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About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Accessibility StatementSkip Navigation – Fifth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis – – Comprehensive Intellectual Property Strategy Secures Protection Into 2041 in the U.S., Unless Extended Further – NEW YORK, Sept. 9, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that it has received a Notice o ...

Summary of Immunic, Inc. Conference Call Company Overview - **Company Name**: Immunic, Inc. - **Ticker**: IMUX - **Industry**: Biotechnology - **Focus**: Developing small molecule therapies for chronic inflammatory and autoimmune diseases [1][2] Core Products - **IMU-856**: - Phase II-ready asset targeting SIRT6 to regenerate gut wall and barrier function in gastrointestinal diseases. - Proof-of-concept data in celiac disease showing a dose-dependent increase in endogenous GLP-1 [2][3]. - **Vidofludimus Calcium**: - Phase III molecule for relapsing forms of multiple sclerosis (MS). - Addresses both neuroinflammation and neurodegeneration, which are critical in MS progression [3][5]. Unmet Need in Multiple Sclerosis - MS leads to significant physical and cognitive disabilities. - Current therapies primarily address neuroinflammation but do not halt chronic disability accumulation. - Vidofludimus calcium aims to provide neuroprotective benefits alongside anti-inflammatory effects [3][4][5]. Mechanism of Action - **Dual Mechanistic Approach**: - Inhibits dihydroorotate dehydrogenase (DHODH) to reduce inflammation. - Activates nuclear receptor-related protein 1 (NRR-1) for neuroprotection [5][6]. - **Epstein-Barr Virus**: - Vidofludimus calcium may prevent reactivation of this virus, which is linked to MS symptoms [6][7]. Clinical Data - **Phase II EMPhASIS Study**: - 268 patients; significant reduction in cumulative active lesions (76%) and gadolinium-enhanced lesions (80%) at week 24 with 30 mg dose [11]. - Confirmed disability worsening was 1.6% for vidofludimus calcium vs. 3.7% for placebo, indicating over 50% benefit [11][12]. - Long-term follow-up showed less than 8% of patients reported confirmed disability worsening at week 144 [12]. - Significant reductions in serum neurofilament light chain, a biomarker for disability worsening [13]. - **Safety Profile**: - Low discontinuation rates (2.8%) compared to other therapies (e.g., Aubagio at 20%) [14]. - No increased risk of serious infections or hepatotoxicity observed [14]. Ongoing Studies - **ENSURE I and ENSURE II**: - Phase III studies fully enrolled with over 1,100 patients each, focusing on time to first relapse [16]. - Expected top-line data in late 2026 [16]. - **CALIBRATE Study**: - Exploratory Phase II study for progressive MS, showing a 31% reduction in disability worsening for primary progressive MS [17][18]. Market Opportunity - **Market Size**: - MS market valued at $23 billion, projected to grow to $30 billion [20]. - Vidofludimus calcium could capture a significant share as the first oral disease-modifying therapy for both relapsing and progressive MS [20][21]. - **Potential Revenue**: - Estimated $1 billion to $2 billion opportunity in relapsing MS and over $2 billion in progressive MS if successful [21]. Conclusion - Vidofludimus calcium represents a transformative opportunity in the MS market with its dual mechanism of action and favorable safety profile. - The company anticipates significant commercial potential if ongoing studies confirm its efficacy [21][22].

