NEW YORK, Nov. 5, 2020 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical
company developing a pipeline of selective oral immunology
therapies aimed at treating chronic inflammatory and autoimmune
diseases, today announced financial results for the third quarter
ended September 30, 2020 and provides
corporate update.
"The third quarter was marked by a significant achievement for
our lead asset, selective oral DHODH inhibitor, IMU-838, with the
release of top-line data from our phase 2 EMPhASIS trial in
patients with relapsing-remitting multiple sclerosis, and
subsequent publication of the full unblinded data set. IMU-838
demonstrated robust efficacy, through the achievement of all
primary and key secondary endpoints, combined with an outstanding
safety and tolerability profile. We believe that the phase 2
results emphasize the game-changing potential of IMU-838 as a
once-daily oral therapy for this indication," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "On the heels of this overwhelmingly positive
data, we completed a successful common stock offering, raising
$103.5 million in gross proceeds,
significantly bolstering our balance sheet. We are currently
preparing our end-of-phase 2 submission for IMU-838 in
relapsing-remitting multiple sclerosis to regulatory authorities,
anticipated in the first quarter of next year, after which we look
forward to scheduling our end-of-phase 2 meetings, during which we
will have the opportunity to discuss our plans for a phase 3
program."
Dr. Vitt continued, "We have also made notable strides in our
development of IMU-838 in patients with moderate COVID-19, most
recently securing a financing agreement of up to €24.5 million
(approximately $29 million) with the
European Investment Bank for the ongoing development of our phase 2
CALVID-1 trial, a potential expansion into a confirmatory phase 3
trial and commercial-scale manufacturing of IMU-838. Additionally,
we reported that an Independent Data Monitoring Committee
recommended the continuation, without changes, of the CALVID-1
trial after an interim safety analysis. Recruitment has accelerated
due to the spread of disease within the countries included in the
trial and, at the beginning of November, we reached the enrollment
goal of 200 patients, pre-specified in the protocol as sufficient
to perform the main efficacy analysis of the phase 2 part of the
CALVID-1 trial. The data of this unblinded main analysis of all
available efficacy, biomarker and virus titer data is expected to
be available in the first quarter of next year."
The company's current cash position of approximately
$133.2 million, at September 30, 2020, is expected to fund
activities into the second half of 2022, and specifically through
key value inflection points including those for the COVID-19 phase
2 trial with IMU-838; preparation for, and initiation of, a phase 3
trial of IMU-838 in relapsing-remitting multiple sclerosis (RRMS);
the phase 2 readouts of IMU-838 in patients with ulcerative colitis
(UC) and primary sclerosing cholangitis (PSC); as well as
completion of the phase 1 trials of IMU-935 and IMU-856,
respectively, including pharmacodynamic evaluations in patients for
both of these trials.
Third Quarter 2020 and Subsequent Highlights
- November 2020: Announced 200
patients enrolled and randomized in phase 2 CALVID-1 trial of
IMU-838 for the treatment of moderate COVID-19, allowing for main
phase 2 efficacy analysis to proceed.
- October 2020: Signed financing
agreement with the European Investment Bank for up to €24.5 million
(approximately $29 million) to
support the development of IMU-838 in patients with moderate
COVID-19.
- September 2020: Announced results
of interim safety analysis from ongoing phase 2 CALVID-1 trial of
IMU-838 in patients with moderate COVID-19. Independent Data
Monitoring Committee recommended continuation of the trial without
changes.
- September 2020: Published full
unblinded clinical data set from phase 2 EMPhASIS trial of IMU-838
in patients with RRMS and announced poster presentation at the
MSVirtual2020/8th Joint ACTRIMS-ECTRIMS Meeting. Data confirmed and
expanded on the previously announced top-line results, which showed
achievement of all primary and secondary endpoints.
- August 2020: Dosed first healthy
volunteer in phase 1 clinical program of IMU-856, targeting
restoration of intestinal barrier function.
- August 2020: Completed a
$103.5 million public offering of
5,750,000 shares of common stock, including the full exercise of
underwriters' option to purchase an additional 750,000 shares.
- August 2020: Announced positive
top-line data from phase 2 EMPhASIS trial of IMU-838 in patients
with RRMS. Study met all primary and key secondary endpoints,
indicating activity in RRMS patients.
- July 2020: Enrolled first
patients in investigator-sponsored phase 2 IONIC trial of IMU-838
in combination with Oseltamivir (Tamiflu®), in collaboration with
sponsor and lead site, University Hospitals Coventry and
Warwickshire (UHCW) NHS Trust.
