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 Q1 2023

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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 ) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Jessica Breu - Vice President, Investor Relations & Communications Daniel Vitt - Chief Executive Officer, President & Director Glenn Whaley - Chief Financial Officer Conference Call Participants Matt Kaplan - Ladenburg Thalmann Jun-Goo Kwak - Piper Sandler Mayank Mamtani - B. Riley Tom Smith - Leerink Partners Jessica Breu Good morning, and welcome to Immunic First Quarter 2024 Earnings Call.

Immunic, Inc. (IMUX) Q1 2024 Earnings Call Transcript

Immunic Inc (NASDAQ:IMUX) continued to advance its clinical programs for its lead drug asset, nuclear receptor related 1 (Nurr1) activator vidofludimus calcium (IMU-838), during the first quarter of 2024. CEO Daniel Vitt highlighted progress in the company's Phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and the twin Phase 3 ENSURE trials in relapsing multiple sclerosis (RMS) for its “potentially groundbreaking” therapy vidofludimus calcium.

Immunic advances ‘potentially groundbreaking' MS therapy vidofludimus calcium during Q1

– Substantially Bolstered Balance Sheet Through 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 – – Received Fourth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis; Multilayered Intellectual Property Strategy Provides Protection Into 2041 in the United States – – Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain Underway – – Webcast to be Held Today, May 8, 2024, at 8:00 am ET – NEW YORK , May 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 first quarter ended March 31, 2024, and provided a corporate update. "During the first quarter and subsequent period, we have continued to advance both the phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and the twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially groundbreaking, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838)," stated Daniel Vitt, Ph.D.

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

NEW YORK , May 6, 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 investor and scientific conferences in May: May 12-14 and 21-22: Bio€quity Europe 2024. Jessica Breu, Vice President Investor Relations and Communications at Immunic, will attend and host one-on-one investor meetings at this conference taking place in San Sebastián, Spain and virtually.

Immunic to Participate in Investor and Scientific Conferences in May

– Webcast to be Held at 8:00 am ET on May 8, 2024 – NEW YORK , May 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 first quarter ended March 31, 2024, including a corporate update, on Wednesday, May 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 First Quarter Ended March 31, 2024, and Provide Corporate Update

Immunic Inc (NASDAQ:IMUX) has published extended data from its Phase 2 EMPhASIS trial of its lead asset vidofludimus calcium in relapsing-remitting Multiple Sclerosis (RRMS) in the peer-reviewed journal Neurology, Neuroimmunology and Neuroinflammation, an official journal of the American Academy of Neurology. Immunic is developing its small molecule investigational drug vidofludimus calcium as an oral treatment option for patients with MS and other chronic inflammatory and autoimmune diseases.

Immunic publishes extended data from Phase 2 MS trial in peer-reviewed journal

– 30 mg and 45 mg Daily Doses of Vidofludimus Calcium Suppressed Development of Gadolinium-Enhancing Lesions by 78% and 74% Compared to Pooled Placebo at 24 Weeks – – Improvements in Serum Neurofilament Light Chain Consistent with Recently Announced Interim Phase 2 CALLIPER Data in Progressive Multiple Sclerosis – – Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain Underway – NEW YORK , April 30, 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 data from its phase 2 EMPhASIS trial of lead asset, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS) has been published online on April 25, 2024 in Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology. The paper, lead authored by coordinating investigator, Robert J.

Immunic Announces Publication of Extended Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis in the Peer Reviewed Journal, Neurology® Neuroimmunology & Neuroinflammation

NEW YORK , April 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 that it will host a Multiple Sclerosis (MS) Research and Development (R&D) Day and participate in the following investor conferences in April: April 9: Immunic's MS R&D Day . Management of Immunic, including Daniel Vitt, Ph.D.

Immunic to Host MS R&D Day and Participate in Investor Conferences in April

Immunic Inc (NASDAQ:IMUX) has received a Notice of Allowance for a composition-of-matter patent covering a specific polymorph of vidofludimus calcium, which is being advanced as a treatment for chronic inflammatory and autoimmune diseases, particularly multiple sclerosis. The patent, titled "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents", solidifies the company's intellectual property protection around its lead, late-stage asset.

Immunic granted patent for specific polymorph of vidofludimus calcium in US

– Patent Will Also Cover a Related Method of Production of the Material – – Fourth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis – – Multilayered Intellectual Property Strategy Provides Protection Into 2041 in the United States and Into 2039 Internationally, Unless Extended Further – NEW YORK, March 20, 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 it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 16/981,122, entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium (IMU-838) and a related method of production of the material. The claims are expected to provide protection into 2039, unless extended further.

