Immunic Inc.
02/26/2026 | Press release | Distributed by Public on 02/26/2026 06:17
Annual Report for Fiscal Year Ending December 31, 2025 (Form 10-K)
Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this Annual Report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in "Risk Factors" included elsewhere in this Annual Report. As used in this report, unless the context suggests otherwise, "we," "us," our" or "the Company" refer to Immunic, Inc. and its subsidiaries.
Overview
Immunic, Inc. ("Immunic," "we," "us," "our" or the "Company") is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. We are headquartered in New York City with our main operations in Gräfelfing near Munich, Germany. We had 92 employees as of February 1, 2026.
We are 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 multiple sclerosis ("RRMS"), progressive multiple sclerosis ("PMS") and other diseases; 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"), and Graft-versus-Host-Disease ("GvHD"); and the IMU-381 program, which comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging our nuclear receptor-related 1 ("Nurr1") platform.
We have incurred net losses since inception and have an accumulated deficit of $608.6 million through December 31, 2025. We anticipate that we will continue to incur losses for at least the next several years. Due to the uncertainties involved with therapeutic product development and the clinical trial process, we cannot predict the timing or level of future expenses with certainty, when product approval might occur, if ever, or when profitability may be achieved or sustained.
Recent Events
Key Status Updates
February 2026 Private Placement
Securities Purchase Agreement
On February 12, 2026, we into a securities purchase agreement (the "February Securities Purchase Agreement") with certain accredited investors (the "February Investors"), pursuant to which we agreed to issue and sell, in a private placement (the "February 2026 Offering"), pre-funded warrants (the "February 2026 Pre-Funded Warrants", and the shares of Common Stock issuable upon exercise of the February 2026 Pre-Funded Warrants, the "February 2026 Pre-Funded Warrant Shares") to purchase up to 0.0001 shares of Common Stock, with each February 2026 Pre-Funded Warrant accompanied by a warrant to purchase (i) a share of Common Stock or (ii) a pre-funded warrant to purchase a share of Common Stock (collectively, the "February 2026 Common Warrants" and together with the February 2026 Pre-Funded Warrants, the "February 2026 Warrants", and the shares of Common Stock issuable upon exercise of the February 2026 Common Warrants, the "February 2026 Common Warrant Shares", and together with the February 2026 Pre-Funded Warrant Shares, the "February 2026 Warrant Shares").
The purchase price for each February 2026 Pre-Funded Warrant and accompanying February 2026 Common Warrant was $0.873120. Each February 2026 Pre-Funded Warrant is immediately exercisable at a price of $0.0001 per share. Each February 2026 Common Warrant is exercisable at a price $0.873220 per share (subject to adjustment as set forth therein) following the completion of the Reverse Stock Split (as defined below) until the earlier of (i) 30 trading days following the date of our initial public announcement of topline data from its Phase 3 ENSURE trials (for the avoidance of doubt, the later date of the initial public announcement of topline data from ENSURE-1 or ENSURE-2, if announced separately) (the "Topline Data Announcement"), (ii) immediately upon the exercise of the February 2026 Pre-Funded Warrants if such exercise of February 2026 Pre-Funded Warrants is prior to the Topline Data Announcement, provided that if the February 2026 Pre-Funded Warrant is not exercised in full, the February 2026 Common Warrant expires proportionally only to the extent the Pre-Funded Warrant is exercised, and (iii) February 17, 2031.
The Offering closed on February 17, 2026 (the "February 2026 Closing Date").
The aggregate gross proceeds to the Company from the issuance and sale of the February 2026 Warrants was approximately $200 million, before deducting fees to be paid to the placement agents and financial advisors of the Company and other estimated offering expenses payable by the Company. The aggregate exercise price of the February 2026 Warrants is approximately $200 million.
Leerink Partners LLC acted as lead placement agent for the Offering, Stifel, Guggenheim Securities, William Blair, LifeSci Capital, B. Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC also acted as placement agents for the February 2026 Offering. As compensation in connection with the February 2026 Offering, we agreed to pay the placement agents a fee equal to 6% of the aggregate gross proceeds received by us (i) upon the issuance of the February 2026 Warrants at closing and (ii) upon the cash exercise of the February 2026 Common Warrants.
The Offering
We intend to use the net proceeds from the February 2026 Offering to fund our clinical trials and operations and for working capital and other general corporate purposes.
The securities issued in the February 2026 Offering have not been registered under the Securities Act, and until so registered the securities may not be offered or sold absent registration or availability of an applicable exemption from registration. There is no established public trading market for the February 2026 Warrants, and we do not intend to list such securities on any national securities exchange or nationally recognized trading system.
In connection with the February 2026 Offering, we and each February 2026 Investor entered into a registration rights agreement simultaneously with the February 2026 Securities Purchase Agreement (the "February 2026 Registration Rights Agreement"). Pursuant to the February 2026 Registration Rights Agreement, as promptly as reasonably practicable following the February 2026 Closing Date but, in any event, not later than 45 days thereafter (the "Filing Date") we shall file a resale registration statement on Form S-3 (or Form S-1 if Form S-3 is not available) providing for the resale by the Investors of the Registrable Securities (as defined in the February 2026 Registration Rights Agreement) and to use reasonable best efforts to cause such resale registration statement to be declared effective by the staff of the Securities and Exchange Commission (the "SEC") at the earliest possible date but no later than the earlier of (a) the 60th calendar day following the Filing Date if the SEC notifies us that it will review the registration statement and (b) the fifth business day after we are notified by the SEC that the registration statement will not be "reviewed" or will not be subject to further review or (ii) the fifth business day following the receipt of Reverse Split Stockholder Approval (as defined below) and the consummation of the Reverse Stock Split.
