Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 30, 2023 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
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 $0.0001 per share | |
Trading Symbol | GANX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 12,328,846 | |
Entity Central Index Key | 0001819411 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 5,988,202 | $ 7,311,611 |
Marketable securities - current | 11,827,528 | 12,826,954 |
Tax credits | 137,383 | 103,877 |
Prepaid expenses and other current assets | 1,368,871 | 848,854 |
Total current assets | 19,321,984 | 21,091,296 |
Non-current assets: | ||
Marketable securities - non current | 988,388 | 1,941,488 |
Property and equipment, net | 144,636 | 144,379 |
Internal-use software | 208,913 | 213,967 |
Operating lease - right of use assets | 609,877 | 659,933 |
Restricted cash | 31,122 | 30,818 |
Long-term deposits and other non-current assets | 17,655 | 17,506 |
Total non-current assets | 2,000,591 | 3,008,091 |
Total assets | 21,322,575 | 24,099,387 |
Current liabilities: | ||
Accounts payable | 2,213,489 | 1,626,100 |
Operating lease liability - current | 232,507 | 229,080 |
Other current liabilities | 2,599,763 | 2,106,756 |
Deferred income | 55,180 | |
Loans - current | 109,200 | 108,135 |
Total current liabilities | 5,154,959 | 4,125,251 |
Non-current liabilities: | ||
Defined benefit pension plan | 164,568 | 157,580 |
Operating lease liability - non-current | 385,922 | 441,784 |
Loans - non-current | 478,296 | 495,258 |
Total non-current liabilities | 1,028,786 | 1,094,622 |
Total liabilities | 6,183,745 | 5,219,873 |
Stockholders' equity | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; nil shares issued and outstanding as of March 31, 2023 and December 31, 2022. | 0 | 0 |
Common stock, $0.0001 par value: 50,000,000 shares authorized; 12,087,142 issued and outstanding as of March 31, 2023; 11,883,368 issued and outstanding as of December 31, 2022. | 1,209 | 1,189 |
Additional paid-in capital | 58,694,827 | 57,358,895 |
Accumulated other comprehensive income | 96,310 | 35,627 |
Accumulated deficit | (38,516,197) | (20,925,459) |
Loss for the period | (5,137,319) | (17,590,738) |
Total stockholders' equity | 15,138,830 | 18,879,514 |
Total liabilities and stockholders' equity | $ 21,322,575 | $ 24,099,387 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
CONDENSED 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 | 12,087,142 | 11,883,368 |
Common stock, shares, outstanding | 12,087,142 | 11,883,368 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues: | ||
Collaboration revenues | $ 55,180 | $ 37,538 |
Other income | 7,468 | |
Total revenues | 55,180 | 45,006 |
Operating expenses: | ||
Research and development | (2,791,205) | (1,556,440) |
General and administrative | (2,493,759) | (1,777,043) |
Total operating expenses | (5,284,964) | (3,333,483) |
Loss from operations | (5,229,784) | (3,288,477) |
Other income (expense): | ||
Interest income/(expense), net | 152,035 | (1,651) |
Foreign exchange gain/(loss), net | (42,842) | 19,162 |
Loss before income tax | (5,120,591) | (3,270,966) |
Income tax | (16,728) | (1,677) |
Net loss | $ (5,137,319) | $ (3,272,643) |
Net loss per shares: | ||
Net loss per share attributable to common stockholders - Basic | $ (0.43) | $ (0.28) |
Net loss per share attributable to common stockholders - Diluted | $ (0.43) | $ (0.28) |
Weighted average common stock - Basic | 11,935,081 | 11,883,368 |
Weighted average common stock - Diluted | 11,935,081 | 11,883,368 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (5,137,319) | $ (3,272,643) |
Other comprehensive gain/(loss): | ||
Unrealized gain on available-for-sale securities | 43,262 | |
Defined benefit pension plan | (670) | 4,149 |
Foreign currency translation | 18,091 | (27,806) |
Other comprehensive income/(loss) | 60,683 | (23,657) |
Comprehensive loss | $ (5,076,636) | $ (3,296,300) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock Common Stock | APIC | AOCI | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 1,189 | $ 55,832,461 | $ (90,645) | $ (20,925,459) | $ 34,817,546 |
Balance (in shares) at Dec. 31, 2021 | 11,883,368 | ||||
Stock-based compensation | 306,545 | 306,545 | |||
Defined benefit pension plan | 4,149 | 4,149 | |||
Foreign currency translation | (27,806) | (27,806) | |||
Net loss | (3,272,643) | (3,272,643) | |||
Balance at Mar. 31, 2022 | $ 1,189 | 56,139,006 | (114,302) | (24,198,102) | 31,827,791 |
Balance (in shares) at Mar. 31, 2022 | 11,883,368 | ||||
Balance at Dec. 31, 2022 | $ 1,189 | 57,358,895 | 35,627 | (38,516,197) | 18,879,514 |
Balance (in shares) at Dec. 31, 2022 | 11,883,368 | ||||
Stock-based compensation | 565,432 | 565,432 | |||
Issuance of shares in at-the-market (ATM) offering (Shares) | 203,774 | ||||
Issuance of shares in at-the-market (ATM) offering | $ 20 | 770,500 | 770,520 | ||
Defined benefit pension plan | (670) | (670) | |||
Foreign currency translation | 18,091 | 18,091 | |||
Net unrealized gain on available for sale securities | 43,262 | 43,262 | |||
Net loss | (5,137,319) | (5,137,319) | |||
Balance at Mar. 31, 2023 | $ 1,209 | $ 58,694,827 | $ 96,310 | $ (43,653,516) | $ 15,138,830 |
Balance (in shares) at Mar. 31, 2023 | 12,087,142 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities: | ||
Net loss | $ (5,137,319) | $ (3,272,643) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 19,242 | 8,209 |
Stock-based compensation expense | 565,432 | 306,545 |
Other non cash items | (122,237) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other currents assets | (547,299) | (1,215,638) |
Other non-current assets | (2,336) | |
Accounts payable and other liabilities | 1,057,567 | 1,743,143 |
Defined benefit pension plan | 4,715 | 46,302 |
Deferred income | (55,180) | (63,309) |
Total changes in operating assets and liabilities | 457,467 | 510,498 |
Cash used in operating activities | (4,217,415) | (2,447,391) |
Cash flows from investing activities: | ||
Purchase of property and equipment and internal use of software | (11,045) | (7,825) |
Purchases of marketable securities | (1,956,350) | |
Maturity of marketable securities | 4,074,375 | |
Cash provided by/(used in) investing activities | 2,106,980 | (7,825) |
Cash flows from financing activities: | ||
Net proceeds from issuance of shares in at-the-market (ATM) offering (Note 13) | 770,520 | |
Payments of current portion of long-term debt | (21,612) | (37,974) |
Cash provided by/(used in) financing activities | 748,908 | (37,974) |
Effect of exchange rate changes | 38,422 | (49,317) |
Net (decrease)/increase in cash, cash equivalents and restricted cash | (1,323,105) | (2,542,507) |
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 | $ 6,019,324 | $ 34,369,445 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 3 Months Ended |
Mar. 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. (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, resulting in GT Gain Therapeutics SA becoming 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”). In conjunction with the IPO the Company completed a reverse stock split of the Company’s outstanding equity instruments. The reverse stock split was approved by the stockholders on March 4, 2021 and became effective on March 17, 2021. Upon closing of the IPO, the Series A and the Series B Preferred Stock, as resulting from the reverse stock split, were converted to common stock at a ratio of 1-for-1. 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 exclusively in-licensed computational target and drug discovery platform, Site-Directed Enzyme Enhancement Therapy (“SEE-Tx®”), 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. Basis of Presentation The accompanying unaudited interim condensed financial statements (the “interim financial statements”) reflect the accounts of Gain Therapeutics, Inc., 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 interim financial statements. The interim financial statements have been prepared in conformity 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 (“ASU”) of the Financial Accounting Standards Board (“FASB”). The interim financial statements have been prepared on the same basis as applied for the audited annual consolidated financial statements as of and for the year ended December 31, 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 March 31, 2023, the results of its operations and its statements of stockholders’ equity and its statements of cash flows for the three months ended March 31, 2023 and 2022. The results for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “Annual Report”). The accompanying interim financial statements reflect the application of significant accounting policies as described below and elsewhere in these notes to the unaudited condensed consolidated financial statements. As of March 31, 2023, the Company’s significant accounting policies and estimates, which are detailed in the Annual Report, have not changed. 