Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2024 | May 02, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-36201 | |
Entity Registrant Name | Immunic, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 56-2358443 | |
Entity Address, Address Line One | 1200 Avenue of the Americas | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | New York, | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10036 | |
City Area Code | 332 | |
Local Phone Number | 255-9818 | |
Title of 12(b) Security | Common Stock, $0.0001 par value | |
Trading Symbol | IMUX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 90,079,016 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Central Index Key | 0001280776 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 97,312 | $ 46,674 |
Other current assets and prepaid expenses | 5,303 | 5,860 |
Total current assets | 102,615 | 52,534 |
Property and equipment, net | 442 | 466 |
Right-of-use assets, net | 1,098 | 1,299 |
Total assets | 104,155 | 54,299 |
Current liabilities: | ||
Accounts payable | 6,767 | 5,099 |
Accrued expenses | 12,419 | 18,664 |
Other current liabilities | 960 | 966 |
Total current liabilities | 20,146 | 24,729 |
Long-term liabilities | ||
Operating lease liabilities | 433 | 639 |
Total long-term liabilities | 433 | 639 |
Total liabilities | 20,579 | 25,368 |
Commitments and contingencies (Note 4) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding as of March 31, 2024 and December 31, 2023 | 0 | 0 |
Common stock, $0.0001 par value; 500,000,000 and 130,000,000 shares authorized as of March 31, 2024 and December 31, 2023, respectively, and 90,079,016 and 45,177,730 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 8 | 4 |
Additional paid-in capital | 519,757 | 436,060 |
Accumulated other comprehensive income | 4,287 | 3,759 |
Accumulated deficit | (440,476) | (410,892) |
Total stockholders’ equity | 83,576 | 28,931 |
Total liabilities and stockholders’ equity | $ 104,155 | $ 54,299 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 500,000,000 | 130,000,000 |
Common stock, shares issued (in shares) | 90,079,016 | 45,177,730 |
Common stock, shares outstanding (in shares) | 90,079,016 | 45,177,730 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses: | ||
Research and development | $ 18,736 | $ 22,963 |
General and administrative | 5,145 | 4,288 |
Total operating expenses | 23,881 | 27,251 |
Loss from operations | (23,881) | (27,251) |
Other income (expense): | ||
Interest income | 1,187 | 800 |
Change in fair value of the tranche rights | (4,796) | 0 |
Other income (expense), net | (2,094) | 1,179 |
Total other income (expense) | (5,703) | 1,979 |
Net loss | $ (29,584) | $ (25,272) |
Net loss per share, basic (in USD per share) | $ (0.30) | $ (0.58) |
Net loss per share, diluted (in USD per share) | $ (0.30) | $ (0.58) |
Weighted-average common shares outstanding, basic (in shares) | 97,299,955 | 43,664,783 |
Weighted-average common shares outstanding, diluted (in shares) | 97,299,955 | 43,664,783 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (29,584) | $ (25,272) |
Other comprehensive income: | ||
Foreign currency translation | 528 | 776 |
Total comprehensive loss | $ (29,056) | $ (24,496) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | January 2024 PIPE Transaction | At The Market Sales Agreement | Common Stock | Common Stock January 2024 PIPE Transaction | Common Stock At The Market Sales Agreement | Additional Paid-In Capital | Additional Paid-In Capital January 2024 PIPE Transaction | Additional Paid-In Capital At The Market Sales Agreement | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2022 | 39,307,286 | ||||||||||
Beginning balance at Dec. 31, 2022 | $ 113,684 | $ 4 | $ 427,925 | $ 3,035 | $ (317,280) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (25,272) | (25,272) | |||||||||
Stock-based compensation | 1,979 | 1,979 | |||||||||
Foreign currency translation | 776 | ||||||||||
Foreign exchange translation adjustment | 776 | 776 | |||||||||
Shares issued from exercise of pre-funded warrants (in shares) | 5,096,552 | ||||||||||
Shares issued from exercise of pre-funded warrants | 51 | 51 | |||||||||
Ending balance (in shares) at Mar. 31, 2023 | 44,403,838 | ||||||||||
Ending balance at Mar. 31, 2023 | $ 91,218 | $ 4 | 429,955 | 3,811 | (342,552) | ||||||
Beginning balance (in shares) at Dec. 31, 2023 | 45,177,730 | 45,177,730 | |||||||||
Beginning balance at Dec. 31, 2023 | $ 28,931 | $ 4 | 436,060 | 3,759 | (410,892) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (29,584) | (29,584) | |||||||||
Stock-based compensation | 2,750 | 2,750 | |||||||||
Foreign currency translation | 528 | 528 | |||||||||
Issuance of common stock (in shares) | 44,751,286 | 150,000 | |||||||||
Issuance of common stock | $ 52,364 | $ 191 | $ 4 | $ 52,360 | $ 191 | ||||||
Conversion of tranche rights liability to equity | $ 28,396 | 28,396 | |||||||||
Ending balance (in shares) at Mar. 31, 2024 | 90,079,016 | 90,079,016 | |||||||||
Ending balance at Mar. 31, 2024 | $ 83,576 | $ 8 | $ 519,757 | $ 4,287 | $ (440,476) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders’ Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
January 2024 PIPE Transaction | |
Issuance costs | $ 4,037 |
At The Market Sales Agreement | |
Issuance costs | $ 6 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (29,584) | $ (25,272) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 26 | 32 |
Unrealized foreign currency loss | 340 | 516 |
Stock-based compensation | 2,750 | 1,979 |
Change in fair value of tranche rights | 4,796 | 0 |
Fees expensed as part of January 2024 Financing | 1,690 | 0 |
Changes in operating assets and liabilities: | ||
Other current assets and prepaid expenses | 389 | 123 |
Accounts payable | 1,794 | 986 |
Accrued expenses | (6,145) | 2,072 |
Other liabilities | (25) | 51 |
Net cash used in operating activities | (23,969) | (19,513) |
Cash flows from investing activities: | ||
Sale of investments - other | 0 | 5,439 |
Purchases of property and equipment | (31) | (104) |
Net cash provided by (used in) investing activities | (31) | 5,335 |
Cash flows from financing activities: | ||
Proceeds from public offering of common stock through At The Market Sales Agreement, net | 191 | 0 |
Proceeds from the exercise of pre-funded warrants | 0 | 51 |
Proceeds from January 2024 Financing, net of issuance costs | 74,273 | 0 |
Net cash provided by financing activities | 74,464 | 51 |
Effect of exchange rate changes on cash and cash equivalents | 174 | 143 |
Net change in cash and cash equivalents | 50,638 | (13,984) |
Cash and cash equivalents, beginning of period | 46,674 | 106,745 |
Cash and cash equivalents, end of period | 97,312 | 92,761 |
Supplemental disclosure of noncash investing and financing activities: | ||
Conversion of tranche rights liability to equity upon increase in authorized shares | 28,396 | 0 |
Operating lease right-of use asset obtained in exchange for lease liability | $ 0 | $ 544 |
Description of Business and Bas
Description of Business and Basis of Financial Statements | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Financial Statements | Description of Business and Basis of Financial Statements Description of Business Immunic, Inc. ("Immunic" or the "Company") is a biotechnology company developing a clinical pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The Company is headquartered in New York City with its main operations in Gräfelfing near Munich, Germany. The Company had approximately 80 employees as of May 1, 2024. The Company is pursuing clinical development of orally administered, small molecule programs, each of which has unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases. These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 clinical development for patients with multiple sclerosis (“MS”) and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MS, progressive MS and moderate-to-severe ulcerative colitis (“UC”); the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease, short bowel syndrome and irritable bowel syndrome with diarrhea; and the IMU-381 program, which is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. The Company’s business, operating results, financial condition and growth prospects are subject to significant risks and uncertainties, including the failure of its clinical trials to meet their endpoints, failure to obtain regulatory approval and needing additional funding to complete the development and commercialization of the Company's three development programs. Liquidity and Financial Condition Immunic has no products approved for commercial sale and has not generated any revenue from product sales. It has never been profitable and has incurred operating losses in each year since inception in 2016. The Company has an accumulated deficit of approximately $440.5 million as of March 31, 2024 and $410.9 million as of December 31, 2023. Substantially all of Immunic's operating losses resulted from expenses incurred in connection with its research and development programs and from general and administrative costs associated with its operations. Immunic expects to incur significant expenses and increasing operating losses for the foreseeable future as it initiates and continues the development of its product candidates and adds personnel necessary to advance its pipeline of product candidates. Immunic expects that its operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to timing of development programs. From inception through March 31, 2024, Immunic has raised net cash of approximately $430.9 million from private and public offerings of preferred stock, common stock, pre-funded warrants and tranche rights. As of March 31, 2024, the Company had cash and cash equivalents of approximately $97.3 million. With these funds, Immunic expects to be able to fund its operations beyond twelve months from the date of the issuance of the accompanying condensed consolidated financial statements. Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles ("U.S. GAAP") and include the accounts of Immunic and its wholly-owned subsidiaries, Immunic AG and Immunic Australia Pty Ltd. All intercompany accounts and transactions have been eliminated in consolidation. Immunic manages its operations as a single reportable segment for the purposes of assessing performance and making operating decisions. Unaudited Interim Financial Information Immunic has prepared the accompanying interim unaudited condensed consolidated financial statements in accordance with United States generally accepted accounting principles, (“US GAAP”), for interim financial information and with the |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements. The most significant estimates in the Company’s financial statements and accompanying notes relate to clinical trial expenses and share-based compensation. Management believes its estimates to be reasonable under the circumstances. Actual results could differ materially from those estimates and assumptions. Foreign Currency Translation and Presentation The Company’s reporting currency is United States (“U.S.”) dollars. Immunic AG is located in Germany with the euro being its functional currency. Immunic Australia Pty Ltd.’s functional currency is the Australian dollar. All amounts in the financial statements where the functional currency is not the U.S. dollar are translated into U.S. dollar equivalents at exchange rates as follows: • assets and liabilities at reporting period-end rates; • income statement accounts at average exchange rates for the reporting period; and • components of equity at historical rates. Gains and losses from translation of the financial statements into U.S. dollars are recorded in stockholders’ equity as a component of accumulated other comprehensive income (loss). Realized and unrealized gains and losses resulting from foreign currency transactions denominated in currencies other than the functional currency are reflected as general and administrative expenses in the Consolidated Statements of Operations. Foreign currency transaction gains and losses related to long-term intercompany loans that are payable in the foreseeable future are recorded in Other Income (Expense). The Consolidated Statements of Cash Flows were prepared by using the average exchange rate in effect during the reporting period which reasonably approximates the timing of the cash flows. Cash and Cash Equivalents and Investments- other The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on hand and deposits in banks located in the U.S. of approximately $73.2 million, Germany of approximately $22.5 million and Australia of approximately $1.6 million as of March 31, 2024. The Company maintains cash and cash equivalent balances denominated in Euro and U.S. dollars with major financial institutions in the U.S. and Germany in excess of the deposit limits insured by the government. Management periodically reviews the credit standing of these financial institutions. The Company currently deposits its cash and cash equivalents with two large financial institutions. Cash and Cash equivalents in the U.S. are held at JP Morgan and are primarily held in a U.S. Government money market fund account earning interest at a rate of 5.2% during the period ended March 31, 2024. Cash and cash equivalents in Germany are earning interest at a rate of 3.5% to 3.75% during the period ended March 31, 2024. Fair Value Measurement Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 1 assets consisted of money market funds for the periods presented. The Company had no Level 1 liabilities for the periods presented. Level 2—Inputs other than observable quoted prices for the asset or liability, either directly or indirectly; these include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. The Company had no Level 2 assets or liabilities for the periods presented. Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of assets or liabilities. The Company had no Level 3 assets or liabilities for the periods presented. The carrying value of cash and cash equivalents, other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximates fair value due to the short period of time to maturity. Property and Equipment Property and equipment is stated at cost. Depreciation is computed using the straight-line method based on the estimated service lives of the assets, which range from three Impairment of Long-Lived Assets The Company records impairment losses on long-lived assets used in operations when indicators of impairment are present and the undiscounted cash flows estimated to be generated by those assets are less than the assets’ carrying amount. Impaired assets are then recorded at their estimated fair value. There were no impairment losses during the three months ended March 31, 2024 and 2023. Research and Development Expenses These costs primarily include external development expenses and internal personnel expenses for its development programs, vidofludimus calcium and IMU-856. Immunic has spent the majority of its research and development resources on vidofludimus calcium, the Company's lead development program, for clinical trials in MS and UC. Research and development expenses consist of expenses incurred in research and development activities, which include clinical trials, contract research services, certain milestone payments, salaries and related employee benefits, allocated facility costs and other outsourced services. Research and development expenses are charged to operations as incurred. The Company enters into agreements with contract research organizations (“CROs”) to provide clinical trial services for individual studies and projects by executing individual work orders governed by a Master Service Arrangement (“MSA”). The MSAs and associated work orders provide for regular recurrent payments and payments upon the completion of certain milestones. The Company regularly assesses the timing of payments against actual costs incurred to ensure a proper accrual of related expenses in the appropriate accounting period. Collaboration Arrangements Certain collaboration and license agreements may include payments to or from the Company of one or more of the following: non-refundable or partially refundable upfront or license fees; development, regulatory and commercial milestone payments; payment for manufacturing supply services; partial or complete reimbursement of research and development costs; and royalties on net sales of licensed products. The Company assesses whether such contracts are within the scope of Financial Accounting Standards Board (FASB) Accounting Standards Update (“ASU”) 2014-09 “ Revenue from Contracts with Customers ” and ASU No. 2018-18, “ Collaborative Arrangements” ("ASU 2018-18"). ASU 2018-18, clarifies that certain elements of collaborative arrangements could qualify as transactions with customers in the scope of ASC 606. In October 2018, the Company entered into an option and license agreement (the "Daiichi Sankyo Agreement") with Daiichi Sankyo Co., Ltd. ("Daiichi Sankyo") which granted the Company the right to license a group of compounds, designated by the Company as IMU-856, as a potential new oral treatment option for gastrointestinal diseases such as celiac disease, inflammatory bowel disease, irritable bowel syndrome with diarrhea and other barrier function associated diseases. During the option period, the Company performed agreed upon research and development activities for which it was reimbursed by Daiichi Sankyo up to a maximum agreed-upon limit. Such reimbursement was recorded as other income. There are no additional research and development reimbursements expected under this agreement. On January 5, 2020, the Company exercised its option to obtain the exclusive worldwide right to commercialization of IMU-856. Among other things, the option exercise grants Immunic AG the rights to Daiichi Sankyo’s patent application related to IMU-856, for which the Company received a notice of allowance from the U.S. Patent & Trademark Office in August 2022. In connection with the option exercise, the Company paid a one-time upfront licensing fee to Daiichi Sankyo. Under the Daiichi Sankyo Agreement, Daiichi Sankyo is also eligible to receive future development, regulatory and sales milestone payments, as well as royalties related to IMU-856. Government assistance Government assistance relating to research and development performed by Immunic Australia is recorded as a component of other (income) expense. This government assistance is recognized at a rate of 43.5% of the qualified research and development expenditures which are incurred. We also receive government assistance from the German Government for reimbursement of research and development expenses up to one million Euros per year. We recognized $36,000 and $1.8 million of other income General and Administrative Expenses General and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, business development and other support functions. Other general and administrative expenses include, but are not limited to, stock-based compensation, insurance costs, professional fees for legal, accounting and tax services, consulting, related facility costs and travel. Stock-Based Compensation The Company measures the cost of employee and non-employee services received in exchange for equity awards based on the grant-date fair value of the award recognized generally as an expense (i) on a straight-line basis over the requisite service period for those awards whose vesting is based upon a service condition, and (ii) on an accelerated method for awards whose vesting is based upon a performance condition, but only to the extent it is probable that the performance condition will be met. Stock-based compensation is (i) estimated at the date of grant based on the award’s fair value for equity classified awards and (ii) final measurement date for liability classified awards. Forfeitures are recorded in the period in which they occur. The Company estimates the fair value of stock options using the Black-Scholes-Merton option-pricing model ("BSM"), which requires the use of estimates and subjective assumptions, including the risk-free interest rate, the fair value of the underlying common stock, the expected dividend yield of the Company’s common stock, the expected volatility of the price of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future. Leases The Company leases office space and office equipment. The underlying lease agreements have lease terms of less than 12 months and up to 60 months. Leases with terms of 12 months or less at inception are not included in the operating lease right of use asset and operating lease liability. The Company has three existing leases for office and laboratory space. At inception of a lease agreement, the Company determines whether an agreement represents a lease and at commencement each lease agreement is assessed as to classification as an operating or financing lease. The Company's leases have been classified as operating leases and an operating lease right-of-use asset and an operating lease liability have been recorded on the Company’s balance sheet. A right-of-use lease asset represents the Company’s right to use the underlying asset for the lease term and the lease obligation represents its commitment to make the lease payments arising from the lease. Right-of-use lease assets and obligations are recognized at the commencement date based on the present value of remaining lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company has used an estimated incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The right-of-use lease asset includes any lease payments made prior to commencement and excludes any lease incentives. The lease term used in estimating future lease payments may include options to extend when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or changes in expectations regarding the lease term. Variable lease costs such as common area costs and property taxes are expensed as incurred. Leases with an initial term of twelve months or less are not recorded on the balance sheet. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Accumulated other comprehensive income (loss) has been reflected as a separate component of stockholders’ equity in the accompanying Consolidated Balance Sheets and consists of foreign currency translation adjustments (net of tax). Income Taxes The Company is subject to corporate income tax laws and regulations in the U.S., Germany and Australia. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment in their application. The Company utilizes the asset and liability method of accounting for income taxes which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the audited consolidated financial statements. Deferred income tax assets and liabilities are determined based on the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of changes in tax rates on deferred tax assets and liabilities is recognized in operations in the period that includes the enactment date. Deferred taxes are reduced by a valuation allowance when, in the opinion of management, it is more likely than not some portion or the entire deferred tax asset will not be realized. As of March 31, 2024 and 2023, respectively, the Company maintained a full valuation allowance against the balance of deferred tax assets. It is the Company’s policy to provide for uncertain tax positions and the related interest and penalties based upon management’s assessment of whether a tax benefit is more likely than not to be sustained upon examination by tax authorities. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. The Company is subject to U.S. federal, New York, California, Texas, German and Australian income taxes. The Company is subject to U.S. federal or state income tax examination by tax authorities for tax returns filed for the years 2003 and forward due to the carryforward of NOLs. Tax years 2019 through 2022 are subject to audit by German and Australian tax authorities. The Company is not currently under examination by any tax jurisdictions. Warrants and Tranche Rights The Company accounts for issued financial instruments either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”). Under ASC 480-10, financial instruments are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If financial instruments do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the financial instruments should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified financial instruments are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the financial instruments after the issuance date is recorded in the consolidated statements of operations as a gain or loss. If financial instruments do not require liability classification under ASC 815-40, in order to conclude financial instruments should be classified as equity, the Company assesses whether the financial instruments are indexed to its common stock and whether the financial instruments are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified financial instruments are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and, if dilutive, common stock equivalents outstanding for the period determined using the treasury-stock method. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. The weighted average shares outstanding calculation for basic and diluted earnings per share for the three months ended March 31, 2024 includes 11,193,564 pre-funded warrants. Potentially dilutive securities, not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive, are as follows: As of March 31, 2024 2023 Options to purchase common stock 10,318,323 5,595,841 Recently Issued and/or Adopted Accounting Standards There are no recently issued accounting standards that would have a significant impact on the Company's consolidated financial statements. |
