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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 firm focusing on orally administered therapies for chronic inflammatory diseases, will participate in several investor and scientific conferences in May 2023. Key events include:
- Aegis Virtual Conference: CEO Daniel Vitt will present on May 4 at 11:00 am ET.
- ISIRV-AVG Conference: CSO Hella Kohlhof will discuss preclinical data on DHODH inhibitors on May 3.
- European Congress of Virology: Dr. Alexandra Herrmann will present DHODH inhibitor data on May 5.
- Digestive Disease Week: Dr. Franziska Buriánek will discuss phase 1 data of IMU-856 on May 6.
- Bio€quity Europe: CEO will present on May 15.
- XXII National Congress of Neurology: Dr. Sonya Ivanova will present EMPhASIS trial results on May 21.
For more information, visit Immunic's website.
Immunic, Inc. (NASDAQ: IMUX) announced positive results from the 50-week maintenance phase of its CALDOSE-1 trial for vidofludimus calcium (IMU-838) in patients with moderate-to-severe ulcerative colitis. The 30 mg dose showed a statistically significant clinical remission rate of 61.5% versus 27.8% for the placebo (p=0.0358) and an endoscopic healing rate of 73.1% compared to 35.3% for placebo (p=0.0259). As a result, Immunic will concentrate resources on vidofludimus calcium and the IMU-856 programs while deprioritizing the izumerogant (IMU-935) program. Initial data for IMU-856 is expected this quarter.
On March 2, 2023, Immunic (Nasdaq: IMUX) announced its participation in several key investor and scientific conferences throughout March. Notable events include the BioCapital Europe conference on March 9 in Amsterdam where CEO Daniel Vitt will present at 3:20 PM CET. Additionally, the company will attend the 2023 American Academy of Dermatology Annual Meeting from March 17-21 in New Orleans, and the 32nd Annual Meeting of the Society for Virology from March 28-31 in Germany, featuring multiple poster presentations by its preclinical team.
Immunic, Inc. (NASDAQ: IMUX) reported a net loss of approximately $120.4 million for the year ending December 31, 2022, compared to a loss of $92.9 million in 2021. Their cash position stood at $116.4 million, expected to sustain operations into Q4 2024. Key developments include upcoming interim results from the Phase 2 CALLIPER trial for vidofludimus calcium in progressive MS and results from the ongoing Phase 1 trial of IMU-856 for celiac disease, both anticipated mid-2023. R&D expenses rose to $71.3 million, with significant costs related to ongoing clinical programs. An impairment of goodwill totaling $33 million was also recorded due to a stock price decline following trial announcements.
Immunic, Inc. (Nasdaq: IMUX) announced promising results from the open-label extension of its phase 2 EMPhASIS trial for vidofludimus calcium in relapsing-remitting multiple sclerosis (RRMS). Key findings show a low rate of confirmed disability worsening (CDW): only 1.6% in treatment arms versus 3.7% in placebo. After 48 weeks, 97.2% of patients were free from 12-week CDW. The data will be presented at ACTRIMS Forum 2023 in San Diego, highlighting vidofludimus calcium's potential against historical MS treatments. CEO Daniel Vitt expressed optimism about the ongoing phase 3 ENSURE program and phase 2 CALLIPER trial, set for data updates later this year.
Immunic, Inc. (Nasdaq: IMUX) has scheduled a release of its financial results for the fourth quarter and year ended December 31, 2022, on February 23, 2023, before U.S. market opening. A webcast will follow at 8:00 am ET, providing corporate updates. The company is advancing its pipeline of selective oral immunology therapies aimed at chronic inflammatory and autoimmune diseases. Key products include vidofludimus calcium (IMU-838) for multiple sclerosis, IMU-935 for psoriasis and prostate cancer, and IMU-856 focusing on bowel barrier restoration. For more details, visit Immunic's official website.
Immunic, Inc. (NASDAQ: IMUX) has announced a virtual Celiac Disease R&D Day set for February 9, 2023, from 11:00 am to 1:00 pm ET. During this webcast, management, including CEO Daniel Vitt, will discuss the complexities of celiac disease and its treatment, emphasizing the unmet medical needs of patients. Key opinion leaders Joseph A. Murray and Michael Schumann will present their insights on the immune response and intestinal barrier function in celiac disease. The event highlights Immunic's commitment to developing therapeutic options beyond the current gluten-free diet. Archived footage will be available after the event.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company, announced its participation in several key scientific and investor conferences throughout February 2023. On February 2, Darius-Jean Namdjou will join a panel on EU and UK pharmacovigilance regulations in London. A webcast on celiac disease research featuring experts will be held on February 9. CEO Daniel Vitt will present a company overview at the SVB Securities Global Biopharma Conference on February 16. Additionally, Robert J. Fox will present data on the phase 2 EMPhASIS trial at the ACTRIMS Forum in San Diego from February 23-25. More details and registration links are available on Immunic's website.
Immunic, Inc. (Nasdaq: IMUX) announced promising results from its phase 2 EMPhASIS trial of vidofludimus calcium (IMU-838) for treating relapsing-remitting multiple sclerosis (RRMS). The drug demonstrated a low rate of confirmed disability worsening (1.6%) compared to 3.7% in the placebo group over a 24-week period. Long-term treatment showed 97.6% of patients free from disability worsening after 48 weeks. The company anticipates further data from its phase 3 ENSURE program and phase 2 CALLIPER trial in 2023, highlighting the drug's potential through its neuroprotective and anti-inflammatory effects.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company, will participate in several investor and scientific conferences during November and December 2022. Key events include:
- November 17: A webcast discussing multiple sclerosis research and vidofludimus calcium development at 11:00 am ET.
- December 1: Fireside chat at the Piper Sandler Healthcare Conference at 12:30 pm ET.
- November 29 - December 2: Presentations at various conferences, including a poster on IMU-856 in Perth, Australia.
For more details, visit www.imux.com.
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