Immunic Receives Notice of Allowance for Composition-of-Matter Patent of a Specific Polymorph of Vidofludimus Calcium in the United States

NEW YORK , March 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 participation in the following investor and scientific conferences in March: March 11-13: Leerink Partners Global Biopharma Conference . Daniel Vitt, Ph.D.

Immunic to Participate in Investor and Scientific Conferences in March

Immunic Inc (NASDAQ:IMUX) announced that it will present data from its Phase 2 CALLIPER and CALVID-1 clinical trials of its lead asset vidofludimus calcium (IMU-838) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. "Having two poster presentations on our lead asset, vidofludimus calcium, at the prestigious ACTRIMS Forum is a testament to the strength of the data we have generated," Immunic CEO Dr. Daniel Vitt said in a statement.

Immunic to present data for lead asset vidofludimus calcium from Phase 2 MS and COVID-19 trials

NEW YORK , Feb. 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 the presentation of data from the company's phase 2 CALLIPER and CALVID-1 clinical trials of 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 2024, taking place from February 29 to March 2, in West Palm Beach, FL. "Having two poster presentations on our lead asset, vidofludimus calcium, at the prestigious ACTRIMS Forum is a testament to the strength of the data we have generated," stated Daniel Vitt, Ph.D.

Immunic Presents Data From Phase 2 CALLIPER and CALVID-1 Trials of Vidofludimus Calcium at the ACTRIMS Forum 2024

Immunic, Inc. (NASDAQ:IMUX) Q4 2023 Earnings Conference Call February 22, 2024 8:00 AM ET

Immunic, Inc. (IMUX) Q4 2023 Earnings Call Transcript

Biotechnology company Immunic Inc (NASDAQ:IMUX) disclosed its financial results for the fourth quarter and year ended December 31, 2023, alongside significant clinical advancements, marking a pivotal year for the firm. Immunic CEO Daniel Vitt lauded the company's strides in 2023, citing the successful completion of a three-tranche private placement worth up to $240 million.

Immunic expects financial stability through 2025 as MS clinical programs advance

– Significantly Strengthened Balance Sheet in January 2024 with Execution of Three-Tranche Private Placement of up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025 Based on Initial $80 Million Tranche – – Evidence for Neuroprotective Activity of Vidofludimus Calcium from Phase 2 CALLIPER Interim Analysis, Consistent Across the Entire Progressive Multiple Sclerosis Population and All Subtypes; Top-Line CALLIPER Data Expected in April 2025 – – Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing – – Expanded Vidofludimus Calcium Patent Portfolio  with Additional New Patents Granted; Exclusivity Protection Expected Into 2041 in the United States, Unless Extended Further – – Webcast to be Held Today, February 22, 2024, at 8:00 am ET – NEW YORK , Feb. 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 financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update. "Immunic made remarkable progress throughout 2023, and these achievements were punctuated by the successful three-tranche private placement of up to $240 million, which we announced last month.

Immunic, Inc. Reports Year End 2023 Financial Results and Provides Corporate Update

The journey toward effective therapies for patients with multiple sclerosis (MS) is marked by persistent challenges. Despite advancements in addressing relapses, the specter of disability progression looms large, leaving a significant unmet need in patient care.

Immunic's cutting-edge MS treatment approach: insights from CEO Dr Daniel Vitt

– Webcast to be Held at 8:00 am ET on February 22, 2024 – NEW YORK , Feb. 15, 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 fourth quarter and year ended December 31, 2023, including a corporate update, on Thursday, February 22, 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 Year Ended December 31, 2023, and Provide Corporate Update

Immunic Inc (NASDAQ:IMUX) Chief Scientific Officer Hella Kohlhof sheds light on her crucial role and the groundbreaking strides being made in the scientific world ahead of the International Day of Women and Girls in Science on 11 February. As CSO, Kohlhof is pivotal in crafting the scientific strategy for Immunic's projects, focusing on understanding molecular actions, ensuring safety in preclinical regulatory work, and developing biomarkers for early activity indications.

Immunic CSO highlights her role ahead of International Day of Women and Girls in Science

NEW YORK , Feb. 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 participation in the following investor and scientific conferences in February: February 8: BioCapital Europe 2024 . Daniel Vitt, Ph.D.

Immunic to Participate in Investor and Scientific Conferences in February

Immunic Inc (NASDAQ:IMUX) shares took off after the biotechnology firm announced it would be raising up to $240 million in a private placement. Immunic stock was up 11.2% at US$1.58 before Friday's opening bell.

Immunic announces up to $240M financing

– 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.

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