & Furniture 12.5 % - Electronic office equipment: 20 % - Leasehold Improvements based on the terms of the lease - Laboratory equipment: 15 % |
Cash, cash equivalents and re_2
Cash, cash equivalents and restricted cash (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Cash, cash equivalents and restricted cash | |
Schedule of Cash, cash equivalents and restricted cash | December 31, December 31, 2023 2022 Cash 5,027,658 2,910,446 Money Market 6,767,291 4,401,165 Total cash and cash equivalents $ 11,794,949 $ 7,311,611 Restricted cash $ 34,021 $ 30,818 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Marketable Securities | |
Schedule of Marketable Securities | 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, current 5,004,679 — — (4,975) 4,999,704 Totals $ 5,004,679 $ — $ — $ (4,975) $ 4,999,704 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses and Other Current Assets | |
Schedule of Prepaid Expenses and Other Current Assets | December 31, December 31, 2023 2022 Tax Credits 242,577 103,877 Prepaid and deferred expenses 608,638 552,882 Other receivable — 87,430 Prepaid D&O Insurance 133,000 208,542 Total Prepaid expenses and other current assets $ 741,638 $ 848,854 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property and Equipment, net | |
Schedule of Property and equipment | December 31, December 31, 2023 2022 Computer $ 83,894 $ 71,774 Furniture and fixtures 62,825 57,603 Leasehold improvements 33,992 31,437 Laboratory instruments 38,048 36,894 Total property and equipment $ 218,759 $ 197,708 Less: accumulated depreciation (92,797) (53,329) Property and equipment, net $ 125,962 $ 144,379 |
Operating Lease. Right of Use (
Operating Lease. Right of Use ("ROU") Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Operating Lease; Right of Use ("ROU") Assets | |
Schedule of components of lease accounting | December 31, December 31, 2023 2022 Operating lease- right of use assets $ 459,215 $ 659,933 Operating lease liability - current $ 229,693 $ 229,080 Operating lease liability - non current $ 229,855 $ 441,784 Weighted average remaining lease term - years 2.25 3.05 Weighted average discount rate 1.51 1.53 |
Schedule of components of lease expense | Year Ended December 31 2023 2022 Research and development 141,591 134,210 General and administrative 104,574 94,529 Total operating lease costs $ 246,165 $ 228,739 |
Schedule of future minimum lease payments | Fiscal Year Operating Leases 2024 234,576 2025 174,585 2026 57,889 Total future minimum lease payments 467,050 Less amount representing interest or imputed interest 7,502 Present value of lease liabilities $ 459,548 |
Other Current Liabilities and_2
Other Current Liabilities and Deferred Income (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Other Current Liabilities and Deferred Income | |
Schedule of Other current liabilities and deferred income | December 31, December 31, 2023 2022 Payable for social security $ 368,345 $ 256,798 Accrued payroll 726,474 660,556 Accrued expenses 1,016,582 1,082,091 Tax provision 48,965 107,311 Total Other Current Liabilities $ 2,160,366 $ 2,106,756 Deferred income 1,216,924 55,180 Total Other Current Liabilities and Deferred Income $ 3,377,290 $ 2,161,936 |
Pension Obligations (Tables)
Pension Obligations (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Pension obligations | |
Schedule of Pension obligations | December 31, December 31, 2023 2022 End of year funded status: Fair value of plan assets $ 822,763 $ 675,127 (Projected benefit obligation) (1,130,217) (832,707) Funded status $ (307,454) $ (157,580) Accumulated benefit obligation 1,076,742 785,478 Reconciliation of funded status: Funded status beginning of year $ (157,580) $ (329,458) Expense (149,309) (179,924) Employer contribution 143,599 123,193 Translation differences (16,563) 1,478 Change in AOCI over the year (127,601) 227,131 Funded status at end of year $ (307,454) $ (157,580) Component of net periodic pension costs: Service cost $ 144,565 $ 169,709 Interest cost 19,264 3,376 Expected return on plan assets (11,786) (9,000) Amortization of (gain)/losses — 16,753 Amortization of prior service cost (2,734) (914) Total $ 149,309 $ 179,924 Service cost is reported in general and administrative expenses. All other components of net period costs are reported in interest income, net in the consolidated statement of operations Reconciliation of projected benefit obligation: Projected benefit obligation at January 1 $ 832,707 $ 1,272,483 Services cost 144,565 169,709 Employee contribution 96,099 83,731 Interest Cost 19,264 3,376 Benefit payments (119,897) (413,780) (Gain) / loss on financial assumptions 132,781 (242,607) (Gain) / loss on demographic assumptions 2,730 — (Gain) / loss on experience (61,208) (715) Translation differences 91,689 (25,130) Plan Amendment (8,513) (14,360) $ 1,130,217 $ 832,707 December 31, December 31, 2023 2022 Reconciliation of fair value of plan assets: Fair value at January 1 $ 675,127 $ 943,025 Expected return on plan assets 11,786 9,000 Gain/(loss) on plan assets (59,077) (46,390) Employer contributions 143,599 123,193 Employee contributions 96,099 83,731 Benefit payments (119,897) (413,780) Translation differences 75,126 (23,652) Fair value at December 31 $ 822,763 $ 675,127 December 31, December 31, 2023 2022 Change in net (gain)/loss: (Gain)/loss at beginning of year $ 49,541 $ 263,226 (Gain)/loss on PBO during the year 74,303 (243,322) (Gain)/loss on assets during the year 59,077 46,390 Amortization of gain/(loss) — (16,753) (Gain)/loss at end of year $ 182,921 $ 49,541 December 31, December 31, 2023 2022 Change in accumulated other comprehensive income (AOCI): AOCI at beginning of year $ 28,670 $ 255,801 Net gain/(loss) amortized — (16,753) (Gain)/loss on PBO during the year 74,303 (243,322) (Gain)/loss on assets during the year 59,077 46,390 Prior Service Cost/(credit) occurring over the year (8,513) (14,360) Net prior service (cost)/credit amortized 2,734 914 Total AOCI at end of year $ 156,271 $ 28,670 |
