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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 | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0027 | -0.20% | 1.3373 | 1.30 | 1.34 | 2,979 | 14:12:22 |
NEW YORK, Aug. 6, 2021 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced financial results for the second quarter ended June 30, 2021 and highlighted recent activity.
"So far this year, we have made outstanding progress with both our selective oral DHODH inhibitor, IMU-838, as well as IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt, enabling what we believe will be an eventful and potentially transformative first half of 2022. In particular, we anticipate five data read-outs from clinical trials within the next twelve months, and expect to begin our first phase 3 program very soon. I want to congratulate our entire team for this remarkable momentum," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "In June, we received U.S. Food and Drug Administration (FDA) clearance for our Investigational New Drug (IND) application for the phase 3 ENSURE program of IMU-838 in patients with relapsing-remitting multiple sclerosis (RRMS), and the supportive phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS). Initiation of these trials in the second half of this year will mark a major milestone for our lead program. Additionally, we look forward to completing recruitment of our ongoing phase 2 CALDOSE-1 trial of IMU-838 in patients with ulcerative colitis (UC) during the second half of 2021, and reporting top-line data for this potential second key indication for IMU-838 in the first half of 2022."
"At our virtual R&D Day just last month, we presented very encouraging in vitro data showing that IMU-935 may inhibit both the generation of Th17 cells and the production of IL-17 cytokines that are responsible for the development of autoimmune diseases, without impairing thymocyte development, thereby avoiding a potential risk for lymphoma that has complicated third-party programs in this space. We also detailed highly encouraging new preclinical data which suggests that IMU-935 can affect castration-resistant prostate cancer (CRPC) both directly by reducing androgen receptor (AR) expression via RORγ and inhibiting tumor growth, and indirectly by inhibiting tumorigenesis-promoting Th17 and IL-17. Based on the strength of this data, we are preparing a phase 1 trial in metastatic CRPC (mCRPC) patients with Johann Sebastian de Bono, M.D., Ph.D., Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, United Kingdom, acting as the Principal Investigator. We expect this trial to commence during the fourth quarter of this year and also anticipate availability of initial human data from moderate-to-severe psoriasis patients from our phase 1 trial of IMU-935 during the second quarter of 2022."
Dr. Vitt added, "As previously announced, at the end of the first quarter of 2021, we settled our remaining royalty obligation to 4SC AG for both IMU-838 and IMU-935, for $17.3 million, which was paid 50% in cash and 50% in shares of Immunic's common stock during the second quarter. This strategic decision provides us with 100% of the future sales potential of our two lead programs and should drive significant value for our shareholders. Last month, we were able to offset this payment by bolstering our balance sheet with a $45.0 million financing, providing us with anticipated runway through multiple value inflection points into 2023."
Second Quarter 2021 and Subsequent Highlights
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 focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, IMU-838, 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, is currently being developed as a treatment option for multiple sclerosis, ulcerative colitis, Crohn's disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor RORγt, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barré syndrome. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction. 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 relating to Immunic's three development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and the company's expected cash runway. 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, 2020, filed with the SEC on February 26, 2021, 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
Paula Schwartz
+1-917-322-2216
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
Financials
Immunic, Inc. Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) | |||||||||||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||
Research and development | $ | 15,738 | $ | 9,987 | $ | 27,257 | $ | 16,421 | |||||||||||||||||||
General and administrative | 3,432 | 2,235 | 7,050 | 4,815 | |||||||||||||||||||||||
4SC Royalty Settlement | — | — | 17,250 | — | |||||||||||||||||||||||
Total operating expenses | 19,170 | 12,222 | 51,557 | 21,236 | |||||||||||||||||||||||
Loss from operations | (19,170) | (12,222) | (51,557) | (21,236) | |||||||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||||||
Interest income | 13 | 4 | 41 | 28 | |||||||||||||||||||||||
Other income (expense), net | 1,223 | 760 | (952) | 1,263 | |||||||||||||||||||||||
Total other income (expense) | 1,236 | 764 | (911) | 1,291 | |||||||||||||||||||||||
Net loss | $ | (17,934) | $ | (11,458) | $ | (52,468) | $ | (19,945) | |||||||||||||||||||
Net loss per share, basic and diluted | $ | (0.82) | $ | (0.90) | $ | (2.44) | $ | (1.70) | |||||||||||||||||||
Weighted-average common shares outstanding, | 21,749,439 | 12,695,989 | 21,463,656 | 11,722,725 |
Immunic, Inc. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) | |||||||
June 30, | December 31, | ||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 87,175 | $ | 127,452 | |||
Other current assets and prepaid expenses | 14,512 | 6,293 | |||||
Total current assets | 101,687 | 133,745 | |||||
Property and equipment, net | 194 | 203 | |||||
Goodwill | 32,970 | 32,970 | |||||
Right-of-use assets, net | 1,165 | 901 | |||||
Other long-term assets | 42 | 42 | |||||
Total assets | $ | 136,058 | $ | 167,861 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 4,182 | $ | 3,700 | |||
Accrued expenses | 6,175 | 4,318 | |||||
Other current liabilities | 4,130 | 379 | |||||
Total current liabilities | 14,487 | 8,397 | |||||
Long term liabilities | |||||||
Operating lease liabilities | 829 | 679 | |||||
Total long-term liabilities | 829 | 679 | |||||
Total liabilities | 15,316 | 9,076 | |||||
Commitments and contingencies (Note 4) | |||||||
Stockholders' equity: | |||||||
Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued | — | — | |||||
Common stock, $0.0001 par value; 130,000,000 shares authorized and | 2 | 2 | |||||
Additional paid-in capital | 278,534 | 266,823 | |||||
Accumulated other comprehensive loss | (1,398) | (4,112) | |||||
Accumulated deficit | (156,396) | (103,928) | |||||
Total stockholders' equity | 120,742 | 158,785 | |||||
Total liabilities and stockholders' equity | $ | 136,058 | $ | 167,861 |
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SOURCE Immunic, Inc.
Copyright 2021 PR Newswire
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