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 is required to make certain additional disclosures if it concludes substantial doubt exists about the Company’s ability to continue as a going concern. 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 initial public offering (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, acquiring, 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. The Company plans to seek additional funding through public or private equity offerings, debt financings, other collaborations, strategic alliances and licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding when and if needed, the Company could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects. Management believes that the Company will be able to fund its operating expenses and capital expenditure requirements into the third quarter of 2024. The Company based this estimate on assumptions that may prove to be wrong, and the Company could exhaust the available capital resources sooner than expected. In accordance with ASU No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”, the Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. As of the issuance date of these financial statements, the Company expects that its cash and cash equivalents will be sufficient to fund its forecasted operating expenses and capital expenditure requirements for at least the next twelve months from the issuance date of these financial statements. 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 Switzerland and Spain. The Company does not consider these geographies to be separate segments. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Foreign Currency Transactions The Company is incorporated in the United States of America and has operations in Switzerland and Spain. The Company’s functional currency is U.S dollars (USD). The functional currencies of the Company’s foreign operations are the local currencies (Swiss Franc in Switzerland and Euro in Spain). Assets and liabilities reported in the consolidated balance sheets are translated into USD (the currency in which these financial statements are presented) at the exchange rates applicable at the balance sheet dates and for the consolidated 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 March 31, 2023 and December 31, 2022, accumulated currency translation adjustment recorded in accumulated other comprehensive loss amounted to $176,668 and $158,576. Use of Estimates The preparation of the Company’s 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, the Company evaluates its estimates, judgments and assumptions including those related to recognition of accrued expenses, defined benefit pension liability, share-based compensation, and recognition of research grants. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable by management under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. Changes in estimates are recorded in the period in which they become known. To the extent that material differences arise between the estimates and actual results, the Company’s future results of operations will be affected. Cash and Cash Equivalents The Company classifies cash on hand and held at banks, and all highly liquid investments in money market, certificates of deposit, time deposit, and other short-term liquid securities with original maturities of less than 90 days, as cash and cash equivalents. Marketable Securities The Company classifies marketable securities as held-to-maturity or available-for-sale at the time these instruments are purchased, based on the requirements of ASC 320. 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 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 may capitalize 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 March 31, 2023 and December 31, 2022, internal-use software amount to $209 thousand and $214 thousand, 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. 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 Company 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 working lives. 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. Equity-based Compensation and Warrants 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 issues equity-based compensation with service-based vesting conditions and records the expense for these awards using the straight-line method. The Company recognizes the related costs in the consolidated statement of operations and as additional paid-in capital in the consolidated statement of shareholders’ equity, in accordance with the vesting period during which the award recipients are required to provide services in exchange for the award. The Company accounts for forfeitures as they occur. Before becoming a public company, given the absence of an active trading market for the Company’s common stock, the Company and its Board of Directors estimated the fair value of the Company’s common stock at the grant date for determining the estimated fair value of the Company’s equity instruments based on a number of factors, including prices paid for the Company’s convertible preferred stock sold to outside investors in arm’s-length transactions, the Company’s stage of development and the fact that the grants of stock-based awards involved illiquid securities in a private company. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Given the absence of an active public market for the Company’s common stock prior to March 18, 2021, which was the first day the Company’s common stock began trading on the Nasdaq Global Market (“Nasdaq”), the Company determined the volatility and the expected term for awards granted based on an analysis of reported data for a peer group of similar biopharmaceutical companies that issued options with substantially similar terms. After the IPO, the Company continues to determine its volatility in the same manner, and it expects not to change its methodology until such time as the Company has reliable historical data regarding the volatility of the Company’s traded stock price and expected term of exercise patterns. 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 zero. 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 Company recognizes expenses related to Restricted Stock Units (or RSUs) based on fair market value, determined as the closing price on Nasdaq of the Company’s common stock on grant date, on a straight-line basis over the requisite service period for the entire award. Forfeitures are recognized as they occur. 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” Collaborative Arrangements” In determining the appropriate amount of revenue to be recognized as we fulfill our obligations, the Company applies the five-step model of ASC606: (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 measurement The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company applies the following fair value hierarchy, which prioritizes the inputs used to measure fair value into three levels based on their observability in the market and degree of judgment involved: ● Level 1 – Quoted prices in active markets for identical assets or liabilities. ● Level 2 – Observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 – Inputs that are generally unobservable and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and consider counterparty credit risk in their assessment of fair value. Comprehensive income/(loss) Comprehensive income/(loss) is composed of net income/(loss) and certain changes in stockholder’s equity that are excluded from the net income/(loss), primarily foreign currency translation adjustments, 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. The Company gives consideration to all potentially dilutive impacts, except where the effect of including such securities would be antidilutive. As of March 31, 2023 and December 31, 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 |
Cash, cash equivalents and rest
Cash, cash equivalents and restricted cash | 3 Months Ended |
Mar. 31, 2023 | |
Cash, cash equivalents and restricted cash | |