Schedule of assumptions used | December 31, December 31, 2023 2022 Financial Assumptions (%pa): Discount rate 1.40% 2.30% Interest credit rate / ERoA 1.25% 1.50% 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 65/64 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 |
Schedule of expected benefit payments | December 31, December 31, 2023 2022 Expected benefit payments: Year 1 $ 43,703 $ 38,493 Year 2 50,060 44,884 Year 3 55,679 50,459 Year 4 60,285 55,444 Year 5 64,215 59,369 Next 5 years $ 482,594 $ 450,981 Other disclosure items: Next year's expected employer contribution $ 156,395 $ 128,746 |
Loans (Tables)
Loans (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Loans | |
Schedule of future loan payments | The future loan payments are reported in the table below: December, 31 Total 2024 2025 2026 2027 2028 Thereafter Loan $ (567,850) (118,797) (95,038) (95,038) (95,038) (95,038) (68,901) |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair value measurement | |
Schedule of assets measured at fair value | 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, 2023: Assets Marketable securities available for sale: Debt securities - U.S. government treasury securities, current 4,999,704 — — Debt securities - U.S. government treasury securities, non current — — — 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 and cash equivalents: Money market funds 6,767,291 — — Total cash and cash equivalents $ 6,767,291 $ — $ — Total financial assets $ 11,766,995 $ — $ 822,763 December 31, 2022: Assets Marketable securities available for sale: Debt securities - U.S. government treasury securities, current 12,826,954 — — Debt securities - U.S. government treasury securities, non current 1,941,488 — — Total marketable securities available for sale $ 14,768,442 $ — $ — Defined Benefit Pension Plan: Pension Plan Asset — — 675,127 Total Defined Benefit Pension Plan $ — $ — $ 675,127 Cash and cash equivalents: Money market funds 4,401,165 — — Total cash and cash equivalents $ 4,401,165 $ — $ — Total financial assets $ 19,169,607 $ — $ 675,127 |
Common Stock, Preferred Stock_2
Common Stock, Preferred Stock and Warrants -Black-Scholes option pricing model using assumptions (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Common Stock, Preferred Stock and Warrants | |
Schedule of assumptions used in calculating fair market value of warrants | Year Ended December 31, 2023 Public Private Pre Funded Agent Warrants Warrants Warrants Warrants Market Price at Grant Date $ 2.16 $ 2.16 $ 2.16 $ 2.16 Volatility 70.30 % 70.30 % — % 70.30 % Expected term (years) 2.50 2.75 — 2.75 Risk-free interest rate 4.73 % 4.73 % — % 4.73 % Expected dividend yield — — — — Grant date fair value per share $ 0.83 $ 0.88 $ 0.16 $ 0.88 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity Incentive Plan | |
Summary of the Company's stock option activity | Options Weighted Weighted Weighted Average Outstanding Average Average Remaining Aggregate Number of Exercise Price Fair Value Contractual Intrinsic Shares Per Share Per Share Life (in years) Value Options outstanding as of December 31, 2022 1,879,662 $ 4.42 $ 2.94 8.85 $ — Granted 721,850 $ 4.81 $ 3.40 Exercised — $ — $ — Canceled and forfeited (27,213) $ 5.03 $ 3.66 Options outstanding as of December 31, 2023 2,574,299 $ 4.52 $ 3.06 7.70 $ — Vested as of December 31, 2023 1,516,053 $ 4.33 $ 2.77 6.93 $ — Options exercisable as of December 31, 2023 1,516,053 $ 4.33 $ 2.77 6.93 $ — |
Schedule of assumptions to determine grant-date fair value of stock options granted during the period | Year Ended December 31, 2023 2022 Grant date fair value $ 3.40 $ 2.49 Volatility 77 % 80 % Expected term (years) 6.60 5.24 Risk-free interest rate 3.49 % 3.39 % Expected dividend yield — — |
Schedule of RSUs and PRSUs awarded during the period | The following table summarizes the Company’s RSUs and PRSUs activity for the year ended December 31, 2023: Weighted Average Grant Date Fair Numbers of Shares Value per Share Outstanding as of December 31, 2022 303,050 $ 1.18 Granted 362,500 4.41 Vested (171,751) 4.10 Cancelled/forfeited — — Outstanding as of December 31, 2023 493,799 $ 2.54 |
Schedule of stock-based compensation expense recognized for stock options granted to employees and non-employees | Year Ended December 31 2023 2022 Research and development 846,571 583,764 General and administrative 2,412,455 942,670 Total stock-based compensation $ 3,259,026 $ 1,526,434 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income taxes | |
Schedule of components of loss before income taxes provision | Year Ended December 31, 2023 2022 Domestic $ (22,477,695) $ (17,341,701) Foreign 289,450 (156,061) Total $ (22,188,245) $ (17,497,762) |
Schedule of components of income tax expense | Year Ended December 31, 2023 2022 Current: Federal — — State — — Foreign 79,275 92,976 Total $ 79,275 $ 92,976 Deferred: Federal — — State — — Foreign — — Total — — Total income tax expense $ 79,275 $ 92,976 |
