NEW YORK, March 16, 2020 /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 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 RORγt. 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 success in 2020."
Recent Highlights
- January 2020: Exercised option
from Daiichi Sankyo Co., Ltd. for the exclusive worldwide license
to a group of compounds, designated by Immunic as IMU-856, aimed at
restoring intestinal barrier function.
- December 2019: Presented data,
for the first time, on IMU-856, at the Crohn's and Colitis
Foundation IBD Innovate Conference. The presentation highlighted
preclinical data indicating that the compound potentially restores
intestinal barrier function without impairing the immune system.
This represents a new and possibly disruptive approach for the
treatment of intestinal diseases.
- November 2019: Expanded the Board
of Directors to seven members with the appointment of biotechnology
executive Barclay "Buck" A. Phillips.
- October 2019: Expanded the Board
of Directors to six members with the appointment of industry
veteran Tamar Howson.
- October 2019: Announced early
completion of patient enrollment (nine months ahead of initial
schedule) for the phase 2 EMPhASIS trial of IMU-838, for the
treatment of RRMS.
Upcoming Anticipated Clinical Milestones
- Top-line data from the phase 2 EMPhASIS trial in RRMS is
expected to be available in the third quarter of 2020.
- Completion of the preclinical and manufacturing activities that
are necessary for the initiation of phase 1 clinical studies of
IMU-856 is expected during the first half of 2020.
- The current, single ascending dose trial of IMU-935 is planned
to be followed by a phase 1 multiple ascending dose trial in
healthy volunteers and a phase 1 trial in patients with
mild-to-moderate psoriasis; both are expected to start during the
first half of this year.
- Top-line data from the phase 2 CALDOSE-1 trial in UC is
expected to be available during the fourth quarter of 2021.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$22.5 million for the year ended
December 31, 2019, compared to
$9.6 million for the same period
during 2018, an increase of $12.9
million. The increase is primarily due to (i) higher
external development costs for the company's IMU-838 program for
the phase 2 clinical trial in patients with RRMS and UC and
preparation costs related to the phase 2 clinical trial for
patients with Crohn's disease totaling $8.3
million, (ii) an increase of drug supply costs to support
clinical trials of IMU-838 totaling $1.5
million, (iii) a contingent payment under the asset purchase
agreement with 4SC AG settled in stock valued at $1.5 million, (iv) external R&D costs related
to the company's IMU-856 program of $1.1
million and (v) $0.5 million
related to increases across numerous categories.
- General and Administrative (G&A) Expenses were
$14.5 million for the year ended
December 31, 2019, compared to
$2.4 million for the same period
during 2018, an increase of $12.1
million. The increase is primarily due to (i) one-time costs
related to the stock-for-stock exchange transaction completed on
April 12, 2019 with Vital Therapies,
including $6.4 million of stock-based
compensation for executives, key employees and members of the board
and $1.7 million of investment
banking and legal fees, (ii) $2.6
million related to becoming a public company, including
directors and officers liability insurance, audit and legal fees
and personnel costs for executives and staff in the U.S. corporate
headquarters, (iii) $0.5 million
related to travel and (iv) $0.9
million related to increases across numerous
categories.
- Other Income for the year ended December 31, 2019 was $2.1
million compared to $450,000
for the same period of 2018, an increase of $1.6 million. The increase is primarily
attributable to a $0.9 million
year-over-year increase in reimbursement of research and
development expenses in connection with the option and license
agreement with Daiichi Sankyo Co., Ltd., the $0.3 million as a result of the sale of certain
of Vital Therapies' clinical development-related assets and related
intellectual property, $0.3 million
related to research and development tax incentives for clinical
trials in Australia and
$0.1 million related to interest
income.
- Net Loss for year ended December
31, 2019 was approximately $34.9 million, or $4.52 per basic and diluted share, based on
7,722,269 weighted average common shares outstanding, compared to a
net loss of approximately $11.5 million, or $13.63 per basic and diluted share, based on
846,953 weighted average common shares outstanding for the year
ended December 31, 2018.
Substantially all of the company's operating losses resulted from
expenses incurred in connection with its R&D programs and from
G&A costs associated with operations.
- Cash and Cash Equivalents, as of December 31, 2019, of $29.4 million, is expected to fund the company's
operations into the first quarter of 2021.
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 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.
Contact Information
Immunic, Inc.
Jessica Breu
Manager IR and Communications
+49 89 2080 477 09
jessica.breu@imux.com
Or
Rx Communications Group
Melody
Carey
+1-917-322-2571
immunic@rxir.com
Financials
Immunic,
Inc.
|
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
|
Immunic,
Inc.
|
Consolidated
Balance Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
|
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
|
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SOURCE Immunic, Inc.