IMMUNIC, INC.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Condensed Consolidated 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 90 employees as of July 31, 2025.
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 relapsing multiple sclerosis (“RMS”), and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MS ("RRMS"), progressive MS (“PMS”) 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 ("IBD"), Graft-versus-Host-Disease ("GvHD") and possibly weight management; 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 continue and potentially complete the development and commercialization of the Company'sthree development programs.
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 $563.7 million as of June 30, 2025 and $511.4 million as of December 31, 2024. 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 June 30, 2025, Immunic has raised net cash of approximately $496.3 million from private and public offerings of preferred stock, common stock, pre-funded warrants and tranche rights. As of June 30, 2025, the Company had cash and cash equivalents of approximately $55.3 million. With these funds, the Company does not have adequate liquidity to fund its operations for at least twelve months from the issuance of these condensed consolidated financial statements included in this quarterly report without raising additional capital and such actions are not solely within the control of the Company. If the Company is unable to obtain additional capital, it would have a material adverse effect on the operations of the Company, its clinical development program, and the Company may have to cease operations altogether. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
Basis of Presentation and Consolidation
The accompanying condensed 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 instructions to Form 10-Q and Regulation S-X of the SEC. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These interim unaudited condensed consolidated financial statements reflect all adjustments consisting of normal recurring accruals which, in the opinion of management, are necessary to present fairly Immunic’s consolidated financial position, consolidated results of operations, consolidated statement of stockholders’ equity (deficit) and consolidated cash flows for the periods and as of the dates presented. The Company’s fiscal year ends on December 31. The condensed consolidated balance sheet as of December 31, 2024 was derived from audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the annual consolidated financial statements and the notes thereto included on the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (the"SEC") on March 31, 2025. The nature of Immunic’s business is such that the results of any interim period may not be indicative of the results to be expected for the entire year or for corresponding interim periods in an any subsequent year.
- 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 stock-based compensation and the valuation of the tranche rights. 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 (deficit) 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
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 $47.9 million, Germany of approximately $7.3 million and Australia of approximately $0.1 million as of June 30, 2025. 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 withtwo 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 4.1% during the period ended June 30, 2025. Cash and cash equivalents in Germany are earning interest at a rate of 1.6% to 3.25% during the period ended June 30, 2025.
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 Company did have tranche rights that were at level 3 during the first quarter of 2024.
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 tothirteen years. Depreciation expense was $43,000 and $31,000 for the three months ended June 30, 2025 and 2024, respectively, and $86,000 and $57,000 for the six months ended June 30, 2025 and 2024, respectively.
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 wereno impairment losses during the six months ended June 30, 2025 and 2024.
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.
Daiichi Sankyo Agreement
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.
Ludwig-Maximilians-University Agreement
Effective June 30, 2025 Immunic AG entered into a licensing agreement with Ludwig-Maximilians-University for an exclusive license to develop, manufacture and commercialize products derived for a series of new molecules for treating neuroinflammatory diseases. Under the agreement Ludwig-Maximilians-University is entitled to receive future development, regulatory and sales milestone payments.
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 3.5 million Euros per year. We had recognized expense of $7,000 and income of $3,000 for the three months ended June 30, 2025 and 2024, respectively and $1.0 million and $39,000 ofother income related to research activities performed during the six months ended June 30, 2025 and 2024, respectively.
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) based on the 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 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 hasthree 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 consolidated 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.
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.
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 June 30, 2025 and December 31, 2024, 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 2023 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”). 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. 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, the instrument is classified in permanent equity. Equity-classified financial instruments are accounted for based on allocated proceeds on the issuance date with no subsequent measurement 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 and six months ended June 30, 2025 includes 8,580,507 pre-funded warrants from the January 2024 Financing and 86,666,667 pre-funded warrants from the May 2025 Offering that remain unexercised as of June 30, 2025. The weighted average shares outstanding calculation for basic and diluted earnings per share for the three and six months ended June 30, 2024 includes 11,193,564 per-funded warrants from the January 2024 Financing that were unexercised as of June 30, 2024.