Cash, cash equivalents and restricted cash | 3. Cash, cash equivalents and restricted cash The Company considers all short-term, highly liquid investments, with an original maturity of three months or less, to be cash equivalents. The Company’s cash and cash equivalents include short-term highly liquid investments which are readily convertible into cash and relate to money market securities. The Company’s institutional money market accounts permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions, which are considered Level 1 inputs in the fair value hierarchy. Given their short-term maturities and the underlying value being mainly represented by cash equivalents, their face value amount approximates the related fair market value. The Company has not experienced any losses in these accounts and does not believe it is exposed to any significant credit risk on cash and cash equivalents. Cash, cash equivalents and restricted cash are broken down as follows: March 31, December 31, 2023 2022 Cash 2,911,404 2,910,446 Money market 3,076,798 4,401,165 Total cash and cash equivalents $ 5,988,202 $ 7,311,611 Restricted cash $ 31,122 $ 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 for expenses to be incurred in case of damage to the premises upon the termination of the lease. |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2023 | |
Marketable Securities | |
Marketable Securities | 4. Marketable Securities As of March 31, 2023, the Company reports $12.8 million of marketable securities, related to United States Treasury Securities (“USTS”), within current and non-current assets. The USTS purchased have maturity dates ranging from April 2023 to April 2024, on a monthly basis, in tranches of $1.0 million 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 March 31, 2023: March 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 11,879,563 — — (52,035) 11,827,528 Debt Securities - U.S. government treasury securities, non-current 987,370 — 1,018 — 988,388 Totals $ 12,866,933 $ — $ 1,018 $ (52,035) $ 12,815,916 As of March 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 March 31, 2023 were primarily due to changes in interest rates, and not due to increased credit risks associated with specific securities. Accordingly, as of March 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 | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | 5. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following: March 31, December 31, 2023 2022 Tax credits 137,383 103,877 Prepaid and deferred expenses 730,108 552,882 Other receivables 33,261 87,430 Prepaid D&O insurance costs 605,502 208,542 Total prepaid expenses and other current assets $ 1,368,871 $ 848,854 Tax credits consist of a value added tax credit (“VAT”), which is an indirect tax receivable from Swiss and Spanish tax authorities on purchases of goods and services executed in those countries. Prepaid expenses refers to pre-payments made to the Company’s vendors for future services. Deferred expenses mainly refer to research agreements entered into with third parties for research projects that will be recognized as expenses throughout the research period. Prepaid D&O insurance costs relate to an annual insurance premium which will be recognized in the statement of operations on a monthly basis throughout the one-year insurance period. |
Property and Equipment, net
Property and Equipment, net | 3 Months Ended |
Mar. 31, 2023 | |
Property and Equipment, net | |
Property and Equipment, net | 6. Property and Equipment, net Property and equipment, net consisted of the following : March 31, December 31, 2023 2022 Computer $ 79,660 $ 71,774 Furniture and fixtures 58,132 57,603 Leasehold improvements 31,765 31,437 Laboratory instruments 37,342 36,894 Total property and equipment $ 206,899 $ 197,708 Less: accumulated depreciation (62,263) (53,329) Property and equipment, net $ 144,636 $ 144,379 Property and equipment consist of computers, furniture and fixtures, lab instruments. 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 three months ended March 31, 2023 and 2022 was $8,300 and $5,300, respectively. |
Operating Lease. Right of Use (
Operating Lease. Right of Use ("ROU") Assets | 3 Months Ended |
Mar. 31, 2023 | |
Operating Lease; Right of Use ("ROU") Assets | |
Operating Lease; Right of Use ("ROU") Assets | 7. 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 three 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. March 31, December 31, 2023 2022 Operating Lease Operating lease- right of use assets $ 609,877 $ 659,933 Operating lease liability - current $ 232,507 $ 229,080 Operating lease liability - non-current $ 385,922 $ 441,784 Weighted average remaining lease term - years 2.90 3.05 Weighted average discount rate 1.52 1.53 The operating lease expenses were as follows: March 31, March 31, 2023 2022 Operating lease costs $ 60,601 $ 58,170 The future minimum lease payments for the Company’s operating leases as of March 31, 2023, are as follows: Fiscal Year Operating Leases March 31, 2024 245,466 March 31, 2025 207,793 March 31, 2026 147,882 March 31, 2027 30,365 Total future minimum lease payments 631,506 Less amount representing interest or imputed interest 13,077 Present value of lease liabilities $ 618,429 |
Accounts Payable
Accounts Payable | 3 Months Ended |
Mar. 31, 2023 | |
Accounts Payable | |
Accounts Payable | 8. 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 March 31, 2023 and December 31, 2022, accounts payable amounted to $2.2 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 | 3 Months Ended |
Mar. 31, 2023 | |
Other Current Liabilities and Deferred Income | |
Other Current Liabilities and Deferred Income | 9. Other Current Liabilities and Deferred Income Other current liabilities and deferred income consist of the following as of March 31, 2023 and December 31, 2022: March 31, December 31, 2023 2022 Payable for social security and withholding taxes $ 225,772 $ 256,798 Accrued payroll 990,025 660,556 Accrued expenses 1,263,183 1,082,091 Tax provision 120,783 107,311 Total other current liabilities $ 2,599,763 $ 2,106,756 Deferred income — 55,180 Total other current liabilities and deferred income $ 2,599,763 $ 2,161,936 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. Increase versus prior year is attributable to the allocation of stock-based compensation expenses on stock options granted to our Spanish employees whose costs, for tax purposes, will be deductible at the time of the exercise. |
Pension Obligations
Pension Obligations | 3 Months Ended |
Mar. 31, 2023 | |
Pension obligations | |
Pension obligations | 10. Pension Obligations Net pension obligation related to the Company’s defined pension plan refers only to Swiss employees and as of March 31, 2023 and December 31, 2022, can be summarized as follows: March 31, December 31, 2023 2022 Reconciliation of funded status: Funded status beginning of period $ (157,580) $ (329,458) Expense (36,230) (179,924) Employer contribution 31,847 123,193 Translation differences (1,935) 1,478 Change in accumulated other comprehensive income (670) 227,131 Funded status at end of period $ (164,568) $ (157,580) Component of net periodic pension costs: Service cost $ 35,078 $ 169,709 Interest cost 4,675 3,376 Expected return on plan assets (2,860) (9,000) Amortization of (gain)/losses — 16,753 Amortization of prior service cost (663) (914) Total $ 36,230 $ 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. |
Loans
Loans | 3 Months Ended |
Mar. 31, 2023 | |
Loans | |
Loans | 11. Loans In August 2020, the Company obtained a CHF 638,000 ($700,221 at the historical foreign 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 payments under the loan are reported in the table below: March, 31 Total 2024 2025 2026 2027 2028 Thereafter Loan $ 587,496 109,200 87,360 87,360 87,360 87,360 128,856 |
Fair Value Measurement
Fair Value Measurement | 3 Months Ended |
Mar. 31, 2023 | |
Fair value measurement | |
Fair value measurement | 12. 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 Quoted prices in active market for identical assets Significant other observable inputs Significant unobservable inputs (level 1) (level 2) (level 3) March 31, 2023: Assets Marketable securities available for sale Debt securities - U.S. government treasury securities, current 11,827,528 — — Debt securities - U.S. government treasury securities, non-current 988,388 — — Total marketable securities available for sale $ 12,815,916 — — Cash equivalents: Money market funds 3,076,798 — — Total cash equivalents $ 3,076,798 — — Total financial assets $ 15,892,714 — — 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 — — Cash equivalents: Money market funds 4,401,165 — — Total cash equivalents $ 4,401,165 — — Total financial assets $ 19,169,607 — — 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. |
Common and Preferred Stock
Common and Preferred Stock | 3 Months Ended |
Mar. 31, 2023 | |
Common and Preferred Stock | |
