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Immunic, Inc. (Nasdaq: IMUX) is a leading clinical-stage biopharmaceutical company focused on developing selective oral immunology therapies for chronic inflammatory and autoimmune diseases. With a dedicated pursuit of innovative solutions, Immunic is at the forefront of transforming therapeutic approaches for conditions such as relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis.
The company’s flagship product, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). Currently in phase 2 and 3 clinical trials for various indications, IMU-838 has shown promising results in treating relapsing-remitting and progressive multiple sclerosis as well as moderate-to-severe ulcerative colitis. Additionally, IMU-838's mechanism as a nuclear receptor related 1 (Nurr1) activator underscores its potential neuroprotective effects.
Immunic is also advancing IMU-935, an inverse agonist of RORγt, and IMU-856, which aims to restore intestinal barrier function. IMU-856 is particularly notable for its innovative approach to gastrointestinal diseases, such as celiac disease and irritable bowel syndrome with diarrhea, by focusing on bowel architecture regeneration rather than immunomodulation.
Financially, Immunic has fortified its position with a significant private placement of up to $240 million, ensuring a strong cash runway through key clinical milestones. The company boasts robust partnerships with top-tier investors like BVF Partners and Janus Henderson Investors, reflecting strong market confidence in its clinical programs.
Highlighting its cutting-edge research, Immunic has presented pivotal data at prominent medical conferences, including the ACTRIMS Forum and has its results published in esteemed journals such as Neurology® Neuroimmunology & Neuroinflammation. These milestones not only solidify Immunic's scientific credibility but also mark significant progress in its clinical pipeline.
As of the latest updates, Immunic is gearing up for major clinical readouts, including the top-line data from the phase 2 CALLIPER trial expected in April 2025, and interim analyses from the phase 3 ENSURE trials anticipated in late 2024. The company’s achievements in these trials could potentially position vidofludimus calcium as a groundbreaking treatment option in the MS landscape.
Immunic continues to expand its patent portfolio, securing intellectual property rights that extend protection into the next two decades. This strategic move not only enhances its market exclusivity but also strengthens its competitive edge in the biotech industry.
Overall, Immunic, Inc. is poised for significant impact with its innovative oral therapies, backed by a strong financial foundation, strategic partnerships, and a commitment to addressing unmet medical needs in chronic inflammatory and autoimmune diseases.
Immunic, Inc. (Nasdaq: IMUX), a biotechnology company focused on developing oral therapies for chronic inflammatory and autoimmune diseases, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. CEO Daniel Vitt will lead a fireside chat on December 5, 2024, at 11:30 am ET in New York.
The company's leadership team, including CFO Glenn Whaley and VP of Investor Relations Jessica Breu, will be available for one-on-one investor meetings during the conference, which runs from December 3-5, 2024. A webcast of the event will be accessible on Immunic's website with a 90-day replay availability.
Immunic (NASDAQ: IMUX) announced the publication of its phase 1/1b clinical trial data for IMU-856 in The Lancet Gastroenterology & Hepatology. The trial evaluated IMU-856, an oral SIRT6 modulator, in healthy subjects and celiac disease patients. The study included 71 healthy subjects in Parts A and B, and 43 celiac disease patients in Part C. The trial demonstrated positive effects in four key areas: gut architecture protection, symptom improvement, biomarker response, and nutrient absorption enhancement. Both 80mg and 160mg doses were found to be safe and well-tolerated, with no serious adverse events reported. The treatment shows promise as a potential first-in-class oral therapy for celiac disease, which currently affects 1.4% of the global population.
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.
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