Immunic, Inc. develops novel oral therapies for neurologic diseases, with a lead program, vidofludimus calcium (IMU-838), focused on multiple sclerosis. Company news commonly covers clinical and scientific presentations, patent protection for vidofludimus calcium, pipeline updates, and corporate communications tied to its late-stage development strategy.
Updates also include governance changes, board and executive appointments, Nasdaq listing compliance, capital actions such as its reverse stock split, and investor conference participation. Immunic's pipeline references additional earlier-stage programs, including IMU-856 and IMU-381, tied to neurodegenerative, chronic inflammatory, and autoimmune-related disease areas.
Immunic (NASDAQ: IMUX) reported Q3 2024 financial results and corporate updates. The company announced positive interim analysis of its Phase 3 ENSURE program for multiple sclerosis, with the Independent Data Monitoring Committee confirming trials should continue as planned. R&D expenses were $21.4M for Q3 2024, up from $19.8M in Q3 2023. Net loss was $24.4M ($0.24 per share) compared to $22.8M ($0.51 per share) in Q3 2023. Cash position of $59.1M is expected to fund operations into Q3 2025. The company expects top-line data from Phase 2 CALLIPER trial in April 2025, with ENSURE-1 completion anticipated in Q2 2026 and ENSURE-2 in H2 2026.
Immunic (Nasdaq: IMUX), a biotechnology company focused on developing oral therapies for chronic inflammatory and autoimmune diseases, has scheduled its Q3 2024 financial results announcement and corporate update for November 7, 2024, before U.S. markets open. The company will host a webcast at 8:00 am ET on the same day. Participants can register through the company's website or via the provided Zoom link, and a replay will be available approximately one hour after the event.
Immunic Inc (Nasdaq: IMUX) has announced its participation in several key conferences during November 2024. The company will attend BIO-Europe in Stockholm (Nov 4-6) for partnering activities. At the Immuno-Mediated Diseases of the GI Tract Symposium in Florence (Nov 8-9), Dr. Sara Elhag will present data from their phase 1b trial of IMU-856, targeting SIRT6 in celiac disease patients. The company will also participate in the Jefferies London Healthcare Conference (Nov 19-21) and the Virtual Investor Summit (Nov 21), where CEO Daniel Vitt will present a company overview and conduct one-on-one meetings.
Immunic, Inc. (Nasdaq: IMUX) announced a positive outcome from the interim futility analysis of its phase 3 ENSURE program, testing vidofludimus calcium for relapsing multiple sclerosis (RMS). An Independent Data Monitoring Committee (IDMC) recommended continuing the trials without changes, confirming that predetermined futility criteria were not met.
Key points:
- The ENSURE program remains on track for completion in 2026
- The IDMC's recommendations suggest the trial design and assumptions are in line with observed data
- Immunic remains blinded to all data
- The ENSURE program consists of two identical phase 3 trials, each enrolling about 1,050 adult RMS patients
- The primary endpoint is time to first relapse up to 72 weeks
- Completion of ENSURE-1 is expected in Q2 2026, and ENSURE-2 in H2 2026
Immunic, Inc. (Nasdaq: IMUX) presented key data on vidofludimus calcium (IMU-838) at the 40th Congress of ECTRIMS, highlighting its potential in multiple sclerosis (MS) treatment. The data included:
1. Neurofilament light chain (NfL) reduction: In the CALLIPER trial interim analysis, vidofludimus calcium reduced serum NfL levels by 22.4% compared to placebo after 24 weeks, consistent across progressive MS subtypes.
2. Potential fatigue reduction: Clinical signals suggest vidofludimus calcium may reduce fatigue in MS patients by preventing Epstein-Barr virus reactivation.
3. Neuroprotective effects: Preclinical data showed improved neuronal survival, likely driven by Nurr1 activation.
4. T cell modulation: Vidofludimus calcium reduced or prevented development of pathogenic peripheral T helper cells in preclinical experiments.
The company expects to release CALLIPER top-line data in April 2025.
Immunic, Inc. (Nasdaq: IMUX) announced the enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of vidofludimus calcium (IMU-838) for Post COVID Syndrome (PCS). The trial, named RAPID_REVIVE, is sponsored by Goethe University Frankfurt and funded by a German government grant. The study aims to assess vidofludimus calcium's effectiveness in treating PCS symptoms, particularly fatigue, and its ability to suppress Epstein-Barr virus (EBV) reactivation.
The trial will enroll 376 patients across 11 German sites, with a primary endpoint of change in physical function measured by SF-36-PF. Vidofludimus calcium has shown promise in preclinical and clinical studies for its antiviral and anti-inflammatory effects, as well as potential to reduce fatigue in PCS and multiple sclerosis (MS) patients.
Immunic, Inc. (Nasdaq: IMUX) announces its participation in multiple scientific and investor conferences in September 2024. Key events include:
1. MS R&D Day on September 10, featuring discussions on vidofludimus calcium (IMU-838) for MS treatment.
2. 40th ECTRIMS Congress (Sept 18-20) with presentations on vidofludimus calcium's impact on MS.
3. DMDG 50th Open Meeting (Sept 2-4) showcasing pharmacokinetics study results of vidofludimus calcium.
4. 20th International Celiac Disease Symposium (Sept 5-7) presenting data on IMU-856 for celiac disease treatment.
5. 2024 Cantor Fitzgerald Global Healthcare Conference (Sept 17-19) featuring a fireside chat with CEO Daniel Vitt.
These events highlight Immunic's progress in developing treatments for chronic inflammatory and autoimmune diseases.
Immunic, Inc. (IMUX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Appointment of Jason Tardio as Chief Operating Officer and President, bringing MS drug commercialization experience.
2. Strengthened Board of Directors with Simona Skerjanec, a senior pharmaceutical executive.
3. Phase 3 ENSURE trials in Relapsing MS and Phase 2 CALLIPER trial in Progressive MS remain on track.
4. Q2 2024 R&D expenses decreased to $18.3 million from $21.2 million in Q2 2023.
5. Net loss for Q2 2024 was $21.4 million, or $0.21 per share.
6. Cash and cash equivalents of $79.7 million as of June 30, 2024, expected to fund operations into Q3 2025.
7. Top-line data from Phase 2 CALLIPER trial expected in April 2025.
Immunic, Inc. (Nasdaq: IMUX), a biotechnology company focused on developing oral therapies for chronic inflammatory and autoimmune diseases, has announced that it will release its financial results for the second quarter ended June 30, 2024, along with a corporate update, on Thursday, August 8, 2024, before the U.S. financial markets open. The company will host a webcast at 8:00 am ET on the same day to discuss the results.
Interested parties can register for the webcast in advance through the provided link or on Immunic's website. An archived replay of the webcast will be available approximately one hour after its completion on the company's website.
Immunic, Inc. (Nasdaq: IMUX) has appointed Simona Skerjanec, M.Pharm, MBA, to its board of directors, effective July 22, 2024. Skerjanec brings nearly three decades of global pharmaceutical experience, particularly in brain health and drug development. She previously served as Senior Vice President, Global Head Neuroscience and Rare Diseases at Roche, where she led the successful commercial launch of Ocrevus®, a blockbuster multiple sclerosis (MS) therapy.
This appointment follows the recent hiring of Jason Tardio as Immunic's new Chief Operating Officer and President. The company is strengthening its leadership as it approaches multiple late-stage readouts for vidofludimus calcium in MS over the next two years. Skerjanec's expertise is expected to be valuable in potentially bringing this oral drug candidate to market and achieving commercial success.