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.

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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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Immunic Inc (NASDAQ:IMUX) has announced the publication of preclinical data highlighting the neuroprotective potential of its investigational drug, vidofludimus calcium (IMU-838). The data confirms that vidofludimus calcium acts as a potent activator of the nuclear receptor-related 1 (Nurr1), in addition to its known function as a dihydroorotate dehydrogenase (DHODH) inhibitor.

Immunic notes neuroprotective potential of vidofludimus calcium highlighted in preclinical data

– Preclinical Data Published in the Peer-Reviewed Journal of Medicinal Chemistry Identifies Vidofludimus Calcium as a Potent Nurr1 Activator – – Nurr1 Activation Suggested to Prevent Neurodegeneration Which is Relevant in Multiple Sclerosis, Parkinson's Disease and Beyond – NEW YORK , May 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 publication of preclinical data confirming that vidofludimus calcium (IMU-838) acts as a potent nuclear receptor related 1 (Nurr1) activator, in addition to its known mode of action as a dihydroorotate dehydrogenase (DHODH) inhibitor. Activation of Nurr1 could be responsible for the drug's postulated neuroprotective effects and may contribute to the previously reported reduction of confirmed disability worsening events in multiple sclerosis patients.

Immunic Announces That Vidofludimus Calcium Acts as Potent Nurr1 Activator, Reinforcing Neuroprotective Potential in Multiple Sclerosis

Proof of concept established using IMU-856 for the treatment of patients with Celiac Disease in a phase 1 study. With proof of concept established using IMU-856 for the treatment of patients with Celiac Disease, company has enough data to initiate a phase 2b study.

Immunic: Proof Of Concept With IMU-856 Provides Additional Shot On Goal

Immunic, Inc. (NASDAQ:IMUX ) Q1 2023 Earnings Conference Call May 11, 2023 8:00 AM ET Company Participants Jessica Breu - Head of Investor Relations & Communications Daniel Vitt - Chief Executive officer, President & Director Glenn Whaley - Chief Financial Officer Conference Call Participants Andreas Argyrides - Wedbush Matt Kaplan - Ladenburg Tom Smith - SVB Securities Jessica Breu Good morning, and welcome to Immunic's First Quarter 2023 Earnings Call. My name is Jessica Breu, Head of Investor Relations and Communications at Immunic.

Immunic, Inc. (IMUX) Q1 2023 Earnings Call Transcript

Immunic shares are higher Thursday after the company announced its results for the first quarter ended March 31 and issued a corporate update. "In the first quarter of 2023, we reported outstanding results from two key clinical programs.

Immunic stock rises following corporate update of clinical program progress

– 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 Second Half of 2023 – – $97.1 Million in Cash, Cash Equivalents and Investments Expected to Fund Immunic Into the Fourth Quarter of 2024 – – Webcast to be Held Today, May 11, 2023, at 8:00 am ET – NEW YORK , May 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, today announced financial results for the first quarter ended March 31, 2023, and provided a corporate update. "In the first quarter of 2023, we reported outstanding results from two key clinical programs.

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

– Webcast to be Held at 8:00 am ET on May 11, 2023 – NEW YORK , May 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 that the company will release its financial results for the first quarter ended March 31, 2023, including a corporate update, on Thursday, May 11, 2023, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET.

Immunic, Inc. to Announce Financial Results for the First Quarter Ended March 31, 2023, and Provide Corporate Update

Immunic Inc (NASDAQ:IMUX) said it has presented new clinical and pre-clinical data on the molecule IMU-856 at Digestive Disease Week (DDW) 2023 currently underway in Chicago.  The presentation includes data on how IMU-856 has been shown to have a beneficial effect on gut health by helping to modulate, stabilize and enhance expression of the Sirtuin 6 (SIRT6) protein in the gastrointestinal tract.

Immunic presents data showing beneficial effects of IMU-856 on gut health at Digestive Disease Week 2023

– IMU-856 is an Orally Available, Systemically Acting, Highly Selective and Potent Small Molecule Modulator of SIRT6 – – Targets Regeneration of Bowel Epithelium and Restoration of Intestinal Barrier Function – – Builds on Recently Released Phase 1b Data Showing Beneficial Effects in Celiac Disease Histology, Disease Symptoms, Biomarkers and Nutrient Absorption – – Virtual ePoster to be Presented Today, May 6, 2023, During 9:30 am - 4:00 pm CT Poster Session – NEW YORK , May 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 the presentation of clinical and preclinical data for IMU-856. Included in this presentation are new data on IMU-856's mode of action as a potent modulator of SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium.