Update on Activities Relating to the Preparation of a Phase 3
Program for IMU-838 in RRMS
As previously announced, the full unblinded clinical data set
from the company's phase 2 trial of IMU-838 in patients with RRMS
showed achievement of all primary and key secondary endpoints, with
high statistical significance. Notably, both doses (30 and 45
mg/day) appeared to be equally safe and efficacious, reducing the
number of combined unique active (CUA) magnetic resonance imaging
(MRI) lesions up to week 24, as compared to placebo. Based on this
phase 2 data as well as established regulatory guidance that the
lowest effective dose should be considered for future clinical
trials, Immunic may propose the dose of 30 mg/day of IMU-838 for
investigation in a phase 3 program.
Given the relative equal performance of the two doses tested,
however, and to allow for pharmacodynamic modeling of the
dose-response relationship, data from a lower dose in the effective
dose range would be beneficial to complete a dose-effect assessment
of IMU-838 in RRMS. For this reason, Immunic has already started an
additional, small Cohort 2 sub-trial to obtain exploratory data on
the expanded dose response of IMU-838. This additional,
double-blind assessment includes a cohort of 60 patients who
receive 10 mg/day of IMU-838 or placebo for 24 weeks. The
still-active sites of the phase 2 trial of IMU-838 in RRMS continue
to be used and, as a result, the company expects that this
assessment can be executed in an accelerated fashion. This
additional sub-trial is not expected to change any conclusions for
dosing of IMU-838 in a future phase 3 program. Rather, it is
expected to provide additional data to address any potential
regulatory requests in the context of the design of a phase 3
program. Management believes that this strategy will enable risk
reduction for end-of-phase 2 discussions with regulatory
agencies.
The company intends to separate formal end-of-phase 2 meeting
preparations from regulatory advice for non-clinical phase 3
related topics to be submitted to regulatory authorities in the
near future. Subsequently, the company intends to submit formal
end-of-phase 2 meeting requests with a sole focus on the phase 2
data, including the Cohort 2 interim data, and a proposed phase 3
program to regulatory authorities at the end of the first quarter
2021. The end-of-phase 2 meetings are expected to be held in or
about May 2021.
In parallel to the preparation and execution of the regulatory
discussions, Immunic has begun performing formal feasibility
activities for a phase 3 program of IMU-838 in RRMS, including
country and site selection, as well as other preparatory
activities. The company also believes that this feasibility
assessment will help ensure an expeditious execution of the
development strategy for IMU-838.
Additional Anticipated Clinical Milestones
- IMU-838 in PSC: Due to the COVID-19 pandemic,
recruitment for the phase 2, investigator-sponsored
proof-of-concept clinical trial for IMU-838 in PSC, being conducted
at the Mayo Clinic, is currently paused as patients with PSC are
considered high risk for COVID-19 infections and were advised by
the investigators to avoid travelling to the clinical sites.
Together with the investigators, Immunic currently expects a
potential data readout during the fourth quarter of 2020 using the
18 patients who were enrolled prior to the COVID-19 pandemic. The
overall recruitment target for this open-label study is 30
patients.
- IMU-838 in COVID-19: Top-line efficacy, biomarker and
virus titer data from the phase 2 CALVID-1 trial of IMU-838 in
patients with moderate COVID-19, based on approximately 200
patients treated, is expected to be available in the first quarter
of 2021, after which the company will be able to evaluate whether
the program may be expanded into a confirmatory phase 3 trial.
- IMU-838 in UC: Although the recruitment of the phase 2
clinical trial of IMU-838 for the treatment of UC has continued
during the COVID-19 pandemic, the pandemic has affected, among
other things, access to endoscopy sites or hospitals in some
countries, which has interfered with recruitment speed, new site
activations and clinical site access. As a result, top-line data is
now expected to be available in the first half of 2022, instead of
in the fourth quarter of 2021 as previously announced.
- IMU-935 phase 1 program: The current, single ascending
dose part of the ongoing phase 1 trial of IMU-935 is planned to be
followed by a multiple ascending dose portion in healthy volunteers
and a safety evaluation in patients with mild-to-moderate
psoriasis. The trial has been resumed after a temporary pause of
trials in healthy volunteers imposed by ethics committees in
Australia due to COVID-19.
Unblinded safety data from the single and multiple ascending dose
parts in healthy volunteers is expected to be available in the
first half of 2021. Initiation of the third portion in patients
with mild-to-moderate psoriasis is expected in the first half of
2021 and is expected to last approximately 12 months.
- Potential IMU-935 phase 2 trial in an orphan autoimmune
disorder: Upon completion of the single and multiple ascending
dose portions of the ongoing phase 1 trial, Immunic anticipates
that it may also begin a phase 2 proof-of-concept clinical trial of
IMU-935 in an orphan autoimmune indication. This orphan approach
may allow for an accelerated path to approval, in parallel to
IMU-935's previously planned development in psoriasis. After a
thorough review of suitable autoimmune conditions, the company has
targeted IMU-935 for further development in Guillain-Barré
syndrome, an acute neurological disorder in which the body's immune
system attacks its peripheral nervous system, and for which very
few therapies exist. The company plans to announce additional
details as soon as design and timing of the envisaged trial are
defined.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$11.0 million for the three months
ended September 30, 2020, as compared
to $7.1 million for the same period
ended September 30, 2019. The
$3.9 million increase was primarily
attributable to (i) a $2.9 million
increase in external development costs for IMU-838, related to the
phase 2 clinical trial in patients with COVID-19, (ii) a
$2.2 million increase in license
fees, drug supply and phase 1 costs related to IMU-856, (iii) a
$0.6 million increase in development
costs for the IMU-935 program, and (iv) a $0.5 million increase in personnel costs. The
increases were partially offset by a decrease of $2.3 million in costs related to the phase 2
clinical trial of IMU-838 in patients with RRMS.
For the nine months ended September 30,
2020, R&D expenses were $27.5
million, as compared to $16.5
million for the same period ended September 30, 2019. The $11.0 million increase was primarily attributable
to (i) a $4.8 million increase in
external development costs for IMU-838, related to the phase 2
clinical trial in patients with COVID-19, (ii) a $4.5 million increase in license fees, drug
supply and phase 1 costs related to IMU-856, (iii) a $1.4 million increase in drug supply costs
related to IMU-935, (iv) a $1.2
million increase in drug supply costs related to IMU-838,
and (v) a $0.6 million increase in
personnel costs. The increases were partially offset by a decrease
of $1.5 million related to the phase
2 clinical trial of IMU-838 in patients with RRMS.
- General and Administrative (G&A) Expenses were
$2.5 million for the three months
ended September 30, 2020, as compared
to $2.1 million for the same period
ended September 30, 2019. The
$0.4 million increase was primarily
due to increased personnel expenses.
For the nine months ended September 30,
2020, G&A expenses were $7.3
million, as compared to $12.4
million for the same period ended September 30, 2019. The $5.0 million decrease was primarily due to (i)
non-recurring costs related to the transaction with Vital Therapies
including $6.4 million of stock-based
compensation for company executives, key employees and members of
the board of directors, and (ii) $2.1
million of non-recurring investment banking and legal fees
in the first nine months of 2019. The decrease was partially offset
by (i) a $2.3 million increase in
personnel expenses, (ii) $1.0 million
of increased legal, accounting and consultancy costs, and (iii)
$0.2 million of increased costs
across numerous categories primarily due to becoming a public
company and expanding operations in the
United States.
- Other Income was $0.6
million for the three months ended September 30, 2020, as compared to $0.9 million for the same period ended
September 30, 2019. The $0.3 million decrease was primarily attributable
to 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 assets of Vital Therapies
(ELAD Assets), partially offset by the $0.1
million write-off of the investment in Vital Therapies
(Beijing) Company Limited (VTL
China) included in the ELAD Assets sale.
For the nine months ended September 30,
2020, other income was $1.9
million, as compared to $1.6
million for the same period ended September 30, 2019. The $0.3 million increase was primarily attributable
to $0.7 million of R&D tax
incentives for clinical trials in Australia as a result of increased spending on
clinical trials in Australia,
partially offset by a decrease attributable to (i) 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 the $0.1
million write-off of the investment in VTL China included in
the ELAD Assets sale, and (ii) a $0.1
million decrease of recognized income attributable to
reimbursements of R&D expenses in connection with the option
agreement with Daiichi Sankyo Co., Ltd.
- Net Loss for the three months ended September 30, 2020 was approximately $12.9 million, or $0.70 per basic and diluted share, based on
18,405,840 weighted average common shares outstanding, compared to
a net loss of approximately $8.2
million, or $0.82 per basic
and diluted share, based on 10,022,856 weighted average common
shares outstanding for the same period ended September 30, 2019.
Net loss for the nine months ended September
30, 2020 was approximately $32.9
million, or $2.35 per basic
and diluted share, based on 13,966,690 weighted average common
shares outstanding, compared to a net loss of approximately
$27.2 million, or $3.96 per basic and dilutes share, based on
6,880,057 weighted average common shares outstanding for the same
period ended September 30, 2019.
- Cash and Cash Equivalents, as of September 30, 2020, were $133.2 million, which management expects to be
sufficient to fund operations into the second half of 2022.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage
biopharmaceutical company with 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.
Immunic is developing three small molecule products: its lead
development program, IMU-838, is 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; IMU-935 is an inverse agonist of RORγt; and IMU-856 targets
the restoration of the intestinal barrier function. Immunic
announced positive results from its phase 2 EMPhASIS trial of
IMU-838 in patients with relapsing-remitting multiple sclerosis,
reporting achievement of both primary and key secondary endpoints
with high statistical significance. IMU-838 is also in phase 2
clinical development for ulcerative colitis and COVID-19, 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 to safely and effectively target diseases; clinical data
for IMU-838; the timing of current and future clinical trials; the
potential for IMU-838 as a treatment for severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) infections associated with
coronavirus disease 2019 (COVID-19) and any clinical trials,
collaborations and approvals relating to such potential treatment;
the future use of the EIB venture loan; 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, 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, 2019, filed with the SEC on
March 16, 2020, the company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 3, 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.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.
Contact Information
Immunic, Inc.
Jessica
Breu
Head of Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Melody Carey
+1 917 322 2571
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.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,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
11,040
|
|
|
$
|
7,102
|
|
|
$
|
27,461
|
|
|
$
|
16,486
|
|
General and
administrative
|
|
2,505
|
|
|
2,075
|
|
|
7,320
|
|
|
12,360
|
|
Total operating
expenses
|
|
13,545
|
|
|
9,177
|
|
|
34,781
|
|
|
28,846
|
|
Loss from
operations
|
|
(13,545)
|
|
|
(9,177)
|
|
|
(34,781)
|
|
|
(28,846)
|
|
Other
income:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
20
|
|
|
58
|
|
|
48
|
|
|
92
|
|
Other income,
net
|
|
612
|
|
|
904
|
|
|
1,875
|
|
|
1,512
|
|
Total other
income
|
|
632
|
|
|
962
|
|
|
1,923
|
|
|
1,604
|
|
Net loss
|
|
$
|
(12,913)
|
|
|
$
|
(8,215)
|
|
|
$
|
(32,858)
|
|
|
$
|
(27,242)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.70)
|
|
|
$
|
(0.82)
|
|
|
$
|
(2.35)
|
|
|
$
|
(3.96)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares
outstanding, basic and diluted
|
|
18,405,840
|
|
|
10,022,856
|
|
|
13,966,690
|
|
|
6,880,057
|
|
Immunic,
Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share
amounts)
|
|
|
September 30,
2020
|
|
December 31,
2019
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
133,183
|
|
|
$
|
29,369
|
|
Other current assets
and prepaid expenses
|
4,358
|
|
|
2,861
|
|
Total current
assets
|
137,541
|
|
|
32,230
|
|
Property and
equipment, net
|
147
|
|
|
80
|
|
Goodwill
|
32,970
|
|
|
32,970
|
|
Right-of-use assets,
net
|
940
|
|
|
633
|
|
Other long-term
assets
|
42
|
|
|
42
|
|
Total
assets
|
$
|
171,640
|
|
|
$
|
65,955
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
3,419
|
|
|
$
|
2,423
|
|
Accrued
expenses
|
4,253
|
|
|
3,298
|
|
Other current
liabilities
|
358
|
|
|
1,351
|
|
Total current
liabilities
|
8,030
|
|
|
7,072
|
|
Long term
liabilities
|
|
|
|
Operating lease
liabilities
|
735
|
|
|
520
|
|
Total long-term
liabilities
|
735
|
|
|
520
|
|
Total
liabilities
|
8,765
|
|
|
7,592
|
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.0001 par value; 20,000,000 authorized and no shares
issued or outstanding at September 30, 2020 and December 31,
2019
|
—
|
|
|
—
|
|
Common stock, $0.0001
par value; 130,000,000 shares authorized and
20,718,340 and 10,744,806 shares issued and outstanding as of
September
30, 2020 and December 31, 2019, respectively
|
2
|
|
|
1
|
|
Additional paid-in
capital
|
257,394
|
|
|
119,646
|
|
Accumulated other
comprehensive loss
|
(1,752)
|
|
|
(1,373)
|
|
Accumulated
deficit
|
(92,769)
|
|
|
(59,911)
|
|
Total stockholders'
equity
|
162,875
|
|
|
58,363
|
|
Total liabilities and
stockholders' equity
|
$
|
171,640
|
|
|
$
|
65,955
|
|
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SOURCE Immunic, Inc.