What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-02-26 compared with 2025-03-31 · 271 added, 135 removed, 196 unchanged (67% of the section changed)

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Immunic, Inc.

("Immunic," “we,” “us,” “our” or the "Company") is a biotechnology company developing a clinical pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases.

(“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 91 employees as of March 1, 2025.

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 and Phase 2 clinical development for patients with relapsing and progressive multiple sclerosis (“MS”), respectively, and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MS ("RRMS"), progressive MS and moderate-to-severe ulcerative colitis (“UC”);

the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease (“IBD”), Graft-versus-Host-Disease ("GvHD") and weight management;

and the IMU-381 program, which is a next generation molecule being developed to specifically address the needs of gastrointestinal 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;

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.

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Recent Events

Private Placement of up to $240 Million (The "January 2024 Offering")

On January 4, 2024, Immunic entered into a Securities Purchase Agreement with select accredited and institutional investors, pursuant to which the Company agreed to issue and sell to the Investors in a three-tranche private placement shares of the Company’s common stock, $0.0001 par value per share or in lieu thereof, pre-funded warrants to purchase shares of Common Stock.

The Pre-Funded Warrants are exercisable immediately for $0.0001 per share and until exercised in full.

• The first tranche, which closed on January 8, 2024, resulted in the purchase by the Investors of an aggregate of $80 million of Common Stock (or Pre-Funded Warrants) from the Company at a price of $1.43 per share;

• The second tranche is a conditional mandatory purchase by the Investors of an additional $80 million of Common Stock (or Pre-Funded Warrants) from the Company at a price of $1.716 per share, equal to 120% of the price paid in the first tranche and is subject to the satisfaction of three conditions:

◦ release by the Company of topline data from its Phase 2b clinical trial of vidofludimus calcium (IMU-838) in progressive multiple sclerosis, which data is currently expected in or around April 2025;

◦ the 10-day volume-weighted average price of the Common Stock is at least $8.00 per share during the 6 months following the data release;

◦ 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.

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 Janaury 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.

Assuming that 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.

However, the amount of cash received in the third tranche would depend on the extent to which the Investors elect to fund the third tranche through a “cashless” or net settlement basis.

Therefore, total gross proceeds from the offering to the Company could actually be between $80 million and $240 million.

Gross proceeds to the Company will be reduced by fees paid to the placement agents, capital markets advisors and payments of transaction expenses.

The Company intends to use the net proceeds from the Private Placement to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-856 and IMU-381, and for other general corporate purposes.

Notice of Allowance for Composition-of-Matter Patent of a Specific Polymorph of Vidofludimus Calcium in the United States

On March 20, 2024, we announced Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for patent application 16/981,122, entitled, “Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents,” covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material.

The claims are expected to provide protection into 2041, unless extended further.

The patent was previously granted to the Company in Australia, Canada, Indonesia, Japan and Mexico.

Publication of Extended Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS in the Peer Reviewed Journal, Neurology® Neuroimmunology & Neuroinflammation

On April 30, 2024, we announced that data from our Phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS has been published online on April 25, 2024 in Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology.

The paper, lead authored by coordinating investigator, Robert J.

Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, is entitled, “Safety and Dose-Response of Vidofludimus Calcium in Relapsing Multiple Sclerosis:

Extended Results of a Placebo-Controlled Phase 2 Trial.”

Appointment of Jason Tardio as Chief Operating Officer and President and Promotion of Werner Gladdines to Chief Development Officer

On July 9, 2024, we announced that seasoned biopharmaceutical executive, Jason Tardio, will be joining the company as Chief Operating Officer and President, effective July 12, 2024.

In the newly created role, Mr.

Tardio leads internal efforts to prepare for the potential launch of vidofludimus calcium.

Jason also works closely with Patrick Walsh, Chief Business Officer, to prepare the Company for a range of potential partnership outcomes for vidofludimus calcium, as well as our other drug candidates.

On July 9, 2024, we also reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, has been promoted to Chief Development Officer.

In his new role, Mr.

Gladdines takes over additional strategic and operational responsibility for our overall clinical operations functions.

Appointment of Simona Skerjanec to Board of Directors

On July 24, 2024, we announced the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience in drug development and commercialization, as a member of our Board of Directors, effective as of July 22, 2024.

As a Class I director, Ms.

Skerjanec’s term lasts until the Company’s 2027 annual meeting of stockholders.

First Patient Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of Vidofludimus Calcium in Patients with Post COVID Syndrome

On September 4, 2024, we announced enrollment of the first patient in an investigator-sponsored Phase 2 clinical trial of vidofludimus calcium, entitled, “Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE).” The Phase 2 RAPID_REVIVE trial, for which Immunic is providing study medication, is a randomized, placebo-controlled, double-blind, parallel group trial sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research.

Hosted Two Multiple Sclerosis R&D Days in New York City and San Francisco

At two MS R&D Days, on September 10, 2024 in New York City and on April 9, 2024 in San Francisco, management discussed the latest developments in the MS landscape, along with recent mode of action, preclinical and clinical data supporting the combined neuroprotective, anti-inflammatory and antiviral profile of vidofludimus calcium.

Presented Key Vidofludimus Calcium Data at the 40th Congress of ECTRIMS, Highlighting Its Therapeutic Potential in Multiple Sclerosis

On September 18, 2024, we announced the presentation of key data at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (“ECTRIMS”), highlighting vidofludimus calcium’s therapeutic potential in MS.