Balance Sheet Details
Balance Sheet Details | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | Balance Sheet Details Other Current Assets and Prepaid Expenses Other Current Assets and Prepaid Expense consist of (in thousands): March 31, 2024 December 31, 2023 Prepaid clinical and related costs $ 2,767 $ 2,314 VAT receivable 770 703 Australian research and development tax incentive 676 670 Research grant — 1,104 Other 1,090 1,069 Total $ 5,303 $ 5,860 Accounts Payable Accounts Payable consist of (in thousands): March 31, 2024 December 31, 2023 Clinical costs $ 6,211 $ 4,726 Legal and audit costs 115 160 Other 441 213 Total $ 6,767 $ 5,099 Accrued Expenses Accrued Expenses consist of (in thousands): March 31, 2024 December 31, 2023 Accrued clinical and related costs $ 11,497 $ 16,863 Accrued legal and audit costs 234 216 Accrued compensation 610 1,460 Accrued other 78 125 Total $ 12,419 $ 18,664 Other Current Liabilities Other Current Liabilities consist of (in thousands): March 31, 2024 December 31, 2023 Lease liabilities $ 697 $ 695 Other 263 271 Total $ 960 $ 966 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Lease The Company leases certain office space under non-cancelable operating leases. The leases terminate on July 31, 2025 for the New York City office, June 30, 2025 for the Gräfelfing, Germany office and November 30, 2028 for the research laboratory in Planegg, Germany. These agreements include both lease (e.g., fixed rent) and non-lease components (e.g., common-area and other maintenance costs). The non-lease components are deemed to be executory costs and are therefore excluded from the minimum lease payments used to determine the present value of the operating lease obligation and related right-of-use asset. The New York City lease was extended on December 22, 2022 for an additional 27 months resulting in the new lease termination date of July 31, 2025. The New York City lease has a renewal option, but this was not included in calculating the right of use asset and liabilities. On April 7, 2020, the Company signed a five year lease for its facility in Gräfelfing, Germany. On March 1, 2021 and August 1, 2022 the Company added additional lease space at the Gräfelfing, Germany office. Renewal options were not included in calculating the right of use asset and liabilities for this facility. In February 2023, the Company leased space in Germany for a research laboratory. The leases do not have concessions, leasehold improvement incentives or other build-out clauses. Further, the leases do not contain contingent rent provisions. The New York City lease had a six month rent holiday at the beginning of the lease as well as a three month rent holiday upon the 27 month extension starting May 2023. There were net additions of $544,000 related to the addition of new laboratory space in Planegg, Germany in February 2023. The leases do not provide an implicit rate and, due to the lack of a commercially salable product, the Company is generally considered unable to obtain commercial credit. Therefore, the Company estimated its incremental interest rate to be 6% for the original leases and 8% for the New York City extension and German laboratory, considering the quoted rates for the lowest investment-grade debt and the interest rates implicit in recent financing leases. Immunic used its estimated incremental borrowing rate and other information available at the lease commencement date in determining the present value of the lease payments. Immunic’s operating lease costs and variable lease costs were $257,000 and $195,000 for the three months ended March 31, 2024 and 2023, respectively. Variable lease costs consist primarily of common area maintenance costs, insurance and taxes which are paid based upon actual costs incurred by the lessor. Maturities of the operating lease obligation are as follows as of March 31, 2024 : 2024 $ 551,000 2025 433,000 2026 78,000 2027 82,000 2028 79,000 Thereafter — Total 1,223,000 Interest (93,000) Present value of obligation $ 1,130,000 Contractual Obligations As of March 31, 2024, the Company has non-cancelable contractual obligations under certain agreements related to its development programs vidofludimus calcium and IMU-856 totaling approximately $3.0 million, all of which is expected to be paid in 2024 and 2025. Other Commitments and Obligations Daiichi Sankyo Agreement On January 5, 2020, the Company exercised its option to obtain the exclusive worldwide right to commercialization of IMU-856. Among other things, the option exercise grants Immunic AG the rights to Daiichi Sankyo’s patent application related to IMU-856, for which the Company received a notice of allowance from the U.S. Patent & Trademark Office in August 2022. In connection with the option exercise, the Company paid a one-time upfront licensing fee to Daiichi Sankyo. Under the Daiichi Sankyo Agreement, Daiichi Sankyo is also eligible to receive future development, regulatory and sales milestone payments, as well as royalties related to IMU-856. Legal Proceedings The Company is not currently a party to any litigation, nor is it aware of any pending or threatened litigation, that it believes would materially affect its business, operating results, financial condition or cash flows. However, its industry is characterized by frequent claims and litigation including securities litigation, claims regarding patent and other intellectual property rights and claims for product liability. As a result, in the future, the Company may be involved in various legal proceedings from time to time. |
Fair Value
Fair Value | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value | Fair Value The following fair value hierarchy tables present information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair Value Measurement at March 31, 2024 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 72,961 $ 72,961 $ — $ — Total assets at fair value 72,961 72,961 $ — $ — Fair Value Measurement at December 31, 2023 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 34,087 $ 34,087 $ — $ — Total assets at fair value $ 34,087 $ 34,087 $ — $ — There were no transfers between Level 1, Level 2 or Level 3 assets during the periods presented. For the Company’s money market funds which are included as a component of cash and cash equivalents on the consolidated balance sheet, realized gains and losses are included in interest income (expense) on the consolidated statements of operations. Our money market fund account is held in our bank in the U.S. and was earning interest at a rate of 5.2% in a U.S. Government money market fund. The Company has cash balances in banks in excess of the maximum amount insured by the FDIC and other international agencies as of March 31, 2024. The Company has not historically experienced any credit losses with balances in excess of FDIC limits. The Company recorded tranche rights of $23.6 million at January 8, 2024 as a result of the January 2024 Financing (see note 6). The fair value measurement of the tranche rights associated with the January 2024 Financing was classified as Level 3 under the fair value hierarchy. The fair value of the the tranche rights was determined using a Black Scholes Option Pricing Model. The inputs to this model included a risk-free rate range of 3.93%-4.36%, a stock price volatility range of 105-115%, an expected dividend rate of —% and remaining term of 1.81-4.81 years. This liability was revalued on March 4, 2024, upon approval to increase its authorized shares of common stock from 130 million to 500 million, which resulted in the reclassification of the tranche rights from a liability to equity. This revaluation resulted in an increase in the tranche rights liability of $4.8 million using a Black Scholes Option Pricing Model. The inputs to this model as of the date of the reclassification included a risk-free rate range of 4.16%-4.63%, a stock price volatility range of 90-105%, an expected dividend rate of —% and remaining term of 1.66-4.66 years. The inputs used in the determination of fair value of the liability are level 3 inputs. A rollforward of the fair value of the tranche rights is as follows (in thousands): December 31, 2023 $ — Fair value as of January 8, 2024 $ 23,600 Change in fair value through March 4, 2024 $ 4,796 Reclassification to equity $ (28,396) March 31, 2024 $ — |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Common Stock | Common Stock Shelf Registration Statement In November 2023, we filed a shelf registration statement on Form S-3 (the "2023 Shelf Registration Statement"). The 2023 Shelf Registration Statement permits the offering, issuance and sale of up to $250.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination of the foregoing. As of May 8, 2024, the 2023 Shelf Registration statement has not been declared effective by the SEC, however, the Company can (i) continue to sell, subject to applicable SEC requirements, unsold securities remaining on the expired 2020 Shelf Registration Statement until the 2023 Shelf Registration Statement has been declared effective (or May 22, 2024, if sooner); and (ii) after the 2023 Shelf Registration Statement has been declared effective, offer and sell additional securities registered on the new Form S-3, as well as unsold securities from the expired 2020 Shelf Registration Statement that are permitted by SEC rules to be included in the 2023 Shelf Registration Statement. In November 2020, the Company filed a shelf registration statement on Form S-3 (the "2020 Shelf Registration Statement"). The 2020 Shelf Registration Statement permitted the offering, issuance and sale of up to $250.