Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
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 $0.0001 per share | |
Trading Symbol | GANX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 11,883,368 | |
Entity Central Index Key | 0001819411 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 10,879,884 | $ 36,880,673 |
Marketable securities - current | 11,850,614 | |
Tax credits | 66,467 | 113,586 |
Prepaid expenses and other current assets | 1,552,358 | 727,785 |
Total current assets | 24,349,323 | 37,722,044 |
Non-current assets: | ||
Property and equipment, net | 136,717 | 105,986 |
Internal-use software | 208,328 | 202,609 |
Marketable securities - non current | 2,916,330 | |
Operating lease - right of use assets | 670,261 | 901,042 |
Restricted cash | 28,859 | 31,279 |
Long-term deposits | 15,801 | 22,111 |
Total non-current assets | 3,976,296 | 1,263,027 |
Total assets | 28,325,619 | 38,985,071 |
Current liabilities: | ||
Accounts payable | 1,018,809 | 560,479 |
Operating lease liability - current | 214,971 | 219,137 |
Other current liabilities | 2,942,073 | 1,402,600 |
Deferred income | 55,180 | 266,504 |
Loans - current | 101,260 | 103,826 |
Total current liabilities | 4,332,293 | 2,552,546 |
Non-current liabilities: | ||
Defined benefit pension plan | 377,782 | 329,458 |
Operating lease liability - non current | 468,760 | 695,053 |
Loans - non current | 484,023 | 590,468 |
Total non current liabilities | 1,330,565 | 1,614,979 |
Total liabilities | 5,662,858 | 4,167,525 |
Stockholders' equity | ||
Common stock, $0.0001 par value: 50,000,000 shares authorized; 11,883,368 issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 1,189 | 1,189 |
Additional paid-in capital | 56,800,203 | 55,832,461 |
Accumulated other comprehensive loss | (296,900) | (90,645) |
Accumulated deficit | (20,925,459) | (7,034,853) |
Loss of the period | (12,916,272) | (13,890,606) |
Total stockholders' equity | 22,662,761 | 34,817,546 |
Total liabilities and stockholders' equity | $ 28,325,619 | $ 38,985,071 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
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 | 11,883,368 | 11,883,368 |
Common stock, shares, outstanding | 11,883,368 | 11,883,368 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues: | ||||
Collaboration revenues | $ 15,971 | $ 132,640 | $ 97,587 | |
Other income | 11,374 | 7,468 | 24,199 | |
Total revenues | 27,345 | 140,108 | 121,786 | |
Operating expenses: | ||||
Research and development | $ (1,964,784) | (2,476,739) | (6,103,448) | (5,691,756) |
General and administrative | (2,786,200) | (2,186,531) | (7,252,506) | (5,047,434) |
Total operating expenses | (4,750,984) | (4,663,270) | (13,355,954) | (10,739,190) |
Loss from operations | (4,750,984) | (4,635,925) | (13,215,846) | (10,617,404) |
Other income (expense): | ||||
Interest income, net | 153,332 | 4,918 | 211,580 | 12,228 |
Foreign exchange gain/(loss), net | 43,491 | (27,412) | 102,865 | (53,245) |
Loss before income tax | (4,554,161) | (4,658,419) | (12,901,401) | (10,658,421) |
Income tax | (4,048) | (5,114) | (14,871) | (12,252) |
Net loss | $ (4,558,209) | $ (4,663,533) | $ (12,916,272) | $ (10,670,673) |
Net loss per shares: | ||||
Net loss per share attributable to common stockholders - Basic | $ (0.38) | $ (0.39) | $ (1.09) | $ (1.11) |
Net loss per share attributable to common stockholders - Diluted | $ (0.38) | $ (0.39) | $ (1.09) | $ (1.11) |
Weighted average common shares - Basic | 11,883,368 | 11,876,745 | 11,883,368 | 9,587,189 |
Weighted average common shares - Diluted | 11,883,368 | 11,876,745 | 11,883,368 | 9,587,189 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (4,558,209) | $ (4,663,533) | $ (12,916,272) | $ (10,670,673) |
Other comprehensive gain/(loss): | ||||
Unrealized loss on available-for-sale securities | (103,142) | (98,038) | ||
Defined benefit pension plan | 3,569 | 12,288 | 11,483 | (27,118) |
Foreign currency translation | (51,759) | 39,752 | (119,700) | 67,738 |
Other comprehensive loss | (151,332) | 52,040 | (206,255) | 40,620 |
Comprehensive loss | $ (4,709,541) | $ (4,611,493) | $ (13,122,527) | $ (10,630,053) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Preferred Stock Series A Preferred Stock. | Preferred Stock Series B Preferred Stock | Common Stock Common Stock | APIC | AOCI | Accumulated Deficit | Total |
Balance at Dec. 31, 2020 | $ 118 | $ 297 | $ 354 | $ 13,388,771 | $ (152,698) | $ (7,034,853) | $ 6,201,989 |
Balance (in shares) at Dec. 31, 2020 | 1,185,879 | 2,965,600 | 3,543,163 | ||||
Conversion of Series A Preferred Stock into Common Stock | $ (118) | $ 118 | |||||
Conversion of Series A Preferred Stock into Common Stock (in shares) | (1,185,879) | 1,185,879 | |||||
Conversion of Series B Preferred Stock into Common Stock | $ (297) | $ 297 | |||||
Conversion of Series B Preferred Stock into Common Stock (in shares) | (2,965,600) | 2,965,600 | |||||
Issuance of Common Stock in IPO, net of issuance costs | $ 419 | 40,558,103 | 40,558,522 | ||||
Issuance of Common Stock in IPO (In shares) | 4,181,818 | ||||||
Issuance of common stock due to warrants cashless exercise (in shares) | 3,283 | ||||||
Stock based compensation expense | 553,111 | 553,111 | |||||
Issuance of warrants | 861,667 | 861,667 | |||||
Defined benefit pension plan | (27,118) | (27,118) | |||||
Foreign currency translation | 67,738 | 67,738 | |||||
Net loss | (10,670,673) | (10,670,673) | |||||
Balance at Sep. 30, 2021 | $ 1,188 | 55,361,652 | (112,078) | (17,705,526) | 37,545,236 | ||
Balance (in shares) at Sep. 30, 2021 | 11,879,743 | ||||||
Balance at Jun. 30, 2021 | $ 1,188 | 54,593,827 | (164,118) | (13,041,993) | 41,388,904 | ||
Balance (in shares) at Jun. 30, 2021 | 11,876,460 | ||||||
Issuance of common stock due to warrants cashless exercise (in shares) | 3,283 | ||||||
Stock based compensation expense | 250,825 | 250,825 | |||||
Issuance of warrants | 517,000 | 517,000 | |||||
Defined benefit pension plan | 12,288 | 12,288 | |||||
Foreign currency translation | 39,752 | 39,752 | |||||
Net loss | (4,663,533) | (4,663,533) | |||||
Balance at Sep. 30, 2021 | $ 1,188 | 55,361,652 | (112,078) | (17,705,526) | 37,545,236 | ||
Balance (in shares) at Sep. 30, 2021 | 11,879,743 | ||||||
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 expense | 967,742 | 967,742 | |||||
Defined benefit pension plan | 11,483 | 11,483 | |||||
Foreign currency translation | (119,700) | (119,700) | |||||
Net unrealized gain on available for sale securities | (98,038) | (98,038) | |||||
Net loss | (12,916,272) | (12,916,272) | |||||
Balance at Sep. 30, 2022 | $ 1,189 | 56,800,203 | (296,900) | (33,841,731) | 22,662,761 | ||
Balance (in shares) at Sep. 30, 2022 | 11,883,368 | ||||||
Balance at Jun. 30, 2022 | $ 1,189 | 56,444,556 | (145,568) | (29,283,522) | 27,016,655 | ||
Balance (in shares) at Jun. 30, 2022 | 11,883,368 | ||||||
Stock based compensation expense | 355,647 | 355,647 | |||||
Defined benefit pension plan | 3,569 | 3,569 | |||||
Foreign currency translation | (51,759) | (51,759) | |||||
Net unrealized gain on available for sale securities | (103,142) | (103,142) | |||||
Net loss | (4,558,209) | (4,558,209) | |||||
Balance at Sep. 30, 2022 | $ 1,189 | $ 56,800,203 | $ (296,900) | $ (33,841,731) | $ 22,662,761 | ||
Balance (in shares) at Sep. 30, 2022 | 11,883,368 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities: | ||
Net loss | $ (12,916,272) | $ (10,670,673) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 46,058 | 9,696 |
Stock based compensation expense | 967,742 | 553,111 |
Other non cash items | (65,894) | |
Warrants | 861,667 | |
Internal use software | (27,059) | |
Changes in operating assets and liabilities: | ||
Account receivables | (16,165) | |
Prepaid expenses and other current assets | (385,568) | 52,283 |
Other non-current assets | 152,351 | (369,959) |
Accounts payable and other liabilities | 1,533,555 | 1,254,651 |
Defined benefit pension plan | 88,237 | 44,935 |
Deferred income | (207,735) | 88,208 |
Total changes in operating assets and liabilities | 1,180,840 | 1,053,953 |
Cash used in operating activities | (10,787,526) | (8,219,305) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (109,555) | (83,114) |
Purchases of marketable securities | (15,804,035) | |
Maturity of marketable securities | 1,004,947 | |
Cash used in investing activities | (14,908,643) | (83,114) |
Cash flow from financing activities: | ||
Proceeds from issuance of common shares upon completion of initial public offering, net of underwriter discounts | 42,629,998 | |
Payments of deferred offering costs | (853,488) | |
Payments of current portion of long-term debt | (57,192) | |
Cash (used in)/provided by financing activities | (57,192) | 41,776,510 |
Effect of exchange rate changes | (249,848) | 36,270 |
Net (decrease)/increase in cash, cash equivalents and restricted cash | (26,003,209) | 33,510,361 |
Cash, cash equivalents and restricted cash at beginning of period | 36,911,952 | 7,504,281 |
Cash, cash equivalents and restricted cash at end of period | $ 10,908,743 | $ 41,014,642 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Nature of the Business and Basis of Presentation | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Operations and Business Gain Therapeutics, Inc. (and together with its wholly-owned subsidiaries, the “Company”), is a biotechnology company developing small molecule therapeutics to treat diseases across several therapeutic areas, including central nervous system (“CNS”) disorders, lysosomal storage disorders (“LSDs”), metabolic disorders as well as 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 misfolded 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. SEE-Tx® is uniquely suited to identify allosteric binding sites on the protein surface, which are different from the protein’s active (or orthosteric) binding site where the natural ligand of the protein binds. Targeting an allosteric binding site instead of the active binding site of a protein provides numerous advantages, including: the ability to regulate proteins implicated in disease through several different mechanisms of action covering both functional and conformational effects, including stabilization, destabilization, targeted degradation, allosteric inhibition, and allosteric activation of the targeted protein; improved specificity of small molecules because binding to an allosteric binding site is non-competitive with the natural substrate that binds to the active binding site; and the ability to identify small molecules with more favorable drug-like properties. The SEE-Tx® platform has been used to identify novel allosteric sites and small molecules for all of our internal programs and partnered programs. Discovering and targeting novel allosteric sites with the Company’s platform not only reduces traditional drug discovery timelines but enables rational drug design and offers the potential for superior small molecule drugs that are highly specific and that can penetrate hard to reach tissues and cross the blood-brain barrier. The Company’s operations to date 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 does not have any product candidates