Immunic Inc

Immunic, Inc. is a clinical-stage biopharmaceutical company, which develops a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases. It focuses on ulcerative colitis, Crohn’s disease, relapsing-remitting multiple sclerosis, and psoriasis. The firm’s products include IMU-838, IMU-935, and IMU-856. The company is headquartered in New York, NY.

Earnings data Q1 2021

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Earnings data Q3 2023

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Earnings data Q1 2024

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Immunic Inc reports Q4 sales growth, faces challenges in psoriasis trials

Immunic Inc's financial performance in Q4 2022 was marked by strong sales and strategic financing, offset by challenges in the IMU-935 psoriasis trial. The company's focus on advancing its pipeline, exploring new treatment approaches, and upcoming milestones present opportunities for growth and innovation.

Immunic Inc reports Q1 loss, highlights clinical progress and partnership opportunities

Immunic Inc's Q1 2023 performance reflects a strong focus on advancing clinical programs despite reporting a net loss.
The company's financial stability, positive clinical data, and upcoming milestones highlight its potential for growth and innovation.
Challenges in managing expenses and gaining regulatory approvals are balanced by opportunities for partnerships and market differentiation.
Overall, Immunic Inc's strategic approach to R&D and openness to collaborations position it well for future success in the biopharmaceutical industry.

Immunic Inc reports Q2 loss, highlights promising trial results

Immunic Inc showcased solid financial positioning with sufficient cash reserves to support operations into Q4 2024, despite reporting a net loss in Q2 2023.
The positive trial results of vidofludimus calcium and IMU-856 underscore the company's strong pipeline and potential for therapeutic innovation.
While facing challenges in patient enrollment and partnership development, Immunic has opportunities to advance its clinical programs and expand its market reach.

Immunic Inc reports positive trial results and patent extension

Immunic Inc's Q3 performance reflects a focus on advancing its pipeline with positive trial results.
The company faces challenges in enrollment progress, financial sustainability, and regulatory approvals.
Opportunities lie in partnerships, upcoming milestones, and innovative treatment approaches.
Overall, Immunic Inc shows promise in its pipeline but must navigate challenges for sustained growth.

Immunic Inc reports positive clinical data and secures funding boost

Immunic Inc demonstrated strong performance in clinical trials and financial management, positioning the company for future growth and success.
With a robust pipeline, new patents, and ample funding, Immunic has the potential to drive innovation in autoimmune disease treatments.
While facing challenges in advancing drug candidates and managing expenses, Immunic can leverage opportunities for partnerships and revenue generation.
Investors should monitor Immunic's progress on upcoming milestones and the successful execution of its clinical development strategies.

Immunic Inc secures funding, patents, and positive trial data

Immunic Inc's Q1 2024 performance reflects strong financial positioning and promising clinical developments. While challenges exist in managing losses and upcoming milestones, opportunities in the gastrointestinal space and upcoming trial read-outs offer growth potential.

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– Evidence for Neuroprotective Activity of Vidofludimus Calcium from Phase 2 CALLIPER Interim Analysis , Consistent Across the Entire Progressive Multiple Sclerosis Population and All Subtypes – – Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing – – Improvements in Gut Health Demonstrated in Phase 1b Clinical Trial of IMU-856 in Celiac Disease – – Expanded Vidofludimus Calcium Patent Portfolio  with Additional New Patents Granted; Exclusivity Protection Expected Into 2041 in the United States, Unless Extended Further – – Significantly Strengthened Balance Sheet; Cash Runway Extended Into the Third Quarter of 2025 Based on First Tranch of January 2024 Financing – NEW YORK , Jan. 5, 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 highlighted its 2023 accomplishments and upcoming milestones. "The past year has been an extra-ordinarily productive and successful one for Immunic, with key clinical data releases highlighting the uniqueness and enormous value potential of each of our two latest-stage clinical assets," stated Daniel Vitt, Ph.D.