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination of the foregoing. The 2020 Shelf Registration Statement expired in November 2023 but, as explained above, unsold securities from this expired registration statement can continue to be sold under the 2023 Shelf Registration Statement. As of March 31, 2024, there is $75.0 million of unsold securities from this 2020 Shelf Registration Statement. In December 2020, the Company filed a Prospectus Supplement for the offering, issuance and sale of up to a maximum aggregate offering price of $50.0 million of common stock that may be issued and sold under an at-the-market sales agreement with SVB Leerink LLC (now Leerink Partners LLC) as agent ("December 2020 ATM"). The Company has used and intends to continue to use the net proceeds from the December 2020 ATM to continue to fund the ongoing clinical development of our product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates. The December 2020 ATM will terminate upon the earlier of (i) the issuance and sale of all of the shares through Leerink Partners LLC on the terms and subject to the conditions set forth in the December 2020 ATM or (ii) termination of the December 2020 ATM as otherwise permitted thereby. The December 2020 ATM may be terminated at any time by either party upon ten days’ prior notice, or by Leerink Partners LLC at any time in certain circumstances, including the occurrence of a material adverse effect on us. As of March 31, 2024, $7.3 million in capacity remains under the December 2020 ATM. In May 2022, the Company filed a Prospectus Supplement to the 2020 Shelf Registration Statement for the offering, issuance and sale of up to a maximum aggregate offering price of $80.0 million of common stock that may be issued and sold under another at-the-market sales agreement ("May 2022 ATM") with Leerink Partners LLC (formerly SVB Leerink LLC) as agent. The Company intends to use the net proceeds from the offering to continue to fund the ongoing clinical development of its product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates. The May 2022 ATM will terminate upon the earlier of (i) the issuance and sale of all of the shares through Leerink Partners LLC on the terms and subject to the conditions set forth in the May 2022 ATM or (ii) termination of the May 2022 ATM as otherwise permitted thereby. The May 2022 ATM may be terminated at any time by either party upon ten days’ prior notice, or by Leerink Partners LLC at any time in certain circumstances, including the occurrence of a material adverse effect on the Company. As of March 31, 2024, $80.0 million in capacity remains under the May 2022 ATM. The Company has agreed to pay Leerink Partners LLC a commission equal to 3.0% of the gross proceeds from the sales of common shares pursuant to both ATM's and has agreed to provide Leerink Partners LLC with customary indemnification and contribution rights. For the three months ended March 31, 2024, we raised gross proceeds of $0.2 million pursuant to the December 2020 ATM through the sale of 150,000 shares of common stock at a weighted average price of $1.31 per share. The net proceeds from the December 2020 ATM were $0.2 million after deducting sales agent commissions of $6,000. The Company did not have any ATM activity during the three months ended March 31, 2023. Equity Offerings Private Placement of up to $240 million ("The January 2024 Financing") On January 4, 2024, Immunic entered into a Securities Purchase Agreement with select accredited investors, pursuant to which the Company agreed to issue and sell to the Investors in a three-tranche private placement shares of the Company’s common stock, $0.0001 par value per share or in lieu thereof, pre-funded warrants to purchase shares of Common Stock. The Pre-Funded Warrants are exercisable immediately for $0.0001 per share and until exercised in full. • The first tranche, which closed on January 8, 2024, resulted in the purchase by the Investors of an aggregate of $80 million of Common Stock (or pre-funded warrants) from the Company at a price of $1.43 per share; • The second tranche is a conditional mandatory purchase by the Investors of an additional $80 million of Common Stock (or pre-funded warrants) from the Company at a price of $1.716 per share, equal to 120% of the price paid in the first tranche and is subject to the satisfaction of three conditions: ◦ release by the Company of topline data from its Phase 2b clinical trial of vidofludimus calcium (IMU-838) in progressive multiple sclerosis, which data is currently expected in or around April 2025; ◦ the 10-day volume-weighted average price of the Common Stock is at least $8.00 per share during the 6 months following the data release; and ◦ aggregate trading volume during the same 10-day period is at least $100 million. • The third tranche must occur no later than three years after the second tranche and is conditioned on the same volume-weighted average share price and minimum trading volumes as the second tranche. The third tranche provides for the issuance of $80 million of shares of common stock (or pre-funded warrants) at the same price per share as the second tranche, but permits investors to fund their purchase obligations on a “cashless” or net settlement basis, which would reduce the cash proceeds to be raised by the Company in the Private Placement. Any of the conditions in the second or third tranches can be waived by holders of a majority of the outstanding securities (including the lead investor). The Private Placement resulted in gross proceeds to the Company of approximately $80 million in the first tranche, and an additional $80 million if and when the second tranche occurs. If the second tranche is completed and conditions for the third tranche are satisfied or waived, the Company could receive up to an additional $80 million in the third tranche. As of the closing date of the transaction of January 8, 2024, the Company did not have enough authorized shares to be able to issue the potential shares for tranche 2 and tranche 3 (collectively referred to hereafter as "the tranche rights"). Therefore, the Company recorded the value associated to the tranche rights as a liability of $23.6 million and allocated the remainder of the $80 million received (or $56.4 million) with the common stock and pre-funded warrants to equity. On March 4, 2024, the stockholders voted to increase the Company's authorized common shares from 130 million to 500 million shares. As a result of the ability to issue shares in satisfaction of the tranche rights, the instrument was reclassified to stockholders' equity. The Company allocated the transaction cost across the instruments on a relative fair value basis at the grant date. As a result $4.0 million was netted against the equity proceeds and $1.7 million was recorded in other expense in the Consolidated Statements of Operation for the three months ended March 31, 2024. The Company registered for resale by the investors in the January 2024 Financing up to 55,944,850 shares of common stock issued (or issuable upon exercise of pre-funded warrants) in the first tranche. The Company will not receive any proceeds from the sale of these shares of common stock. These shares are registered on a registration statement on Form S-3 (registration No. 333-277040), which was declared effective by the SEC on April 30, 2024. Common Stock On March 4, 2024, the stockholders of the Company voted to increase the authorized shares of the Company from 130,000,000 shares of common stock to 500,000,000 shares of common stock, par value of $0.0001 per share. The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of any holders of preferred stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the Board of Directors, if any. Through March 31, 2024, no cash dividends had been declared or paid. Pre-funded Warrants The Company issued 11,193,564 pre-funded warrants in connection with the January 2024 Financing, which all remain outstanding as of March 31, 2024. Preferred Stock The Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue 20 million shares of $0.0001 par value preferred stock, rights and preferences to be set by the Board of Directors. No preferred shares were issued or outstanding as of March 31, 2024. Stock Reserved for Future Issuance Shares reserved for future issuance at March 31, 2024 are as follows: Number of Common stock reserved for issuance for: 2021 Employee stock purchase plan 1,000,011 Pre-funded stock warrants 11,193,564 Outstanding stock options 10,318,323 Shares reserved for tranche 2 rights 46,620,046 Maximum shares reserved for tranche 3 rights 46,620,046 Common stock options available for future grant: 2014 Equity Incentive Plan 43,311 2017 Inducement Equity Incentive Plan 46,250 2019 Omnibus Equity Incentive Plan 9,131,506 Total common shares reserved for future issuance 124,973,057 |
Stock-Based Compensation Plans
Stock-Based Compensation Plans | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation Plans | Stock-Based Compensation Plans 2021 Employee Stock Purchase Plan On April 25, 2021, the Company adopted the 2021 Employee Stock Purchase Plan ("ESPP"), which was approved by stockholder vote at the 2021 Annual Meeting of Stockholders held on June 10, 2021. The ESPP provides eligible employees of the Company with an opportunity to purchase common stock of the Company through accumulated payroll deductions, which are included in other current liabilities until they are used to purchase Company shares. Eligible employees participating in the bi-annual offering period can choose to have up to the lesser of 15% of their annual base earnings or the IRS annual share purchase limit of $25,000 in aggregate market value to purchase shares of the Company’s common stock. The purchase price of the stock is the lesser of (i) 85% of the closing market price on the date of purchase and (ii) the closing market price at the beginning of the bi-annual offering period. The maximum number of shares initially reserved for delivery under the plan was 200,000 shares. This maximum number was increased by 1 million shares through approval by stockholders of the Company at the Company's Special Meeting of stockholders held on March 4, 2024. The first enrollment period under the plan commenced on August 1, 2021 and the Company has issued 199,989 shares life-to-date under the ESPP. The Company recognized $0 and $46,000 of expense related to the plan during the three months ended March 31, 2024 and 2023, respectively. Stock Option Programs In July 2019, the Company’s stockholders approved the 2019 Omnibus Equity Incentive Plan, as amended on June 28, 2023 (the “2019 Plan”), which was adopted by the Board of Directors (the "Board") with an effective date of June 14, 2019. The 2019 Plan allows for the grant of equity awards to employees, consultants and non-employee directors. An initial maximum of 1,500,000 shares of the Company’s common stock were available for grant under the 2019 Plan. The 2019 Plan included an evergreen provision that allowed for the annual addition of up to 4% of the Company’s fully-diluted outstanding stock, with a maximum allowable increase of 4,900,000 shares over the term of the 2019 Plan. In accordance with this provision, the shares available for grant were increased in 2020 through 2023 by a total of 4,408,871 shares. At the Company's Annual Stockholders meeting on June 28, 2023, stockholders voted to increase the allowable shares under the 2019 plan by 4,440,000 shares as well as to eliminate the evergreen provision. On March 4, 2024, the stockholders voted at the Company's Special Meeting to increase the allowable shares under the 2019 plan by 9,100,000. The 2019 Plan is currently administered by the Board, or, at the discretion of the Board, by a committee of the Board, which determines the exercise prices, vesting schedules and other restrictions of awards under the 2019 Plan at its discretion. Options to purchase stock may not have an exercise price that is less than the fair market value of underlying shares on the date of grant, and may not have a term greater than ten years. Incentive stock options granted to employees typically vest over four years. Non-statutory options granted to employees, officers, members of the Board, advisors, and consultants of the Company typically vest over three Shares that are expired, terminated, surrendered or canceled under the 2019 Plan without having been fully exercised will be available for future awards. Stock Option Repricing On March 4, 2024, the Company's stockholders voted to approve the repricing of outstanding stock options having an exercise price above $3.00 per share to $1.72 per share. All other terms of the grant remained the same. There were 3,317,596 stock options that were repriced to $1.72 per share. The repricing will result in an addition $1.2 million of stock compensation being recognized by the Company over the remaining term of the repriced grants