Immunic(IMUX) - 2025 Q2 - Quarterly Results

Company Update and Business Highlights This section provides an overview of Immunic's recent clinical advancements and financial strengthening through successful fundraising efforts Q2 2025 and Subsequent Corporate Highlights 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] - In April 2025, a $5.1 million registered direct offering was completed[5] - 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] - In June 2025, additional data from the Phase 2 CALLIPER trial were announced, further confirming the neuroprotective potential of vidofludimus calcium[8] - 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] - 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] CEO's Commentary on Clinical Progress 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] - 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] - 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] - The company is preparing for further clinical testing of IMU-856 and exploring potential financing, licensing, or partnership opportunities[4] Anticipated Clinical Milestones 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] - Further clinical testing of IMU-856 is in preparation, contingent on financing, licensing, or collaboration[8] Financial Performance Overview 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 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] - 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] General and Administrative (G&A) Expenses 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] - 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] Interest Income 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][10] Other Income (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] - 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][17] Net Loss and EPS 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][17] Cash and Liquidity Position 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][19] - 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] Condensed Consolidated Financial Statements This section presents Immunic's unaudited condensed consolidated financial statements, including statements of operations and balance sheets Condensed Consolidated Statements of Operations 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 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] - As of June 30, 2025, total stockholders' equity increased to $33.91 million from $18.43 million as of December 31, 2024[19] About Immunic, Inc. 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] - 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] - 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] Cautionary Statement Regarding Forward-Looking Statements 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] - 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] - Immunic disclaims any intention or obligation to update these forward-looking statements to reflect events or circumstances occurring after the date of publication[14] Contact Information 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] - US Investor Relations Contact: Rx Communications Group, Paula Schwartz, Contact: +1 917 633 7790, immunic@rxir.com[15] - US Media Contact: KCSA Strategic Communications, Caitlin Kasunich, Contact: +1 212 896 1241, ckasunich@kcsa.com[15]