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)

[Company Update and Business Highlights](index=1&type=section&id=Company%20Update%20and%20Business%20Highlights) This section provides an overview of Immunic's recent clinical advancements and financial strengthening through successful fundraising efforts [Q2 2025 and Subsequent Corporate Highlights](index=1&type=section&id=Q2%202025%20and%20Subsequent%20Corporate%20Highlights) Immunic achieved significant clinical progress in Q2 2025 and beyond, including positive data for vidofludimus calcium in MS trials and strengthened its balance sheet through two financings - In April 2025, positive data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) patients were announced, showing a reduced relative risk of 24-week confirmed disability worsening (24wCDW) events compared to placebo, with no new safety signals identified[5](index=5&type=chunk) - In April 2025, a **$5.1 million** registered direct offering was completed[5](index=5&type=chunk) - In May 2025, an oversubscribed **$65 million** underwritten public offering was completed, with the potential for the company to receive up to an additional **$130 million** if all Series A and Series B warrants are exercised for cash[5](index=5&type=chunk) - In June 2025, additional data from the Phase 2 CALLIPER trial were announced, further confirming the neuroprotective potential of vidofludimus calcium[8](index=8&type=chunk) - In June 2025, patient enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) patients was completed on schedule, with ENSURE-1 enrolling **1,121 patients** and ENSURE-2 enrolling **1,100 patients**[8](index=8&type=chunk) - In June 2025, long-term open-label extension (OLE) data from the Phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) patients were reported, showing that at Week 144, **92.3%** of patients had no 12-week confirmed disability worsening and **92.7%** had no 24-week confirmed disability worsening, demonstrating good long-term safety and tolerability[8](index=8&type=chunk) [CEO's Commentary on Clinical Progress](index=1&type=section&id=CEO's%20Commentary%20on%20Clinical%20Progress) CEO Dr. Daniel Vitt highlighted significant clinical progress for vidofludimus calcium (IMU-838) in MS treatment, including Phase 3 ENSURE trial enrollment and neuroprotective effects in Phase 2 CALLIPER, also noting IMU-856's potential in GI diseases and weight management - Vidofludimus calcium (IMU-838), an oral Nurr1 activator, is progressing in Phase 3 ENSURE trials for relapsing multiple sclerosis (RMS), with topline data expected by the end of **2026**[2](index=2&type=chunk) - The Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) showed a **23.8%** reduction in time to 24-week confirmed disability worsening (24wCDW) compared to placebo, with a **31.3%** reduction in the primary progressive multiple sclerosis (PPMS) subgroup and a **19.2%** reduction in the non-active secondary progressive multiple sclerosis (naSPMS) subgroup[2](index=2&type=chunk) - IMU-856, an oral SIRT6 modulator, shows potential in gastrointestinal diseases and weight management, with late-stage analysis of Phase 1b clinical trials indicating up to a **250%** increase in GLP-1 levels in fasting celiac disease patients compared to placebo[4](index=4&type=chunk) - The company is preparing for further clinical testing of IMU-856 and exploring potential financing, licensing, or partnership opportunities[4](index=4&type=chunk) [Anticipated Clinical Milestones](index=3&type=section&id=Anticipated%20Clinical%20Milestones) Immunic anticipates topline data for vidofludimus calcium in RMS Phase 3 ENSURE trials by late 2026 and plans further IMU-856 clinical testing pending financing, licensing, or collaboration - Topline data for vidofludimus calcium in the Phase 3 ENSURE-1 and ENSURE-2 twin trials for multiple sclerosis (MS) are expected by the end of **2026**[8](index=8&type=chunk) - Further clinical testing of IMU-856 is in preparation, contingent on financing, licensing, or collaboration[8](index=8&type=chunk) [Financial Performance Overview](index=3&type=section&id=Financial%20Performance%20Overview) This section provides a summary of Immunic's financial results for Q2 and H1 2025, detailing changes in expenses, income, net loss, and liquidity [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D expenses increased in Q2 and H1 2025 compared to the prior year, primarily due to higher external development costs for vidofludimus calcium, partially offset by reduced IMU-856 project costs Research and Development Expenses (in thousands of USD) | Period | 2025 | 2024 | Change | | :------------------- | :----- | :----- | :----- | | Three Months Ended June 30 | $21,369 | $18,323 | +$3,046 | | Six Months Ended June 30 | $42,902 | $37,059 | +$5,843 | - The increase for the three-month period primarily reflects a **$2.6 million** increase in external development costs related to the vidofludimus calcium program and a **$0.6 million** increase