approved for sale and has not generated any revenue from product sales. The Company’s product candidates are subject to long development cycles and the Company may be unsuccessful in its efforts to develop, obtain regulatory approval for or, assuming regulatory approval is obtained, market its product candidates. The Company was originally incorporated under the laws of the State of Delaware on June 26, 2020. On July 20, 2020, the Company consummated a corporate reorganization pursuant to which all of the issued and outstanding common and preferred stock of GT Gain Therapeutics SA, a Swiss company formed in 2017, were exchanged for common stock or preferred stock, as applicable, of Gain Therapeutics, Inc., reflecting a 10:1 stock split. The corporate reorganization was accounted for as a recapitalization for accounting purposes, with GT Gain Therapeutics SA 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. For periods and at dates prior to the corporate reorganization, the condensed consolidated financial statements presented were prepared based on the historical financial statements of GT Gain Therapeutics SA, adjusted to give retroactive effect to the share exchange transactions. On March 3, 2021, the Company’s Board of Directors (the “Board”) approved a 1-for- 0.880784 On March 17, 2021, the Company completed its IPO, in which the Company issued and sold 3,636,364 shares of common stock at a public offering price of $11.00 per share for net proceeds of $34,978 thousand after deducting underwriting discounts and commissions of $2,950 thousand and other offering expenses of $2,071 thousand. On March 22, 2021, the Company issued and sold 545,454 additional shares of common stock, pursuant to the full exercise of the underwriters’ option to purchase additional shares, for net proceeds of $5,580 thousand after deducting underwriting discounts and commissions of $420 thousand. Thus, the aggregate net proceeds to the Company from the IPO, after deducting underwriting discounts commissions, were $42,630 thousand. After deducting other IPO offering expenses amounting to $2,071 thousand, the net cash proceeds resulting from the IPO are $40,558 thousand, which are reflected in the Company’s statement of stockholders’ equity as “issuance of common stock in IPO, net of issuance costs”. Upon the closing of the IPO, series A convertible preferred stock (the “Series A Preferred Stock”) and series B convertible preferred stock (the “Series B Preferred Stock” and, together with the Series A Preferred Stock, collectively referred to as the “Preferred Stock”) were converted into shares of common stock at a ratio of 1-for-1. On May 18, 2022, the Company filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”) with the U.S. Securities and Exchange Commission (“SEC”), which covers the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $100.0 million of any combination of the Company’s common stock, preferred stock, debt securities and/or warrants from time to time in one or more offerings. The Shelf Registration Statement was declared effective by the SEC on June 1, 2022. The Shelf Registration Statement contains a sales agreement prospectus supplement covering up to a maximum aggregate offering price of $16.0 million of common stock that may be issued and sold by the Company from time to time through or to Cantor Fitzgerald & Co., acting as the Company’s agent or principal, in accordance with the terms of a Controlled Equity Offering SM 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 the 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, and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing 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. The Company expects to continue to incur losses from operations for the foreseeable future and additional capital will be required to fund future operations. The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2022, will be sufficient to fund its operating expenses and capital expenditure requirements through at least the next 12 months from the date these financial statements were issued. 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 as of September 30, 2022 reflect, for all periods presented, the retroactive application of the reverse stock split that occurred effective March 17, 2021. All amounts in the interim financial statements are expressed in United States dollars (USD/$) and disclosed within these explanatory notes in United States dollars (USD/$) or Swiss Franc (CHF), which are the functional currencies of the Company and its operating subsidiary, GT Gain Therapeutics SA, respectively. 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, 2021, 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 September 30, 2022, the results of its operations and its statements of stockholders’ equity for the three and nine months ended September 30, 2022 and 2021 and its statements of cash flows for the nine months ended September 30, 2022 and 2021. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, 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, 2021, and the notes thereto, which are included in the Company’s 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 September 30, 2022, 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 and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt 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 proceeds from capital contributions. 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 operations have consisted primarily of organizing and staffing the Company, expanding its operations, securing financing, acquiring, developing and securing our 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. In accordance with Accounting Standards Update, or “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. Accordingly, the consolidated financial statements have been prepared assuming that the Company will continue as a going concern. 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, and only has one operating segment. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
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 the U.S. dollar. The functional currencies of the Company’s foreign operations are the respective local currencies (Swiss Franc in Switzerland and Euro in Spain). Assets and liabilities reported in the Company’s consolidated balance sheets are translated into U.S. dollars (the currency in which these financial statements are presented) at the exchange rates applicable at the balance sheet dates and for the consolidated statement of operations accounts 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 September 30, 2022 and December 31, 2021, accumulated currency translation adjustment recorded in accumulated other comprehensive loss amounted to $45,456 and $165,156, respectively. Use of Estimates The preparation of 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 grant funds, accrued expenses, defined benefit pension liability, warrants and stock-based compensation. These estimates, judgments and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. Changes in estimates are recorded in the period in which they become known. To the extent that material differences arise between the estimates and actual results, the Company’s future results of operations will be affected. To date, the COVID 19 pandemic has not had a significant impact on the Company’s estimates. 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 day, as cash and cash equivalents. Marketable Securities The Company classifies marketable securities as held-to-maturity or available-for-sale at the time these instruments are purchased, based on the requirements of ASC 320. Marketable securities are classified as held-to-maturity when the Company has the positive intent and the capacity to hold the marketable securities until the maturity date. Held-to-maturity marketable securities are carried out at amortized cost, with the accretion of discounts (or amortization of premiums) included within the calculation of the effective interest method. The effective interests of the period are accounted for in the Company’s statements of operations as financial income (or expense). Marketable securities are classified as available-for-sale when 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/losses” excluded from the computation of the earnings of the period and accounted for in other comprehensive income. 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 reporting entity’s reasonable expectation 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 form 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 rates recorded in the consolidated statements of operations 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” The Company amortizes the capitalized software development costs on a straight-line basis over the estimated useful life of the software, which is six years, beginning when the asset is substantially ready for use. The amortization of capitalized software development costs is reflected in general and administrative expenses. Amortization expense for the periods ended September 30, 2022 and 2021 was $27,198 and nil, respectively Impairment of Long-lived Assets In accordance with ASC Topic 360-10-20, ‘‘Property, Plant and Equipment,’’ the Company performs an impairment test whenever events or circumstances indicate that the carrying value of long-lived assets with finite lives may be impaired. Impairment is measured by comparing the carrying value of the long-lived assets to the estimated undiscounted pre-tax cash flows expected to result from the use of such assets and their ultimate disposition. In circumstances where impairment is determined to exist, the Company will write down the asset to its fair value based on the present value of estimated cash flows. To date, no impairments have been identified by management as of and for all periods presented. Patents Patent-related costs refer to legal fees incurred by the Company in connection with filing and prosecuting patent applications and are expensed as incurred due to uncertainty about the recovery of the expenditures. 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 to it at that time at the date 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 employee 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 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 biopharmaceuticals 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 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. The fair market value for RSUs is based on the closing price of our stock on the grant date. We recognize expenses related to RSUs based on the fair market value, as determined on the grant date, on a straight line basis over the requisite service period for the entire award. Forfeitures are recognized as they occur. 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 (such as those awarded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA and from Innosuisse – Swiss Innovation Agency), 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 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. The Company recognizes tax liabilities from an uncertain tax position if it is more likely than not that the tax position will not be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. There are no uncertain tax positions that have been recognized in the accompanying consolidated financial statements. 