Immunic Presents Clinical and Preclinical Data for IMU-856 at Digestive Disease Week 2023, Including Its Molecular Mode of Action

Immunic Inc (NASDAQ:IMUX) said the results from the part C portion of its phase 1 clinical trial of IMU-856 in patients with celiac disease are positive, providing what the company believes as initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders. The data showed that there was protection of gut architecture and reduction of gluten-induced intestinal damage, improvement of the symptoms related to gluten exposure experienced by patients, dose-dependent changes in biomarker responses and the enhancement of nutrient absorption.

Immunic reports positive results from part C of phase 1 clinical trial of IMU-856 in patients with celiac disease

– Positive Effects Demonstrated Over Placebo in Four Key Dimensions of Celiac Disease Pathophysiology: Protection of Gut Architecture, Improvement of Patients' Symptoms, Biomarker Response, and Enhancement of Nutrient Absorption – – Corroborates Hypothesized Ability of IMU-856 to Renew Gut Wall and Restore Gut Health – – No Safety or Tolerability Issues Detected – – Conference Call and Webcast to be Held Today, May 4, 2023 at 8:00 am ET – NEW YORK , May 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 positive results from the part C portion of its phase 1 clinical trial of IMU-856 in patients with celiac disease. The company believes that this data set provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.

Immunic Reports Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders

Immunic Inc (NASDAQ:IMUX) has announced the appointment of Dr Richard Rudick to its board of directors, effective April 26, 2023. The biotechnology company developing small molecule therapies for chronic inflammatory and autoimmune diseases noted that Dr Rudick is a thought leader in multiple sclerosis with decades of experience in the clinic, academia, and industry.

Immunic Inc announces appointment of Dr Richard Rudick to board of directors

– Thought-Leader in Multiple Sclerosis with Decades of Experience in Academic Medicine and the Pharmaceutical Industry – NEW YORK , April 27, 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 appointment of Richard Rudick, M.D., a thought-leader in multiple sclerosis with decades of experience in the clinic, academia and industry, to its board of directors, effective April 26, 2023.

Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Richard Rudick, M.D.

Immunic (IMUX) reports positive results from the maintenance phase of the phase II study evaluating its lead candidate, vidofludimus calcium, to treat patients with ulcerative colitis.

Immunic's (IMUX) Ulcerative Colitis Study Shows Positive Data

Immunic has caught the attention of market analysts with the release of positive data from the maintenance phase of its Phase 2b CALDOSE-1 trial of lead asset vidofludimus calcium (IMU-838) in patients with moderate-to-severe ulcerative colitis (UC). The company on Wednesday said data from the maintenance phase of CALDOSE-1 showed a dose-linear increase in clinical remission as compared to the placebo at week 50.

Immunic's positive trial data for IMU-838 impresses analysts

Immunic (NASDAQ: IMUX ) stock is getting a boost on Wednesday after the company released results from its Phase 2 CALDOSE-1 Trial. This study had it testing the effectiveness of vidofludimus calcium as a treatment for moderate-to-severe ulcerative colitis (UC).

Why Is Immunic (IMUX) Stock Up 23% Today?

Immunic Inc (NASDAQ:IMUX) has announced positive data from the maintenance phase of its phase 2b CALDOSE-1 trial of lead asset vidofludimus calcium (IMU-838) in patients with moderate-to-severe ulcerative colitis (UC). The company said data from the maintenance phase of CALDOSE-1 showed a dose-linear increase in clinical remission as compared to the placebo at week 50.

