– Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events by 20% in Overall Study Population Compared to Placebo; Even More Prominent 30% Reduction in High Unmet Need Population of Primary Progressive Multiple Sclerosis –
– Showed Consistent Reduction of Disability Worsening in Subpopulations Without Inflammatory Lesions at Baseline in Overall Study Population; Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events in Patients Without Gadolinium-Enhancing Lesions at Baseline by 29% Compared to Placebo –
NEW YORK, April 10, 2025 /PRNewswire/ -- Immunic, Inc. ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the closing of its previously announced registered direct offering of 5,666,667 shares of its common stock at a price of $0.90 per share, led by Aberdeen Investments. All securities in the offering were sold by Immunic.
The gross proceeds from the offering were approximately $5.1 million before deducting commissions and offering expenses. The offering closed on April 10, 2025.
NEW YORK, April 9, 2025 /PRNewswire/ -- Immunic, Inc. ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the pricing of a registered direct offering of 5,666,667 shares of its common stock at the market under Nasdaq rules at a price of $0.90 per share, led by Aberdeen Investments. All securities in the offering are being sold by Immunic.
NEW YORK, April 1, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and industry conferences in April:
April 5-9: American Academy of Neurology (AAN) 2025 Annual Meeting. Members of Immunic's management, medical and preclinical teams will attend this meeting in San Diego, California. The team will be available throughout the event at booth #2233.April 9-10: German Biotech Days 2025 (Deutsche Biotechnologietage, DBT 2025). Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present "Vidofludimus Calcium – Designed to Combine the Best of Two Worlds: Neuroprotection and Relapse Prevention," highlighting lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), as well as Immunic's journey from company foundation to late-stage clinical trials, during a symposia at this conference in Heidelberg, Germany. The presentation will be available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Symposia: All Grown Up? Mature Biotech Companies Present their ProgressSession Date: Wednesday, April 9, 2025Session Time: 2:20-3:30 pm CET (8:20-9:30 am ET)Session Location: Saal 2NEW YORK, March 3, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and investor conferences in March:
March 4-7: 34th Annual Meeting of the Society for Virology. Two abstracts have been accepted for abstract talk presentations at this conference in Hamburg, Germany. The presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Title: Orally Bioavailable RORγ/DHODH Dual Host-Targeting Small Molecules with Broad-Spectrum Antiviral ActivityPresenting Author: Friedrich Hahn, Ph.D., Institute for Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, GermanyAbstract Talk: O 081Session: Antiviral therapy and resistance IDate: March 6, 2025Time: 9:30-9:45 am CET (3:30-3:45am ET)Title: Novel Vidofludimus-Based DHODH Inhibitors Containing Carboxylic Acid Bioisosters with Superior Broad-Spectrum Antiviral ActivityPresenting Author: Alexandra Herrmann, Ph.D., Manager Translational Pharmacology, ImmunicAbstract Talk: O 112Session: Antiviral therapy and resistance IIDate: March 7, 2025Time: 11:00-11:15am CET (5:00-5:15am ET)– Vidofludimus Calcium's Activation of Nurr1 Reduces Neuronal Loss and Injury Directly and Indirectly By Decreasing Microglial Activations in Preclinical Models –
– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April –
NEW YORK, Feb. 26, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the presentation of data on its lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025, taking place from February 27 to March 1, in West Palm Beach, Florida.
– New Data Suggests that IMU-856 Could Be a Potential Oral Treatment Option for Weight Management; Program Is Phase 2 Ready –
– Dose-Dependent Increase of Endogenous GLP-1 Levels Observed in Post Hoc Analysis of Patients From Phase 1b Clinical Trial in Celiac Disease –
– Dose-Dependent Reduction of Body Weight Gain and Food Consumption Observed in Preclinical Study –
– Webcast to be Held Today, February 20 at 8:00 am ET –
NEW YORK, Feb. 20, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of patients from its phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing. These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.