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, we utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and consider counterparty credit risk in their assessment of fair value. Comprehensive income/(loss) Comprehensive income/(loss) is composed of net income/(loss) and certain changes in stockholder’s equity that are excluded from net income/(loss), primarily foreign currency translation adjustments, unrealized gains/losses on available for sale securities and defined benefit obligation adjustments. 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 September 30, 2022 and 2021, common stock equivalents consisted of stock options 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. COVID-19 Pandemic In regard to the ongoing COVID-19 global pandemic, the Company has taken measures to secure its research and development activities, while work in its laboratories and facilities has been re-organized to reduce risks of COVID-19 transmission. Given the global impact and the other risks and uncertainties associated with the COVID-19 pandemic, the Company’s business, financial condition and results of operations could be materially adversely affected. The Company continues to closely monitor the COVID-19 pandemic and evolve its business continuity plans, clinical development plans and response strategy to mitigate any potential impact. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from those estimates, and any such differences may be material to the Company’s financial statements. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that the Company adopts as of the specified effective date. There were no new material accounting pronouncements issued in the first nine months of 2022 with a material impact on the Company’s interim financial statements. |
Cash, cash equivalents and rest
Cash, cash equivalents and restricted cash | 9 Months Ended |
Sep. 30, 2022 | |
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. These investments relate to money market securities with maturities of three months or less when acquired. The Company’s institutional money market accounts permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions, which are considered Level 1 inputs in the fair value hierarchy. Given their short-term maturities and the underlying value being 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: September 30, December 31, 2022 2021 Cash 1,847,024 3,262,977 Money market 9,032,860 33,617,696 Total cash and cash equivalents $ 10,879,884 $ 36,880,673 Restricted cash $ 28,859 $ 31,279 Restricted cash refers to an amount required under the Company’s new 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. Details of the cash and cash equivalents balances as of September 30, 2022 and December 31, 2021, broken down by currency in which the funds are denominated, are reported in the following table: September 30, December 31, 2022 2021 Cash in CHF 367,043 157,310 Cash in EUR 571,507 338,766 Cash in USD 9,948,299 36,322,777 |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2022 | |
Marketable Securities | |
Marketable Securities | 4. Marketable Securities As of September 30, 2022, the Company reports $14,767 thousand of marketable securities, related to United States Treasury Securities (“USTS”), within current and non-current assets. The USTS purchased have maturity dates going from September 2022 to December 2023, on a monthly basis, in tranches of USD 1,000 thousand each month. The Company classifies the USTS, which are accounted for as available-for-sale, within the Level 1 fair value hierarchy category as the fair value is based on quoted market prices in active markets with a high level of daily trading volume. The following table summarizes the Company’s investment in available-for-sale marketable securities with the detail of the unrealized gains /losses and the estimated fair value as of September 30, 2022: September 30, 2022 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 $ 14,864,982 $ — $ — $ (98,038) $ 14,766,944 Totals $ 14,864,982 $ — $ — $ (98,038) $ 14,766,944 The Company regularly reviews the securities in an unrealized loss position and evaluates the current expected credit loss by considering factors such historical experience, market data, the financial condition and near-term prospects of the investee, the extent of the loss related to credit of the issuer, the expected cash flows from the security, the Company’s intent to sell the security, and whether or not the Company will be required to sell the security before the recovery of its amortized cost. As of September 30, 2022, 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 September 30, 2022 were primarily due to changes in interest rates, and not due to increased credit risks associated with specific securities. Accordingly, as of September 30, 2022, 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 | 9 Months Ended |
Sep. 30, 2022 | |
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 consists of the following: September 30, December 31, 2022 2021 Tax credits $ 66,467 $ 113,586 Prepaid and deferred expenses 998,151 498,252 Other receivables 101,916 81,862 Prepaid D&O insurance costs 452,291 147,671 Total prepaid expenses and other current assets $ 1,552,358 $ 727,785 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 | 9 Months Ended |
Sep. 30, 2022 | |
Property and Equipment, net | |
Property and Equipment, net | 6. Property and Equipment, net Property and equipment, net consists of the following : September 30, December 31, 2022 2021 Computer $ 67,714 $ 55,141 Furniture and fixtures 54,187 42,148 Leasehold improvements 29,272 17,327 Laboratory instruments 27,617 19,759 Total property and equipment $ 178,790 $ 134,375 Less: accumulated depreciation (42,073) (28,389) Property and equipment, net $ 136,717 $ 105,986 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 periods ended September 30, 2022 and 2021 was $18,860 and $9,699, respectively. |
Operating Lease. Right of Use (
Operating Lease. Right of Use ("ROU") Assets | 9 Months Ended |
Sep. 30, 2022 | |
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. Its current lease portfolio consists of leases with remaining terms ranging from three we will exercise the renewal option. The Company’s lease agreements do not contain residual value guarantees or material restrictive covenants. On December 24, 2020, the Company renewed a five-year operating lease term in Cluster II Building with Parc Scientific de Barcelona to lease lab and office space of 1,042 square feet. In connection with the lease, the Company paid a security deposit of EUR 6,469 classified as deposit in non-current assets. The Company is required to pay for operating costs, which are billed monthly based on the Company’s share of the total rentable square footage. These additional charges are considered variable lease costs and are recognized in the period in which the costs are incurred. The Company accounted for the renewal as a modification of the original agreement and recorded an additional right-of-use asset and corresponding lease liability based on the incremental borrowing rate determined as of the effective date of the modified lease. On June 1, 2021, the Company entered into a five-year operating lease agreement to lease office space in Via Soave, n.6 in Lugano, Switzerland. The lease agreement is renewable for an additional five years. The Company is required to pay for operating costs, which are considered variable lease costs and are recognized in the period in which the costs are incurred. In connection with the lease, as guarantee for any damages claimed by the lessor, the Company deposited CHF 28,500 (USD 28,859) into a restricted bank account, which is classified in the financial statements as restricted cash. On October 1, 2021, the Company entered into a three-year operating lease agreement to lease office space in Bethesda, Maryland. In connection with the lease, the Company paid a security deposit of USD 5,227, classified as deposit in non-current assets, for the performance of all obligations, covenants and conditions and agreements under the lease. On November 1, 2021, the Company entered into a five-year operating lease agreement in Torre D Building with Parc Scientific de Barcelona for larger office space of 1,417 square feet to accommodate the Company’s continued growth and contemporaneously terminated a lease, entered in October 2020, in Torre I Building for 830 square feet. In connection with the Torre D Building lease, the Company paid a security deposit of EUR 4,325 classified as deposit in non-current assets. The Company is required to pay for operating costs, which are billed monthly based on the Company's share of the total rentable square footage. These additional charges are considered variable lease costs and are recognized in the period in which the costs are incurred. On July 10, 2022, the Company entered into a three-year operating lease agreement in Cluster II Building with Parc Scientific de Barcelona for a warehouse space of 245 square feet. In connection with the lease, the Company paid a security deposit of EUR 685 classified as deposit in non-current assets. The Company is required to pay for operating costs, which are billed monthly based on the Company's share of the total rentable square footage. These additional charges are considered variable lease costs and are recognized in the period in which the costs are incurred. Operating leases are reflected on our balance sheet as operating lease ROU assets and the related current and non-current operating lease liabilities. ROU assets represent the right to use an underlying asset for the lease term, and lease liabilities represent the obligation to make lease payments arising from the lease agreement. Operating lease ROU assets and liabilities are recognized at the commencement date, or the date on which the lessor makes the underlying asset available for use, based upon the present value of the lease payments over the respective lease term. Lease expense is recognized on a straight-line basis over the lease term. Variable lease costs such as common area maintenance, property taxes and insurance are expensed as incurred. 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. September 30, December 31, 2022 2021 Operating Lease Operating lease- right of use assets $ 670,261 $ 901,042 Operating lease liability - current $ 214,971 $ 219,137 Operating lease liability - non-current $ 468,760 $ 695,053 Weighted average remaining lease term - years 3.31 4.02 Weighted average discount rate 1.53 1.86 The operating lease expenses were as follows: September 30, September 30, 2022 2021 Operating lease costs $ 170,241 $ 133,604 The future minimum lease payments for the Company’s operating leases as of September 30, 2022, are as follows: Fiscal Year Operating Leases September 30, 2023 $ 228,837 September 30, 2024 229,564 September 30, 2025 157,978 September 30, 2026 79,884 September 30, 2027 4,235 Total future minimum lease payments 700,498 Less amount representing interest or imputed interest 16,767 Present value of lease liabilities $ 683,731 |
