UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-------------------------------------------------------------------------------------------------------|-------------------------------------------| | For the transition pe ...

Immunic, Inc. Reports Third Quarter 2024 Financial Results and Provides Corporate Update – Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility Criteria Have Not Been Met and Recommended Trials Should Continue as Planned – – Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track – – Top-Line Data from Phase 2 CALLIPER Trial Expected i ...

Clinical Trials and Pipeline Updates - The phase 3 ENSURE program for vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS) received a positive interim futility analysis, confirming the trials are not futile and should continue as planned without sample size adjustments [1][2] - Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) is expected in April 2025 [2][4] - The company is preparing for phase 2 clinical testing of IMU-856 in celiac disease, contingent on financing, licensing, or partnering [4] - Vidofludimus calcium demonstrated potential neuroprotective effects in PMS through Nurr1 activation, supported by interim data from the CALLIPER trial [2] - IMU-856 showed positive effects in phase 1b trials for celiac disease, including gut architecture protection, symptom improvement, biomarker response, and nutrient absorption enhancement [2] Financial Performance - Research and Development (R&D) expenses for Q3 2024 were $21.4 million, a $1.6 million increase from Q3 2023, driven by higher external development costs for vidofludimus calcium and IMU-856 [5] - For the nine months ended September 30, 2024, R&D expenses decreased by $5.5 million to $58.4 million, primarily due to deprioritizing the izumerogant program [6] - General and Administrative (G&A) expenses increased to $4.4 million in Q3 2024, up $0.6 million from Q3 2023, mainly due to higher personnel costs [7] - Net loss for Q3 2024 was $24.4 million, or $0.24 per share, compared to a net loss of $22.8 million, or $0.51 per share, in Q3 2023 [13] - Cash and cash equivalents as of September 30, 2024, were $59.1 million, expected to fund operations into Q3 2025 [15] Corporate and Strategic Developments - The company presented key data on vidofludimus calcium at the 40th Congress of ECTRIMS, highlighting its therapeutic potential in MS [3] - Immunic hosted an MS R&D Day in New York, featuring discussions on vidofludimus calcium's potential to become a leading treatment for relapsing and progressive MS [3] - The company appointed Simona Skerjanec to the Board of Directors and Jason Tardio as Chief Operating Officer and President to support the potential launch of vidofludimus calcium [3] - Immunic is exploring financing, licensing, or partnering opportunities to fund the IMU-856 clinical program [2] Market and Industry Context - Vidofludimus calcium combines neuroprotective, anti-inflammatory, and antiviral effects, positioning it as a unique treatment option for MS [2][17] - IMU-856 targets SIRT6, aiming to restore intestinal barrier function and regenerate bowel epithelium, with potential applications in various gastrointestinal disorders [17] - The company's pipeline focuses on orally administered small molecule therapies for chronic inflammatory and autoimmune diseases, addressing significant unmet medical needs [17]

– Webcast to be Held at 8:00 am ET on November 7, 2024 – NEW YORK, Oct. 31, 2024 /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 the company will release its financial results for the third quarter ended September 30, 2024, including a corporate update, on Thursday, November 7, 2024, before the opening of the U.S. financial markets. A we ...

NEW YORK, Oct. 29, 2024 /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 participation in the following industry, scientific and investor conferences in November: November 4-6: BIO-Europe. Members of Immunic's management, business development and investor relations teams will participate in partnering activities at this conference in Stockholm ...

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, ...

– Based on a Review of Unblinded Data, an Independent Data Monitoring Committee (IDMC) Confirmed that Predetermined Futility Criteria Have Not Been Met –– IDMC Also Recommended Continuing Trial without Changes, Including no Need for a Potential Upsizing –– ENSURE Program Remains on Track to be Completed in 2026 –– Webcast to be Held Today, October 22, at 8:00 am ET –NEW YORK, Oct. 22, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administ ...

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, The ...

– Vidofludimus Calcium Consistently Reduced Neurofilament Light Chain Levels, Compared to Placebo, in the Interim Analysis of the Phase 2 CALLIPER Trial, Across Age and Disability Levels at Baseline For All Progressive Multiple Sclerosis Subtypes – – Clinical Signal Shown for Vidofludimus Calcium on Post COVID Fatigue May Be Related to Epstein-Barr Virus Reactivation; Preventing This Reactivation May Contribute to Fatigue Reduction in Multiple Sclerosis Patients – – Preclinical Data Showed Improved Neuronal ...

Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler joined Proactive to discuss a research update for the company's lead compound vidofludimus calcium. Vidofludimus calcium is being supplied for an investigator-sponsored Phase 2 clinical trial focused on treating post-COVID syndrome (PCCS). The drug is also currently in Phase 3 trial for Multiple Sclerosis (MS). Proactive: You have announced the start of an investigator-sponsored Phase 2 clinical trial for vidofludimus calcium. Can you tell u ...