The February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement contain certain representations and warranties, covenants and indemnities customary for similar transactions. The representations, warranties and covenants contained in the February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement were made solely for the benefit of the parties to the February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement, respectively, and may be subject to limitations agreed upon by the contracting parties.
Special Meeting and Reverse Stock Split
The February 2026 Securities Purchase Agreement provides that no later than three days following the February 2026 Closing Date, we must file a preliminary proxy statement with the SEC for the purpose of receiving stockholder approval ("Reverse Split Stockholder Approval") of an amendment to our certificate of incorporation to effect a reverse stock split of the Company's issued and outstanding Common Stock, at a ratio of not less than 10:1 (the "Reverse Stock Split"). The Company filed this proxy statement on February 20, 2026.
Royalty Purchase Agreement
As previously disclosed, on June 3, 2025, the Company issued series B common stock warrants to purchase up to an aggregate of 86,666,667 shares of Common Stock (or prefunded warrants to purchase shares of Common Stock) in an underwritten public offering (the "Series B Warrants"). On February 12, 2026, the Company entered into a purchase and sale agreement (the "Royalty Purchase Agreement") with certain Series B Warrant holders who had purchased a predetermined number of Series B Warrants (each a "Participating Series B Holder") and BVF Partners, L.P. ("BVF"), acting as royalty interest agent (the "Warrant Exchange").
Pursuant to the Royalty Purchase Agreement, the Participating Series B Holders will exchange an aggregate of 51,087,000 Series B Warrants for a pro rata share of an aggregate 5% synthetic royalty on future sales of the Company's vidofludimus calcium program in any country (the "Royalty Interests"). The pro rata share for each Participating Series B Holder is equal to the number of Series B Warrants exchanged by such Participating Series B Holder divided by the number of Series B Warrants
exchanged by all Participating Series B Holders (expressed as a percentage). Royalty Interests will be due and payable quarterly by the Company to the Participating Series B Holders following the First Commercial Sale (as defined in the Royalty Purchase Agreement).
Pursuant to the Royalty Purchase Agreement, the Company has agreed to specified affirmative and negative covenants, including without limitation covenants regarding periodic reporting of information by the Company to the Participating Series B Holders, and audits of royalties paid under the Royalty Purchase Agreement. The Royalty Purchase Agreement also contains representations and warranties, other covenants, indemnification obligations, and other provisions customary for transactions of this nature.
On the Closing Date, Series B Warrants to purchase up to an aggregate of 51,087,000 shares of Common Stock were surrendered by Participating Series B Holders and cancelled, and Series B Warrants to purchase up to an aggregate of 35,579,667 shares of Common Stock remain issued and outstanding.
Changes to the Board of Directors - Appointment of Director
On February 12, 2026, our board of directors (the "Board"), following the recommendation of the Nominating and Corporate Governance Committee of the Board (the "Committee"), appointed Thor Nagel, an Analyst with BVF, to the Board until the 2026 annual meeting of stockholders as a Class III director or until his respective successors are duly elected and qualified.
Changes to the Board of Directors - Appointment of Chair
On February 12, 2026, following the recommendation of the Committee, the Board appointed Simona Skerjanec, a member of the Board since July 2024, to serve as Interim Chairperson of the Board. Dr. Duane Nash, former Chairman, remains a member of the Board.
Changes to the Board of Directors - Resignation of Director
On February 12, 2026, Maria Törnsén resigned as a member of the Board in connection with the February Offering. The resignation of Ms. Törnsén was not the result of any disagreement with the Company on any matter relating to the Company's operations, policies, or practices. The Board and the Company are deeply grateful for Ms. Törnsén's service, dedication, and contributions to the Company.
CEO Search
Our Co-Founder and Chief Executive Officer, Dr. Daniel Vitt, and the Board will begin a search for a new CEO with deep commercial expertise in the MS space to lead Immunic through its next stage of growth and into commercialization. Subsequently, Dr. Vitt plans to transition to a new senior executive role focused on strengthening the company's scientific strategy and driving portfolio advancement. He will continue to support the organization in this capacity and as a member of the Board of Directors.
Presented Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the ACTRIMS Forum 2026
On February 4, 2026, we announced the presentation of additional data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS at the Americas Committee for Treatment and Research in Multiple Sclerosis ("ACTRIMS") Forum 2026. The findings presented in two poster presentations provide additional evidence of vidofludimus calcium's effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus ("EBV") and magnetic resonance imaging ("MRI") markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in MS patients.
Presented Key Vidofludimus Calcium Data at the 41st Congress of ECTRIMS, Highlighting Its Potential in MS
On September 24, 2025, we announced presentations of key vidofludimus calcium data at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis ("ECTRIMS"). The results from our Phase 2 CALLIPER trial in PMS, also selected for the Best of ECTRIMS 2025 slide deck, highlighted vidofludimus calcium's neuroprotective potential and its promise to slow disease progression in patients with or without focal inflammation. Importantly, the consistent 24-week confirmed disability worsening ("24wCDW") results across patient populations and subgroups, including in patients without evidence of baseline inflammatory gadolinium-enhancing ("Gd+") lesions during MRI, were seen both in the overall population and in the primary progressive multiple sclerosis ("PPMS") and non-active secondary progressive multiple sclerosis ("naSPMS") subgroups. Additionally, data regarding 24-week confirmed disability improvement ("24wCDI") showed an over
two-fold probability for vidofludimus calcium over placebo, statistically significant in the overall PMS population, with consistent trends across the subtypes. The CALLIPER findings support our hypothesis of clinically measurable neuroprotective effects of vidofludimus calcium, consistent with its Nurr1 activation mechanism. We believe that, since 24wCDW is an accepted regulatory endpoint to demonstrate clinical benefit in PMS, this evidence of clinical activity merits further investigation and de-risks a potential Phase 3 program.
