NEW YORK, Feb. 26, 2021 /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 year
ended December 31, 2020 and
highlighted recent activity.
"2020 was a year marked by significant operational and clinical
milestone achievements across our pipeline, culminating most
recently in two important data readouts for our lead asset,
selective oral DHODH inhibitor, IMU-838," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "The main analysis of our phase 2 CALVID-1
trial showed evidence of clinical activity in hospitalized patients
with moderate COVID-19, a highly encouraging result. The trial
generated very meaningful clinical data which indicate that IMU-838
may have potential as a more convenient and highly effective
therapeutic option for COVID-19. At the same time, we were also
pleased to have just reported positive top-line data from the
investigator-sponsored phase 2 proof-of-concept trial of IMU-838 in
primary sclerosing cholangitis (PSC), which was conducted at Mayo
Clinic. Achievement of a therapeutic benefit, combined with a
statistically significant decrease in serum alkaline phosphatase in
the per-protocol population and the other liver biochemistry
parameters showing a stable pattern, is noteworthy and gives real
hope to PSC patients, who currently have no treatment options."
"The strength of these results, including confirmation of the
safety and tolerability of IMU-838, speaks volumes about its broad
potential in numerous indications. Following the excellent efficacy
and safety data from our phase 2 EMPhASIS trial in patients with
relapsing-remitting multiple sclerosis (RRMS), which we announced
in August and September 2020,
respectively, we are on track to file our end-of-phase 2
submissions to regulatory authorities around the end of the first
quarter and expect the outcome of the meetings, including our plans
for a phase 3 program which we intend to begin in the second half
of 2021, to be available around May of this year. Data from our
fully enrolled 60-subject Cohort 2 sub-trial of IMU-838 in RRMS,
intended to obtain dose response data in patients receiving 10
mg/day of IMU-838 or placebo for 24 weeks, is anticipated at the
end of March or in early April, and should serve to de-risk our
phase 3 discussions with regulatory authorities."
Dr. Vitt continued, "Our ability to measurably bolster our
balance sheet in 2020 reflects investors' belief in the core value
of our technology and pipeline potential, and the approximately
$127.5 million in cash and cash
equivalents at year-end should fund us through significant clinical
milestones into the second half of 2022. Given our progress and
expectations for each of our clinical programs, during the fourth
quarter of 2020, we announced the formation of a Scientific-Medical
Advisory Board. The Board's inaugural members include some of the
most highly distinguished authorities in inflammatory and
autoimmune diseases, including Drs. Fred D. Lublin, Bruce E. Sands, Jerrold
R. Turner and Paul J. Utz.
The experience and guidance of these internationally recognized
experts will be invaluable as we continue to advance our pipeline
going forward."
Fourth Quarter 2020 and Subsequent Highlights
- February 2021: Reported positive
top-line data from the investigator-sponsored phase 2
proof-of-concept clinical trial of IMU-838 in PSC, conducted in
collaboration with investigators at Mayo Clinic. Data showed a
statistically significant decrease in serum alkaline phosphatase
(ALP) levels (p=0.041) in the 11-patient per-protocol (PP)
population after 24-weeks of treatment, as compared to baseline.
Additionally, the primary objective, a clinically relevant
reduction of serum ALP higher than 25% without an increase in liver
biochemistry of more than 33%, was achieved in 27.3% of the
patients in the PP population at week 24, as compared to baseline.
Other liver biochemistry parameters evaluated, including aspartate
aminotransferase (AST), alanine aminotransferase (ALT), and
total/direct/indirect bilirubin, remained stable in both the ITT
and PP populations, and IMU-838's favorable safety and tolerability
profile was confirmed in the patient population.