Common and Preferred Stock | 13. Common and Preferred Stock As of March 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 March 31, 2023 and December 31, 2022, there were 12,087,142 and 11,883,368 shares of common stock respectively, $0.0001 par value, issued and outstanding. In May 2022, the Company entered into a Controlled Equity Offering SM stock under the ATM Program at an average selling price of $4.48 per share for aggregate net proceeds of $0.8 million (net of $0.1 million in sales commissions and other offering expenses). |
Equity Incentive Plans
Equity Incentive Plans | 3 Months Ended |
Mar. 31, 2023 | |
Equity Incentive Plan | |
Equity Incentive Plan | 14. 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 2022 Plan. Stock Option Grants The following table summarizes the Company’s stock option activity for the three months ended March 31, 2023: Weighted Average Weighted Average Remaining Aggregate Grant Date Weighted Average Contractual Intrinsic Shares Fair Value Exercise Price Terms (Years) Value Options outstanding as of December 31, 2022 1,879,662 $ 2.94 $ 4.42 8.85 — Options granted 558,850 3.46 4.79 9.97 — Options exercised — — — — — Options cancelled/forfeited — — — — — Options outstanding as of March 31, 2023 2,438,512 $ 3.05 $ 4.50 8.91 — Options Outstanding Options Exercisable Weighted Weighted Average Weighted Weighted- Average Years Average Grant Date Average Exercise Number Remaining on Contractual Exercise Fair Value Number Exercise Price Outstanding Life Price Exercisable Price $3.29 2,500 9.50 $ 3.29 $ 2.45 — — $3.30 14,000 9.18 $ 3.30 $ 2.45 — — $3.38 496,662 7.57 $ 3.38 $ 2.30 424,726 $ 3.38 $3.47 10,000 9.25 $ 3.47 $ 2.56 — — $3.50 453,800 9.47 $ 3.50 $ 1.99 — — $4.01 242,700 9.25 $ 4.01 $ 2.97 — — $4.08 39,750 9.83 $ 4.08 $ 2.76 — — $4.22 245,800 9.03 $ 4.22 $ 2.94 50,000 $ 4.22 $4.84 519,100 9.98 $ 4.84 $ 3.52 — — $5.86 210,000 8.73 $ 5.86 $ 4.22 66,376 $ 5.86 $5.99 31,000 8.33 $ 5.99 $ 4.34 12,409 $ 5.99 $7.80 95,000 8.36 $ 7.80 $ 5.52 39,566 $ 7.80 $10.03 78,200 8.11 $ 10.03 $ 5.25 76,195 $ 10.03 The aggregate intrinsic value of stock options is calculated as the difference between the weighted average exercise price of the underlying stock options and the market price of the Company’s common stock on March 31, 2023. Based on this calculation the intrinsic value of the outstanding stock options as of March 31, 2023 was nil. 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: Three Months Ended March 31, 2023 2022 Grant date fair value $ 3.46 $ — Volatility 77 % — % Expected term (years) 6.93 — Risk-free interest rate 3.38 — Expected dividend yield — — Each of these inputs is subjective and generally requires significant judgment to determine. The weighted average grant-date fair value of the Company’s stock options granted as of March 31, 2023 and 2022 was $3.46 and nil, respectively. Restricted Stock Units and Performance Restricted Stock Units The following table summarizes the Company’s RSUs activity for the three months ended March 31, 2023: Weighted average Duration of the Grant Date Vesting Period Shares Fair Value (years) RSUs outstanding as of December 31, 2022 103,050 $ 3.48 2.40 RSUs granted 192,500 4.24 4.00 RSUs vested — — — RSUs cancelled/forfeited — — — RSUs outstanding as of March 31, 2023 295,550 $ 3.97 3.44 For the three months ended March 31, 2023, the Company granted a total of 192,500 RSUs covering an equal number of shares of the Company’s common stock, to employees with a weighted-average grant date fair value of $4.24. 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 duration of the vesting period for the RSUs outstanding as of March 31, 2023 was 3.44 years. 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 this 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 $1,139 thousand, using the closing price of the Company’s common stock on the grant date. 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 and RSUs, granted to employees and non-employees, has been reported in the Company’s consolidated statements of operations as follows: Three Months Ended March 31 2023 2022 Research and development 166,869 114,118 General and administrative 398,563 192,427 Total stock-based compensation $ 565,432 $ 306,545 As of March 31, 2023, the total unrecognized compensation cost related to non-vested stock options and RSUs granted was $5.7 million and is expected to be recognized over 4 years. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2023 | |
Warrants | |
Warrants | 15. Warrants 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. 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 March 31, 2023, no such warrants had been exercised or exchanged. |
Collaboration Agreement
Collaboration Agreement | 3 Months Ended |
Mar. 31, 2023 | |
Collaboration Agreement | |
Collaboration Agreement | 16. Collaboration Agreement On April 20, 2021, the Company entered into a multi-target collaboration agreement (the “Zentalis Collaboration Agreement”) with Zentalis to discover new product candidates for the treatment of cancer. Under the terms of the Zentalis Collaboration Agreement, the Company will use its in-licensed SEE-Tx® computational platform technology to identify binding sites on target proteins and determine the potential suitability of these sites as drug targets, as well as their prospective therapeutic use in oncology. Pursuant to the terms of the Zentalis Collaboration Agreement, Zentalis agreed to pay the Company, on a program-by-program basis, a non-creditable, non-refundable, program initiation fee and reimbursement of expenses incurred by the Company in accordance with the agreed-upon research budget for each target in a multi-target agreement with a maximum of five mutually agreed to targets at the option of Zentalis. The collaboration between the Company and Zentalis has been concluded. |
Net loss per common share
Net loss per common share | 3 Months Ended |
Mar. 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 and RSUs are considered to be potentially dilutive securities, but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore basic and diluted net loss per share are the same for all periods presented. The following table sets forth the outstanding weighted-average potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would have resulted in anti-dilutive impacts: Three Months Ended March 31 2023 2022 Options to purchase common stock 1,949,213 960,216 RSUs 120,161 — Warrants to purchase common stock 425,387 425,387 In addition to the above, the Company granted 200,000 PRSUs, in December 2021, which were issued subject to performance-based vesting conditions. |
Related Parties
Related Parties | 3 Months Ended |
Mar. 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 March 31, 2023 and December 31, 2022, there were no receivables and payables, revenues or expenses with Minoryx. |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2023 | |
Commitments | |
Commitments | 19. Commitments As of March 31, 2023, the Company had research commitments for $3.2 million for activities that will be performed during fiscal year 2023. |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Nature of the Business and Basis of Presentation | |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim condensed financial statements (the “interim financial statements”) reflect the accounts of Gain Therapeutics, Inc., 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 interim financial statements. The interim financial statements have been prepared in conformity 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 (“ASU”) of the Financial Accounting Standards Board (“FASB”). The interim financial statements have been prepared on the same basis as applied for the audited annual consolidated financial statements as of and for the year ended December 31, 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 March 31, 2023, the results of its operations and its statements of stockholders’ equity and its statements of cash flows for the three months ended March 31, 2023 and 2022. The results for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “Annual Report”). The accompanying interim financial statements reflect the application of significant accounting policies as described below and elsewhere in these notes to the unaudited condensed consolidated financial statements. As of March 31, 2023, the Company’s significant accounting policies and estimates, which are detailed in the Annual Report, have not changed. |