Immunic Highlights 2023 Accomplishments and Upcoming Milestones

NEW YORK , Jan. 5, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX) ("Immunic" or the "Company"), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced it has entered into a securities purchase agreement with select accredited investors to purchase shares of common stock (or pre-funded warrants in lieu thereof) in a three-tranche offering. The first tranche is an upfront payment of $80 million at $1.43 per share, which is expected to close on January 8, 2024, subject to customary closing conditions.

Immunic, Inc. Announces Private Placement of up to $240 Million

Immunic, Inc. said the US Patent and Trademark Office has given it a notice of allowance for patent application 17/992,162 entitled entitled 'Compounds and Dosage Regimen for Use in the Prevention or Treatment of Chronic Inflammatory and/or Autoimmune Diseases'. The patent covers dosing regimens associated with the company's lead asset, vidofludimus calcium and other salt forms as well as free acid forms for the treatment of multiple sclerosis, providing protection into 2038.

Immunic gets patent notice of allowance for lead asset to treat multiple sclerosis

– Fundamental New Patent Covers Treatment of Multiple Sclerosis Into 2038 and Beyond – – Third U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis – – Multilayered Intellectual Property Strategy Provides Protection Into 2041 in the U.S. and Into 2038 Internationally, Unless Extended Further – – Adds on Recently Allowed U.S. Patent Protecting Specific Dose Strength for Relapsing Multiple Sclerosis Treatment – NEW YORK , Nov. 21, 2023 /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 it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 17/992,162, entitled, "Compounds and Dosage Regimen for Use in the Prevention or Treatment of Chronic Inflammatory and/or Autoimmune Diseases." Specifically, the resulting patent covers dosing regimens associated with lead asset, vidofludimus calcium (IMU-838), and other salt forms as well as free acid forms for the treatment of multiple sclerosis (MS), including all regimens tested in the company's MS clinical program.

Immunic Receives Notice of Allowance for United States Patent Protecting Vidofludimus Calcium's Dosing Regimens in Multiple Sclerosis

Immunic, Inc. (NASDAQ:IMUX ) Q3 2023 Earnings Conference Call November 14, 2023 8:00 AM ET Company Participants Jessica Breu - Head of IR & Communications Dr. Daniel Vitt - CEO and President Glenn Whaley - CFO Conference Call Participants Caroline Pocher - Wedbush PacGrow Liam Hiester - Piper Sandler Matt Kaplan - Ladenberg Thalmann Tom Smith - Leerink Partners William Wood - B. Riley Jessica Breu Good morning, and welcome to Immunic's Third Quarter 2023 Earnings Call.

Immunic, Inc. (IMUX) Q3 2023 Earnings Call Transcript

Immunic Inc (NASDAQ:IMUX) – a biotechnology company developing a pipeline of orally administered small molecule therapies for chronic inflammatory and autoimmune diseases - during the three months ending in September advanced its lead drug asset, a nuclear receptor-related 1 (Nurr1) activator vidofludimus calcium IMU-838. Immunic exited the third quarter with cash, cash equivalents and investments of $59.7 million which it said it expects will fund its operations into September of 2024.

Immunic advances drug targeting progressive multiple sclerosis during 3Q

– Positive Interim Analysis from Phase 2 CALLIPER Trial Showed Improvements in Serum Neurofilament Light Chain for Vidofludimus Calcium, Consistent Throughout the Overall Progressive Multiple Sclerosis Population and All Subtypes – –  Notice of Allowance for United States Patent Protecting the Treatment of Relapsing Multiple Sclerosis with Vidofludimus and Its Salts Bolsters Multilayered Intellectual Property Position – – $59.7 Million in Cash and Cash Equivalents as of September 30, 2023 Expected to Fund Immunic Into September of 2024 – – Webcast to be Held Today, November 14, 2023, at 8:00 am ET – NEW YORK , Nov. 14, 2023 /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 ended September 30, 2023, and provided a corporate update. "We have continued to make tangible progress on the clinical development of our lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838).

Immunic, Inc. Reports Third Quarter 2023 Financial Results and Provides Corporate Update

– Webcast to be Held at 8:00 am ET on November 14, 2023 – NEW YORK , Nov. 7, 2023 /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, 2023, including a corporate update, on Tuesday, November 14, 2023, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET.