Company Overview - Immunic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral therapies for chronic inflammatory and autoimmune diseases[5] - The company's lead drug candidate, Vidofludimus Calcium, has a peak sales potential of $3-7 billion in Multiple Sclerosis (MS)[5] - As of June 30, 2025, Immunic had a cash balance of $55.3 million[5] Clinical Pipeline - Vidofludimus Calcium's Phase 2 EMPhASIS trial in Relapsing-Remitting Multiple Sclerosis (RRMS) was successfully completed, showing a reduction in disability worsening[6] - The CALLIPER trial for Progressive Multiple Sclerosis (PMS) with Vidofludimus Calcium also showed substantial reductions in disability worsening[6] - Top-line data for the ENSURE trials (ENSURE-1 and ENSURE-2) in Relapsing Multiple Sclerosis (RMS) are expected by the end of 2026[6] Vidofludimus Calcium Efficacy - The EMPhASIS trial showed a 78% reduction in cumulative unique active (CUA) lesions and a 74% reduction in Gadolinium-enhancing (Gd+) lesions with the 45mg dose compared to placebo[44] - In the CALLIPER trial, Vidofludimus Calcium demonstrated a 24% risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population[94] - A 34% reduction of 24wCDW was observed in patients without baseline inflammatory lesions in the CALLIPER trial[95] Market Opportunity - The Multiple Sclerosis (MS) market is large and growing, with many brands generating over $1 billion in global annual sales in 2024[100] - The MS therapies market is currently a $20 billion market growing at 4% year-over-year[101] - Vidofludimus Calcium has a potential peak sales of $1-2 billion for Relapsing MS (RMS), $1-2 billion for non-active Secondary Progressive MS (naSPMS), and $2-3 billion for Primary Progressive MS (PPMS)[108]

Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [6] - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for treating relapsing multiple sclerosis, with top-line data expected by the end of 2026 [6] - Vidofludimus calcium has shown therapeutic activity in phase 2 trials for both relapsing-remitting and progressive multiple sclerosis [6] Upcoming Conferences - Immunic will participate in several investor and scientific conferences in September 2025, including the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, where company executives will present an overview and hold one-on-one meetings [1] - The company will also attend the Leerink Partners Biopharma Summit from September 17-19, and the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from September 24-26, where data on vidofludimus calcium will be presented [5] Presentation Details - At ECTRIMS, Immunic will present data on vidofludimus calcium, including an oral presentation and four poster presentations, one of which is a late-breaking poster [5] - Key presentations will include efficacy and safety data from the Phase 2 CALLIPER Trial for progressive multiple sclerosis, with specific sessions scheduled for September 24, 2025 [5][6]

Core Insights - Immunic Inc's CEO Dr. Daniel Vitt highlighted the promising results from the Phase 2 CALLIPER trial of vidofludimus calcium, showing a 24% reduction in disability progression across the full study population, with over 30% reduction in patients with primary progressive MS [1][2]. Clinical Progress - The CALLIPER study aimed to analyze the neuroprotective effect of vidofludimus calcium in patients with progressive forms of multiple sclerosis, addressing a significant unmet medical need [2]. - The CALLIPER data is deemed important for various forms of MS, including primary progressive, secondary progressive, and relapsing MS, with ongoing Phase 3 ENSURE studies expected to benefit from the drug's neuroprotective features [3]. Trial Enrollment and Milestones - The company completed enrollment for both ENSURE trials, involving a total of 2,200 patients, marking a significant milestone in the quarter [4]. - The trials are set to read out next year, indicating a step closer to potential new treatment options for patients with relapsing MS [4]. EMPhASIS Trial Results - New data from the Phase 2 EMPhASIS trial indicated that over 90% of patients treated with vidofludimus calcium for 144 weeks were free of disability progression, showcasing the drug's effectiveness [6]. Financial Position - The company strengthened its balance sheet through two financings, positioning itself well to advance its clinical trials, particularly the Phase 3 studies in relapsing MS [7][8].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

