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Immunic, Inc. Announces Formation of Scientific-Medical Advisory Board
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced the formation of a Scientific-Medical Advisory Board (SAB). Inaugural members include Drs. Fred D. Lublin, Bruce E. Sands, Jerrold R. Turner and Paul J. Utz, all internationally recognized experts in their respective fields of inflammatory and autoimmune diseases. The newly created SAB will provide management with external scientific review and high-level advice with regard to the company’s preclinical and clinical development activities and product pipeline. "The establishment of a Scientific-Medical Advisory Board marks an important milestone for Immunic and we are honored to have such highly…
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Immunic, Inc. Reports Third Quarter 2020 Financial Results and Provides Corporate Update
– Released Very Positive Phase 2 Data for IMU-838 in Relapsing-Remitting Multiple Sclerosis; Company to Submit End-of-Phase 2 Meeting Requests to Regulatory Authorities at the End of Q1 2021 – – 200 Patients Randomized in Phase 2 Trial of IMU-838 for the Treatment of Moderate COVID-19; Top-Line Data From Main Phase 2 Efficacy Analysis Expected in Q1 2021 – – Readout of 18 Patients From Phase 2, Investigator-Sponsored Proof-of-Concept Clinical Trial of IMU-838 in Primary Sclerosing Cholangitis, Being Conducted at the Mayo Clinic, Expected During Q4 2020 – – With Approximately $133 Million in Cash and Cash Equivalents, Immunic is Funded Through Key Value Inflection Points into the Second…
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Immunic, Inc. Announces 200 Patients Enrolled in Its Phase 2 CALVID-1 Trial of IMU-838 for the Treatment of Moderate COVID-19, Allowing for Main Phase 2 Efficacy Analysis to Proceed
Immunic, Inc. (Nasdaq: IMUX),a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced that the company has enrolled and randomized 200 patients, pre-specified in the protocol as sufficient to perform the main efficacy analysis of the phase 2 part of the CALVID-1 trial for its selective oral DHODH inhibitor, IMU-838, in hospitalized patients with moderate coronavirus disease 2019 (COVID-19). The aim of the CALVID-1 trial is to investigate IMU-838 as an oral treatment option for moderate COVID-19 and to support potential use of IMU-838 as a treatment for current and potential future viral pandemic threats. The trial is being…
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EIB Provides Immunic With up to €24.5 Million to Support Ongoing Development of a Potential COVID-19 Therapy
European Investment Bank and Immunic sign a financing agreement of up to €24.5 million to support the development of Immunic’s lead asset, IMU-838, in moderate COVID-19 IMU-838 is an orally available small molecule, which, because of its broad-spectrum antiviral effect and selective immunomodulatory properties, is currently being evaluated for the treatment of COVID-19 The EIB venture loan is financed under the Infectious Diseases Finance Facility set up as part of Horizon 2020, the European Union’s research and innovation program for 2014-2020 The European Investment Bank (EIB) and Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune…
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Immunic, Inc. Announces Results From Interim Safety Analysis and Recruitment Update From Its Ongoing Phase 2 CALVID-1 Trial of IMU-838 in Patients With Moderate COVID-19
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced the results of a pre-planned interim safety analysis and a recruitment update from the ongoing phase 2 CALVID-1 trial of its selective oral DHODH inhibitor, IMU-838, in patients with moderate coronavirus disease 2019 (COVID-19). Based on the available safety data, an Independent Data Monitoring Committee (IDMC) has concluded that the study should continue without changes. The IDMC will perform a second safety analysis when additional patient data is available. To date, 110 patients have been enrolled in the CALVID-1 trial and enrollment is progressing well. During…
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Immunic, Inc. Publishes Full Unblinded Clinical Data From Phase 2 EMPhASIS Trial of IMU-838 in Patients With Relapsing-Remitting Multiple Sclerosis and Announces Poster Presentation at the MSVirtual2020
Unblinded Subgroup Analyses Show Consistent Effect for MRI Lesion Suppression Across Different Populations T ime Course of MRI Lesion Suppression Shows Reduction of Lesions Already Present at First Post-Baseline Scan at Week 6, Validating Rapid Attainment of Stable Therapeutic Drug Levels of IMU-838 A Robust Decrease in Serum Neurofilament Light Chain, A Biomarker for Axonal Damage, Was Observed in Both Treatment Arms of IMU-838 But Not in the Placebo Arm Poster, Including Audio Track, With Summary of Full Data Set, to be Presented Online at the MSVirtual2020 / 8th Joint ACTRIMS-ECTRIMS Meeting by Robert J. Fox, M.D. Conference Call and Webcast to Review the Full Unblinded EMPhASIS Data to be…
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Immunic, Inc. Announces Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced dosing of the first healthy volunteer in the company’s phase 1 clinical program of IMU-856, an orally available, small molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and paradigm-shifting approach to the treatment of gastrointestinal diseases by potentially restoring intestinal barrier function while maintaining immunocompetency. Immunic’s Australian subsidiary, Immunic Australia Pty Ltd., received clearance from the Bellberry Human Research Ethics Committee in Australia to…
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Immunic, Inc. Announces Closing of $103.5 Million Public Offering, including Full Exercise of Underwriters‘ Option to Purchase Additional Shares
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, announced the closing of an underwritten public offering of 5,750,000 shares of its common stock at a public offering price of $18.00 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 750,000 shares. Immunic received total proceeds from the offering, before deducting the underwriting discounts and other offering expenses, of $103.5 million. SVB Leerink acted as sole bookrunning manager for the offering. Wedbush PacGrow and Ladenburg Thalmann acted as co-managers for the offering. The Company intends to…
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Immunic, Inc. Announces Pricing of $90.0 Million Public Offering of Common Stock
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $18.00 per share. The proceeds of the offering to the Company are expected to be $90.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The…
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Immunic, Inc. Announces Proposed Public Offering of 5 Million Shares of Common Stock
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced that it intends to offer and sell 5 million shares of its common stock in an underwritten public offering. In connection with the offering, the Company intends to grant the underwriters an option for 30 days to purchase up to an additional 750,000 shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. SVB Leerink and Piper Sandler are acting as joint bookrunning managers…
