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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 Q1 2021 financial results with a net loss of approximately $34.5 million, or $1.63 per share. R&D expenses rose to $11.5 million, driven by costs for ongoing clinical trials, while G&A expenses increased to $20.9 million, primarily due to a royalty settlement. Key developments included positive interim data from the phase 2 EMPhASIS study of IMU-838 for RRMS, confirming a 30 mg dose for future phase 3 trials. The company plans to initiate additional trials for IMU-838 in PSC and UC, with expectations to file an IND application in the U.S. soon.
Immunic, Inc. (Nasdaq: IMUX) reported interim data from its phase 2 EMPhASIS trial of IMU-838 for relapsing-remitting multiple sclerosis (RRMS). The data indicate that 30 mg once daily is the most suitable dosage for future trials. Highlights include a dose-response pattern and comparable efficacy between 30 mg and 45 mg previously studied doses. The company plans to submit an Investigational New Drug application directly to the FDA, with phase 3 initiation expected in H2 2021. Current results support the viability of IMU-838 as a promising oral therapy for RRMS.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in key scientific and investor conferences in April 2021. Notably, at the 2021 Virtual AAN Annual Meeting, Robert J. Fox, M.D., will present data from the phase 2 EMPhASIS trial of IMU-838 for relapsing-remitting multiple sclerosis. The B. Riley Neuroscience Conference will also feature Dr. Daniel Vitt discussing Immunic's developments. Furthermore, Dr. Vitt will present on IMU-838's application in COVID-19 at the German Corona Showcase 2021. Access to presentation materials will be available on Immunic's website.
On March 31, 2021, Immunic (Nasdaq: IMUX) announced an agreement with 4SC AG to settle a 4.4% royalty on net sales of their lead program, IMU-838, for $17.25 million. Payment will be made 50% in cash and 50% in stock. This acquisition eliminates remaining payment obligations and allows Immunic to capture 100% of future sales from IMU-838, which targets conditions like multiple sclerosis and ulcerative colitis. The company plans to initiate a phase 3 trial later in 2021, furthering its potential market growth.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on immunology therapies, announced its participation in several industry and investor conferences in March 2021. Key events include the 2nd Annual European HealthTech CEO Forum on March 8-9, where CEO Daniel Vitt will discuss IMU-838's potential for COVID-19. Other conferences include the H.C. Wainwright Global Life Sciences Conference, BioCapital Europe 2021, and the 33rd Annual Roth Conference. Participants can view presentations on Immunic's website.
Immunic, Inc. (Nasdaq: IMUX) reported its financial results for the year ending December 31, 2020, highlighting significant clinical milestones. The company demonstrated clinical activity of its lead asset, IMU-838, in COVID-19 patients and reported positive outcomes in a phase 2 trial for primary sclerosing cholangitis. R&D expenses rose to $38.6 million, while G&A expenses decreased to $10.3 million. The net loss was approximately $44 million. Immunic ended 2020 with $127.5 million in cash, projected to fund operations into mid-2022.
Immunic, Inc. (Nasdaq: IMUX) announced promising data from a phase 2 proof-of-concept trial for IMU-838, targeting primary sclerosing cholangitis (PSC). Out of 18 enrolled patients, 11 completed the treatment. Statistically significant reductions in serum alkaline phosphatase (ALP) were noted, with 27.3% of evaluable patients achieving a >25% reduction. The drug demonstrated safety with rare mild adverse events. Although limited by COVID-19 challenges, the results suggest further development for IMU-838 in treating PSC is warranted, with potential for additional trials.
Immunic, Inc. (Nasdaq: IMUX) reported positive results from its phase 2 CALVID-1 trial evaluating IMU-838, a selective oral DHODH inhibitor, for hospitalized COVID-19 patients. The analysis included data from 204 patients, demonstrating low rates of invasive ventilation (<1%) and mortality (<2%). IMU-838 showed clinical activity, with a higher proportion of patients recovering by day 28 (71.3% vs. 66.7% placebo). The drug was found to be safe and well-tolerated, with notable benefits for high-risk and elderly populations. A full analysis of all 223 patients is expected in Q2 2021.
Immunic, Inc. (Nasdaq: IMUX) announced CEO Daniel Vitt will participate in a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference on February 25, 2021, at 10:00 am ET. A live audio webcast will be accessible on Immunic's website, with an archived version available for 90 days post-conference. Immunic focuses on developing selective oral therapies for chronic inflammatory and autoimmune diseases, including multiple sclerosis and ulcerative colitis. Its lead program, IMU-838, has shown positive results in clinical trials.
Immunic, Inc. (Nasdaq: IMUX) announced its participation in two major investor conferences in January: the H.C. Wainwright BioConnect 2021 Conference and the 39th Annual J.P. Morgan Healthcare Conference. CEO Daniel Vitt will present at the Wainwright event starting January 11, while Glenn Whaley, Vice President Finance, will attend the J.P. Morgan event. Additionally, Immunic updated its phase 2 clinical trial for IMU-838 to treat primary sclerosing cholangitis, with results expected in Q1 2021 due to COVID-19 delays.
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