PART I - FINANCIAL INFORMATION This section presents Immunic, Inc.'s unaudited condensed consolidated financial statements, management's discussion, market risk, and controls [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Immunic, Inc.'s unaudited condensed consolidated financial statements for June 30, 2025, and December 31, 2024, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, are presented with detailed notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) A summary of Immunic, Inc.'s financial position at June 30, 2025, and December 31, 2024, is presented | Metric | June 30, 2025 (Unaudited) (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------- | :------------------------------- | | Cash and cash equivalents | $55,310 | $35,668 | | Total current assets | $59,842 | $39,332 | | Total assets | $61,429 | $40,868 | | Total current liabilities | $27,313 | $22,175 | | Total liabilities | $27,518 | $22,439 | | Total stockholders' equity | $33,911 | $18,429 | - Cash and cash equivalents increased by **$19,642 thousand** from December 31, 2024, to June 30, 2025[8](index=8&type=chunk) - Total assets increased by **$20,561 thousand**, while total liabilities increased by **$5,079 thousand** over the six-month period[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Immunic, Inc.'s financial performance, including revenues and expenses, for the periods ended June 30, 2025, and 2024, is detailed | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $21,369 | $18,323 | $42,902 | $37,059 | | General and administrative | $5,714 | $4,491 | $11,006 | $9,636 | | Total operating expenses | $27,083 | $22,814 | $53,908 | $46,695 | | Loss from operations | $(27,083) | $(22,814) | $(53,908) | $(46,695) | | Net loss | $(26,820) | $(21,380) | $(52,293) | $(50,964) | | Net loss per share, basic and diluted | $(0.20) | $(0.21) | $(0.45) | $(0.51) | - Net loss increased by **$5,440 thousand (25%)** for the three months ended June 30, 2025, compared to the same period in 2024, primarily due to higher operating expenses and lower interest income[11](index=11&type=chunk) - Research and development expenses increased by **$3,046 thousand (17%)** for the three months ended June 30, 2025, driven by external development costs for vidofludimus calcium programs and personnel expenses[11](index=11&type=chunk)[196](index=196&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Immunic, Inc.'s comprehensive loss, including net loss and other comprehensive income/loss, is presented | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(26,820) | $(21,380) | $(52,293) | $(50,964) | | Foreign currency translation | $(1,399) | $(505) | $(1,684) | $23 | | Total comprehensive loss | $(28,219) | $(21,885) | $(53,977) | $(50,941) | - Total comprehensive loss increased to **$(53,977) thousand** for the six months ended June 30, 2025, from **$(50,941) thousand** in the prior year, primarily due to a higher net loss and negative foreign currency translation adjustments[14](index=14&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Changes in Immunic, Inc.'s stockholders' equity for the six months ended June 30, 2025, are summarized | Metric (in thousands) | Balance at January 1, 2025 | Balance at June 30, 2025 | | :-------------------- | :------------------------- | :----------------------- | | Common Stock Amount | $8 | $9 | | Additional Paid-In Capital | $525,611 | $595,069 | | Accumulated Other Comprehensive Income | $4,209 | $2,525 | | Accumulated Deficit | $(511,399) | $(563,692) | | Total Stockholders' Equity | $18,429 | $33,911 | - Total stockholders' equity increased significantly from **$18,429 thousand** at January 1, 2025, to **$33,911 thousand** at June 30, 2025, primarily driven by proceeds from the May 2025 Offering (**$60,661 thousand**) and April 2025 Offering (**$4,734 thousand**), despite a net loss of **$(52,293) thousand**[16](index=16&type=chunk) - The accumulated deficit grew from **$(511,399) thousand** to **$(563,692) thousand** during the six-month period due to ongoing operating losses[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Immunic, Inc.'s cash inflows and outflows from operating, investing, and financing activities are presented | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(46,385) | $(41,008) | | Net cash used in investing activities | $(83) | $(211) | | Net cash provided by financing activities | $65,518 | $74,464 | | Net change in cash and cash equivalents | $19,642 | $33,024 | | Cash and cash equivalents, end of period | $55,310 | $79,698 | - Operating activities used **$46,385 thousand** in cash for the six months ended June 30, 2025, an increase from **$41,008 thousand** in the prior year, primarily due to the net loss[21](index=21&type=chunk)[233](index=233&type=chunk) - Financing activities provided **$65,518 thousand** in cash for the six months ended June 30, 2025, mainly from the April 2025 and May 2025 equity offerings[21](index=21&type=chunk)[236](index=236&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes provide additional information on Immunic, Inc.'s business, accounting policies, and financial position [1. Description of Business and Basis of Financial Statements](index=9&type=section&id=1.