Schedule of net operating losses and related deferred tax assets | Year Ended December 31, 2023 2022 NOLs (domestic) $ (27,850,813) $ (22,833,222) NOLs (foreign) (10,932,386) (11,455,938) Total NOLs $ (38,783,199) $ (34,289,160) Deferred tax assets related to: Net operating loss (domestic) 7,662,929 6,283,703 Net operating loss (foreign) 2,001,169 2,140,174 Stock based compensation (domestic) 820,078 399,538 Stock based compensation (foreign) 96,173 41,093 Section 174 - Capitalized R&D 947,754 — Warrant expense 278,198 278,198 Patent expense 103,386 202,149 Other temporary differences 147,245 117,371 Total deferred tax assets $ 12,056,932 $ 9,462,226 Deferred tax liabilities Depreciation and other (15,977) (20,011) Total deferred tax liabilities $ (15,977) $ (20,011) Valuation allowance 12,040,955 9,442,215 Net deferred tax assets — — |
Schedule of effective income tax rate reconciliation | Year Ended December 31, 2023 2022 Federal income tax at US statutory rate 21.00% 21.00% State income taxes, net of federal benefit 2.41% 6.22% Permanent differences (9.48)% (0.17)% Provision to return (2.80)% (0.13)% Foreign taxes rate differential 0.04% (0.12)% Valuation allowance (11.53)% (27.33)% Effective income tax rate (0.36)% (0.53)% |
Net loss per common share (Tabl
Net loss per common share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Net loss per common share | |
Schedule of potentially dilutive common stock excluded from the computation of diluted net loss per share attributable to common stockholders | Year Ended December 31 2023 2022 Options to purchase common stock 2,411,327 1,394,676 RSUs, PRSUs 497,899 235,764 Warrants to purchase common stock 843,613 425,387 |
Nature of the Business and Ba_3
Nature of the Business and Basis of Presentation (Details) $ in Millions | 1 Months Ended | ||
Jul. 20, 2020 | Nov. 30, 2023 shares | Dec. 31, 2023 USD ($) | |
Subsidiary, Sale of Stock [Line Items] | |||
Stock split ratio | 10 | ||
Cash, cash equivalents and marketable securities | $ | $ 16.8 | ||
Public Offering | |||
Subsidiary, Sale of Stock [Line Items] | |||
Shares issued | shares | 2,545,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies | ||
Accumulated currency translation adjustments | $ 408,487 | $ 158,576 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional disclosures (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Internal-use software | $ 193,375 | $ 213,967 |
Amortization expense, capitalized software development costs | 45,507 | 37,536 |
Accumulated amortization, capitalized software development costs | 91,262 | $ 39,021 |
Impairments of long-lived assets | $ 0 | |
Dividend yield | 0% | |
Capitalized Software | ||
Property, Plant and Equipment [Line Items] | ||
Finite-Lived Intangible Asset, Useful Life | 6 years | |
Equipment & Furniture | ||
Property, Plant and Equipment [Line Items] | ||
Depreciation rates (as a percent) | 12.50% | |
Electronic office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Depreciation rates (as a percent) | 20% | |
Laboratory instruments | ||
Property, Plant and Equipment [Line Items] | ||
Depreciation rates (as a percent) | 15% |
Research Grants (Details)
Research Grants (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
May 31, 2023 | Mar. 31, 2023 | Jul. 31, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | |||||
Deferred Income | $ 1,216,924 | $ 55,180 | |||
Eurostars-2 | |||||
Disaggregation of Revenue [Line Items] | |||||
Reduction of research and development expenses through expenses reimbursed | 0 | $ 82,000 | |||
Eurostars and Innosuisse | |||||
Disaggregation of Revenue [Line Items] | |||||
Reduction of research and development expenses through expenses reimbursed | 600,000 | ||||
Amount of research grant awarded | $ 450,000 | ||||
Deferred Income | $ 1,200,000 | ||||
Innosuisse | |||||
Disaggregation of Revenue [Line Items] | |||||
Amount of research grant awarded | $ 2,800,000 | ||||
Consortium with GT Gain Therapeutics SA, Institute for Research in Biomedicine and Neuro-Sys SAS | Eurostars-2 | |||||
Disaggregation of Revenue [Line Items] | |||||
Term of research grant | 3 years | ||||
Consortium with GT Gain Therapeutics SA, Institute for Research in Biomedicine, Newcells Biotech and the University of Helsinki | Eurostars and Innosuisse | |||||
Disaggregation of Revenue [Line Items] | |||||
Amount of research grant awarded | $ 1,300,000 |
Cash, cash equivalents and re_3
Cash, cash equivalents and restricted cash (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | $ 11,794,949 | $ 7,311,611 |
Restricted cash | 34,021 | 30,818 |
Cash | ||
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | 5,027,658 | 2,910,446 |
Money market | ||
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | $ 6,767,291 | $ 4,401,165 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Marketable Securities [Line Items] | ||
Marketable securities - current | $ 4,999,704 | $ 12,826,954 |
U.S. government treasury securities | ||
Marketable Securities [Line Items] | ||
Marketable securities - current | 5,000,000 | |
Debt Instrument, Periodic Payment | $ 1,000,000 |
Marketable Securities - Marketa
Marketable Securities - Marketable securities available for sale (Details) | Dec. 31, 2023 USD ($) |
Marketable Securities [Line Items] | |
Amortized Cost | $ 5,004,679 |
Gross Unrealized Losses | (4,975) |
Estimated Fair Value | 4,999,704 |
U.S. government treasury securities | |
Marketable Securities [Line Items] | |
Amortized Cost | 5,004,679 |
Gross Unrealized Losses | (4,975) |
Estimated Fair Value | $ 4,999,704 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses and Other Current Assets | ||