and $0.9 million of this amount recognized in the quarter ended March 31, 2024. Movements during the year The following table summarizes stock option activity for the quarters ended March 31, 2024 and 2023, respectively, for the 2019 Plan: Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2024 6,196,140 $ 7.15 Granted 4,175,349 $ 1.21 Exercised — $ — Repricing Modification — $ 9.55 Forfeited or expired (53,166) $ 5.25 Outstanding as of March 31, 2024 10,318,323 $ 1.68 8.64 $ 462,223 Options vested and expected to vest as of March 31, 2024 10,318,323 $ 1.68 8.64 $ 462,223 Options exercisable as of March 31, 2024 3,224,039 $ 2.21 7.23 $ 5,500 Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2023 3,791,688 $ 11.33 Granted 1,815,314 $ 1.41 Exercised — $ — Forfeited or expired (11,161) $ 13.29 Outstanding as of March 31, 2023 5,595,841 $ 8.11 8.66 $ 161,428 Options vested and expected to vest as of March 31, 2023 5,595,841 $ 8.11 8.66 $ 161,428 Options exercisable as of March 31, 2023 1,888,367 $ 12.66 7.67 $ 1,980 Measurement The weighted-average assumptions used in the BSM option pricing model to determine the fair value of the employee and non-employee stock option grants relating to the 2019 Plan were as follows: Risk-Free Interest Rate The risk-free rate assumption is based on U.S. Treasury instruments with maturities similar to the expected term of the stock options. Expected Dividend Yield The Company has not issued any dividends and does not expect to issue dividends over the life of the options. As a result, the Company has estimated the dividend yield to be zero. Expected Volatility Due to the Company’s limited operating history and a lack of company specific historical and implied volatility data, the Company estimates expected volatility based on the historical volatility of its own stock combined with a group of comparable companies that are publicly traded. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. Expected Term The expected term of options is estimated considering the vesting period at the grant date, the life of the option and the average length of time similar grants have remained outstanding in the past. The weighted-average grant date fair value of stock options granted under the 2019 Plan (excluding the repriced stock options) during the three months ended March 31, 2024 and 2023 was $0.97 and $1.15, respectively. The weighted average grant date fair value of the repriced stock options was $1.22. The following are the underlying assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted to employees and to non-employees under this stock plan: Three Months Ended March 31, 2024 2023 Risk-free interest rate 4.05% 3.97% Expected dividend yield 0% 0% Expected volatility 100.0% 102.0% Expected term of options (years) 6.02 6.02 Stock-Based Compensation Expense Total stock-based compensation expense for all stock awards recognized in the accompanying unaudited condensed consolidated statements of operations is as follows: Three Months 2024 2023 Research and development $ 1,163,000 $ 903,000 General and administrative 1,587,000 1,076,000 Total $ 2,750,000 $ 1,979,000 As of March 31, 2024, there was $13.5 million in total unrecognized compensation expense relating to the 2019 Plan, including $0.3 million related to repriced stock options, to be recognized over a weighted average period of 3.17 years. There was $0.6 million and $0.3 million of stock-based compensation expense during the three months ended March 31, 2024 related to the repricing included in general and administrative and research and development expense respectively. Summary of Equity Incentive Plans Assumed from Vital Therapies, Inc. On April 12, 2019, we assumed the equity incentive plans of Vital Therapies, Inc. (“Vital”) following an exchange transaction (the “Transaction”) with Immunic AG. In the Transaction, holders of ordinary shares of Immunic AG exchanged all of their shares for shares of our common stock, resulting in Immunic AG becoming our wholly owned subsidiary. Following the Transaction, we changed our name to Immunic, Inc. Upon completion of the Transaction with Vital on April 12, 2019, Vital’s 2012 Stock Option Plan (the “2012 Plan”), Vital’s 2014 Equity Incentive Plan (the “2014 Plan”) and Vital’s 2017 Inducement Equity Incentive Plan (the “Inducement Plan”), were assumed by the Company. All awards granted under these plans have either been forfeited or expired. There remain 43,311 shares available for grant under the 2014 Plan as of March 31, 2024. In September 2017, Vital’s board of directors approved the Inducement Plan, which was amended and restated in November 2017. Under the Inducement Plan 46,250 shares of Vital’s common stock were reserved to be used exclusively for non-qualified grants to individuals who were not previously employees or directors as an inducement material to a grantee's entry into employment within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. No expense was recorded for the plans assumed from Vital during the three months ended March 31, 2024 and 2023, respectively. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Executive Chairman Agreement with Duane Nash On April 15, 2020, the compensation committee of the Board of Directors of the Company independently reviewed and approved entering into an employment agreement with the Executive Chairman of the Board, Duane Nash, MD, JD, MBA (the “Executive Chairman Agreement”) and pursuant to such approval, on April 17, 2020, the Company and Dr. Nash entered into the Executive Chairman Agreement. The Executive Chairman Agreement establishes an “at will” employment relationship. On December 28, 2022, the Company and Dr. Nash entered into Addendum No. Four, which extended the term of employment from December 31, 2022 to December 31, 2023 with a base salary of $30,250 per month. On October 17, 2023, Immunic, Inc. and Dr. Duane Nash entered into Addendum Number 5 to the Employment Agreement dated April 17, 2020, as amended as of October 15, 2020, April 15, 2021, March 15, 2022, and December 28, 2022, to extend the term of Dr. Nash’s employment as Executive Chairman of the Board of Directors of the Company to December 31, 2024. In connection with the Addendum, the Company increased Dr. Nash’s monthly base salary to $32,368 from $30,250 (which includes the cash retainer payable for serving on the Company’s Board or for acting as the Chairman of the Board). All other terms of the Executive Chairman Agreement remain the same. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles ("U.S. GAAP") and include the accounts of Immunic and its wholly-owned subsidiaries, Immunic AG and Immunic Australia Pty Ltd. All intercompany accounts and transactions have been eliminated in consolidation. Immunic manages its operations as a single reportable segment for the purposes of assessing performance and making operating decisions. Unaudited Interim Financial Information Immunic has prepared the accompanying interim unaudited condensed consolidated financial statements in accordance with United States generally accepted accounting principles, (“US GAAP”), for interim financial information and with the |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements. The most significant estimates in the Company’s financial statements and accompanying notes relate to clinical trial expenses and share-based compensation. Management believes its estimates to be reasonable under the circumstances. Actual results could differ materially from those estimates and assumptions. |
Foreign Currency Translation and Presentation | Foreign Currency Translation and Presentation The Company’s reporting currency is United States (“U.S.”) dollars. Immunic AG is located in Germany with the euro being its functional currency. Immunic Australia Pty Ltd.’s functional currency is the Australian dollar. All amounts in the financial statements where the functional currency is not the U.S. dollar are translated into U.S. dollar equivalents at exchange rates as follows: • assets and liabilities at reporting period-end rates; • income statement accounts at average exchange rates for the reporting period; and • components of equity at historical rates. Gains and losses from translation of the financial statements into U.S. dollars are recorded in stockholders’ equity as a component of accumulated other comprehensive income (loss). Realized and unrealized gains and losses resulting from foreign currency transactions denominated in currencies other than the functional currency are reflected as general and administrative expenses in the Consolidated Statements of Operations. Foreign currency transaction gains and losses related to long-term intercompany loans that are payable in the foreseeable future are recorded in Other Income (Expense). The Consolidated Statements of Cash Flows were prepared by using the average exchange rate in effect during the reporting period which reasonably approximates the timing of the cash flows. |
Cash and Cash Equivalents and Investments- other | Cash and Cash Equivalents and Investments- other The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on hand and deposits in banks located in the U.S. of approximately $73.2 million, Germany of approximately $22.5 million and Australia of approximately $1.6 million as of March 31, 2024. The Company maintains cash and cash equivalent balances denominated in Euro and U.S. dollars with major financial institutions in the U.S. and Germany in excess of the deposit limits insured by the government. Management periodically reviews the credit standing of these financial institutions. The Company currently deposits its cash and cash equivalents with two large financial institutions. Cash and Cash equivalents in the U.S. are held at JP Morgan and are primarily held in a U.S. Government money market fund account earning interest at a rate of 5.2% during the period ended March 31, 2024. Cash and cash equivalents in Germany are earning interest at a rate of 3.5% to 3.75% during the period ended March 31, 2024. |
Fair Value Measurement | Fair Value Measurement Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 1 assets consisted of money market funds for the periods presented. The Company had no Level 1 liabilities for the periods presented. Level 2—Inputs other than observable quoted prices for the asset or liability, either directly or indirectly; these include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. The Company had no Level 2 assets or liabilities for the periods presented. Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of assets or liabilities. The Company had no Level 3 assets or liabilities for the periods presented. The carrying value of cash and cash equivalents, other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximates fair value due to the short period of time to maturity. |
Property and Equipment | Property and Equipment three |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets |
Research and Development Expenses | Research and Development Expenses These costs primarily include external development expenses and internal personnel expenses for its development programs, vidofludimus calcium and IMU-856. Immunic has spent the majority of its research and development resources on vidofludimus calcium, the Company's lead development program, for clinical trials in MS and UC. Research and development expenses consist of expenses incurred in research and development activities, which include clinical trials, contract research services, certain milestone payments, salaries and related employee benefits, allocated facility costs and other outsourced services. Research and development expenses are charged to operations as incurred. The Company enters into agreements with contract research organizations (“CROs”) to provide clinical trial services for individual studies and projects by executing individual work orders governed by a Master Service Arrangement (“MSA”). The MSAs and associated work orders provide for regular recurrent payments and payments upon the completion of certain milestones. The Company regularly assesses the timing of payments against actual costs incurred to ensure a proper accrual of related expenses in the appropriate accounting period. |