%20Description%20of%20Business%20and%20Basis%20of%20Financial%20Statements) Immunic, Inc.'s business, operations, and the basis of its financial statement preparation are described - Immunic, Inc. is a biotechnology company focused on developing oral immunology therapies for chronic inflammatory and autoimmune diseases, with **approximately 90 employees** as of July 31, 2025[24](index=24&type=chunk)[145](index=145&type=chunk) - The company has an accumulated deficit of **approximately $563.7 million** as of June 30, 2025, and has never been profitable, raising substantial doubt about its ability to continue as a going concern without additional capital[26](index=26&type=chunk)[28](index=28&type=chunk)[158](index=158&type=chunk)[160](index=160&type=chunk) - The financial statements are prepared in conformity with U.S. GAAP and include Immunic and its wholly-owned subsidiaries, Immunic AG and Immunic Australia Pty Ltd., managed as a single reportable segment[29](index=29&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Key accounting policies used in preparing Immunic, Inc.'s financial statements are outlined - The company's reporting currency is U.S. dollars, with functional currencies of Euro for Immunic AG and Australian dollar for Immunic Australia Pty Ltd., with translation gains/losses recorded in accumulated other comprehensive income (loss)[32](index=32&type=chunk) - Research and development expenses, primarily for vidofludimus calcium and IMU-856 programs, are expensed as incurred[43](index=43&type=chunk)[44](index=44&type=chunk) - Stock-based compensation is measured at grant-date fair value for equity awards and recognized over the service period, using the Black-Scholes-Merton option-pricing model[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk) [3. Balance Sheet Details](index=15&type=section&id=3.%20Balance%20Sheet%20Details) Detailed information on specific balance sheet accounts is provided | Account (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------- | :------------ | :---------------- | | Prepaid clinical and related costs | $2,467 | $1,871 | | Accounts payable - Clinical costs | $7,015 | $7,561 | | Accrued clinical and related costs | $16,227 | $12,456 | | Accrued compensation | $1,457 | $354 | - Prepaid clinical and related costs increased by **$596 thousand**, while accrued clinical and related costs increased by **$3,771 thousand** from December 31, 2024, to June 30, 2025[67](index=67&type=chunk)[69](index=69&type=chunk) [4. Leases](index=16&type=section&id=4.%20Leases) Information regarding Immunic, Inc.'s operating lease arrangements and obligations is presented - The company leases office and laboratory space in New York City and Germany, with lease terms up to **60 months**[71](index=71&type=chunk) | Year | Operating Lease Obligation (in thousands) | | :--- | :---------------------------------------- | | 2025 | $415 | | 2026 | $444 | | 2027 | $85 | | 2028 | $82 | | Total | $1,026 | | Interest | $(47) | | Present value of obligation | $979 | - Operating lease costs were **$312 thousand** for the three months ended June 30, 2025, and **$591 thousand** for the six months ended June 30, 2025[73](index=73&type=chunk) [5. Fair Value](index=17&type=section&id=5.%20Fair%20Value) Details on the fair value measurements of Immunic, Inc.'s financial assets and liabilities are provided | Asset (in thousands) | Fair Value at June 30, 2025 | Fair Value at December 31, 2024 | | :------------------- | :-------------------------- | :------------------------------ | | Money market funds | $47,190 | $14,751 | - Money market funds, classified as Level 1 assets, increased significantly from **$14,751 thousand** at December 31, 2024, to **$47,190 thousand** at June 30, 2025[75](index=75&type=chunk) - The company had no Level 2 or Level 3 assets or liabilities for the periods presented, except for tranche rights in Q1 2024 which were reclassified to equity[39](index=39&type=chunk)[78](index=78&type=chunk) [6. Common Stock](index=18&type=section&id=6.