Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 15, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 001-38869 | ||
Entity Registrant Name | HOOKIPA PHARMA INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 81-5395687 | ||
Entity Address, Address Line One | 350 Fifth Avenue, 72nd Floor, Suite 7240 | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10118 | ||
Country Region | +43 | ||
City Area Code | 1 | ||
Local Phone Number | 890 63 60 | ||
Title of 12(b) Security | Common Stock, $0.0001 Par Value per Share | ||
Trading Symbol | HOOK | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 71.7 | ||
Auditor Name | PwC Wirtschaftsprüfung GmbH | ||
Auditor Firm ID | 1259 | ||
Auditor Location | Vienna, Austria | ||
Entity Central Index Key | 0001760542 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Common stock | |||
Document Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 96,550,590 | ||
Class A common stock | |||
Document Information [Line Items] | |||
Entity Common Stock, Shares Outstanding | 2,399,517 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 117,096 | $ 112,488 |
Restricted cash | 537 | |
Accounts receivable | 511 | 6,533 |
Receivable research incentives | 18,760 | 15,479 |
Prepaid expenses and other current assets | 10,749 | 12,159 |
Total current assets | 147,116 | 147,196 |
Non-current assets: | ||
Restricted cash | 425 | 419 |
Property, plant and equipment, net | 7,742 | 17,970 |
Operating lease right of use assets | 5,473 | 4,006 |
Other non-current assets | 581 | 863 |
Total non-current assets | 14,221 | 23,258 |
Total assets | 161,337 | 170,454 |
Current liabilities | ||
Accounts payable | 12,498 | 5,488 |
Deferred revenues | 14,631 | 15,684 |
Operating lease liabilities, current | 1,638 | 1,688 |
Accrued expenses and other current liabilities | 12,101 | 11,178 |
Loans payable, current | 1,120 | 1,594 |
Total current liabilities | 41,988 | 35,632 |
Non-current liabilities | ||
Loans payable, non-current | 911 | |
Operating lease liabilities, non-current | 3,801 | 2,310 |
Deferred revenues, non-current | 19,674 | 25,664 |
Other non-current liabilities | 6,017 | 3,420 |
Total non-current liabilities | 29,492 | 32,305 |
Total liabilities | 71,480 | 67,937 |
Commitments and contingencies (Note 14) | ||
Stockholders' equity: | ||
Preferred Stock | 0 | 0 |
Additional paid-in capital | 467,041 | 397,349 |
Accumulated other comprehensive loss | (7,933) | (7,156) |
Accumulated deficit | (369,261) | (287,681) |
Total stockholders' equity | 89,857 | 102,517 |
Total liabilities and stockholders' equity | 161,337 | 170,454 |
Common stock | ||
Stockholders' equity: | ||
Common stock | 10 | 5 |
Class A common stock | ||
Stockholders' equity: | ||
Common stock | $ 0 | $ 0 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Series A convertible preferred stock | ||
Preferred stock shares designated (in shares) | 2,978 | 2,978 |
Preferred stock, shares outstanding | 370 | 1,697 |
Series A-1 convertible preferred stock | ||
Preferred stock shares designated (in shares) | 15,800 | 15,800 |
Preferred stock, shares outstanding | 10,800 | 15,800 |
Series A-2 convertible preferred stock | ||
Preferred stock shares designated (in shares) | 15,268 | 0 |
Preferred stock, shares outstanding | 15,268 | 0 |
Common stock | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 96,550,590 | 52,317,138 |
Common stock, shares outstanding (in shares) | 96,550,590 | 52,317,138 |
Class A common stock | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 3,900,000 | 3,900,000 |
Common stock, shares issued (in shares) | 2,399,517 | 2,399,517 |
Common stock, shares outstanding (in shares) | 2,399,517 | 2,399,517 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||
Revenue from collaboration and licensing | $ 20,129 | $ 14,249 | $ 18,448 |
Revenue from Contract with Customer, Product and Service [Extensible List] | hook:CollaborationAndLicensingMember | hook:CollaborationAndLicensingMember | hook:CollaborationAndLicensingMember |
Operating expenses: | |||
Research and development | $ (86,424) | $ (68,645) | $ (82,853) |
General and administrative | (18,633) | (18,759) | (17,269) |
Impairment expense | (12,766) | 0 | 0 |
Total operating expenses | (117,823) | (87,404) | (100,122) |
Loss from operations | (97,694) | (73,155) | (81,674) |
Other income (expense): | |||
Grant income | 11,193 | 7,916 | 9,724 |
Interest income | 5,293 | 1,633 | 27 |
Interest expense | (317) | (687) | (898) |
Other income and (expenses), net | 313 | (392) | (2,843) |
Total other income, net | 16,482 | 8,470 | 6,010 |
Net loss before tax | (81,212) | (64,685) | (75,664) |
Income tax expense | (368) | (230) | (1) |
Net loss | (81,580) | (64,915) | (75,665) |
Other comprehensive (loss) income: | |||
Foreign currency translation (loss) gain, net of tax | (777) | (2,376) | 1,287 |
Comprehensive loss | $ (82,357) | $ (67,291) | $ (74,378) |
Net loss per share - basic | $ (0.86) | $ (0.99) | $ (2.30) |
Net loss per share - diluted | $ (0.86) | $ (0.99) | $ (2.30) |
CONSOLIDATED STATEMENTS OF CONV
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Convertible Preferred Stock Series A convertible preferred stock Public offering | Convertible Preferred Stock Series A convertible preferred stock | Convertible Preferred Stock Series A-1 convertible preferred stock | Convertible Preferred Stock Series A-2 convertible preferred stock Public offering | Convertible Preferred Stock | Common Stock Common stock Public offering | Common Stock Common stock Stock Purchase Agreement | Common Stock Common stock | Common Stock Class A common stock | Common Stock Series A convertible preferred stock Public offering | Common Stock Series A convertible preferred stock | Common Stock Series A-1 convertible preferred stock | Additional Paid-In Capital Common stock | Additional Paid-In Capital Series A convertible preferred stock Public offering | Additional Paid-In Capital Series A convertible preferred stock | Additional Paid-In Capital Series A-1 convertible preferred stock | Additional Paid-In Capital Series A-2 convertible preferred stock Public offering | Additional Paid-In Capital Public offering | Additional Paid-In Capital Stock Purchase Agreement | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Common stock Public offering | Common stock Stock Purchase Agreement | Common stock | Series A-1 convertible preferred stock Public offering | Series A-1 convertible preferred stock | Series A-2 convertible preferred stock Public offering | Public offering | Stock Purchase Agreement | Total |
Balance at the beginning of the period at Dec. 31, 2020 | $ 0 | $ 3 | $ 0 | $ 309,288 | $ (6,067) | $ (147,101) | $ 156,123 | ||||||||||||||||||||||||
Balance at the beginning of the period (in shares) at Dec. 31, 2020 | 2,978 | 25,948,712 | 3,819,732 | ||||||||||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||||||||||||||||||||
Conversion of preferred stock into common stock | $ 0 | $ 0 | $ 0 | ||||||||||||||||||||||||||||
Conversion of preferred stock into common stock (in shares) | (1,281) | 1,281,000 | |||||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options | $ 0 | 203 | 203 | ||||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 110,071 | ||||||||||||||||||||||||||||||
Vesting of restricted stock | $ 0 | 0 | |||||||||||||||||||||||||||||
Vesting of restricted stock (in shares) | 43,700 | ||||||||||||||||||||||||||||||
Foreign currency translation adjustment, net of tax | 1,287 | 1,287 | |||||||||||||||||||||||||||||
Stock-based compensation expense | 7,644 | 7,644 | |||||||||||||||||||||||||||||
Net Income (Loss) | (75,665) | (75,665) | |||||||||||||||||||||||||||||
Balance at the end of the period at Dec. 31, 2021 | $ 0 | $ 3 | $ 0 | 317,135 | (4,780) | (222,766) | 89,592 | ||||||||||||||||||||||||
Balance at the end of the period (in shares) at Dec. 31, 2021 | 1,697 | 27,383,483 | 3,819,732 | ||||||||||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||||||||||||||||||||
Issuance of stock | $ 0 | $ 2 | $ 0 | $ 29,625 | $ 40,685 | $ 5,000 | $ 29,625 | $ 40,687 | $ 5,000 | ||||||||||||||||||||||
Issuance of stock (in shares) | 15,800 | 21,700,000 | 1,666,666 | ||||||||||||||||||||||||||||
Conversion of Class A common stock to common stock | $ 0 | $ 0 | |||||||||||||||||||||||||||||
Conversion of Class A common stock to common stock (in shares) | 1,420,215 | (1,420,215) | |||||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options | $ 0 | $ 3 | $ 3 | ||||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 34,223 | ||||||||||||||||||||||||||||||
Vesting of equity grants | $ 0 | $ 0 | |||||||||||||||||||||||||||||
Vesting of equity grants (in shares) | 112,551 | ||||||||||||||||||||||||||||||
ATM costs | (142) | (142) | |||||||||||||||||||||||||||||
Issuance costs | $ (2,713) | $ 0 | $ (1,975) | ||||||||||||||||||||||||||||
Foreign currency translation adjustment, net of tax | (2,376) | (2,376) | |||||||||||||||||||||||||||||
Stock-based compensation expense | 5,043 | 5,043 | |||||||||||||||||||||||||||||
Net Income (Loss) | (64,915) | (64,915) | |||||||||||||||||||||||||||||
Balance at the end of the period at Dec. 31, 2022 | $ 0 | $ 5 | $ 0 | 397,349 | (7,156) | (287,681) | 102,517 | ||||||||||||||||||||||||
Balance at the end of the period (in shares) at Dec. 31, 2022 | 17,497 | 52,317,138 | 2,399,517 | ||||||||||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||||||||||||||||||||
Issuance of stock | $ 0 | $ 2 | $ 2 | $ 18,530 | $ 27,791 | $ 21,112 | $ 18,530 | $ 27,793 | $ 21,114 | ||||||||||||||||||||||
Issuance of stock (in shares) | 15,268 | 22,900,768 | 15,000,000 | ||||||||||||||||||||||||||||
Conversion of preferred stock into common stock | $ 0 | $ 0 | $ 0 | $ 1 | $ 0 | $ (1) | |||||||||||||||||||||||||
Conversion of preferred stock into common stock (in shares) | (1,327) | (5,000) | 1,327,000 | 5,000,000 | |||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options | $ 0 | 1 | $ 1 | ||||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 5,684 | 5,684 | |||||||||||||||||||||||||||||
ATM costs | (86) | $ (86) | |||||||||||||||||||||||||||||
Issuance costs | $ (2,207) | $ (136) | $ (1,471) | ||||||||||||||||||||||||||||
Foreign currency translation adjustment, net of tax | (777) | (777) | |||||||||||||||||||||||||||||
Stock-based compensation expense | 2,345 | 2,345 | |||||||||||||||||||||||||||||
Net Income (Loss) | (81,580) | (81,580) | |||||||||||||||||||||||||||||
Balance at the end of the period at Dec. 31, 2023 | $ 0 | $ 10 | $ 0 | $ 467,041 | $ (7,933) | $ (369,261) | $ 89,857 | ||||||||||||||||||||||||
Balance at the end of the period (in shares) at Dec. 31, 2023 | 26,438 | 96,550,590 | 2,399,517 |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2023 | Dec. 31, 2022 | Jun. 05, 2023 | Mar. 04, 2022 | Feb. 15, 2022 | |
Stock Purchase Agreement | |||||
Share price (in USD per share) | $ 3 | ||||
Series A-1 convertible preferred stock | |||||
Share price (in USD per share) | $ 2,000 | ||||
Series A-1 convertible preferred stock | Public offering | |||||
Share price (in USD per share) | $ 2,000 | ||||
Issuance costs | $ 1,975 | ||||
Series A-2 convertible preferred stock | |||||
Share price (in USD per share) | $ 1,310 | ||||
Series A-2 convertible preferred stock | Public offering | |||||
Share price (in USD per share) | $ 1,310 | ||||
Issuance costs | $ 1,471 | ||||
Common stock | |||||
Share price (in USD per share) | $ 1.31 | $ 2 | |||
Common stock | Public offering | |||||
Share price (in USD per share) | $ 1.31 | $ 2 | |||
Issuance costs | $ 2,207 | $ 2,713 | |||
Common stock | Stock Purchase Agreement | |||||
Share price (in USD per share) | $ 1.4167 | $ 3 | |||
Issuance costs | $ 136 | $ 0 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities: | |||
Net loss | $ (81,580) | $ (64,915) | $ (75,665) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 2,345 | 5,043 | 7,644 |
Depreciation and amortization expense | 3,552 | 3,602 | 4,640 |
Impairment expense | 12,766 | 0 | 0 |
Other non-cash items | 64 | 160 | 1,226 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 6,180 | (341) | (1,943) |
Receivable research incentives | (2,726) | (1,958) | (295) |
Prepaid expenses and other current assets | 1,735 | 2,007 | (7,091) |
Other non-current assets | 304 | 424 | 416 |
Accounts payable | 6,499 | (1,999) | 858 |
Deferred revenues | (8,258) | 35,508 | 1,422 |
Operating lease liabilities | (1,622) | (1,584) | (1,588) |
Accrued expenses and other liabilities | 490 | 2,510 | 4,776 |
Other non-current liabilities | 2,727 | 1,546 | (416) |
Net cash used in operating activities | (57,524) | (19,997) | (66,016) |
Investing activities: | |||
Purchases of property and equipment | (4,159) | (5,017) | (12,581) |
Net cash used in investing activities | (4,159) | (5,017) | (12,581) |
Financing activities: | |||
Payments related to finance leases | (25) | (438) | |
Proceeds from issuance of convertible preferred stock, net of issuance costs | 18,530 | 29,625 | |
Proceeds from issuance of common stock, net of issuance costs | 49,043 | 45,691 | 203 |
Payments for deferred offering costs | (149) | (195) | |
Repayments of borrowings | (1,754) | (2,825) | |
Net cash provided by (used in) financing activities | 65,670 | 72,271 | (235) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 3,987 | 47,257 | (78,832) |
Cash, cash equivalents and restricted cash at beginning of period | 113,444 | 66,912 | 143,177 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 90 | (725) | 2,567 |
Cash, cash equivalents and restricted cash at end of period | 117,521 | 113,444 | 66,912 |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | (14) | (32) | (48) |
Cash paid for income taxes | (403) | (1) | (1) |
Supplemental disclosure of non-cash financing activities: | |||
Property and equipment additions in accounts payable and accrued expenses | (34) | (56) | (742) |
Lease assets obtained in exchange for new operating lease liabilities | $ 2,874 | $ 225 | 2,727 |
Lease assets derecognized upon lease cancellation | $ 1,061 |
Nature of the business and orga
Nature of the business and organization | 12 Months Ended |
Dec. 31, 2023 | |
Nature of the business and organization | |
Nature of the business and organization | 1. Nature of the business and organization HOOKIPA Pharma Inc. (“HOOKIPA” or the “Company”) is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that is designed to reprogram the body’s immune system. The Company was incorporated under the name of Hookipa Biotech, Inc. under the laws of the State of Delaware in February 2017 as a fully-owned subsidiary of Hookipa Biotech AG. In June 2018, the Company changed its name from Hookipa Biotech, Inc. to HOOKIPA Pharma Inc. and in order to effectuate the change of the jurisdiction of incorporation, the Company acquired all of the shares of Hookipa Biotech AG, now Hookipa Biotech GmbH. HOOKIPA is headquartered in New York, with European research and preclinical development operations headquartered in Vienna, Austria. In April 2019, the Company closed its initial public offering (“IPO”) and its common stock started trading on the Nasdaq Global Select Market under the ticker symbol “HOOK”. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the ability to establish clinical- and commercial-scale manufacturing processes and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities and may not ultimately lead to a marketing approval and commercialization of a product. Even if the Company’s drug development efforts are successful, it is uncertain if and when the Company will realize significant revenue from product sales. |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2023 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Basis of presentation The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. Going concern Since inception, the Company’s activities have consisted primarily of performing research and development to advance its technologies. The Company is still in the development phase and has not been marketing its technologies to date. Through December 31, 2023, the Company has funded its operations with proceeds from sales of common stock, sales of convertible preferred stock, sales of redeemable convertible preferred stock, collaboration and licensing agreements, grants and borrowings under various agreements with foreign public funding agencies. Since inception, the Company has incurred recurring losses, including net losses of $81.6 million, $64.9 million and $75.7 million for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023, the Company had an accumulated deficit of $369.3 million. The Company expects to continue to generate operating losses in the foreseeable future. As of March 22, 2024, the filing date of this Annual Report on Form 10-K, the Company expects that its cash and cash equivalents will be sufficient to fund its operating expenses, capital expenditure requirements and debt service payments through at least 12 months from the issuance date of the consolidated financial statements. The Company will seek additional funding in order to reach its development and commercialization objectives. The Company may seek funds through further equity financings, debt financings, collaborations, strategic alliances and marketing, distribution or 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 collaborations or other arrangements. 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, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary if the Company is unable to continue as a going concern. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue, income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the recognition of revenue and income, the accrual of research and development expenses and general and administrative expenses, the present value of lease right of use assets and corresponding liabilities, the valuation of stock-based awards, the valuation of current and non-current loans payable and the impairment of long-lived assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. As of the date of issuance of these consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions. Foreign currency and currency translation The functional currency for the Company is the United States dollar and the functional currency for the Company's wholly owned foreign subsidiary, Hookipa Biotech GmbH, is the euro. Assets and liabilities of Hookipa Biotech GmbH are translated into United States dollars at the exchange rate in effect on the balance sheet date. Income items and expenses are translated at the average exchange rate in effect during the period. Unrealized translation gains and losses are recorded as a cumulative translation adjustment, which is included in the Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) as a component of Accumulated other comprehensive loss. Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other income and expenses, net in the Consolidated Statements of Operations and Comprehensive Loss as incurred. Concentrations of credit risk and of significant suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and short-term bank deposits held with banks in excess of publicly insured limits. For the years ended December 31, 2023 and December 31, 2022 the net proceeds from the Company’s offerings have been deposited in interest-bearing bank accounts with two of the largest investment grade U.S. financial institutions and have been partially invested in money market funds. The money market funds, held in U.S. dollars, are primarily invested in U.S. and foreign short-term debt obligations. As of December 31, 2023 and December 31, 2022, the Company’s cash and cash equivalents included smaller amounts of cash balances held in accounts with regional European banks at the Company’s Austrian subsidiary, partially in euros. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company relies, and expects to continue to rely, on a small number of vendors to manufacture supplies and raw materials for its development programs. These programs could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials. As of December 31, 2023 and December 31, 2022, respectively, Gilead Sciences, Inc. (“Gilead”) and F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (together “Roche”) accounted for the majority of the accounts receivable balance. For the years ended December 31, 2023, December 31, 2022 and December 31, 2021 Gilead and Roche accounted for the majority of the Company’s revenues. Other customers accounted for less than 10.0% of accounts receivable or net sales. The Company monitors the financial performance of its customers so that it can appropriately respond to changes in their credit worthiness. To date, the Company has not experienced any significant losses with respect to collection of its accounts receivable. Cash equivalents The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. As of December 31, 2023 and December 31, 2022 cash equivalents consisted of money market funds and short-term deposits. Deferred offering costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of the additional paid-in capital on a pro-rata basis generated as a result of the offering. Should the in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statements of operations and comprehensive loss. Fair value measurements Certain assets and liabilities are carried at fair value under GAAP. 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. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1 - Quoted prices in active markets for identical assets or liabilities. ● Level 2 - Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 5). Property and equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated useful life Leasehold improvements shorter of useful life or term of lease Laboratory equipment 2 - 10 years Furniture and fixtures 2 - 10 years Computer equipment and software 2 - 4 years Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. Expenditures for repairs and maintenance are charged to expense as incurred. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in the consolidated statements of operations. Leases The determination whether an arrangement qualifies as a lease is made at contract inception. A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, or (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded as operating leases and are included in right of use (“ROU”) assets and lease liabilities in the consolidated balance sheets. For leases with an initial term of 12 months or less, the Company does not recognize a right of use asset or lease liability. These short-term leases are expensed on a straight-line basis over the lease term. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the option will be exercised. The Company uses the implicit rate when readily determinable and uses its incremental borrowing rate when the implicit rate is not readily determinable based upon the information available at the commencement date in determining the present value of the lease payments. The incremental borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease. The lease payments used to determine ROU assets may include lease incentives, stated rent increases and escalation clauses linked to rates of inflation when determinable and are recognized as ROU asset on the consolidated balance sheet. In addition, certain of the Company’s arrangements contain lease and non-lease components. The Company generally separates lease payments from non-lease payments. Operating leases are reflected in operating lease assets, in current operating lease liabilities and non-current operating lease liabilities in the consolidated balance sheets. Finance leases are reflected in finance lease assets, in accrued expenses and other current liabilities and in other non-current operating lease liabilities in the consolidated balance sheets. The ROU asset is tested for impairment in accordance with Accounting Standards Codification (“ASC”) 360. Capitalized Software Development Cost The Company capitalizes certain implementation costs for internal-use software incurred in a cloud computing agreement that is a service contract. Eligible costs associated with cloud computing arrangements, such as software business applications used in the normal course of business, are capitalized in accordance with ASC 350. These costs are recognized on a straight-line basis in the same line item in the statement of operations and comprehensive loss as the expense for fees for the associated cloud computing arrangement, over the term of the arrangement, plus reasonably certain renewals. Amortization expense of $0.1 million associated with the Company's cloud computing arrangements has been recognized during each of the fiscal years ended December 31, 2023 and December 31, 2022 (see Note 6). The Company tests for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Impairment of long-lived assets Long-lived assets, including operating and finance lease right of use assets, consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative technological, scientific or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value (see Note 4. and Note 6.). Segment information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company's singular focus is on developing pharmaceutical products to prevent and cure infectious diseases and cancer. The Chief Executive Officer is the chief operating decision maker, and regularly reviews the consolidated operating results to make decisions about the allocation of the Company's resources. The majority of the Company's tangible assets are held in Austria. Revenue recognition from contracts with customers The Company recognized revenue from collaboration and license agreements with Gilead and Roche. Under the collaboration and license agreement with Gilead (as amended and restated, the “Gilead Collaboration Agreement”), the parties agreed to collaborate with respect to two preclinical research programs to evaluate potential vaccine products for the treatment, cure, diagnosis or prevention of the hepatitis B virus (“HBV”) and the human immunodeficiency virus (“HIV”). In February 2022, the parties signed an amended and restated collaboration agreement (the “Restated Gilead Collaboration Agreement”), which revised the terms only for the HIV program, whereby the Company took on development responsibilities for the HIV program candidate through a Phase 1b clinical trial. The Company’s performance obligations under the terms of the original agreement include one combined performance obligation for each research program (HBV and HIV) comprised of the transfer of intellectual property rights (licenses) and providing research and development services. The terms of the Restated Gilead Collaboration Agreement added an additional performance obligation to perform research and development work for the HIV program. The licenses do not represent distinct performance obligations, because they cannot be used without the research and development services. Payments to the Company under the Restated Gilead Collaboration Agreement include a non-refundable up-front payment, payments for research and development activities, payments based upon the achievement of defined milestones, and if certain future conditions are met, payments for manufacturing services, commercial milestones and royalties on product sales. Under the research collaboration and license agreement with Roche (the “Roche Collaboration Agreement”), the Company has agreed to conduct research and early clinical development through Phase 1b for HB-700, a novel investigational arenaviral immunotherapy for the treatment of KRAS-mutated cancers. The Roche Collaboration Agreement also includes an obligation of the Company to deliver a specified package of preclinical data and results with respect to a second program, targeting undisclosed cancer antigens (collectively “UCAs”) and an option for Roche to license the UCA program. The Company’s performance obligations under the terms of the Roche Collaboration Agreement include one combined performance obligation for the transfer of intellectual property rights (licenses) and providing research and development services for the HB-700 program, and a second, separate performance obligation to perform research and development services with respect to the UCA program. The UCA Option provides a right to license the program at the standalone selling price and therefore does not constitute a separate performance obligation. Payments to the Company under the Roche Collaboration Agreement include a non-refundable up-front payment, payments based upon the achievement of defined milestones, an additional payment if the option for the UCA program is exercised and royalties on product sales. In January 2024, Roche provided written notice of the termination of the collaboration and licensing agreement to the Company. The Company evaluates its collaboration and licensing arrangements pursuant to ASC 606 Revenue from Contracts with Customers. To determine the recognition of revenue from arrangements that fall within the scope of ASC 606, the Company performs the following five steps: (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) the Company satisfies a performance obligation. Under ASC 606, the Company applies significant judgement to evaluate whether the promises under the collaboration and licensing arrangements, represent separate or one or more combined performance obligations, the allocation of the transaction price to identified performance obligations, the timing of revenue recognition, whether the UCA Option constitutes a material right, and the determination of when milestone payments are probable of being received. Upfront payment and program initiation fee The non-refundable upfront-payment received by the Company upon signing of the Gilead Collaboration Agreement, and milestone payments that were linked to future performance obligations, were initially recorded as deferred revenue and allocated between the two research program performance obligations. Such amounts are recognized as revenue over the performance period of the respective services on a percent of completion basis using total estimated research and development labor hours (input method) for each of the obligations. The percent of completion basis using labor hours was considered the best measure of progress in which control of the combined performance obligations transfers to the customer, due to the short time intervals in which research results are shared with the collaboration partner and the nature of the work being performed. The non-refundable program initiation payment received from Gilead upon signing of the Restated Collaboration Agreement was also initially recorded as deferred revenue and is recognized on a percent of completion basis using total estimated research and development costs (input method) for the performance of the obligations. The percent of completion basis using research and development costs was considered the best measure of progress in which control of the performance obligations transfers to the customer, due to the immediate benefit that it adds to the value of the customer’s rights on the program, the short time intervals in which development results are shared and the nature of the work being performed. The non-refundable upfront-payment received by the Company upon signing of the Roche Collaboration Agreement, was initially recorded as deferred revenue and allocated between the HB-700 program and the UCA program. Such amounts are recognized as revenue over the performance period of the respective services on a percent of completion basis using total estimated research and development costs (input method) for each of the obligations during the initial term of the contract. The percent of completion basis using research and development costs was considered the best measure of progress in which control of the performance obligations transfers to the customer. Reimbursement for services Under the Gilead Collaboration Agreement and the Roche Collaboration Agreement, the Company incurs employee expenses as well as external costs for research, manufacturing and clinical trial activities presented as operating expenses or prepaid expenses. Based on the nature of the Company's responsibilities under the collaboration arrangements, reimbursement of those costs are presented as revenue and not deducted from expenses, as the Company controls the research activities. Amounts of consideration allocated to the performance of research or manufacturing services are recognized over the period in which services are performed. Reimbursements for external costs are recognized as revenues as progress is achieved. Unpaid reimbursement amounts are presented as Accounts Receivable. Research and development milestones The Gilead Collaboration Agreement and the Roche Collaboration Agreement include contingent milestone payments related to specified preclinical and clinical development milestones. These milestone payments represent variable consideration that are not initially recognized within the transaction price as they are fully constrained under the guidance in ASC 606, due to the scientific uncertainties and the required commitment from Gilead and Roche. The Company will continue to assess the probability of significant reversals for any amounts that become likely to be realized prior to including the variable consideration associated with these payments within the transaction price. Sales-based milestones and royalty payments The Gilead Collaboration Agreement and the Roche Collaboration Agreement also include certain sales-based milestone and royalty payments upon successful commercialization of a licensed product. In accordance with ASC 606-10-55-65 Sales Based or Usage Based Royalties, the Company recognizes revenues from sales-based milestone and royalty payments at the later of (i) the occurrence of the subsequent sale; or (ii) the performance obligation to which some or all of the sales-based milestone or royalty payments has been allocated has been satisfied. The Company anticipates recognizing these milestones and royalty payments if and when subsequent sales are generated from a licensed product by the collaboration partner. Cost to fulfill contracts The Company incurs costs for personnel, supplies and other costs related to its laboratory operations as well as fees from third parties and license expenses in connection with its research and development obligations under the collaboration and licensing agreement. These costs are recognized as research and development expenses over the period in which services are performed. Sublicense fees triggered by the receipt of payments are capitalized as an asset when the obligation to pay the fee arises. The capitalized asset is amortized over the period in which the revenue from the triggering payment is recognized. Research and development costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, stock-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, manufacturing expenses and external costs of vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. Upfront payments, milestone payments and annual payments made for the licensing of technology are generally expensed as research and development in the period in which they are incurred. Incremental sublicense fees triggered by contracts with customers are capitalized and expensed as research and development expenses over the period in which the related revenue is recognized. Research and manufacturing contract costs and accruals The Company has entered into various research and development and manufacturing contracts. Related payments are recorded as the corresponding expenses are incurred. The Company records accruals for estimated ongoing costs and prepaid expenses for advance payments. When evaluating the adequacy of the accrued liabilities and prepaid expenses, the Company analyzes progress of the research studies or clinical trials and manufacturing activities, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company's estimates. The Company's historical accrual estimates have not been materially different from the actual costs. Government grant agreements and research incentives The Company recognizes funding from grants and research incentives received from Austrian government agencies as well as from New York State and New York City government agencies in the United States as other income. Income from grants and incentives is recognized in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants or incentives were provided have been met. For grants under funding agreements and for proceeds under research incentive programs, the Company recognizes grant and incentive income in an amount equal to the estimated qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. Grant funding that has been received by the Company in advance of incurring qualifying expenses is recorded as deferred income. Grant and incentive income recognized upon incurring qualifying expenses in advance of receipt of grant funding or proceeds from research and development incentives is recorded in the consolidated balance sheets as prepaid expenses and other current assets. The Company has received loans under funding agreements that bear interest at rates that are below market rates of interest. The Company accounts for the imputed benefit arising from the difference between a market rate of interest and the rate of interest charged as additional grant funding, and records interest expense for the loans at a market rate of interest. On the date that loan proceeds are received, the Company recognizes the portion of the loan proceeds allocated to grant funding as a discount to the carrying value of the loan and as other liability, which is subsequently recognized as additional grant income over the term of the funding agreement. Stock-based compensation The Company measures stock-based awards granted to employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model for options or the difference between the purchase price per share of the award, if any, and the fair value of the Company's common stock for restricted common stock awards. Compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award. The Company uses the graded-vesting method to record the expense of awards with service-based vesting conditions. The Company classifies stock-based compensation expense in its Consolidated Statements of Operations and Comprehensive Loss in the same manner in which the recipient's payroll costs are classified or in which the recipient's service payments are classified. Comprehensive loss Comprehensive loss includes net loss and foreign currency translation adjustments. For the years ended December 31, 2023 and December 31, 2022 comprehensive loss included $0.8 million and $2.4 million, respectively, of foreign currency translation loss adjustments. For the year ended December 31, 2021, comprehensive loss included $1.3 million of foreign currency translation gain adjustments. Net loss per share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of shares outstanding for the period, including potential dilutive shares assuming the dilutive effect of outstanding stock options and of convertible preferred stock. For periods in which the Company has reported net losses, diluted net loss per common share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their affect is anti-dilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2023, 2022 and 2021. Income taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or in the Company's tax returns. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income |
Collaboration and Licensing Agr
Collaboration and Licensing Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Collaboration and Licensing Agreements | |