Immunic to Announce Financial Results for the Third Quarter Ended September 30, 2023, and Provide Corporate Update

Immunic Inc (NASDAQ:IMUX) told investors it has received a Notice of Allowance from the US Patent and Trademark Office for a patent application protecting the treatment of relapsing multiple sclerosis (RMS). The company said in a statement that patent application 17/391,442, entitled, "Treatment of Multiple Sclerosis Comprising DHODH Inhibitors," covers a daily dose of about 10 mg to 45 mg of vidofludimus calcium (IMU-838) and other salts as well as free acid forms for the treatment of RMS.

Immunic gets Notice of Allowance for US patent protecting treatment of relapsing MS with vidofludimus and salts

NEW YORK , Nov. 2, 2023 /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 it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 17/391,442, entitled, "Treatment of Multiple Sclerosis Comprising DHODH Inhibitors," covering a daily dose of about 10 mg to 45 mg of vidofludimus calcium (IMU-838) and other salt as well as free acid forms for the treatment of relapsing multiple sclerosis (RMS). The claims are expected to provide protection into 2041, unless extended further.

Immunic Receives Notice of Allowance for United States Patent Protecting the Treatment of Relapsing Multiple Sclerosis with Vidofludimus and Its Salts

NEW YORK , Oct. 26, 2023 /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 November: November 2-5: Association of European Coeliac Societies (AOECS) 35th General Assembly Conference 2023 . Franziska Buriánek, M.D.

Immunic to Participate in Scientific and Industry Conferences in November

Positive interim analysis from its phase 2 CALLIPER study achieved, showing a statistically significant reduction in neurofilament light chain (NfL) in progressive multiple sclerosis patients when given vidofludimus calcium. Vidofludimus calcium performed better in terms of NfL biomarker reduction in PMS patients compared to Roche's Ocrevus, a market leader in the multiple sclerosis space.

Immunic: Latest CALLIPER Data Reinforces Vidofludimus Calcium For Multiple Sclerosis

NEW YORK , Oct. 16, 2023 /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 from the company's phase 2 CALDOSE-1 trial of vidofludimus calcium (IMU-838) in an oral presentation at the United European Gastroenterology Week (UEGW) 2023, taking place October 14-17 in Copenhagen. Geert R. D'Haens, M.D.

Immunic Presents Data From Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Ulcerative Colitis at the United European Gastroenterology Week 2023

NEW YORK , Oct. 15, 2023 /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 from the company's phase 1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease in a moderated poster session at the United European Gastroenterology Week (UEGW) 2023, taking place October 14-17 in Copenhagen. In this phase 1b, double-blind, randomized, placebo-controlled trial in patients with celiac disease, IMU‑856 showed positive effects over placebo in four key dimensions of clinical outcome: protection of the gut architecture, improvement of patients' symptoms, biomarker response and enhancement of nutrient absorption.

Immunic Presents Data From Phase 1b Clinical Trial of IMU-856 in Celiac Disease at the United European Gastroenterology Week 2023

Immunic Inc (NASDAQ:IMUX) announced that data from its Phase 2 EMPhASIS trial of nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing-remitting multiple sclerosis (RRMS) has been presented at MSMilan 2023, the 9th Joint ECTRIMS-ACTRIMS Meeting by Dr. Robert Fox.

Immunic presents data from Phase 2 study of vidofludimus calcium in relapsing-remitting MS

– Improvement in Serum Neurofilament Light Chain (NfL) Observed in Both Treatment Arms of Vidofludimus Calcium Over Placebo – – NfL Effect Consistent With Recently Released Data from Separate, Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis – NEW YORK , Oct. 11, 2023 /PRNewswire/ --  Immunic, Inc.  (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced that Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, today presented data from the company's phase 2 EMPhASIS trial of nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing-remitting multiple sclerosis (RRMS) at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting, taking place October 11-13 in Milan, Italy.

Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting

Shares in Immunic Therapeutics Inc. soared 48% in after-hours trading following the release of encouraging interim data from its phase II CALLIPER trial assessing the potential of its treatment for progressive multiple sclerosis (PMS).

Immunic shares soar 48% after-hours buoyed by interim MS data

– 24-Week Data from First Half of Patients Shows Improvements in Biomarker NfL, Consistent Throughout the Overall Progressive Multiple Sclerosis Population as well as All Subtypes  – – NfL Effect in Non-Active Subpopulation Reinforces Vidofludimus Calcium's Neuroprotective Potential – – Brain Volume Data of the Full 467 CALLIPER Patient Cohort Expected in April 2025 – – Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing – – Conference Call and Webcast to be Held Tomorrow, October 10, 2023 at 8:00 am ET – NEW YORK , Oct. 9, 2023 /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 positive interim data from its phase 2 CALLIPER trial of nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). The Company believes that this data shows biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, thereby further reinforcing its neuroprotective potential.

Immunic Reports Positive Interim Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis

NEW YORK , Oct. 4, 2023 /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 conferences in October: October 11-13: MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting. Robert J. Fox, MD, Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio, will present data from Immunic's phase 2 EMPhASIS trial of vidofludimus calcium (IMU-838) in relapsing-remitting multiple sclerosis (MS), in an ePoster at this meeting in Milan, Italy.

Immunic to Participate in Scientific Conferences in October

NEW YORK , Sept. 6, 2023 /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 and investor conferences in September: September 13-14: BioPharm America™.

Immunic to Participate in Industry and Investor Conferences in September

Immunic Inc (NASDAQ:IMUX) said it has completed the enrollment of its phase 2 CALLIPER trial of lead asset vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). A total of 467 patients with primary MS or active or non-active secondary MS have been randomized to either 45mg of vidofludimus calcium or placebo.

Immunic completes enrollment in trial of vidofludimus calcium in patients with progressive MS

– Unblinded Interim Biomarker Analysis Expected in the Fall of 2023 – –  Full Data Readout Expected in April 2025 – NEW YORK , Aug. 17, 2023 /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 completion of enrollment of its phase 2 CALLIPER trial of lead asset, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). In total, 467 patients with primary PMS, or active or non-active secondary PMS have been randomized to either 45mg of vidofludimus calcium or placebo.

Immunic Completes Enrollment of Its Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis

Immunic, Inc. said that at the end of its second quarter to June 30, 2023, it had cash, cash equivalents and investments of $77.3 million with which it expects to be able to fund its operations into the fourth quarter of 2024. "During the second quarter, we reported important clinical and preclinical data from our two, lead pipeline programs, including the most advanced drug candidate, vidofludimus calcium (IMU-838), as well as IMU-856," Daniel Vitt, CEO and President of Immunic, said in a statement.

Immunic reports 2Q results; expects to be able to fund operations into 4Q 2024

– Preclinical Data Published in the Journal of Medicinal Chemistry Identifies Vidofludimus Calcium as a Potent Nurr1 Activator, Reinforcing Neuroprotective Potential in Multiple Sclerosis – – Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease Provide Proof-of-Concept for a New Therapeutic Approach to Treat Gastrointestinal Diseases by Promoting Regeneration of Bowel Architecture – – Interim Results From Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in the Fall of 2023 – – $77.3 Million in Cash, Cash Equivalents and Investments Expected to Fund Immunic Into the Fourth Quarter of 2024 – – Webcast to be Held Today, August 3, 2023, at 8:00 am ET – NEW YORK , Aug. 3, 2023 /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 second quarter ended June 30, 2023, and provided a corporate update. "During the second quarter, we reported important clinical and preclinical data from our two, lead pipeline programs, including the most advanced drug candidate, vidofludimus calcium (IMU-838), as well as IMU-856," stated Daniel Vitt, Ph.D.

Immunic, Inc. Reports Second Quarter 2023 Financial Results and Provides Corporate Update

NEW YORK , Aug. 1, 2023 /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 August: August 8-9: 2023 Wedbush PacGrow Healthcare Conference. Daniel Vitt, Ph.D.

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