SAN DIEGO, Aug. 8, 2019 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a
clinical-stage biopharmaceutical company focused on
developing potentially best-in-class oral therapies for the
treatment of chronic inflammatory and autoimmune diseases, today
announced financial results for the second quarter ended
June 30, 2019 and highlights recent
activity.
"The April closing of our transaction with Vital Therapies,
listing on The Nasdaq Capital Market and capital infusion of
$30 million from a key investor
syndicate, have strengthened the company, increased our visibility
and allowed the team to meaningfully progress and soon expand our
product pipeline," stated Daniel
Vitt, Ph.D., Chief Executive Officer and President of
Immunic. "The pace of our recent activity and anticipated
milestones testifies to these efforts. As previously reported, we
expect to announce the findings from our interim dosing analysis of
IMU-838 as part of the CALDOSE-1 phase 2 study in patients with
moderate-to-severe ulcerative colitis during the third quarter of
2019. We expect that this data will inform dose selection for the
CALDOSE-2 phase 2 trial of IMU-838 in Crohn's disease patients,
expected to begin during the second half of the year. Further, we
plan to dose the first healthy volunteer as part of our phase 1
single and multiple ascending dose trials of IMU-935, directed by
our Australian subsidiary, during September. Additional key
inflection points are expected to follow next year."
Second Quarter 2019 and Subsequent Highlights:
- July 2019: Appointed Sanjay S.
Patel, CFA, as Chief Financial Officer, succeeding Interim Chief
Financial Officer, Tamara A.
Seymour, MBA.
- June 2019: Presented previously
unpublished preclinical data at the GI Inflammatory Diseases Summit
in Boston confirming that IMU-838,
currently in phase 2 clinical development for the treatment of
ulcerative colitis (UC) and relapsing-remitting multiple sclerosis
(RRMS), appears selective towards high producer T cells and acts in
a synergistic fashion with current anti-TNFa antibodies, such
as infliximab.
- June 2019: Filed an 8-K/A
containing certain financial statements and pro forma financial
information related to the transaction between the company
(formerly named Vital Therapies, Inc.) and Immunic AG, which closed
on April 12, 2019. An updated review
of Immunic's key development programs was also provided.
- June 2019: Presented newly
available preclinical data at the 2nd Conference on
Molecular Mechanisms of Inflammation in Trondheim, Norway, confirming IMU-935 as a highly potent
small molecule inverse agonist of RORγt with additional activity on
DHODH – which was shown to lead to a strong synergism on the
reduction of pro-inflammatory cytokine release and to potent
inhibition of Th17 differentiation while allowing normal thymocyte
maturation.
- April 2019: Completed
stock-for-stock exchange transaction between the company (formerly
named Vital Therapies, Inc.) and Immunic AG, and listed on The
Nasdaq Capital Market. Concurrently, raised $30 million from an investor syndicate including
LSP, Omega Funds, Fund+, LifeCare Partners, Bayern Kapital,
High-Tech Gründerfonds and IBG Beteiligungsgesellschaft
Sachsen-Anhalt.
Upcoming Anticipated Clinical Milestones
- Patient enrollment in Immunic's phase 2 CALDOSE-1 dose-finding
trial of IMU-838 in patients with moderate-to-severe UC is expected
to conclude during the second half of 2020 with top-line data
expected to be available in the first quarter of 2021. An interim
dosing analysis, which will inform the dose selection for the
company's CALDOSE-2 trial, is expected in the third quarter of
2019.
- Initiation of the phase 2 CALDOSE-2 dose-finding trial of
IMU-838 for the treatment of active Crohn's disease (CD) is on
track to begin in the second half of 2019.
- Patient recruitment in Immunic's phase 2 EMPhASIS trial of
IMU-838 in RRMS is expected to conclude in the first half of 2020,
with top line data expected to be available in the third quarter of
2020.
- A phase 1, double-blind, placebo-controlled, single ascending
dose trial of IMU-935 is expected to begin in September 2019. A phase 1, multiple ascending
dose trial of IMU-935 is expected to follow and management expects
to extend these studies in the first half of 2020 to assess safety
and mechanism-related biomarkers in psoriasis patients.
- An investigator-sponsored trial of IMU-838 in patients with
primary sclerosing cholangitis, being conducted by the Mayo Clinic,
is expected to begin enrollment in the second half of 2019.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$6.0 million for the three months
ended June 30, 2019, compared to
$2.2 million for the same period
ended June 30, 2018. The increase was
primarily attributable to i) higher external clinical development
costs for the company's IMU-838 program of $1.9 million and ii) a contingent payment,
triggered by the exchange agreement, under the asset purchase
agreement with 4SC AG settled in stock valued at $1.5 million.
For the six months ended June 30,
2019, R&D expenses were $9.4
million, compared to $3.9
million for the same period ended June 30, 2018. The increase is primarily due to
i) higher external development costs for the IMU-838 program of
$3.0 million, and ii) a contingent
payment under the asset purchase agreement with 4SC AG, triggered
by the exchange agreement with Immunic AG, settled in stock valued
at $1.5 million.
- General and Administrative (G&A) Expenses were
$9.0 million for the three months
ended June 30, 2018, compared to
$0.5 million for the period ended
June 30, 2018. The increase is
primarily attributable to i) one-time costs related to the exchange
agreement transaction, including $6.4
million of stock-based compensation for the company's
executives, key employees and members of the board of directors and
$1.2 million in transaction costs
related to the stock-for-stock exchange transaction with Immunic
AG, and ii) $0.6 million of public
company expenses.