%20Common%20Stock) Information on Immunic, Inc.'s common stock, including recent offerings and Nasdaq compliance, is presented - The company completed an April 2025 Offering, issuing **5,666,667 shares** of common stock for gross proceeds of **approximately $5.1 million** and net proceeds of **$4.7 million**[85](index=85&type=chunk)[88](index=88&type=chunk) - A May 2025 Equity Offering involved the issuance of pre-funded warrants, Series A warrants, and Series B warrants, generating **approximately $65 million** in gross proceeds, with potential for an additional **$130 million** if warrants are fully exercised for cash[89](index=89&type=chunk)[92](index=92&type=chunk) - Immunic received a Nasdaq non-compliance notice on June 27, 2025, for its common stock trading **below $1.00** for **30 consecutive business days**, with a compliance period until December 24, 2025[102](index=102&type=chunk) [7. Stock-Based Compensation Plans](index=22&type=section&id=7.%20Stock-Based%20Compensation%20Plans) Details on Immunic, Inc.'s stock-based compensation plans and related expenses are provided - Total stock-based compensation expense for the six months ended June 30, 2025, was **$3,941 thousand**, a decrease from **$4,632 thousand** in the prior year[121](index=121&type=chunk) | Expense Category (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $761 | $842 | $1,592 | $2,005 | | General and administrative | $1,138 | $1,040 | $2,349 | $2,627 | | Total | $1,899 | $1,882 | $3,941 | $4,632 | - As of June 30, 2025, there was **$15.6 million** in total unrecognized compensation expense related to the 2019 Plan, to be recognized over a weighted average period of **3.16 years**[121](index=121&type=chunk) [8. Related Party Transactions](index=25&type=section&id=8.%20Related%20Party%20Transactions) Information on transactions and agreements with Immunic, Inc.'s related parties is disclosed - The Executive Chairman Agreement with Duane Nash was extended to December 31, 2025, with his monthly base salary increasing to **$33,986** in 2025[127](index=127&type=chunk) [9. Commitments and Contingencies](index=25&type=section&id=9.%20Commitments%20and%20Contingencies) Immunic, Inc.'s contractual obligations, licensing agreements, and potential litigation are outlined - As of June 30, 2025, the company has non-cancelable contractual obligations of **approximately $2.1 million** related to its development programs for vidofludimus calcium and IMU-856, expected to be paid in 2025 and 2026[128](index=128&type=chunk)[239](index=239&type=chunk) - Immunic AG entered into a licensing agreement with Ludwig-Maximilians-University for new neuroinflammatory molecules, entitling the university to future development, regulatory, and sales milestone payments[130](index=130&type=chunk) - The company is not currently a party to any material litigation but acknowledges the industry's susceptibility to claims regarding intellectual property and product liability[131](index=131&type=chunk)[250](index=250&type=chunk) [10. Segment Disclosures](index=26&type=section&id=10.%20Segment%20Disclosures) Information on Immunic, Inc.'s operating segments and how performance is assessed is provided - The company operates as a single reportable segment: life science, focused on developing clinical and preclinical product candidates[132](index=132&type=chunk) - The Chief Executive Officer, as the CODM, assesses performance based on net loss and allocates resources based on cash resources and the probability of success of R&D activities[133](index=133&type=chunk) | Operating Expenses (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Clinical product candidates | $35,491 | $29,882 | | Pre-clinical product candidates | $345 | $400 | | Employee costs- research and development | $4,761 | $3,881 | | Employee costs-general and administrative | $3,643 | $2,704 | | Non-cash stock compensation | $3,941 | $4,632 | | Total operating expenses | $53,908 | $46,695 | [11. Subsequent Events](index=28&type=section&id=11.%20Subsequent%20Events) Significant events occurring after the balance sheet date are disclosed - On July 7, 2025, the Board authorized grants of up to **35,000,000 Stock Appreciation Rights (SARs)** to employees and executive officers, with an exercise price of **$0.77**[137](index=137&type=chunk) - These SARs are intended to be settled for common stock, pending stockholder approval to amend the 2019 Omnibus Equity Incentive Plan to provide sufficient shares[137](index=137&type=chunk) - SAR exercisability is contingent on various milestones, including the exercise of Series A and B warrants and the completion of the second and third tranches of the January 2024 private placement[138](index=138&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's perspective on the company's financial condition, operations, liquidity, and key business developments is provided [Forward-Looking Statements](index=28&type=section&id=Forward-Looking%20Statements) This section contains cautionary statements regarding Immunic, Inc.'s future expectations and potential risks - The report contains forward-looking statements regarding development programs, financial