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 is required to make certain additional disclosures if it concludes substantial doubt exists about the Company’s ability to continue as a going concern. 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 initial public offering (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, acquiring, 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. The Company plans to seek additional funding through public or private equity offerings, debt financings, other collaborations, strategic alliances and licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding when and if needed, the Company could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects. Management believes that the Company will be able to fund its operating expenses and capital expenditure requirements into the third quarter of 2024. The Company based this estimate on assumptions that may prove to be wrong, and the Company could exhaust the available capital resources sooner than expected. In accordance with ASU No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”, the Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. As of the issuance date of these financial statements, the Company expects that its cash and cash equivalents will be sufficient to fund its forecasted operating expenses and capital expenditure requirements for at least the next twelve months from the issuance date of these financial statements. |
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 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) | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |
Foreign Currency Transactions | Foreign Currency Transactions The Company is incorporated in the United States of America and has operations in Switzerland and Spain. The Company’s functional currency is U.S dollars (USD). The functional currencies of the Company’s foreign operations are the local currencies (Swiss Franc in Switzerland and Euro in Spain). Assets and liabilities reported in the consolidated balance sheets are translated into USD (the currency in which these financial statements are presented) at the exchange rates applicable at the balance sheet dates and for the consolidated 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 March 31, 2023 and December 31, 2022, accumulated currency translation adjustment recorded in accumulated other comprehensive loss amounted to $176,668 and $158,576. |
Use of Estimates | Use of Estimates The preparation of the Company’s 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, the Company evaluates its estimates, judgments and assumptions including those related to recognition of accrued expenses, defined benefit pension liability, share-based compensation, and recognition of research grants. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable by management under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. Changes in estimates are recorded in the period in which they become known. To the extent that material differences arise between the estimates and actual results, the Company’s future results of operations will be affected. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company classifies 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 days, 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 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 may capitalize 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 March 31, 2023 and December 31, 2022, internal-use software amount to $209 thousand and $214 thousand, 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. |
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 Company 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 working lives. 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. |
Equity-based Compensation and Warrants | Equity-based Compensation and Warrants 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 issues equity-based compensation with service-based vesting conditions and records the expense for these awards using the straight-line method. The Company recognizes the related costs in the consolidated statement of operations and as additional paid-in capital in the consolidated statement of shareholders’ equity, in accordance with the vesting period during which the award recipients are required to provide services in exchange for the award. The Company accounts for forfeitures as they occur. Before becoming a public company, given the absence of an active trading market for the Company’s common stock, the Company and its Board of Directors estimated the fair value of the Company’s common stock at the grant date for determining the estimated fair value of the Company’s equity instruments based on a number of factors, including prices paid for the Company’s convertible preferred stock sold to outside investors in arm’s-length transactions, the Company’s stage of development and the fact that the grants of stock-based awards involved illiquid securities in a private company. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Given the absence of an active public market for the Company’s common stock prior to March 18, 2021, which was the first day the Company’s common stock began trading on the Nasdaq Global Market (“Nasdaq”), the Company determined the volatility and the expected term for awards granted based on an analysis of reported data for a peer group of similar biopharmaceutical companies that issued options with substantially similar terms. After the IPO, the Company continues to determine its volatility in the same manner, and it expects not to change its methodology until such time as the Company has reliable historical data regarding the volatility of the Company’s traded stock price and expected term of exercise patterns. 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 zero. 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 Company recognizes expenses related to Restricted Stock Units (or RSUs) based on fair market value, determined as the closing price on Nasdaq of the Company’s common stock on grant date, on a straight-line basis over the requisite service period for the entire award. Forfeitures are recognized as they occur. 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” Collaborative Arrangements” In determining the appropriate amount of revenue to be recognized as we fulfill our obligations, the Company applies the five-step model of ASC606: (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 measurement The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company applies the following fair value hierarchy, which prioritizes the inputs used to measure fair value into three levels based on their observability in the market and degree of judgment involved: ● Level 1 – Quoted prices in active markets for identical assets or liabilities. ● Level 2 – Observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 – Inputs that are generally unobservable and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and consider counterparty credit risk in their assessment of fair value. |
Comprehensive income/(loss) | Comprehensive income/(loss) 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. The Company gives consideration to all potentially dilutive impacts, except where the effect of including such securities would be antidilutive. As of March 31, 2023 and December 31, 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 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 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) | 3 Months Ended |
Mar. 31, 2023 | |
Cash, cash equivalents and restricted cash | |
Schedule of Cash, cash equivalents and restricted cash | March 31, December 31, 2023 2022 Cash 2,911,404 2,910,446 Money market 3,076,798 4,401,165 Total cash and cash equivalents $ 5,988,202 $ 7,311,611 Restricted cash $ 31,122 $ 30,818 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Marketable Securities | |
Schedule of Marketable Securities | March 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 11,879,563 — — (52,035) 11,827,528 Debt Securities - U.S. government treasury securities, non-current 987,370 — 1,018 — 988,388 Totals $ 12,866,933 $ — $ 1,018 $ (52,035) $ 12,815,916 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expenses and Other Current Assets | |
Schedule of Prepaid Expenses and Other Current Assets | March 31, December 31, 2023 2022 Tax credits 137,383 103,877 Prepaid and deferred expenses 730,108 552,882 Other receivables 33,261 87,430 Prepaid D&O insurance costs 605,502 208,542 Total prepaid expenses and other current assets $ 1,368,871 $ 848,854 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property and Equipment, net | |
Schedule of Property and equipment | March 31, December 31, 2023 2022 Computer $ 79,660 $ 71,774 Furniture and fixtures 58,132 57,603 Leasehold improvements 31,765 31,437 Laboratory instruments 37,342 36,894 Total property and equipment $ 206,899 $ 197,708 Less: accumulated depreciation (62,263) (53,329) Property and equipment, net $ 144,636 $ 144,379 |
