Immunic Inc Stock Price, News & Analysis

Immunic announced positive results from its phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis patients. The drug showed a 20% reduction in disability worsening risk across all patients, with an impressive 30% reduction specifically in primary progressive multiple sclerosis (PPMS) patients.

Key findings include a 29% risk reduction in patients without gadolinium-enhancing lesions and a 20% decrease in thalamic brain volume loss compared to placebo. The trial involved 467 patients across North America and Europe, focusing on PPMS and non-active secondary progressive MS patients.

The drug demonstrated a favorable safety profile with no new safety concerns identified. Treatment-related adverse events were similar between drug (69.4%) and placebo (68.5%) groups. The company plans to present detailed results at upcoming scientific meetings, while phase 3 trials in relapsing multiple sclerosis continue with expected completion in 2026.

Immunic (Nasdaq: IMUX) has successfully closed its previously announced registered direct offering, raising $5.1 million in gross proceeds through the sale of 5,666,667 shares of common stock at $0.90 per share. The offering, which closed on April 10, 2025, was led by Aberdeen Investments.

The biotechnology company, focused on developing oral small molecule therapies for chronic inflammatory and autoimmune diseases, plans to utilize the net proceeds to fund clinical trials, operations, and other general corporate purposes. Titan Partners Group, a division of American Capital Partners, served as the sole placement agent for the offering.

Immunic (Nasdaq: IMUX) has announced the pricing of a $5.1 million registered direct offering of common stock, led by Aberdeen Investments. The company is offering 5,666,667 shares at $0.90 per share.

The biotechnology company, which develops oral small molecule therapies for chronic inflammatory and autoimmune diseases, expects to close the offering around April 10, 2025. The net proceeds will be used to fund clinical trials, operations, and general corporate purposes.

Titan Partners Group, a division of American Capital Partners, is serving as the sole placement agent for this offering, which is being conducted under a previously filed shelf registration statement that became effective on May 31, 2024.

Immunic (Nasdaq: IMUX), a biotechnology company focused on developing oral small molecule therapies for chronic inflammatory and autoimmune diseases, has announced its participation in two major conferences in April 2025.

The company will attend the American Academy of Neurology (AAN) 2025 Annual Meeting from April 5-9 in San Diego, California, where their team will be available at booth #2233.

Additionally, at the German Biotech Days 2025 (April 9-10) in Heidelberg, Chief Scientific Officer Hella Kohlhof, Ph.D., will present on their lead asset vidofludimus calcium (IMU-838), a nuclear receptor-related 1 (Nurr1) activator. The presentation titled 'Vidofludimus Calcium – Designed to Combine the Best of Two Worlds: Neuroprotection and Relapse Prevention' will discuss the company's journey from foundation to late-stage clinical trials.

Immunic (Nasdaq: IMUX) has announced its participation in two major conferences this March 2025. At the 34th Annual Meeting of the Society for Virology in Hamburg (March 4-7), two abstracts will be presented:

1. Dr. Friedrich Hahn will present research on orally bioavailable RORγ/DHODH dual host-targeting small molecules on March 6.

2. Dr. Alexandra Herrmann will discuss novel vidofludimus-based DHODH inhibitors on March 7.

Additionally, at the Leerink Partners Global Healthcare Conference in Miami (March 10-12), CEO Daniel Vitt will participate in a fireside chat on March 12. The company's executives will also be available for one-on-one investor meetings during this conference.

Immunic (Nasdaq: IMUX) presented key data on its lead asset vidofludimus calcium (IMU-838) at the ACTRIMS Forum 2025 through two poster presentations. The first presentation analyzes baseline characteristics of patients in subpopulations from the phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), comparing them with four major PMS trials.

The company expects top-line data from the CALLIPER trial in April, which will evaluate vidofludimus calcium's effects on 24-week confirmed disability worsening in non-active PMS patients. The second poster demonstrates the drug's neuroprotective potential through its activation of Nurr1, showing reduced neuronal loss and injury both directly and indirectly by decreasing microglial activation in preclinical models.

Immunic (NASDAQ: IMUX) announced new data showing that IMU-856, their oral SIRT6 modulator, demonstrated promising results for potential weight management applications. A post hoc analysis of their phase 1b celiac disease trial revealed a dose-dependent increase in GLP-1 levels of up to 250% versus placebo, showing high statistical significance (p=0.014 for 80mg; p=0.003 for 160mg).

The clinical findings were supported by a 6-month preclinical study where IMU-856 reduced body weight gain and food consumption by up to 40% compared to the control group. The company suggests that SIRT6 modulation could potentially offer a broader activation of enteroendocrine hormones compared to current injectable treatments.

IMU-856 is now phase 2 ready and could target the obesity market, which is expected to reach over $170 billion globally by 2031. The drug's potential as an oral alternative to current injectable treatments could represent a significant market opportunity.

Immunic (Nasdaq: IMUX) has announced its participation in several key investor and scientific conferences throughout February 2025. The company will present at the BIO CEO & Investor Conference and Oppenheimer 35th Annual Healthcare Life Sciences Conference, where CEO Daniel Vitt will conduct meetings and participate in a fireside chat.

At the 19th Congress of ECCO, the company will present two digital oral presentations on IMU-856, their oral small molecule modulator targeting SIRT6. The presentations will focus on clinical and preclinical data regarding barrier regeneration effects.

Additionally, at the 7th Neuroimmunology Drug Development Summit, CSO Hella Kohlhof will present on vidofludimus calcium (IMU-838). The company will also participate in the ACTRIMS Forum 2025, presenting two posters on multiple sclerosis research, including baseline characteristics across major clinical trials and vidofludimus calcium's potential neuroprotective function.

Immunic (NASDAQ: IMUX) highlighted its 2024 achievements and upcoming milestones for its lead drug candidate vidofludimus calcium. The company expects top-line data from Phase 2 CALLIPER trial in progressive multiple sclerosis in April, while its twin Phase 3 ENSURE trials in relapsing multiple sclerosis are progressing as planned for completion in 2026.

The company secured a three-tranche private placement totaling up to $240 million, with an initial tranche of $80 million completed in January 2024, extending cash runway into Q3 2025. The Phase 3 ENSURE program received positive interim analysis results, with the Independent Data Monitoring Committee recommending continuation without changes.

Additionally, Immunic strengthened its management team with key appointments and published positive results from the Phase 1/1b trial of IMU-856 in The Lancet Gastroenterology & Hepatology, showing promising effects in celiac disease patients.