Immunic reports positive data from maintenance phase of Phase 2 CALDOSE-1 trial

– 50-Week Maintenance Phase Data Shows Dose-Linear Increase in Clinical Remission for Vidofludimus Calcium as Compared to Placebo – – 30 mg Once-Daily Dose of Vidofludimus Calcium Demonstrated Statistically Significant Rates of Clinical Remission (p=0.0358) and Endoscopic Healing (p=0.0259) at Week 50 – – To Focus Resources on High Performing Vidofludimus Calcium and IMU-856 Programs, Immunic Decided to Deprioritize Izumerogant (IMU-935) Program – – Conference Call and Webcast to be Held today, April 5, 2023 at 8:00 am ET – NEW YORK , April 5, 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 reported positive data from the maintenance phase of its phase 2b CALDOSE-1 trial of lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC) (clinicaltrials.gov: NCT03341962). The maintenance phase efficacy data at week 50 are as follows: Placebo 10 mg IMU-838 30 mg IMU-838 Clinical remission rate1 27.8% (N=5/18) 42.3% (N=11/26) 61.5% (N=16/26) Steroid-free clinical remission rate 27.8% (N=5/18) 38.5% (N=10/26) 61.5% (N=16/26) Steroid-free clinical remission rate of patients who received corticosteroids during induction phase 27.3% (N=3) 38.5% (N=5) 66.7% (N=8) Endoscopic healing rate2 35.3% (N=6/17) 53.6% (N=15/28) 73.1% (N=19/26) As shown above, data from the maintenance phase of CALDOSE-1 showed a dose-linear increase in clinical remission as compared to placebo at week 50.

Immunic Reports Positive Data from Maintenance Phase of Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Moderate-to-Severe Ulcerative Colitis

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Immunic, Inc. (NASDAQ:IMUX ) Q4 2022 Earnings Conference Call February 23, 2023 8:00 AM ET Company Participants Jessica Breu - Head, IR & Communications Daniel Vitt - CEO, President & Director Glenn Whaley - CFO Conference Call Participants Yasmeen Rahimi - Piper Sandler & Co. Matthew Kaplan - Ladenburg Thalmann & Co. Andreas Argyrides - Wedbush Securities William Wood - B. Riley Securities Jessica Breu Good morning and welcome to Immunic's Fourth Quarter and Year End 2022 Earnings Call.

Immunic, Inc. (IMUX) Q4 2022 Earnings Call Transcript

– Initial Results From Ongoing Part C of Phase 1 Clinical Trial of IMU-856 in Celiac Disease Expected Mid-2023 – – Interim Results From Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in the Second Half of 2023 – – $116.4 Million in Cash, Cash Equivalents and Investments Expected to Fund Immunic Into the Fourth Quarter of 2024 – – Webcast to be Held Today, February 23, 2023, at 8:00 am ET – NEW YORK , Feb. 23, 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 year ended December 31, 2022, and provided a corporate update. "We made significant progress throughout the year in advancing our lead asset, vidofludimus calcium, for the treatment of multiple sclerosis (MS).

Immunic, Inc. Reports Year End 2022 Financial Results and Provides Corporate Update

– Long-Term Open-Label Treatment With Vidofludimus Calcium Was Associated With a Low Rate of Confirmed Disability Worsening (CDW) Over Time – – CDW Data Compares Favorably to Historical Trial Data for Currently Available Multiple Sclerosis Treatments – NEW YORK , Feb. 22, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced that Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio, will present data from the blinded and open-label extension (OLE) parts of the company's phase 2 EMPhASIS trial of lead asset, vidofludimus calcium (IMU-838), a selective oral DHODH inhibitor, in relapsing-remitting multiple sclerosis (RRMS) at the eighth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023, taking place February 23-25 in San Diego, California.

Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at ACTRIMS Forum 2023

– Webcast to be Held at 8:00 am ET on February 23, 2023 – NEW YORK , Feb. 16, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced that the company will release its financial results for the fourth quarter and year ended December 31, 2022, including a corporate update, on Thursday, February 23, 2023, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET.

Immunic, Inc. to Announce Financial Results for the Year Ended December 31, 2022, and Provide Corporate Update

– Conference Call and Webcast to be Held Today, February 9, 2023, at 11:00 am ET – NEW YORK , Feb. 9, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, announced that its Celiac Disease R&D Webcast will take place today, February 9, 2023 from 11:00 am to 1:00 pm ET. Management of Immunic, including Daniel Vitt, Ph.D.

Immunic to Host Virtual Celiac Disease R&D Day to Highlight Current Pathways for Drug Development and Unmet Medical Need

Interim results from the phase 2 CALLIPER study using IMU-838 for treatment of patients with Progressive MS are expected in the 2nd half of 2023; topline results are end of 2024. Final results from the phase 3 ENSURE study, using IMU-838 for the treatment of patients with relapsing multiple sclerosis, are expected by the end of 2025.

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