Tax credits | $ 242,577 | $ 103,877 |
Prepaid and deferred expenses | 608,638 | 552,882 |
Other receivables | 87,430 | |
Prepaid D&O insurance costs | 133,000 | 208,542 |
Total prepaid expenses and other current assets | $ 741,638 | $ 848,854 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property and Equipment, net | ||
Total property and equipment | $ 218,759 | $ 197,708 |
Less: accumulated depreciation | (92,797) | (53,329) |
Property and equipment, net | 125,962 | 144,379 |
Disposals | 0 | 0 |
Depreciation | 34,875 | 26,632 |
Computer | ||
Property and Equipment, net | ||
Total property and equipment | 83,894 | 71,774 |
Furniture and fixtures | ||
Property and Equipment, net | ||
Total property and equipment | 62,825 | 57,603 |
Leasehold improvements | ||
Property and Equipment, net | ||
Total property and equipment | 33,992 | 31,437 |
Laboratory instruments | ||
Property and Equipment, net | ||
Total property and equipment | $ 38,048 | $ 36,894 |
Operating Lease. Right of Use_2
Operating Lease. Right of Use ("ROU") Assets - Additional information (Details) | Dec. 31, 2023 |
Minimum | |
Lessee, Lease, Description [Line Items] | |
Operating lease remaining term | 1 year |
Maximum | |
Lessee, Lease, Description [Line Items] | |
Operating lease remaining term | 3 years |
Operating Lease. Right of Use_3
Operating Lease. Right of Use ("ROU") Assets - Summary of components of lease accounting (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Operating Lease; Right of Use ("ROU") Assets | ||
Operating lease- right of use assets | $ 459,215 | $ 659,933 |
Operating lease liability - current | 229,693 | 229,080 |
Operating lease liability - non-current | $ 229,855 | $ 441,784 |
Weighted average remaining lease term - years | 2 years 3 months | 3 years 18 days |
Weighted average discount rate | 1.51% | 1.53% |
Operating Lease. Right of Use_4
Operating Lease. Right of Use ("ROU") 1Assets - Summary of components of lease expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease costs | $ 246,165 | $ 228,739 |
Research and development | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease costs | 141,591 | 134,210 |
General and administrative | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease costs | $ 104,574 | $ 94,529 |
Operating Lease. Right of Use_5
Operating Lease. Right of Use ("ROU") Assets - Future minimum lease payments (Details) | Dec. 31, 2023 USD ($) |
Operating Lease; Right of Use ("ROU") Assets | |
2024 | $ 234,576 |
2025 | 174,585 |
2026 | 57,889 |
Total future minimum lease payments | 467,050 |
Less amount representing interest or imputed interest | 7,502 |
Present value of lease liabilities | $ 459,548 |
Accounts Payable (Details)
Accounts Payable (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Accounts Payable | ||
Accounts Payable | $ 1,318,965 | $ 1,626,100 |
Other Current Liabilities and_3
Other Current Liabilities and Deferred Income (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Other Current Liabilities and Deferred Income | ||
Payable for social security payments | $ 368,345 | $ 256,798 |
Accrued payroll | 726,474 | 660,556 |
Accrued expenses | 1,016,582 | 1,082,091 |
Tax provision | 48,965 | 107,311 |
Total Other Current Liabilities | 2,160,366 | 2,106,756 |
Deferred Income | 1,216,924 | 55,180 |
Total Other Current Liabilities and Deferred Income | $ 3,377,290 | $ 2,161,936 |
Pension obligations - End of ye
Pension obligations - End of year funded status (Details) - Pension Plan - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Defined Benefit Plan Disclosure [Line Items] | |||
Fair value of plan assets | $ 822,763 | $ 675,127 | $ 943,025 |
(Projected benefit obligation) | (1,130,217) | (832,707) | (1,272,483) |
Funded status | (307,454) | (157,580) | $ (329,458) |
SWITZERLAND | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Accumulated benefit obligation | $ 1,076,742 | $ 785,478 |
Pension Obligations - Reconcili
Pension Obligations - Reconciliation of funded status (Details) - Pension Plan - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Reconciliation of funded status | ||
Funded status beginning of period | $ (157,580) | $ (329,458) |
Expense | (149,309) | (179,924) |
Employer contribution | 143,599 | 123,193 |
Translation differences | 16,563 | (1,478) |
Translation differences | 75,126 | (23,652) |
Change in AOCI over the year | (127,601) | 227,131 |
Funded status at end of period | $ (307,454) | $ (157,580) |
Pension Obligations - Component
Pension Obligations - Component of net periodic pension costs (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Defined Benefit Plan, Net Periodic Benefit Cost (Credit), Interest Cost, Statement of Income or Comprehensive Income [Extensible Enumeration] | Interest Income (Expense), Net | |
Defined Benefit Plan, Net Periodic Benefit (Cost) Credit, Expected Return (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Interest Income (Expense), Net | |
Defined Benefit Plan, Net Periodic Benefit (Cost) Credit, Amortization of Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Interest Income (Expense), Net | |
Defined Benefit Plan, Net Periodic Benefit Cost (Credit), Amortization of Prior Service Cost (Credit), Statement of Income or Comprehensive Income [Extensible Enumeration] | Interest Income (Expense), Net | |
Pension Plan | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Services cost | $ 144,565 | $ 169,709 |
Interest cost | 19,264 | 3,376 |
Expected return on plan assets | (11,786) | (9,000) |
