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Immunic, Inc. Reports First Quarter 2021 Financial Results and Highlights Recent Activity - EMPhASIS Cohort 2 Interim Analysis Confirmed 30 mg Dose of IMU-838 as Most Appropriate for Planned Phase 3 Program in Relapsing-

Key Takeaway: Immunic, Inc. Reports First Quarter 2021 and Highlights Recent Activity EMPhASIS Cohort 2 Interim Analysis Confirmed 30 mg Dose of IMU-838 as Most Appropriate for Planned Phase 3 Program in Relapsing-Remitting Multiple Sclerosis, Expected to Begin in the Second Half of 2021 -

Full Press Release Details

Immunic, Inc. Reports First Quarter 2021
and Highlights Recent Activity
EMPhASIS Cohort 2 Interim Analysis Confirmed 30 mg Dose of IMU-838 as Most Appropriate for Planned Phase
3 Program in Relapsing-Remitting Multiple Sclerosis, Expected to Begin in the Second Half of 2021 -
Secured Full Rights to IMU-838 with Settlement of Remaining Royalty Obligation to 4SC AG for $17.25 Million (50% in Cash and 50% in Shares
of Immunic's Common Stock) -
$114.8 Million in Cash and Cash Equivalents Expected to Fund Immunic Into the Second Half of 2022 -
May 6, 2021 - 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, 2021 and highlighted recent activity.
"Our clinical program activities have continued
unabated, with significant progress having recently been achieved for our lead asset, selective oral DHODH inhibitor, IMU-838,"
stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Last month, we announced key interim data from our
phase 2 EMPhASIS Cohort 2 sub-trial of IMU-838 in patients with relapsing-remitting multiple sclerosis (RRMS), confirming 30 mg as the
most appropriate dose for our envisaged phase 3 program. We will now move directly to the filing of an Investigational New Drug (IND)
application in the United States and are currently working to complete the package, with the expectation of initiating the phase 3 program
in the second half of this year."
"Beyond RRMS, during the first quarter,
we reported positive top-line data from the investigator-sponsored, open-label phase 2 proof-of-concept trial of IMU-838 in primary sclerosing
cholangitis (PSC), conducted in collaboration with the Mayo Clinic. Results confirmed safety and tolerability and provided encouraging
activity signals. In order to find the optimized dose for future clinical activities in PSC, we plan to initiate a phase 1 trial in hepatic
impaired patients. Backed by the promising results from our phase 2 CALVID-1 trial of IMU-838 which underlined its broad antiviral activity,
our phase 2 trial in ulcerative colitis (UC) has seen recent strong recruitment which we expect to be completed in the second half of
Dr. Vitt added, "With the ongoing accumulation
of robust data for IMU-838, including repeated confirmation of safety and efficacy across multiple indications, we made a strategic decision
during the first quarter to settle our remaining royalty obligation to 4SC AG, giving us full rights to our most advanced asset and securing
our ability to unlock its future potential."
First Quarter 2021 and Subsequent Highlights
Meanwhile, additional available data
from the full analysis of all 223 randomized patients support the conclusions made in the main analysis and have provided data on a few
additional endpoints. Notably, the rate and timing of anti-SARS-CoV-2 antibodies patients are developing in response to the infection
was found to be identical between the IMU-838 and placebo treatment arms. The full analysis was also able to detect a relationship between
drug trough levels in blood plasma and the clinical recovery endpoint.
With the progressing rollout of vaccines
in many countries, however, the company believes that the opportunity to execute a phase 3 program as a monotherapy and to benefit from
any potential commercialization in this indication within a reasonable time frame is no longer viable.
Anticipated Clinical Milestones
Financial and Operating Results
(Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at 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, COVID-19, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR t, is
targeted for development in psoriasis and Guillain-Barr 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.
Statement Regarding Forward-Looking Statements
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;
clinical data for Immunic's development programs; the timing of current and future clinical trials; 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.
Head of Investor Relations and Communications
Rx Communications Group
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
Three Months Ended March 31,
2021 2020
Operating expenses:
Research and development $ 11,519 $ 6,434
General and administrative 20,868 2,580
Total operating expenses 32,387 9,014
Loss from operations (32,387 ) (9,014 )
Other income (expense):
Interest income 28 24
Other income (expense), net (2,175 ) 503
Total other income (expense) (2,147 ) 527
Net loss $ (34,534 ) $ (8,487 )
Net loss per share, basic and diluted $ (1.63 ) $ (0.79 )
Weighted-average common shares outstanding, basic and diluted 21,174,698 10,749,460
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
March 31, 2021 December 31, 2020
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 114,839 $ 127,452
Other current assets and prepaid expenses 5,441 6,293
Total current assets 120,280 133,745
Property and equipment, net 190 203
Goodwill 32,970 32,970
Right-of-use assets, net 1,242 901
Other long-term assets 42 42
Total assets $ 154,724 $ 167,861
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 10,048 $ 3,700
Accrued expenses 5,827 4,318
Other current liabilities 481 379
Total current liabilities 16,356 8,397
Long term liabilities
Operating lease liabilities 922 679
Total long-term liabilities 922 679
Total liabilities 17,278 9,076
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at March 31, 2021 and December 31, 2020 - -
Common stock, $0.0001 par value; 130,000,000 shares authorized and 21,749,439 and 21,168,240 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 2 2
Additional paid-in capital 277,027 266,823
Accumulated other comprehensive loss (1,121 ) (4,112 )
Accumulated deficit (138,462 ) (103,928 )
Total stockholders' equity 137,446 158,785
Total liabilities and stockholders' equity $ 154,724 $ 167,861
Last updated: May 6, 2021