Collaboration and Licensing Agreements | 3. Collaboration and Licensing Agreements Gilead Collaboration and License Agreement In June 2018, the Company entered into the Gilead Collaboration Agreement whereby the Company and Gilead agreed to collaborate with respect to two preclinical research programs to evaluate potential vaccine products for the treatment, cure, diagnosis or prevention of HBV and HIV. In February 2022, the Company signed the Amended and Restated Collaboration Agreement, which altered key aspects of the collaboration pertaining to the HIV therapeutic. Most importantly, the Amended and Restated Collaboration Agreement allocated additional research and development responsibility to the Company with respect to the Company’s HIV candidate and provided for additional funding by Gilead of such research and development activities as well as increased later stage development and commercial milestone payments. Under the Gilead Collaboration Agreement, the Company granted Gilead an exclusive, royalty-bearing license to the Company’s technology platforms. Upon entering into the agreement in June 2018, the Company received a non-refundable $10.0 million upfront payment from Gilead and upon signing of the Restated Gilead Collaboration Agreement in February 2022, the Company received a program initiation fee of $15.0 million. Gilead is also obligated to make additional payments to the Company upon the achievement of pre-clinical, development and commercial milestones. The development milestones amount to $140.0 million for the HBV program, and up to $172.5 million for the HIV program, inclusive of a $10.0 million program completion fee, payable upon Gilead’s exercise of the option to pursue further development activities post Phase 1b. The commercial milestones amount to a total of $50.0 million for the HBV program, and $65.0 million for the HIV program. Additionally, Gilead is obligated to pay royalties on net sales for each program. Payments from Gilead generally have a 60 day payment term. The $10.0 million upfront payment, the $15.0 million initiation fee and $8.0 million in milestone payments were initially recorded as deferred revenue in the consolidated balance sheet and are recognized as revenue when revenue recognition criteria are met. As of December 31, 2023, $7.5 million of such payments were still recorded as a liability in deferred revenues, current and non-current. As of December 31, 2022, $14.3 million of upfront and milestone payments were included as a liability in deferred revenues, current and non-current. Approximately 55.2% of deferred revenue is expected to be recognized as revenue in 2024, 36.8% in 2025 and the remaining 8.0% in 2026. In the year ended December 31, 2023, the Company recognized $7.1 million of the milestone and initiation payments that were originally recorded as deferred revenue. Furthermore, the Company recognized $1.4 million revenue from cost reimbursements for research and development services. In the year ended December 31, 2022, the Company recognized $3.7 million of the upfront and milestone payments that were originally recorded as deferred revenue, $5.2 million revenue from cost reimbursements for research and development services and $5.0 million revenue from a milestone achieved in December 2022. In the year ended December 31, 2021, the Company recognized $2.1 million of the upfront and milestone payments that were originally recorded as deferred revenue and $16.3 million revenue from cost reimbursements for research and development services. Sublicense fees payable to certain licensors of technologies upon the receipt of the deferred upfront and milestone payments, were capitalized as a contract asset and will be amortized over the period in which the revenue from the triggering payment is recognized. As of December 31, 2023 and 2022, the contract asset relating to the sublicense payment was $0.1 million and $0.2 million, respectively, and there was no liability relating to sublicense payment. Roche Collaboration and License Agreement In October 2022, the Company entered into the Roche Collaboration Agreement whereby the Company and Roche agreed to collaborate with respect to the development of novel arenaviral immunotherapies for KRAS-mutated cancers and, potentially, a second, novel arenaviral immunotherapeutic program targeting specific undisclosed cancer antigens. In January 2024, Roche provided written notice of the termination of the collaboration and licensing agreement to the Company (see Note 18. “Subsequent Events”). Under the terms of the terminated Roche Collaboration Agreement, the Company granted Roche an exclusive, royalty-bearing license to the Company’s technology platforms for KRAS-mutated cancers, and an option right to exclusively license a second, novel arenaviral immunotherapeutic program targeting undisclosed cancer antigens. Pursuant to the terms of the Collaboration Agreement, following the termination notice, the Collaboration Agreement will end on April 25, 2024. The Company remains eligible for a final milestone payment associated with an IND submission. Effective April 25, 2024, the Company will regain full control of the associated intellectual property portfolio and will have full collaboration and licensing rights for the KRAS program. Upon signing the Roche Collaboration Agreement in October 2022, the Company received a non-refundable upfront payment of $25.0 million. This upfront payment, and a $10.0 million milestone payment received in the twelve months ended December 31, 2023 were initially recorded as deferred revenue in the consolidated balance sheet and are recognized as revenue when revenue recognition criteria are met. As of December 31, 2023, $26.8 million of such payments were still recorded as a liability in deferred revenues, current and non-current. As of December 31, 2022, $27.0 million of the upfront payment was included as a liability in deferred revenues, current and non-current. The deferred revenues related to the $25.0 million upfront payment and the $10.0 million milestone payment are subject to foreign currency exchange rate fluctuations in future accounting periods. In the year ended December 31, 2023, the Company recognized $11.1 million of the upfront and milestone payments that were originally recorded as deferred revenue. Furthermore, the Company recognized $0.5 million revenue from cost reimbursements for activities related to the preparation of a first in human trial. In the year ended December 31, 2022, the Company recognized $0.3 million of the upfront payment that was originally recorded as deferred revenue. Sublicense fees payable to certain licensors of technologies upon the receipt of the deferred upfront and milestone payments, were capitalized as a contract asset and will be amortized over the period in which the revenue from the triggering payment is recognized. As of December 31, 2023, the contract asset relating to the sublicense payment was $2.0 million and there was no liability relating to sublicense payment. As of December 31, 2022 the contract asset and the liability relating to the sublicense payment was $1.5 million and $1.2 million, respectively. |
Impairment
Impairment | 12 Months Ended |
Dec. 31, 2023 | |
Impairment | |
Impairment | 4. Impairment On January 29, 2024, the Company announced its decision to prioritize the clinical development of its HB-200 program for the treatment of HPV16+ head and neck cancers and its two Gilead-partnered infectious disease programs and to pause development activities related to HB-300 and most of its preclinical research activities (see Note 18. “Subsequent Events”). In connection with this strategic refocus, the Company’s board of directors approved a Restructuring Plan to rebalance the Company’s cost structure, which includes a reduction of the Company’s workforce by approximately 30% and the discontinuation of the Company’s GMP manufacturing facility project. The Company expects the Restructuring Plan to be implemented and substantially completed by the end of the first quarter of 2024. As a result of the strategic considerations preceding the adoption of the Restructuring Plan, the Company assessed the recoverability of the long-lived assets relating to the GMP manufacturing project at December 31, 2023, and determined that the undiscounted cash flows of the asset group were below the carrying values, indicating impairment. The assets were written down to their estimated fair value, which was determined based on the cost approach. The resulting impairment charges were included within Impairment expense in the Consolidated Statements of Operations and Comprehensive Loss. The following table summarizes the effect of non-cash impairment charges (in thousands): December 31, December 31, 2023 2022 Non-cash impairment charges Asset write-offs $ (12,766) $ — Total non-cash charges $ (12,766) $ — |
Fair Value of Financial Assets
Fair Value of Financial Assets | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value of Financial Assets | |
Fair Value of Financial Assets | 5. Fair Value of Financial Assets The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicating the level of the fair value hierarchy utilized to determine such fair values (in thousands): Fair Value Measurement at December 31, 2023 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 91,084 $ — $ — $ 91,084 Total $ 91,084 $ — $ — $ 91,084 Fair Value Measurement at December 31, 2022 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 85,491 $ — $ — $ 85,491 Total $ 85,491 $ — $ — $ 85,491 During the year ended December 31, 2023 , there were no transfers between Level 1, Level 2 and Level 3 . |
Property, plant and equipment,
Property, plant and equipment, net | 12 Months Ended |
Dec. 31, 2023 | |
Property, plant and equipment, net | |
Property, plant and equipment, net | 6. Property, plant and equipment, net Property, plant and equipment, net consisted of the following (in thousands): December 31, December 31, 2023 2022 Land $ 2,025 $ 1,959 Leasehold improvements 3,300 3,164 Construction in progress 212 10,567 Laboratory equipment 8,722 7,403 Furniture and fixtures 654 622 Computer equipment and software 2,652 2,034 Property and equipment, gross 17,565 25,749 Less: Accumulated depreciation (9,823) (7,779) Property and equipment, net $ 7,742 $ 17,970 Depreciation expense for the years ended December 31, 2023, 2022 and 2021 was $2.0 million, $1.9 million and $2.1 million, respectively. Construction-in-progress as of December 31, 2022 mainly related to investments in connection with the Company’s GMP manufacturing facility project. As a result of the strategic considerations preceding the adoption of the Restructuring Plan (see Note 4. and Note 18.) the Company determined that the estimated undiscounted future cash flows for its asset group related to the GMP manufacturing facility project were less than their carrying values. The Company therefore recognized an impairment loss of $12.8 million related to the GMP manufacturing facility project for the year ended December 31, 2023, which reduced the carrying value of this asset group to zero. Impairment charges are included within Impairment expense in the Consolidated Statements of Operations and Comprehensive Loss. There were no impairments in the years ended December 31, 2022 and 2021. |
Receivable research incentive
Receivable research incentive | 12 Months Ended |
Dec. 31, 2023 | |
Receivable research incentive | |
Receivable research incentive | 7. Receivable research incentive The Company participates in a research incentive program provided by the Austrian government under which it is entitled to reimbursement of a percentage of qualifying research and development expenses and capital expenditures incurred in Austria. Submissions for reimbursement under the program are submitted annually. Incentive amounts are generally paid out during the calendar year that follows the year of the expenses but remain subject to subsequent examinations by the responsible authority. Reimbursements received in excess of the recognized receivable research incentive for a certain period are recorded within other long term liabilities for potential repayment until such time that an audit has taken place, upon expiration of the potential reclaim period, or when it is no longer probable that a reclaim will happen. The years 2018 to present remain open to examination by the authorities. Furthermore, the Company participated in the life sciences research and development program provided by the New York State government under which it was entitled to reimbursement of a percentage of qualifying research and development expenses in New York State up to $0.5 million per year for the years 2019 to 2021. Incentive amounts are generally paid out six to nine months after amended tax returns including a certificate of tax credit issued by Empire State Development are filed. The Company also participates in the New York City biotechnology tax credit program, according to which certain expenses for business in the biotechnology field in New York City limited to $0.25 million per year for three consecutive years from January 1, 2023 to December 31, 2025 are incentivized. The biotechnology tax credit can be refunded or applied against the next year's tax if it exceeds the current year's tax liability. As of December 31, 2023, the Company recognized receivables of $18.8 million from the research incentive programs, which are reported in research incentive receivables in the Company’s consolidated balance sheet. $17.3 million relate to the Austrian research incentive program, $1.4 million relate to the New York State life sciences research and development program and $0.1 million relate to the New York City biotechnology tax credit program. As of December 31, 2022, the receivables from the research incentive program were $15.5 million and related to the Austrian research incentive program. During the years ended December 31, 2023, 2022 and 2021, the Company recorded $10.9 million, $7.3 million and $8.9 million, respectively, of income related to the incentive programs within the Company’s consolidated statements of operations and comprehensive loss as part of the grant income. Income for the year ended December 31, 2023 included $9.4 million related to the Austrian incentive program, $1.4 million related to the New York State life sciences research and development program and $0.1 million related to the New York City biotechnology tax credit program. Income for the years ended December 31, 2022 and 2021 related to the Austrian incentive program. Research incentives depend on the eligible research and development expenses of the respective period. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Leases | 8. Leases The Company leases real estate, including office and laboratory space and has entered into various other agreements with respect to assets used in conducting its business. The Company’s leases have remaining lease terms ranging from less than 1 year to 5.2 years. Some of the lease agreements contain rent holidays and rent escalation clauses that were included in the calculation of the right of use assets and lease liabilities. The Company’s current leases qualify as operating leases. The Company is required to maintain a cash balance of $0.4 million to secure letters of credit associated with real estate leases. This amount was classified as non-current restricted cash in the consolidated balance sheet as of December 31, 2023. The following table summarizes the effect of lease costs in the Company’s consolidated statements of operations and comprehensive loss (in thousands): Year ended Year ended Year ended Income statement location December 31, 2023 December 31, 2022 December 31, 2021 Operating lease expenses Research and development expenses $ 1,347 $ 1,430 1,910 General and administrative expenses 242 219 203 Finance lease amortization expenses Research and development expenses — 89 425 General and administrative expenses — — 7 Interest on finance lease liabilities Interest expenses — 0 5 Sublease income Other income (expense) — — (40) Net lease expense $ 1,589 $ 1,738 2,510 The minimum lease payments for the next five years and thereafter are expected to be as follows (in thousands): December 31, 2023 Operating lease 2024 1,655 2025 1,627 2026 1,351 2027 1,213 2028 4 Thereafter 1 Total lease payments 5,851 Less: interest 412 Present value of lease liabilities $ 5,439 The weighted average remaining lease term and weighted average discount rate of operating leases are as follows: December 31, December 31, 2023 2022 Weighted average remaining lease term in years 3.7 2.8 Weighted average discount rate (1) 4.1 % 1.3 % (1) During the year ended December 31, 2023, the Company agreed on a lease amendment, which extended the term of the lease for its corporate headquarters in New York City by approximately 2.2 years ending at the end of August 2026. The Company also extended the estimated lease term of existing operating leases for the office and laboratory space in Vienna, Austria, by approximately 2.0 years ending at the end of December 2027. Furthermore, the Company signed a lease amendment, which extended the term of the lease for certain parking spaces in its Vienna Office by approximately 5.5 years ending at the end of February 2029. These lease amendments did not include additional right-of-use other than the extended lease term. There is no additional renewal term included in the lease amendments to consider in the estimate of the lease term. The respective lease liabilities were remeasured and the amounts resulting from the remeasurement of the lease liability were recognized as an adjustment to the corresponding right of use asset. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Accrued expenses and other current liabilities | |
Accrued expenses and other current liabilities | 9. Accrued expenses and other current liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, December 31, 2023 2022 Salaries and bonuses 5,665 4,481 Social security contributions 340 267 Unearned grant income (current) 52 300 Sublicense fees — 1,220 Accrued external research and development expenses 4,594 3,458 Accrued external general and administration expenses 292 898 Accrued for property and equipment acquisitions 14 — Income taxes 367 230 Other accruals and liabilities 777 324 $ 12,101 $ 11,178 |
Loans payable
Loans payable | 12 Months Ended |
Dec. 31, 2023 | |
Loans payable | |
Loans payable | 10. Loans payable As of December 31, 2023 and December 31, 2022, loans payable consisted of the following (in thousands): December 31, December 31, 2023 2022 Loans from FFG $ 1,172 $ 2,855 Unamortized debt discount (52) (350) Total loans payable, net $ 1,120 $ 2,505 In connection with the funding agreements with the Austrian Research Promotion Agency, ( Österreichische Forschungsförderungsgesellschaft, The FFG Loans bear interest at rates that are below market rates of interest. The Company accounts for the imputed benefit arising from the difference between an estimated market rate of interest and the rate of interest charged by FFG as grant income from FFG. On the date that FFG loan proceeds are received, the Company recognizes the portion of the loan proceeds allocated to grant funding as a discount to the carrying value of the loan and as unearned income, which is recognized as grant income over the term of the funding agreement. The Company recognized grant income of $0.3 million, $0.6 million and $0.8 million during the years ended December 31, 2023, 2022 and 2021, respectively, related to the recognition of the unearned income recorded for the imputed benefit of FFG Loans at below-market interest rates. Unearned income (current) related to the imputed benefit of FFG Loans at below-market interest rates was less than $0.1 million and $0.3 million as of December 31, 2023 and 2022, respectively. Unearned income (non-current) presented under loans payable non-current related to such benefit was $0.1 million as of December 31, 2022, and no non-current unearned income as of December31, 2023. In addition, the Company has recorded a discount to the carrying value of each FFG Loan for the portion of the loan proceeds allocated to grant funding, which is being amortized to interest expense over the term of the loan using the effective interest method. As of December 31, 2023 and 2022, the unamortized debt discount related to FFG Loans was $0.1 million and $0.4 million, respectively. The Company recognized interest expense of $0.3 million, $0.7 million and $0.9 million during the years ended December 31, 2023, 2022 and 2021, respectively, related to the FFG Loans, which included interest expense related to the amortization of debt discount of $0.3 million, $0.7 million and $0.8 million during the years ended December 31, 2023, 2022 and 2021, respectively. Principal repayments of $1.8 million, and $2.8 million were made in the years ended December 31, 2023 and 2022, respectively. The Company uses an estimated market rate of 20%, which was determined based on an average of the available interest rates on unsecured loans to comparable companies. A 10% increase or decrease in the estimated market rate of interest would have no material impact on grant income or liabilities. In the event that the underlying program research results in a scientific or technical failure, the principal then outstanding under any loan may be forgiven by FFG on a project-by-project basis. The FFG Loans contain no financial covenants and are not secured by any of the Company's assets. As of December 31, 2023, the aggregate minimum future principal payments due in connection with the FFG Loans are summarized as follows (in thousands): Payments Due by Calendar Year Amount 2024 1,172 2025 — 2026 — 2027 — 2028 — Thereafter — Total $ 1,172 |
