Immunic, Inc. develops novel oral therapies for neurologic diseases, with a lead program, vidofludimus calcium (IMU-838), focused on multiple sclerosis. Company news commonly covers clinical and scientific presentations, patent protection for vidofludimus calcium, pipeline updates, and corporate communications tied to its late-stage development strategy.
Updates also include governance changes, board and executive appointments, Nasdaq listing compliance, capital actions such as its reverse stock split, and investor conference participation. Immunic's pipeline references additional earlier-stage programs, including IMU-856 and IMU-381, tied to neurodegenerative, chronic inflammatory, and autoimmune-related disease areas.
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.
Immunic, Inc. (Nasdaq: IMUX) reported Q2 2021 financial results, showing a net loss of approximately $17.9 million, or $0.82 per share. R&D expenses rose to $15.7 million, up from $10.0 million year-over-year. The company has received FDA clearance for phase 3 trials of IMU-838 in multiple sclerosis and expects to initiate these studies soon. Following a $45 million public offering, Immunic is well-positioned financially, anticipating funding through various clinical milestones into 2023. Upcoming data read-outs within the next year may significantly impact its stock performance.
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical firm, announced its participation in two upcoming investor conferences in August 2021. The BTIG Virtual Biotechnology Conference will occur from August 9-10, with CEO Daniel Vitt speaking on August 9 at 11:30 am ET. The Wedbush PacGrow Healthcare Virtual Conference will follow on August 10-11, where Dr. Vitt will present on August 10 at 8:00 am ET. Webcasts of these events will be available on the company's website for 90 days.