estimates, and capital resources, which are subject to risks and uncertainties[140](index=140&type=chunk)[141](index=141&type=chunk) - Investors are cautioned not to place undue reliance on these statements, as actual results may differ materially due to various factors, including clinical trial outcomes and funding availability[142](index=142&type=chunk)[144](index=144&type=chunk) [Overview](index=29&type=section&id=Overview) An overview of Immunic, Inc.'s biotechnology business, product candidates, and clinical trial status is provided - Immunic is a biotechnology company developing oral immunology therapies for chronic inflammatory and autoimmune diseases, with main operations in Germany and headquarters in New York City[145](index=145&type=chunk) - Key product candidates include vidofludimus calcium (IMU-838) in Phase 3 for relapsing multiple sclerosis (RMS) and Phase 2 for progressive MS (PMS) and ulcerative colitis (UC); IMU-856 for gastrointestinal diseases; and IMU-381 for gastrointestinal diseases in preclinical testing[146](index=146&type=chunk)[147](index=147&type=chunk)[153](index=153&type=chunk) - Enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in RMS was completed in May 2025, with top-line data expected by the end of 2026[148](index=148&type=chunk) [Strategy](index=31&type=section&id=Strategy) Immunic, Inc.'s strategic focus on developing immunology therapies and key initiatives are outlined - The company's strategy focuses on developing new molecules for immunological targets, leveraging R&D infrastructure in Germany and Australia for efficient development in high unmet need indications[157](index=157&type=chunk) - Strategic initiatives include executing Phase 3 ENSURE trials, analyzing Phase 2 CALLIPER data, advancing IMU-856, continuing preclinical research, preparing for commercial launch, and evaluating strategic collaborations[161](index=161&type=chunk) [Financial Condition, Liquidity and Going Concern](index=31&type=section&id=Financial%20Condition,%20Liquidity%20and%20Going%20Concern) Immunic, Inc.'s financial health, capital resources, and ability to continue as a going concern are discussed - Immunic has no product revenue, has never been profitable, and incurred an accumulated deficit of **approximately $563.7 million** as of June 30, 2025[158](index=158&type=chunk) - The company expects significant and increasing operating losses, and its cash and cash equivalents of **$55.3 million** as of June 30, 2025, are insufficient to fund operations for at least **twelve months** without raising additional capital, raising substantial doubt about its going concern ability[159](index=159&type=chunk)[160](index=160&type=chunk) [Key Status Updates](index=31&type=section&id=Key%20Status%20Updates) Important updates on Immunic, Inc.'s clinical trials and product candidate development are presented - IMU-856 demonstrated a dose-dependent increase of endogenous GLP-1 levels in celiac disease patients and reduced body weight gain in preclinical testing, suggesting potential for weight management[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) - Positive data from the Phase 2 CALLIPER trial of vidofludimus calcium in PMS showed a **30% reduction** in 24-week confirmed disability worsening (24wCDW) in PPMS patients and a **20% reduction** in thalamic brain volume loss[164](index=164&type=chunk)[165](index=165&type=chunk) - Long-term open-label extension data from the Phase 2 EMPhASIS trial in RRMS showed **92.3% of patients** remained free of 12-week CDW at week 144, with a favorable safety profile over **5.5 years**[170](index=170&type=chunk) [Components of Results of Operations](index=35&type=section&id=Components%20of%20Results%20of%20Operations) An explanation of the key components contributing to Immunic, Inc.'s financial results is provided - The company has not generated product sales revenue and does not expect to in the foreseeable future, relying on successful development and regulatory approval of product candidates[186](index=186&type=chunk) - Research and development expenses, totaling **approximately $421.2 million** through June 30, 2025, are expensed as incurred and are expected to increase due to ongoing clinical trials and inflationary pressures[187](index=187&type=chunk)[188](index=188&type=chunk)[189](index=189&type=chunk) - Other income (expense) includes deal costs from the January 2024 Financing, R&D tax incentives from Australia, and a German Government R&D grant[195](index=195&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) A detailed analysis of Immunic, Inc.'s financial performance for the reported periods is presented | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Research and development | $21,369 | $18,323 | $3,046 | 17% | | General and administrative | $5,714 | $4,491 | $1,223 | 27% | | Total operating expenses | $27,083 | $22,814 | $4,269 | 19% | | Net loss | $(26,820) | $(21,380) | $(5,440) | 25% | | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Research and development | $42,902 | $37,059 | $5,843 | 16% | | General and administrative | $11,006 | $9,636 | $1,370 | 14% | | Total operating expenses | $53,908 | $46,695 | $7,213 | 15% | | Net loss | $(52,293) | $(50,964) | $(1,329) | 3% | - Interest income decreased by **$0.8 million (76%)** for the three months and **$1.8 million (81%)** for the six months ended June 30, 2025, due to a lower average cash balance[197](index=197&type=chunk)[201](index=201&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) Immunic, Inc.'s cash position, capital-raising activities, and funding needs are discussed - As of June 30, 2025, Immunic had **$55.3 million** in cash and cash equivalents, which is not adequate to fund operations for at least **twelve months** without additional capital[206](index=206&type=chunk)[231](index=231&type=chunk) - The company raised **approximately $4.7 million** net from the April 2025 Offering and **$60.7 million** net from the May 2025 Equity Offering[215](index=215&type=chunk)[220](index=220&type=chunk) - The January 2024 Financing provided **$80 million** in gross proceeds from the first tranche, with potential for an additional **$160 million** from conditional second and third tranches[223](index=223&type=chunk)[226](index=226&type=chunk) [Off-Balance Sheet Arrangements](index=43&type=section&id=Off-Balance%20Sheet%20Arrangements) Information on Immunic, Inc.'s off-balance sheet arrangements is disclosed - As of June 30, 2025, the company has not entered into any off-balance sheet arrangements or relationships with unconsolidated entities[237](index=237&type=chunk) [Other Commitments and Obligations](index=43&type=section&id=Other%20Commitments%20and%20Obligations) Immunic, Inc.'s additional contractual commitments and obligations are detailed - The company has non-cancelable contractual obligations of **approximately $2.1 million** for development programs, expected to be paid in 2025 and 2026[239](index=239&type=chunk) - Obligations under the Daiichi Sankyo and Ludwig-Maximilians-University agreements include potential future development, regulatory, and sales milestone payments[238](index=238&type=chunk) [Critical Accounting Policies and Estimates](index=43&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Key accounting policies and estimates requiring significant judgment in Immunic, Inc.'s financial reporting are identified - The company's financial statements require estimates and judgments, particularly for stock-based compensation and valuation of tranche rights, which are reviewed with the Audit Committee[240](index=240&type=chunk) [Recently Issued Accounting Standards](index=43&type=section&id=Recently%20Issued%20Accounting%20Standards) Updates on recently adopted and pending accounting standards relevant to Immunic, Inc. are provided - The company adopted ASU No. 2023-09 (Income Taxes) for the annual period starting January 1, 2025, to improve income tax disclosures[241](index=241&type=chunk) - ASU 2024-03 (Expense Disaggregation Disclosures) is effective for fiscal years beginning after December 15, 2026, and the company is evaluating its impact[65](index=65&type=chunk)[66](index=66&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's exposure to market risks, including interest rate sensitivity and foreign currency exchange risk, is discussed [Interest Rate Sensitivity](index=43&type=section&id=Interest%20Rate%20Sensitivity) Immunic, Inc.'s exposure to interest rate fluctuations and their potential financial impact are discussed - The company held **$55.3 million** in cash and cash equivalents as of June 30, 2025, primarily for working capital, and does not believe it has material exposure to changes in fair value from interest rate fluctuations due to the short-term nature of these investments[243](index=243&type=chunk) [Foreign Currency Exchange Risk](index=44&type=section&id=Foreign%20Currency%20Exchange%20Risk) Immunic, Inc.'s exposure to foreign currency exchange rate fluctuations and their potential impact are analyzed - The company is exposed to foreign currency exchange rate fluctuations, primarily between the U.S. dollar, Euro, and Australian dollar, due to R&D operations in Germany and Australia[244](index=244&type=chunk) - A hypothetical **10% adverse change** in foreign currency exchange rates could impact net current liabilities by **$1.4 million** and net loss by **approximately $4.1 million** for the six months ended June 30, 2025[246](index=246&type=chunk) - The