Amortization of (gain)/losses | 16,753 | |
Amortization of prior service cost | (2,734) | (914) |
Total | $ 149,309 | $ 179,924 |
Pension obligations - Reconci_2
Pension obligations - Reconciliation of projected benefit obligation (Details) - Pension Plan - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Projected benefit obligation at January 1 | $ 832,707 | $ 1,272,483 |
Services cost | 144,565 | 169,709 |
Employee contribution | 96,099 | 83,731 |
Interest Cost | 19,264 | 3,376 |
Benefit payments | (119,897) | (413,780) |
(Gain) / loss on financial assumptions | 132,781 | (242,607) |
(Gain) / loss on demographic assumptions | 2,730 | |
(Gain)/loss on experience | (61,208) | (715) |
Translation differences | 91,689 | (25,130) |
Plan Amendment | (8,513) | (14,360) |
Projected benefit obligation at December 31 | $ 1,130,217 | $ 832,707 |
Pension obligations - Reconci_3
Pension obligations - Reconciliation of fair value of plan assets (Details) - Pension Plan - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Fair value at January 1 | $ 675,127 | $ 943,025 |
Expected return on plan assets | 11,786 | 9,000 |
Gain/(loss) on plan assets | (59,077) | (46,390) |
Employer contributions | 143,599 | 123,193 |
Employee contributions | 96,099 | 83,731 |
Benefit payments | 119,897 | 413,780 |
Translation differences | (75,126) | 23,652 |
Fair value at December 31 | $ 822,763 | $ 675,127 |
Pension obligations - Change in
Pension obligations - Change in net (gain)/loss (Details) - Pension Plan - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||
(Gain)/loss at beginning of year | $ (49,541) | $ (263,226) |
(Gain)/loss on PBO during the year | 74,303 | (243,322) |
(Gain)/loss on assets during the year | 59,077 | 46,390 |
Amortization of (gain)/losses | (16,753) | |
(Gain)/loss at end of year | $ (182,921) | $ (49,541) |
Pension obligations - Change _2
Pension obligations - Change in accumulated other comprehensive income (AOCI) (Details) - Pension Plan - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||
AOCI at beginning of year | $ 28,670 | $ 255,801 |
Net gain/(loss) amortized | (16,753) | |
(Gain)/loss on PBO during the year | 74,303 | (243,322) |
(Gain)/loss on assets during the year | 59,077 | 46,390 |
Prior Service Cost/(credit) occurring over the year | (8,513) | (14,360) |
Net prior service (cost)/credit amortized | 2,734 | 914 |
Total AOCI at end of year | $ 156,271 | $ 28,670 |
Pension obligations - Assumptio
Pension obligations - Assumptions (Details) - Pension Plan - age | Dec. 31, 2023 | Dec. 31, 2022 |
Financial and Demographic Assumptions | ||
Discount rate | 1.40% | 2.30% |
Interest credit rate / ERoA | 1.25% | 1.50% |
Salary increases | 2.50% | 2.50% |
Pension increases | 0% | 0% |
Inflation | 1.50% | 1.50% |
Lump-sum option | 25% | 25% |
Allowance for child pensions | 5% | 5% |
Longevity improvement | (1.25%) | |
Disability | 80% | 80% |
Maximum | ||
Financial and Demographic Assumptions | ||
Retirement age | 65 | 65 |
Minimum | ||
Financial and Demographic Assumptions | ||
Retirement age | 64 | 64 |
Pension obligations - Expected
Pension obligations - Expected benefit payments (Details) - Pension Plan - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Defined Benefit Plan Disclosure [Line Items] | ||
Year 1 | $ 43,703 | $ 38,493 |
Year 2 | 50,060 | 44,884 |
Year 3 | 55,679 | 50,459 |
Year 4 | 60,285 | 55,444 |
Year 5 | 64,215 | 59,369 |
Next 5 years | 482,594 | 450,981 |
Next year's expected employer contribution | $ 156,395 | $ 128,746 |
Pension obligations - Additiona
Pension obligations - Additional Information (Details) | 12 Months Ended | |||
Dec. 31, 2023 USD ($) | Dec. 31, 2023 GBP (£) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 GBP (£) | |
Defined Benefit Plan Disclosure [Line Items] | ||||
Expenses related to savings plan | $ | $ 19,938 | $ 15,875 | ||
Foreign Plan | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Expenses related to savings plan | £ | £ 16,753 | £ 5,165 |
Loans (Details)
Loans (Details) - August 2020 CHF loan | 1 Months Ended | |||
Aug. 31, 2020 CHF (SFr) | Dec. 31, 2023 CHF (SFr) | Aug. 31, 2020 USD ($) | Aug. 31, 2020 CHF (SFr) | |
Debt Instrument [Line Items] | ||||
Loan amount | $ 700,221 | SFr 638,000 | ||
Term of loan | 9 years | |||
Interest rate (as a percent) | 0% | 0% | ||
Quarterly installments | SFr 20,000 | |||
Deferred issuance costs | SFr 0 |
Loans - Future loan payments (D
Loans - Future loan payments (Details) | Dec. 31, 2023 USD ($) |
Loans | |
Total | $ 567,850 |
2024 | 118,797 |
2025 | 95,038 |
2026 | 95,038 |
2027 | 95,038 |
2028 | 95,038 |
Thereafter | $ 68,901 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Level 1 | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | $ 11,766,995 | $ 19,169,607 |
Level 1 | Total cash equivalents | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 6,767,291 | 4,401,165 |
Level 1 | Money market funds | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 6,767,291 | 4,401,165 |
Level 1 | Marketable securities available for sale | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 4,999,704 | 14,768,442 |
Level 1 | U.S. government treasury securities, current | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 4,999,704 | 12,826,954 |
Level 1 | U.S. government treasury securities, non current | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 1,941,488 | |
Level 3 | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 822,763 | 675,127 |
Level 3 | Total Defined Benefit Pension Plan | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 822,763 | 675,127 |