Potentially dilutive securities, which are 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 June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Options to purchase common stock | 25,853,605 | 10,819,558 |
| Placement agent warrants | 283,334 | — |
| 26,136,939 | 10,819,558 | |
Recently Issued and/or Adopted Accounting Standards
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The new guidance is expected to improve income tax disclosures primarily related to the rate reconciliation and income taxes paid information by requiring 1) consistent categories and greater disaggregation of information in the rate reconciliation and 2) income taxes paid disaggregated by jurisdiction. The guidance is effective on a prospective basis, although retrospective application and early adoption is permitted. The standard was adopted by the Company for the annual period starting January 1, 2025.
On November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Income Statement - Reporting Comprehensive Income (Topic 220): Expense Disaggregation Disclosures to improve the disclosures about a public entity’s expenses and provide more detailed information about the types of expenses in commonly presented expense captions such as inventory purchases, employee compensation, depreciation and intangible asset amortization. The disclosure requirements must be applied retrospectively to all prior periods presented in the financial statements. The effective date for the standard is for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effects adoption of this guidance will have on the consolidated financial statements.
- Balance Sheet Details
Other Current Assets and Prepaid Expenses
Other Current Assets and Prepaid Expenses consist of (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Prepaid clinical and related costs | $2,467 | $1,871 |
| VAT receivable | 594 | 647 |
| Prepaid insurance | 610 | 198 |
| Other | 861 | 948 |
| Total | $4,532 | $3,664 |
Accounts Payable
Accounts Payable consist of (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Clinical costs | $7,015 | $7,561 |
| Legal and audit costs | 743 | 31 |
| Other | 135 | 254 |
| Total | $7,893 | $7,846 |
Accrued Expenses
Accrued expenses consist of (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Accrued clinical and related costs | $16,227 | $12,456 |
| Accrued legal and audit costs | 353 | 72 |
| Accrued compensation | 1,457 | 354 |
| Accrued other | 76 | 31 |
| Total | $18,113 | $12,913 |
Other Current Liabilities
Other Current Liabilities consist of (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Lease liabilities | $774 | $740 |
| Other | 533 | 676 |
| Total | $1,307 | $1,416 |
- Leases
Operating Leases
The Company leases certain office space under non-cancelable operating leases. The leases terminate on July 31, 2026 for the New York City office, December 31, 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 November 8, 2024 for an additional 12 months resulting in the new lease termination date of July 31, 2026. 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 afive 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. The lease term has expired, however, the Company is currently operating on a one-year monthly rolling lease and the Company needs to provide one-years notice to terminate the lease. 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. There were net additions of $448,000 related to the extension of the New York City lease and Gräfelfing offices during the year ended December 31, 2024.
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. 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 $312,000 and $270,000 for the three months ended June 30, 2025 and 2024, respectively and $591,000 and $527,000 for the six months ended June 30, 2025 and 2024, 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 June 30, 2025 (in thousands):
| 2025 | $415 |
| 2026 | 444 |
| 2027 | 85 |
| 2028 | 82 |
| Total | $1,026 |
| Interest | (47) |
| Present value of obligation | $979 |
- 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 June 30, 2025 | ||||
|---|---|---|---|---|
| Fair Value | Level 1 | Level 2 | Level 3 | |
| Assets | ||||
| Money market funds | $47,190 | $47,190 | $— | $— |
| Total assets at fair value | $47,190 | $47,190 | $— | $— |
| Fair Value Measurement at Fair Value Measurement at December 31, 2024 | ||||
|---|---|---|---|---|
| Fair Value | Level 1 | Level 2 | Level 3 | |
| Assets | ||||
| Money market funds | $14,751 | $14,751 | $— | $— |
| Total assets at fair value | $14,751 | $14,751 | $— | $— |
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 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 4.1% 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 June 30, 2025. 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 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 0% and remaining term of 1.81-4.81 years. This liability was revalued on March 4, 2024, upon stockholder 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 0% 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 in March 2024 | $(28,396) |
| December 31, 2024 | $— |
The carrying amounts of other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximate their fair values due to their short-term nature. The fair value and book value of the money market funds presented in the table above are the same.
- Common Stock
Shelf Registration Statements
In December 2020, the Company filed a Prospectus Supplement to the shelf registration statement on Form S-3 filed on November 13, 2020 and declared effective on November 24, 2020 (the "2020 Shelf Registration Statement") 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 used the net proceeds from the December 2020 ATM 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 terminated in May 2024.
