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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) reported a net loss of approximately $21.2 million for Q3 2022, a loss of $0.69 per share, compared to $19.3 million the previous year. Cash and equivalents totaled $72.8 million as of September 30, 2022, bolstered by a $60 million private placement in October. The interim analysis of the phase 1b trial for IMU-935 in psoriasis showed no significant benefit over placebo. Despite this, Immunic remains optimistic about the drug's potential. They also reported positive results for IMU-856 and are advancing their phase 2 CALLIPER trial for IMU-838 in multiple sclerosis.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company, will announce its financial results for Q3 2022 on November 3, 2022, before U.S. market opening. The announcement will include a corporate update, followed by a webcast at 8:00 am ET. Immunic is focused on developing selective oral immunology therapies targeting chronic inflammatory and autoimmune diseases, with key products in its pipeline, including IMU-838 for multiple sclerosis and IMU-935 targeting psoriasis.
Immunic, Inc. (Nasdaq: IMUX) announced the results of an interim analysis from its Phase 1b clinical trial of IMU-935 for moderate-to-severe psoriasis. The analysis revealed that the treatment arms did not significantly outperform a high placebo response at four weeks. While no new safety signals were identified, the unexpected high placebo rates were disappointing and will require further investigation. Despite this, the company remains optimistic about IMU-935's potential and will continue its development, with cash reserves expected to fund operations into Q4 2024.
Immunic, Inc. (Nasdaq: IMUX) announced a $60 million PIPE financing agreement to issue 8,696,552 shares at $4.35 per share and 5,096,552 Pre-Funded Warrants at $4.34 each. The deal, with participation from notable investors, is set to close on October 12, 2022. Proceeds will fund clinical development for leading candidates IMU-838, IMU-935, and IMU-856, enhancing Immunic's pipeline for chronic inflammatory and autoimmune diseases. The company also anticipates initial clinical activity data for IMU-935 in psoriasis later this month.
Immunic, Inc. (Nasdaq: IMUX), a biopharmaceutical company focusing on oral immunology therapies for chronic inflammatory diseases, will participate in several conferences in October 2022. Key events include the 30th UEG Week in Vienna (Oct 8-11), where its clinical team will attend; the International Celiac Disease Symposium in Italy (Oct 19-22), featuring a presentation on IMU-856; and BIO-Europe 2022 in Leipzig (Oct 24-26). Additionally, data from the phase 2 trial of vidofludimus calcium (IMU-838) will be presented at ECTRIMS in Amsterdam (Oct 26-28). More details can be found on their website.
Immunic, Inc. (Nasdaq: IMUX) announced favorable results from its Phase 1 clinical trial of IMU-856, indicating a positive safety, tolerability, and pharmacokinetic profile. The trial included single ascending doses (SAD) and multiple ascending doses (MAD) in healthy subjects, where no maximum tolerated dose was reached, and no serious adverse events occurred. The trial is ongoing with patients suffering from celiac disease. Results showed stable plasma concentrations and support the potential of IMU-856 as a first-in-class oral therapy for celiac disease and other gastrointestinal conditions.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in several investor conferences throughout September 2022. Key events include the Citi's 17th Annual BioPharma Conference on September 7-8 in Boston, where CEO Daniel Vitt and Head of Investor Relations Jessica Breu will attend. The Wells Fargo 2022 Healthcare Conference will feature Dr. Vitt in a fireside chat on September 9 at 9:45 am EDT, with a live broadcast available on the company's website. Additionally, Breu will present at the 2022 Ladenburg Thalmann Healthcare Conference on September 29 at 1:00 pm EDT in New York.
Immunic, Inc. (NASDAQ: IMUX) announced receipt of a Notice of Allowance from the USPTO for its patent application 16/646130, covering the composition-of-matter of IMU-856. This patent is expected to provide protection until at least 2038. The license for IMU-856 was acquired from Daiichi Sankyo in 2020. The drug targets intestinal barrier function, aiming to treat gastrointestinal diseases. A phase 1 clinical trial for IMU-856 in celiac disease has commenced, with safety data expected in Q3 2022. This milestone enhances Immunic's intellectual property portfolio.
Immunic (Nasdaq: IMUX) announced its financial results for Q2 2022 and provided updates on its clinical programs. The company reported a net loss of $21.9 million for the quarter, with cash reserves of $88.1 million expected to sustain operations through Q4 2023. Key upcoming clinical milestones include initial activity results for IMU-935 in psoriasis expected in Q4 2022 and unblinded safety data for IMU-856 anticipated in Q3 2022. Immunic remains optimistic about the potential of vidofludimus calcium in multiple sclerosis despite previous challenges in ulcerative colitis trials.
Immunic, Inc. (Nasdaq: IMUX), a biopharmaceutical company focused on chronic inflammatory and autoimmune diseases, announced CEO Daniel Vitt will speak at the 2022 Wedbush PacGrow Virtual Healthcare Conference on August 9, 2022, at 8:00 am ET. The conference runs from August 9-10. A live webcast will be accessible on the company's website, with an archived replay available for 90 days. Immunic is advancing therapies targeting conditions like multiple sclerosis and psoriasis.
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