Level 3 | Pension Plan Asset | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | $ 822,763 | $ 675,127 |
Common Stock, Preferred Stock_3
Common Stock, Preferred Stock and Warrants (Details) - USD ($) | 2 Months Ended | 12 Months Ended | ||||
Dec. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | May 31, 2022 | May 06, 2021 | Mar. 31, 2021 | |
Class of Stock [Line Items] | ||||||
Authorized capital, Common stock (in shares) | 50,000,000 | 50,000,000 | 50,000,000 | |||
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Authorized capital, Preferred stock (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Common stock issued (in shares) | 16,206,680 | 16,206,680 | 11,883,368 | |||
Common stock outstanding (in shares) | 16,206,680 | 16,206,680 | 11,883,368 | |||
Warrants and Rights, Exercised or Exchanged, Number | 0 | 0 | ||||
Payments of deferred offering costs | $ 900,000 | |||||
Warrants to designees of the placement agent, issued July 2020 | ||||||
Class of Stock [Line Items] | ||||||
Warrants outstanding | 225,387 | 225,387 | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 237,249 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 5.07 | |||||
Warrants and Rights Outstanding | $ 413,887 | |||||
Warrants and Rights Outstanding, Term | 5 years | |||||
Warrants to designees of investment bank, issued May 2021 | ||||||
Class of Stock [Line Items] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 200,000 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 13.75 | |||||
Warrants and Rights Outstanding | $ 1,000,000 | |||||
Warrants and Rights Outstanding, Term | 4 years | |||||
Warrants and Rights, Exercised or Exchanged, Number | 0 | 0 | ||||
At the Market Offering, May 2022 [Member] | ||||||
Class of Stock [Line Items] | ||||||
Shares issued price per share | $ 4.60 | $ 4.60 | ||||
Shares issued | 862,535 | |||||
Proceeds | $ 3,900,000 | |||||
Payments of deferred offering costs | $ 400,000 | |||||
At the Market Offering, May 2022 [Member] | Maximum | ||||||
Class of Stock [Line Items] | ||||||
Aggregate offering price in at the market offering | $ 16,000,000 |
Common Stock, Preferred Stock_4
Common Stock, Preferred Stock and Warrants - Public Offering and private Placement (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 2 Months Ended |
Nov. 30, 2023 USD ($) item $ / shares shares | Dec. 31, 2023 USD ($) shares | |
Class of Stock [Line Items] | ||
Proceeds from Issuance or Sale of Equity | $ | $ 10.1 | |
Stock issuance costs | $ | $ 1.2 | |
Payments of deferred offering costs | $ | $ 0.9 | |
Warrants exercised or exchanged | shares | 0 | |
Public Offering | ||
Class of Stock [Line Items] | ||
Shares issued | shares | 2,545,000 | |
Offering price per unit | $ / shares | $ 4.01 | |
Effective price per share | $ / shares | $ 2 | |
Public Offering | Public Warrants | ||
Class of Stock [Line Items] | ||
Warrants to purchase common stock | shares | 1,272,500 | |
Number of shares to purchase to receive entitlement to one warrant | item | 2 | |
Effective price per warrant | $ / shares | $ 0.01 | |
Warrants exercise price | $ / shares | $ 2.75 | |
Warrants term | 5 years | |
Number of warrants for each share of common stock purchased | item | 0.5 | |
Private Placement | ||
Class of Stock [Line Items] | ||
Offering price per unit | $ / shares | $ 2 | |
Private Placement | Accredited Investors | ||
Class of Stock [Line Items] | ||
Shares issued | shares | 744,026 | |
Private Placement | Pre Funded Warrants | ||
Class of Stock [Line Items] | ||
Number of warrants issued | shares | 1,756,062 | |
Warrants exercise price | $ / shares | $ 0.0001 | |
Warrants term | 5 years | |
Private Placement | Private Warrants | ||
Class of Stock [Line Items] | ||
Warrants to purchase common stock | shares | 2,500,088 | |
Warrants exercise price | $ / shares | $ 2.75 | |
Number of shares callable per warrant | shares | 1 | |
Private Placement | Placement Agent Warrants | ||
Class of Stock [Line Items] | ||
Number of warrants issued | shares | 175,006 | |
Warrants exercise price | $ / shares | $ 2.75 | |
Underwriters' option | Public Warrants | ||
Class of Stock [Line Items] | ||
Number of warrants issued | shares | 178,150 | |
Warrants exercise price | $ / shares | $ 2.75 |
Common Stock, Preferred Stock_5
Common Stock, Preferred Stock and Warrants - Assumptions under Black-Scholes option pricing model (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) Y $ / shares shares | |
Class of Warrant or Right [Line Items] | |
Warrants exercised or exchanged | shares | 0 |
Public Offering and Private Placement | |
Class of Warrant or Right [Line Items] | |
Shares issued during the period, value | $ | $ 6,250,000 |
Public Warrants | |
Class of Warrant or Right [Line Items] | |
Market Price at Grant Date | $ / shares | $ 2.16 |
Grant date fair value per share | $ / shares | $ 0.83 |
Warrants issued during the period, value | $ | $ 820,000 |
Public Warrants | Volatility | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | $ | 0.7030 |
Public Warrants | Expected term | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | Y | 2.50 |
Public Warrants | Risk-free interest rate | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | 0.0473 |
Private Warrants | |
Class of Warrant or Right [Line Items] | |
Market Price at Grant Date | $ / shares | $ 2.16 |
Grant date fair value per share | $ / shares | $ 0.88 |
Warrants issued during the period, value | $ | $ 2,690,000 |
Private Warrants | Volatility | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | $ | 0.7030 |