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 to 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 2020 Shelf Registration Statement expired in November 2023.
In November 2023, the Company 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. This registration statement was declared effective on May 31, 2024. Unsold securities from the expired 2020 Shelf Registration Statement can continue to be sold under the 2023 Shelf Registration Statement. As a result of the April 2025 Offering and May 2025 Offering, the amount available under the 2023 Shelf Registration Statement was reduced by $70.1 million to $342.2 million as of June 30, 2025.
In May 2024, we filed a Prospectus Supplement to the 2023 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 an at-the-market sales agreement with Leerink Partners LLC as agent ("May 2024 ATM"), which rolls over the $80.0 million of unsold common stock from the May 2022 ATM. We intend to use the net proceeds from the May 2024 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 May 2024 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 2024 ATM or (ii) termination of the May 2024 ATM as otherwise permitted thereby. The May 2024 ATM may be terminated at any time by either party uponten 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 June 30, 2025, $80.0 million in capacity remains under the May 2024 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 stock pursuant to the May 2024 ATM and has agreed to provide Leerink Partners LLC with customary indemnification and contribution rights.
The Company did not have any ATM activity during the three or six months ended June 30, 2025.
For the three and six months ended June 30, 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.
On April 9, 2025, Immunic entered into a securities purchase agreement with certain institutional and accredited investors relating to the issuance and sale of an aggregate of 5,666,667 shares of the Company’s common stock, par value $0.0001 per share. The purchase price per share was $0.90 for aggregate gross proceeds to the Company of approximately $5.1 million. The offer and sale of the shares is referred to herein as the “April 2025 Offering.” The April 2025 Offering closed on April 10, 2025.
In addition, on April 9, 2025, the Company entered into a placement agency agreement with Titan Partners Group LLC, a division of American Capital Partners, LLC (the “Placement Agent”), relating to the April 2025 Offering. Pursuant to the Placement Agency Agreement, the Company agreed to pay the Placement Agent a cash fee of 6.0% of the gross proceeds from the April 2025 Offering raised from investors and to reimburse the Placement Agent for certain costs incurred in connection therewith. Additionally, upon the closing of the April 2025 Offering, the Company agreed to issue to the Placement Agent, or its designees, warrants to purchase up to an aggregate of 283,334 shares of common stock, representing 5.0% of the shares sold in the April 2025 Offering (the “Placement Agent Warrants”). The Placement Agent Warrants will be exercisable, in whole or in part, commencing 180 days from the date of the Placement Agency Agreement and expiring on the five year anniversary of the Placement Agency Agreement, at an initial exercise price per share of common stock of $1.125, which is equal to 125% of the price per share to investors in the April 2025 Offering. The Placement Agent Warrants and the shares of common stock underlying the Placement Agent Warrants were offered pursuant to the exemptions from registration provided in Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder.
The April 2025 Shares were registered under the Securities Act of 1933, as amended (the “Securities Act”), on the Company’s Registration Statement on Form S-3 (Registration No. 333-275717), previously filed with the SEC, and declared effective on May 31, 2024.
On May 28, 2025, Immunic entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC, issuance and sale of (i) pre-funded warrants to purchase an aggregate of 86,666,667 shares of common stock, par value $0.0001 (“Common Stock”) of the Company (the “Pre-Funded Warrants”), (ii) accompanying series A warrants to purchase an aggregate of 86,666,667 shares of Common Stock of the Company (or Pre-Funded Warrants) (the “Series A Warrants”), and (iii) accompanying series B warrants to purchase an aggregate of 86,666,667 shares of Common Stock of the Company (or Pre-Funded Warrants) (the “Series B Warrants”) (the “May 2025 Offering”). The price per Pre-Funded Warrant and accompanying Series A Warrant and Series B Warrant was $0.7499.
