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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) will announce its financial results for Q2 2022, ending June 30, on August 4, 2022, prior to U.S. market opening. A webcast will follow at 8:00 am ET, with registration available through their website. The company develops selective oral immunology therapies aimed at chronic inflammatory and autoimmune diseases, with products like IMU-838 for multiple sclerosis and IMU-935 for psoriasis and prostate cancer.
Immunic, Inc. (Nasdaq: IMUX) announced the appointment of Maria Törnsén to its Board of Directors, effective July 5, 2022. Törnsén brings 20 years of global commercial experience in the biopharmaceutical sector. She replaces Jan Van den Bossche, who stepped down after six years. Chairman Duane Nash emphasized Törnsén's sales and marketing expertise will enhance the company's strategic focus as it advances its clinical programs, particularly the phase 3 ENSURE program targeting multiple sclerosis with its lead asset, vidofludimus calcium.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in three key industry conferences this July focused on immunology therapies. From July 5-6, members will attend the 3rd FORUM Science & Health: Medicine of the Future in Fürstenfeldbruck, Germany. Notably, Evelyn Peelen, Ph.D., will present findings on IMU-935, an oral IL-17 inhibitor, at the 16th World Immune Regulation Meeting from July 6-9 in Davos, Switzerland. Additionally, Dr. Peelen will discuss IMU-935 at the B & T Cell-Mediated Autoimmune Disease Drug Development Summit from July 26-28 in Boston.
On June 15, 2022, Immunic, Inc. (Nasdaq: IMUX) announced the publication of positive results from its phase 2 EMPhASIS trial of vidofludimus calcium in patients with relapsing-remitting multiple sclerosis (RRMS). The study demonstrated that treatment significantly reduced MRI lesion counts by 62% and 70% for 45 mg and 30 mg doses, respectively, compared to placebo. The drug was found to be safe and well-tolerated, with no significant adverse effects. Following these findings, Immunic is progressing with its phase 2 CALLIPER trial and phase 3 ENSURE program, aiming to explore further potential of vidofludimus.
Immunic, Inc. (Nasdaq: IMUX), a biopharmaceutical company focused on oral immunology therapies for chronic inflammatory and autoimmune diseases, announced its participation in several conferences this June. Highlights include a presentation on IMU-935, a novel oral IL-17 inhibitor, at the 13th International Congress on Autoimmunity from June 10-13 in Athens, Greece. The company will also hold meetings during the BIO International Convention in San Diego from June 12-16 and participate in the JMP Securities Life Sciences Conference on June 15-16 in New York.
Immunic reported results from its phase 2 CALDOSE-1 trial of vidofludimus calcium (IMU-838) for ulcerative colitis, which failed to meet the primary endpoint of clinical remission. Unexpected interference with corticosteroids was noted, where patients on steroids showed lower remission rates. The company will not pursue further UC development independently and will focus on ongoing multiple sclerosis trials instead. As of May 31, 2022, Immunic reported $93.1 million in cash, projected to last until Q4 2023.
Immunic, Inc. (Nasdaq: IMUX) announced its Q1 2022 financial results, reporting a net loss of $20.8 million ($0.74 per share), down from a loss of $34.5 million in Q1 2021. Research and development expenses increased to $17.4 million, while general and administrative expenses rose to $4.0 million. The company expects its cash reserves of $95.7 million will fund operations into Q3 2023. Notable clinical milestones include upcoming top-line data from the Phase 2 CALDOSE-1 trial of vidofludimus calcium in ulcerative colitis, expected next month.
Immunic, Inc. (Nasdaq: IMUX) announced the initiation of Part C in its ongoing phase 1 clinical trial of IMU-856, aimed at treating celiac disease. This milestone marks the inclusion of 42 patients in a double-blind, placebo-controlled study focusing on the safety and tolerability of IMU-856, which is an orally available small molecule modulator. Preclinical data suggest its potential to restore intestinal barrier function. The company anticipates sharing full safety data later this year. Celiac disease affects 1 in 100 individuals globally, highlighting a critical need for effective treatments.
Immunic, Inc. (Nasdaq: IMUX) will announce its financial results for the first quarter ending March 31, 2022, on May 10, 2022, before market opening. A webcast will follow at 8:00 am ET. The company develops selective oral therapies for chronic inflammatory and autoimmune diseases, with ongoing programs targeting diseases such as multiple sclerosis and ulcerative colitis. This release also includes a corporate update and highlights the company’s significant development pipeline. Archived webcast will be available post-event.
Immunic, Inc. (Nasdaq: IMUX), a biopharmaceutical company focused on immunology therapies for chronic diseases, will participate in key investor and industry conferences. Upcoming events include the B. Riley Securities' Neuro & Ophthalmology Conference (April 27-28), where CEO Daniel Vitt will speak, and the Outsourcing in Clinical Trials Europe (May 4-5) in Barcelona. Additionally, the company will present at Bio€quity Europe (May 16-18 and May 23-24) and attend the Digestive Disease Week (May 21-24) in San Diego. Details of the events and presentations can be found on Immunic's website.
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