Accounts Payable
Accounts Payable | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022, and December 31, 2021, accounts payable amounted to $1,018,809 and $560,479, respectively. All accounts payable are due in less than 12 months. |
Other Current Liabilities and D
Other Current Liabilities and Deferred Income | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Payable for social security payments $ 254,586 $ 255,068 Accrued payroll 606,274 465,382 Accrued expenses 2,068,366 681,770 Tax provision 12,847 380 Total other current liabilities $ 2,942,073 $ 1,402,600 Deferred income 55,180 266,504 Total other current liabilities and deferred income $ 2,997,253 $ 1,669,104 Payables for social security payments refers to amounts withheld by the Company and due to for social security and employee withholding taxes. Accrued payroll refers to accruals for year-end bonuses, accrued vacations and overtime including social security charges, to be paid to employees. Accrued expenses refer to invoices to be received from vendors for services performed and not yet billed. Deferred income refers to income from the Company’s collaboration agreement (the “Zentalis Collaboration Agreement”) with Zentalis Pharmaceuticals, Inc (“Zentalis”). It will be recognized in the statement of operations in accordance with the costs sustained. |
Pension Obligations
Pension Obligations | 9 Months Ended |
Sep. 30, 2022 | |
Pension Obligations | |
Pension Obligations | 10. Pension Obligations Net pension obligations related to the Company’s defined pension plan refer only to Swiss employees and as of September 30, 2022 and December 31, 2021, can be summarized as follows: September 30, December 31, 2022 2021 Reconciliation of funded status: Funded status beginning of year $ (329,458) $ (171,558) Expense (135,334) (144,146) Employer contribution 45,783 88,819 Translation differences 29,744 (1,437) Change in accumulated other comprehensive income 11,483 (101,136) Funded status at end of year $ (377,782) $ (329,458) Component of net periodic pension costs: Service cost $ 127,652 $ 132,809 Interest cost 2,538 1,318 Expected return on plan assets (6,771) (5,558) Amortization of (gain)/losses 12,602 16,212 Amortization of prior service cost (687) (635) Total $ 135,334 $ 144,146 The service cost component of net periodic benefit cost is presented in the same line items on the consolidated statement of operations where the other employee compensation costs are reported: research and development expenses and general and administrative expenses. All other components of net periodic benefit costs are presented as part of other income (expenses) net, on the consolidated statement of operations. |
Loans
Loans | 9 Months Ended |
Sep. 30, 2022 | |
Loans | |
Loans | 11. Loans In March 2020, the Company obtained a CHF 14,600 five-year loan. The loan had zero interest and original maturity on June 30, 2025. The loan was guaranteed through joint and several sureties by the Swiss government. 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. In February 2022, the Company early extinguished the loan. No expenses or charges were incurred for the early extinguishment of the loan. In August 2020, the Company obtained a CHF 638,000 (USD 700,221 at the historical foreign exchange rate) nine-year loan. The loan has zero interest. The loan 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 do 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: September, 30 Total 2023 2024 2025 2026 2027 Thereafter Loan $ 585,283 101,260 81,008 81,008 81,008 81,008 159,991 |
Fair Value Measurement
Fair Value Measurement | 9 Months Ended |
Sep. 30, 2022 | |
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) September 30, 2022: Marketable securities available for sale Debt securities - U.S. government treasury securities, current 11,850,614 — — Debt securities - U.S. government treasury securities, non current 2,916,330 — — Total marketable securities available for sale $ 14,766,944 — — Cash and cash equivalents: Money market funds 9,032,860 — — Total cash and cash equivalents $ 9,032,860 — — December 31, 2021: Cash and cash equivalents: Money market funds 33,617,696 — — Total cash and cash equivalents $ 33,617,696 — — 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 | 9 Months Ended |
Sep. 30, 2022 | |
Common and Preferred Stock | |
Common and Preferred Stock | 13. Common and Preferred Stock As of September 30, 2022 and December 31, 2021, 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 September 30, 2022 and December 31, 2021, there were 11,883,368 shares of common stock, $0.0001 par value, issued and outstanding. No shares of preferred stock were outstanding as of September 30, 2022 and December 31, 2021. There were 1,185,879 (1,346,390 before the reverse stock split) shares Preferred shares Preferred of December 31, 2020. The reverse stock split did not result in any change of the original par value of the Company common and preferred stock. Upon closing of the IPO, the Series A Preferred Stock and Series B Preferred Stock, as resulting from the reverse stock split, was converted to common stock at a ratio of 1-for-1. The holders of the Company’s Series A Preferred Stock and Series B Preferred Stock had certain voting, dividend, and redemption rights, as well as liquidation preferences and conversion privileges. All rights, preferences, and privileges associated with the Series A Preferred Stock and Series B Preferred Stock were terminated at the time of the Company’s IPO in conjunction with the conversion of all outstanding shares of Series A Preferred Stock and Series B Preferred Stock into shares of common stock. |
Equity Incentive Plans
Equity Incentive Plans | 9 Months Ended |
Sep. 30, 2022 | |
Equity Incentive Plans | |
Equity Incentive Plans | 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, as adjusted after a stock split of 1-for- 0.880784 lthough all outstanding awards granted under the 2020 Omnibus Plan will continue to be subject to the terms and conditions as set forth in the agreements evidencing such awards and the terms of the 2020 Omnibus Plan On December 23, 2021, the Board determined it advisable and in the best interests of the Company to adopt an 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 and the related guidance issued thereunder with respect to the Company and its affiliates. The maximum number of shares reserved for issuance pursuant to awards granted under the 2021 Inducement Equity Incentive Plan is 1,000,000. On June 16, 2022, at the Company’s annual meeting of stockholders, the Company’s stockholders approved the Company’s 2022 Equity Incentive Plan (the “2022 Plan”). The 2022 Plan was approved by the Board on May 12, 2022 subject to stockholder approval and became effective upon such approval by the Company’s stockholders at the 2022 annual meeting. The 2022 Plan is the successor to and continuation of the 2020 Omnibus Plan, i n order to allow the Company to continue to utilize a broad array of equity incentives in order to secure and retain the services of our employees, directors, and consultants, and that are intended to align the interests of our employees, directors, and consultants with the interests of our stockholders. In addition, beginning on January 1, 2023 and ending on (and including) January 1, 2032, the maximum number of shares of common stock that may be issued under the 2022 Plan will cumulatively be increased by 6% of the number of shares of common stock issued and outstanding on the immediately preceding December st exercise price of a stock option generally cannot be less than 100% of the fair market value of our common stock on the date of grant for non-statutory stock options. Stock Based Compensation The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2022: 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, 2021 960,216 $3.46 $5.13 9.23 — Options granted 1,003,300 $2.49 $3.80 9.60 — Options exercised — — — — — Options cancelled/forfeited (48,322) $4.16 $5.99 — — Options outstanding as of September 30, 2022 1,915,194 $2.93 $4.41 9.10 — Options Outstanding Options Exercisable Weighted Average Number Weighted- Average Years Weighted Average Number Weighted Average Exercise Price Outstanding Remaining on Contractual Grant Date Exercisable Exercise Price Life Fair Value $3.30 - $4.22 1,493,744 9.14 $1.73 - $3.03 365,881 $3.30 - $4.22 $5.86 - $5.99 239,250 9.17 $4.22 - $6.75 32,421 $5.86 - $5.99 $7.80 - $10.03 182,200 8.75 $5.47 - $6.18 108,057 $7.80 - $10.03 On March 3, 2021, the Board approved a 1-for- 0.880784 The reverse stock split did not impact the fair value of the stock option awards previously recorded and no modification accounting is required because all the three following conditions were met: (i) the fair value of the modified award is the same as the fair value of the original award immediately before the original award is modified; (ii) the vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified and (iii) the classification of the modified award as an equity instrument is the same as the classification of the original award immediately before modification. 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 September 30, 2022. 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: Nine Months Ended September 30, 2022 2021 Grant date fair value $ 2.49 $ 4.30 Volatility 80 % 80 % Expected term (years) 5.24 4.51 Risk-free interest rate 3.38 0.59 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 for the nine months ended September 30, 2022 and 2021 was $2.49 and $4.30, respectively. Restricted Stock Units and Performance Stock Units The following table lists the RSUs and PRSUs awarded under the 2022 Plan for the nine months ended September 30, 2022 and 2021: Three Months Ended September 30 Nine Months Ended September 30 2022 2021 2022 2021 RSUs granted 103,050 — 103,050 — Grant date fair value $ 3.48 $ — $ 3.48 $ — 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 maximum 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. RSUs and PRSUs do not have the voting rights of ordinary shares, and the shares underlying the RSUs and PRSUs are not considered issued and outstanding. Under the 2022 Plan, each RSU/PRSU represents a contingent right to receive one of our ordinary shares. Total stock-based compensation expense is recognized for stock options and RSUs granted to employees and non-employees and has been reported in the Company’s consolidated statements of operations as follows: Three Months Ended September 30 Nine Months Ended September 30 2022 2021 2022 2021 Research and development 167,929 97,605 431,222 230,623 General and administrative 187,718 153,220 536,520 322,488 Total stock-based compensation $ 355,647 $ 250,825 $ 967,742 $ 553,111 As of September 30, 2022, the total unrecognized compensation cost related to non-vested stock options and RSUs granted was USD 4,148 thousand and is expected to be recognized over 4 years. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2022 | |