Collaboration Arrangements | Collaboration Arrangements Certain collaboration and license agreements may include payments to or from the Company of one or more of the following: non-refundable or partially refundable upfront or license fees; development, regulatory and commercial milestone payments; payment for manufacturing supply services; partial or complete reimbursement of research and development costs; and royalties on net sales of licensed products. The Company assesses whether such contracts are within the scope of Financial Accounting Standards Board (FASB) Accounting Standards Update (“ASU”) 2014-09 “ Revenue from Contracts with Customers ” and ASU No. 2018-18, “ Collaborative Arrangements” ("ASU 2018-18"). ASU 2018-18, clarifies that certain elements of collaborative arrangements could qualify as transactions with customers in the scope of ASC 606. In October 2018, the Company entered into an option and license agreement (the "Daiichi Sankyo Agreement") with Daiichi Sankyo Co., Ltd. ("Daiichi Sankyo") which granted the Company the right to license a group of compounds, designated by the Company as IMU-856, as a potential new oral treatment option for gastrointestinal diseases such as celiac disease, inflammatory bowel disease, irritable bowel syndrome with diarrhea and other barrier function associated diseases. During the option period, the Company performed agreed upon research and development activities for which it was reimbursed by Daiichi Sankyo up to a maximum agreed-upon limit. Such reimbursement was recorded as other income. There are no additional research and development reimbursements expected under this agreement. On January 5, 2020, the Company exercised its option to obtain the exclusive worldwide right to commercialization of IMU-856. Among other things, the option exercise grants Immunic AG the rights to Daiichi Sankyo’s patent application related to IMU-856, for which the Company received a notice of allowance from the U.S. Patent & Trademark Office in August 2022. In connection with the option exercise, the Company paid a one-time upfront licensing fee to Daiichi Sankyo. Under the Daiichi Sankyo Agreement, Daiichi Sankyo is also eligible to receive future development, regulatory and sales milestone payments, as well as royalties related to IMU-856. |
Government assistance | Government assistance Government assistance relating to research and development performed by Immunic Australia is recorded as a component of other (income) expense. This government assistance is recognized at a rate of 43.5% of the qualified research and development expenditures which are incurred. We also receive government assistance from the German Government for reimbursement of research and development expenses up to one million Euros per year. We recognized $36,000 and $1.8 million of other income |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, business development and other support functions. Other general and administrative expenses include, but are not limited to, stock-based compensation, insurance costs, professional fees for legal, accounting and tax services, consulting, related facility costs and travel. |
Stock-Based Compensation | Stock-Based Compensation The Company measures the cost of employee and non-employee services received in exchange for equity awards based on the grant-date fair value of the award recognized generally as an expense (i) on a straight-line basis over the requisite service period for those awards whose vesting is based upon a service condition, and (ii) on an accelerated method for awards whose vesting is based upon a performance condition, but only to the extent it is probable that the performance condition will be met. Stock-based compensation is (i) estimated at the date of grant based on the award’s fair value for equity classified awards and (ii) final measurement date for liability classified awards. Forfeitures are recorded in the period in which they occur. The Company estimates the fair value of stock options using the Black-Scholes-Merton option-pricing model ("BSM"), which requires the use of estimates and subjective assumptions, including the risk-free interest rate, the fair value of the underlying common stock, the expected dividend yield of the Company’s common stock, the expected volatility of the price of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future. |
Leases | Leases The Company leases office space and office equipment. The underlying lease agreements have lease terms of less than 12 months and up to 60 months. Leases with terms of 12 months or less at inception are not included in the operating lease right of use asset and operating lease liability. The Company has three existing leases for office and laboratory space. At inception of a lease agreement, the Company determines whether an agreement represents a lease and at commencement each lease agreement is assessed as to classification as an operating or financing lease. The Company's leases have been classified as operating leases and an operating lease right-of-use asset and an operating lease liability have been recorded on the Company’s balance sheet. A right-of-use lease asset represents the Company’s right to use the underlying asset for the lease term and the lease obligation represents its commitment to make the lease payments arising from the lease. Right-of-use lease assets and obligations are recognized at the commencement date based on the present value of remaining lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company has used an estimated incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The right-of-use lease asset includes any lease payments made prior to commencement and excludes any lease incentives. The lease term used in estimating future lease payments may include options to extend when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or changes in expectations regarding the lease term. Variable lease costs such as common area costs and property taxes are expensed as incurred. Leases with an initial term of twelve months or less are not recorded on the balance sheet. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Accumulated other comprehensive income (loss) has been reflected as a separate component of stockholders’ equity in the accompanying Consolidated Balance Sheets and consists of foreign currency translation adjustments (net of tax). |
Income Taxes | Income Taxes The Company is subject to corporate income tax laws and regulations in the U.S., Germany and Australia. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment in their application. The Company utilizes the asset and liability method of accounting for income taxes which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the audited consolidated financial statements. Deferred income tax assets and liabilities are determined based on the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of changes in tax rates on deferred tax assets and liabilities is recognized in operations in the period that includes the enactment date. Deferred taxes are reduced by a valuation allowance when, in the opinion of management, it is more likely than not some portion or the entire deferred tax asset will not be realized. As of March 31, 2024 and 2023, respectively, the Company maintained a full valuation allowance against the balance of deferred tax assets. It is the Company’s policy to provide for uncertain tax positions and the related interest and penalties based upon management’s assessment of whether a tax benefit is more likely than not to be sustained upon examination by tax authorities. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. The Company is subject to U.S. federal, New York, California, Texas, German and Australian income taxes. The Company is subject to U.S. federal or state income tax examination by tax authorities for tax returns filed for the years 2003 and forward due to the carryforward of NOLs. Tax years 2019 through 2022 are subject to audit by German and Australian tax authorities. The Company is not currently under examination by any tax jurisdictions. |
Warrants and Tranche Rights | Warrants and Tranche Rights The Company accounts for issued financial instruments either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”). Under ASC 480-10, financial instruments are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If financial instruments do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the financial instruments should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified financial instruments are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the financial instruments after the issuance date is recorded in the consolidated statements of operations as a gain or loss. If financial |
Net Loss Per Share | Net Loss Per Share |
Recently Issued and/or Adopted Accounting Standards | Recently Issued and/or Adopted Accounting Standards There are no recently issued accounting standards that would have a significant impact on the Company's consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share | Potentially dilutive securities, not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive, are as follows: As of March 31, 2024 2023 Options to purchase common stock 10,318,323 5,595,841 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Other Current Assets and Prepaid Expenses | Other Current Assets and Prepaid Expense consist of (in thousands): March 31, 2024 December 31, 2023 Prepaid clinical and related costs $ 2,767 $ 2,314 VAT receivable 770 703 Australian research and development tax incentive 676 670 Research grant — 1,104 Other 1,090 1,069 Total $ 5,303 $ 5,860 |
Schedule of Accounts Payable and Accrued Expenses | Accounts Payable consist of (in thousands): March 31, 2024 December 31, 2023 Clinical costs $ 6,211 $ 4,726 Legal and audit costs 115 160 Other 441 213 Total $ 6,767 $ 5,099 Accrued Expenses consist of (in thousands): March 31, 2024 December 31, 2023 Accrued clinical and related costs $ 11,497 $ 16,863 Accrued legal and audit costs 234 216 Accrued compensation 610 1,460 Accrued other 78 125 Total $ 12,419 $ 18,664 |
Schedule of Other Current Liabilities | Other Current Liabilities consist of (in thousands): March 31, 2024 December 31, 2023 Lease liabilities $ 697 $ 695 Other 263 271 Total $ 960 $ 966 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Maturities of Operating Lease Obligation | Maturities of the operating lease obligation are as follows as of March 31, 2024 : 2024 $ 551,000 2025 433,000 2026 78,000 2027 82,000 2028 79,000 Thereafter — Total 1,223,000 Interest (93,000) Present value of obligation $ 1,130,000 |
Fair Value (Tables)
Fair Value (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following fair value hierarchy tables present information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair Value Measurement at March 31, 2024 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 72,961 $ 72,961 $ — $ — Total assets at fair value 72,961 72,961 $ — $ — Fair Value Measurement at December 31, 2023 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 34,087 $ 34,087 $ — $ — Total assets at fair value $ 34,087 $ 34,087 $ — $ — |
Schedule of Fair Value of Tranche Rights | A rollforward of the fair value of the tranche rights is as follows (in thousands): December 31, 2023 $ — Fair value as of January 8, 2024 $ 23,600 Change in fair value through March 4, 2024 $ 4,796 Reclassification to equity $ (28,396) March 31, 2024 $ — |
Common Stock (Tables)
Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Schedule of Shares Reserved for Future Issuance | Shares reserved for future issuance at March 31, 2024 are as follows: Number of Common stock reserved for issuance for: 2021 Employee stock purchase plan 1,000,011 Pre-funded stock warrants 11,193,564 Outstanding stock options 10,318,323 Shares reserved for tranche 2 rights 46,620,046 Maximum shares reserved for tranche 3 rights 46,620,046 Common stock options available for future grant: 2014 Equity Incentive Plan 43,311 2017 Inducement Equity Incentive Plan 46,250 2019 Omnibus Equity Incentive Plan 9,131,506 Total common shares reserved for future issuance 124,973,057 |