NEW YORK, Feb. 4, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following investor and scientific conferences in February:
February 10-11: BIO CEO & Investor Conference 2025. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will participate in one-on-one meetings at this conference, taking place in New York. Interested parties can request a meeting through the BIO Partnering™ system or contact Jessica Breu at: jessica.breu@imux.com.February 11-12: Oppenheimer 35th Annual Healthcare Life Sciences Conference. Dr. Vitt will participate in a fireside chat at this virtual conference on Wednesday, February 12 at 1:20 pm ET. A webcast will be available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Additional team members, including Jason Tardio, President and Chief Operating Officer, Glenn Whaley, Chief Financial Officer, and Jessica Breu, Vice President Investor Relations and Communications, will also be in attendance to participate in one-on-one meetings at the conference. To schedule a meeting, please contact your Oppenheimer representative or Jessica Breu at: jessica.breu@imux.com.February 19-22: 19th Congress of ECCO (European Crohn's and Colitis Organisation). Members of Immunic's medical, clinical and preclinical teams will attend this congress in Berlin, Germany, where two abstracts discussing clinical and preclinical data on IMU-856, Immunic's orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), will be presented as digital oral presentations. The presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Presentation Title: Promising Effects of IMU-856, an Orally Available Epigenetic Modulator of Barrier Regeneration - Biomarker Findings from a Phase 1 Clinical StudyPresenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development, ImmunicAbstract Number: EC25-1515Presentation Number: DOP012Presentation Time: 5:57 pm – 6:03 pm CETSession Name: Digital Oral Presentation (DOP) Session 2: Clinical Trials IISession Date: February 20, 2025Session Hall: A8Presentation Title: Preclinical Characterization of IMU-856, an Orally Available Epigenetic Modulator of Gut Barrier Function and RegenerationPresenting Author: Martina Wirth, Ph.D., Senior Manager Translational Pharmacology, ImmunicAbstract Number: EC25-1096Presentation Number: DOP116Presentation Time: 6:27 pm – 6:33 pm CETSession Name: Digital Oral Presentation (DOP) Session 13: Basic Science in IBDSession Date: February 21, 2025Session Hall: A1February 25-27: 7th Neuroimmunology Drug Development Summit. Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present an overview on Immunic's lead asset, vidofludimus calcium (IMU-838), at this summit in Boston. The presentation will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.Presentation Title: Vidofludimus Calcium (IMU-838) Combines the Best of Two Worlds: Neuroprotection and Relapse Prevention in Multiple SclerosisPresentation Date: Thursday, February 27, 2025Presentation Time: 12:10 pm ETFebruary 27 - March 1: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025. Members of Immunic's medical, clinical and preclinical teams will attend this meeting in West Palm Beach, Florida. Two abstracts have been accepted for poster presentations, which will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, the team will be available throughout the event at booth #322.Poster Title: Baseline Characteristics Across Major Clinical Trials in Progressive Multiple Sclerosis: Insights from ORATORIO, EXPAND, MS-STAT2, HERCULES, and CALLIPERPresenting Author: Robert J. Fox, Staff Neurologist, Mellon Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, OhioAbstract Number: 452Poster Number: P102Poster Session: 1Session Date: Thursday, February 27, 2025Session Time: 6:00 pm – 7:30 pm ET (even-numbered posters present from 6:00-6:45 pm; odd-numbered posters present from 6:45-7:30 pm)Poster Title: Vidofludimus Calcium Shows a Potential Neuroprotective Function in Multiple Sclerosis through its Activity on Nurr1 in Preclinical ModelsPresenting Author: Evelyn Peelen, Ph.D., Head of Research, ImmunicAbstract Number: 427Poster Number: P317Poster Session: 2Session Date: Friday, February 28, 2025Session Time: 6:00 pm – 7:30 pm ET (even-numbered posters present from 6:00-6:45 pm; odd-numbered posters present from 6:45-7:30 pm)– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April –
– Reported Positive Outcome from Interim Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be Completed in 2026 –
– Strengthened Management Team and Board of Directors with Key Hires –
– Announced a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche –
NEW YORK, Nov. 26, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will participate in a fireside chat on Thursday, December 5, 2024, at 11:30 am ET, during the Piper Sandler 36th Annual Healthcare Conference, taking place December 3-5, 2024, in New York.
Dr. Vitt, Glenn Whaley, Chief Financial Officer, and Jessica Breu, Vice President Investor Relations and Communications, will also participate in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Piper Sandler representative or Jessica Breu at: jessica.breu@imux.com.
– Includes Phase 1 Data in Healthy Human Subjects and Phase 1b Data in Celiac Disease Patients –
NEW YORK, Nov. 13, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that the data from its phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Lead authored by Dr. A. James Daveson, Gastroenterologist, Wesley Research Institute and Coral Sea Clinical Research Institute, Queensland, Australia, the paper is entitled, "Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial." It can be accessed through the following link: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00248-6/fulltext.
– Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility Criteria Have Not Been Met and Recommended Trials Should Continue as Planned –
– Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track –
– Top-Line Data from Phase 2 CALLIPER Trial Expected in April 2025 –
– Webcast to be Held Today, November 7, at 8:00 am ET –
NEW YORK, Nov. 7, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced financial results for the third quarter and nine months ended September 30, 2024, and provided a corporate update.
– Webcast to be Held at 8:00 am ET on November 7, 2024 –
NEW YORK, Oct. 31, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that the company will release its financial results for the third quarter ended September 30, 2024, including a corporate update, on Thursday, November 7, 2024, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET.