Moreover, at ECTRIMS, we also presented additional long-term data from the open-label extension ("OLE") period of our Phase 2 EMPhASIS trial in RRMS which further reinforced the robust efficacy signals and favorable safety and tolerability observed, to date. The long-term EMPhASIS OLE data demonstrated that vidofludimus calcium was well-tolerated in patients with RRMS for treatment durations of up to 5.5 years. Among 182 patients remaining on therapy as of January 14, 2025, cumulative exposure totaled approximately 952 treatment years, with an annualized discontinuation rate of only approximately 6.4%. The most common treatment-emergent adverse events were mild, with low rates of renal and liver-related events and no new safety signals observed. Serious adverse events were infrequent and none were deemed related to treatment. These results suggest a favorable long-term safety and tolerability profile for vidofludimus calcium in RRMS.
Received Notice of Allowance from the United States Patent and Trademark Office Protecting Vidofludimus Calcium's Dose Strengths in PMS
On September 9, 2025, we announced that we received a Notice of Allowance from the United States Patent and Trademark Office ("USPTO") for patent application 18/529,946, entitled "Treatment of multiple sclerosis comprising DHODH inhibitors." Specifically, the resulting patent covers dose strengths associated with vidofludimus calcium and other salt forms as well as free acid forms, at a daily dose of about 10 mg to 45 mg, for the treatment of PMS, including the sub-groups PPMS and secondary progressive multiple sclerosis ("SPMS"). The patent is expected to provide protection into 2041, and a potential Patent Term Extension may offer additional market exclusivity in the United States. Allowance of this new key patent represents a significant advancement for vidofludimus calcium program in PMS and further strengthens its robust, multi-layered intellectual property portfolio.
New, Positive Long-Term Open-Label Extension Data from Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS
On June 24, 2025, we announced new long-term OLE data from our Phase 2 EMPhASIS trial in patients with RRMS. The data at week 144 showed that 92.3% of patients remained free of 12w CDW, and 92.7% free of 24w CDW. A total of 29 CDW events were confirmed at 12 weeks following the trigger event through week 144. Of these, 44.8% were associated with relapse-associated worsening ("RAW"), while only 13.8% were associated with progression independent of relapse activity ("PIRA"). Additionally, the cumulative data available from the EMPhASIS OLE period, thus far, further reinforces the favorable safety and tolerability profile of vidofludimus calcium, showing low discontinuation rates and low rates of treatment-emergent and serious adverse events. Importantly, no new safety signals have emerged during treatment durations up to 5.5 years.
The Phase 2 EMPhASIS trial in RRMS includes an optional OLE period for up to 9.5 years to evaluate long-term safety and tolerability of vidofludimus calcium. Of the 268 patients that started the double-blind main treatment period, 254 patients continued in the OLE period. At the time of data cutoff on January 14, 2025, 182 patients (71.6% of patients starting OLE) were evaluated up to week 144, which translates into approximately 952 overall treatment years.
Completion of Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in RMS
On June 5, 2025, we announced completion of enrollment for both Phase 3 ENSURE trials. The ENSURE program comprises two identical multicenter, randomized, double-blind Phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, enrolled adult patients with active RMS at more than 100 sites in 15 countries, including the United States, India and countries in the Middle East and North Africa ("MENA") region, Latin America, and Central and Eastern Europe. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo. The primary endpoint for both trials is time to first relapse up to 72 weeks. Secondary endpoints include time to confirmed disability worsening based on the expanded disability status scale ("EDSS"), volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and MRI-based endpoints. The top-line data from both ENSURE trials is expected by the end of 2026, which should allow for a synchronized readout and a pooled assessment of the confirmed disability worsening secondary endpoint.
Additional Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in PMS
On June 5, 2025, we also announced additional data from our Phase 2 CALLIPER trial in PMS, further supporting the positive top-line results announced on April 30, 2025. Building on the top-line data showing reductions in the relative risk of 24wCDW events based on the EDSS at the end of the main treatment period, data for the secondary endpoint of time to 24wCDW based on the EDSS further reinforced the neuroprotective potential of vidofludimus calcium in the overall PMS patient population and in the PPMS, naSPMS and active secondary progressive multiple sclerosis ("aSPMS") subtypes. Similarly, consistent with the top-line data, further analyses of subpopulations - both with and without inflammatory gadolinium-enhanced lesion activity at baseline, who are largely shown to not benefit from current anti-inflammatory therapies - continued to demonstrate promising results for the overall study population as well as the PPMS and naSPMS subtypes.
Vidofludimus Calcium Reduced Risk of Disability Worsening in Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial
On April 30, 2025, we announced the results from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS. In the overall PMS patient population, vidofludimus calcium reduced the relative risk of 24wCDW events based on changes in the EDSS compared to placebo. Further analyses by disease subtype demonstrated that vidofludimus calcium was associated with similar reductions in the relative risk of 24wCDW events in the PPMS and the naSPMS study populations compared to placebo. A consistent reduction of disability worsening was observed in the different subpopulations with or without inflammatory gadolinium-enhanced lesion activity at baseline and during the study. Vidofludimus calcium reduced the relative risk of 24wCDW events in patients without gadolinium-enhancing lesions at baseline compared to placebo.