Private Warrants | Expected term | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | Y | 2.75 |
Private Warrants | Risk-free interest rate | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | 0.0473 |
Pre Funded Warrants | |
Class of Warrant or Right [Line Items] | |
Market Price at Grant Date | $ / shares | $ 2.16 |
Grant date fair value per share | $ / shares | $ 0.16 |
Warrants issued during the period, value | $ | $ 340,000 |
Placement Agent Warrants | |
Class of Warrant or Right [Line Items] | |
Market Price at Grant Date | $ / shares | $ 2.16 |
Grant date fair value per share | $ / shares | $ 0.88 |
Warrants issued during the period, value | $ | $ 300,000 |
Placement Agent Warrants | Volatility | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | $ | 0.7030 |
Placement Agent Warrants | Expected term | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | Y | 2.75 |
Placement Agent Warrants | Risk-free interest rate | |
Class of Warrant or Right [Line Items] | |
Warrants, measurement input | 0.0473 |
Equity Incentive Plans (Details
Equity Incentive Plans (Details) - shares | Jan. 01, 2023 | May 12, 2022 | Dec. 23, 2021 | Sep. 24, 2020 |
2021 Inducement Equity Incentive Plan | ||||
Equity Incentive Plan | ||||
Maximum number of shares reserved for issuance | 1,000,000 | |||
Equity Incentive Plan 2022 | ||||
Equity Incentive Plan | ||||
Maximum number of shares reserved for issuance | 2,513,002 | 1,800,000 | ||
Additional number of shares reserved for issuance | 713,002 | 646,173 | ||
Annual increase in shares authorized for issue under plan, as percentage of common stock issued and outstanding at beginning of year | 6% | |||
Number of shares issuable more than ten years after original plan was authorized | 0 | |||
2020 Omnibus Plan | ||||
Equity Incentive Plan | ||||
Maximum number of shares reserved for issuance | 1,153,827 |
Equity Incentive Plans - Stock
Equity Incentive Plans - Stock Option Grants (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Shares | ||
Outstanding as at beginning of period (in shares) | 1,879,662 | |
Options granted (in shares) | 721,850 | |
Options cancelled/forfeited (in shares) | (27,213) | |
Options outstanding as at end of period (in shares) | 2,574,299 | 1,879,662 |
Vested and expected to vest as at the end of period (in shares) | 1,516,053 | |
Options exercisable as at end of period (in shares) | 1,516,053 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price Per Share, Outstanding as at beginning of period | $ 4.42 | |
Weighted Average Exercise Price Per Share, Options granted | 4.81 | |
Weighted Average Exercise Price Per Share, Options cancelled/forfeited | 5.03 | |
Weighted Average Exercise Price Per Share, Options outstanding as at end of period | 4.52 | $ 4.42 |
Weighted Average Exercise Price Per Share, vested and expected to vest at end of period | 4.33 | |
Weighted Average Exercise Price Per Share, options exercisable at end of period | 4.33 | |
Weighted Average Grant Date Fair Value | ||
Weighted Average Fair Value Per Share, options outstanding at beginning of period | 2.94 | |
Weighted Average Fair Value Per Share, options granted | 3.40 | 2.49 |
Weighted Average Fair Value Per Share, options cancelled/forfeited | 3.66 | |
Weighted Average Fair Value Per Share, options outstanding at end of period | 3.06 | $ 2.94 |
Weighted Average Fair Value Per Share, vested and expected to vest as at end of period | 2.77 | |
Weighted Average Fair Value Per Share, options exercisable as at end of period | $ 2.77 | |
Additional disclosures | ||
Weighted Average Remaining Contractual Years Outstanding | 7 years 8 months 12 days | 8 years 10 months 6 days |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 6 years 11 months 4 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 11 months 4 days | |
Aggregate Intrinsic Value | $ 0 |
Equity Incentive Plans - Assump
Equity Incentive Plans - Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity Incentive Plan | ||
Grant date fair value | $ 3.40 | $ 2.49 |
Volatility | 77% | 80% |
Expected term (years) | 6 years 7 months 6 days | 5 years 2 months 26 days |
Risk-free interest rate | 3.49% | 3.39% |
Expected dividend yield | 0% |
Equity Incentive Plans - Restri
Equity Incentive Plans - Restricted Stock Units and Performance Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2023 | Dec. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
RSUs and PRSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Awards granted | 362,500 | |||
Grant date fair value | $ 4.41 | |||
Vesting period | 4 years | 2 years | ||
Performance-Based Restricted Stock Units | Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Awards granted | 100,000 | 200,000 | ||
Grant date fair value | $ 0 | |||
Performance-Based Restricted Stock Units | Maximum | Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Potential fair value of awards based on performance | $ 1.1 |
Equity Incentive Plans - RSUs a
Equity Incentive Plans - RSUs activity (Details) - RSUs and PRSUs | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Beginning balance | shares | 303,050 |
RSUs granted | shares | 362,500 |
RSUs vested | shares | 171,751 |
Ending balance | shares | 493,799 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Beginning balance, Weighted Average Grant Date Fair Value | $ / shares | $ 1.18 |
RSUs granted, Weighted Average Grant Date Fair Value | $ / shares | 4.41 |
RSUs vested, Weighted Average Grant Date Fair Value | $ / shares | 4.10 |
