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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Immunic Inc | NASDAQ:IMUX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.02 | 1.50% | 1.35 | 1.00 | 1.51 | 1.39 | 1.33 | 1.35 | 112,415 | 05:00:11 |
NEW YORK, Nov. 5, 2020 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced financial results for the third quarter ended September 30, 2020 and provides corporate update.
"The third quarter was marked by a significant achievement for our lead asset, selective oral DHODH inhibitor, IMU-838, with the release of top-line data from our phase 2 EMPhASIS trial in patients with relapsing-remitting multiple sclerosis, and subsequent publication of the full unblinded data set. IMU-838 demonstrated robust efficacy, through the achievement of all primary and key secondary endpoints, combined with an outstanding safety and tolerability profile. We believe that the phase 2 results emphasize the game-changing potential of IMU-838 as a once-daily oral therapy for this indication," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "On the heels of this overwhelmingly positive data, we completed a successful common stock offering, raising $103.5 million in gross proceeds, significantly bolstering our balance sheet. We are currently preparing our end-of-phase 2 submission for IMU-838 in relapsing-remitting multiple sclerosis to regulatory authorities, anticipated in the first quarter of next year, after which we look forward to scheduling our end-of-phase 2 meetings, during which we will have the opportunity to discuss our plans for a phase 3 program."
Dr. Vitt continued, "We have also made notable strides in our development of IMU-838 in patients with moderate COVID-19, most recently securing a financing agreement of up to €24.5 million (approximately $29 million) with the European Investment Bank for the ongoing development of our phase 2 CALVID-1 trial, a potential expansion into a confirmatory phase 3 trial and commercial-scale manufacturing of IMU-838. Additionally, we reported that an Independent Data Monitoring Committee recommended the continuation, without changes, of the CALVID-1 trial after an interim safety analysis. Recruitment has accelerated due to the spread of disease within the countries included in the trial and, at the beginning of November, we reached the enrollment goal of 200 patients, pre-specified in the protocol as sufficient to perform the main efficacy analysis of the phase 2 part of the CALVID-1 trial. The data of this unblinded main analysis of all available efficacy, biomarker and virus titer data is expected to be available in the first quarter of next year."
The company's current cash position of approximately $133.2 million, at September 30, 2020, is expected to fund activities into the second half of 2022, and specifically through key value inflection points including those for the COVID-19 phase 2 trial with IMU-838; preparation for, and initiation of, a phase 3 trial of IMU-838 in relapsing-remitting multiple sclerosis (RRMS); the phase 2 readouts of IMU-838 in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC); as well as completion of the phase 1 trials of IMU-935 and IMU-856, respectively, including pharmacodynamic evaluations in patients for both of these trials.
Third Quarter 2020 and Subsequent Highlights
Update on Activities Relating to the Preparation of a Phase 3 Program for IMU-838 in RRMS
As previously announced, the full unblinded clinical data set from the company's phase 2 trial of IMU-838 in patients with RRMS showed achievement of all primary and key secondary endpoints, with high statistical significance. Notably, both doses (30 and 45 mg/day) appeared to be equally safe and efficacious, reducing the number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24, as compared to placebo. Based on this phase 2 data as well as established regulatory guidance that the lowest effective dose should be considered for future clinical trials, Immunic may propose the dose of 30 mg/day of IMU-838 for investigation in a phase 3 program.
Given the relative equal performance of the two doses tested, however, and to allow for pharmacodynamic modeling of the dose-response relationship, data from a lower dose in the effective dose range would be beneficial to complete a dose-effect assessment of IMU-838 in RRMS. For this reason, Immunic has already started an additional, small Cohort 2 sub-trial to obtain exploratory data on the expanded dose response of IMU-838. This additional, double-blind assessment includes a cohort of 60 patients who receive 10 mg/day of IMU-838 or placebo for 24 weeks. The still-active sites of the phase 2 trial of IMU-838 in RRMS continue to be used and, as a result, the company expects that this assessment can be executed in an accelerated fashion. This additional sub-trial is not expected to change any conclusions for dosing of IMU-838 in a future phase 3 program. Rather, it is expected to provide additional data to address any potential regulatory requests in the context of the design of a phase 3 program. Management believes that this strategy will enable risk reduction for end-of-phase 2 discussions with regulatory agencies.