While vidofludimus calcium had a modest benefit on the exploratory primary MRI endpoint, it substantially reduced the annualized rate of thalamic brain volume loss in patients with PMS compared to placebo. The total volume of new or enlarging T2 lesions showed a substantial difference between vidofludimus calcium and placebo over time, with vidofludimus calcium decreasing and placebo increasing.
The top-line CALLIPER data set supports the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials. No new safety signals were identified.
IMU-856 Demonstrated Dose-Dependent Increase of GLP-1 in Celiac Disease Patients and Corresponding Effects in Preclinical Testing
On February 20, 2025, we announced that IMU-856 demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 ("GLP-1") levels in a post hoc analysis of patients from our Phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivotesting
The post hoc analysis of our Phase 1b clinical trial of IMU-856 in celiac disease patients measured blood concentrations of GLP-1, between baseline and day 28, in a fasting state. A highly statistically significant (day 29: 80 mg p=0.014; 160 mg p=0.003) and dose-dependent increase of GLP-1 versus placebo control was detectable, even in the small patient population in this Phase 1b clinical trial (baseline: N placebo = 11, N 80 mg IMU-856 = 13, N 160 mg IMU-856 = 13). These clinical findings were corroborated by effects observed in a 6-month preclinical in vivostudy, where IMU-856 was found to reduce body weight gain accompanied by food consumption in a dose-dependent fashion up to -40 %, compared to the control group, which was found to be linked to reduced food intake.
April 2025 Offering
On April 9, 2025, we 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 our Common Stock (the "April 2025 Shares"). The purchase price per share was $0.90 for aggregate gross proceeds 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 are exercisable, in whole or in part, for five years from the 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 net proceeds to the Company from the April 2025 Offering, after deducting commissions and the Company's offering expenses, was approximately $4.7 million.
The April 2025 shares were registered under 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.
May 2025 Equity Offering
On May 28, 2025, we entered into an underwriting agreement (the "May 2025 Underwriting Agreement") with Leerink Partners LLC, for the issuance and sale of (i) pre-funded warrants to purchase an aggregate of 86,666,667 shares of Common stock (the "May 2025 Pre-Funded Warrants"), (ii) accompanying series A warrants to purchase an aggregate of 86,666,667 shares of Common Stock (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 (or Pre-Funded Warrants) (the "Series B Warrants") (the "May 2025 Offering"). The price per May 2025 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. The Series A Warrants are exercisable for one share of Common Stock at an exercise price of $0.75 per share. All but 10,666,667 of the Series A Warrants expired on December 31, 2025. The expiration date for the remaining 10,666,667 Series A Warrants was extended to February 28, 2026. Each Series B Warrant is exercisable on the earlier of (i) October 1, 2025, (ii) the first day following any five 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. 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.
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. On February 12, 2026, as part of the Royalty Purchase Agreement, 51,087,000 warrants were exchanged for the right to share a 5% royalty and 35,579,667 Series B warrants are still outstanding (see note 12 "Subsequent events"). The Company may receive up to an aggregate of approximately $27 million of additional gross proceeds if the remaining Series B Warrants are exercised in full for cash and up to $8.0 million gross proceeds if the remaining Series A Warrants are exercised 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 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 filed with the SEC pursuant to Rule 424(b) under the Securities Act, on May 30, 2025. The closing of the May 2025 Offering took place on June 3, 2025.
Transfer of Nasdaq Market Listing and Notice of Non-Compliance with Nasdaq Listing Rule 5450(a)(1)
On January 5, 2026, we were notified by the Nasdaq Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") that our application to transfer the listing of our Common Stock from the Nasdaq Global Select Market to the Nasdaq Capital Market had been approved (the "Approval"). The common stock was transferred to the Nasdaq Capital Market at the opening of business on January 7, 2026. The common stock will continue to trade under the symbol "IMUX." The Nasdaq Capital Market operates in substantially the same manner as the Nasdaq Global Select Market, and listed companies must meet certain financial requirements and comply with Nasdaq's corporate governance requirements.
As previously disclosed, on June 27, 2025, we received a letter from Nasdaq indicating that we were not in compliance with Nasdaq Listing Rule 5450(a)(1) because the closing bid price per share for Common Stock had closed below $1.00 for the
previous 30 consecutive business days (the "Bid Price Rule"). We were given a 180-day grace period, until December 24, 2025, to regain compliance with the rule. We had not regained compliance with the Bid Price Rule by December 24, 2025. Therefore, we transferred the listing of our Common Stock from the Nasdaq Global Select Market to the Nasdaq Capital Market. As a result of the Approval, we have been granted an additional 180-day grace period, or until June 22, 2026, to regain compliance with the Bid Price Rule. To regain compliance with the Bid Price Rule and qualify for continued listing on the Nasdaq Capital Market, the minimum bid price per share of the Common Stock must be at least $1.00 for at least 10 consecutive business days on or prior to June 22, 2026. If we fail to regain compliance during the additional compliance period, then Nasdaq will notify us of its determination to delist the Common Stock, at which point we would have an opportunity to appeal the delisting determination to a Nasdaq Listing Qualifications Panel (the "Panel"), but there can be no assurance that the Panel would grant our request for continued listing. As a condition of the Approval imposed by Nasdaq Listing Rule 5810(c)(3)(a)(i), we notified Nasdaq that it would seek to implement a reverse stock split, if necessary, to regain compliance with the Bid Price Rule. The Company filed a proxy statement to obtain shareholder approval for a reverse stock split on February 20, 2026.
