Indivumed GmbH

Name ›

Address/P.O. Box › Postal Code/City › Country › Contact Person ›

Telephone › Email › Website › Social Media › Number of Employees › Founded (year) ›

Areas of Activity ›

External ›

Collaborations Immunic Therapeutics

Lochhamer Schlag 21 82166 Gräfelfing Germany Jessica Breu (Head of Investor Relations and Communications) +49-89-2080477-09 info@imux.com www.imux.com

F LI

55 2016

| Immunology | Chronic inflammatory and autoimmune diseases

| In November 2018, Japanese pharma company Daiichi Sankyo granted Immunic an exclusive global option to license IMU-856. Immunic exercised the option in January 2020. | In support of the InnoMuNiCH project, funded by the German Ministry of Education and Research, Immunic together with three partners – a Japanese pharma company, the University of Kyoto, and quattro research – initiated a three-year research project running from August 2019 to July 2022.

Immunic is a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company’s development pipeline consists of three small molecule products: vidofludimus calcium (IMU-838) is a selective immune modulator that inhibits the intracellular metabolism of hyperactivated immune cells by blocking the enzyme DHODH; IMU-935 is a selective inverse agonist of the transcription factor RORγ/RORγt; and IMU-856 targets the restoration of the intestinal barrier function.

Lead programme vidofludimus calcium, in clinical phase III development

Immunic’s lead development programme, vidofludimus calcium (IMU-838), is an orally available, selective immune modulator that inhibits the intracellular metabolism of hyperactivated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g., in fighting infections. In previous trials, vidofludimus calcium did not show an increased rate of infections, as compared to a placebo. In addition, DHODH inhibitors are known to possess a direct antiviral effect, which is independent of specific virus proteins and their structure. Therefore, DHODH inhibition may be broadly applicable against multiple viruses.

In the third quarter of 2020, Immunic reported excellent results from its phase II trial of vidofludimus calcium in relapsing-remitting multiple sclerosis (MS), achieving both primary and key secondary endpoints with high statistical significance. In the second half of 2021, Immunic enrolled the first patients in its phase III programme of vidofludimus calcium in relapsing MS and in its supportive phase II trial of vidofludimus calcium in progressive MS, which is designed to corroborate the drug’s neuroprotective potential. In addition, vidofludimus calcium is being tested in a phase II trial in ulcerative colitis. Top-line data is expected to be available in the second quarter of 2022.

IMU-935: An oral IL-17 inhibitor in clinical phase I development

IMU-935 is a highly potent and selective inverse agonist of the transcription factor RORγ/RORγt. The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. In December 2021, Immunic reported positive safety, tolerability, and pharmacokinetic results from the single and multiple ascending dose portions of the phase I trial of IMU-935 in healthy volunteers. Immunic extended this trial, as planned, to assess safety, tolerability, and exploratory disease endpoints in patients with psoriasis. In addition, Immunic is currently conducting an open-label phase I dose escalation trial of IMU-935 in progressive metastatic castration-resistant prostate cancer.

Immunic’s third programme, IMU-856, is an orally available, small molecule modulator that targets a yet undisclosed protein. Based on preclinical data, Immunic believes this compound appears to represent a novel and potentially paradigm-shifting treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function. A phase I trial is currently ongoing. The single and multiple ascending dose studies in healthy volunteers are planned to be followed by a third one in patients with diseases involving bowel barrier dysfunction.

From inception to Nasdaq in only 3 years

Immunic AG was founded in 2016. Since April 2019, the company has been operating under the name Immunic, Inc. with its corporate headquarters in New York City and has been trading on the Nasdaq Stock Market under the ticker symbol IMUX. The listing followed a reverse takeover transaction with US-based Vital Therapies, Inc. The company’s research and development activities continue to be conducted in Germany.

From inception through 2021, Immunic raised net cash of approximately USD 260 million from private and public offerings of preferred and common stock.