Warrants | |
Warrants | 15. Warrants In July 2020, in connection with the issuance of the Series B Preferred Stock through a private placement, the Company issued equity-classified warrants to designees of the placement agent to purchase an aggregate of 269,360 shares of our common stock at an exercise price of $4.46 per share, valued in the aggregate at USD 413,887 and included in the issuance costs of the Series B Preferred Stock. The warrants vested immediately upon issuance, provide for a cashless exercise right and are exercisable for a period of five years from July 20, 2020. On March 3, 2021, the Board approved a 1-for- 0.880784 On May 6, 2021, the Company entered into an investment banking services and financial advisory agreement and issued equity-classified warrants to designees of the investment bank 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 USD 1,034 thousand. 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 nine months service period as general and administrative expense. As of September 30, 2022, no warrants were exercised or exchanged. |
Collaboration Agreement
Collaboration Agreement | 9 Months Ended |
Sep. 30, 2022 | |
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. In May 2021, the first target development program under the Zentalis Collaboration Agreement was identified, and the estimated development costs were approved and collected in July 2021. The transaction price of this first target development program includes (i) a fixed, one-time payment of $50 thousand as program initiation fee, (ii) up to an aggregate of $272 thousand as reimbursement for employee and external research and development costs, (iii) a potential payment in the amount of $250 thousand subject to the exercise by Zentalis of a research program option, (iv) up to an aggregate of $41.5 million payable in the form of event-based milestone payments, if certain goals are met in the future, and (v) other royalty-based payments based on future net sales. The Company analyzed the Zentalis Collaboration Agreement and concluded that it represents a contract with a customer within the scope of ASC 606 and ASC 808. Based on that evaluation, (i) the program initiation fee was recognized as revenue in full as of June 30, 2021 at a point in time, at program inception as there is no unsatisfied performance obligation; (ii) the performance obligation to provide development services, is satisfied over a period of time as services are performed and Zentalis receives the benefit for the services. The Company will recognize revenue associated with the performance obligation as the research and development services are provided using an input method, according to the costs incurred. As of September 30, 2022, the Company recognized $133 thousand of revenues under the Zentalis Collaboration Agreement, and reported current portion of deferred revenues for $55 thousand. |
Net loss per common share
Net loss per common share | 9 Months Ended |
Sep. 30, 2022 | |
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 determined using the treasury-stock and if-converted methods. 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 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 September 30 Nine Months Ended September 30 2022 2021 2022 2021 Options to purchase common stock 1,505,562 662,203 1,221,021 575,910 RSUs 38,839 — 13,088 — Warrants to purchase common stock 425,387 436,089 425,387 344,550 In addition 200,000 PRSUs, granted in December 2021, contingently issuable upon meeting certain performance conditions are outstanding and will be included in the computation upon not resulting in anti-dilutive impacts and when the related performance conditions will be met. |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2022 | |
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). In addition to royalties, the Company shall pay Minoryx certain milestones payments of 1.25% of any consideration received in the event of a sale of the Company or substantially all of the assets, including by merger, change of control, or reorganization. As of September 30, 2022 and 2021, there were no receivables and payables, revenues or expenses with Minoryx. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Commitments | |
Commitments | 19. Commitments As of September 30, 2022, the Company had research commitments for $1,176 thousands. |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Nature of the Business and Basis of Presentation | |
Basis of presentation | Basis of Presentation The accompanying unaudited interim condensed financial statements (the “interim financial statements”) reflect the accounts of Gain Therapeutics, Inc., GT Gain Therapeutics SA and its wholly owned branch Gain Therapeutics Sucursal en España. All intercompany transactions and balances have been eliminated in the preparation of the interim financial statements. The interim financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“US GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The interim financial statements as of September 30, 2022 reflect, for all periods presented, the retroactive application of the reverse stock split that occurred effective March 17, 2021. All amounts in the interim financial statements are expressed in United States dollars (USD/$) and disclosed within these explanatory notes in United States dollars (USD/$) or Swiss Franc (CHF), which are the functional currencies of the Company and its operating subsidiary, GT Gain Therapeutics SA, respectively. 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, 2021, 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 September 30, 2022, the results of its operations and its statements of stockholders’ equity for the three and nine months ended September 30, 2022 and 2021 and its statements of cash flows for the nine months ended September 30, 2022 and 2021. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, 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, 2021, and the notes thereto, which are included in the Company’s 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 September 30, 2022, 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 and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt 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 proceeds from capital contributions. 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 operations have consisted primarily of organizing and staffing the Company, expanding its operations, securing financing, acquiring, developing and securing our 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. In accordance with Accounting Standards Update, or “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. Accordingly, the consolidated financial statements have been prepared assuming that the Company will continue as a going concern. |
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, and only has one operating segment. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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 the U.S. dollar. The functional currencies of the Company’s foreign operations are the respective local currencies (Swiss Franc in Switzerland and Euro in Spain). Assets and liabilities reported in the Company’s consolidated balance sheets are translated into U.S. dollars (the currency in which these financial statements are presented) at the exchange rates applicable at the balance sheet dates and for the consolidated statement of operations accounts 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 September 30, 2022 and December 31, 2021, accumulated currency translation adjustment recorded in accumulated other comprehensive loss amounted to $45,456 and $165,156, respectively. |
Use of Estimates | Use of Estimates The preparation of 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 grant funds, accrued expenses, defined benefit pension liability, warrants and stock-based compensation. These estimates, judgments and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. Changes in estimates are recorded in the period in which they become known. To the extent that material differences arise between the estimates and actual results, the Company’s future results of operations will be affected. To date, the COVID 19 pandemic has not had a significant impact on the Company’s estimates. |
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 day, as cash and cash equivalents. |
Marketable Securities | Marketable Securities The Company classifies marketable securities as held-to-maturity or available-for-sale at the time these instruments are purchased, based on the requirements of ASC 320. Marketable securities are classified as held-to-maturity when the Company has the positive intent and the capacity to hold the marketable securities until the maturity date. Held-to-maturity marketable securities are carried out at amortized cost, with the accretion of discounts (or amortization of premiums) included within the calculation of the effective interest method. The effective interests of the period are accounted for in the Company’s statements of operations as financial income (or expense). Marketable securities are classified as available-for-sale when 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/losses” excluded from the computation of the earnings of the period and accounted for in other comprehensive income. 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 reporting entity’s reasonable expectation 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 form 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 rates recorded in the consolidated statements of operations 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” The Company amortizes the capitalized software development costs on a straight-line basis over the estimated useful life of the software, which is six years, beginning when the asset is substantially ready for use. The amortization of capitalized software development costs is reflected in general and administrative expenses. Amortization expense for the periods ended September 30, 2022 and 2021 was $27,198 and nil, respectively |
Impairment of Long-lived Assets | Impairment of Long-lived Assets In accordance with ASC Topic 360-10-20, ‘‘Property, Plant and Equipment,’’ the Company performs an impairment test whenever events or circumstances indicate that the carrying value of long-lived assets with finite lives may be impaired. Impairment is measured by comparing the carrying value of the long-lived assets to the estimated undiscounted pre-tax cash flows expected to result from the use of such assets and their ultimate disposition. In circumstances where impairment is determined to exist, the Company will write down the asset to its fair value based on the present value of estimated cash flows. To date, no impairments have been identified by management as of and for all periods presented. |