Critical Accounting Policies and Estimates
The preparation of financial statements in conformity with generally accepted accounting principles in the United States ("US"), or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an on-going basis, management makes its best estimate of the ultimate outcome for these items based on historical trends and other information available when the financial statements are prepared. Changes in estimates are typically recognized in the period when new information regarding estimates becomes available to management. Actual results could differ from those estimates.
Our significant accounting policies are described in more detail in Note 2, "Summary of Significant Accounting Policies," in the notes to the consolidated financial statements. See below for what we believe are our Critical Accounting Policies.
Foreign Currency Translation and Presentation
Our reporting currency is US dollars. During the years ended December 31, 2025 and 2024, Immunic AG's operations were 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 US dollar are translated into US 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.
Research and Development Expenses
These costs primarily include external development expenses and internal personnel expenses for its development programs, vidofludimus calcium, IMU-856 and IMU 381. 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.
Share-Based Compensation
Stock Options
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.
Stock Appreciation Rights ("SARs")
The Company may issue SARs to its employees in exchange for services. The Company estimates the fair value of SARs using a Monte Carlo simulation, which requires the use of estimates and subjective assumptions, including the risk-free interest rate, the probability of a corporate transaction, 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 SARs. 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.
If SARs meet the requirements to be classified as a liability, the Company shall measure the SARs at each reporting date at their fair value and recognize expense based on the latest fair value for the percentage the requisite service period that has been provided for each vesting condition contained within the SAR award which may relate to service, market and performance conditions depending on the terms of the award.
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 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 December 31, 2025 and 2024, 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, Massachusetts, North Carolina 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 2025 are subject to audit
by German and Australian tax authorities. The Company is currently under examination by German tax authorities for its Immunic AG and Immunic GmbH subsidiaries for the years ended December 31, 2021-2023.
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.
Components of Results of Operations
Revenue
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates or achieving market acceptance and commercial success for any product that does receive regulatory approval.
Research and Development Expenses
Research and development expenses consist of costs associated with our research activities, including our product discovery efforts and the development of our product candidates. Our research and development expenses include:
•external research and development expenses and milestone payments incurred under arrangements with third parties, such as CROs, contract manufacturing organizations, collaborations with partners, consultants, and our scientific advisors; and
•internal personnel expenses.
We expense research and development costs as incurred. Non-refundable advance payments for goods and services that will be used in future research and development activities are capitalized as prepaid expenses and expensed when the service has been performed or when the goods have been received.
Since our inception in March 2016, we have spent a total of approximately $460.0 million in research and development expenses through December 31, 2025.
These costs primarily include external development expenses and internal personnel expenses for the three development programs, vidofludimus calcium, IMU-856 and IMU-381. We have spent the majority of our research and development resources on vidofludimus calcium, our lead development program, for clinical trials in MS and UC.
Our research and development expenses are expected to increase in the foreseeable future as we continue to conduct ongoing research and development activities, initiate new preclinical and clinical trials and build our pipeline of product candidates. Our research and development expenses may also increase in the foreseeable future due to the current inflationary environment as well as supply chain shortages and tariffs, which result in increased costs. The process of conducting clinical trials and preclinical studies necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving regulatory approval for any of our product candidates.
Successful development of product candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each product candidate and are difficult to predict. We anticipate that we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis
in response to the development and regulatory success of each product candidate, and ongoing assessments as to each product candidate's commercial potential.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel expenses, professional fees for legal, accounting, tax and business consulting services, insurance premiums and stock-based compensation.
Other Income (Expense), Net
Interest Income
Interest income consists of interest earned on our money market funds and bank accounts which are a portion of our cash and cash equivalents balance.
Change in the Fair Value of the Tranche Rights
The change in fair value of the tranche rights is a non-cash charge related to the change in fair value of the tranche 2 and tranche 3 rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024.
Other Income (Expense), Net
Other income (expense) primarily consists of (i) deal costs from the January 2024 Financing related to tranche rights that were established at the time of the deal closing (ii) a research and development tax incentive related to clinical trials performed in Australia and (iii) a German Government research and development grant.
Results of Operations
Comparison of Fiscal Years Ended December 31, 2025 and 2024
The following table summarizes our operating expenses for the years ended December 31, 2025 and 2024 (dollars in thousands):
| Years Ended December 31, | Change | ||||||||||||||||||||||
| 2025 | 2024 | $ | % | ||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | $ | 81,983 | $ | 80,046 | $ | 1,937 | 2 | % | |||||||||||||||
| General and administrative | 21,245 | 18,006 | 3,239 | 18 | % | ||||||||||||||||||
| Total operating expenses | 103,228 | 98,052 | 5,176 | 5 | % | ||||||||||||||||||
| Loss from operations | (103,228) | (98,052) | (5,176) | 5 | % | ||||||||||||||||||
| Other income (expense): | |||||||||||||||||||||||
| Interest income | 1,040 | 3,390 | (2,350) | (69) | % | ||||||||||||||||||
| Change in fair value of the tranche rights | - | (4,796) | 4,796 | NM | |||||||||||||||||||
| Other income (expense), net | 5,016 | (1,049) | 6,065 | (578) | % | ||||||||||||||||||
| Total other income (expense), net | 6,056 | (2,455) | 8,511 | (347) | % | ||||||||||||||||||
| Net loss | (97,172) | (100,507) | 3,335 | (3) | % | ||||||||||||||||||
Research and development expenses increased by $1.9 million during the twelve months ended December 31, 2025, as compared to the twelve months ended December 31, 2024. The increase reflects (i) a $3.9 million increase in external development costs related to the vidofludimus calcium program and (ii) a $1.8 million increase in personnel expenses for research and development. The increase was offset by (i) a $3.0 million decrease in external development costs related to IMU-856 primarily due to the timing of the purchase of drug supply for this program and (ii) a $0.8 million decrease across numerous categories.