Each Pre-Funded Warrant is immediately exercisable for one share of Common Stock at an exercise price of $0.0001 per share and will expire when exercised in full. Each Series A Warrant is immediately exercisable for one share of Common Stock at an exercise price of $0.75 per share and will expire on December 31, 2025. Each Series B Warrant is exercisable on the earlier of (i) October 1, 2025, (ii) the first day following anyfive trading days during which the volume weighted average price for the Common Stock of the Company during such five trading day period is $1.25 or greater (the “VWAP Target”), or (iii) immediately prior to the consummation of a Fundamental Transaction (as defined in the Series B Warrants) for one share of Common Stock at an exercise price of $0.75 per share and will expire five years from the date of issuance. Each Series A Warrant and Series B Warrant will immediately expire in proportion to the extent that the corresponding Pre-Funded Warrant is exercised prior to September 30, 2025; provided that this term will not apply to the Series B Warrants immediately as of the date of achievement of the VWAP Target. The holder of the Pre-Funded Warrants and Series B Warrants may also satisfy its obligation to pay the exercise price through a “cashless exercise,” in which the holder receives the net value of such warrant in shares of Common Stock determined according to the formula set forth in the applicable warrant. Holders of Series A Warrants may, provided there is no effective registration statement or prospectus available which covers the warrants and shares of Common Stock issuable upon exercise of the Series A Warrants, in lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate exercise price, elect instead to receive upon such exercise (either in whole or in part) the net number of shares of Common Stock determined according to a formula set forth in the Series A Warrant.
The Company is prohibited from effecting an exercise of any Pre-Funded Warrants, Series A Warrants or Series B Warrants to the extent that such exercise would result in the number of shares of Common Stock beneficially owned by such holder and its affiliates exceeding 4.99% (or 9.99% at election of the holder) of the total number of shares of Common Stock outstanding immediately after giving effect to the exercise (the “Beneficial Ownership Limitation”), which percentage may be increased or decreased at the holder’s election, not to exceed 19.99%. Any increase to the Beneficial Ownership Limitation will not be effective until the 61st day after such notice is delivered to the Company. If a holder is not permitted to exercise a Series A Warrant or a Series B Warrant for Common Stock due to the Beneficial Ownership Limitation, then the holder may exercise such Series A Warrant or Series B Warrant for an equivalent number of Pre-Funded Warrants.
The aggregate proceeds from the May 2025 Offering were approximately $65 million before deducting underwriting discounts and commissions and offering expenses payable by the Company in connection with the May 2025 Offering. The Company may receive up to an aggregate of $130 million of additional gross proceeds if the Series A Warrants and Series B Warrants are exercised in full for cash. Pursuant to the Placement Agency Agreement, the Company agreed to pay the Placement Agent a cash fee of 6.0% of the gross proceeds from the May 2025 Offering raised from investors and to reimburse the Placement Agent for certain costs incurred in connection therewith.
The May 2025 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-275717), as amended, previously filed with the Securities and Exchange Commission (the “SEC”) on November 22, 2023, and declared effective by the SEC on May 31, 2024, as supplemented by the preliminary prospectus supplement, dated May 28, 2025, and a final prospectus supplement (the “Prospectus Supplement”) filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the “Securities Act”), on May 30, 2025. The closing of the May 2025 Offering took place on June 3, 2025.
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 athree-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 ofthree 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 was announced on April 30, 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 January 2024 Financing.
The volume-weighted average share price and minimum trading volume conditions of the second and third tranches have not
been satisfied as of June 30, 2025. 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 fair value methodology used by the Company assumed the conditions will be waived if the trading price of the stock exceeds the purchase price. Through June 30, 2025, the investors in
the first tranche have not purchased any additional shares of common stock from the Company pursuant to the terms of the January 2024 Financing.
The January 2024 Financing 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 stock 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 costs 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 Operations for the six months ended June 30, 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).
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 toone 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 June 30, 2025, no cash dividends had been declared or paid.
Notice of Non-Compliance with Nasdaq Listing Rule 5450(a)(1)
On June 27, 2025, Immunic, Inc. received a written notification (the “Notice Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that we were not in compliance with Nasdaq Listing Rule 5450(a)(1), as the closing bid price for our common stock was below the $1.00 per share requirement for the last 30 consecutive business days. The Notice Letter stated that we have 180 calendar days, or until December 24, 2025 (the “Initial Compliance Period”), to regain compliance with the minimum bid price requirement. If we do not regain compliance by the end of the Initial Compliance Period, we may apply for an additional compliance period as provided for in the Notice Letter. Nasdaq’s determination of whether we qualify for an additional compliance period will depend on whether we will meet the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market, with the exception of the minimum bid price requirement, and a written notice of our intention to cure the deficiency during the additional compliance period by effecting a reverse stock split, if necessary.