Stock-Based Compensation Plans
Stock-Based Compensation Plans (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes stock option activity for the quarters ended March 31, 2024 and 2023, respectively, for the 2019 Plan: Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2024 6,196,140 $ 7.15 Granted 4,175,349 $ 1.21 Exercised — $ — Repricing Modification — $ 9.55 Forfeited or expired (53,166) $ 5.25 Outstanding as of March 31, 2024 10,318,323 $ 1.68 8.64 $ 462,223 Options vested and expected to vest as of March 31, 2024 10,318,323 $ 1.68 8.64 $ 462,223 Options exercisable as of March 31, 2024 3,224,039 $ 2.21 7.23 $ 5,500 Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2023 3,791,688 $ 11.33 Granted 1,815,314 $ 1.41 Exercised — $ — Forfeited or expired (11,161) $ 13.29 Outstanding as of March 31, 2023 5,595,841 $ 8.11 8.66 $ 161,428 Options vested and expected to vest as of March 31, 2023 5,595,841 $ 8.11 8.66 $ 161,428 Options exercisable as of March 31, 2023 1,888,367 $ 12.66 7.67 $ 1,980 |
Schedule of Valuation Assumptions Used | The following are the underlying assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted to employees and to non-employees under this stock plan: Three Months Ended March 31, 2024 2023 Risk-free interest rate 4.05% 3.97% Expected dividend yield 0% 0% Expected volatility 100.0% 102.0% Expected term of options (years) 6.02 6.02 |
Schedule of Stock-based Compensation Expense for Stock Awards Recognized | Total stock-based compensation expense for all stock awards recognized in the accompanying unaudited condensed consolidated statements of operations is as follows: Three Months 2024 2023 Research and development $ 1,163,000 $ 903,000 General and administrative 1,587,000 1,076,000 Total $ 2,750,000 $ 1,979,000 |
Description of Business and B_2
Description of Business and Basis of Financial Statements (Details) $ in Thousands | 99 Months Ended | ||||
Mar. 31, 2024 USD ($) lease | May 01, 2024 employee | Dec. 31, 2023 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Subsequent Event [Line Items] | |||||
Number of development programs | lease | 3 | ||||
Accumulated deficit | $ (440,476) | $ (410,892) | |||
Proceeds from issuance of private placement | 430,900 | ||||
Cash, cash equivalents and restricted cash | $ 97,312 | $ 46,674 | $ 92,761 | $ 106,745 | |
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Number of employees | employee | 80 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) € in Millions | 3 Months Ended | |||
Mar. 31, 2024 USD ($) lease financialInstitution shares | Mar. 31, 2023 USD ($) | Mar. 31, 2024 EUR (€) lease financialInstitution shares | Dec. 31, 2023 USD ($) | |
Property, Plant and Equipment [Line Items] | ||||
Cash and cash equivalents | $ 97,312,000 | $ 46,674,000 | ||
Number of financial institutions used for cash deposits | financialInstitution | 2 | 2 | ||
Depreciation expense | $ 26,000 | $ 32,000 | ||
Impairment losses | 0 | 0 | ||
Australian research and development tax incentive | 676,000 | $ 670,000 | ||
Government assistance, amount | $ 36,000 | $ 1,800,000 | ||
Government Assistance, Statement of Income or Comprehensive Income [Extensible Enumeration] | Nonoperating Income (Expense) | Nonoperating Income (Expense) | ||
Number of existing operating leases | lease | 3 | 3 | ||
Pre-funded stock warrants | ||||
Property, Plant and Equipment [Line Items] | ||||
Warrant exercised (in shares) | shares | 11,193,564 | 11,193,564 | ||
United States | ||||
Property, Plant and Equipment [Line Items] | ||||
Cash and cash equivalents | $ 73,200,000 | |||
Investment interest rate | 5.20% | 5.20% | ||
United States | Money market funds | ||||
Property, Plant and Equipment [Line Items] | ||||
Investment interest rate | 5.20% | 5.20% | ||
Germany | ||||
Property, Plant and Equipment [Line Items] | ||||
Cash and cash equivalents | $ 22,500,000 | |||
Australian research and development tax incentive | € | € 1 | |||
Australia | ||||
Property, Plant and Equipment [Line Items] | ||||
Cash and cash equivalents | $ 1,600,000 | |||
Government R&D assistance rate | 43.50% | |||
Maximum | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful life (in years) | 13 years | 13 years | ||
Lease term (in months) | 60 months | 60 months | ||
Maximum | Germany | Money market funds | ||||
Property, Plant and Equipment [Line Items] | ||||
Investment interest rate | 3.75% | 3.75% | ||
Minimum | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful life (in years) | 3 years | 3 years | ||
Lease term (in months) | 12 months | 12 months | ||
Minimum | Germany | Money market funds | ||||
Property, Plant and Equipment [Line Items] | ||||
Investment interest rate | 3.50% | 3.50% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Options to purchase common stock (in shares) | 10,318,323 | 5,595,841 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Other Current Assets and Prepaid Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid clinical and related costs | $ 2,767 | $ 2,314 |
VAT receivable | 770 | 703 |
Australian research and development tax incentive | 676 | 670 |
Research grant | 0 | 1,104 |
Other | 1,090 | 1,069 |
Total | $ 5,303 | $ 5,860 |
Balance Sheet Details - Sched_2
Balance Sheet Details - Schedule of Accounts Payable (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical costs | $ 6,211 | $ 4,726 |
Legal and audit costs | 115 | 160 |
Other | 441 | 213 |
Total | $ 6,767 | $ 5,099 |
Balance Sheet Details - Sched_3
Balance Sheet Details - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued clinical and related costs | $ 11,497 | $ 16,863 |
Accrued legal and audit costs | 234 | 216 |
Accrued compensation | 610 | 1,460 |
Accrued other | 78 | 125 |
Total | $ 12,419 | $ 18,664 |
Balance Sheet Details - Sched_4
Balance Sheet Details - Schedule of Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Lease liabilities | $ 697 | $ 695 |
Other | 263 | 271 |
Total | $ 960 | $ 966 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total | Total |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Loss Contingencies [Line Items] | ||
Operating and variable lease cost | $ 257 | $ 195 |
Contractual obligation | $ 3,000 | |
Grafelfing, Germany | ||
Loss Contingencies [Line Items] | ||
Lease term (in years) | 5 years | |
New York City | ||
Loss Contingencies [Line Items] | ||
Renewal option period (in months) | 27 months | |
Rent holiday period | 6 months | |
Lessee, operating lease, extended rent holiday period | 3 months | |
Incremental borrowing rate on operating leases | 6% | |
Planegg, Germany | ||
Loss Contingencies [Line Items] | ||
Increase in operating lease, right-of-use asset | $ 544 | |
Incremental borrowing rate on operating leases | 8% |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Maturities of Operating Lease Obligation (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 551 |
2025 | 433 |
2026 | 78 |
2027 | 82 |
2028 | 79 |
Thereafter | 0 |
Total | 1,223 |
Interest | (93) |
Present value of obligation | $ 1,130 |
Fair Value - Schedule of Financ
Fair Value - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Assets | ||
Total assets at fair value | $ 72,961 | $ 34,087 |
Level 1 | ||
Assets | ||
Total assets at fair value | 72,961 | 34,087 |
Level 2 | ||
Assets | ||
Total assets at fair value | 0 | 0 |
Level 3 | ||
Assets | ||
Total assets at fair value | 0 | 0 |
Money market funds | ||
Assets | ||
Total assets at fair value | 72,961 | 34,087 |
Money market funds | Level 1 | ||
Assets | ||
Total assets at fair value | 72,961 | 34,087 |
Money market funds | Level 2 | ||
Assets | ||
Total assets at fair value | 0 | 0 |
Money market funds | Level 3 | ||
Assets | ||
Total assets at fair value | $ 0 | $ 0 |
Fair Value - Schedule of Fair V
Fair Value - Schedule of Fair Value of Tranche Rights (Details) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
December 31, 2023 | $ 0 |
Fair value as of January 8, 2024 | 23,600 |
Change in fair value through March 4, 2024 | 4,796 |
Reclassification to equity | (28,396) |
March 31, 2024 | $ 0 |
Fair Value - Additional Informa
Fair Value - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |||
Mar. 04, 2024 | Jan. 08, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Tranche right, fair value | $ 23.6 | |||
Expected dividend yield | 0% | 0% | 0% | |
Common stock, shares authorized (in shares) | 500,000,000 | 130,000,000 | 500,000,000 | 130,000,000 |
Reclassification of future tranche right liability upon settlement | $ 4.8 | |||
Minimum | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Risk-free interest rate | 4.16% | 3.93% | ||
Expected volatility | 90% | 105% | ||
Expected term of options (years) | 1 year 7 months 28 days | 1 year 9 months 21 days | ||
Common stock, shares authorized (in shares) | 130,000,000 | |||
Maximum | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Risk-free interest rate | 4.63% | 4.36% | ||
Expected volatility | 105% | 115% | ||
Expected term of options (years) | 4 years 7 months 28 days | 4 years 9 months 21 days | ||
Common stock, shares authorized (in shares) | 500,000,000 | |||
United States | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investment interest rate | 5.20% |
Common Stock - Shelf Registrati
Common Stock - Shelf Registration Statement (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Mar. 31, 2024 USD ($) d $ / shares shares | Mar. 31, 2023 USD ($) | May 31, 2022 USD ($) | Dec. 31, 2020 USD ($) | |
Class of Stock [Line Items] | ||||
Commission, percent of gross proceeds from sale of common stock | 3% | |||
Proceeds from issuance of common stock | $ 191 | $ 0 | ||
December 2020 ATM | ||||
Class of Stock [Line Items] | ||||
Maximum aggregate offering price of common stock, preferred stock, warrants, debt securities, and/or units | $ 50,000 | |||
Shelf registration, termination, prior written notice, number of days | d | 10 | |||
Sale of stock, remaining capacity | $ 7,300 | |||
Shares issued | $ 200 | |||
Stock issued (in shares) | shares | 150,000 | |||
Issuance of stock (in USD per share) | $ / shares | $ 1.31 | |||
Proceeds from issuance of common stock | $ 200 | |||
Underwriter commissions | $ 6 | |||
May 2022 ATM | ||||
Class of Stock [Line Items] | ||||
Maximum aggregate offering price of common stock, preferred stock, warrants, debt securities, and/or units | $ 80,000 | |||
Shelf registration, termination, prior written notice, number of days | d | 10 | |||
Sale of stock, remaining capacity | $ 80,000 |
Common Stock - Equity Offering
Common Stock - Equity Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 99 Months Ended | ||||||
Jan. 08, 2024 | Jan. 04, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 04, 2024 | Mar. 03, 2024 | Dec. 31, 2023 | |
Class of Stock [Line Items] | ||||||||
Proceeds from issuance of private placement | $ 430,900 | |||||||
Reclassification of future tranche right liability upon settlement | $ 4,800 | |||||||
Common stock, shares authorized (in shares) | 130,000,000 | 500,000,000 | 500,000,000 | 500,000,000 | 130,000,000 | |||
Change in fair value of the tranche rights | $ 4,796 | $ 0 | ||||||
Equity | ||||||||
Class of Stock [Line Items] | ||||||||
Change in fair value of the tranche rights | 4,000 | |||||||
Other Nonoperating Income (Expense) | ||||||||
Class of Stock [Line Items] | ||||||||
Change in fair value of the tranche rights | $ 1,700 | |||||||
Minimum | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, shares authorized (in shares) | 130,000,000 | |||||||
Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, shares authorized (in shares) | 500,000,000 | |||||||
Common Stock | Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Reclassification of future tranche right liability upon settlement | $ 23,600 | |||||||
Common stock, shares authorized (in shares) | 500,000,000 | 130,000,000 | ||||||
Private Placement | Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock, price per share (in USD per share) | $ 0.0001 | |||||||