NEW YORK, Oct. 29, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following industry, scientific and investor conferences in November:
November 4-6: BIO-Europe. Members of Immunic's management, business development and investor relations teams will participate in partnering activities at this conference in Stockholm, Sweden. To schedule a meeting, please use the BIO-Europe partneringONE portal.November 8-9: Symposium 238: Immuno-Mediated Diseases of the GI Tract: Where Do We Stand? Sara Elhag, Ph.D., Associate Manager Translational Pharmacology at Immunic, will present data from the company's phase 1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator targeting SIRT6 (Sirtuin 6), in patients with celiac disease, in a poster presentation at this symposium in Florence, Italy. The poster will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.November 19-21: Immunic's management, business development and investor relations teams will be hosting one-on-one meetings in London in connection with the Jefferies London Healthcare Conference 2024. To schedule a meeting, please contact Jessica Breu, Vice President Investor Relations and Communications, at: jessica.breu@imux.com.November 21: Virtual Investor Summit. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will present a company overview on Thursday, November 21, 2024 and participate in one-on-one investor meetings at this conference. To listen to the company presentation, register for the conference using this link. The presentation and presentation time will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations, once they are available.– Based on a Review of Unblinded Data, an Independent Data Monitoring Committee (IDMC) Confirmed that Predetermined Futility Criteria Have Not Been Met –
– IDMC Also Recommended Continuing Trial without Changes, Including no Need for a Potential Upsizing –
– ENSURE Program Remains on Track to be Completed in 2026 –
– Webcast to be Held Today, October 22, at 8:00 am ET –
NEW YORK, Oct. 22, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced a positive outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.
– Vidofludimus Calcium Consistently Reduced Neurofilament Light Chain Levels, Compared to Placebo, in the Interim Analysis of the Phase 2 CALLIPER Trial, Across Age and Disability Levels at Baseline For All Progressive Multiple Sclerosis Subtypes –
– Clinical Signal Shown for Vidofludimus Calcium on Post COVID Fatigue May Be Related to Epstein-Barr Virus Reactivation; Preventing This Reactivation May Contribute to Fatigue Reduction in Multiple Sclerosis Patients –
– Preclinical Data Showed Improved Neuronal Survival, Likely Driven by Vidofludimus Calcium's Induction of Nurr1 Activation, as Demonstrated by Primary Target Gene Regulation –
– Investigator Study Sponsored by Goethe University Frankfurt (Germany), Funded via a German Government Grant; Study Drug Vidofludimus Calcium Provided by Immunic –
– In Addition to Post COVID Readouts, Study Designed to Deliver Important Data on the Activity of Vidofludimus Calcium Suppressing Epstein-Barr Virus Reactivation and Related Fatigue Symptoms; Third-Party Research Identified Epstein-Barr Virus Reactivation as Potential Cause for Post COVID Fatigue –
– Severe Fatigue Also a Common and Debilitating Symptom for Multiple Sclerosis Patients with No Effective Therapies Available; Potential Read-Through to Immunic's Multiple Sclerosis Development Program –
NEW YORK, Aug. 28, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that the company will host a Multiple Sclerosis (MS) Research and Development (R&D) Day and participate in the following scientific and investor conferences in September:
September 10: Immunic's MS R&D Day. Management of Immunic, including Daniel Vitt, Ph.D., Chief Executive Officer; Jason Tardio, M.B.A., Chief Operating Officer and President; Andreas Muehler, M.D., M.B.A., Chief Medical Officer; and Hella Kohlhof, Ph.D., Chief Scientific Officer, will be joined by two of the MS industry's renowned experts to discuss the MS landscape as well as Immunic's orally available lead-asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838) and its potential to become the treatment of choice for both relapsing and progressive MS patients.Date: Tuesday, September 10, 2024Time: 10:30 am to 12:30 pm ET, followed by a networking lunchLocation: One Five One, 151 West 42nd Street, New York, NY 10036Featured Experts:Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO) and University Hospital San Luigi Gonzaga of Orbassano, Turin, ItalyAmit Bar-Or, M.D., FRCPC, Melissa and Paul Anderson Distinguished Chair, Director, Center for Neuroinflammation and Experimental Therapeutics, Chief, Multiple Sclerosis Division, Department of Neurology, Perelman School of Medicine, University of PennsylvaniaTo register, please RSVP by sending an email to: ir@imux.com.September 18-20: 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Members of Immunic's management, medical, clinical and preclinical teams will attend this conference in Copenhagen, Denmark. Data on vidofludimus calcium will be presented in an oral presentation and three ePosters. Additionally, the team will be available throughout the event at booth #60. All poster presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.– Jason Tardio, Experienced Multiple Sclerosis Drug Commercialization Executive, Formerly with Novartis and Biogen, Appointed Chief Operating Officer and President –
– Strengthened Board of Directors with Appointment of Simona Skerjanec, Senior Pharmaceutical Executive and Thought Leader in Brain Health –
– Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track –
– Webcast to be Held Today, August 8, at 8:00 am ET –
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