Operating Lease. Right of Use_2
Operating Lease. Right of Use ("ROU") Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Operating Lease; Right of Use ("ROU") Assets | |
Schedule of components of lease accounting | March 31, December 31, 2023 2022 Operating Lease Operating lease- right of use assets $ 609,877 $ 659,933 Operating lease liability - current $ 232,507 $ 229,080 Operating lease liability - non-current $ 385,922 $ 441,784 Weighted average remaining lease term - years 2.90 3.05 Weighted average discount rate 1.52 1.53 |
Schedule of components of lease expense | March 31, March 31, 2023 2022 Operating lease costs $ 60,601 $ 58,170 |
Schedule of future minimum lease payments | Fiscal Year Operating Leases March 31, 2024 245,466 March 31, 2025 207,793 March 31, 2026 147,882 March 31, 2027 30,365 Total future minimum lease payments 631,506 Less amount representing interest or imputed interest 13,077 Present value of lease liabilities $ 618,429 |
Other Current Liabilities and_2
Other Current Liabilities and Deferred Income (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Other Current Liabilities and Deferred Income | |
Schedule of Other current liabilities and deferred income | March 31, December 31, 2023 2022 Payable for social security and withholding taxes $ 225,772 $ 256,798 Accrued payroll 990,025 660,556 Accrued expenses 1,263,183 1,082,091 Tax provision 120,783 107,311 Total other current liabilities $ 2,599,763 $ 2,106,756 Deferred income — 55,180 Total other current liabilities and deferred income $ 2,599,763 $ 2,161,936 |
Pension Obligations (Tables)
Pension Obligations (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Pension obligations | |
Schedule of Pension obligations | March 31, December 31, 2023 2022 Reconciliation of funded status: Funded status beginning of period $ (157,580) $ (329,458) Expense (36,230) (179,924) Employer contribution 31,847 123,193 Translation differences (1,935) 1,478 Change in accumulated other comprehensive income (670) 227,131 Funded status at end of period $ (164,568) $ (157,580) Component of net periodic pension costs: Service cost $ 35,078 $ 169,709 Interest cost 4,675 3,376 Expected return on plan assets (2,860) (9,000) Amortization of (gain)/losses — 16,753 Amortization of prior service cost (663) (914) Total $ 36,230 $ 179,924 |
Loans (Tables)
Loans (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Loans | |
Schedule of future loan payments | The future payments under the loan are reported in the table below: March, 31 Total 2024 2025 2026 2027 2028 Thereafter Loan $ 587,496 109,200 87,360 87,360 87,360 87,360 128,856 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair value measurement | |
Schedule of assets measured at fair value | Fair value measurement at reporting date Quoted prices in active market for identical assets Significant other observable inputs Significant unobservable inputs (level 1) (level 2) (level 3) March 31, 2023: Assets Marketable securities available for sale Debt securities - U.S. government treasury securities, current 11,827,528 — — Debt securities - U.S. government treasury securities, non-current 988,388 — — Total marketable securities available for sale $ 12,815,916 — — Cash equivalents: Money market funds 3,076,798 — — Total cash equivalents $ 3,076,798 — — Total financial assets $ 15,892,714 — — 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 — — Cash equivalents: Money market funds 4,401,165 — — Total cash equivalents $ 4,401,165 — — Total financial assets $ 19,169,607 — — |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity Incentive Plan | |
Summary of the Company's stock option activity | Weighted Average Weighted Average Remaining Aggregate Grant Date Weighted Average Contractual Intrinsic Shares Fair Value Exercise Price Terms (Years) Value Options outstanding as of December 31, 2022 1,879,662 $ 2.94 $ 4.42 8.85 — Options granted 558,850 3.46 4.79 9.97 — Options exercised — — — — — Options cancelled/forfeited — — — — — Options outstanding as of March 31, 2023 2,438,512 $ 3.05 $ 4.50 8.91 — Options Outstanding Options Exercisable Weighted Weighted Average Weighted Weighted- Average Years Average Grant Date Average Exercise Number Remaining on Contractual Exercise Fair Value Number Exercise Price Outstanding Life Price Exercisable Price $3.29 2,500 9.50 $ 3.29 $ 2.45 — — $3.30 14,000 9.18 $ 3.30 $ 2.45 — — $3.38 496,662 7.57 $ 3.38 $ 2.30 424,726 $ 3.38 $3.47 10,000 9.25 $ 3.47 $ 2.56 — — $3.50 453,800 9.47 $ 3.50 $ 1.99 — — $4.01 242,700 9.25 $ 4.01 $ 2.97 — — $4.08 39,750 9.83 $ 4.08 $ 2.76 — — $4.22 245,800 9.03 $ 4.22 $ 2.94 50,000 $ 4.22 $4.84 519,100 9.98 $ 4.84 $ 3.52 — — $5.86 210,000 8.73 $ 5.86 $ 4.22 66,376 $ 5.86 $5.99 31,000 8.33 $ 5.99 $ 4.34 12,409 $ 5.99 $7.80 95,000 8.36 $ 7.80 $ 5.52 39,566 $ 7.80 $10.03 78,200 8.11 $ 10.03 $ 5.25 76,195 $ 10.03 |
Schedule of grant-date fair value of stock options granted to employees and directors | Three Months Ended March 31, 2023 2022 Grant date fair value $ 3.46 $ — Volatility 77 % — % Expected term (years) 6.93 — Risk-free interest rate 3.38 — Expected dividend yield — — |
Schedule of stock-based compensation expense recognized for stock options granted to employees and non-employees | Three Months Ended March 31 2023 2022 Research and development 166,869 114,118 General and administrative 398,563 192,427 Total stock-based compensation $ 565,432 $ 306,545 |
Schedule of unvested restricted stock units | Weighted average Duration of the Grant Date Vesting Period Shares Fair Value (years) RSUs outstanding as of December 31, 2022 103,050 $ 3.48 2.40 RSUs granted 192,500 4.24 4.00 RSUs vested — — — RSUs cancelled/forfeited — — — RSUs outstanding as of March 31, 2023 295,550 $ 3.97 3.44 |
Net loss per common share (Tabl
Net loss per common share (Tables) | 3 Months Ended |
Mar. 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 | Three Months Ended March 31 2023 2022 Options to purchase common stock 1,949,213 960,216 RSUs 120,161 — Warrants to purchase common stock 425,387 425,387 |
Nature of the Business and Ba_3
Nature of the Business and Basis of Presentation (Details) | Mar. 17, 2021 | Jul. 20, 2020 |
Subsidiary, Sale of Stock [Line Items] | ||
Stock split ratio | 10 | |
IPO | ||
Subsidiary, Sale of Stock [Line Items] | ||
Preferred stock to common stock conversion ratio | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies | ||
Accumulated currency translation adjustments | $ 176,668 | $ 158,576 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional disclosures (Details) - USD ($) | 3 Months Ended | 15 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||||
Internal-use software | $ 208,913 | $ 208,913 | $ 213,967 | |
Impairments of long-lived assets | $ 0 | |||
Dividend yield | 0% | 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% |
Cash, cash equivalents and re_3
Cash, cash equivalents and restricted cash (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | $ 5,988,202 | $ 7,311,611 |
Restricted cash | 31,122 | 30,818 |
Cash | ||
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | 2,911,404 | 2,910,446 |
Money market | ||
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | $ 3,076,798 | $ 4,401,165 |
Marketable Securities (Details)
Marketable Securities (Details) - U.S. government treasury securities $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Marketable Securities [Line Items] | |
Marketable securities, current and non-current, at fair value | $ 12.8 |
Debt Instrument, Periodic Payment | $ 1 |
Marketable Securities - Marketa
Marketable Securities - Marketable securities available for sale (Details) | Mar. 31, 2023 USD ($) |
Marketable Securities [Line Items] | |
Amortized Cost | $ 12,866,933 |
Gross Unrealized Gains | 1,018 |
Gross Unrealized Losses | (52,035) |
Estimated Fair Value | 12,815,916 |
U.S. government treasury securities | |
Marketable Securities [Line Items] | |
Amortized Cost, Current | 11,879,563 |
Gross Unrealized Losses, Current | (52,035) |
Estimated Fair Value, Current | 11,827,528 |
Amortized Cost, Non Current | 987,370 |
Gross Unrealized Gains, Non Current | 1,018 |
Estimated Fair Value, Non Current | $ 988,388 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses and Other Current Assets | ||
Tax credits | $ 137,383 | $ 103,877 |
Prepaid and deferred expenses | 730,108 | 552,882 |
Other receivables | 33,261 | 87,430 |
Prepaid D&O insurance costs | 605,502 | 208,542 |
Total prepaid expenses and other current assets | $ 1,368,871 | $ 848,854 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Property and Equipment, net | |||
Total property and equipment | $ 206,899 | $ 197,708 | |