The Notice Letter has no immediate effect on the listing of our common stock on The Nasdaq Global Select Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we can regain compliance if the closing bid price of our common stock is at least $1.00 for a minimum of 10 consecutive business days. In the event that we do not regain compliance with Listing Rule 5450(a)(1) prior to the expiration of the Initial Compliance Period (or additional compliance period, if applicable), we will receive written notification that our securities are subject to delisting.
The Company intends to actively monitor the closing bid price of its common stock and is evaluating available options to regain compliance with the minimum bid price requirement. There can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or that the Company will otherwise remain in compliance with the other listing standards for the Nasdaq. If the Company’s common stock is delisted from Nasdaq, it could have a material adverse effect on the trading price and liquidity of the common stock.
Pre-funded Warrants
The Company issued 11,193,564 pre-funded warrants in connection with the January 2024 Financing,2,613,057 of which were exercised in the quarter ended June 30, 2025 and 8,580,507 of which remain outstanding as of June 30, 2025.
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, with such voting powers (if any), designations, powers, preferences, and relative, participating, optional or other rights, if any, and any qualifications, limitations or restrictions thereof, as shall be set by the Board of Directors. No preferred shares were issued or outstanding as of June 30, 2025.
Stock Reserved for Future Issuance
Shares reserved for future issuance at June 30, 2025 are as follows:
| Number ofShares | |
|---|---|
| Common stock reserved for issuance for: | |
| 2021 Employee stock purchase plan | 708,161 |
| Pre-funded stock warrants | 8,580,507 |
| Placement agent warrants | 283,334 |
| Outstanding stock options | 25,853,605 |
| Shares reserved for the second tranche of the January 2024 financing | 46,620,046 |
| Maximum shares reserved for the second tranche of the January 2024 financing | 46,620,046 |
| Shares reserved for the May 2025 Pre-funded warrants | 86,666,667 |
| Shares reserved for the May 2025 Series A warrants | 86,666,667 |
| Maximum shares reserved for the May 2025 Series B warrants | 86,666,667 |
| Common stock options available for future grant: | |
| 2017 Inducement Equity Incentive Plan | 46,250 |
| 2019 Omnibus Equity Incentive Plan | 596,224 |
| Total common shares reserved for future issuance | 389,308,174 |
- 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. An increase of 1 million shares to 1.2 million shares was approved 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 491,839 shares life-to-date under the ESPP. The Company recognized $22,000 and $48,000 of expense related to the plan during the three and six months ended June 30, 2025, respectively. The Company recognizedno expense related to the plan during the three and six months ended June 30, 2024, respectively.
Stock Option Programs
In July 2019, the Company’s stockholders approved the 2019 Omnibus Equity Incentive Plan, (as amended, 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 shares. On June 4, 2025, at the Company’s 2025 Annual Meeting of Stockholders, the Company’s stockholders approved a proposal to amend the terms of the 2019 Plan to, among other things, increase the allowable shares under the 2019 plan by 7,000,000 shares. The 2019 Plan (as amended on June 28, 2023 and
March 4, 2024) 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 thanten 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 orfour years.
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 resulted in $1.2 million of stock compensation being recognized by the Company over the remaining term of the repriced grants. $52,000 and $0.1 million was recognized in the three months and six months ended June 30, 2025, respectively and $17,000 and $1.0 million of this amount was recognized in the three months and six months ended June 30, 2024, respectively.
Corporate Transaction Option Acceleration Plan
On February 4, 2025, the Company established a Corporate Transaction Option Acceleration Plan, pursuant to which in the case of a merger or consolidation of the Company with or into another corporation or a sale of substantially all of the stock of the Company each option award held by an eligible employee will become fully vested upon the occurrence of a Corporate Transaction.