Patents | Patents Patent-related costs refer to legal fees incurred by the Company in connection with filing and prosecuting patent applications and are expensed as incurred due to uncertainty about the recovery of the expenditures. 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 | 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 to it at that time at the date 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 employee 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 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 biopharmaceuticals 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 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. The fair market value for RSUs is based on the closing price of our stock on the grant date. We recognize expenses related to RSUs based on the fair market value, as determined on the grant date, on a straight line basis over the requisite service period for the entire award. Forfeitures are recognized as they occur. |
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 (such as those awarded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA and from Innosuisse – Swiss Innovation Agency), 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 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. The Company recognizes tax liabilities from an uncertain tax position if it is more likely than not that the tax position will not be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. There are no uncertain tax positions that have been recognized in the accompanying consolidated financial statements. |
Fair value measurements | 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, we utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and consider counterparty credit risk in their assessment of fair value. |
Comprehensive income/(loss) | Comprehensive income/(loss) Comprehensive income/(loss) is composed of net income/(loss) and certain changes in stockholder’s equity that are excluded from net income/(loss), primarily foreign currency translation adjustments, unrealized gains/losses on available for sale securities and defined benefit obligation adjustments. |
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 September 30, 2022 and 2021, common stock equivalents consisted of stock options 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. |
COVID-19 Pandemic | COVID-19 Pandemic In regard to the ongoing COVID-19 global pandemic, the Company has taken measures to secure its research and development activities, while work in its laboratories and facilities has been re-organized to reduce risks of COVID-19 transmission. Given the global impact and the other risks and uncertainties associated with the COVID-19 pandemic, the Company’s business, financial condition and results of operations could be materially adversely affected. The Company continues to closely monitor the COVID-19 pandemic and evolve its business continuity plans, clinical development plans and response strategy to mitigate any potential impact. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from those estimates, and any such differences may be material to the Company’s financial statements. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that the Company adopts as of the specified effective date. There were no new material accounting pronouncements issued in the first nine months of 2022 with a material impact on the Company’s interim financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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) | 9 Months Ended |
Sep. 30, 2022 | |
Cash, cash equivalents and restricted cash | |
Schedule of cash, cash equivalents and restricted cash | September 30, December 31, 2022 2021 Cash 1,847,024 3,262,977 Money market 9,032,860 33,617,696 Total cash and cash equivalents $ 10,879,884 $ 36,880,673 Restricted cash $ 28,859 $ 31,279 |
Schedule of cash and cash equivalents balances broken down by currency | September 30, December 31, 2022 2021 Cash in CHF 367,043 157,310 Cash in EUR 571,507 338,766 Cash in USD 9,948,299 36,322,777 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Marketable Securities | |
Schedule of Marketable Securities | September 30, 2022 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 $ 14,864,982 $ — $ — $ (98,038) $ 14,766,944 Totals $ 14,864,982 $ — $ — $ (98,038) $ 14,766,944 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expenses and Other Current Assets | |
Schedule of Prepaid Expenses and Other Current Assets | September 30, December 31, 2022 2021 Tax credits $ 66,467 $ 113,586 Prepaid and deferred expenses 998,151 498,252 Other receivables 101,916 81,862 Prepaid D&O insurance costs 452,291 147,671 Total prepaid expenses and other current assets $ 1,552,358 $ 727,785 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property and Equipment, net | |
Schedule of Property and equipment | September 30, December 31, 2022 2021 Computer $ 67,714 $ 55,141 Furniture and fixtures 54,187 42,148 Leasehold improvements 29,272 17,327 Laboratory instruments 27,617 19,759 Total property and equipment $ 178,790 $ 134,375 Less: accumulated depreciation (42,073) (28,389) Property and equipment, net $ 136,717 $ 105,986 |
Operating Lease. Right of Use_2
Operating Lease. Right of Use ("ROU") Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Operating Lease. Right of Use ("ROU") Assets | |
Schedule of components of lease accounting | September 30, December 31, 2022 2021 Operating Lease Operating lease- right of use assets $ 670,261 $ 901,042 Operating lease liability - current $ 214,971 $ 219,137 Operating lease liability - non-current $ 468,760 $ 695,053 Weighted average remaining lease term - years 3.31 4.02 Weighted average discount rate 1.53 1.86 |
Schedule of components of lease expense | September 30, September 30, 2022 2021 Operating lease costs $ 170,241 $ 133,604 |
Schedule of future minimum lease payments | The future minimum lease payments for the Company’s operating leases as of September 30, 2022, are as follows: Fiscal Year Operating Leases September 30, 2023 $ 228,837 September 30, 2024 229,564 September 30, 2025 157,978 September 30, 2026 79,884 September 30, 2027 4,235 Total future minimum lease payments 700,498 Less amount representing interest or imputed interest 16,767 Present value of lease liabilities $ 683,731 |
Other Current Liabilities and_2
Other Current Liabilities and Deferred Income (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Other Current Liabilities and Deferred Income | |
Schedule of Other current liabilities and deferred income | September 30, December 31, 2022 2021 Payable for social security payments $ 254,586 $ 255,068 Accrued payroll 606,274 465,382 Accrued expenses 2,068,366 681,770 Tax provision 12,847 380 Total other current liabilities $ 2,942,073 $ 1,402,600 Deferred income 55,180 266,504 Total other current liabilities and deferred income $ 2,997,253 $ 1,669,104 |
Pension Obligations (Tables)
Pension Obligations (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Pension Obligations | |
Schedule of Pension obligations | September 30, December 31, 2022 2021 Reconciliation of funded status: Funded status beginning of year $ (329,458) $ (171,558) Expense (135,334) (144,146) Employer contribution 45,783 88,819 Translation differences 29,744 (1,437) Change in accumulated other comprehensive income 11,483 (101,136) Funded status at end of year $ (377,782) $ (329,458) Component of net periodic pension costs: Service cost $ 127,652 $ 132,809 Interest cost 2,538 1,318 Expected return on plan assets (6,771) (5,558) Amortization of (gain)/losses 12,602 16,212 Amortization of prior service cost (687) (635) Total $ 135,334 $ 144,146 |
Loans (Tables)
Loans (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Loans | |
Schedule of future loan payments | The future payments under the loan are reported in the table below: September, 30 Total 2023 2024 2025 2026 2027 Thereafter Loan $ 585,283 101,260 81,008 81,008 81,008 81,008 159,991 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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) September 30, 2022: Marketable securities available for sale Debt securities - U.S. government treasury securities, current 11,850,614 — — Debt securities - U.S. government treasury securities, non current 2,916,330 — — Total marketable securities available for sale $ 14,766,944 — — Cash and cash equivalents: Money market funds 9,032,860 — — Total cash and cash equivalents $ 9,032,860 — — December 31, 2021: Cash and cash equivalents: Money market funds 33,617,696 — — Total cash and cash equivalents $ 33,617,696 — — |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity Incentive Plans | |
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, 2021 960,216 $3.46 $5.13 9.23 — Options granted 1,003,300 $2.49 $3.80 9.60 — Options exercised — — — — — Options cancelled/forfeited (48,322) $4.16 $5.99 — — Options outstanding as of September 30, 2022 1,915,194 $2.93 $4.41 9.10 — Options Outstanding Options Exercisable Weighted Average Number Weighted- Average Years Weighted Average Number Weighted Average Exercise Price Outstanding Remaining on Contractual Grant Date Exercisable Exercise Price Life Fair Value $3.30 - $4.22 1,493,744 9.14 $1.73 - $3.03 365,881 $3.30 - $4.22 $5.86 - $5.99 239,250 9.17 $4.22 - $6.75 32,421 $5.86 - $5.99 $7.80 - $10.03 182,200 8.75 $5.47 - $6.18 108,057 $7.80 - $10.03 |
Schedule of grant-date fair value of stock options granted to employees and directors | Nine Months Ended September 30, 2022 2021 Grant date fair value $ 2.49 $ 4.30 Volatility 80 % 80 % Expected term (years) 5.24 4.51 Risk-free interest rate 3.38 0.59 Expected dividend yield — — |
Schedule of RSUs and PRSUs awarded during the period | The following table lists the RSUs and PRSUs awarded under the 2022 Plan for the nine months ended September 30, 2022 and 2021: Three Months Ended September 30 Nine Months Ended September 30 2022 2021 2022 2021 RSUs granted 103,050 — 103,050 — Grant date fair value $ 3.48 $ — $ 3.48 $ — |
Schedule of stock-based compensation expense recognized for stock options granted to employees and non-employees | Three Months Ended September 30 Nine Months Ended September 30 2022 2021 2022 2021 Research and development 167,929 97,605 431,222 230,623 General and administrative 187,718 153,220 536,520 322,488 Total stock-based compensation $ 355,647 $ 250,825 $ 967,742 $ 553,111 |
Net loss per common share (Tabl
Net loss per common share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30 Nine Months Ended September 30 2022 2021 2022 2021 Options to purchase common stock 1,505,562 662,203 1,221,021 575,910 RSUs 38,839 — 13,088 — Warrants to purchase common stock 425,387 436,089 425,387 344,550 |
Nature of the Business and Ba_3
Nature of the Business and Basis of Presentation (Details) | 9 Months Ended | |||||||
Mar. 22, 2021 USD ($) | Mar. 22, 2021 USD ($) shares | Mar. 17, 2021 USD ($) $ / shares shares | Mar. 03, 2021 | Jul. 20, 2020 | Sep. 30, 2022 segment | Sep. 30, 2021 USD ($) | May 18, 2022 USD ($) | |
Subsidiary, Sale of Stock [Line Items] | ||||||||
Stock split ratio | 1.1353521 | 10 | ||||||
Preferred stock to common stock conversion ratio | 1 | |||||||
Payments of Stock Issuance Costs | $ 853,488 | |||||||
Number of operating segments | segment | 1 | |||||||
