Immunic Inc Stock Price, News & Analysis

Immunic, Inc. (Nasdaq: IMUX) announced the enrollment of the first patient in an open-label phase 1 trial for IMU-935, a selective inverse agonist targeting metastatic castration-resistant prostate cancer (mCRPC). Approved by UK regulatory bodies, the trial aims to evaluate safety, tolerability, and anti-tumor activity in 18-24 patients over three cycles. Initial clinical data is anticipated in Q3 2022. Preclinical data suggests IMU-935 could suppress drivers of CRPC, highlighting its potential as a treatment option for this challenging cancer.

Immunic, Inc. (Nasdaq: IMUX) announced participation in the Piper Sandler & Co. 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. CEO Daniel Vitt, Ph.D., will present a fireside chat available to registered attendees from November 22 to December 2. The presentation will also be accessible on Immunic's website under the 'Events and Presentations' section. Immunic focuses on developing selective oral immunology therapies for chronic inflammatory and autoimmune diseases, including lead product, vidofludimus calcium (IMU-838).

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.