Less: accumulated depreciation | (62,263) | (53,329) | |
Property and equipment, net | 144,636 | 144,379 | |
Disposals | 0 | $ 0 | |
Depreciation | 8,300 | $ 5,300 | |
Computer | |||
Property and Equipment, net | |||
Total property and equipment | 79,660 | 71,774 | |
Furniture and fixtures | |||
Property and Equipment, net | |||
Total property and equipment | 58,132 | 57,603 | |
Leasehold improvements | |||
Property and Equipment, net | |||
Total property and equipment | 31,765 | 31,437 | |
Laboratory instruments | |||
Property and Equipment, net | |||
Total property and equipment | $ 37,342 | $ 36,894 |
Operating Lease. Right of Use_3
Operating Lease. Right of Use ("ROU") Assets - Additional information (Details) | Mar. 31, 2023 |
Minimum | |
Lessee, Lease, Description [Line Items] | |
Operating lease remaining term | 3 years |
Maximum | |
Lessee, Lease, Description [Line Items] | |
Operating lease remaining term | 5 years |
Operating Lease. Right of Use_4
Operating Lease. Right of Use ("ROU") Assets - Summary of components of lease accounting (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Operating Lease; Right of Use ("ROU") Assets | ||
Operating lease- right of use assets | $ 609,877 | $ 659,933 |
Operating lease liability - current | 232,507 | 229,080 |
Operating lease liability - non-current | $ 385,922 | $ 441,784 |
Weighted average remaining lease term - years | 2 years 10 months 24 days | 3 years 18 days |
Weighted average discount rate | 1.52% | 1.53% |
Operating Lease. Right of Use_5
Operating Lease. Right of Use ("ROU") Assets - Summary of components of lease expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Lease; Right of Use ("ROU") Assets | ||
Operating lease costs | $ 60,601 | $ 58,170 |
Operating Lease. Right of Use_6
Operating Lease. Right of Use ("ROU") Assets - Future minimum lease payments (Details) | Mar. 31, 2023 USD ($) |
Operating Lease; Right of Use ("ROU") Assets | |
March 31, 2024 | $ 245,466 |
March 31, 2025 | 207,793 |
March 31, 2026 | 147,882 |
March 31, 2027 | 30,365 |
Total future minimum lease payments | 631,506 |
Less amount representing interest or imputed interest | 13,077 |
Present value of lease liabilities | $ 618,429 |
Accounts Payable (Details)
Accounts Payable (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Accounts Payable | ||
Accounts Payable | $ 2,213,489 | $ 1,626,100 |
Other Current Liabilities and_3
Other Current Liabilities and Deferred Income (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Other Current Liabilities and Deferred Income | ||
Payable for social security and withholding taxes | $ 225,772 | $ 256,798 |
Accrued payroll | 990,025 | 660,556 |
Accrued expenses | 1,263,183 | 1,082,091 |
Tax provision | 120,783 | 107,311 |
Total other current liabilities | 2,599,763 | 2,106,756 |
Deferred income | 55,180 | |
Total other current liabilities and deferred income | $ 2,599,763 | $ 2,161,936 |
Pension Obligations - Reconcili
Pension Obligations - Reconciliation of funded status (Details) - Pension Plan - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Reconciliation of funded status | ||
Funded status beginning of period | $ (157,580) | $ (329,458) |
Expense | (36,230) | (179,924) |
Employer contribution | 31,847 | 123,193 |
Translation differences | 1,935 | (1,478) |
Change in accumulated other comprehensive income | (670) | 227,131 |
Funded status at end of period | $ (164,568) | $ (157,580) |
Pension Obligations - Component
Pension Obligations - Component of net periodic pension costs (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 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] | ||
Service cost | $ 35,078 | $ 169,709 |
Interest cost | 4,675 | 3,376 |
Expected return on plan assets | (2,860) | (9,000) |
Amortization of (gain)/losses | 16,753 | |
Amortization of prior service cost | (663) | (914) |
Total | $ 36,230 | $ 179,924 |
Loans (Details)
Loans (Details) - August 2020 CHF loan | 1 Months Ended | |||
Aug. 31, 2020 CHF (SFr) | Mar. 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) | Mar. 31, 2023 USD ($) |
Loans | |
Total | $ 587,496 |
2024 | 109,200 |
2025 | 87,360 |
2026 | 87,360 |
2027 | 87,360 |
2028 | 87,360 |
Thereafter | $ 128,856 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - Level 1 - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | $ 15,892,714 | $ 19,169,607 |
Total cash equivalents | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 3,076,798 | 4,401,165 |
Money market funds | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 3,076,798 | 4,401,165 |
Marketable securities available for sale | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 12,815,916 | 14,768,442 |
U.S. government treasury securities, current | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 11,827,528 | 12,826,954 |
U.S. government treasury securities, non current | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | $ 988,388 | $ 1,941,488 |
Common and Preferred Stock (Det
Common and Preferred Stock (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Dec. 31, 2022 | May 31, 2022 | |
Class of Stock [Line Items] | |||
Authorized capital, Common stock (in shares) | 50,000,000 | 50,000,000 | |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |
Authorized capital, Preferred stock (in shares) | 10,000,000 | 10,000,000 | |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |
Common stock issued (in shares) | 12,087,142 | 11,883,368 | |
Common stock outstanding (in shares) | 12,087,142 | 11,883,368 | |
Preferred stock, shares outstanding | 0 | 0 | |
Proceeds | $ 770,520 | ||
At the Market Offering, May 2022 [Member] | |||
Class of Stock [Line Items] | |||
Shares issued price per share | $ 4.48 | ||
Shares issued | 203,774 | ||
Proceeds | $ 800,000 | ||
Payments of deferred offering costs | $ 100,000 | ||
At the Market Offering, May 2022 [Member] | Maximum | |||
Class of Stock [Line Items] | |||
Aggregate offering price in at the market offering | $ 16,000,000 |
Equity Incentive Plans (Details
Equity Incentive Plans (Details) | Jan. 01, 2023 shares | May 12, 2022 shares | Jul. 20, 2020 | Mar. 31, 2023 shares | Dec. 31, 2022 shares | Dec. 23, 2021 shares | Sep. 24, 2020 shares |
Equity Incentive Plan | |||||||
Reverse stock split ratio | 10 | ||||||
Number outstanding | 2,438,512 | 1,879,662 | |||||
2021 Inducement Equity Incentive Plan | |||||||
Equity Incentive Plan | |||||||
Maximum number of shares reserved for issuance | 1,000,000 | ||||||
Incentive plans 2020 and 2022 | |||||||
Equity Incentive Plan | |||||||
Maximum number of shares reserved for issuance | 2,513,002 | ||||||
Equity Incentive Plan 2022 | |||||||
Equity Incentive Plan | |||||||
Maximum number of shares reserved for issuance | 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 ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Shares | |||
Outstanding as at beginning of period (in shares) | 1,879,662 | ||
Options granted (in shares) | 558,850 | ||
Options outstanding as at end of period (in shares) | 2,438,512 | 1,879,662 | |
Weighted Average Grant Date Fair Value | |||
Weighted Average Grant Date Fair Value, options outstanding at beginning of period | $ 2.94 | ||
Weighted Average Grant Date Fair Value, options granted | 3.46 | $ 0 | |
Weighted Average Grant Date Fair Value, options outstanding at end of period | 3.05 | $ 2.94 | |
Weighted Average Exercise Price | |||
Outstanding as at beginning of period (in dollars per share) | 4.42 | ||
Options granted (in dollars per share) | 4.79 | ||
Options outstanding as at end of period (in dollars per share) | $ 4.50 | $ 4.42 | |
Additional disclosures | |||
Weighted Average Remaining Contractual Years Outstanding | 8 years 10 months 28 days | 8 years 10 months 6 days | |
Weighted Average Remaining Contractual Years Options granted | 9 years 11 months 19 days | ||
Aggregate Intrinsic Value | $ 0 |
Equity Incentive Plans - Option
Equity Incentive Plans - Options Outstanding and Exercisable (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Equity Incentive Plan | ||
Number outstanding | 2,438,512 | 1,879,662 |
Weighted- Average Years Remaining on Contractual Life | 8 years 10 months 28 days | 8 years 10 months 6 days |
Weighted Average Exercise Price | $ 4.50 | $ 4.42 |
Weighted Average Grant Date Fair Value | 3.05 | $ 2.94 |
$3.29 | ||
Equity Incentive Plan | ||
Exercise price | $ 3.29 | |
Number outstanding | 2,500 | |
Weighted- Average Years Remaining on Contractual Life | 9 years 6 months | |
Weighted Average Exercise Price | $ 3.29 | |
Weighted Average Grant Date Fair Value | 2.45 | |
$3.30 | ||
Equity Incentive Plan | ||
Exercise price | $ 3.30 | |
Number outstanding | 14,000 | |
