Full Press Release Details
Inc. Reports Year End 2019 Financial Results and
- Top-Line Data from Phase 2 EMPhASIS
Trial in Relapsing-Remitting Multiple Sclerosis Expected
in Third Quarter 2020 -
- Cash of $29.4 Million Provides
Funding Through Key 2020 Inflection Points -
NEW YORK, March 16, 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 year ended December 31,
2019 and highlighted recent achievements.
"In addition to the closing of our
stock-for-stock exchange transaction with Vital Therapies, Inc., which provided our Nasdaq listing and a significant capital infusion,
2019 was punctuated by the attainment of other important milestones," stated Daniel Vitt, Ph.D., Chief Executive Officer
and President of Immunic. "Most notably, we completed enrollment for our phase 2 EMPhASIS trial of our lead compound, IMU-838,
for patients with relapsing-remitting multiple sclerosis (RRMS), roughly nine months ahead of our initial plan. With preclinical
data showing a solidly superior profile compared to DHODH inhibitor, teriflunomide, IMU-838 holds promise as an important new,
best-in-class oral therapy for RRMS and other underserved immunologic diseases. We anticipate reporting top-line results in the
third quarter of this year and believe that positive data could allow us to move quickly into a pivotal phase 3 trial.
"We also reported progress for IMU-838
in moderate-to-severe ulcerative colitis (UC) and primary sclerosing cholangitis (PSC), with a positive phase 2 interim dosing
analysis in UC and the initiation of our investigator-sponsored, phase 2 trial in PSC, led by the Mayo Clinic. Given that the interim
dosing analysis from the CALDOSE-1 study in patients with UC showed that it was likely not ineffective at the lowest 10 mg dose
and that none of the three dose levels revealed unacceptable intolerance, the trial was expanded to 240 patients and top-line data
is expected in the fourth quarter of 2021."
Dr. Vitt continued, "Our earlier
stage programs have also advanced, with the dosing of healthy volunteers in several dose cohorts in our phase 1 trial of IMU-935,
a potentially best-in-class inverse agonist of ROR t. Additionally, we plan to complete the preclinical and manufacturing
activities required in order to initiate phase 1 clinical studies of IMU-856, during the first half of this year, having just announced
in January 2020 the exercise of our option for the exclusive worldwide license to IMU-856 from Daiichi Sankyo, Co., Ltd. We are
highly encouraged by the data we have generated thus far for our programs, most especially for IMU-838, and look forward to additional
Upcoming Anticipated Clinical Milestones
Financial and Operating Results
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 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. 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, IMU-935 and IMU-856 to safely
and effectively target diseases; preclinical data for IMU-856; the timing of 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 IR and Communications
Rx Communications Group
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
| Years Ended December 31, | ||||||||
| 2019 | 2018 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 22,512 | $ | 9,595 | ||||
| General and administrative | 14,520 | 2,402 | ||||||
| Total operating expenses | 37,032 | 11,997 | ||||||
| Loss from operations | (37,032 | ) | (11,997 | ) | ||||
| Other income (expense): | ||||||||
| Interest income (expense) | 107 | (1 | ) | |||||
| Other income, net | 1,992 | 456 | ||||||
| Total other income | 2,099 | 455 | ||||||
| Net loss | $ | (34,933 | ) | $ | (11,542 | ) | ||
| Net loss per share, basic and diluted | $ | (4.52 | ) | $ | (13.63 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 7,722,269 | 846,953 |
Consolidated Balance Sheets
(In thousands, except share and per share
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 29,369 | $ | 13,072 | ||||
| Other current assets and prepaid expenses | 2,861 | 259 | ||||||
| Total current assets | 32,230 | 13,331 | ||||||
| Property and equipment, net | 80 | 40 | ||||||
| Goodwill | 32,970 | - | ||||||
| Right of use asset, net | 633 | - | ||||||
| Other long-term assets | 42 | - | ||||||
| Total assets | $ | 65,955 | $ | 13,371 | ||||
| Liabilities, Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,423 | $ | 1,400 | ||||
| Accrued expenses | 3,298 | 416 | ||||||
| Other current liabilities | 1,351 | 104 | ||||||
| Total current liabilities | 7,072 | 1,920 | ||||||
| Long-term liabilities: | ||||||||
| Operating lease liabilities | 520 | - | ||||||
| Total long-term liabilities | 520 | - | ||||||
| Total liabilities | 7,592 | 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 December 31, 2019 and 2018 | - | - | ||||||
| Common stock, $0.0001 par value; 130,000,000 and 846,953 shares authorized and 10,744,806 and 846,953 shares issued and outstanding at December 31, 2019 and 2018, respectively | 1 | - | ||||||
| Additional paid-in capital | 119,646 | 56 | ||||||
| Accumulated other comprehensive loss | (1,373 | ) | (819 | ) | ||||
| Accumulated deficit | (59,911 | ) | (24,978 | ) | ||||
| Total stockholders' equity (deficit) | 58,363 | (25,741 | ) | |||||
| Total liabilities, preferred stock and stockholders' equity (deficit) | $ | 65,955 | $ | 13,371 |