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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) announced the enrollment of the first patient in its phase 3 ENSURE program for vidofludimus calcium (IMU-838) aimed at treating relapsing multiple sclerosis (RMS). This pivotal trial follows a supportive phase 2 trial and involves approximately 1,050 patients across more than 100 sites worldwide. The primary endpoint is the time to first relapse within 72 weeks. The company believes that the positive outcomes from earlier studies, including the phase 2 EMPhASIS trial, support its path toward regulatory approval.
Immunic, Inc. (Nasdaq: IMUX) reported its third-quarter financial results for 2021, revealing a net loss of $19.3 million, or $0.76 per share. The company highlighted major developments in its clinical pipeline, including the completion of patient enrollment in the CALDOSE-1 trial for IMU-838 in ulcerative colitis and the initiation of the CALLIPER trial in progressive multiple sclerosis. Financially, R&D expenses rose to $15.5 million, driven by increased clinical trial costs. The company ended the quarter with $110.4 million in cash, projected to cover operations into 2023.
Immunic, Inc. (Nasdaq: IMUX) will announce its third-quarter financial results for the period ending September 30, 2021, on November 4, 2021, prior to market open, followed by a webcast at 8:00 am ET. The company focuses on developing selective oral immunology therapies for chronic inflammatory and autoimmune diseases, including lead candidate IMU-838 for multiple sclerosis and other conditions. Immunic emphasizes that forward-looking statements involve risks and uncertainties which may affect future performance.
Immunic, Inc. (Nasdaq: IMUX) announced the enrollment of the final patient in its phase 2 CALDOSE-1 trial, assessing IMU-838 for moderate-to-severe ulcerative colitis (UC). This multicenter study has randomized 263 patients across 19 countries, focusing on efficacy and safety. Top-line data is expected in Q2 2022. Previous trials indicated a strong safety profile for IMU-838, making it a potential oral treatment alternative to biologics for UC patients. The trial's primary endpoint includes a composite of patient-reported outcomes and endoscopic assessments.
Immunic, Inc. (Nasdaq: IMUX) has enrolled its first psoriasis patient in Part C of the ongoing Phase 1 clinical trial for IMU-935, a selective RORγt inverse agonist. This double-blind, placebo-controlled trial aims to evaluate the safety and tolerability of IMU-935 in about 52 moderate-to-severe psoriasis patients. The trial will also assess various efficacy markers, including the Psoriasis Area and Severity Index (PASI). With over 10 participating sites in Australia and New Zealand, Immunic aims to offer a convenient oral treatment alternative for psoriasis patients.
Immunic, Inc. (Nasdaq: IMUX) has appointed Patrick Walsh as its new Chief Business Officer, effective immediately. In this role, Walsh will drive business development and strategic partnerships as part of the executive management team. He previously held senior roles at Akebia Therapeutics and AVEO Oncology, bringing substantial experience in building biopharmaceutical companies. Walsh aims to enhance Immunic's clinical programs, which include three candidates in development targeting chronic inflammatory and autoimmune diseases. His expertise is anticipated to strengthen Immunic's strategic position.
Immunic, Inc. (Nasdaq: IMUX) has commenced its phase 2 CALLIPER trial for IMU-838, a selective DHODH inhibitor, in patients with progressive multiple sclerosis (PMS). The multicenter trial aims to enroll approximately 450 patients across over 70 sites globally, with a primary focus on assessing brain volume change over 120 weeks. An interim analysis will evaluate serum neurofilament light chain levels, a potential indicator of neuroprotection. Successful outcomes could position IMU-838 favorably against other oral MS treatments, with phase 3 trials anticipated to start in Q4 2021.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in several significant scientific and investor conferences in October 2021. Key events include the B & T Cell-Mediated Autoimmune Disease Drug Development Summit on October 6-7, where IMU-838 will be presented, and the 37th Congress of ECTRIMS from October 13-15, featuring three accepted abstracts related to IMU-838. Following these, Immunic will join the Jefferies Next Generation IBD Therapeutics Summit on October 19 and the BIO-Europe Digital conference from October 25-28. Further details will be available on their website.
Immunic, Inc. (Nasdaq: IMUX) has signed an in-license agreement with the University Medical Center Goettingen to combine DHODH inhibitors and nucleoside analogues for treating COVID-19 and Influenza. Preclinical studies show Immunic's lead drug, IMU-838, significantly reduces SARS-CoV-2 replication in vitro. IMU-838 demonstrated up to 99.9% reduction in viral RNA, particularly effective against various variants. The company retains plans to pursue strategic options for this program. Upcoming data releases are expected for various ongoing clinical trials in 2021 and 2022.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in key investor and scientific conferences in September 2021. From September 13-15, CEO Daniel Vitt will present at the H.C. Wainwright 23rd Annual Global Investment Conference, with an on-demand presentation available. Following this, Irina Betscheider will showcase IMU-935 at the 50th Annual ESDR Meeting between September 22-25. Lastly, Dr. Vitt will engage in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on September 28. For updates, visit www.imux.com.
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