in personnel expenses[6](index=6&type=chunk) - The increase for the six-month period primarily reflects a **$7.3 million** increase in external development costs related to the vidofludimus calcium program, partially offset by a **$1.5 million** decrease in external development costs related to the IMU-856 program[7](index=7&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) G&A expenses rose in Q2 and H1 2025 compared to the prior year, mainly due to increased personnel, legal, and consulting fees General and Administrative Expenses (in thousands of USD) | Period | 2025 | 2024 | Change | | :------------------- | :----- | :----- | :----- | | Three Months Ended June 30 | $5,714 | $4,491 | +$1,223 | | Six Months Ended June 30 | $11,006 | $9,636 | +$1,370 | - The increase for the three-month period was due to an **$0.8 million** increase in personnel expenses and a **$0.4 million** increase in legal and consulting fees[9](index=9&type=chunk) - The increase for the six-month period was due to a **$0.7 million** increase in personnel expenses, a **$0.5 million** increase in legal and consulting fees, and a **$0.2 million** increase in other cost categories[9](index=9&type=chunk) [Interest Income](index=3&type=section&id=Interest%20Income) Interest income significantly decreased in Q2 and H1 2025 compared to the prior year, primarily due to lower average cash balances Interest Income (in thousands of USD) | Period | 2025 | 2024 | Change | | :------------------- | :----- | :----- | :----- | | Three Months Ended June 30 | $241 | $998 | -$757 | | Six Months Ended June 30 | $424 | $2,185 | -$1,761 | - The decrease in interest income was due to lower average cash balances[9](index=9&type=chunk)[10](index=10&type=chunk) [Other Income (Expense)](index=4&type=section&id=Other%20Income%20(Expense)) Other income (expense) significantly increased in H1 2025, driven by a government grant and the absence of prior-year tranche right-related expenses, while Q2 saw a decrease Other Income (Expense) (in thousands of USD) | Period | 2025 | 2024 | Change | | :------------------- | :----- | :----- | :----- | | Three Months Ended June 30 | $22 | $436 | -$414 | | Six Months Ended June 30 | $1,191 | $(1,658) | +$2,849 | - The **$2.8 million** increase for the six-month period was primarily attributable to a **$1.0 million** grant income from the German Federal Ministry of Finance recognized in Q1 2025, and the absence of **$1.7 million** in transaction costs related to tranche rights from a January 2024 financing[11](index=11&type=chunk) - The change in fair value of tranche rights was **$0** for H1 2025, compared to a negative **$4.8 million** for H1 2024, as these tranche rights were reclassified to equity on March 4, 2024[13](index=13&type=chunk)[17](index=17&type=chunk) [Net Loss and EPS](index=4&type=section&id=Net%20Loss%20and%20EPS) Immunic reported increased net losses for Q2 and H1 2025 year-over-year, but basic and diluted net loss per share decreased due to a higher weighted-average number of common shares outstanding Net Loss and EPS (in thousands of USD, except per share amounts) | Period | Net Loss 2025 | Net Loss 2024 | Change | EPS 2025 | EPS 2024 | | :------------------- | :------------ | :------------ | :----- | :------- | :------- | | Three Months Ended June 30 | $(26,820) | $(21,380) | $(5,440) | $(0.20) | $(0.21) | | Six Months Ended June 30 | $(52,293) | $(50,964) | $(1,329) | $(0.45) | $(0.51) | - The weighted-average number of common shares outstanding significantly increased: **132,175,202 shares** for Q2 2025 compared to **101,272,580 shares** for the same period in 2024; and **116,844,985 shares** for H1 2025 compared to **99,607,158 shares** for the same period in 2024[11](index=11&type=chunk)[17](index=17&type=chunk) [Cash and Liquidity Position](index=4&type=section&id=Cash%20and%20Liquidity%20Position) As of June 30, 2025, Immunic held $55.3 million in cash and cash equivalents but stated existing liquidity is insufficient to fund operations for at least twelve months without additional capital - As of June 30, 2025, cash and cash equivalents totaled **$55.3 million**[11](index=11&type=chunk)[19](index=19&type=chunk) - The company does not have sufficient liquidity to fund its operations for at least twelve months beyond June 30, 2025, without raising additional capital[11](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents Immunic's unaudited condensed consolidated financial statements, including statements of operations and balance sheets [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section provides unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024, detailing operating expenses, other income (expense), and net loss Condensed Consolidated Statements of Operations (in thousands of USD, except per share amounts) | | 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) | | Interest income | $241 | $998 | $424 | $2,185 | | Change in fair value of the tranche rights | $0 | $0 | $0 | $(4,796) | | Other income (expense), net | $22 | $436 | $1,191 | $(1,658) | | Total other income (expense) | $263 | $1,434 | $1,615 | $(4,269) | | 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) | | Weighted-average common shares outstanding | 132,175,202 | 101,272,580 | 116,844,985 | 99,607,158 | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides unaudited condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands of USD) | | June 30, 2025 (Unaudited) | December 31, 2024 | | :---------------------------------- | :-------------------------- | :------------------ | | **Assets** | | | | Cash and cash equivalents | $55,310 | $35,668 | | Total current assets | $59,842 | $39,332 | | Total assets | $61,429 | $40,868 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $27,313 | $22,175 | | Total liabilities | $27,518 | $22,439 | | Total stockholders' equity | $33,911 | $18,429 | | Total liabilities and stockholders' equity | $61,429 | $40,868 | - As of June 30, 2025, cash and cash equivalents increased to **$55.31 million** from **$35.67 million** as of December 31, 2024[19](index=19&type=chunk) - As of June 30, 2025, total stockholders' equity increased to **$33.91 million** from **$18.43 million** as of December 31, 2024[19](index=19&type=chunk) [About Immunic, Inc.](index=4&type=section&id=About%20Immunic%2C%20Inc.) Immunic, Inc. is a biotechnology company focused on developing oral small molecule therapies for chronic inflammatory and autoimmune diseases, with lead program vidofludimus calcium (IMU-838) in Phase 3 for RMS and other pipeline candidates like IMU-856 and IMU-381 - Immunic, Inc. is dedicated to developing oral small molecule therapies for chronic inflammatory and autoimmune diseases[12](index=12&type=chunk) - The lead development program, vidofludimus calcium (IMU-838), a Nurr1 activator and DHODH inhibitor, is currently in Phase 3 clinical trials for relapsing multiple sclerosis and has shown therapeutic activity in Phase 2 trials for relapsing-remitting multiple sclerosis and progressive multiple sclerosis[12](index=12&type=chunk) - Other pipeline programs include IMU-856 (SIRT6 modulator), designed to restore gut barrier function and regenerate intestinal epithelium, potentially applicable to various gastrointestinal diseases and weight management; and IMU-381, a next-generation molecule in preclinical testing specifically targeting gastrointestinal disease needs[12](index=12&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=5&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) This press release contains forward-looking statements subject to significant risks and uncertainties, where actual results may differ materially from expectations due to factors like inflation, geopolitical conflicts, financing, clinical trial outcomes, and regulatory approvals. Immunic disclaims any obligation to update these statements - This press release contains "forward-looking statements" subject to significant risks and uncertainties[14](index=14&type=chunk) - Actual results and performance may differ materially from those projected in forward-looking statements due to various factors, including inflation, geopolitical conflicts, cash use and reserves, financing capabilities, unpredictability of clinical trial results, changes in target market size, intellectual property protection, drug development and regulatory approval processes, and competitive product and technology changes[14](index=14&type=chunk) - Immunic disclaims any intention or obligation to update these forward-looking statements to reflect events or circumstances occurring after the date of publication[14](index=14&type=chunk) [Contact Information](index=6&type=section&id=Contact%20Information) This section provides contact details for Immunic, Inc.'s investor relations and media inquiries, including internal contacts and US-based representatives - Immunic, Inc. Vice President Investor Relations and Communications: Jessica Breu, Contact: **+49 89 2080 477 09**, jessica.breu@imux.com[15](index=15&type=chunk) - US Investor Relations Contact: Rx Communications Group, Paula Schwartz, Contact: **+1 917 633 7790**, immunic@rxir.com[15](index=15&type=chunk) - US Media Contact: KCSA Strategic Communications, Caitlin Kasunich, Contact: **+1 212 896 1241**, ckasunich@kcsa.com[15](index=15&type=chunk)

