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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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.05 | 3.76% | 1.38 | 1.37 | 1.38 | 1.38 | 1.33 | 1.35 | 72,794 | 19:40:15 |
NEW YORK, Nov. 7, 2019 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced financial results for the third quarter ended September 30, 2019 and highlighted recent activity.
"The third quarter was marked by several key clinical milestones. Chief among them was the early completion of enrollment for our phase 2 EMPhASIS trial for IMU-838 in relapsing-remitting multiple sclerosis, nine months ahead of initial expectation," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "This achievement demonstrates our ability to execute on the program and highlights patients' urgent need for a safer oral treatment option for this progressive, debilitating disease. We also reported positive results from the interim dosing analysis of the CALDOSE-1 trial of IMU-838 in moderate-to-severe ulcerative colitis. Specifically, the data indicated a potentially broader active dose range than originally thought, and the trial is continuing with all three dosing arms. Based partially on these interim results, we anticipate beginning the phase 2 CALDOSE-2 trial in Crohn's disease next year. Additionally, during the third quarter, our Australian subsidiary dosed the first healthy volunteer, on schedule, in the phase 1 clinical program of IMU-935, which we believe holds tremendous promise in multiple indications.
"On the operational side, I am pleased to announce that during the first week of November, we opened an office in New York City which is planned to serve as our U.S. corporate headquarters. The office is headed by our Chief Financial Officer, Sanjay S. Patel, who joined the company in July of this year. Additionally, we announced the appointment of highly regarded industry veteran, Tamar Howson, to our Board of Directors in October. Tamar has immediately begun contributing her knowledge and expertise and we are delighted to welcome her to Immunic's growing team," Dr. Vitt added.
Third Quarter 2019 and Subsequent Highlights
Anticipated Clinical Milestones
Financial and Operating Results
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing 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: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of RORγt; and IMU-856 targets the restoration of the intestinal barrier function. Immunic's lead development program, IMU-838, is in phase 2 clinical development for relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial planned 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.immunic-therapeutics.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, IMU-935 and IMU-856 to safely and effectively target diseases; the timing of future clinical trials and expected results of such trials; 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, 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. 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.
Contact Information
Immunic, Inc.
Jessica Breu
Manager IR and Communications
+49 89 250 0794 69
jessica.breu@immunic.de
Or
Rx Communications Group
Melody Carey
+1-917-322-2571
immunic@rxir.com
Financials | |||||||||||
Immunic, Inc. | |||||||||||
Condensed Consolidated Statements of Operations | |||||||||||
(In thousands, except share and per share amounts) | |||||||||||
(Unaudited) | |||||||||||
Three Months | Nine Months | ||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||
Operating expenses: | |||||||||||
Research and development | $ | 7,102 | $ | 1,410 | $ | 16,486 | $ | 5,350 | |||
General and administrative | 2,075 | 395 | 12,360 | 1,412 | |||||||
Total operating expenses | 9,177 | 1,805 | 28,846 | 6,762 | |||||||
Loss from operations | (9,177) | (1,805) | (28,846) | (6,762) | |||||||
Other income (expense): | |||||||||||
Interest income (expense) | 58 | — | 92 | (1) | |||||||
Other income, net | 904 | 8 | 1,512 | 33 | |||||||
Total other income | 962 | 8 | 1,604 | 32 | |||||||
Net loss | $ | (8,215) | $ | (1,797) | $ | (27,242) | $ | (6,730) | |||
Net loss per share, basic and diluted | $ | (0.82) | $ | (2.12) | $ | (3.96) | $ | (7.95) | |||
Weighted-average common shares outstanding, basic and diluted | 10,022,856 | 846,953 | 6,880,057 | 846,953 |
Immunic, Inc. | |||||
Condensed Consolidated Balance Sheets | |||||
(In thousands, except share and per share amounts) | |||||
September 30, | December 31, | ||||
(Unaudited) | |||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 30,460 | $ | 13,072 | |
Other current assets and prepaid expenses | 4,059 | 259 | |||
Total current assets | 34,519 | 13,331 | |||
Property and equipment, net | 44 | 40 | |||
Goodwill | 32,970 | — | |||
Right of use assets, net | 71 | — | |||
Total assets | $ | 67,604 | $ | 13,371 | |
Liabilities, Preferred Stock and Stockholders' Equity (Deficit) | |||||
Current liabilities: | |||||
Accounts payable | $ | 3,718 | $ | 1,400 | |
Accrued expenses | 3,236 | 416 | |||
Other current liabilities | 82 | 104 | |||
Total current liabilities | 7,036 | 1,920 | |||
Long-term liabilities: | |||||
Other long-term liabilities | 41 | — | |||
Total long-term liabilities | 41 | — | |||
Total liabilities | 7,077 | 1,920 | |||
Commitments and contingencies (Note 6) | |||||
Series A-2 Convertible preferred stock, €1.00 par value, 299,456 shares authorized, issued and outstanding at December 31, 2018 | — | 34,313 | |||
Series A-1 Convertible preferred stock, €1.00 par value, 13,541 shares authorized, issued and outstanding at December 31, 2018 | — | 2,879 | |||
Stockholders' equity (deficit): | |||||
Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at September 30, 2019 and December 31, 2018 | — | — | |||
Common stock, $0.0001 par value; 130,000,000 and 846,953 shares authorized and 10,070,680 and 846,953 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 1 | — | |||
Additional paid-in capital | 114,550 | 56 | |||
Accumulated other comprehensive loss | (1,804) | (819) | |||
Accumulated deficit | (52,220) | (24,978) | |||
Total stockholders' equity (deficit) | 60,527 | (25,741) | |||
Total liabilities, preferred stock and stockholders' equity (deficit) | $ | 67,604 | $ | 13,371 |
View original content to download multimedia:http://www.prnewswire.com/news-releases/immunic-inc-reports-third-quarter-2019-financial-results-and-highlights-recent-activity-300954317.html
SOURCE Immunic, Inc.
Copyright 2019 PR Newswire
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