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

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

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) Chief Medical Officer Dr. Andreas Muehler talked with Proactive about the publication of the company's Phase 1 and Phase 1b clinical trial results for IMU-856 in The Lancet Gastroenterology & Hepatology.

Immunic's IMU-856 shows potential in gastrointestinal health trials - ICYMI

Immunic Inc (NASDAQ:IMUX) announced that data from its phase 1/1b clinical trial for IMU-856, a small molecule targeting SIRT6, has been published in The Lancet Gastroenterology & Hepatology. The study, led by Dr James Daveson, a gastroenterologist with Wesley Research Institute in Australia, evaluated IMU-856's safety and efficacy in patients with celiac disease.

Immunic reports positive Phase 1 results for celiac disease therapy published in The Lancet

–  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.

Immunic Announces Publication of Data From Phase 1/1b Clinical Trial of IMU-856 in the Peer Reviewed Journal, The Lancet Gastroenterology & Hepatology

Immunic, Inc. (NASDAQ:IMUX ) Q3 2024 Earnings Conference Call November 7, 2024 8:00 AM ET Company Participants Jessica Breu - Vice President Investor Relations and Communications Daniel Vitt - Chief Executive Officer and Director Glenn Whaley - Chief Financial Officer Jason Tardio - President and Chief Operating Officer Conference Call Participants William Wood - B. Riley Matt Cowper - Leerink Partners Matt Kaplan - Ladenburg Operator Good morning, and welcome to Immunic's Third Quarter 2024 Earnings Call.

Immunic, Inc. (IMUX) Q3 2024 Earnings Call Transcript

Immunic Inc (NASDAQ:IMUX) ended the third quarter with over $59 million in cash to advance its key clinical programs, including its lead candidate, vidofludimus calcium (IMU-838), for multiple sclerosis (MS). During the third quarter ended September 30, 2024, the firm advanced both its phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and a twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS) looking at orally available lead asset, nuclear receptor related 1 (Nurr1) activator, IMU-838.

Immunic highlights progress in multiple sclerosis programs, targets 2025 milestones

– 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. "During the third quarter, we have continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially transformative, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838)," stated Daniel Vitt, Ph.D.

Immunic, Inc. Reports Third Quarter 2024 Financial Results and Provides 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.

Immunic, Inc. to Announce Financial Results for the Third Quarter Ended September 30, 2024, and Provide Corporate Update

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.

Immunic to Participate in Industry, Scientific and Investor Conferences in November

Immunic Inc (NASDAQ:IMUX) announced a positive outcome from the interim futility analysis of its Phase 3 ENSURE program which is investigating its lead asset vidofludimus calcium in relapsing multiple sclerosis (RMS). The company said an Independent Data Monitoring Committee (IDMC) reviewed unblinded data and concluded that the trials had not met futility criteria, recommending that the study continue as planned without any changes.

Immunic Phase 3 MS study advances following positive recommendation from independent committee

– 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.

Immunic Announces Positive Outcome of Interim Analysis of Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing Multiple Sclerosis

Immunic Inc (NASDAQ:IMUX) announced that it is presenting key data for its lead asset vidofludimus calcium at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which has highlighted its therapeutic potential in multiple sclerosis (MS). Vidofludimus calcium consistently reduced neurofilament light chain (NfL) levels in the Phase 2 CALLIPER trial, suggesting it may slow disease progression across all progressive MS subtypes, the company reported.

Immunic highlights lead asset's promise in multiple sclerosis at ECTRIMS Congress

– Vidofludimus Calcium Consistently Reduce d 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 M ultiple 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 – – In Preclinical Experiments, Vidofludimus Calcium Reduced or Prevented Development of Pathogenic Peripheral T Helper Cells, Which Could be One of the Treatment Pathways in Multiple Sclerosis – NEW YORK , Sept. 18, 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 the presentation of key data at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), highlighting Immunic's lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium's (IMU-838) therapeutic potential in multiple sclerosis (MS).

Immunic Presents Key Vidofludimus Calcium Data at the 40th Congress of ECTRIMS, Highlighting Its Therapeutic Potential in Multiple Sclerosis

Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler joined Proactive to discuss a research update for the company's lead compound vidofludimus calcium. Vidofludimus calcium is being supplied for an investigator-sponsored Phase 2 clinical trial focused on treating post-COVID syndrome (PCCS).

Immunic drug targeting post-COVID syndrome in Phase 2 trial - ICYMI

Immunic Inc (NASDAQ:IMUX) announced that the first patient has been enrolled in an investigator-sponsored Phase 2 trial of its lead asset vidofludimus calcium for post-COVID syndrome. The RAPID_REVIVE study is sponsored by Goethe University Frankfurt, Germany, with funding received via a grant from the German Federal Ministry of Education and Research.

