Immunic, Inc. Reports Positive Top-line Data from Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis
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About Relapsing-Remitting Multiple Sclerosis Multiple sclerosis (MS) is an autoimmune disease that affects the brain, spinal cord and optic nerve. In MS, myelin, the coating that protects the nerves, is attacked and damaged by the immune system. Thus, MS is considered an immune-mediated demyelinating disease of the central nervous system. Relapsing-remitting MS (RRMS) is the most common form of the disease. Approximately 85% of patients with MS are expected to develop RRMS, with some of these patients later developing more progressive forms of the disease. RRMS is characterized by clearly defined attacks of new or increasing neurologic symptoms. These relapses are followed by periods of remission, or partial or complete recovery. During remissions, all symptoms may disappear, or some symptoms may continue and become permanent. MS is a progressive disease which, without effective treatment, leads to severe disability. MS affects more than 700,000 people in the United States, and more than 2.2 million people worldwide. The disease mainly affects young adults of prime working age, although MS can occur at any age. MS is at least two to three times more common in women than in men.
About IMU-838 IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 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, IMU-838 did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors, such as IMU-838, are known to possess a host-based antiviral effect, which is independent with respect to specific virus proteins and their structure. Therefore, DHODH inhibition may be broadly applicable against multiple viruses. IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in phase 2 trials in patients with COVID-19, relapsing-remitting multiple sclerosis and ulcerative colitis. Furthermore, Immunic's collaboration partner, the Mayo Clinic, has started an investigator-sponsored proof-of-concept clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis. To date, IMU-838 has already been tested in about 650 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. IMU-838 is not yet licensed or approved in any country and has not been demonstrated to be safe or effective for any use.
About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis. The company is developing three small molecule products: lead development program, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect; IMU-935 is an inverse agonist of ROR?t; and IMU-856 targets the restoration of the intestinal barrier function. IMU-838 is in phase 2 clinical development for COVID-19, relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial considered in Crohn's disease. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. For further information, please visit: www.imux.com.
Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's three development programs and the targeted diseases; the potential for IMU-838 to safely and effectively target diseases, including relapsing-remitting multiple sclerosis; preclinical and clinical data for IMU-838; the timing of current and future clinical trials; the availability, safety or efficacy of potential treatment options for patients with relapsing-remitting multiple sclerosis or other conditions, if any, that may be supported by the Company's phase 2 EMPhASIS trial data; future analysis of the EMPhASIS trial data and presentations related thereto; the potential availability and frequency of administration of IMU-838 as a potential treatment for patients with relapsing-remitting multiple sclerosis or for patients with other conditions; the potential for IMU-838 as a treatment for patients with relapsing-remitting multiple sclerosis or for patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections associated with coronavirus disease 2019 (COVID-19) and any clinical trials, collaborations and approvals relating to such potential treatments; preparations for a clinical phase 3 program for IMU-838 in relapsing-remitting multiple sclerosis; future readouts of clinical data from phase 2 trials of IMU-838 in COVID-19; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on March 16, 2020, the company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 3, 2020, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.
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Immunic, Inc. Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
Three MonthsEnded June 30, Six MonthsEnded June 30, 2020 2019 2020 2019 Operating expenses: Research and development $ 9,987 $ 6,029 $ 16,421 $ 9,384 General and administrative 2,235 8,978 4,815 10,285 Total operating expenses 12,222 15,007 21,236 19,669 Loss from operations (12,222) (15,007) (21,236) (19,669) Other income: Interest income 4 34 28 34 Other income, net 760 259 1,263 608 Total other income 764 293 1,291 642 Net loss $ (11,458) $ (14,714) $ (19,945) $ (19,027) Net loss per share, basic and diluted $ (0.90) $ (1.52) $ (1.70) $ (3.60) Weighted-average common shares outstanding, basic and diluted 12,695,989 9,669,129 11,722,725 5,282,412
Immunic, Inc. Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
June 30, 2020 December 31, 2019 (Unaudited) Assets Current assets: Cash and cash equivalents $ 48,607 $ 29,369 Other current assets and prepaid expenses 4,416 2,861 Total current assets 53,023 32,230 Property and equipment, net 121 80 Goodwill 32,970 32,970 Right-of-use assets, net 996 633 Other long-term assets 42 42 Total assets $ 87,152 $ 65,955 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 1,728 $ 2,423 Accrued expenses 5,450 3,298 Other current liabilities 496 1,351 Total current liabilities 7,674 7,072 Long term liabilities Operating lease liabilities 793 520 Total long-term liabilities 793 520 Total liabilities 8,467 7,592 Commitments and contingencies (Note 5) Stockholders' equity: Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at June 30, 2020 and December 31, 2019 - - Common stock, $0.0001 par value; 130,000,000 shares authorized and 14,968,340 and 10,744,806 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively 1 1 Additional paid-in capital 160,148 119,646 Accumulated other comprehensive loss (1,608) (1,373) Accumulated deficit (79,856) (59,911) Total stockholders' equity 78,685 58,363 Total liabilities and stockholders' equity $ 87,152 $ 65,955
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