Common stock, Class A common st
Common stock, Class A common stock and convertible preferred stock | 12 Months Ended |
Dec. 31, 2023 | |
Common stock, Class A common stock and convertible preferred stock | |
Common stock, Class A common stock and convertible preferred stock | 11. Common stock, Class A common stock and convertible preferred stock The Company’s capital structure consists of common stock, Class A common stock and preferred stock. As of December 31, 2023, the Company was authorized to issue 200,000,000 shares of common stock, 3,900,000 shares of Class A common stock and 10,000,000 shares of preferred stock. The Company has designated 2,978 of the 10,000,000 authorized shares of preferred stock as non-voting Series A convertible preferred stock, 15,800 of the 10,000,000 authorized shares of preferred stock as non-voting Series A-1 convertible preferred stock and 15,268 of the 10,000,000 authorized shares of preferred stock as non-voting Series A-2 convertible preferred stock. As of December 31, 2023, the Company had 96,550,590 shares of common stock Class A common Series A Series A-1 Series A-2 On June 5, 2023, the Company closed a public offering of 22,900,768 shares of its common stock and 15,268 shares of Series A-2 convertible preferred stock at a public offering price of $1.31 and $1,310.00 per share, respectively, for net proceeds of $46.2 million after deducting underwriting discounts and commissions and offering expenses. In July 2022 and August 2022 certain of the Company’s stockholders elected to convert an aggregate of 1,420,215 shares (769,734 and 650,481 shares, respectively) of Class A common stock owned by such holders into an aggregate of 1,420,215 shares of the Company’s common stock. On February 15, 2022, the Company entered into a stock purchase agreement with Gilead (“Stock Purchase Agreement”), that requires Gilead, at the Company’s option, to purchase up to $35.0 million of the Company’s common stock. On February 15, 2022, Gilead purchased an initial amount of 1,666,666 shares of the Company’s common stock in exchange for $5.0 million in cash at a purchase price per share equal to $3.00. On December 20, 2023, the parties amended and restated the Stock Purchase Agreement (the “Amended Stock Purchase Agreement”) and Gilead purchased 15,000,000 shares of the Company’s common stock in exchange for approximately $21.3 million in cash at a purchase price per share equal to $1.4167. Pursuant to the terms of the Amended Stock Purchase Agreement, the Company may require Gilead to purchase the balance of the $8.7 million of common stock as pro-rata participation in potential future equity raises. The Company’s right to sell shares of its common stock to Gilead is subject to specified limitations, including a limitation that prevents the Company from requesting purchases of shares of common stock by Gilead that would result in a beneficial ownership of more than 19.9% of the total number of outstanding shares of common stock by Gilead. The Company agreed to file a registration statement on Form S-3 to register for resale any additional shares of common stock issued to Gilead within four months from issuance. On March 4, 2022, the Company closed a public offering of 21,700,000 shares of its common stock and of 15,800 shares of Series A-1 convertible preferred stock at a public offering price of $2.00 and $2,000.00 per share, respectively, for net proceeds of $70.2 million after deducting underwriting discounts and commissions and offering expenses. The Company has three series of preferred stock authorized, issued and outstanding as of December 31, 2023: Series A convertible preferred stock, Series A-1 convertible preferred stock, and Series A-2 convertible preferred stock. Shares of Series A, Series A-1 and Series A-2 convertible preferred stock may be independently converted into common stock. Holders of Series A, Series A-1 and Series A-2 convertible preferred stock have equal rights, powers and privileges. Holders of common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. The holders of Class A common stock and Series A, Series A-1 and Series A-2 convertible preferred stock are not entitled to vote, except as required by law. The holders of common stock and Class A common stock do not have any cumulative voting rights. Each holder of Class A common stock has the right to convert each share of Class A common stock into one share of common stock at such holder's election. Each holder of Series A, Series A-1 and Series A-2 convertible preferred stock has the right to convert each share of Series A, Series A-1 and Series A-2 convertible preferred stock into 1,000 shares of common stock at any time at the holder’s option, provided that the holder will be prohibited, subject to certain exceptions, from converting Series A, Series A-1 and Series A-2 preferred stock into shares of our common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99% of the total number of shares of the Company’s common stock then issued and outstanding. Holders of common stock and Class A common stock are entitled to receive ratably any dividends declared by the board of directors out of funds legally available for that purpose, subject to any preferential dividend rights of any outstanding preferred stock. Holders of Series A. Series A-1 and Series A-2 preferred stock will be entitled to receive dividends at a rate equal to (on an as-if-converted-to-common stock basis), and in the same form and manner as, dividends actually paid on shares of the Company’s common stock. Holders of common stock and Class A common stock have no preemptive rights, conversion rights, or other subscription rights or redemption or sinking fund provisions. In the event of a liquidation, dissolution, or winding up of the Company, holders of our Series A, Series A-1 and Series A-2 preferred stock will receive a payment equal to $0.001 per share of Series A, Series A-1 and Series A-2 preferred stock before any proceeds are distributed to the holders of common stock. Then, holders of common stock and Class A common stock will be entitled to share ratably in all assets remaining after payment of all debts and other liabilities. There were 370 and 1,697 shares of Series A convertible preferred stock, 10,800 and 15,800 shares of Series A-1 convertible preferred stock and 15,268 and no shares of Series A-2 convertible preferred stock outstanding as of December 31, 2023 and December 31, 2022, respectively. In May 2023 certain of the Company’s stockholders elected to convert an aggregate of 1,327 shares of Series A convertible preferred stock and an aggregate of 5,000 shares of Series A-1 convertibles preferred stock owned by such holders into an aggregate of 6,327,000 shares of the Company’s common stock. |
Stock-based compensation
Stock-based compensation | 12 Months Ended |
Dec. 31, 2023 | |
Stock-based compensation | |
Stock-based compensation | 12. Stock-based compensation 2018 Stock Option and Grant Plan In June 2018, the Board of Directors approved the 2018 Stock Option and Grant Plan. Options granted under the 2018 Stock Option and Grant Plan generally vest over four years, with 25% of the options vesting upon the first anniversary of the grant date and the remaining 75% of the options vesting in 12 equal quarterly installments following the first anniversary of the grant date, provided the option holder continues to have an employment or service relationship with the Company on each vesting date. The options expire on the 10 th 2019 Stock Option and Incentive Plan On April 1, 2019, the Company’s stockholders approved the 2019 Stock Option and Incentive Plan, which became effective as of the effective date of the registration statement in connection with the Company’s IPO. The plan provides for the grant of shares of restricted stock, long term incentive awards, stock options or other equity-based awards. As of December 31, 2023, the maximum number of shares of the Company’s common stock that may be issued under the Company’s 2019 Stock Option and Incentive Plan was 8,067,480 shares which shall be cumulatively increased each year by up to 4.0% of the then outstanding number of shares of common stock and Class A common stock. Options granted under the 2019 Stock Option and Incentive Plan generally vest over four years, with 25% of the options vesting upon the first anniversary of the grant date and the remaining 75% of the options vesting in 12 equal quarterly installments following the first anniversary of the grant date, provided the option holder continues to have an employment or service relationship with the Company on each vesting date. Initial options granted to non-executive directors upon their election generally vest over a three-year term with 33% of the options vesting upon the first anniversary of the grant date and the remaining 67% of the options vesting in eight equal quarterly installments following the first anniversary of the grant date. Option re-grants to non-executive directors generally vest on the first anniversary of the grant date. The options expire on the 10 th In addition, there were 500,000 shares reserved for stock options issued as inducement grants to new employees granted outside of the Company’s equity-based compensation plans under Rule 5635(c)(4) of the Nasdaq Listing Rules. On August 7, 2023, the Company’s board of directors approved a one-time offer to eligible non-executive, non-director employees to exchange certain outstanding stock options for new stock options with modified terms. Under the stock option exchange program (the “Offer”), the Company offered to exchange certain out-of-the-money stock options for new stock options at an exchange ratio of between 1.75 and 2.50 surrendered options for one new option exercisable for shares of common stock with a lower exercise price and extended vesting terms. Pursuant to the Offer, a total of 82 eligible participants tendered, and the Company accepted for cancellation, stock options to purchase an aggregate of 543,228 shares of the Company’s common stock with exercise prices between $6.90 and $14.00. The eligible options that were accepted for cancellation represented approximately 86.6% of the total shares of common stock underlying all of the eligible options. In accordance with the terms and conditions of the Offer, on September 12, 2023, the Company issued new options to purchase an aggregate of 274,485 shares of common stock in exchange for the cancellation of the tendered eligible options. The exercise price per share of each new option granted in the Offer is $1.00. New options issued for previously vested stock options vest on the first anniversary of the grant date and new options issued for previously unvested stock options vest over a three-year term in twelve equal quarterly installments. The stock option exchange offer resulted in incremental stock-based compensation expense of $0.1 million, which will be recognized using the graded-vesting method over the remaining requisite service period of the new stock options. The following table presents a summary of awards outstanding: As of December 31, 2023 2018 Plan 2019 Plan Inducement Awards Total Granted and outstanding awards: Stock options 782,176 7,099,399 230,000 8,111,575 Total 782,176 7,099,399 230,000 8,111,575 Stock option valuation The Company estimates the option’s fair value on the date of grant using the Black-Scholes option-pricing model. Black-Scholes utilizes assumptions related to expected term, volatility, the risk-free interest rate, the dividend and employee exercise behavior. Forfeitures are accounted for when they occur. Expected volatilities utilized in the Black-Scholes model are based on historical volatilities of a group of comparable companies. The group of representative companies have characteristics similar to the Company, including the stage of product development and focus on the life science industry. Management believes that this represents the most accurate basis for estimating expected future volatilities under the current conditions. The risk-free interest rate is derived from the yields for U.S. Treasuries with a remaining term approximating the expected life of the options. The expected term represents the period of time that the options granted are expected to be outstanding. The following table summarizes, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model for estimating the fair value of stock options granted during: Year ended December 31, 2023 2022 2021 Risk-free interest rate 3.70 % 3.09 % 1.07 % Expected term (in years) 5.7 6.0 6.1 Expected volatility 93.6 % 85.4 % 85.5 % Expected dividends — % — % — % For the 2021, 2022 and 2023 grants, the Company used the simplified method in developing an estimate of the expected term due to a lack of historical exercise data. Stock option activity The following table summarizes the Company’s stock option activity since January 1, 2023 (in thousands, except share and per share amounts): Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price Term Value (in years) Outstanding as of December 31, 2022 6,532,523 $ 6.19 7.7 $ 490 Granted 2,880,985 1.00 Exercised (5,684) 0.10 Forfeited (1,296,249) 6.63 Outstanding as of December 31, 2023 8,111,575 $ 4.28 7.4 $ 486 Options exercisable as of December 31, 2023 4,101,520 $ 6.83 6.1 $ 486 Options unvested as of December 31, 2023 4,010,055 $ 1.67 8.8 $ — The aggregate intrinsic value of stock options was calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The fair value per common stock used for calculating the intrinsic values as of December 31, 2023, December 31, 2022 and December 31, 2021, was $0.81, $0.81 and $2.33, respectively. The aggregate intrinsic value of options exercised during the years ended December 31, 2023, 2022 and 2021 was less than $0.1 million, $0.1 million and $1.0 million, respectively. The weighted average grant-date fair value per share of stock options granted during the years ended December 31, 2023, 2022 and 2021 was $0.55, $1.55 and $11.46, respectively. The total fair value of stock options vested during the years ended December 31, 2023 and 2022 was $5.1 million and $7.9 million, respectively. Cash received from stock option exercise under share-based payment arrangements for the years ended December 31, 2023, 2022 and 2021 was $1 thousand, $3 thousand and $203 thousand, respectively. Common Stock Awards In the year ended December 31, 2022 the Company issued unrestricted shares of common stock to its executive team. The Company’s executive team agreed to convert a portion of their base salaries, for the six months ended June 30, 2022, for shares of the Company’s fully vested common stock having a value equal to their foregone salary, determined based on a value of $3.00 per share. This resulted in the issuance of 112,551 shares of common stock with a total fair value of $0.2 million. The grant date fair value per share of common stock was $1.50 and was measured at the closing price of the common stock on the date of grant. Expenses were recorded immediately and are included in stock based compensation in the year ended December 31, 2022. No unrestricted shares of common stock were issued in the year ended December 31, 2023. Stock-based compensation Stock-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows (in thousands): Year ended December 31, 2023 2022 2021 Research and development expenses $ 861 $ 2,074 $ 3,200 General and administrative expenses 1,484 2,969 4,444 $ 2,345 $ 5,043 $ 7,644 As of December 31, 2023 total unrecognized compensation cost related to the unvested stock-based awards was $1.5 million, which is expected to be recognized over a weighted average period of 1.5 years. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income taxes | |
Income taxes | 13. Income taxes Income tax expense during the years ended December 31, 2023 and December 31, 2022 resulted from US federal and state income tax as well as minimum tax obligations in Austria. From inception through December 31, 2021, we have not been required to pay U.S. federal and state income taxes because of current and accumulated net operating losses. Income tax expense during the year ended December 31, 2021 resulted from minimum tax obligations. During the years ended December 31, 2023, 2022 and 2021, the Company recorded no income tax benefits for the net operating losses incurred in each year, due to its uncertainty of realizing a benefit from those items. The Company's losses before income taxes were generated in the United States and Austria. For financial reporting purposes, losses before income taxes for the years ended December 31, 2023, 2022 and 2021 consisted of the following (in thousands): Year ended December 31, 2023 2022 2021 United States $ 1,710 $ (7,222) $ (11,403) Foreign (Austria) (82,922) (57,463) (64,261) Net loss before tax $ (81,212) $ (64,685) $ (75,664) The components of the consolidated income tax provision for the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands): Year ended December 31, 2023 2022 2021 Current Federal $ 145 $ 217 $ — State 222 12 — Foreign (Austria) 1 1 1 Total current tax expense 368 230 1 Deferred Federal — — — State — — — Foreign (Austria) — — — Total deferred tax expense — — — Total income tax expense $ 368 $ 230 $ 1 The Company's worldwide effective tax rate for the years ended December 31, 2023, 2022 and 2021 was 0.5%, 0.3% and 0.0%, respectively. The tax rate is affected by recurring items, such as tax rates in foreign jurisdictions and the relative amounts of income earned in those jurisdictions, which is expected to be fairly consistent in the near term. It is also affected by discrete items that may occur in any given year, but are not consistent from year to year. The following items had the most significant impact on the difference between the statutory U.S. federal income tax rate of 21% for the years ended December 31, 2023, 2022 and 2021 and the effective tax rate: Year ended December 31, 2023 2022 2021 U.S. federal statutory income tax rate (21.0) % (21.0) % (21.0) % State income taxes, net of federal benefit (0.3) — — Foreign tax rate differential (1) (2.7) (4.0) (4.0) Not taxable government grants (2) (6.8) (3.8) (3.8) Stock-based compensation 0.6 0.5 (1.5) Global intangible low-taxed income 2.3 1.4 — Other 0.2 0.1 0.1 Change in deferred tax asset valuation allowance (3) 28.2 27.1 30.2 Effective income tax rate 0.5 % 0.3 % — % (1) (2) (3) Components of the net deferred tax assets or liabilities as of the years ended December 31, 2023 and 2022 consisted of the following (in thousands): Year ended December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 87,445 $ 66,201 Capitalized R&D expenses 2,657 1,354 Credit carryforwards 1,265 64 Accrued expenses and other 317 366 Stock-based compensation 1,421 1,251 Operating lease liabilities 1,254 918 Total deferred tax assets 94,359 70,154 Valuation allowance (89,309) (65,774) Total deferred tax assets 5,050 4,380 Deferred tax liabilities: Accrued expenses and other (3,774) (3,450) Fixed assets (14) (10) Operating lease right of use asset (1,262) (920) Total deferred tax liabilities (5,050) (4,380) Net deferred tax assets $ — $ — As of December 31, 2023, 2022 and 2021, the Company had Austrian net operating loss carryforwards of $378.1 million, $275.3 million and $219.7 million, respectively, that do not expire, however these carryforwards are limited to 75% of the taxable income in any one tax period. As of December 31, 2023, 2022 and 2021, the Company had federal net operating loss carryforwards that were generated after December 31, 2017 of $2.2 million, $13.8 million and $17.9 million, respectively, that do not expire, however these carryforwards are limited to 80% of the taxable income in any one tax period. The Company generated US taxable income in the current year and was able to offset 80% the taxable income utilizing net operating loss carryforwards which gave rise to current taxes during 2023. The federal net operating loss carryforward as of December 31, 2023 were $2.2 million, and US Federal net operating loss carryforwards as of December 31, 2022 were $13.8 million. The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets resulting from its net operating loss carryforwards. Management has considered the Company's history of cumulative net losses incurred since inception and the uncertainties related to the long period necessary to achieve profits from commercialization of any products and has concluded that it is more likely than not that the Company will not realize the benefits of its deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2023, 2022 and 2021. According to a tax reform in Austria in 2022, the corporate income tax rate will be reduced from 24.0% to 23.0% in 2024. The future tax rate of 23.0% was used to determine deferred taxes and the valuation allowance for the Austrian business. Management reevaluates the positive and negative evidence at each reporting period. The amount of the deferred tax asset considered realizable, however, could be adjusted if estimates of future taxable income during the carryforward period are reduced or increased or if objective negative evidence in the form of losses is no longer present and additional weight may be given to subjective evidence. The tax years in which the tax carryforwards were generated may still be adjusted upon examination by the tax authorities. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2023, 2022 and 2021 related primarily to the increases in net operating loss carryforwards as follows (in thousands): Year ended December 31, 2023 2022 2021 Valuation allowance at beginning of period $ (65,774) $ (53,728) $ (46,064) Increases (23,535) (12,046) (7,664) Valuation allowance at end of period $ (89,309) $ (65,774) $ (53,728) On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (“Tax Reform Legislation” or “TCJA”). The Tax Reform Legislation introduced section 951A, a new tax on so-called “global intangible low-taxed income”. GILTI applies to income of a controlled foreign corporation (“CFC”) that is not otherwise subpart F income, and consists of the excess "tested income" over a 10% return on the CFC's “qualified business asset investment,” or “QBAI”. QBAI is the total tax basis of the CFC's depreciable, tangible property used in the production of tested income. The full amount of GILTI is included in taxable income. The GILTI inclusion is then reduced by 50% (reduced to 37.5% after 2025). However, that reduction in GILTI may be limited based on the level of U.S. taxable income. A limited allowance for foreign tax credits is allowed that would reduce the U.S. tax cost. GILTI foreign tax credits can only reduce U.S. taxes owed on GILTI and are not eligible for carryforward. The Company's Austrian subsidiary falls under the category of a CFC and due to the nature of its business model as a technology company, there may not be a material amount of tangible assets if this subsidiary starts to generate profits. GILTI taxation therefore may be applicable. The Company estimated approximately $8.8 million of GILTI inclusion for the year ended December 31, 2023. The Company previously estimated $3.6 million for the tax year ended December 31, 2022, but did not recognize any GILTI inclusion upon filing of the December 31, 2022 statements. The U.S. tax on GILTI, net of research credits, was $0.4 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively. The Company files income tax returns in the U.S. federal jurisdiction as well as in New York. The tax years from 2018 to present remain open to examination by the jurisdictions in which the Company is subject to tax. There are currently no pending income tax examinations in the U.S. The Company evaluates tax positions for recognition using a more likely than not recognition threshold, and those tax positions eligible for recognition are measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon the effective settlement with a taxing authority that has full knowledge of all relevant information. As of December 31, 2023 and 2022, the Company had no unrecognized income tax benefits that would affect the Company’s effective tax rate if recognized. |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and contingencies | |
Commitments and contingencies | 14. Commitments and contingencies Contract manufacturing arrangements The Company has entered into arrangements with contract manufacturing organizations (“CMOs”) for manufacturing of materials for research and development purposes, including manufacturing of clinical trial materials. These contracts generally provide for non-cancellable obligations or cancellation penalties depending on the time of cancellation. As of December 31, 2023, the Company’s total non-cancellable obligations under contracts with CMOs were $7.4 million, of which $0.9 million relate to 2024 deliverables and $6.5 million relate to 2025 deliverables. Intellectual property licenses The Company has entered into certain license agreements under which it is obligated to make milestone payments upon the achievement of certain development and regulatory milestones, to pay royalties on net sales of licensed products, and to pay a percentage of the sublicense fees which the Company receives from its sublicensees. In the years ended December 31, 2023, 2022 and 2021, the Company recorded $1.6 million, $1.0 million and $1.3 million, respectively, in licensing fees related to intellectual property licenses as research and development expenses. The amount for the year ended December 31, 2021 mainly related to the upfront payment and milestone payments received by the Company under the Gilead Collaboration Agreement. The amount for the years ended December 31, 2023 and December 31, 2022 mainly related to the upfront payment and milestone payments received by the Company under the Gilead Collaboration Agreement and the Roche Collaboration Agreement. The amounts recognized as expenses have been agreed to by the licensors but calculation of sublicensing fees on future payments may be subject to interpretation and may change until agreed to by the receiving party. Indemnification agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its Board of Directors and senior management that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2023 or December 31, 2022. Legal proceedings At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company was recently a party to a patent proceeding opposing European Patent No. 3218504 (the “EP ’504 Patent”), which was granted to the University of Geneva in July 2020 and is exclusively licensed to the Company. In a decision that has become final, the Opposition Division of the European Patent Office (“EPO”) dismissed the opposition, and maintained the patent as granted. The Company expenses the costs related to this case and other such legal proceedings as incurred. |
401(k) Savings Plan
401(k) Savings Plan | 12 Months Ended |
Dec. 31, 2023 | |
401(k) Savings Plan | |
401(k) Savings Plan | 15. 401(k) Savings Plan The Company established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan provides that eligible employees can elect to contribute to the 401(k) Plan, subject to certain limitations, on a pretax basis. The Company matches up to 100% of the first 4% of each employee’s contribution. During the years ended December 31, 2023, December 31, 2022 and December 31, 2021 expenses recognized for the 401(k) Plan were $0.6 million, $0.6 million and $0.4 million, respectively. |
Net loss per share
Net loss per share | 12 Months Ended |
Dec. 31, 2023 | |
Net loss per share | |
Net loss per share | 16. Net loss per share The following table sets forth the computation of the basic and diluted net loss per share attributable to common stockholders (in thousands, except for per share amounts): Year ended December 31, 2023 2022 2021 Numerator: Net loss $ (81,580) $ (64,915) $ (75,665) Denominator: Weighted-average common shares outstanding, basic and diluted 72,422,676 50,743,080 29,945,954 Weighted-average Series A convertible preferred shares outstanding, basic and diluted, presented as if converted into common stock (1) 835,359 1,697,000 2,887,636 Weighted-average Series A-1 convertible preferred shares outstanding, basic and diluted, presented as if converted into common stock (1) 12,526,027 13,072,877 — Weighted-average Series A-2 convertible preferred shares outstanding, basic and diluted, presented as if converted into common stock (1) 8,742,499 — — Total number of shares used to calculate net loss per share, basic and diluted 94,526,561 65,512,957 32,833,590 Net loss per share, basic and diluted $ (0.86) $ (0.99) $ (2.30) (1) shares common Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares (common stock and Class A common stock) outstanding would have been anti-dilutive. Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows: Year ended December 31, 2023 2022 2021 Options issued and outstanding 8,111,575 6,532,523 4,231,178 Total 8,111,575 6,532,523 4,231,178 |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2023 | |
Related Parties | |
Related parties | 17. Related parties Effective September 15, 2023, Malte Peters, a member of the Company’s board of directors, agreed to lead the Company’s clinical activities ad interim as Senior Clinical Advisor. During the year ended December 31, 2023, the Company recorded expense of $0.1 million related to a consulting agreement entered into with Dr. Peters, effective September 15, 2023. In the years ended December 31, 2022 and December 31, 2021, the Company did not record any related party transactions. |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 18. Subsequent events Roche Collaboration and License Agreement On January 25, 2024, the Company received written notice of termination from Roche of the Roche Collaboration Agreement (see Note 3.). The termination was made according to Roche’s right to terminate without cause, acknowledging that, to date, the Company had met all go-forward criteria under the agreement. The Company remains eligible for a final milestone payment of $10.0 million associated with an IND submission for the HB-700 program. Upon the termination effective date April 25, 2024, the Company will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for this program. At December 31, 2023, $26.8 million of non-refundable upfront and milestone payments received from Roche were still recorded as deferred revenue and may be early recognized as revenue as a result of the termination in the first half of 2024. January 2024 Restructuring Plan On January 29, 2024, the Company announced its decision to prioritize the clinical development of its HB-200 program for the treatment of HPV16+ head and neck cancers and its two Gilead-partnered infectious disease programs and to pause development activities related to HB-300 and most of its preclinical research activities. In connection with this strategic refocus, the Company’s Board of Directors approved to reduce the Company’s workforce by 55 fulltime employees, or approximately 30% of the Company’s then-current employee base and to rebalance the Company’s cost structure in alignment with the new prioritization of research and development programs (together, the “Restructuring Plan”). The Company expects the Restructuring Plan to be implemented and substantially completed by the end of the first quarter of 2024. In connection with the Restructuring Plan, the Company estimates that it will incur cash charges of approximately $1.6 million for severance and other personnel and restructuring related costs. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of significant accounting policies | |
Basis of presentation | Basis of presentation The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. |
Going concern | Going concern Since inception, the Company’s activities have consisted primarily of performing research and development to advance its technologies. The Company is still in the development phase and has not been marketing its technologies to date. Through December 31, 2023, the Company has funded its operations with proceeds from sales of common stock, sales of convertible preferred stock, sales of redeemable convertible preferred stock, collaboration and licensing agreements, grants and borrowings under various agreements with foreign public funding agencies. Since inception, the Company has incurred recurring losses, including net losses of $81.6 million, $64.9 million and $75.7 million for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023, the Company had an accumulated deficit of $369.3 million. The Company expects to continue to generate operating losses in the foreseeable future. As of March 22, 2024, the filing date of this Annual Report on Form 10-K, the Company expects that its cash and cash equivalents will be sufficient to fund its operating expenses, capital expenditure requirements and debt service payments through at least 12 months from the issuance date of the consolidated financial statements. The Company will seek additional funding in order to reach its development and commercialization objectives. The Company may seek funds through further equity financings, debt financings, collaborations, strategic alliances and marketing, distribution or 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 collaborations or other arrangements. 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, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary if the Company is unable to continue as a going concern. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue, income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the recognition of revenue and income, the accrual of research and development expenses and general and administrative expenses, the present value of lease right of use assets and corresponding liabilities, the valuation of stock-based awards, the valuation of current and non-current loans payable and the impairment of long-lived assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. As of the date of issuance of these consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions. |
Foreign currency and currency translation | Foreign currency and currency translation The functional currency for the Company is the United States dollar and the functional currency for the Company's wholly owned foreign subsidiary, Hookipa Biotech GmbH, is the euro. Assets and liabilities of Hookipa Biotech GmbH are translated into United States dollars at the exchange rate in effect on the balance sheet date. Income items and expenses are translated at the average exchange rate in effect during the period. Unrealized translation gains and losses are recorded as a cumulative translation adjustment, which is included in the Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) as a component of Accumulated other comprehensive loss. Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other income and expenses, net in the Consolidated Statements of Operations and Comprehensive Loss as incurred. |
Concentrations of credit risk and of significant suppliers | Concentrations of credit risk and of significant suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and short-term bank deposits held with banks in excess of publicly insured limits. For the years ended December 31, 2023 and December 31, 2022 the net proceeds from the Company’s offerings have been deposited in interest-bearing bank accounts with two of the largest investment grade U.S. financial institutions and have been partially invested in money market funds. The money market funds, held in U.S. dollars, are primarily invested in U.S. and foreign short-term debt obligations. As of December 31, 2023 and December 31, 2022, the Company’s cash and cash equivalents included smaller amounts of cash balances held in accounts with regional European banks at the Company’s Austrian subsidiary, partially in euros. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company relies, and expects to continue to rely, on a small number of vendors to manufacture supplies and raw materials for its development programs. These programs could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials. As of December 31, 2023 and December 31, 2022, respectively, Gilead Sciences, Inc. (“Gilead”) and F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (together “Roche”) accounted for the majority of the accounts receivable balance. For the years ended December 31, 2023, December 31, 2022 and December 31, 2021 Gilead and Roche accounted for the majority of the Company’s revenues. Other customers accounted for less than 10.0% of accounts receivable or net sales. The Company monitors the financial performance of its customers so that it can appropriately respond to changes in their credit worthiness. To date, the Company has not experienced any significant losses with respect to collection of its accounts receivable. |
Cash equivalents | Cash equivalents The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. As of December 31, 2023 and December 31, 2022 cash equivalents consisted of money market funds and short-term deposits. |
Deferred offering costs | Deferred offering costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of the additional paid-in capital on a pro-rata basis generated as a result of the offering. Should the in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statements of operations and comprehensive loss. |
Fair value measurements | Fair value measurements Certain assets and liabilities are carried at fair value under GAAP. 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. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1 - Quoted prices in active markets for identical assets or liabilities. ● Level 2 - Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 5). |
Property and equipment | Property and equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated useful life Leasehold improvements shorter of useful life or term of lease Laboratory equipment 2 - 10 years Furniture and fixtures 2 - 10 years Computer equipment and software 2 - 4 years Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. Expenditures for repairs and maintenance are charged to expense as incurred. When property and equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is reflected in the consolidated statements of operations. |
Leases | Leases The determination whether an arrangement qualifies as a lease is made at contract inception. A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, or (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded as operating leases and are included in right of use (“ROU”) assets and lease liabilities in the consolidated balance sheets. For leases with an initial term of 12 months or less, the Company does not recognize a right of use asset or lease liability. These short-term leases are expensed on a straight-line basis over the lease term. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the option will be exercised. The Company uses the implicit rate when readily determinable and uses its incremental borrowing rate when the implicit rate is not readily determinable based upon the information available at the commencement date in determining the present value of the lease payments. The incremental borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease. The lease payments used to determine ROU assets may include lease incentives, stated rent increases and escalation clauses linked to rates of inflation when determinable and are recognized as ROU asset on the consolidated balance sheet. In addition, certain of the Company’s arrangements contain lease and non-lease components. The Company generally separates lease payments from non-lease payments. Operating leases are reflected in operating lease assets, in current operating lease liabilities and non-current operating lease liabilities in the consolidated balance sheets. Finance leases are reflected in finance lease assets, in accrued expenses and other current liabilities and in other non-current operating lease liabilities in the consolidated balance sheets. The ROU asset is tested for impairment in accordance with Accounting Standards Codification (“ASC”) 360. |