General and administrative expenses increased by $3.2 million during the twelve months ended December 31, 2025, as compared to the twelve months ended December 31, 2024. The increase was due to (i) a $1.9 million increase related to
personnel expenses, of which $0.3 million was related to non-cash stock compensation, (ii) a $0.8 million increase in legal and consultancy expenses and (iii) a $0.5 million increase related to costs across numerous categories.
Interest income decreased by $2.4 million during the twelve months ended December 31, 2025, as compared to the twelve months ended December 31, 2024, due to a lower average cash balance.
In the twelve months ended December 31, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in our authorized shares from 130 million to 500 million shares of common stock and, therefore, the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the twelve months ended December 31, 2025.
Other income (expense) increased by $6.1 million during the twelve months ended December 31, 2025, as compared to the twelve months ended December 31, 2024. The increase was primarily attributable to (i) $4.8 million of grant income from the German Federal Ministry of Finance, of which $1 million was recognized in the first quarter 2025 and $3.8 million was recognized in the fourth quarter 2025, (ii) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024 and (iii) a $0.3 million increase across numerous categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia.
Liquidity and Capital Resources
Liquidity and Financial Condition
We have no products approved for commercial sale and have not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since our inception in 2016. Our net losses were approximately $97.2 million and $100.5 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of approximately $608.6 million. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we initiate and continue the preclinical and clinical development of our product candidates and add personnel necessary to operate as a company with an advanced clinical pipeline of product candidates. To the extent additional funds are necessary to meet long-term liquidity needs as we continue to execute our business strategy, we anticipate that they will be obtained through the incurrence of indebtedness, additional equity financings, product licensing or a combination of these potential sources of funds, although we can provide no assurance that these sources of funding will be available on reasonable terms, if at all.
From inception through December 31, 2025, we have 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 December 31, 2025, we had cash and cash equivalents of approximately $15.5 million. On February 17, 2026, we announced the closing of a private placement with net cash proceeds of approximately $187.0 million. With these funds we expect to be able to fund our operations beyond twelve months from the date of the issuance of the accompanying consolidated financial statements.
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. The 2023 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 total amount available under the 2023 Shelf Registration Statement was reduced by $70.1 million to $262.2 million as of December 31, 2025. The Company can also use the unused amount (currently $80 million) of the available ATM as additional shelf availability.
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 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 December 31, 2025, $80.0 million in capacity remains under the May 2024 ATM.
We agreed to pay Leerink Partners LLC a commission equal to 3.0% of the gross proceeds from the sales of common shares pursuant to the May 2024 ATM and have agreed to provide Leerink Partners LLC with customary indemnification and contribution rights.
We did not have any ATM activity during the twelve months ended December 31, 2025.
For the year ended December 31, 2024, the Company 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.
Equity Offerings
February 2026 Private Placement
Securities Purchase Agreement
On February 12, 2026, we into a securities purchase agreement (the "February Securities Purchase Agreement") with certain accredited investors (the "February Investors"), pursuant to which we agreed to issue and sell, in a private placement (the "February 2026 Offering"), pre-funded warrants (the "February 2026 Pre-Funded Warrants", and the shares of Common Stock issuable upon exercise of the February 2026 Pre-Funded Warrants, the "February 2026 Pre-Funded Warrant Shares") to purchase up to 0.0001 shares of Common Stock, with each February 2026 Pre-Funded Warrant accompanied by a warrant to purchase (i) a share of Common Stock or (ii) a pre-funded warrant to purchase a share of Common Stock (collectively, the "February 2026 Common Warrants" and together with the February 2026 Pre-Funded Warrants, the "February 2026 Warrants", and the shares of Common Stock issuable upon exercise of the February 2026 Common Warrants, the "February 2026 Common Warrant Shares", and together with the February 2026 Pre-Funded Warrant Shares, the "February 2026 Warrant Shares").
The purchase price for each February 2026 Pre-Funded Warrant and accompanying February 2026 Common Warrant was $0.873120. Each February 2026 Pre-Funded Warrant is immediately exercisable at a price of $0.0001 per share. Each February 2026 Common Warrant is exercisable at a price $0.873220 per share (subject to adjustment as set forth therein) following the completion of the Reverse Stock Split (as defined below) until the earlier of (i) 30 trading days following the date of our initial public announcement of topline data from its Phase 3 ENSURE trials (for the avoidance of doubt, the later date of the initial public announcement of topline data from ENSURE-1 or ENSURE-2, if announced separately) (the "Topline Data Announcement"), (ii) immediately upon the exercise of the February 2026 Pre-Funded Warrants if such exercise of February 2026 Pre-Funded Warrants is prior to the Topline Data Announcement, provided that if the February 2026 Pre-Funded Warrant is not exercised in full, the February 2026 Common Warrant expires proportionally only to the extent the Pre-Funded Warrant is exercised, and (iii) February 17, 2031.
The Offering closed on February 17, 2026 (the "February 2026 Closing Date").