The company intends to separate formal end-of-phase 2 meeting preparations from regulatory advice for non-clinical phase 3 related topics to be submitted to regulatory authorities in the near future. Subsequently, the company intends to submit formal end-of-phase 2 meeting requests with a sole focus on the phase 2 data, including the Cohort 2 interim data, and a proposed phase 3 program to regulatory authorities at the end of the first quarter 2021. The end-of-phase 2 meetings are expected to be held in or about May 2021.
In parallel to the preparation and execution of the regulatory discussions, Immunic has begun performing formal feasibility activities for a phase 3 program of IMU-838 in RRMS, including country and site selection, as well as other preparatory activities. The company also believes that this feasibility assessment will help ensure an expeditious execution of the development strategy for IMU-838.
Additional Anticipated Clinical Milestones
Financial and Operating Results
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. Immunic is developing three small molecule products: its 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 RORγt; and IMU-856 targets the restoration of the intestinal barrier function. Immunic announced positive results from its phase 2 EMPhASIS trial of IMU-838 in patients with relapsing-remitting multiple sclerosis, reporting achievement of both primary and key secondary endpoints with high statistical significance. IMU-838 is also in phase 2 clinical development for ulcerative colitis and COVID-19, 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; clinical data for IMU-838; the timing of current and future clinical trials; the potential for IMU-838 as a treatment for 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 treatment; the future use of the EIB venture loan; the nature, strategy and focus of the company; 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 quarter 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.
Contact Information
Immunic, Inc.
Jessica Breu
Head of Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Melody Carey
+1 917 322 2571
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
Financials
Immunic, Inc. | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 11,040 | $ | 7,102 | $ | 27,461 | $ | 16,486 | ||||||||
General and administrative | 2,505 | 2,075 | 7,320 | 12,360 | ||||||||||||
Total operating expenses | 13,545 | 9,177 | 34,781 | 28,846 | ||||||||||||
Loss from operations | (13,545) | (9,177) | (34,781) | (28,846) | ||||||||||||
Other income: | ||||||||||||||||
Interest income | 20 | 58 | 48 | 92 | ||||||||||||
Other income, net | 612 | 904 | 1,875 | 1,512 | ||||||||||||
Total other income | 632 | 962 | 1,923 | 1,604 | ||||||||||||
Net loss | $ | (12,913) | $ | (8,215) | $ | (32,858) | $ | (27,242) | ||||||||
Net loss per share, basic and diluted | $ | (0.70) | $ | (0.82) | $ | (2.35) | $ | (3.96) | ||||||||
Weighted-average common shares | 18,405,840 | 10,022,856 | 13,966,690 | 6,880,057 |
Immunic, Inc. | |||||||
September 30, | December 31, | ||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 133,183 | $ | 29,369 | |||
Other current assets and prepaid expenses | 4,358 | 2,861 | |||||
Total current assets | 137,541 | 32,230 | |||||
Property and equipment, net | 147 | 80 | |||||
Goodwill | 32,970 | 32,970 | |||||
Right-of-use assets, net | 940 | 633 | |||||
Other long-term assets | 42 | 42 | |||||
Total assets | $ | 171,640 | $ | 65,955 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,419 | $ | 2,423 | |||
Accrued expenses | 4,253 | 3,298 | |||||
Other current liabilities | 358 | 1,351 | |||||
Total current liabilities | 8,030 | 7,072 | |||||
Long term liabilities | |||||||
Operating lease liabilities | 735 | 520 | |||||
Total long-term liabilities | 735 | 520 | |||||
Total liabilities | 8,765 | 7,592 | |||||
Commitments and contingencies | |||||||
Stockholders' equity: | |||||||
Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares | — | — | |||||
Common stock, $0.0001 par value; 130,000,000 shares authorized and | 2 | 1 | |||||
Additional paid-in capital | 257,394 | 119,646 | |||||
Accumulated other comprehensive loss | (1,752) | (1,373) | |||||
Accumulated deficit | (92,769) | (59,911) | |||||
Total stockholders' equity | 162,875 | 58,363 | |||||
Total liabilities and stockholders' equity | $ | 171,640 | $ | 65,955 |
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SOURCE Immunic, Inc.
Copyright 2020 PR Newswire
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