Capitalized Software Development Cost | Capitalized Software Development Cost The Company capitalizes certain implementation costs for internal-use software incurred in a cloud computing agreement that is a service contract. Eligible costs associated with cloud computing arrangements, such as software business applications used in the normal course of business, are capitalized in accordance with ASC 350. These costs are recognized on a straight-line basis in the same line item in the statement of operations and comprehensive loss as the expense for fees for the associated cloud computing arrangement, over the term of the arrangement, plus reasonably certain renewals. Amortization expense of $0.1 million associated with the Company's cloud computing arrangements has been recognized during each of the fiscal years ended December 31, 2023 and December 31, 2022 (see Note 6). The Company tests for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. |
Impairment of long-lived assets | Impairment of long-lived assets Long-lived assets, including operating and finance lease right of use assets, consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative technological, scientific or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value (see Note 4. and Note 6.). |
Segment information | Segment information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company's singular focus is on developing pharmaceutical products to prevent and cure infectious diseases and cancer. The Chief Executive Officer is the chief operating decision maker, and regularly reviews the consolidated operating results to make decisions about the allocation of the Company's resources. The majority of the Company's tangible assets are held in Austria. |
Revenue recognition from contracts with customers | Revenue recognition from contracts with customers The Company recognized revenue from collaboration and license agreements with Gilead and Roche. Under the collaboration and license agreement with Gilead (as amended and restated, the “Gilead Collaboration Agreement”), the parties agreed to collaborate with respect to two preclinical research programs to evaluate potential vaccine products for the treatment, cure, diagnosis or prevention of the hepatitis B virus (“HBV”) and the human immunodeficiency virus (“HIV”). In February 2022, the parties signed an amended and restated collaboration agreement (the “Restated Gilead Collaboration Agreement”), which revised the terms only for the HIV program, whereby the Company took on development responsibilities for the HIV program candidate through a Phase 1b clinical trial. The Company’s performance obligations under the terms of the original agreement include one combined performance obligation for each research program (HBV and HIV) comprised of the transfer of intellectual property rights (licenses) and providing research and development services. The terms of the Restated Gilead Collaboration Agreement added an additional performance obligation to perform research and development work for the HIV program. The licenses do not represent distinct performance obligations, because they cannot be used without the research and development services. Payments to the Company under the Restated Gilead Collaboration Agreement include a non-refundable up-front payment, payments for research and development activities, payments based upon the achievement of defined milestones, and if certain future conditions are met, payments for manufacturing services, commercial milestones and royalties on product sales. Under the research collaboration and license agreement with Roche (the “Roche Collaboration Agreement”), the Company has agreed to conduct research and early clinical development through Phase 1b for HB-700, a novel investigational arenaviral immunotherapy for the treatment of KRAS-mutated cancers. The Roche Collaboration Agreement also includes an obligation of the Company to deliver a specified package of preclinical data and results with respect to a second program, targeting undisclosed cancer antigens (collectively “UCAs”) and an option for Roche to license the UCA program. The Company’s performance obligations under the terms of the Roche Collaboration Agreement include one combined performance obligation for the transfer of intellectual property rights (licenses) and providing research and development services for the HB-700 program, and a second, separate performance obligation to perform research and development services with respect to the UCA program. The UCA Option provides a right to license the program at the standalone selling price and therefore does not constitute a separate performance obligation. Payments to the Company under the Roche Collaboration Agreement include a non-refundable up-front payment, payments based upon the achievement of defined milestones, an additional payment if the option for the UCA program is exercised and royalties on product sales. In January 2024, Roche provided written notice of the termination of the collaboration and licensing agreement to the Company. The Company evaluates its collaboration and licensing arrangements pursuant to ASC 606 Revenue from Contracts with Customers. To determine the recognition of revenue from arrangements that fall within the scope of ASC 606, the Company performs the following five steps: (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) the Company satisfies a performance obligation. Under ASC 606, the Company applies significant judgement to evaluate whether the promises under the collaboration and licensing arrangements, represent separate or one or more combined performance obligations, the allocation of the transaction price to identified performance obligations, the timing of revenue recognition, whether the UCA Option constitutes a material right, and the determination of when milestone payments are probable of being received. Upfront payment and program initiation fee The non-refundable upfront-payment received by the Company upon signing of the Gilead Collaboration Agreement, and milestone payments that were linked to future performance obligations, were initially recorded as deferred revenue and allocated between the two research program performance obligations. Such amounts are recognized as revenue over the performance period of the respective services on a percent of completion basis using total estimated research and development labor hours (input method) for each of the obligations. The percent of completion basis using labor hours was considered the best measure of progress in which control of the combined performance obligations transfers to the customer, due to the short time intervals in which research results are shared with the collaboration partner and the nature of the work being performed. The non-refundable program initiation payment received from Gilead upon signing of the Restated Collaboration Agreement was also initially recorded as deferred revenue and is recognized on a percent of completion basis using total estimated research and development costs (input method) for the performance of the obligations. The percent of completion basis using research and development costs was considered the best measure of progress in which control of the performance obligations transfers to the customer, due to the immediate benefit that it adds to the value of the customer’s rights on the program, the short time intervals in which development results are shared and the nature of the work being performed. The non-refundable upfront-payment received by the Company upon signing of the Roche Collaboration Agreement, was initially recorded as deferred revenue and allocated between the HB-700 program and the UCA program. Such amounts are recognized as revenue over the performance period of the respective services on a percent of completion basis using total estimated research and development costs (input method) for each of the obligations during the initial term of the contract. The percent of completion basis using research and development costs was considered the best measure of progress in which control of the performance obligations transfers to the customer. Reimbursement for services Under the Gilead Collaboration Agreement and the Roche Collaboration Agreement, the Company incurs employee expenses as well as external costs for research, manufacturing and clinical trial activities presented as operating expenses or prepaid expenses. Based on the nature of the Company's responsibilities under the collaboration arrangements, reimbursement of those costs are presented as revenue and not deducted from expenses, as the Company controls the research activities. Amounts of consideration allocated to the performance of research or manufacturing services are recognized over the period in which services are performed. Reimbursements for external costs are recognized as revenues as progress is achieved. Unpaid reimbursement amounts are presented as Accounts Receivable. Research and development milestones The Gilead Collaboration Agreement and the Roche Collaboration Agreement include contingent milestone payments related to specified preclinical and clinical development milestones. These milestone payments represent variable consideration that are not initially recognized within the transaction price as they are fully constrained under the guidance in ASC 606, due to the scientific uncertainties and the required commitment from Gilead and Roche. The Company will continue to assess the probability of significant reversals for any amounts that become likely to be realized prior to including the variable consideration associated with these payments within the transaction price. Sales-based milestones and royalty payments The Gilead Collaboration Agreement and the Roche Collaboration Agreement also include certain sales-based milestone and royalty payments upon successful commercialization of a licensed product. In accordance with ASC 606-10-55-65 Sales Based or Usage Based Royalties, the Company recognizes revenues from sales-based milestone and royalty payments at the later of (i) the occurrence of the subsequent sale; or (ii) the performance obligation to which some or all of the sales-based milestone or royalty payments has been allocated has been satisfied. The Company anticipates recognizing these milestones and royalty payments if and when subsequent sales are generated from a licensed product by the collaboration partner. Cost to fulfill contracts The Company incurs costs for personnel, supplies and other costs related to its laboratory operations as well as fees from third parties and license expenses in connection with its research and development obligations under the collaboration and licensing agreement. These costs are recognized as research and development expenses over the period in which services are performed. Sublicense fees triggered by the receipt of payments are capitalized as an asset when the obligation to pay the fee arises. The capitalized asset is amortized over the period in which the revenue from the triggering payment is recognized. |
Research and development costs | Research and development costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, stock-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, manufacturing expenses and external costs of vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. Upfront payments, milestone payments and annual payments made for the licensing of technology are generally expensed as research and development in the period in which they are incurred. Incremental sublicense fees triggered by contracts with customers are capitalized and expensed as research and development expenses over the period in which the related revenue is recognized. |
Research and manufacturing contract costs and accruals | Research and manufacturing contract costs and accruals The Company has entered into various research and development and manufacturing contracts. Related payments are recorded as the corresponding expenses are incurred. The Company records accruals for estimated ongoing costs and prepaid expenses for advance payments. When evaluating the adequacy of the accrued liabilities and prepaid expenses, the Company analyzes progress of the research studies or clinical trials and manufacturing activities, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company's estimates. The Company's historical accrual estimates have not been materially different from the actual costs. |
Government grant agreements and research incentives | Government grant agreements and research incentives The Company recognizes funding from grants and research incentives received from Austrian government agencies as well as from New York State and New York City government agencies in the United States as other income. Income from grants and incentives is recognized in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants or incentives were provided have been met. For grants under funding agreements and for proceeds under research incentive programs, the Company recognizes grant and incentive income in an amount equal to the estimated qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. Grant funding that has been received by the Company in advance of incurring qualifying expenses is recorded as deferred income. Grant and incentive income recognized upon incurring qualifying expenses in advance of receipt of grant funding or proceeds from research and development incentives is recorded in the consolidated balance sheets as prepaid expenses and other current assets. The Company has received loans under funding agreements that bear interest at rates that are below market rates of interest. The Company accounts for the imputed benefit arising from the difference between a market rate of interest and the rate of interest charged as additional grant funding, and records interest expense for the loans at a market rate of interest. On the date that loan proceeds are received, the Company recognizes the portion of the loan proceeds allocated to grant funding as a discount to the carrying value of the loan and as other liability, which is subsequently recognized as additional grant income over the term of the funding agreement. |
Stock-based compensation | Stock-based compensation The Company measures stock-based awards granted to employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model for options or the difference between the purchase price per share of the award, if any, and the fair value of the Company's common stock for restricted common stock awards. Compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award. The Company uses the graded-vesting method to record the expense of awards with service-based vesting conditions. The Company classifies stock-based compensation expense in its Consolidated Statements of Operations and Comprehensive Loss in the same manner in which the recipient's payroll costs are classified or in which the recipient's service payments are classified. |
Comprehensive loss | Comprehensive loss Comprehensive loss includes net loss and foreign currency translation adjustments. For the years ended December 31, 2023 and December 31, 2022 comprehensive loss included $0.8 million and $2.4 million, respectively, of foreign currency translation loss adjustments. For the year ended December 31, 2021, comprehensive loss included $1.3 million of foreign currency translation gain adjustments. |
Net loss per share | Net loss per share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of shares outstanding for the period, including potential dilutive shares assuming the dilutive effect of outstanding stock options and of convertible preferred stock. For periods in which the Company has reported net losses, diluted net loss per common share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their affect is anti-dilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2023, 2022 and 2021. |
Income taxes | Income taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or in the Company's tax returns. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. Changes in deferred tax assets and liabilities are recorded in income tax expense. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. The 2017 Tax Cuts and Jobs Act subjects a US shareholder to tax on global intangible low-taxed income (“GILTI”) earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income, states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in the future years or provide for tax expense related to GILTI in the year the tax is incurred. The Company has elected to recognize tax expense related to GILTI in the year the tax is incurred. |
Recent accounting pronouncements | Recent 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. Adopted as of current period In July 2023, the FASB issued ASU 2023-03, Presentation of Financial Statements (Topic 205), Income Statement - Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation - Stock Compensation (Topic 718) to amend various SEC paragraphs in the Accounting Standards Codification to primarily reflect the issuance of SEC Staff Accounting Bulletin No. 120. Staff Accounting Bulletin No. 120 provides guidance to companies issuing share-based awards shortly before announcing material, nonpublic information to consider such material nonpublic information to adjust observable market prices if the release of material nonpublic information is expected to affect the share price. The ASU does not provide any new guidance so there is no transition or effective date associated with it and therefore, the Company adopted the ASU with no impact to its consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40). The ASU provides guidance that simplified the accounting for certain financial instruments with characteristics of liabilities and equity. The new guidance reduced the number of accounting models for convertible debt and convertible preferred stock instruments and made certain disclosure amendments intended to improve the information provided to users. The guidance also amended the derivative guidance for the “own stock” scope exception, which exempts qualifying instruments from being accounted for as derivatives if certain criteria are met. Finally, the standard changed the way certain convertible instruments are treated when calculating earnings per share. This guidance is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years with early adoption permitted. The Company adopted this standard with no impact to its consolidated financial statements. Recently Issued Accounting Pronouncements In December 2023, the FASB issued final guidance in ASU No. 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures requiring entities to provide additional information in the rate reconciliation and disclosures about income taxes paid. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. The Company is not early adopting, and therefore, this ASU is not adopted in the current period. The Company does not expect this ASU to have a material impact on the consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures which requires public entities to disclose significant segment expenses regularly provided to the chief operating decision-maker. Public entities with a single reporting segment have to provide all disclosures required by ASC 280, including the significant segment expense disclosures. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. The Company is not early adopting, and therefore this ASU is not adopted in the current period. The Company does not expect this ASU to have a material impact on the consolidated financial statements. |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of significant accounting policies | |