Weighted- Average Years Remaining on Contractual Life | 9 years 2 months 4 days | |
Weighted Average Exercise Price | $ 3.30 | |
Weighted Average Grant Date Fair Value | 2.45 | |
$3.38 | ||
Equity Incentive Plan | ||
Exercise price | $ 3.38 | |
Number outstanding | 496,662 | |
Weighted- Average Years Remaining on Contractual Life | 7 years 6 months 25 days | |
Weighted Average Exercise Price | $ 3.38 | |
Weighted Average Grant Date Fair Value | $ 2.30 | |
Number exercisable | 424,726 | |
Weighted Average Exercise Price, options exercisable | $ 3.38 | |
$3.47 | ||
Equity Incentive Plan | ||
Exercise price | $ 3.47 | |
Number outstanding | 10,000 | |
Weighted- Average Years Remaining on Contractual Life | 9 years 3 months | |
Weighted Average Exercise Price | $ 3.47 | |
Weighted Average Grant Date Fair Value | 2.56 | |
$3.50 | ||
Equity Incentive Plan | ||
Exercise price | $ 3.50 | |
Number outstanding | 453,800 | |
Weighted- Average Years Remaining on Contractual Life | 9 years 5 months 19 days | |
Weighted Average Exercise Price | $ 3.50 | |
Weighted Average Grant Date Fair Value | 1.99 | |
$4.01 | ||
Equity Incentive Plan | ||
Exercise price | $ 4.01 | |
Number outstanding | 242,700 | |
Weighted- Average Years Remaining on Contractual Life | 9 years 3 months | |
Weighted Average Exercise Price | $ 4.01 | |
Weighted Average Grant Date Fair Value | 2.97 | |
$4.08 | ||
Equity Incentive Plan | ||
Exercise price | $ 4.08 | |
Number outstanding | 39,750 | |
Weighted- Average Years Remaining on Contractual Life | 9 years 9 months 29 days | |
Weighted Average Exercise Price | $ 4.08 | |
Weighted Average Grant Date Fair Value | 2.76 | |
$4.22 | ||
Equity Incentive Plan | ||
Exercise price | $ 4.22 | |
Number outstanding | 245,800 | |
Weighted- Average Years Remaining on Contractual Life | 9 years 10 days | |
Weighted Average Exercise Price | $ 4.22 | |
Weighted Average Grant Date Fair Value | $ 2.94 | |
Number exercisable | 50,000 | |
Weighted Average Exercise Price, options exercisable | $ 4.22 | |
$4.84 | ||
Equity Incentive Plan | ||
Exercise price | $ 4.84 | |
Number outstanding | 519,100 | |
Weighted- Average Years Remaining on Contractual Life | 9 years 11 months 23 days | |
Weighted Average Exercise Price | $ 4.84 | |
Weighted Average Grant Date Fair Value | 3.52 | |
$5.86 | ||
Equity Incentive Plan | ||
Exercise price | $ 5.86 | |
Number outstanding | 210,000 | |
Weighted- Average Years Remaining on Contractual Life | 8 years 8 months 23 days | |
Weighted Average Exercise Price | $ 5.86 | |
Weighted Average Grant Date Fair Value | $ 4.22 | |
Number exercisable | 66,376 | |
Weighted Average Exercise Price, options exercisable | $ 5.86 | |
$5.99 | ||
Equity Incentive Plan | ||
Exercise price | $ 5.99 | |
Number outstanding | 31,000 | |
Weighted- Average Years Remaining on Contractual Life | 8 years 3 months 29 days | |
Weighted Average Exercise Price | $ 5.99 | |
Weighted Average Grant Date Fair Value | $ 4.34 | |
Number exercisable | 12,409 | |
Weighted Average Exercise Price, options exercisable | $ 5.99 | |
$7.80 | ||
Equity Incentive Plan | ||
Exercise price | $ 7.80 | |
Number outstanding | 95,000 | |
Weighted- Average Years Remaining on Contractual Life | 8 years 4 months 9 days | |
Weighted Average Exercise Price | $ 7.80 | |
Weighted Average Grant Date Fair Value | $ 5.52 | |
Number exercisable | 39,566 | |
Weighted Average Exercise Price, options exercisable | $ 7.80 | |
$10.03 | ||
Equity Incentive Plan | ||
Exercise price | $ 10.03 | |
Number outstanding | 78,200 | |
Weighted- Average Years Remaining on Contractual Life | 8 years 1 month 9 days | |
Weighted Average Exercise Price | $ 10.03 | |
Weighted Average Grant Date Fair Value | $ 5.25 | |
Number exercisable | 76,195 | |
Weighted Average Exercise Price, options exercisable | $ 10.03 |
Equity Incentive Plans - Assump
Equity Incentive Plans - Assumptions (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Equity Incentive Plan | ||
Grant date fair value | $ 3.46 | $ 0 |
Volatility | 77% | |
Expected term (years) | 6 years 11 months 4 days | |
Risk-free interest rate | 3.38% | |
Expected dividend yield | 0% | 0% |
Equity Incentive Plans - Restri
Equity Incentive Plans - Restricted Stock Units and Performance Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended |
Dec. 31, 2021 | Mar. 31, 2023 | |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards granted | 192,500 | |
RSUs | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards granted | 192,500 | |
Grant date fair value | $ 4.24 | |
Performance-Based Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards granted | 200,000 | |
Grant date fair value | $ 0 | |
Performance-Based Restricted Stock Units | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Potential fair value of awards based on performance | $ 1,139 |
Equity Incentive Plans - RSUs a
Equity Incentive Plans - RSUs activity (Details) - RSUs - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Beginning balance | 103,050 | |
RSUs granted | 192,500 | |
Ending balance | 295,550 | 103,050 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Beginning balance | $ 3.48 | |
RSUs granted | 4.24 | |
Ending balance | $ 3.97 | $ 3.48 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Additional Disclosures [Abstract] | ||
Weighted average Duration of the Vesting Period beginning | 3 years 5 months 8 days | 2 years 4 months 24 days |
Weighted average duration of the Vesting Period RSUs granted | 4 years | |
Weighted average duration of the Vesting Period ending | 3 years 5 months 8 days | 2 years 4 months 24 days |
Equity Incentive Plans - Stock-
Equity Incentive Plans - Stock-based compensation (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Equity Incentive Plan | ||
Total stock-based compensation | $ 565,432 | $ 306,545 |
Unrecognized compensation cost related to non-vested stock options and RSUs | $ 5,700,000 | |
Unrecognized compensation cost, recognition period | 4 years | |
Research and development | ||
Equity Incentive Plan | ||
Total stock-based compensation | $ 166,869 | 114,118 |
General and administrative | ||
Equity Incentive Plan | ||
Total stock-based compensation | $ 398,563 | $ 192,427 |
Warrants (Details)
Warrants (Details) | Jul. 20, 2020 | Mar. 31, 2023 shares | May 06, 2021 USD ($) $ / shares shares | Jul. 31, 2020 USD ($) $ / shares shares |
Class of Warrant or Right [Line Items] | ||||
Reverse stock split ratio | 10 | |||
Warrants to designees of the placement agent, issued July 2020 | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants to purchase common stock | 237,249 | |||
Warrants exercise price | $ / shares | $ 5.07 | |||
Warrants value | $ | $ 413,887 | |||
Warrants term | 5 years | |||
Warrants to designees of investment bank, issued May 2021 | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants to purchase common stock | 200,000 | |||
Warrants exercise price | $ / shares | $ 13.75 | |||
Warrants value | $ | $ 1,000,000 | |||
Warrants term | 4 years | |||
Warrants exercised or exchanged | 0 |
Collaboration Agreement (Detail
Collaboration Agreement (Details) | Apr. 20, 2021 item |
Multi-target collaboration agreement | Zentalis Pharmaceuticals, Inc. | Maximum | |
Collaboration Agreement | |
Number of targets | 5 |
Net loss per common share - Com
Net loss per common share - Computation of diluted net loss per share (Details) - shares | 1 Months Ended | 3 Months Ended | |
Dec. 31, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | |
Options 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) | 1,949,213 | 960,216 | |
RSUs | |||
Net loss per common share | |||
Antidilutive securities excluded from computation of diluted net loss per share attributable to common stockholders (in shares) | 120,161 | ||
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) | 425,387 | 425,387 | |
Performance restricted stock units | |||
Net loss per common share | |||
Antidilutive securities excluded from computation of diluted net loss per share attributable to common stockholders (in shares) | 200,000 |
Related Parties (Details)
Related Parties (Details) - License agreement Minoryx Therapeutics SL - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended |
Dec. 31, 2017 | Mar. 31, 2023 | Dec. 31, 2022 | |
Related Parties | |||
Receivables | $ 0 | $ 0 | |
Payables | 0 | 0 | |
Revenues | 0 | 0 | |
Expenses | $ 0 | $ 0 | |
Maximum | |||
Related Parties | |||
Percentage of net revenue based on one composition matter | 8% | ||
Percentage of net revenue based on one method of claim | 3% |
Commitments - Summary of obliga
Commitments - Summary of obligations by contractual maturity (Details) $ in Millions | Mar. 31, 2023 USD ($) |
Research Agreements | |
Commitments | |
Commitments | $ 3.2 |