Movements during the year
The following table summarizes stock option activity for the six months ended June 30, 2025 and 2024, respectively, for the 2019 Plan:
| Options | Weighted-AverageExercisePrice | Weighted-AverageRemainingContractualTerm (Years) | AggregateIntrinsicValue | |
|---|---|---|---|---|
| Outstanding as of January 1, 2025 | 16,136,045 | $1.52 | ||
| Granted | 9,937,100 | $0.78 | ||
| Exercised | — | $— | ||
| Forfeited or expired | (219,540) | $1.50 | ||
| Outstanding as of June 30, 2025 | 25,853,605 | $1.24 | 8.77 | $— |
| Options exercisable as of June 30, 2025 | 7,042,889 | $1.79 | 7.04 | $— |
| Options | Weighted-AverageExercisePrice | Weighted-AverageRemainingContractualTerm (Years) | AggregateIntrinsicValue | |
|---|---|---|---|---|
| Outstanding as of January 1, 2024 | 6,196,140 | $7.15 | ||
| Granted | 4,810,349 | $1.22 | ||
| Exercised | — | $— | ||
| Repricing Modification | — | $9.55 | ||
| Forfeited or expired | (186,931) | $2.55 | ||
| Outstanding as of June 30, 2024 | 10,819,558 | $1.66 | 8.43 | $1,875 |
| Options exercisable as of June 30, 2024 | 3,606,762 | $2.14 | 6.97 | $— |
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 bezero.
Expected Volatility
The Company estimates expected volatility based on the historical volatility of its own stock. The historical volatility data was computed using the daily closing prices 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 during the six months ended June 30, 2025 and 2024 was $0.67 and $0.98, respectively. 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:
| Six Months Ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Risk-free interest rate | 4.14% | 4.10% |
| Expected dividend yield | 0% | 0% |
| Expected volatility | 116.0% | 99.6% |
| Expected term of options (years) | 5.91 | 5.95 |
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 Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Research and development | $761,000 | $842,000 | $1,592,000 | $2,005,000 |
| General and administrative | 1,138,000 | 1,040,000 | 2,349,000 | 2,627,000 |
| Total | $1,899,000 | $1,882,000 | $3,941,000 | $4,632,000 |
As of June 30, 2025, there was $15.6 million in total unrecognized compensation expense relating to the 2019 Plan, to be recognized over a weighted average period of 3.16 years. There was $28,000 and $24,000 of stock-based compensation expense during the three months ended June 30, 2025 related to the repricing included in general and administrative and research and development expense respectively. There was $56,000 and $49,000 of stock-based compensation expense during the six months ended June 30, 2025 related to the repricing included in general and administrative and research and development expense, respectively. There was $9,000 and $8,000 of stock-based compensation expense during the three months ended June 30, 2024 related to the repricing included in general and administrative and research and development expense respectively. There was
$0.6 million and $0.3 million of stock-based compensation expense during the six months ended June 30, 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
Upon completion of the Transaction with Vital Therapies, inc. ("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 areno longer any shares available for grant under the 2014 Plan as of June 30, 2025.
On 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 or six months ended June 30, 2025 and 2024, respectively.
- 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 October 17, 2023, Immunic, Inc. and Dr. Duane Nash entered into Addendum Number 5 to the Executive Chairman Agreement 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 Addendum Number 5, 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). On August 29, 2024, Immunic, Inc. and Dr. Duane Nash entered into Addendum Number 6 to the Executive Chairman Agreement to extend the term of Dr. Nash’s employment as Executive Chairman of the Board of Directors of the Company to December 31, 2025. In connection with Addendum Number 6, the Company increased Dr. Nash’s monthly base salary in 2025 to $33,986 from $32,368 (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.
- Commitments and Contingencies
Contractual Obligations
As of June 30, 2025, the Company has non-cancelable contractual obligations under certain agreements related to its development programs for vidofludimus calcium and IMU-856 totaling approximately $2.1 million, all of which is expected to be paid in 2025 and 2026.
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.
Ludwig-Maximilians-University Agreement
Effective June 30, 2025 Immunic AG entered into a licensing agreement with Ludwig-Maximilians-University for an exclusive license to develop, manufacture and commercialize products derived for a series of new molecules for treating neuroinflammatory diseases. Under the agreement Ludwig-Maximilians-University is entitled to receive future development, regulatory and sales milestone payments.
