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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) announced the enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of vidofludimus calcium (IMU-838) for Post COVID Syndrome (PCS). The trial, named RAPID_REVIVE, is sponsored by Goethe University Frankfurt and funded by a German government grant. The study aims to assess vidofludimus calcium's effectiveness in treating PCS symptoms, particularly fatigue, and its ability to suppress Epstein-Barr virus (EBV) reactivation.
The trial will enroll 376 patients across 11 German sites, with a primary endpoint of change in physical function measured by SF-36-PF. Vidofludimus calcium has shown promise in preclinical and clinical studies for its antiviral and anti-inflammatory effects, as well as potential to reduce fatigue in PCS and multiple sclerosis (MS) patients.
Immunic, Inc. (Nasdaq: IMUX) announces its participation in multiple scientific and investor conferences in September 2024. Key events include:
1. MS R&D Day on September 10, featuring discussions on vidofludimus calcium (IMU-838) for MS treatment.
2. 40th ECTRIMS Congress (Sept 18-20) with presentations on vidofludimus calcium's impact on MS.
3. DMDG 50th Open Meeting (Sept 2-4) showcasing pharmacokinetics study results of vidofludimus calcium.
4. 20th International Celiac Disease Symposium (Sept 5-7) presenting data on IMU-856 for celiac disease treatment.
5. 2024 Cantor Fitzgerald Global Healthcare Conference (Sept 17-19) featuring a fireside chat with CEO Daniel Vitt.
These events highlight Immunic's progress in developing treatments for chronic inflammatory and autoimmune diseases.
Immunic, Inc. (IMUX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Appointment of Jason Tardio as Chief Operating Officer and President, bringing MS drug commercialization experience.
2. Strengthened Board of Directors with Simona Skerjanec, a senior pharmaceutical executive.
3. Phase 3 ENSURE trials in Relapsing MS and Phase 2 CALLIPER trial in Progressive MS remain on track.
4. Q2 2024 R&D expenses decreased to $18.3 million from $21.2 million in Q2 2023.
5. Net loss for Q2 2024 was $21.4 million, or $0.21 per share.
6. Cash and cash equivalents of $79.7 million as of June 30, 2024, expected to fund operations into Q3 2025.
7. Top-line data from Phase 2 CALLIPER trial expected in April 2025.
Immunic, Inc. (Nasdaq: IMUX), a biotechnology company focused on developing oral therapies for chronic inflammatory and autoimmune diseases, has announced that it will release its financial results for the second quarter ended June 30, 2024, along with a corporate update, on Thursday, August 8, 2024, before the U.S. financial markets open. The company will host a webcast at 8:00 am ET on the same day to discuss the results.
Interested parties can register for the webcast in advance through the provided link or on Immunic's website. An archived replay of the webcast will be available approximately one hour after its completion on the company's website.
Immunic, Inc. (Nasdaq: IMUX) has appointed Simona Skerjanec, M.Pharm, MBA, to its board of directors, effective July 22, 2024. Skerjanec brings nearly three decades of global pharmaceutical experience, particularly in brain health and drug development. She previously served as Senior Vice President, Global Head Neuroscience and Rare Diseases at Roche, where she led the successful commercial launch of Ocrevus®, a blockbuster multiple sclerosis (MS) therapy.
This appointment follows the recent hiring of Jason Tardio as Immunic's new Chief Operating Officer and President. The company is strengthening its leadership as it approaches multiple late-stage readouts for vidofludimus calcium in MS over the next two years. Skerjanec's expertise is expected to be valuable in potentially bringing this oral drug candidate to market and achieving commercial success.
Immunic announced the appointment of Jason Tardio as Chief Operating Officer and President, effective July 12, 2024. Tardio, a former executive at Novartis and Biogen, brings extensive experience in MS drug commercialization. He will lead efforts to launch vidofludimus calcium, an oral treatment for relapsing and progressive MS.
Additionally, Werner Gladdines has been promoted to Chief Development Officer. He previously served as Vice President, Program Management & Clinical Development Operations. Gladdines will now assume greater strategic and operational responsibilities for Immunic's clinical operations.
Tardio's notable achievements include launching successful MS drugs and leading commercial businesses. His expertise is expected to significantly aid Immunic as it approaches the completion of phase 3 trials for vidofludimus calcium and prepares for potential partnerships.
Immunic (Nasdaq: IMUX), a biotechnology company focused on developing oral therapies for chronic inflammatory and autoimmune diseases, announced its participation in key industry and scientific conferences in June 2024. The company will present at the BIO International Convention in San Diego, California, from June 3-6, with Jessica Breu, VP of Investor Relations and Communications, presenting on June 4 at 11:00 am PDT. Immunic's management will engage in partnering activities at this event. Additionally, Werner Gladdines, VP of Program Management and Clinical Development Operations, will join a panel discussion at the Pharmaceutical Contract Management Group (PCMG) Assembly in Den Haag, The Netherlands, from June 5-7. His panel, 'Spin the Wheel of Collaboration!', is scheduled for June 6 at 12:05 pm CEST.
Immunic, Inc. reported Q1 2024 financial results, highlighting a three-tranche private placement of up to $240 million to extend cash runway, received a fourth US patent for MS treatment, and is progressing with phase 3 ENSURE trials in RMS and phase 2 CALLIPER trial in PMS. The company aims to position vidofludimus calcium as the first oral treatment for MS, while also advancing IMU-856 for gastrointestinal disorders.
Immunic, Inc. (Nasdaq: IMUX) will be participating in various investor and scientific conferences in May, presenting data from clinical trials of their small molecule therapies targeting chronic inflammatory and autoimmune diseases. The conferences include Bio€quity Europe, Digestive Disease Week, The Consortium of Multiple Sclerosis Centers, and the National Congress of Neurology. Key presentations will focus on the phase 1b clinical trial of IMU-856 for celiac disease and the phase 2 CALLIPER trial of vidofludimus calcium for multiple sclerosis.
Immunic, Inc., a biotechnology company focused on developing small molecule therapies for chronic inflammatory and autoimmune diseases, is set to announce its financial results for the first quarter ending March 31, 2024, along with a corporate update on May 8, 2024. A webcast will be held at 8:00 am ET on the same day. Participants can register in advance on the company's website to join the webcast.
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