Permitted offering in Shelf Registration Statement | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Maximum aggregate offering price in shelf registration statement | $ 100,000,000 | |||||||
Maximum aggregate offering price of common stock in sales agreement prospectus supplement | $ 16,000,000 | |||||||
IPO | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Stock Issued During Period, Shares, New Issues | shares | 3,636,364 | |||||||
Public offering price | $ / shares | $ 11 | |||||||
Proceeds | $ 40,558,000 | $ 34,978,000 | ||||||
Underwriting Discounts and Commissions | 2,950,000 | |||||||
Other Offering Expenses | 2,071,000 | $ 2,071,000 | ||||||
Proceeds before deduction of offering expenses | $ 42,630,000 | |||||||
Preferred stock to common stock conversion ratio | 1 | |||||||
Underwriters' option | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Stock Issued During Period, Shares, New Issues | shares | 545,454 | |||||||
Proceeds | $ 5,580,000 | |||||||
Underwriting Discounts and Commissions | $ 420,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Summary of Significant Accounting Policies | ||
Accumulated currency translation adjustments | $ 45,456 | $ 165,156 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional disclosures (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||
Internal-use software | $ 208,328 | $ 202,609 | |
Impairments of long-lived assets | $ 0 | ||
Dividend yield | 0% | ||
Uncertain tax positions recognized | $ 0 | ||
Capitalized Software | |||
Property, Plant and Equipment [Line Items] | |||
Finite-Lived Intangible Asset, Useful Life | 6 years | ||
Amortization expense | $ 27,198 | $ 0 | |
Equipment and 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 ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | $ 10,879,884 | $ 36,880,673 |
Restricted cash | 28,859 | 31,279 |
Cash | ||
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | 1,847,024 | 3,262,977 |
Money Market | ||
Cash, cash equivalents and restricted cash | ||
Total cash and cash equivalents | $ 9,032,860 | $ 33,617,696 |
Cash, cash equivalents and re_4
Cash, cash equivalents and restricted cash - Schedule of Cash and cash equivalents balances (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents balances | $ 10,908,743 | $ 36,911,952 | $ 41,014,642 | $ 7,504,281 |
CHF | ||||
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents balances | 367,043 | 157,310 | ||
EUR | ||||
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents balances | 571,507 | 338,766 | ||
USD | ||||
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents balances | $ 9,948,299 | $ 36,322,777 |
Marketable Securities (Details)
Marketable Securities (Details) | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Marketable Securities [Line Items] | |
Marketable securities, current and non-current, at fair value | $ 14,766,944 |
U.S. government treasury securities | |
Marketable Securities [Line Items] | |
Marketable securities, current and non-current, at fair value | 14,766,944 |
Debt Instrument, Periodic Payment | $ 1,000,000 |
Marketable Securities - Marketa
Marketable Securities - Marketable securities available for sale (Details) | Sep. 30, 2022 USD ($) |
Marketable Securities [Line Items] | |
Amortized Cost | $ 14,864,982 |
Gross Unrealized Losses | (98,038) |
Estimated Fair Value | 14,766,944 |
U.S. government treasury securities | |
Marketable Securities [Line Items] | |
Amortized Cost | 14,864,982 |
Gross Unrealized Losses | (98,038) |
Estimated Fair Value | $ 14,766,944 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid Expenses and Other Current Assets | ||
Tax credits | $ 66,467 | $ 113,586 |
Prepaid and deferred expenses | 998,151 | 498,252 |
Other receivables | 101,916 | 81,862 |
Prepaid D&O Insurance costs | 452,291 | 147,671 |
Total prepaid expenses and other current assets | $ 1,552,358 | $ 727,785 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Property and Equipment, net | |||
Total property and equipment | $ 178,790 | $ 134,375 | |
Less: accumulated depreciation | (42,073) | (28,389) | |
Property and equipment, net | 136,717 | 105,986 | |
Disposals | 0 | $ 0 | |
Impairment of Long-Lived Assets Held-for-use | 0 | 0 | |
Depreciation expense | 18,860 | $ 9,699 | |
Computer | |||
Property and Equipment, net | |||
Total property and equipment | 67,714 | 55,141 | |
Furniture and fixtures | |||
Property and Equipment, net | |||
Total property and equipment | 54,187 | 42,148 | |
Leasehold improvements | |||
Property and Equipment, net | |||
Total property and equipment | 29,272 | 17,327 | |
Laboratory instruments | |||
Property and Equipment, net | |||
Total property and equipment | $ 27,617 | $ 19,759 |
Operating Lease. Right of Use_3
Operating Lease. Right of Use (ROU) Assets - Additional information (Details) | Jul. 10, 2022 EUR (€) ft² | Nov. 01, 2021 EUR (€) ft² | Oct. 01, 2021 USD ($) | Dec. 24, 2020 EUR (€) ft² | Sep. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jun. 01, 2021 USD ($) | Jun. 01, 2021 CHF (SFr) |
Lessee, Lease, Description [Line Items] | ||||||||
Restricted cash | $ | $ 28,859 | $ 31,279 | ||||||
Lab and office space, Cluster II Building, Parc Scientific de Barcelona | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease term | 5 years | |||||||
Increase (Decrease) in Security Deposits | € | € 6,469 | |||||||
Office space | 1,042 | |||||||
Office space, Via Soave n6 (Lugano, Switzerland) | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease term | 5 years | 5 years | ||||||
Operating lease renewal term | 5 years | 5 years | ||||||
Restricted cash | $ 28,859 | SFr 28,500 | ||||||
Office space in Bethesda, Maryland | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease term | 3 years | |||||||
Increase (Decrease) in Security Deposits | $ | $ 5,227 | |||||||
Office space, Torre D building (Barcelona) | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease term | 5 years | |||||||
Increase (Decrease) in Security Deposits | € | € 4,325 | |||||||
Office space | 1,417 | |||||||
Office space, Torre I building (Barcelona) | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Office space | 830 | |||||||
Warehouse space, Cluster II Building, Parc Cientific de Barcelona | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease term | 3 years | |||||||
Increase (Decrease) in Security Deposits | € | € 685 | |||||||
Office space | 245 | |||||||
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 ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Operating Lease. Right of Use ("ROU") Assets | ||
Operating lease- right of use assets | $ 670,261 | $ 901,042 |
Operating lease liability - current | 214,971 | 219,137 |
Operating lease liability - non current | $ 468,760 | $ 695,053 |
Weighted average remaining lease term - years | 3 years 3 months 21 days | 4 years 7 days |
Weighted average discount rate | 1.53% | 1.86% |
Operating Lease. Right of Use_5
Operating Lease. Right of Use (ROU) Assets - Summary of components of lease expense (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating Lease. Right of Use ("ROU") Assets | ||
Operating lease costs | $ 170,241 | $ 133,604 |
Operating Lease. Right of Use_6
Operating Lease. Right of Use (ROU) Assets - Future minimum lease payments (Details) | Sep. 30, 2022 USD ($) |
Operating Lease. Right of Use ("ROU") Assets | |
June 30, 2023 | $ 228,837 |
June 30, 2024 | 229,564 |
June 30, 2025 | 157,978 |
June 30, 2026 | 79,884 |
June 30, 2027 | 4,235 |
Total future minimum lease payments | 700,498 |
Less amount representing interest or imputed interest | 16,767 |
Present value of lease liabilities | $ 683,731 |
Accounts Payable (Details)
Accounts Payable (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Accounts Payable | ||
Accounts Payable | $ 1,018,809 | $ 560,479 |
Other Current Liabilities and_3
Other Current Liabilities and Deferred Income (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Other Current Liabilities and Deferred Income | ||
Payable for social security payments | $ 254,586 | $ 255,068 |
Accrued payroll | 606,274 | 465,382 |
Accrued expenses | 2,068,366 | 681,770 |
Tax provision | 12,847 | 380 |
Total other current liabilities | 2,942,073 | 1,402,600 |
Deferred income | 55,180 | 266,504 |
Total other current liabilities and deferred income | $ 2,997,253 | $ 1,669,104 |
Pension Obligations - Reconcili
Pension Obligations - Reconciliation of funded status (Details) - Pension Plan - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Reconciliation of funded status | ||
Funded status beginning of the year | $ (329,458) | $ (171,558) |
Expense | (135,334) | (144,146) |
Employer contribution | 45,783 | 88,819 |
Translation differences | 29,744 | (1,437) |
Change in accumulated other comprehensive income | 11,483 | (101,136) |
Funded status at end of year | $ (377,782) | $ (329,458) |
Pension Obligations - Component
Pension Obligations - Component of net periodic pension costs (Details) - Pension Plan - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Service cost | $ 127,652 | $ 132,809 |
Interest cost | 2,538 | 1,318 |
Expected return on plan assets | (6,771) | (5,558) |
Amortization of (gain)/losses | 12,602 | 16,212 |
Amortization of prior service cost | (687) | (635) |
Total | $ 135,334 | $ 144,146 |
Loans (Details)
Loans (Details) | 1 Months Ended | |||||
Feb. 28, 2022 CHF (SFr) | Aug. 31, 2020 CHF (SFr) | Mar. 31, 2020 CHF (SFr) | Sep. 30, 2022 CHF (SFr) | Aug. 31, 2020 USD ($) | Aug. 31, 2020 CHF (SFr) | |
March 2020 CHF loan | ||||||
Debt Instrument [Line Items] | ||||||
Loan amount | SFr 14,600 | |||||
Term of loan | 5 years | |||||
Interest rate (as a percent) | 0% | |||||
Expenses incurred for early extinguishment of loan | SFr 0 | |||||
August 2020 CHF loan | ||||||
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) | Sep. 30, 2022 USD ($) |
Loans | |
Total | $ 585,283 |
June 30, 2023 | 101,260 |
June 30, 2024 | 81,008 |
June 30, 2025 | 81,008 |
June 30, 2026 | 81,008 |
June 30, 2027 | 81,008 |
Thereafter | $ 159,991 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - Level 1 - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | $ 9,032,860 | $ 33,617,696 |
Money market funds | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 9,032,860 | $ 33,617,696 |
Marketable securities available for sale | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 14,766,944 | |
U.S. government treasury securities, current | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | 11,850,614 | |
U.S. government treasury securities, non current | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Assets, Fair Value Disclosure | $ 2,916,330 |
Common and Preferred Stock (Det
Common and Preferred Stock (Details) | Mar. 17, 2021 | Sep. 30, 2022 $ / shares shares | Dec. 31, 2021 $ / shares shares | Mar. 16, 2021 shares | Dec. 31, 2020 $ / shares shares |
Common and Preferred Stock | |||||
Authorized capital, Common stock (in shares) | 50,000,000 | 50,000,000 | |||
Common stock par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Authorized capital, Preferred stock (in shares) | 10,000,000 | 10,000,000 | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Common stock issued (in shares) | 11,883,368 | 11,883,368 | |||