The aggregate gross proceeds to the Company from the issuance and sale of the February 2026 Warrants was approximately $200 million, before deducting fees to be paid to the placement agents and financial advisors of the Company and other estimated offering expenses payable by the Company. The aggregate exercise price of the February 2026 Warrants is approximately $200 million.
Leerink Partners LLC acted as lead placement agent for the Offering, Stifel, Guggenheim Securities, William Blair, LifeSci Capital, B. Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC also acted as placement agents for the February 2026 Offering. As compensation in connection with the February 2026 Offering, we agreed to pay the placement agents a fee equal to 6% of the aggregate gross proceeds received by us (i) upon the issuance of the February 2026 Warrants at closing and (ii) upon the cash exercise of the February 2026 Common Warrants.
The Offering
We intend to use the net proceeds from the February 2026 Offering to fund our clinical trials and operations and for working capital and other general corporate purposes.
The securities issued in the February 2026 Offering have not been registered under the Securities Act, and until so registered the securities may not be offered or sold absent registration or availability of an applicable exemption from registration. There is no established public trading market for the February 2026 Warrants, and we do not intend to list such securities on any national securities exchange or nationally recognized trading system.
In connection with the February 2026 Offering, we and each February 2026 Investor entered into a registration rights agreement simultaneously with the February 2026 Securities Purchase Agreement (the "February 2026 Registration Rights Agreement"). Pursuant to the February 2026 Registration Rights Agreement, as promptly as reasonably practicable following the February 2026 Closing Date but, in any event, not later than 45 days thereafter (the "Filing Date") we shall file a resale registration statement on Form S-3 (or Form S-1 if Form S-3 is not available) providing for the resale by the Investors of the Registrable Securities (as defined in the February 2026 Registration Rights Agreement) and to use reasonable best efforts to cause such resale registration statement to be declared effective by the staff of the Securities and Exchange Commission (the "SEC") at the earliest possible date but no later than the earlier of (a) the 60th calendar day following the Filing Date if the SEC notifies us that it will review the registration statement and (b) the fifth business day after we are notified by the SEC that the registration statement will not be "reviewed" or will not be subject to further review or (ii) the fifth business day following the receipt of Reverse Split Stockholder Approval (as defined below) and the consummation of the Reverse Stock Split.
The February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement contain certain representations and warranties, covenants and indemnities customary for similar transactions. The representations, warranties and covenants contained in the February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement were made solely for the benefit of the parties to the February 2026 Securities Purchase Agreement and February 2026 Registration Rights Agreement, respectively, and may be subject to limitations agreed upon by the contracting parties.
April 2025 Offering
On April 9, 2025, we 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 our Common Stock (the "April 2025 Shares"). The purchase price per share was $0.90 for aggregate gross proceeds 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 are exercisable, in whole or in part, for five years from the 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 net proceeds to us from the April 2025 Offering, after deducting commissions and our offering expenses, was approximately $4.7 million.
The April 2025 Shares were registered under the Securities Act, on our Registration Statement on Form S-3 (Registration No. 333-275717), previously filed with the SEC, and declared effective on May 31, 2024.
May 2025 Equity Offering
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. The Series A Warrants are exercisable for one share of Common Stock at an exercise price of $0.75 per share, all but 10,666,667 of the Series A Warrants expired on December 31, 2025. The expiration date for the remaining 10,666,667 Series A Warrants was extended to February 28, 2026. Each Series B Warrant is exercisable on the earlier of (i) October 1, 2025, (ii) the first day following any five 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. 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.
The Company is prohibited from effecting an exercise of any Pre-Funded 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 B Warrant for Common Stock due to the Beneficial Ownership Limitation, then the holder may exercise such 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. On February 12, 2026, as part of the Royalty Purchase Agreement, 51,087,000 warrants were exchanged for the right to share a 5% royalty and 35,579,667 Series B warrants are still outstanding (see note 12 "Subsequent events"). The Company may receive up to an aggregate of approximately $27 million of additional gross proceeds if the remaining Series B Warrants are exercised in full for cash and up to $8.0 million gross proceeds if the remaining Series A Warrants are exercised 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 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 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 and third tranches of this financing were not exercised and expired on October 31, 2025.
Future Capital Requirements
As noted above, we have not generated any revenue from product sales and we do not know when, or if, we will generate any revenue from product sales. We will not be able to generate any revenue from product sales unless and until we obtain regulatory approval for and commercialize any of our product candidates. We expect our expenses to continue to increase as we continue the ongoing research, development, manufacture and clinical trials of, and seek regulatory approval for, our product candidates. We also incur additional costs associated with operating as a public company. In addition, subject to obtaining regulatory approval of any of our product candidates, we anticipate that we will need substantial additional funding in connection with our continuing operations.