Immunic reports first patient enrolled in investigator-sponsored post-COVID syndrome trial

– 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 R eactivation 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 , Sept. 4, 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 enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of its lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), entitled, "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID­­_REVIVE).

Immunic Announces First Patient Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of Vidofludimus Calcium in Patients with Post COVID Syndrome

Immunic Inc (NASDAQ:IMUX) announced that it will be hosting a Multiple Sclerosis (MS) Research and Development (R&D) Day on September 10 featuring discussions on the company's lead drug asset vidofludimus calcium potential as a treatment for both relapsing and progressive MS patients. The company's management team, including CEO Daniel Vitt, COO Jason Tardio, chief medical officer Andreas Muehler, and chief scientific officer Hella Kohlhof will be joined by MS industry experts to discuss the MS space and vidofludimus calcium's promise.

Immunic to highlight lead asset's promise at upcoming Multiple Sclerosis R&D Day

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.

Immunic to Host Multiple Sclerosis R&D Day and Participate in Scientific and Investor Conferences in September

Immunic, Inc. (NASDAQ:IMUX ) Q2 2024 Earnings Conference Call August 8, 2024 8:00 AM ET Company Participants Jessica Breu - VP, IR & Communications Daniel Vitt - CEO Glenn Whaley - CFO Jason Tardio - COO Conference Call Participants Yasmeen Rahimi - Piper Sandler Matt Kaplan - Ladenburg Thalmann Tom Smith - Leerink Partners Tyler Bussian - Brookline Madison El-Saadi - B. Riley Jessica Breu Good morning, and welcome to Immunic's Second Quarter 2024 Earnings Call.

Immunic, Inc. (IMUX) Q2 2024 Earnings Call Transcript

Immunic Inc (NASDAQ:IMUX) has highlighted clinical and operational progress achieved during the second quarter, which ended June 30, 2024, and the subsequent period. The biotechnology firm has welcomed experienced multiple sclerosis drug commercialization executive Jason Tardio as its chief operating officer and president and appointed senior pharmaceutical executive Simona Skerjanec to its board of directors.

Immunic strengthens leadership team as MS trials advance toward key milestones

– 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 – NEW YORK , Aug. 8, 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 second quarter and six months ended June 30, 2024, and provided a corporate update. "During the second quarter and subsequent period, we continued to achieve clinical and operational progress, punctuated with the addition of Jason Tardio to our team, in the newly-created position of Chief Operating Officer and President.

Immunic, Inc. Reports Second Quarter 2024 Financial Results and Provides Corporate Update

– Webcast to be Held at 8:00 am ET on August 8, 2024 – NEW YORK , Aug. 1, 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 second quarter ended June 30, 2024, including a corporate update, on Thursday, August 8, 2024, 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 Second Quarter Ended June 30, 2024, and Provide Corporate Update

To mark World Brain Day on July 22, Immunic Inc (NASDAQ:IMUX)'s chief scientific officer Hella Kohlhof joined Proactive to discuss the company's lead asset vidofludimus calcium which is being developed to treat the neurological disease multiple sclerosis (MS). She highlighted that this drug has a dual mode of action, with neuroprotection, anti-inflammatory, and antiviral properties.

Immunic chief scientific officer shares insights on innovative MS therapy - ICYMI

Biotechnology firm Immunic Inc (NASDAQ:IMUX) announced the appointment of Simona Skerjanec to its board of directors. Skerjanec brings nearly three decades of experience in drug development and commercialization, having held senior roles at top pharmaceutical companies.

Immunic appoints Simona Skerjanec to board of directors

– Senior Executive and Thought Leader in Brain Health with Nearly Three Decades of Global Pharmaceutical Experience – – Served as Neuroimmunology Franchise Head Responsible for Roche's Blockbuster Launch of Multiple Sclerosis Therapy Ocrevus® – NEW YORK , July 24, 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 the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience in drug development and commercialization, to its board of directors, effective July 22, 2024. Over a nearly three-decade career in the United States and internationally, Ms.

Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Experienced Pharmaceutical Executive Simona Skerjanec

Biogen

Novartis

Immunic Inc (NASDAQ:IMUX) told investors it has appointed a former Novartis and Biogen executive as its new chief operating officer to lead internal efforts to prepare for the potential launch of vidofludimus calcium. Jason Tardio will join the company in the newly created role of COO and president from July 12, the biotechnology company said.

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