company does not currently use foreign currency hedging transactions[244](index=244&type=chunk) [Effects of Inflation and Tariffs](index=44&type=section&id=Effects%20of%20Inflation%20and%20Tariffs) The impact of inflation and tariffs on Immunic, Inc.'s operations and financial results is assessed - The company has experienced a general increase in costs due to global inflation but does not believe it had a material impact on results of operations for the periods presented[247](index=247&type=chunk) - Currently enacted or proposed tariffs are not expected to have a material impact on operations[247](index=247&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) The evaluation of the company's disclosure controls and procedures and changes in internal control over financial reporting are detailed [Evaluation of Disclosure Controls and Procedures](index=44&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management's assessment of the effectiveness of Immunic, Inc.'s disclosure controls and procedures is presented - As of June 30, 2025, management, including the CEO and Principal Financial Officer, concluded that the company's disclosure controls and procedures were effective[248](index=248&type=chunk) [Changes in Internal Control over Financial Reporting](index=44&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) Any material changes in Immunic, Inc.'s internal control over financial reporting are reported - There were no material changes in internal control over financial reporting during the six months ended June 30, 2025[249](index=249&type=chunk) PART II - OTHER INFORMATION This section details legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material litigation but acknowledges inherent industry risks - The company is not currently a party to any litigation that it believes would materially affect its business, operating results, financial condition, or cash flows[250](index=250&type=chunk) - The biotechnology industry is characterized by frequent claims and litigation, including securities litigation, patent and intellectual property rights, and product liability claims[250](index=250&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) Key risks, particularly potential Nasdaq delisting due to non-compliance with the minimum bid price requirement, are highlighted - The company received a Nasdaq non-compliance notice on June 27, 2025, for its common stock trading **below $1.00** for **30 consecutive business days**, with a compliance period until December 24, 2025[252](index=252&type=chunk) - Failure to regain compliance could lead to delisting, negatively impacting stock price, liquidity, ability to raise capital, and potentially deterring investors[254](index=254&type=chunk) - The company is monitoring its stock price and evaluating options to regain compliance, including a potential reverse stock split[252](index=252&type=chunk)[254](index=254&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - There were no unregistered sales of equity securities or use of proceeds to report during the six months ended June 30, 2025[255](index=255&type=chunk) [Item 3. Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there are no defaults upon senior securities to report - This item is not applicable, indicating no defaults upon senior securities[256](index=256&type=chunk) [Item 4. Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - This item is not applicable, indicating no mine safety disclosures[257](index=257&type=chunk) [Item 5. Other Information](index=46&type=section&id=Item%205.%20Other%20Information) This section reports on Rule 10b5-1 trading arrangements by directors or Section 16 officers - No director or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements during the six months ended June 30, 2025[258](index=258&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including underwriting agreements, certificates of incorporation, equity incentive plans, warrants, and employment agreements - Key exhibits include the Underwriting Agreement for the May 2025 Offering, Amended and Restated Certificate of Incorporation, 2019 Omnibus Equity Incentive Plan, various warrant forms (Pre-Funded, Placement Agent, Series A, Series B), and employment agreements[260](index=260&type=chunk)[261](index=261&type=chunk)

Immunic, Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update – Vidofludimus Calcium Substantially Reduced 24-Week Confirmed Disability Worsening in Phase 2 CALLIPER Trial in Overall Progressive Multiple Sclerosis Study Population and Across Subtypes, Reinforcing the Drug's Neuroprotective Potential and Ability to Slow Disease Progression – – Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected by End ...