Core Insights - Immunic, Inc. has made significant clinical advancements with its lead asset, vidofludimus calcium, particularly in multiple sclerosis treatment, showing promising results in various trials [2][11] - The company has completed enrollment for its phase 3 ENSURE trials, with top-line data expected by the end of 2026, indicating progress towards a potential new treatment option for relapsing multiple sclerosis [2][11] - Financially, Immunic has strengthened its balance sheet with two financings totaling $70.1 million in gross proceeds, although it reported a net loss of approximately $27 million for the second quarter of 2025 [6][9] Clinical Developments - The phase 2 CALLIPER trial demonstrated a 23.8% reduction in time to 24-week confirmed disability worsening in the overall progressive multiple sclerosis population compared to placebo, with even higher reductions in specific subgroups [2][7] - Long-term open-label extension data from the phase 2 EMPhASIS trial showed that 92.3% of patients remained free of 12-week confirmed disability worsening at week 144, reinforcing the drug's efficacy [2][6] - Vidofludimus calcium's neuroprotective effects are believed to be mediated through activation of the Nurr1 target, which may address the complex pathophysiology of multiple sclerosis [2][11] Financial Performance - Research and Development (R&D) expenses for the second quarter of 2025 were $21.4 million, an increase from $18.3 million in the same period of 2024, primarily due to higher external development costs related to vidofludimus calcium [6][8] - General and Administrative (G&A) expenses also increased to $5.7 million for the second quarter of 2025, compared to $4.5 million in the prior year [8] - The company reported a net loss of approximately $27 million for the second quarter of 2025, with a net loss per share of $0.20, reflecting a slight improvement from a net loss of $21.4 million in the same quarter of 2024 [9][14] Market Potential - The market for primary progressive multiple sclerosis is estimated to exceed $6 billion, with vidofludimus calcium positioned as a promising treatment option in this underserved area [2][11] - The company is also preparing for further clinical testing of IMU-856, which targets gastrointestinal disorders and may offer a novel therapeutic approach [3][4]

Core Viewpoint - Immunic Inc reported positive data from the phase 2 EMPhASIS trial of vidofludimus calcium for relapsing-remitting multiple sclerosis (RRMS), indicating a low rate of confirmed disability worsening in treated patients, which supports the drug's potential neuroprotective effects [2][4]. Group 1: Trial Results - The EMPhASIS trial demonstrated a significant reduction in inflammatory lesions on MRI, with 30 mg and 45 mg doses showing reductions of 76% and 78% respectively [4]. - The trial also indicated initial signs of neuroprotection, with a reduction in disability progression by more than 50% [4][5]. - A total of 268 patients were randomized, with 254 entering the open-label extension phase, and 182 remaining on active treatment as of January, highlighting the drug's safety and tolerability [3]. Group 2: Importance of Disability Worsening - Confirmed disability worsening (CDW) is a critical concern for MS patients, as it relates to their independence over time, measured by the EDSS disability score [6]. - The data from the EMPhASIS trial suggests that vidofludimus calcium may address the unmet need to slow down disability progression independent of relapse activity [6]. Group 3: Future Development Plans - Based on the EMPhASIS data, Immunic plans to conduct two phase 3 studies (ENSURE studies) in relapsing MS, with 1,122 patients enrolled, expected to read out by the end of next year [7]. - The studies will also assess the long-term neuroprotective effects as a secondary endpoint, which is crucial for the drug's positioning [8]. - The CALLIPER phase 2 study confirmed a 24% reduction in overall CDW and a 32% reduction in the primary progressive MS subgroup for patients treated with 45 mg, reinforcing the drug's potential efficacy [10].

Core Insights - Immunic, Inc. reported long-term data from the phase 2 EMPhASIS trial of vidofludimus calcium, showing 92.3% of patients remained free of 12-week confirmed disability worsening (CDW) and 92.7% free of 24-week CDW at week 144 [1][3] - The drug demonstrated a favorable safety and tolerability profile, with no new safety signals emerging during treatment durations of up to 5.5 years [1][3] Group 1: Clinical Trial Data - The phase 2 EMPhASIS trial included 268 patients with relapsing-remitting multiple sclerosis (RRMS), achieving both primary and key secondary endpoints with high statistical significance [4] - A total of 29 CDW events were confirmed at 12 weeks, with 44.8% associated with relapse-associated worsening (RAW) and 13.8% with progression independent of relapse activity (PIRA) [3] - The open-label extension (OLE) period provided approximately 952 treatment years of data, reinforcing the drug's safety and tolerability [2][3] Group 2: Drug Mechanism and Potential - Vidofludimus calcium is a first-in-class nuclear receptor-related 1 (Nurr1) activator, combining neuroprotective, anti-inflammatory, and anti-viral effects [6][7] - The drug has shown therapeutic activity in both relapsing-remitting and progressive multiple sclerosis patients, significantly reducing brain lesions and confirmed disability worsening [6][7] - The ongoing phase 3 clinical trials aim to further evaluate the drug's efficacy and safety, with top-line data expected by the end of 2026 [7]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]