Schedule of estimated useful life of each asset | Estimated useful life Leasehold improvements shorter of useful life or term of lease Laboratory equipment 2 - 10 years Furniture and fixtures 2 - 10 years Computer equipment and software 2 - 4 years |
Impairment (Tables)
Impairment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Impairment | |
Schedule of impairment charges were included within Impairment expense | December 31, December 31, 2023 2022 Non-cash impairment charges Asset write-offs $ (12,766) $ — Total non-cash charges $ (12,766) $ — |
Fair Value of Financial Assets
Fair Value of Financial Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value of Financial Assets | |
Schedule of financial assets measured at fair value on a recurring basis | The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicating the level of the fair value hierarchy utilized to determine such fair values (in thousands): Fair Value Measurement at December 31, 2023 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 91,084 $ — $ — $ 91,084 Total $ 91,084 $ — $ — $ 91,084 Fair Value Measurement at December 31, 2022 Using Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 85,491 $ — $ — $ 85,491 Total $ 85,491 $ — $ — $ 85,491 |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, plant and equipment, net | |
Schedule of property, plant and equipment, net | Property, plant and equipment, net consisted of the following (in thousands): December 31, December 31, 2023 2022 Land $ 2,025 $ 1,959 Leasehold improvements 3,300 3,164 Construction in progress 212 10,567 Laboratory equipment 8,722 7,403 Furniture and fixtures 654 622 Computer equipment and software 2,652 2,034 Property and equipment, gross 17,565 25,749 Less: Accumulated depreciation (9,823) (7,779) Property and equipment, net $ 7,742 $ 17,970 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Summary of the effect of lease costs | The following table summarizes the effect of lease costs in the Company’s consolidated statements of operations and comprehensive loss (in thousands): Year ended Year ended Year ended Income statement location December 31, 2023 December 31, 2022 December 31, 2021 Operating lease expenses Research and development expenses $ 1,347 $ 1,430 1,910 General and administrative expenses 242 219 203 Finance lease amortization expenses Research and development expenses — 89 425 General and administrative expenses — — 7 Interest on finance lease liabilities Interest expenses — 0 5 Sublease income Other income (expense) — — (40) Net lease expense $ 1,589 $ 1,738 2,510 |
Summary of maturities of operating lease liabilities | The minimum lease payments for the next five years and thereafter are expected to be as follows (in thousands): December 31, 2023 Operating lease 2024 1,655 2025 1,627 2026 1,351 2027 1,213 2028 4 Thereafter 1 Total lease payments 5,851 Less: interest 412 Present value of lease liabilities $ 5,439 |
Schedule of weighted average remaining lease term and weighted average discount rate of operating leases | The weighted average remaining lease term and weighted average discount rate of operating leases are as follows: December 31, December 31, 2023 2022 Weighted average remaining lease term in years 3.7 2.8 Weighted average discount rate (1) 4.1 % 1.3 % (1) |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued expenses and other current liabilities | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, December 31, 2023 2022 Salaries and bonuses 5,665 4,481 Social security contributions 340 267 Unearned grant income (current) 52 300 Sublicense fees — 1,220 Accrued external research and development expenses 4,594 3,458 Accrued external general and administration expenses 292 898 Accrued for property and equipment acquisitions 14 — Income taxes 367 230 Other accruals and liabilities 777 324 $ 12,101 $ 11,178 |
Loans payable (Tables)
Loans payable (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Loans payable | |
Schedule of loans payable | As of December 31, 2023 and December 31, 2022, loans payable consisted of the following (in thousands): December 31, December 31, 2023 2022 Loans from FFG $ 1,172 $ 2,855 Unamortized debt discount (52) (350) Total loans payable, net $ 1,120 $ 2,505 |
Schedule of aggregate minimum future principal payments due in connection with the FFG Loans | As of December 31, 2023, the aggregate minimum future principal payments due in connection with the FFG Loans are summarized as follows (in thousands): Payments Due by Calendar Year Amount 2024 1,172 2025 — 2026 — 2027 — 2028 — Thereafter — Total $ 1,172 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stock-based compensation | |
Schedule of awards outstanding | As of December 31, 2023 2018 Plan 2019 Plan Inducement Awards Total Granted and outstanding awards: Stock options 782,176 7,099,399 230,000 8,111,575 Total 782,176 7,099,399 230,000 8,111,575 |
Schedule of assumptions used in the Black-Scholes option-pricing model for estimating the fair value of stock options | Year ended December 31, 2023 2022 2021 Risk-free interest rate 3.70 % 3.09 % 1.07 % Expected term (in years) 5.7 6.0 6.1 Expected volatility 93.6 % 85.4 % 85.5 % Expected dividends — % — % — % |
Schedule of summary of stock option activity | The following table summarizes the Company’s stock option activity since January 1, 2023 (in thousands, except share and per share amounts): Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price Term Value (in years) Outstanding as of December 31, 2022 6,532,523 $ 6.19 7.7 $ 490 Granted 2,880,985 1.00 Exercised (5,684) 0.10 Forfeited (1,296,249) 6.63 Outstanding as of December 31, 2023 8,111,575 $ 4.28 7.4 $ 486 Options exercisable as of December 31, 2023 4,101,520 $ 6.83 6.1 $ 486 Options unvested as of December 31, 2023 4,010,055 $ 1.67 8.8 $ — |
Schedule of stock-based compensation expense | Stock-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows (in thousands): Year ended December 31, 2023 2022 2021 Research and development expenses $ 861 $ 2,074 $ 3,200 General and administrative expenses 1,484 2,969 4,444 $ 2,345 $ 5,043 $ 7,644 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income taxes | |
Schedule of losses before income taxes | For financial reporting purposes, losses before income taxes for the years ended December 31, 2023, 2022 and 2021 consisted of the following (in thousands): Year ended December 31, 2023 2022 2021 United States $ 1,710 $ (7,222) $ (11,403) Foreign (Austria) (82,922) (57,463) (64,261) Net loss before tax $ (81,212) $ (64,685) $ (75,664) |
Schedule of components of the consolidated income tax provision | The components of the consolidated income tax provision for the years ended December 31, 2023, 2022 and 2021 were as follows (in thousands): Year ended December 31, 2023 2022 2021 Current Federal $ 145 $ 217 $ — State 222 12 — Foreign (Austria) 1 1 1 Total current tax expense 368 230 1 Deferred Federal — — — State — — — Foreign (Austria) — — — Total deferred tax expense — — — Total income tax expense $ 368 $ 230 $ 1 |
Schedule of effective income tax rate reconciliation | Year ended December 31, 2023 2022 2021 U.S. federal statutory income tax rate (21.0) % (21.0) % (21.0) % State income taxes, net of federal benefit (0.3) — — Foreign tax rate differential (1) (2.7) (4.0) (4.0) Not taxable government grants (2) (6.8) (3.8) (3.8) Stock-based compensation 0.6 0.5 (1.5) Global intangible low-taxed income 2.3 1.4 — Other 0.2 0.1 0.1 Change in deferred tax asset valuation allowance (3) 28.2 27.1 30.2 Effective income tax rate 0.5 % 0.3 % — % (1) (2) (3) |
Schedule of components of the net deferred tax assets or liabilities | Components of the net deferred tax assets or liabilities as of the years ended December 31, 2023 and 2022 consisted of the following (in thousands): Year ended December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 87,445 $ 66,201 Capitalized R&D expenses 2,657 1,354 Credit carryforwards 1,265 64 Accrued expenses and other 317 366 Stock-based compensation 1,421 1,251 Operating lease liabilities 1,254 918 Total deferred tax assets 94,359 70,154 Valuation allowance (89,309) (65,774) Total deferred tax assets 5,050 4,380 Deferred tax liabilities: Accrued expenses and other (3,774) (3,450) Fixed assets (14) (10) Operating lease right of use asset (1,262) (920) Total deferred tax liabilities (5,050) (4,380) Net deferred tax assets $ — $ — |
Schedule of changes in the valuation allowance for deferred tax assets | Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2023, 2022 and 2021 related primarily to the increases in net operating loss carryforwards as follows (in thousands): Year ended December 31, 2023 2022 2021 Valuation allowance at beginning of period $ (65,774) $ (53,728) $ (46,064) Increases (23,535) (12,046) (7,664) Valuation allowance at end of period $ (89,309) $ (65,774) $ (53,728) |
Net loss per share (Tables)
Net loss per share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Net loss per share | |
Schedule of basic and diluted net loss per share | The following table sets forth the computation of the basic and diluted net loss per share attributable to common stockholders (in thousands, except for per share amounts): Year ended December 31, 2023 2022 2021 Numerator: Net loss $ (81,580) $ (64,915) $ (75,665) Denominator: Weighted-average common shares outstanding, basic and diluted 72,422,676 50,743,080 29,945,954 Weighted-average Series A convertible preferred shares outstanding, basic and diluted, presented as if converted into common stock (1) 835,359 1,697,000 2,887,636 Weighted-average Series A-1 convertible preferred shares outstanding, basic and diluted, presented as if converted into common stock (1) 12,526,027 13,072,877 — Weighted-average Series A-2 convertible preferred shares outstanding, basic and diluted, presented as if converted into common stock (1) 8,742,499 — — Total number of shares used to calculate net loss per share, basic and diluted 94,526,561 65,512,957 32,833,590 Net loss per share, basic and diluted $ (0.86) $ (0.99) $ (2.30) (1) shares common |
Schedule of potentially dilutive securities that were not included in the diluted per share calculations | Year ended December 31, 2023 2022 2021 Options issued and outstanding 8,111,575 6,532,523 4,231,178 Total 8,111,575 6,532,523 4,231,178 |
Summary of significant accoun_4
Summary of significant accounting policies - Going concern (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of significant accounting policies | |||
Net losses | $ (81,580) | $ (64,915) | $ (75,665) |
Accumulated deficit | $ (369,261) | $ (287,681) |
Summary of significant accoun_5
Summary of significant accounting policies - Property and equipment (Details) | Dec. 31, 2023 |
Laboratory equipment | Minimum | |
Property and equipment | |
Estimated useful life (in years) | 2 years |
Laboratory equipment | Maximum | |
Property and equipment | |
Estimated useful life (in years) | 10 years |
Furniture and fixtures | Minimum | |
Property and equipment | |
Estimated useful life (in years) | 2 years |
Furniture and fixtures | Maximum | |
Property and equipment | |
Estimated useful life (in years) | 10 years |
Computer equipment and software | Minimum | |
Property and equipment | |
Estimated useful life (in years) | 2 years |
Computer equipment and software | Maximum | |
Property and equipment | |
Estimated useful life (in years) | 4 years |
Summary of significant accoun_6
Summary of significant accounting policies - Others (Details) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 USD ($) item Program | Dec. 31, 2022 USD ($) | |
Summary of significant accounting policies | ||
Amortization expense | $ | $ 0.1 | $ 0.1 |
Number of preclinical research programs | Program | 2 | |
Number of Combined Performance Obligation | 1 | |
Number of combined performance obligation for each research program | 1 | |
Number of research program performance obligations | 2 |
Summary of significant accoun_7
Summary of significant accounting policies - Comprehensive loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of significant accounting policies | |||
Foreign currency translation adjustment, net of tax | $ (777) | $ (2,376) | $ 1,287 |
Collaboration and Licensing A_2
Collaboration and Licensing Agreements (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Oct. 31, 2022 USD ($) | Jun. 30, 2018 USD ($) item | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Collaboration and Licensing Agreements | |||||
Deferred revenues | $ 14,631 | $ 15,684 | |||
Gilead Collaboration and License Agreement | |||||
Collaboration and Licensing Agreements | |||||
Number of preclinical research programs | item | 2 | ||||
Upfront payment received | $ 10,000 | ||||
Program initiation fee | $ 15,000 | ||||
Payment term (in days) | 60 days | ||||
Milestone payment received | $ 8,000 | ||||
Percentage of upfront payment included in deferred revenue expected to be recognized in 2024 | 55.20% | ||||
Percentage of upfront payment included in deferred revenue expected to be recognized in 2025 | 36.80% | ||||
Percentage of upfront payment included in deferred revenue expected to be recognized in 2026 | 8% | ||||
Revenue recognized from milestone payments | $ 7,100 | 3,700 | $ 2,100 | ||
Revenue recognized from cost reimbursements for research and development services | 1,400 | 5,200 | $ 16,300 | ||
Revenue recognized from milestone payments for milestones achieved | 5,000 | ||||
Contract asset relating to the sublicense payment | 100 | 200 | |||
Contract liability relating to sublicense payment | 0 | 0 | |||
Deferred revenues | 14,300 | ||||
Deferred income | 7,500 | ||||
Roche collaboration agreement | |||||
Collaboration and Licensing Agreements | |||||
Upfront payment received | $ 25,000 | ||||
Milestone payment received | 10,000 | ||||
Revenue recognized from upfront payment | 300 | ||||
Revenue recognized from milestone payments | 11,100 | ||||
Collaborative arrangement revenue from cost reimbursements for preparation of first human trial | 500 | ||||
Contract asset relating to the sublicense payment | 2,000 | 1,500 | |||
Contract liability relating to sublicense payment | 0 | 1,200 | |||
Deferred revenues | $ 27,000 | ||||
Deferred income | $ 26,800 | ||||
Development Milestones | HBV program | |||||
Collaboration and Licensing Agreements | |||||
Total milestone amount | 140,000 | ||||
Development Milestones | HIV program | |||||
Collaboration and Licensing Agreements | |||||
program completion fee | 10,000 | ||||
Development Milestones | HIV program | Maximum | |||||
Collaboration and Licensing Agreements | |||||
Total milestone amount | 172,500 | ||||
Commercial Milestones | HBV program | |||||
Collaboration and Licensing Agreements | |||||
Total milestone amount | 50,000 | ||||
Commercial Milestones | HIV program | |||||
Collaboration and Licensing Agreements | |||||
Total milestone amount | $ 65,000 |
Impairment - Additional informa
Impairment - Additional information (Details) | Jan. 29, 2024 |
Employee Severance | January 2024 Restructuring Plan | Subsequent events | |
Impairment | |
Reduction if workforce (in percent) | 30% |
Impairment - Non-cash impairmen
Impairment - Non-cash impairment charges (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Impairment | |||
Non-cash impairment charges | $ (12,766) | $ 0 | $ 0 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value of Financial Assets | ||
Transfers from Level 1 to Level 2 | $ 0 | |
Transfers from Level 2 to Level 1 | 0 | |
Transfers from into Level 3 | 0 | |
Transfers from out of Level 3 | 0 | |
Recurring | ||
Fair Value of Financial Assets | ||
Total | 91,084 | $ 85,491 |
Recurring | Money market funds | ||
Fair Value of Financial Assets | ||
Cash equivalents | 91,084 | 85,491 |
Recurring | Level 1 | ||
Fair Value of Financial Assets | ||
Total | 91,084 | 85,491 |
Recurring | Level 1 | Money market funds | ||
Fair Value of Financial Assets | ||
Cash equivalents | $ 91,084 | $ 85,491 |
Property, plant and equipment_3
Property, plant and equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property and equipment | |||
Property and equipment, gross | $ 17,565 | $ 25,749 | |
Less: Accumulated depreciation | (9,823) | (7,779) | |
Property and equipment, net | 7,742 | 17,970 | |
Depreciation expense | 2,000 | 1,900 | $ 2,100 |
Impairment charges of assets | 12,766 | 0 | $ 0 |
Carrying value | 0 | ||
Land | |||
Property and equipment | |||
Property and equipment, gross | 2,025 | 1,959 | |
Leasehold improvements | |||
Property and equipment | |||
Property and equipment, gross | 3,300 | 3,164 | |
Construction in progress | |||
Property and equipment | |||
Property and equipment, gross | 212 | 10,567 | |
Laboratory equipment | |||
Property and equipment | |||
Property and equipment, gross | 8,722 | 7,403 | |
Furniture and fixtures | |||
Property and equipment | |||
Property and equipment, gross | 654 | 622 | |
Computer equipment and software | |||
Property and equipment | |||
Property and equipment, gross | $ 2,652 | $ 2,034 |
Receivable research incentive (
Receivable research incentive (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Research and Development Incentive Program [Line Items] | |||
Income related to the incentive program recorded as grant income | $ 10,900 | $ 7,300 | $ 8,900 |
Receivable research incentives | 18,760 | $ 15,479 | |
Austrian Research Incentive Program | |||
Research and Development Incentive Program [Line Items] | |||
Income related to the incentive program recorded as grant income | 9,400 | ||
Receivable research incentives | 17,300 | ||
New York State Life Sciences Research and Development Program | |||
Research and Development Incentive Program [Line Items] | |||
Income related to the incentive program recorded as grant income | 1,400 | ||
Receivable research incentives | 1,400 | ||
Reimbursement of research and development expenses | 500 | ||
New York State New York City Biotechnology Tax Credit Program | |||
Research and Development Incentive Program [Line Items] | |||
Income related to the incentive program recorded as grant income | 100 | ||
Receivable research incentives | 100 | ||
Maximum expenses eligible for incentives | $ 250 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Leases | ||
Cash balance maintained to secure a letter of credit associated with a real estate lease | $ 425 | $ 419 |
Minimum | ||
Leases | ||
Remaining lease term (in years) | 1 year | |
Maximum | ||
Leases | ||
Remaining lease term (in years) | 5 years 2 months 12 days |
Leases - Lease costs (Details)
Leases - Lease costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Leases | |||
Net lease expenses | $ 1,589 | $ 1,738 | $ 2,510 |
Research and development expenses | |||
Leases | |||
Operating lease expenses | 1,347 | 1,430 | 1,910 |
Finance lease amortization expenses | 89 | 425 | |
General and administrative expense | |||
Leases | |||
Operating lease expenses | $ 242 | 219 | 203 |
Finance lease amortization expenses | 7 | ||
Interest expenses | |||
Leases | |||
Interest on finance lease liabilities | $ 0 | 5 | |
Other income (expense) | |||
Leases | |||
Sublease income | $ (40) |
Leases - Minimum lease payments
Leases - Minimum lease payments (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Operating leases | |
2024 | $ 1,655 |
2025 | 1,627 |
2026 | 1,351 |
2027 | 1,213 |
2028 | 4 |
Thereafter | 1 |
Total lease payments | 5,851 |
Less: interest | 412 |
Present value of lease liabilities | $ 5,439 |
Leases - Weighted average remai
Leases - Weighted average remaining lease term and weighted average discount rate (Details) | Dec. 31, 2023 | Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] | ||
Operating lease, Weighted average remaining lease term (in years) | 3 years 8 months 12 days | 2 years 9 months 18 days |
Operating lease, Weighted average discount rate | 4.10% | 1.30% |
lease for corporate headquarters in New York City | ||
Lessee, Lease, Description [Line Items] | ||