Our future expenses and capital requirements are difficult to forecast and will depend on many factors, including, but not limited to:
•the timing and structure of any strategic options and transactions, if any;
•personnel-related expenses, including salaries, benefits, stock-based compensation expense and other compensation expenses related to retention and termination of personnel;
•the scope, progress, duration, results and costs of research and development and ongoing clinical trials;
•the cost and timing of future regulatory submissions;
•the cost and timing of developing and validating the manufacturing processes for any potential product candidates;
•the cost and timing of any commercialization activities, including reimbursement, marketing, sales and distribution costs;
•our ability to establish new collaborations, licensing or other arrangements and the financial terms of such agreements;
•the number and characteristics of any future product candidates we pursue;
•the costs involved with being a public company;
•the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patents, including litigation costs and the outcome of such litigation;
•the cost, timing and outcome of any future litigation; and
•the timing, receipt and amount from the sales of, or royalties on, any future products.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of stock offerings, debt financings, strategic alliances, collaborations and licensing arrangements. We do not expect to achieve revenue from product sales prior to the use of all the net proceeds from our public and private offerings to date. We do not have any committed external source of funds. Additional funds may not be available on acceptable terms, if at all. To the extent that we raise additional capital through the sale of equity securities, the ownership interest of our stockholders will be diluted and it may be on terms that are not favorable to us or our stockholders. Sales of equity securities will also be more difficult for at least the foreseeable future because of general volatility in the equity markets for companies like us. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt or other terms that are not favorable to us or our stockholders. Also, the cost of debt financing has increased due to the rise in interest rates over the past few years. If we raise additional funds through collaborations and licensing arrangements with third parties, we would expect to relinquish substantial rights to our technologies or our future products, or grant licenses on terms that may not be favorable to us. If we were to complete a merger, or other business combination, we may relinquish all control over the organization and could experience detrimental tax effects. If we are unable to raise adequate funds, we may have to curtail our product development programs and liquidate some or all of our assets. Any of these factors could harm our operating results and could result in substantial declines in the trading price of our common stock.
From inception through December 31, 2025, we have 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 December 31, 2025, we had cash and cash equivalents of approximately $15.5 million. On February 17, 2026 we raised net cash proceeds in a private placement of approximately $187.0 million. With these funds we expect to be able to fund our operations beyond twelve months from the date of the issuance of the accompanying consolidated financial statements.
Cash Flows
The following table shows a summary of our cash flows for the years ended December 31 (in thousands):
| 2025 | 2024 | ||||||||||
| Cash (used in) provided by: | |||||||||||
| Operating activities | $ | (85,806) | $ | (84,766) | |||||||
| Investing activities | (161) | (264) | |||||||||
| Financing activities | 65,577 | 74,541 | |||||||||
Net cash used in operating activities
During the year ended December 31, 2025, operating activities used $85.8 million of cash. The use of cash related to our net loss of $97.2 million adjusted for non-cash charges of $8.9 million of stock-based compensation, $0.5 million for non-cash lease expense and $0.2 million for depreciation and amortization and a net increase in operating assets and liabilities of $1.8 million. Changes in our operating assets and liabilities during the year ended December 31, 2025 consisted primarily of (i) a net increase of $5.5 million in our other current liabilities and (ii) a $3.2 million decrease in our other current assets and prepaid expenses
During the year ended December 31, 2024, operating activities used $84.8 million of cash. The use of cash related to our net loss of $100.5 million adjusted for non-cash charges of $8.5 million of stock-based compensation, $4.8 million related to a change in the fair value of the tranche rights, $1.7 million for fees expensed as part of the January 2024 financing, $0.2 million for non-cash lease expense and a net increase in operating assets and liabilities of $0.3 million. Changes in our operating assets and liabilities during the year ended December 31, 2024 consisted primarily of (i) a $1.9 million increase in our other current assets and prepaid expenses and (ii) a net decrease of $1.3 million in our other current liabilities.
Net cash used in investing activities
During the year ended December 31, 2025, net investing activities used $0.2 million due to the purchase of property and equipment.
During the year ended December 31, 2024, net investing activities used $0.3 million due to the purchase of property and equipment.
Net cash provided by financing activities
Net cash provided by financing activities was $65.6 million during the year ended December 31, 2025 primarily
consisting of net cash proceeds from the April and May 2025 Offerings and $0.2 million of net proceeds from shares issued in connection with our Employee Stock Purchase Plan.
Net cash provided by financing activities was $74.5 million during the year ended December 31, 2024 primarily
consisting of net cash proceeds from the January 2024 Financing and $0.2 million of net proceeds from sale of common stock through our At The Market Sales Agreement.
Off-Balance Sheet Arrangements
Through December 31, 2025, we have not entered into and did not have any relationships with unconsolidated entities or financial collaborations, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purpose.
Other Commitments and Obligations
See Note 2 - Collaboration Arrangements of the Notes to the Financial Statements regarding the Company's obligations under the option agreement with Daiichi Sankyo, which includes the potential payment of future development, regulatory and sales milestone payments, as well as royalties related to IMU-856 and the Ludwig-Maximilians-University Agreements where the Ludwig-Maximilians-University is entitled to receive future development, regulatory and sales milestone payments related to these molecules.
Maturities of the operating lease obligation are as follows as of December 31, 2025 (in thousands):
| 2026 | $ | 428 | ||||||
| 2027 | $ | 87 | ||||||
| 2028 | $ | 84 | ||||||
| 2029 | $ | - | ||||||
| 2030 | $ | - | ||||||
| Thereafter | $ | - | ||||||
| Total lease payments | $ | 599 | ||||||
| Less: interest portion | $ | (22) | ||||||
| Present value of lease obligation | $ | 577 | ||||||
Contractual Obligations
As of December 31, 2025, the Company has non-cancelable contractual obligations under certain agreements related to its development programs in vidofludimus calcium and IMU-856 totaling approximately $2.8 million, the majority of which is expected to be paid by the end of 2026.
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.
Recently Issued Accounting Standards
In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("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 for the annual period starting January 1, 2025.
In November 2024, the FASB issued 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 may be applied prospectively for the current year or retrospectively for all prior periods presented in the financial statements during the year of adoption. 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.
Immunic Inc. published this content on February 26, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on February 26, 2026 at 12:18 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]