Private Placement | Common Stock | Share-Based Payment Arrangement, Tranche One | ||||||||
Class of Stock [Line Items] | ||||||||
Proceeds from issuance of private placement | $ 80,000 | |||||||
Private Placement | Common Stock | Tranche 2 | ||||||||
Class of Stock [Line Items] | ||||||||
Proceeds from issuance of private placement | $ 80,000 | |||||||
Private Placement | Common Stock | Tranche 3 | ||||||||
Class of Stock [Line Items] | ||||||||
Proceeds from issuance of private placement | $ 80,000 | |||||||
Private Placement | Pre-funded stock warrants | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock, price per share (in USD per share) | $ 0.0001 | |||||||
Private Placement | Accredited Investors | ||||||||
Class of Stock [Line Items] | ||||||||
Proceeds from issuance of private placement | $ 240,000 | |||||||
Private Placement | Accredited Investors | Common Stock | Share-Based Payment Arrangement, Tranche One | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock, price per share (in USD per share) | $ 1.43 | |||||||
Consideration received on transaction | $ 80,000 | |||||||
Number of shares registered for resale | 55,944,850 | |||||||
Private Placement | Accredited Investors | Common Stock | Tranche 2 | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock, price per share (in USD per share) | $ 1.716 | |||||||
Consideration received on transaction | $ 80,000 | |||||||
Sale of stock, consideration received, percentage | 120% | |||||||
Threshold trading days for weighted average price calculation | 10 days | |||||||
Weighted average price (in USD per share) | $ 8 | |||||||
Threshold trading days for aggregate trading volume calculation | 10 days | |||||||
Aggregate trading volume of last 10 days | $ 100,000 | |||||||
Private Placement | Accredited Investors | Common Stock | Tranche 3 | ||||||||
Class of Stock [Line Items] | ||||||||
Consideration received on transaction | $ 80,000 | |||||||
Third tranche close period after second tranche (in years) | 3 years | |||||||
Common Stock and Pre-funded Warrants | Common Stock and Pre-funded Warrants | ||||||||
Class of Stock [Line Items] | ||||||||
Tranche rights as a liability, remainder amount | $ 80,000 | |||||||
Tranche rights as a liability, received amount | $ 56,400 |
Common Stock - Common Stock (De
Common Stock - Common Stock (Details) | 3 Months Ended | |||
Mar. 31, 2024 numberOfVote $ / shares shares | Mar. 04, 2024 $ / shares shares | Jan. 08, 2024 shares | Dec. 31, 2023 $ / shares shares | |
Class of Stock [Line Items] | ||||
Common stock, shares authorized (in shares) | shares | 500,000,000 | 500,000,000 | 130,000,000 | 130,000,000 |
Common stock, par value (in USD per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Number of votes per each share of common stock | numberOfVote | 1 | |||
Common stock, cash dividends declared (in USD per share) | $ / shares | $ 0 | |||
Common stock, cash dividends paid (in USD per share) | $ / shares | $ 0 | |||
Minimum | ||||
Class of Stock [Line Items] | ||||
Common stock, shares authorized (in shares) | shares | 130,000,000 | |||
Maximum | ||||
Class of Stock [Line Items] | ||||
Common stock, shares authorized (in shares) | shares | 500,000,000 |
Common Stock - Pre-funded Warra
Common Stock - Pre-funded Warrants (Details) | Mar. 31, 2024 shares |
Pre-funded stock warrants | |
Class of Stock [Line Items] | |
Shares issued from exercise of pre-funded warrants (in shares) | 11,193,564 |
Common Stock - Preferred Stock
Common Stock - Preferred Stock (Details) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Equity [Abstract] | ||
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common Stock - Schedule of Shar
Common Stock - Schedule of Shares Reserved for Future Issuance (Details) | Mar. 31, 2024 shares |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 124,973,057 |
Tranche 2 | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 46,620,046 |
Tranche 3 | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 46,620,046 |
Outstanding stock options | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 10,318,323 |
Outstanding stock options | 2021 Employee stock purchase plan | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 1,000,011 |
Pre-funded stock warrants | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 11,193,564 |
Common stock options available for future grant: | 2014 Equity Incentive Plan | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 43,311 |
Common stock options available for future grant: | 2017 Inducement Equity Incentive Plan | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 46,250 |
Common stock options available for future grant: | 2019 Omnibus Equity Incentive Plan | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 9,131,506 |
Stock-Based Compensation Plan_2
Stock-Based Compensation Plans - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 48 Months Ended | ||||||||
Mar. 04, 2024 | Jan. 08, 2024 | Jun. 28, 2023 | Aug. 01, 2021 | Apr. 25, 2021 | Sep. 30, 2023 | Jul. 31, 2019 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Options repriced (in shares) | 3,317,596 | ||||||||||
Stock-based compensation, exercise price (in dollars per share) | $ 1.72 | ||||||||||
Share-based payment arrangement | $ 1,200,000 | ||||||||||
Recognized amount | $ 900,000 | ||||||||||
Expected dividend yield | 0% | 0% | 0% | ||||||||
Weight average fair value repriced stock options (in USD per share) | $ 1.22 | ||||||||||
Stock based compensation expense related to stock options | $ 2,750,000 | $ 1,979,000 | |||||||||
General and administrative | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation expense | 600,000 | ||||||||||
Research and development | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation expense | 300,000 | ||||||||||
Maximum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Expected term of options (years) | 4 years 7 months 28 days | 4 years 9 months 21 days | |||||||||
Exercise price of warrants (in USD per share) | $ 3 | ||||||||||
Minimum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Expected term of options (years) | 1 year 7 months 28 days | 1 year 9 months 21 days | |||||||||
Exercise price of warrants (in USD per share) | $ 1.72 | ||||||||||
2021 Employee stock purchase plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Maximum annual contributions per employee (as a percent) | 15% | ||||||||||
Purchase price of the stock, at discount from market price at purchase date (as a percent) | 85% | ||||||||||
Shares available for grant (in shares) | 200,000 | ||||||||||
Shares issued under the ESPP (in shares) | 199,989 | ||||||||||
Share-based compensation expense | $ 0 | $ 46,000 | |||||||||
2021 Employee stock purchase plan | Maximum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Additional shares authorized (in shares) | 1,000,000 | ||||||||||
2019 Omnibus Equity Incentive Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares available for grant (in shares) | 1,500,000 | ||||||||||
Expected term of options (years) | 6 years 7 days | 6 years 7 days | |||||||||
Expected dividend yield | 0% | 0% | |||||||||
Options granted in period, weighted-average grant date fair value (in USD per share) | $ 0.97 | $ 1.15 | |||||||||
Total unrecognized compensation expense | $ 13,500,000 | ||||||||||
Stock based compensation expense related to stock options | $ 300,000 | ||||||||||
Period over which compensation cost will be recognized, in years | 3 years 2 months 1 day | ||||||||||
2019 Omnibus Equity Incentive Plan | Incentive stock options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period (in years) | 4 years | ||||||||||
2019 Omnibus Equity Incentive Plan | Maximum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Expected term of options (years) | 10 years | ||||||||||
2019 Omnibus Equity Incentive Plan | Maximum | Non-statutory options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period (in years) | 4 years | ||||||||||
2019 Omnibus Equity Incentive Plan | Minimum | Non-statutory options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period (in years) | 3 years | ||||||||||
2019 Omnibus Equity Incentive Plan, Evergreen Provision | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Additional shares authorized (in shares) | 4,900,000 | 4,408,871 | |||||||||
Additional shares authorized, percent | 4% | ||||||||||
Increase in other share (in shares) | 9,100,000 | 4,440,000 | |||||||||
2014 Equity Incentive Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares available for grant (in shares) | 43,311 | ||||||||||
2017 Inducement Equity Incentive Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares available for grant (in shares) | 46,250 | ||||||||||
Share-based compensation expense | $ 0 | $ 0 |
Stock-Based Compensation Plan_3
Stock-Based Compensation Plans - Schedule of Stock Option Activity (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Options | ||
Repricing Modification (in shares) | 0 | |
Weighted- Average Exercise Price | ||
Repricing Modifications (usd per share) | $ 9.55 | |
Outstanding stock options | 2019 Omnibus Equity Incentive Plan | ||
Options | ||
Outstanding, beginning balance (in shares) | 6,196,140 | 3,791,688 |
Granted (in shares) | 4,175,349 | 1,815,314 |
Exercised (in shares) | 0 | 0 |
Forfeited or expired (in shares) | (53,166) | (11,161) |
Outstanding, ending balance (in shares) | 10,318,323 | 5,595,841 |
Options vested and expected to vest, Ending balance (in shares) | 10,318,323 | 5,595,841 |
Options exercisable, Ending balance (in shares) | 3,224,039 | 1,888,367 |
Weighted- Average Exercise Price | ||
Outstanding, beginning balance (usd per share) | $ 7.15 | $ 11.33 |
Granted (usd per share) | 1.21 | 1.41 |
Exercised (usd per share) | 0 | 0 |
Forfeited or expired (usd per share) | 5.25 | 13.29 |
Outstanding, ending balance (usd per share) | 1.68 | 8.11 |
Options vested and expected to vest, Weighted-Average Exercise Price, Ending balance (usd per share) | 1.68 | 8.11 |
Options exercisable, Weighted-Average Exercise Price, Ending balance (usd per share) | $ 2.21 | $ 12.66 |
Other Disclosures | ||
Outstanding, Weighted-Average Remaining Contractual Term, Ending balance | 8 years 7 months 20 days | 8 years 7 months 28 days |
Options vested and expected to vest , Weighted-Average Remaining Contractual Term, Ending balance | 8 years 7 months 20 days | 8 years 7 months 28 days |
Options exercisable, Weighted-Average Remaining Contractual Term, Ending balance | 7 years 2 months 23 days | 7 years 8 months 1 day |
Outstanding, Aggregate Intrinsic Value, Ending balance | $ 462,223 | $ 161,428 |
Options vested and expected to vest , Aggregate Intrinsic Value, Ending balance | 462,223 | 161,428 |
Options exercisable, Aggregate Intrinsic Value, Ending balance | $ 5,500 | $ 1,980 |
Stock-Based Compensation Plan_4
Stock-Based Compensation Plans - Schedule of Valuation Assumptions Used (Detail) | 3 Months Ended | |||
Mar. 04, 2024 | Jan. 08, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected dividend yield | 0% | 0% | 0% | |
2019 Omnibus Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 4.05% | 3.97% | ||
Expected dividend yield | 0% | 0% | ||
Expected volatility | 100% | 102% | ||
Expected term of options (years) | 6 years 7 days | 6 years 7 days |
Stock-Based Compensation Plan_5
Stock-Based Compensation Plans - Schedule of Stock-based Compensation Expense for Stock Awards Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 2,750 | $ 1,979 |
Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 2,750 | 1,979 |
Employees | Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 1,163 | 903 |
Employees | General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 1,587 | $ 1,076 |
Related Party Transactions (Det
Related Party Transactions (Details) - Duane Nash, MD, JD, MBA - Executive Chairman Agreement - Board of Directors Chairman - USD ($) | 12 Months Ended | |
Dec. 31, 2024 | Dec. 31, 2023 | |
Related Party Transaction [Line Items] | ||
Salary and Wage, Officer, Monthly Base Salary | $ 30,250 | |
Forecast | ||
Related Party Transaction [Line Items] | ||
Salary and Wage, Officer, Monthly Base Salary | $ 32,368 |