Common stock outstanding (in shares) | 11,883,368 | 11,883,368 | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Preferred stock, shares outstanding | 0 | 0 | |||
Preferred stock, shares issued | 0 | 0 | |||
Preferred stock to common stock conversion ratio | 1 | ||||
Series A Preferred Stock. | |||||
Common and Preferred Stock | |||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||
Preferred stock, shares outstanding | 1,346,390 | 1,185,879 | |||
Preferred stock, shares issued | 1,346,390 | 1,185,879 | |||
Series B Preferred Stock | |||||
Common and Preferred Stock | |||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||
Preferred stock, shares outstanding | 3,366,999 | 2,965,600 | |||
Preferred stock, shares issued | 3,366,999 | 2,965,600 |
Equity Incentive Plans (Details
Equity Incentive Plans (Details) | 9 Months Ended | |||||||||
Mar. 17, 2021 $ / shares | Mar. 16, 2021 $ / shares | Mar. 04, 2021 | Mar. 03, 2021 | Jul. 20, 2020 | Sep. 30, 2022 shares | Jun. 16, 2022 shares | Dec. 31, 2021 shares | Dec. 23, 2021 shares | Sep. 24, 2020 shares | |
Equity Incentive Plan | ||||||||||
Reverse stock split ratio | 1.1353521 | 10 | ||||||||
Common stock outstanding (in shares) | 11,883,368 | 11,883,368 | ||||||||
2020 Omnibus Plan | ||||||||||
Equity Incentive Plan | ||||||||||
Reverse stock split ratio | 1.1353521 | 1.1353521 | ||||||||
Exercise prices upper limit | $ / shares | $ 3.38 | $ 2.97 | ||||||||
2020 Omnibus Plan | Maximum | ||||||||||
Equity Incentive Plan | ||||||||||
Maximum number of shares reserved for issuance | 1,153,827 | |||||||||
2021 Inducement Equity Incentive Plan | ||||||||||
Equity Incentive Plan | ||||||||||
Maximum number of shares reserved for issuance | 1,000,000 | |||||||||
2022 Plan | ||||||||||
Equity Incentive Plan | ||||||||||
Maximum number of shares reserved for issuance | 1,800,000 | |||||||||
2022 Plan | Newly authorized shares under 2022 plan | ||||||||||
Equity Incentive Plan | ||||||||||
Maximum number of shares reserved for issuance | 646,173 | |||||||||
2022 Plan | Maximum | ||||||||||
Equity Incentive Plan | ||||||||||
Award Expiry term | 10 years | |||||||||
Annual increase in shares authorized for issue under plan, as percentage of common stock issued and outstanding at beginning of year | 6% | |||||||||
2022 Plan | Minimum | ||||||||||
Equity Incentive Plan | ||||||||||
Exercise price as a percentage of fair market value of common stock at grant date for non-statutory options | 100% |
Equity Incentive Plans - Stock
Equity Incentive Plans - Stock Option Activity (Details) - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Shares | |||
Outstanding as at beginning of period (in shares) | 960,216 | ||
Options granted (in shares) | 1,003,300 | ||
Options cancelled/forfeited (in shares) | (48,322) | ||
Options outstanding as at end of period (in shares) | 1,915,194 | 960,216 | |
Weighted Average Grant Date Fair Value | |||
Weighted Average Grant Date Fair Value, options outstanding at beginning of period | $ 3.46 | ||
Weighted Average Grant Date Fair Value, options granted | 2.49 | $ 4.30 | |
Weighted Average Grant Date Fair Value, options cancelled/forfeited | 4.16 | ||
Weighted Average Grant Date Fair Value, options outstanding at end of period | 2.93 | $ 3.46 | |
Weighted Average Exercise Price | |||
Outstanding as at beginning of period (in dollars per share) | 5.13 | ||
Options granted (in dollars per share) | 3.80 | ||
Options cancelled/forfeited (in dollars per share) | 5.99 | ||
Options outstanding as at end of period (in dollars per share) | $ 4.41 | $ 5.13 | |
Additional disclosures | |||
Weighted Average Remaining Contractual Years Outstanding | 9 years 1 month 6 days | 9 years 2 months 23 days | |
Weighted Average Remaining Contractual Years Options granted | 9 years 7 months 6 days |
Equity Incentive Plans - Option
Equity Incentive Plans - Options Outstanding and Exercisable (Details) - $ / shares | 9 Months Ended | 12 Months Ended | ||
Mar. 17, 2021 | Mar. 16, 2021 | Sep. 30, 2022 | Dec. 31, 2021 | |
Equity Incentive Plan | ||||
Weighted Average Exercise Price | $ 4.41 | $ 5.13 | ||
Number outstanding | 1,915,194 | 960,216 | ||
Weighted- Average Years Remaining on Contractual Life | 9 years 1 month 6 days | 9 years 2 months 23 days | ||
Weighted Average Grant Date Fair Value | $ 2.93 | $ 3.46 | ||
Unrecognized compensation cost, recognition period | 4 years | |||
Dividend yield | 0% | |||
Exercise Price 3.30-4.22 | ||||
Equity Incentive Plan | ||||
Number outstanding | 1,493,744 | |||
Weighted- Average Years Remaining on Contractual Life | 9 years 1 month 20 days | |||
Number exercisable | 365,881 | |||
Exercise Price 3.30-4.22 | Minimum | ||||
Equity Incentive Plan | ||||
Weighted Average Exercise Price | $ 3.30 | |||
Weighted Average Grant Date Fair Value | 1.73 | |||
Weighted Average Exercise Price, options exercisable | 3.30 | |||
Exercise Price 3.30-4.22 | Maximum | ||||
Equity Incentive Plan | ||||
Weighted Average Exercise Price | 4.22 | |||
Weighted Average Grant Date Fair Value | 3.03 | |||
Weighted Average Exercise Price, options exercisable | $ 4.22 | |||
Exercise Price 5.86-5.99 | ||||
Equity Incentive Plan | ||||
Number outstanding | 239,250 | |||
Weighted- Average Years Remaining on Contractual Life | 9 years 2 months 1 day | |||
Number exercisable | 32,421 | |||
Exercise Price 5.86-5.99 | Minimum | ||||
Equity Incentive Plan | ||||
Weighted Average Exercise Price | $ 5.86 | |||
Weighted Average Grant Date Fair Value | 4.22 | |||
Weighted Average Exercise Price, options exercisable | 5.86 | |||
Exercise Price 5.86-5.99 | Maximum | ||||
Equity Incentive Plan | ||||
Weighted Average Exercise Price | 5.99 | |||
Weighted Average Grant Date Fair Value | 6.75 | |||
Weighted Average Exercise Price, options exercisable | $ 5.99 | |||
Exercise Price 7.80-10.03 | ||||
Equity Incentive Plan | ||||
Number outstanding | 182,200 | |||
Weighted- Average Years Remaining on Contractual Life | 8 years 9 months | |||
Number exercisable | 108,057 | |||
Exercise Price 7.80-10.03 | Minimum | ||||
Equity Incentive Plan | ||||
Weighted Average Exercise Price | $ 7.80 | |||
Weighted Average Grant Date Fair Value | 5.47 | |||
Weighted Average Exercise Price, options exercisable | 7.80 | |||
Exercise Price 7.80-10.03 | Maximum | ||||
Equity Incentive Plan | ||||
Weighted Average Exercise Price | 10.03 | |||
Weighted Average Grant Date Fair Value | 6.18 | |||
Weighted Average Exercise Price, options exercisable | $ 10.03 | |||
2020 Omnibus Plan | ||||
Equity Incentive Plan | ||||
Number outstanding | 517,902 | 588,000 | ||
Exercise price | $ 3.38 | $ 2.97 |
Equity Incentive Plans - Assump
Equity Incentive Plans - Assumptions (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Equity Incentive Plans | ||
Grant date fair value | $ 2.49 | $ 4.30 |
Volatility | 80% | 80% |
Expected term (years) | 5 years 2 months 26 days | 4 years 6 months 3 days |
Risk-free interest rate | 3.38% | 0.59% |
Expected dividend yield | 0% |
Equity Incentive Plans - Perfor
Equity Incentive Plans - Performance-Based Restricted Stock Units (Details) - 2022 Plan $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares, contingent right to receive in exchange for RSU or PRSU | 1 | 1 |
Performance restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards granted | 200,000 | |
Grant date fair value | $ / shares | $ 0 | |
Performance 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 | $ 1,139 |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards granted | 103,050 | 103,050 |
Grant date fair value | $ / shares | $ 3.48 | $ 3.48 |
Equity Incentive Plans - Stock-
Equity Incentive Plans - Stock-based compensation (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Equity Incentive Plan | ||||
Total stock-based compensation | $ 355,647 | $ 250,825 | $ 967,742 | $ 553,111 |
Unrecognized compensation cost related to non-vested stock options and RSUs | 4,148,000 | $ 4,148,000 | ||
Unrecognized compensation cost, recognition period | 4 years | |||
Research and development | ||||
Equity Incentive Plan | ||||
Total stock-based compensation | 167,929 | 97,605 | $ 431,222 | 230,623 |
General and administrative | ||||
Equity Incentive Plan | ||||
Total stock-based compensation | $ 187,718 | $ 153,220 | $ 536,520 | $ 322,488 |
Warrants (Details)
Warrants (Details) | 9 Months Ended | ||||||
Mar. 03, 2021 | Jul. 20, 2020 | Sep. 30, 2022 shares | May 06, 2021 USD ($) $ / shares shares | Mar. 17, 2021 $ / shares shares | Mar. 16, 2021 $ / shares shares | Jul. 31, 2020 USD ($) $ / shares shares | |
Class of Warrant or Right [Line Items] | |||||||
Reverse stock split ratio | 1.1353521 | 10 | |||||
Warrants to designees of the placement agent, issued July 2020 | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants to purchase common stock | 269,360 | ||||||
Warrants exercise price | $ / shares | $ 5.07 | $ 4.46 | $ 4.46 | ||||
Warrants value | $ | $ 413,887 | ||||||
Warrants term | 5 years | ||||||
Reverse stock split ratio | 1.1353521 | ||||||
Class of Warrant or Right, Outstanding | 237,249 | 269,360 | |||||
Warrants exercised or exchanged | 11,862 | ||||||
Issuance of Common Stock due to warrants cashless exercise | 3,283 | ||||||
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 | $ | $ 1,034,000 | ||||||
Warrants term | 4 years | ||||||
Warrants exercised or exchanged | 0 | ||||||
Warrants, Service period | 9 months |
Collaboration Agreement (Detail
Collaboration Agreement (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
May 31, 2021 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Apr. 20, 2021 item | |
Collaboration Agreement | |||||
Revenues | $ 15,971 | $ 132,640 | $ 97,587 | ||
Multi-target collaboration agreement | Zentalis Pharmaceuticals, Inc. | |||||
Collaboration Agreement | |||||
First target development program initiation fees | $ 50,000 | ||||
Option exercise fees | 250,000 | ||||
Unsatisfied performance obligation | 0 | ||||
Revenues | 133,000 | ||||
Current portion of deferred revenue | $ 55,000 | ||||
Multi-target collaboration agreement | Zentalis Pharmaceuticals, Inc. | Maximum | |||||
Collaboration Agreement | |||||
Number of targets | item | 5 | ||||
Employee and external research and development cost | 272,000 | ||||
Event-based milestone payments | $ 41,500,000 |
Net loss per common share - Com
Net loss per common share - Computation of diluted net loss per share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
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) | 1,505,562 | 662,203 | 1,221,021 | 575,910 |
RSUs | ||||
Net loss per common share | ||||
Antidilutive securities excluded from computation of diluted net loss per share attributable to common stockholders (in shares) | 38,839 | 13,088 | ||
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 | 436,089 | 425,387 | 344,550 |
Related Parties (Details)
Related Parties (Details) - License agreement Minoryx Therapeutics SL - USD ($) | 1 Months Ended | 9 Months Ended | |
Dec. 31, 2017 | Sep. 30, 2022 | Sep. 30, 2021 | |
Related Parties | |||
Percentage of consideration received | 1.25% | ||
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 Thousands | Sep. 30, 2022 USD ($) |
Research Agreements | |
Commitments | |
Commitments | $ 1,176 |