Ending balance, Weighted Average Grant Date Fair Value | $ / shares | $ 2.54 |
Equity Incentive Plans - Stock-
Equity Incentive Plans - Stock-based compensation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity Incentive Plan | ||
Total stock-based compensation | $ 3,259,026 | $ 1,526,434 |
Unrecognized compensation cost related to non-vested stock options and RSUs | $ 3,480,000 | |
Unrecognized compensation cost, recognition period | 3 years | |
Research and development | ||
Equity Incentive Plan | ||
Total stock-based compensation | $ 846,571 | 583,764 |
General and administrative | ||
Equity Incentive Plan | ||
Total stock-based compensation | $ 2,412,455 | $ 942,670 |
Income taxes - Domestic and for
Income taxes - Domestic and foreign net operating losses (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Components of loss before income taxes provision | ||
Domestic | $ (22,477,695) | $ (17,341,701) |
Foreign | 289,450 | (156,061) |
Loss before income tax | $ (22,188,245) | $ (17,497,762) |
Income taxes - Components of in
Income taxes - Components of income tax expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Current: | ||
Foreign | $ 79,275 | $ 92,976 |
Total | 79,275 | 92,976 |
Deferred: | ||
Total income tax expense | $ 79,275 | $ 92,976 |
Income taxes - Domestic and f_2
Income taxes - Domestic and foreign NOLs and related DTAs (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Income taxes | ||
Total NOLs | $ (38,783,199) | $ (34,289,160) |
Deferred tax assets related to: | ||
Net operating loss (domestic) | 7,662,929 | 6,283,703 |
Net operating loss (foreign) | 2,001,169 | 2,140,174 |
Stock based compensation (domestic) | 820,078 | 399,538 |
Stock based compensation (foreign) | 96,173 | 41,093 |
Section 174 - Capitalized R&D | 947,754 | |
Warrant expense | 278,198 | 278,198 |
Patent expense | 103,386 | 202,149 |
Other temporary differences | 147,245 | 117,371 |
Total deferred tax assets | 12,056,932 | 9,462,226 |
Deferred tax liabilities | ||
Depreciation and other | (15,977) | (20,011) |
Total deferred tax liabilities | (15,977) | (20,011) |
Valuation allowance | 12,040,955 | 9,442,215 |
Domestic | ||
Income taxes | ||
Total NOLs | (27,850,813) | (22,833,222) |
Foreign | ||
Income taxes | ||
Total NOLs | $ (10,932,386) | $ (11,455,938) |
Income taxes - Additional discl
Income taxes - Additional disclosures (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income taxes | ||
Effective tax rate | (0.36%) | (0.53%) |
Accrued interest or penalties | $ 0 | $ 0 |
Interest or penalties related to uncertain tax positions recognized in the Company's statement of operations | $ 0 | $ 0 |
Income taxes - Federal income t
Income taxes - Federal income tax rate reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income tax rate reconciliation | ||
Federal income tax at US statutory rate | 21% | 21% |
State income taxes, net of federal benefit | 2.41% | 6.22% |
Permanent differences | (9.48%) | (0.17%) |
Provision to return | (2.80%) | (0.13%) |
Foreign taxes rate differential | 0.04% | (0.12%) |
Valuation allowance | (11.53%) | (27.33%) |
Effective income tax rate | (0.36%) | (0.53%) |
Net loss per common share - Com
Net loss per common share - Computation of diluted net loss per share (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pre Funded Warrants | ||
Net loss per common share | ||
Warrants outstanding | 1,756,062 | |
Pre Funded Warrants | Maximum | ||
Net loss per common share | ||
Warrants exercise price | $ 0.0001 | |
Employee Stock Option [Member] | ||
Net loss per common share | ||
Antidilutive securities excluded from computation of diluted net loss per share attributable to common stockholders (in shares) | 2,411,327 | 1,394,676 |
RSUs and PRSUs | ||
Net loss per common share | ||
Antidilutive securities excluded from computation of diluted net loss per share attributable to common stockholders (in shares) | 497,899 | 235,764 |
Warrants to purchase common stock | ||
Net loss per common share | ||
Antidilutive securities excluded from computation of diluted net loss per share attributable to common stockholders (in shares) | 843,613 | 425,387 |
Related Parties (Details)
Related Parties (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | |
Related Parties | |||
Revenues | $ 55,180 | $ 140,108 | |
License agreement Minoryx Therapeutics SL | Related Party | Minoryx Therapeutics SL | |||
Related Parties | |||
Receivables | 0 | 0 | |
Payables | 0 | 0 | |
Revenues | 0 | 0 | |
Expenses | 0 | $ 0 | |
Consulting agreement | Board member | Mr. Eric Richman | |||
Related Parties | |||
Expenses | 236,000 | ||
Consulting agreement | Board member | Board member | Mr. Eric Richman | |||
Related Parties | |||
Receivables | 0 | ||
Payables | $ 0 | ||
Maximum | License agreement Minoryx Therapeutics SL | Related Party | Minoryx Therapeutics SL | |||
Related Parties | |||
Percentage of net revenue based on one composition matter | 8% | ||
Percentage of net revenue based on one method of claim | 3% |
Other Information (Details)
Other Information (Details) - USD ($) $ in Millions | Dec. 31, 2023 | Dec. 31, 2022 |
Research Agreements | ||
Commitments | ||
Commitments | $ 4 | $ 1.5 |
Subsequent Events (Details)
Subsequent Events (Details) | 3 Months Ended |
Mar. 26, 2024 shares | |
Pre Funded Warrants | Subsequent event | |
Subsequent Event [Line Items] | |
Number of warrants exercised during period | 1,756,062 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (22,267,520) | $ (17,590,738) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |