NEW YORK, Nov. 7, 2019 /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 third quarter ended
September 30, 2019 and highlighted
recent activity.
"The third quarter was marked by several key clinical
milestones. Chief among them was the early completion of enrollment
for our phase 2 EMPhASIS trial for IMU-838 in relapsing-remitting
multiple sclerosis, nine months ahead of initial expectation,"
stated Daniel Vitt, Ph.D., Chief
Executive Officer and President of Immunic. "This achievement
demonstrates our ability to execute on the program and highlights
patients' urgent need for a safer oral treatment option for this
progressive, debilitating disease. We also reported positive
results from the interim dosing analysis of the CALDOSE-1 trial of
IMU-838 in moderate-to-severe ulcerative colitis. Specifically, the
data indicated a potentially broader active dose range than
originally thought, and the trial is continuing with all three
dosing arms. Based partially on these interim results, we
anticipate beginning the phase 2 CALDOSE-2 trial in Crohn's disease
next year. Additionally, during the third quarter, our Australian
subsidiary dosed the first healthy volunteer, on schedule, in the
phase 1 clinical program of IMU-935, which we believe holds
tremendous promise in multiple indications.
"On the operational side, I am pleased to announce that during
the first week of November, we opened an office in New York City which is planned to serve as our
U.S. corporate headquarters. The office is headed by our Chief
Financial Officer, Sanjay S. Patel,
who joined the company in July of this year. Additionally, we
announced the appointment of highly regarded industry veteran,
Tamar Howson, to our Board of
Directors in October. Tamar has immediately begun contributing her
knowledge and expertise and we are delighted to welcome her to
Immunic's growing team," Dr. Vitt added.
Third Quarter 2019 and Subsequent Highlights
- October 2019: Expanded Board of
Directors to six members, with appointment of industry veteran,
Tamar Howson.
- October 2019: Announced early
completion of enrollment for phase 2 EMPhASIS trial of lead
compound, IMU-838, in patients with relapsing-remitting multiple
sclerosis (RRMS).
- September 2019: Announced dosing
of first healthy volunteer in phase 1 clinical program of IMU-935,
a potentially best-in-class RORγt inverse agonist which holds
promise as a treatment for various inflammatory and autoimmune
diseases.
- September 2019: Presented
selected available and previously unpublished preclinical data
confirming the favorable profile of IMU-838, as compared to the
DHODH inhibitor, teriflunomide, at the Congress of the European
Committee for the Treatment and Research in Multiple Sclerosis
(ECTRIMS) 2019, held in Stockholm,
Sweden.
- September 2019: Reported positive
interim dosing analysis results from phase 2 CALDOSE-1 study of
IMU-838 in patients with moderate-to-severe ulcerative colitis
(UC). Results showed that the study's lowest, 10 mg dose was not
likely ineffective, that the highest, 45 mg dose was not
intolerable and that no safety signal was identified for any of the
trial's three doses. The study is continuing with all three dosing
arms and the overall number of anticipated patients in the trial
has been expanded to 240 from 195.
- August 2019: Announced first
patient enrolled in an investigator-sponsored proof-of-concept
clinical trial of IMU-838 for the treatment of patients with
primary sclerosing cholangitis (PSC), being conducted in
collaboration with investigators at Arizona
State University and the Mayo Clinic.
- August 2019: Awarded research
grant from the German Federal Ministry of Education and Research of
up to approximately $730,000 in
support of the InnoMuNiCH project. The grant funds will be used to
fund a three-year research project by the company and three
partners to study the effect of small molecule compounds on
cellular metabolism and their impact on the development of T helper
cells and the corresponding regulation of relevant proteins.
- July 2019: Appointed Sanjay S.
Patel, CFA, as Chief Financial Officer, succeeding Interim Chief
Financial Officer, Tamara A.
Seymour, MBA.
Anticipated Clinical Milestones
- Top-line data from Immunic's phase 2 EMPhASIS trial of IMU-838
in RRMS is expected to be available in the third quarter of
2020.
- Phase 2 CALDOSE-1 trial of IMU-838 in patients with
moderate-to-severe UC is ongoing with expanded number of patients;
top-line data is expected during the fourth quarter of 2021.
- Initiation of the phase 2 CALDOSE-2 trial of IMU-838 for the
treatment of Crohn's disease (CD) is expected to begin in 2020,
after (i) completion of a full review of the interim dosing
analysis from CALDOSE-1 (which will guide the definition of
suitable dose strengths for CALDOSE-2), and (ii) consulting with
the appropriate regulatory authorities.
- Proof-of-concept trial underway for IMU-838 in PSC at the Mayo
Clinic in Arizona and Minnesota. Positive data may enable Immunic to
immediately begin a pivotal trial, especially given IMU-838's
best-in-class DHODH inhibitor safety profile and IND already
established in intestinal bowel disease.
- Subsequent to the ongoing phase 1, double-blind,
placebo-controlled, single ascending dose trial of IMU-935 in
healthy volunteers, Immunic plans to initiate a second phase 1,
multiple ascending dose, double-blind, placebo-controlled trial in
healthy volunteers. An extension of the studies, in patients with
psoriasis, is anticipated to begin in the first half of 2020.
- Phase 1 clinical trials of IMU-856, aimed at restoring the
intestinal barrier function without impairing the immune system,
are expected to begin during the first half of 2020.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$7.1 million for the three months
ended September 30, 2019, as compared
to $1.4 million for the same period
ended September 30, 2018. The
increase was primarily attributable to (i) higher external
development costs for the company's IMU-838 program for the phase 2
clinical trials in patients with relapsing-remitting multiple
sclerosis and ulcerative colitis and preparation costs related to
the phase 2 clinical trial for patients with Crohn's disease,
totaling $4.4 million and (ii)
preclinical and drug supply costs related to the IMU-856 program of
$0.8 million.
For the nine months ended September 30,
2019, R&D expenses were $16.5
million, as compared to $5.4
million for the same period ended September 30, 2018. The increase is primarily due
to (i) higher external development costs for the company's IMU-838
program for the phase 2 clinical trials in patients with
relapsing-remitting multiple sclerosis and ulcerative colitis and
preparation costs related to a phase 2 clinical trial in patients
with Crohn's disease totaling $7.4
million, (ii) preclinical and drug supply costs related to
the IMU-856 program of $1.2 million,
(iii) a contingent payment under the asset purchase agreement with
4SC AG, triggered by the stock-for-stock exchange transaction
completed on April 12, 2019 (Exchange
Transaction), settled in stock, valued at $1.5 million and (iv) an increase in drug supply
costs to support clinical development of $0.7 million.
- General and Administrative (G&A) Expenses were
$2.1 million for the three months
ended September 30, 2019, as compared
to $0.4 million for the same period
ended September 30, 2018. The
increase is primarily attributable to (i) an increase of personnel
expenses of $0.2 million in the
company's German offices, (ii) an increase of legal and consulting
costs of $0.2 million and (iii)
$1.1 million related to becoming a
public company, including directors and officers liability
insurance and personnel costs for executives and staff in the U.S.
corporate headquarters.
For the nine months ended September 30,
2019, G&A expenses were $12.4
million, as compared to $1.4
million for the same period ended September 30, 2018. The increase is primarily due
to (i) one-time costs related to the completion of the Exchange
Transaction, including $6.4 million
of stock-based compensation for executives, key employees and
members of the Board and $1.7 million
in investment bank and legal fees and (ii) $1.7 million related to becoming a public company
including directors and officers liability insurance and personnel
costs for executives and staff in the U.S. corporate
headquarters.
- Other Income for the three months ended September 30, 2019 was $1.0 million, as compared to $8,000 for the same period ended September 30, 2018. The increase is primarily due
to (i) a $0.6 million reimbursement
of R&D expenses in connection with the option and license
agreement with Daiichi Sankyo Co., Ltd., and (ii) the $0.4 million difference between the face value
and fair value of the promissory note collected in full in
September 2019 in connection with the
sale of certain clinical development-related assets and related
intellectual property rights ("ELAD Assets"), offset by a
$0.1 million write-off of the equity
interest in Vital Therapies (Beijing) Company Limited (VTL China) included
in the ELAD Assets sale.
Other income for the nine months ended September 30, 2019 was $1.6 million, as compared to $32,000 for the same period ended September 30, 2018. The increase is primarily due
to (i) a $1.1 million reimbursement
of R&D expenses in connection with the option and license
agreement with Daiichi Sankyo Co., Ltd., and (ii) the $0.4 million difference between the face value
and fair value of the promissory note collected in full in
September 2019 in connection with the
sale of ELAD Assets, offset by a $0.1
million write-off of the equity interest in VTL China
included in the ELAD Assets sale.
- Net Loss for the three months ended September 30, 2019 was approximately $8.2 million, or $0.82 per basic and diluted share, based on
10,022,856 weighted average common shares outstanding, compared to
a net loss of approximately $1.8
million, or $2.12 per basic
and diluted share, based on 846,953 weighted average common shares
outstanding for the same period ended September 30, 2018.
Net loss for the nine months ended September
30, 2019 was approximately $27.2 million, or $3.96 per basic and diluted share, based on
6,880,057 weighted average common shares outstanding, compared to a
net loss of approximately $6.7 million, or $7.95 per basic and diluted share, based on
846,953 weighted average common shares outstanding for the same
period ended September 30, 2018.
Substantially all of the company's operating losses have resulted
from expenses incurred in connection with its R&D programs and
from general and administrative costs associated with
operations.
- Cash and Cash Equivalents, as of September 30, 2019, of $30.5 million is expected to fund the company's
operations into the fourth 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 planned 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.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 September 30,
|
|
Nine
Months
Ended September 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
7,102
|
|
$
|
1,410
|
|
$
|
16,486
|
|
$
|
5,350
|
General and
administrative
|
2,075
|
|
395
|
|
12,360
|
|
1,412
|
Total operating
expenses
|
9,177
|
|
1,805
|
|
28,846
|
|
6,762
|
Loss from
operations
|
(9,177)
|
|
(1,805)
|
|
(28,846)
|
|
(6,762)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest income
(expense)
|
58
|
|
—
|
|
92
|
|
(1)
|
Other income,
net
|
904
|
|
8
|
|
1,512
|
|
33
|
Total other
income
|
962
|
|
8
|
|
1,604
|
|
32
|
Net loss
|
$
|
(8,215)
|
|
$
|
(1,797)
|
|
$
|
(27,242)
|
|
$
|
(6,730)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
|
(0.82)
|
|
$
|
(2.12)
|
|
$
|
(3.96)
|
|
$
|
(7.95)
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding, basic and diluted
|
10,022,856
|
|
846,953
|
|
6,880,057
|
|
846,953
|
Immunic,
Inc.
|
Condensed
Consolidated Balance Sheets
|
|
(In thousands,
except share and per share amounts)
|
|
|
September 30,
2019
|
|
December 31,
2018
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
30,460
|
|
$
|
13,072
|
Other current assets
and prepaid expenses
|
4,059
|
|
259
|
Total current
assets
|
34,519
|
|
13,331
|
Property and
equipment, net
|
44
|
|
40
|
Goodwill
|
32,970
|
|
—
|
Right of use assets,
net
|
71
|
|
—
|
Total
assets
|
$
|
67,604
|
|
$
|
13,371
|
Liabilities,
Preferred Stock and Stockholders' Equity (Deficit)
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
3,718
|
|
$
|
1,400
|
Accrued
expenses
|
3,236
|
|
416
|
Other current
liabilities
|
82
|
|
104
|
Total current
liabilities
|
7,036
|
|
1,920
|
Long-term
liabilities:
|
|
|
|
Other long-term
liabilities
|
41
|
|
—
|
Total long-term
liabilities
|
41
|
|
—
|
Total
liabilities
|
7,077
|
|
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 September 30, 2019 and December 31, 2018
|
—
|
|
—
|
Common stock, $0.0001
par value; 130,000,000 and 846,953 shares authorized and 10,070,680
and 846,953 shares issued and outstanding at September 30, 2019 and
December 31, 2018, respectively
|
1
|
|
—
|
Additional paid-in
capital
|
114,550
|
|
56
|
Accumulated other
comprehensive loss
|
(1,804)
|
|
(819)
|
Accumulated
deficit
|
(52,220)
|
|
(24,978)
|
Total stockholders'
equity (deficit)
|
60,527
|
|
(25,741)
|
Total liabilities,
preferred stock and stockholders' equity (deficit)
|
$
|
67,604
|
|
$
|
13,371
|
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SOURCE Immunic, Inc.