Lessee, Operating Lease, | 2 years 2 months 12 days | |
Leases for Office and Laboratory Space in Vienna, Austria | ||
Lessee, Lease, Description [Line Items] | ||
Lessee, Operating Lease, | 2 years | |
Lease for Certain Parking Spaces in Vienna Office | ||
Lessee, Lease, Description [Line Items] | ||
Lessee, Operating Lease, | 5 years 6 months |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued expenses and other current liabilities | ||
Salaries and bonuses | $ 5,665 | $ 4,481 |
Social security contributions | 340 | 267 |
Unearned grant income (current) | 52 | 300 |
Sublicense fees | 1,220 | |
Accrued external research and development expenses | 4,594 | 3,458 |
Accrued external general and administration expenses | 292 | 898 |
Accrued for property and equipment acquisitions | 14 | |
Income taxes | 367 | 230 |
Other accruals and liabilities | 777 | 324 |
Total | $ 12,101 | $ 11,178 |
Loans payable (Details)
Loans payable (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Loans payable | |||
Loans from FFG | $ 1,172 | $ 2,855 | |
Unamortized debt discount | (52) | (350) | |
Total loans payable, net | $ 1,120 | 2,505 | |
Interest rate (as a percent) | 0.75% | ||
Revenue | $ 20,129 | 14,249 | $ 18,448 |
Deferred revenues | 14,631 | 15,684 | |
Deferred revenues, non-current | 19,674 | 25,664 | |
Unamortized debt discount | 100 | 400 | |
Interest expense | 300 | 700 | 900 |
Principal payment | 1,754 | 2,825 | |
Amortization of debt discount | $ 300 | 700 | 800 |
Threshold for change in estimated market rate | 0.10 | ||
Estimated market rate | 20% | ||
Grant | |||
Loans payable | |||
Revenue | $ 300 | 600 | $ 800 |
Deferred revenues, non-current | 0 | 100 | |
Maximum | Grant | |||
Loans payable | |||
Deferred revenues | $ 100 | $ 300 |
Loans payable - Schedule of agg
Loans payable - Schedule of aggregate minimum future principal payments (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2024 | $ 1,172 |
Total | $ 1,172 |
Common stock, Class A common _2
Common stock, Class A common stock and convertible preferred stock (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 2 Months Ended | 12 Months Ended | ||||||||
Dec. 20, 2023 USD ($) $ / shares shares | Jun. 05, 2023 USD ($) $ / shares shares | Mar. 04, 2022 USD ($) $ / shares shares | Feb. 15, 2022 USD ($) $ / shares shares | May 31, 2023 shares | Aug. 31, 2022 shares | Jul. 31, 2022 shares | Aug. 31, 2022 shares | Dec. 31, 2023 USD ($) Vote $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) | |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | |||||||||
Net proceeds from public offering | $ | $ 46,200 | $ 70,200 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 49,043 | $ 45,691 | $ 203 | ||||||||
Register for resale of common stock | 4 months | ||||||||||
Common stock | |||||||||||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | |||||||||
Common stock, issued (in shares) | 96,550,590 | 52,317,138 | |||||||||
Common stock, outstanding (in shares) | 96,550,590 | 52,317,138 | |||||||||
Issuance of stock (in shares) | 22,900,768 | 21,700,000 | |||||||||
Share Price | $ / shares | $ 1.31 | $ 2 | |||||||||
Number of shares elected to convert | 1,420,215 | ||||||||||
Conversion of preferred stock into common stock (in shares) | 6,327,000 | ||||||||||
Number of votes | Vote | 1 | ||||||||||
Class A common stock | |||||||||||
Common stock, shares authorized (in shares) | 3,900,000 | 3,900,000 | |||||||||
Common stock, issued (in shares) | 2,399,517 | 2,399,517 | |||||||||
Common stock, outstanding (in shares) | 2,399,517 | 2,399,517 | |||||||||
Number of shares elected to convert | 650,481 | 769,734 | 1,420,215 | ||||||||
Number of common stock issued upon conversion of each share | 1 | ||||||||||
Series A, SeriesA-1 And SeriesA-2 convertible Preferred Stock | |||||||||||
Number of common stock issued upon conversion of each share | 1,000 | ||||||||||
Threshold percentage for conversion | 9.99% | ||||||||||
Liquidation preference per share | $ / shares | $ 0.001 | ||||||||||
Series A-1 convertible preferred stock | |||||||||||
Preferred stock shares designated (in shares) | 15,800 | 15,800 | |||||||||
Preferred stock, shares issued | 10,800 | ||||||||||
Preferred stock, shares outstanding | 10,800 | 15,800 | |||||||||
Issuance of stock (in shares) | 15,800 | ||||||||||
Share Price | $ / shares | $ 2,000 | ||||||||||
Number of shares elected to convert | 5,000 | ||||||||||
Series A-2 convertible preferred stock | |||||||||||
Preferred stock shares designated (in shares) | 15,268 | 0 | |||||||||
Preferred stock, shares issued | 15,268 | ||||||||||
Preferred stock, shares outstanding | 15,268 | 0 | |||||||||
Issuance of stock (in shares) | 15,268 | ||||||||||
Share Price | $ / shares | $ 1,310 | ||||||||||
Series A convertible preferred stock | |||||||||||
Preferred stock shares designated (in shares) | 2,978 | 2,978 | |||||||||
Preferred stock, shares issued | 370 | ||||||||||
Preferred stock, shares outstanding | 370 | 1,697 | |||||||||
Number of shares elected to convert | 1,327 | ||||||||||
Stock Purchase Agreement | |||||||||||
Issuance of stock (in shares) | 1,666,666 | ||||||||||
Share Price | $ / shares | $ 3 | ||||||||||
Net proceeds from public offering | $ | $ 35,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 5,000 | ||||||||||
Stock Purchase Agreement | Gilead | Gilead Collaboration and License Agreement | |||||||||||
Ownership percentage | 19.90% | ||||||||||
Stock Purchase Agreement | Common stock | |||||||||||
Share Price | $ / shares | $ 1.4167 | $ 3 | |||||||||
Amended Stock Purchase Agreement | |||||||||||
Issuance of stock (in shares) | 15,000,000 | ||||||||||
Share Price | $ / shares | $ 1.4167 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 21,300 | ||||||||||
Outstanding amount | $ | $ 8,700 |
Stock-based compensation - 2018
Stock-based compensation - 2018 Stock Option and Grant Plan (Details) | 12 Months Ended | |
Dec. 31, 2023 installment shares | Dec. 31, 2022 shares | |
Stock-based compensation | ||
Options outstanding | 8,111,575 | 6,532,523 |
2018 Stock Option and Grant Plan | ||
Stock-based compensation | ||
Vesting period | 4 years | |
Options outstanding | 782,176 | |
2018 Stock Option and Grant Plan | Vesting upon first anniversary | ||
Stock-based compensation | ||
Percentage of options vesting | 25% | |
2018 Stock Option and Grant Plan | Vesting in equal quarterly installments | ||
Stock-based compensation | ||
Percentage of options vesting | 75% | |
Number of quarterly installments for vesting | installment | 12 |
Stock-based compensation - 2019
Stock-based compensation - 2019 Stock Option and Incentive Plan (Details) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Sep. 12, 2023 $ / shares shares | Aug. 07, 2023 USD ($) item installment $ / shares shares | Dec. 31, 2023 installment shares | |
Stock-based compensation | |||
Number of common stock entitled for each option upon the exercise of the option | 1 | ||
Stock option exchange offer | |||
Stock-based compensation | |||
Vesting period | 3 years | ||
Number of quarterly installments for vesting | installment | 12 | ||
Eligible participants | item | 82 | ||
Exercise of stock options cancelled | 543,228 | ||
Percentage of options accepted for cancellation | 86.60% | ||
Issuance of common stock | 274,485 | ||
Exercise price per share | $ / shares | $ 1 | ||
Stock option exchange offer resulted in incremental stock-based compensation expense | $ | $ 0.1 | ||
Stock option exchange offer | Minimum | |||
Stock-based compensation | |||
Exchange ratio | 1.75 | ||
Exercise price | $ / shares | $ 6.90 | ||
Stock option exchange offer | Maximum | |||
Stock-based compensation | |||
Exchange ratio | 2.50 | ||
Exercise price | $ / shares | $ 14 | ||
2019 Stock Option and Incentive Plan | |||
Stock-based compensation | |||
Number stock option authorized | 8,067,480 | ||
Number of shares outstanding were cumulatively increased | 4% | ||
Vesting period | 4 years | ||
2019 Stock Option and Incentive Plan | Non Executive Directors | |||
Stock-based compensation | |||
Vesting period | 3 years | ||
2019 Stock Option and Incentive Plan | Vesting upon first anniversary | |||
Stock-based compensation | |||
Percentage of options vesting | 25% | ||
2019 Stock Option and Incentive Plan | Vesting upon first anniversary | Non Executive Directors | |||
Stock-based compensation | |||
Percentage of options vesting | 33% | ||
2019 Stock Option and Incentive Plan | Vesting in equal quarterly installments | |||
Stock-based compensation | |||
Percentage of options vesting | 75% | ||
Number of quarterly installments for vesting | installment | 12 | ||
2019 Stock Option and Incentive Plan | Vesting in equal quarterly installments | Non Executive Directors | |||
Stock-based compensation | |||
Percentage of options vesting | 67% | ||
Number of quarterly installments for vesting | installment | 8 | ||
Inducement Awards | |||
Stock-based compensation | |||
Stock reserved for future issuance | 500,000 |
Stock-based compensation - Summ
Stock-based compensation - Summary of awards outstanding (Details) - shares | Dec. 31, 2023 | Dec. 31, 2022 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options outstanding | 8,111,575 | 6,532,523 |
2018 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options outstanding | 782,176 | |
2019 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options outstanding | 7,099,399 | |
Inducement Awards | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options outstanding | 230,000 |
Stock-based compensation - Stoc
Stock-based compensation - Stock option valuation (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Assumptions used in the Black-Scholes option-pricing model | |||
Risk-free interest rate | 3.70% | 3.09% | 1.07% |
Expected term (in years) | 5 years 8 months 12 days | 6 years | 6 years 1 month 6 days |
Expected volatility | 93.60% | 85.40% | 85.50% |
Stock-based compensation - St_2
Stock-based compensation - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Shares | |||
Beginning balance | 6,532,523 | ||
Granted | 2,880,985 | ||
Exercised | (5,684) | ||
Forfeited | (1,296,249) | ||
Ending balance | 8,111,575 | 6,532,523 | |
Option exercisable | 4,101,520 | ||
Option unvested | 4,010,055 | ||
Weighted Averaged Exercise Price | |||
Beginning balance | $ 6.19 | ||
Granted | 1 | ||
Exercised | 0.10 | ||
Forfeited | 6.63 | ||
Ending balance | 4.28 | $ 6.19 | |
Option exercisable | 6.83 | ||
Option unvested | $ 1.67 | ||
Weighted Average Remaining Contractual Term | |||
Weighted Average Remaining Contractual Term (in years) | 7 years 4 months 24 days | 7 years 8 months 12 days | |
Weighted Average Remaining Contractual Term, option exercisable | 6 years 1 month 6 days | ||
Weighted Average Remaining Contractual Term, option unvested | 8 years 9 months 18 days | ||
Aggregate Intrinsic Value, beginning balance | $ 490 | ||
Aggregate Intrinsic Value, ending balance | 486 | $ 490 | |
Aggregate Intrinsic Value, option exercisable | $ 486 | ||
Fair value per common stock used for calculating intrinsic values | $ 0.81 | $ 0.81 | $ 2.33 |
Weighted average grant-date fair value per share of stock options granted | $ 0.55 | $ 1.55 | $ 11.46 |
Total fair value of stock options vested | $ 5,100 | $ 7,900 | |
Cash received from option exercise under share-based payment arrangements | 1 | 3 | $ 203 |
Maximum | |||
Weighted Average Remaining Contractual Term | |||
Aggregate Intrinsic Value, options exercised | $ 100 | $ 100 | $ 1,000 |
Stock-based compensation - Comm
Stock-based compensation - Common Stock Awards (Details) - Common Stock Awards - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-based compensation | ||
Share Price | $ 3 | |
Share-based awards granted | 0 | 112,551 |
Aggregate fair value of share-based awards granted | $ 0.2 | |
Grant date fair value per share | $ 1.50 |
Stock-based compensation - St_3
Stock-based compensation - Stock-based compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-based compensation | |||
Stock-based compensation expense | $ 2,345 | $ 5,043 | $ 7,644 |
Unrecognized compensation cost related to the unvested stock-based awards | $ 1,500 | ||
Weighted average periods over which expense is expected to be recognized | 1 year 6 months | ||
Research and development expenses | |||
Stock-based compensation | |||
Stock-based compensation expense | $ 861 | 2,074 | 3,200 |
General and administrative expense | |||
Stock-based compensation | |||
Stock-based compensation expense | $ 1,484 | $ 2,969 | $ 4,444 |
Income taxes - Losses before in
Income taxes - Losses before income taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income taxes | |||
Income tax benefits for the net operating losses incurred | $ 0 | $ 0 | $ 0 |
United States | 1,710 | (7,222) | (11,403) |
Foreign (Austria) | (82,922) | (57,463) | (64,261) |
Net loss before tax | $ (81,212) | $ (64,685) | $ (75,664) |
Income taxes - components of th
Income taxes - components of the consolidated income tax provision (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current | |||
Federal | $ 145 | $ 217 | |
State | 222 | 12 | |
Foreign (Austria) | 1 | 1 | $ 1 |
Total current tax expense | 368 | 230 | 1 |
Deferred | |||
Total income tax expense | $ 368 | $ 230 | $ 1 |
Income taxes - Effective income
Income taxes - Effective income tax reconciliation (Details) | 12 Months Ended | |||
Dec. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||||
U.S. federal statutory income tax rate | (21.00%) | (21.00%) | (21.00%) | |
State income taxes, net of federal benefit | (0.30%) | |||
Foreign tax rate differential | (2.70%) | (4.00%) | (4.00%) | |
Not taxable government grants | (6.80%) | (3.80%) | (3.80%) | |
Stock-based compensation | 0.60% | 0.50% | (1.50%) | |
Global intangible low-taxed income | 2.30% | 1.40% | ||
Other | 0.20% | 0.10% | 0.10% | |
Change in deferred tax asset valuation allowance | 28.20% | 27.10% | 30.20% | |
Effective income tax rate | 0.50% | 0.30% | (0.00%) | |
Austria | ||||
Operating Loss Carryforwards [Line Items] | ||||
U.S. federal statutory income tax rate | (23.00%) | (24.00%) | (25.00%) | (25.00%) |
Income taxes - Components of _2
Income taxes - Components of the net deferred tax assets or liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||||
Net operating loss carryforwards | $ 87,445 | $ 66,201 | ||
Capitalized R&D expenses | 2,657 | 1,354 | ||
Credit carryforwards | 1,265 | 64 | ||
Accrued expenses and other | 317 | 366 | ||
Stock-based compensation | 1,421 | 1,251 | ||
Operating lease liabilities | 1,254 | 918 | ||
Total deferred tax assets | 94,359 | 70,154 | ||
Valuation allowance | (89,309) | (65,774) | $ (53,728) | $ (46,064) |
Total deferred tax assets | 5,050 | 4,380 | ||
Deferred tax liabilities: | ||||
Accrued expenses and other | (3,774) | (3,450) | ||
Fixed assets | (14) | (10) | ||
Operating lease right of use asset | (1,262) | (920) | ||
Total deferred tax liabilities | $ (5,050) | $ (4,380) |
Income taxes - Changes in the v
Income taxes - Changes in the valuation allowance for deferred tax assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income taxes | |||
Valuation allowance at beginning of period | $ (65,774) | $ (53,728) | $ (46,064) |
Increases | (23,535) | (12,046) | (7,664) |
Valuation allowance at end of period | $ (89,309) | $ (65,774) | $ (53,728) |
Income taxes -Additional Inform
Income taxes -Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||||
Corporate income tax rate | 21% | 21% | 21% | |
Global Intangible Low Taxed Income estimated | $ 8.8 | $ 3.6 | ||
US Tax on GILTI, net of Research Credits | 0.4 | 0.2 | ||
Unrecognized income tax benefits | 0 | 0 | ||
Federal | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | 2.2 | 13.8 | $ 17.9 | |
Austria | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforwards | $ 378.1 | $ 275.3 | $ 219.7 | |
Corporate income tax rate | 23% | 24% | 25% | 25% |
Commitments and contingencies (
Commitments and contingencies (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and contingencies | |||
Non-cancellable obligations | $ 7.4 | ||
2024 deliverables | 0.9 | ||
2025 deliverables | 6.5 | ||
Licensing fees from intellectual property licenses | $ 1.6 | $ 1 | $ 1.3 |
401(k) Savings Plan (Details)
401(k) Savings Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Contribution Plan Disclosure [Line Items] | |||
Expenses recognized for the 401(k) Plan | $ 0.6 | $ 0.6 | $ 0.4 |
Maximum | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Matching contribution to defined contribution savings plan | 100% | ||
Employer's Matching contribution to defined contribution savings plan | 4% |
Net loss per share (Details)
Net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Numerator: | |||
Net Income (Loss) | $ (81,580) | $ (64,915) | $ (75,665) |
Denominator: | |||
Weighted-average Shares outstanding, basic | 94,526,561 | 65,512,957 | 32,833,590 |
Weighted-average Shares outstanding, diluted | 94,526,561 | 65,512,957 | 32,833,590 |
Net loss per share - basic | $ (0.86) | $ (0.99) | $ (2.30) |
Net loss per share - diluted | $ (0.86) | $ (0.99) | $ (2.30) |
Class A common stock | |||
Denominator: | |||
Number of shares issued for each share of common stock | 1 | ||
Number of common shares issuable upon conversion of common stock | 2,399,517 | ||
Common stock | |||
Denominator: | |||
Weighted-average Shares outstanding, basic | 72,422,676 | 50,743,080 | 29,945,954 |
Weighted-average Shares outstanding, diluted | 72,422,676 | 50,743,080 | 29,945,954 |
Series A convertible preferred stock | |||
Denominator: | |||
Weighted-average Shares outstanding, basic | 835,359 | 1,697,000 | 2,887,636 |
Weighted-average Shares outstanding, diluted | 835,359 | 1,697,000 | 2,887,636 |
Number of shares issued for each share of common stock | 1,000 | ||
Number of common stock issuable upon conversion of convertible preferred stock | 370,000 | ||
Series A-1 convertible preferred stock | |||
Denominator: | |||
Weighted-average Shares outstanding, basic | 12,526,027 | 13,072,877 | |
Weighted-average Shares outstanding, diluted | 12,526,027 | 13,072,877 | |
Number of common stock issued upon conversion of each share of Preferred Stock | 1,000 | ||
Number of common stock issuable upon conversion of convertible preferred stock | 10,800,000 | ||
Series A-2 convertible preferred stock | |||
Denominator: | |||
Weighted-average Shares outstanding, basic | 8,742,499 | ||
Weighted-average Shares outstanding, diluted | 8,742,499 | ||
Number of common stock issued upon conversion of each share of Preferred Stock | 1,000 | ||
Number of common stock issuable upon conversion of convertible preferred stock | 15,268,000 |
Net loss per share - Antidiluti
Net loss per share - Antidilutive securities (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Anti-dilutive securities | |||
Anti-dilutive shares | 8,111,575 | 6,532,523 | 4,231,178 |
Options issued and outstanding | |||
Anti-dilutive securities | |||
Anti-dilutive shares | 8,111,575 | 6,532,523 | 4,231,178 |
Related Parties (Details)
Related Parties (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Board of directors | Malte Peters | Consulting agreement | |
Related parties | |
Expense recorded | $ 0.1 |
Subsequent events (Details)
Subsequent events (Details) $ in Thousands | 12 Months Ended | ||||
Jan. 29, 2024 USD ($) employee | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jan. 25, 2024 USD ($) | |
Subsequent Event [Line Items] | |||||
Impairment charges of assets | $ 12,766 | $ 0 | $ 0 | ||
Roche Collaboration Agreement | |||||
Subsequent Event [Line Items] | |||||
Liability in deferred revenues | $ 26,800 | ||||
Subsequent events | January 2024 Restructuring Plan | Employee Severance | |||||
Subsequent Event [Line Items] | |||||
Number of employees reduced | employee | 55 | ||||
Reduction if workforce (in percent) | 30% | ||||
Severance Costs | $ 1,600 | ||||
Subsequent events | Roche Collaboration Agreement | |||||
Subsequent Event [Line Items] | |||||
Final milestone payment the Company remains eligible | $ 10,000 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net Income (Loss) | $ (81,580) | $ (64,915) | $ (75,665) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b5-1 Arrangement Modified | false |
Non-Rule 10b5-1 Arrangement Modified | false |