The data was presented in an oral poster presentation and three ePosters at this conference in Copenhagen, Denmark.

Positive Outcome of Interim Analysis of Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing Multiple Sclerosis

On October 22, 2024, we announced a positive outcome of an interim analysis of our Phase 3 ENSURE program, investigating vidofludimus calcium for the treatment of RMS.

An unblinded IDMC confirmed that the predetermined futility criteria have not been met and recommended that both ENSURE trials should continue without changes.

The IDMC considered if a sample size adjustment would be appropriate for either of the two trials based on factors that include statistical analysis and ultimately recommended that the sample sizes for both trials should remain unchanged.

Announced Publication of Data From Phase 1/1b Clinical Trial of IMU-856 in the Peer Reviewed Journal, The Lancet Gastroenterology & Hepatology

On November 13, 2024, we announced that the data from our Phase 1/1b clinical trial of IMU-856, has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology .

Lead authored by Dr.

James Daveson, Gastroenterologist, Wesley Research Institute and Coral Sea Clinical Research Institute, Queensland, Australia, the paper is entitled, “Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in celiac disease:

a first-in-human, randomized, double-blind, placebo-controlled, phase 1 trial.”

IMU-856 Demonstrated Dose-Dependent Increase of Glucagon-like Peptide-1 (“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 GLP-1 levels in a post hoc analysis of patients from our Phase 1b clinical trial in celiac disease.

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.

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.

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.

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 vivo testing

These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.

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.

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These clinical findings were corroborated by effects observed in a 6-month preclinical in vivo study, 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

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• components of equity at historical rates.

Gains and losses from translation of the financial statements into US dollars are recorded in stockholders’ equity net of the anticipated income tax effects as a component of accumulated other comprehensive income (loss).

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 (loss).

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 research and development expenses primarily include external development expenses and internal personnel expenses for the three development programs, vidofludimus calcium, IMU-856 and IMU-381.

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.

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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.

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.

Stock-Based Compensation

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.

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Forfeitures are recorded in the period in which they occur.

The Company estimates the fair value of stock options using the Black-Scholes-Merton option-pricing model ("BSM"), which requires the use of estimates and subjective assumptions, including the risk-free interest rate, the fair value of the underlying common stock, the expected dividend yield of the Company’s common stock, the expected volatility of the price of the Company’s common stock, and the expected term of the option.

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.

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.

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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, 2024 and 2023, respectively, the Company maintained a full valuation allowance against the balance of deferred tax assets.

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.

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The Company is subject to U.S.

federal, New York, California, Texas, German and Australian income taxes.

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 2023 are subject to audit by German and Australian tax authorities.

The Company is not currently under examination by any tax jurisdictions.

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

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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 at fair value on the issuance date with no changes in fair value recognized after the issuance date.

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

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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, which result in increased costs.

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.

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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.

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

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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.

Our interest income is expected to decrease as our money market funds balance has decreased and U.S.

interest rates have decreased.

Change in the Fair Value of the Tranche Rights

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Other Income (Expense), Net

Other income (expense) 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.

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

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Net loss (97,172) (100,507) 3,335 (3) %

Research and development expenses decreased by $3.2 million during the year ended December 31, 2024, as compared to the year ended December 31, 2023.

The decrease reflects (i) a decrease of $4.1 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii) a $3.5 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 clinical trial in celiac disease and (iii) a $0.3 million decrease related costs across numerous categories.

The decreases were offset by (i) a $3.5 million increase in external development costs related to the vidofludimus calcium program and (ii) a $1.2 million increase in personnel costs, $0.2 million of which is related to non-cash stock compensation and the remainder of which is due to an increase in headcount.

General and administrative expenses increased by $2.0 million during the year ended December 31, 2024, as compared to the year ended December 31, 2023.

The increase was due to a $2.0 million increase in personnel expense in general and administrative, $1.2 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount.

Interest income increased by $0.3 million during the year ended December 31, 2024, as compared to the year ended December 31, 2023 due to a higher average cash balance.

The change in fair value of the tranche rights of $4.8 million 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.

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.

Other income (expense) decreased by $3.6 million during the year ended December 31, 2024, as compared to the year ended December 31, 2023.

The decrease was primarily attributable to (i) 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 and (ii) a $2.6 million decrease due to the timing of receiving the German Federal Ministry of Finance grant.

In 2023, we recognized grant income from 2022 and 2023 and in 2024, we did not receive approval of the German Federal Ministry of Finance grant as of December 31, 2024, so nothing was recognized.

The decrease was offset by (i) a $0.4 million increase in foreign exchange gains and (ii) a $0.3 million increase related to costs across numerous categories.

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

Financial Condition, Liquidity and Going Concern

Liquidity and Financial Condition

We have no products approved for commercial sale and have not generated any revenue from product sales.

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As of December 31, 2025, we had cash and cash equivalents of approximately $15.5 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 consolidated financial statements 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.

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.

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").

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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 resulting in a total S-3 shelf availability of approximately $412.3 million as of December 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 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.

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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.

For the year ended December 31, 2023, we raised gross proceeds of $0.9 million pursuant to the December 2020 ATM through the sale of 657,012 shares of common stock at a weighted average price of $1.34 per share.

The net proceeds from the December 2020 ATM were $0.9 million after deducting underwriter commissions of $26,000.

Equity Offerings

Janaury 2024 Financing of up to $240 Million