For the six months ended June 30,
2019, G&A expenses were $10.3
million, compared to $1.0
million for the period ended June 30,
2018. The increase is primarily due to i) one-time costs
related to the exchange transaction including $6.4 million of stock-based compensation for the
company's executives, key employees and members of the board of
directors and $1.7 million of
transaction costs, and ii) $0.6
million of public company expenses.
- Other Income for the three months ended June 30, 2019 was $0.3
million compared to none for the three months ended
June 30, 2018. The increase is
primarily due to reimbursement of research and development expenses
in connection with the company's option and license agreement with
Daiichi Sankyo Co., Ltd.
Other income for the six months ended June
30, 2019 was $0.6 million
compared to $24,000 in the same
period of 2018. The increase is primarily due to $0.5 million in reimbursement of research and
development expenses in connection with the aforementioned option
and license agreement with Daiichi Sankyo Co., Ltd.
- Net Loss for the three months ended June 30, 2019 was approximately $14.7 million, or $1.52 per basic and diluted share, based on
9,669,129 weighted average common shares outstanding, compared to a
net loss of approximately $2.7
million, or $3.15 per basic
and diluted share, based on 846,953 weighted average common shares
outstanding for the three months ended June 30, 2018.
Net loss for the six months ended June 30,
2019 was approximately $19.0 million, or $3.60 per basic and diluted share, based on
5,282,412 weighted average common shares outstanding, compared to a
net loss of approximately $4.9 million, or $5.83 per basic and diluted share, based on
846,953 weighted average common shares outstanding for the six
months ended June 30, 2018.
Substantially all of the company's operating losses have resulted
from expenses incurred in connection with its research and
development programs and from general and administrative costs
associated with operations.
- Cash and Cash Equivalents, as of June 30, 2019, of $36.1
million is expected to fund the company's operations into
the third quarter of 2020.
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 in Crohn's disease planned for the second half
of 2019. An investigator-sponsored proof-of-concept
clinical trial for IMU-838 in primary sclerosing cholangitis is
planned to start at the Mayo Clinic. For further information,
please visit: www.immunic-therapeutics.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; the timing of future clinical trials
and expected results of such 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. 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.
Contact Information
Immunic, Inc.
Jessica Breu
Manager IR and Communications
+49 89 250 0794 69
jessica.breu@immunic.de
Or
Rx Communications Group
Melody Carey
+1-917-322-2571
immunic@rxir.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,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
6,029
|
|
|
$
|
2,157
|
|
|
$
|
9,384
|
|
|
$
|
3,940
|
|
General and
administrative
|
8,978
|
|
|
513
|
|
|
10,285
|
|
|
1,017
|
|
Total operating
expenses
|
15,007
|
|
|
2,670
|
|
|
19,669
|
|
|
4,957
|
|
Loss from
operations
|
(15,007)
|
|
|
(2,670)
|
|
|
(19,669)
|
|
|
(4,957)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest income
(expense)
|
34
|
|
|
—
|
|
|
34
|
|
|
(1)
|
|
Other income
(expense), net
|
259
|
|
|
—
|
|
|
608
|
|
|
25
|
|
Total other
income
|
293
|
|
|
—
|
|
|
642
|
|
|
24
|
|
Net loss
|
$
|
(14,714)
|
|
|
$
|
(2,670)
|
|
|
$
|
(19,027)
|
|
|
$
|
(4,933)
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
|
(1.52)
|
|
|
$
|
(3.15)
|
|
|
$
|
(3.60)
|
|
|
$
|
(5.82)
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding,
basic and diluted
|
9,669,129
|
|
|
846,953
|
|
|
5,282,412
|
|
|
846,953
|
|
Immunic, Inc.
Condensed Consolidated
Balance Sheets
(In thousands, except share and per share
amounts)
|
June 30,
2019
|
|
December 31,
2018
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
36,121
|
|
|
$
|
13,072
|
|
Note
receivable
|
920
|
|
|
—
|
|
Other current assets
and prepaid expenses
|
2,452
|
|
|
259
|
|
Total current
assets
|
39,493
|
|
|
13,331
|
|
Property and
equipment, net
|
43
|
|
|
40
|
|
Goodwill
|
32,970
|
|
|
—
|
|
Right of use assets,
net
|
68
|
|
|
—
|
|
Total
assets
|
$
|
72,574
|
|
|
$
|
13,371
|
|
Liabilities,
Preferred Stock and Stockholders' Equity (Deficit)
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
1,462
|
|
|
$
|
1,400
|
|
Accrued
expenses
|
1,586
|
|
|
416
|
|
Other current
liabilities
|
74
|
|
|
104
|
|
Total current
liabilities
|
3,122
|
|
|
1,920
|
|
Long-term
liabilities:
|
|
|
|
Other long-term
liabilities
|
41
|
|
|
—
|
|
Total long-term
liabilities
|
41
|
|
|
—
|
|
Total
liabilities
|
3,163
|
|
|
1,920
|
|
Commitments and
contingencies
|
|
|
|
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 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 June 30, 2019 and December 31, 2018
|
—
|
|
|
—
|
|
Common stock, $0.0001
par value; 130,000,000 and 846,953 shares authorized and
9,986,399 and 846,953 shares issued and outstanding at June 30,
2019 and
December 31, 2018, respectively
|
1
|
|
|
—
|
|
Additional paid-in
capital
|
114,137
|
|
|
56
|
|
Accumulated other
comprehensive (loss)
|
(722)
|
|
|
(819)
|
|
Accumulated
deficit
|
(44,005)
|
|
|
(24,978)
|
|
Total stockholders'
equity (deficit)
|
69,411
|
|
|
(25,741)
|
|
Total liabilities,
preferred stock and stockholders' equity (deficit)
|
$
|
72,574
|
|
|
$
|
13,371
|
|
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SOURCE Immunic, Inc.