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.
- Segment Disclosures
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources in assessing performance. The Company hasone reportable segment: life science. The life science segment consists of the development of clinical and preclinical product candidates for the development of the Company’s proprietary new therapies. The Company’s chief operating decision maker (“CODM”) is the Company's Chief Executive Officer.
The accounting policies of the life science segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the life science segment based on net loss. The measure of segment assets is reported on the balance sheet as total consolidated assets. The CODM allocates resources and assesses performance on a consolidated basis, focused on the Company’s cash resources and an assessment of the probability of success of its ongoing research and development activities. Resource allocation decisions are informed by forecasted cash expenditures and actual expenses incurred to date.
To date, the Company has not generated any product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seeks regulatory approval.
The table below summarizes the significant expense categories regularly reviewed by the CODM for the three and six months ended June 30:
| Three Months Ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Operating expenses: | ||
| Clinical product candidates | $17,710 | $14,931 |
| Pre-clinical product candidates | 231 | 219 |
| Employee costs- research and development | 2,594 | 1,887 |
| Employee costs-general and administrative | 2,083 | 1,348 |
| Non-cash stock compensation | 1,899 | 1,882 |
| Depreciation expense | 43 | 34 |
| Professional fees and other segment expenses | 2,523 | 2,513 |
| Total operating expenses | 27,083 | 22,814 |
| Loss from operations | (27,083) | (22,814) |
| Interest income | 241 | 998 |
| Other income (expense) | 22 | 436 |
| Net loss | $(26,820) | $(21,380) |
| Six Months Ended June 30, | ||
| 2025 | 2024 | |
| Operating expenses: | ||
| Clinical product candidates | $35,491 | $29,882 |
| Pre-clinical product candidates | 345 | 400 |
| Employee costs- research and development | 4,761 | 3,881 |
| Employee costs-general and administrative | 3,643 | 2,704 |
| Non-cash stock compensation | 3,941 | 4,632 |
| Depreciation expense | 86 | 57 |
| Professional fees and other segment expenses | 5,641 | 5,139 |
| Total operating expenses | 53,908 | 46,695 |
| Loss from operations | (53,908) | (46,695) |
| Interest income | 424 | 2,185 |
| Change in fair value of the tranche rights | — | (4,796) |
| Other income (expense) | 1,191 | (1,658) |
| Net loss | $(52,293) | $(50,964) |
- Subsequent Events
Stock Appreciation Rights Plan
On July 7, 2025, the Board of Directors (the “Board”) of Immunic, Inc. (the “Company”) authorized grants, subject to the final approval of the Compensation Committee of the Board, of up to an aggregate of 35,000,000 stock appreciation rights (“SARs”) to the Company’s employees and executive officers. This includes an aggregate of 22,015,000 SARs to the Company’s executive officers. The SARs could be settled for cash, but it is the intention of the Company that these SARs will be settled for shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”) provided the Company obtains stockholder approval to amend the Company’s 2019 Omnibus Equity Incentive Plan, as amended (the “Plan”), to provide for a sufficient number of shares of Common Stock to support the settlement of the SARs in shares of Common Stock. The Company intends to seek stockholder approval to increase the number of shares available under the Plan. The exercise price of each SAR is $0.77, the closing price of the Common Stock on July 7, 2025.
Of the 35,000,000 SARs, (i)5,000,000 will be exercisable beginning August 1, 2026; (ii) up to 10,000,000 will be exercisable beginning August 1, 2026, subject to the exercise of the Company’s Series A warrants by the holders thereof; (iii) up to 10,000,000 will be exercisable beginning August 1, 2026, subject to the exercise of the Company’s Series B warrants by the holders thereof; (iv) up to 5,000,000 will be exercisable beginning August 1, 2026, subject to the Company’s issuance of Common Stock or pre-funded warrants to subscribers in connection with the second tranche of the Company’s January 4, 2024 private placement (the “January 2024 Offering”); and (v) up to 5,000,000 will be exercisable beginning August 1, 2026, subject to the issuance of Common Stock or pre-funded warrants to subscribers in connection with the third tranche of the January 2024 Offering.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.