Full Press Release Details
Immunic, Inc. Reports First Quarter 2020
and Highlights Recent Activity
YORK, May 8, 2020 - 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 first quarter ended March 31, 2020 and highlighted recent activity.
"The global coronavirus disease 2019
(COVID-19) pandemic has led to a period of intense, additional focus for Immunic, as we quickly recognized the potential of our
lead asset, selective oral DHODH inhibitor, IMU-838, as a possible therapeutic for the treatment of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) infections, given its already well-recognized, broad-spectrum antiviral effects," stated Daniel
Vitt, Ph.D., Chief Executive Officer and President of Immunic. "After performing preclinical testing, we recently announced
that, in cellular assays, IMU-838 successfully demonstrated antiviral activity against SARS-CoV-2 at blood concentrations
which are well below those associated with IMU-838 dosing regimens studied in our ongoing and previous clinical trials.
Based on these positive results, we are preparing a phase 2 clinical development program for IMU-838 as a potential treatment for
this devastating disease."
Dr. Vitt continued, "On the heels
of this encouraging preclinical data, we were able to bolster our financial position with a successful $15.0 million financing.
As a result, we expect to be well funded through key, near-term milestones including top-line data from both our phase 2 trial
of IMU-838 for relapsing-remitting multiple sclerosis (RRMS), expected in the third quarter of this year, as well as results from
the investigator-sponsored phase 2 trial for IMU-838 in primary sclerosing cholangitis (PSC), expected in early 2021."
First Quarter 2020 and Subsequent Highlights
Anticipated Clinical Milestones
Financial and Operating Results
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 ROR t; 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 considered in Crohn's disease. The company is also investigating IMU-838 as a potential treatment option for
COVID-19. 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.
Statement Regarding Forward-Looking Statements
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 management's participation in conferences; 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; preclinical
and clinical data for IMU-838, IMU-935 and IMU-856; the timing of current and future clinical 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. 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, 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.immunic-therapeutics.com/sec-filings and on request from Immunic.
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.
Manager Investor Relations and Communications
Rx Communications Group
Condensed Consolidated Statements of
(In thousands, except share and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 6,434 | $ | 3,355 | ||||
| General and administrative | 2,580 | 1,307 | ||||||
| Total operating expenses | 9,014 | 4,662 | ||||||
| Loss from operations | (9,014) | (4,662) | ||||||
| Other income (expense): | ||||||||
| Interest income | 24 | - | ||||||
| Other income, net | 503 | 349 | ||||||
| Total other income | 527 | 349 | ||||||
| Net loss | $ | (8,487) | $ | (4,313) | ||||
| Net loss per share, basic and diluted | $ | (0.79) | $ | (5.09) | ||||
| Weighted-average common shares outstanding, basic and diluted | 10,749,460 | 846,953 |
Condensed Consolidated Balance Sheets
(In thousands, except share and per share
| March 31, 2020 | December 31, 2019 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 18,578 | $ | 29,369 | ||||
| Other current assets and prepaid expenses | 5,021 | 2,861 | ||||||
| Total current assets | 23,599 | 32,230 | ||||||
| Property and equipment, net | 77 | 80 | ||||||
| Goodwill | 32,970 | 32,970 | ||||||
| Right-of-use assets, net | 604 | 633 | ||||||
| Other long-term assets | 42 | 42 | ||||||
| Total assets | $ | 57,292 | $ | 65,955 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,432 | $ | 2,423 | ||||
| Accrued expenses | 3,963 | 3,298 | ||||||
| Other current liabilities | 938 | 1,351 | ||||||
| Total current liabilities | 6,333 | 7,072 | ||||||
| Long term liabilities | ||||||||
| Operating lease liabilities | 471 | 520 | ||||||
| Total long-term liabilities | 471 | 520 | ||||||
| Total liabilities | 6,804 | 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 March 31, 2020 and December 31, 2019 | - | - | ||||||
| Common stock, $0.0001 par value; 130,000,000 shares authorized and 10,823,551 and 10,744,806 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 120,567 | 119,646 | ||||||
| Accumulated other comprehensive loss | (1,682) | (1,373) | ||||||
| Accumulated deficit | (68,398) | (59,911) | ||||||
| Total stockholders' equity | 50,488 | 58,363 | ||||||
| Total liabilities and stockholders' equity | $ | 57,292 | $ | 65,955 |