- February 2021: Announced top-line
clinical efficacy, safety, disease marker and virology data from
the main analysis of the phase 2 CALVID-1 trial of IMU-838 in
hospitalized patients with moderate COVID-19. While primary and key
secondary endpoints were not evaluable due to the very low rates of
serious complications in the study population of hospitalized
patients with moderate COVID-19, the data did show clinical
activity based on multiple secondary endpoints, including (1)
clinically meaningful improvements in time to clinical recovery and
time to clinical improvement; (2) a substantial treatment effect on
high-risk patients and those over 65 years of age; (3) an
anti-viral effect of IMU-838 on SARS-CoV-2, as observed by viral
titers; (4) a robust anti-inflammatory effect, based on a more
effective reduction of C-Reactive Protein (CRP) in treated
patients, as compared to placebo; and (5) an indication, based on
initial data from a post hoc analysis of "Long COVID" symptoms,
that IMU-838 may have the potential to contribute to the prevention
of long-term fatigue. IMU-838 was also found to be safe and
well-tolerated in hospitalized patients with moderate
COVID-19.
- December 2020: Announced
Immunic's addition to the Nasdaq Biotechnology Index, which is
designed to track the performance of a set of securities listed on
The Nasdaq Stock Market® that are classified as either
biotechnology or pharmaceutical according to the Industry
Classification Benchmark.
- November 2020: Announced the
formation of a Scientific-Medical Advisory Board. Initial members
include Drs. Fred D. Lublin, Bruce E.
Sands, Jerrold R. Turner and
Paul J. Utz, all internationally
recognized experts in their respective fields of inflammatory and
autoimmune diseases.
- 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.
Activities Relating to the Preparation of a Phase 3 Program
for IMU-838 in RRMS
As previously announced, the full unblinded clinical data 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, the 30 and 45 mg/day doses of
IMU-838 appear 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
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 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 is conducting an additional,
small Cohort 2 sub-trial to obtain exploratory data on the expanded
dose response of IMU–838, as previously announced. This additional,
double-blind assessment, now fully enrolled, includes a cohort of
approximately 60 patients who receive 10 mg/day of IMU-838 or
placebo for 24 weeks. The results are not expected to change any
conclusions for dosing of IMU-838 in a future phase 3 program.
Rather, the sub-trial is expected to provide additional data to
address any potential regulatory requests in the context of the
design of a phase 3 program. An unblinded interim analysis of
selected MRI data is planned after all Cohort 2 patients have
completed week 12 MRI assessments. The Company expects this data to
be available at the end of March or in early April 2021. Immunic believes that the foregoing
strategy for IMU-838 in RRMS will enable risk reduction for
end-of-phase 2 discussions with regulatory agencies.
Immunic intends to submit formal end-of-phase 2 meeting requests
to discuss the proposed phase 3 program with major regulatory
authorities around the end of the first quarter of 2021. The
outcome of the end-of-phase 2 meetings are expected to be available
in or about May 2021. As previously
announced, 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. Immunic plans to announce details on the design of the
envisaged phase 3 program in RRMS after its end-of-phase 2 meetings
with regulatory authorities. The phase 3 program is expected to
start in the second half of 2021.
Additional Anticipated Clinical Milestones
- IMU-838 in COVID-19: A final analysis of all 223
randomized patients from the phase 2 CALVID-1 trial, which will
comprise data on all endpoints, including subgroup and sensitivity
analyses, is expected to be available in the second quarter of
2021.
- IMU-838 in Ulcerative Colitis (UC): Recruitment of the
phase 2 CALDOSE-1 trial of IMU-838 in patients with UC is expected
to be completed in the second half of 2021 and top-line data of the
induction phase is expected to be available in the first half of
2022, as previously announced.
- IMU-935 phase 1 program: The current, single ascending
dose (SAD) part of the ongoing phase 1 trial of IMU-935 is planned
to be followed by a multiple ascending dose (MAD) portion in
healthy volunteers, which is expected to start in the first quarter
of 2021. Unblinded safety data from the SAD and MAD parts in
healthy volunteers is expected to be available in the second half
of 2021. Initiation of the third portion of the phase 1 trial in
patients with mild-to-moderate psoriasis is expected around
mid-2021 and is expected to last approximately 12 months.
- Potential IMU-935 phase 2 trial in Guillain-Barré
syndrome: Upon completion of at least the first two cohorts of
the MAD portion in healthy volunteers of the ongoing phase 1 trial,
Immunic anticipates that it may also begin a phase 2a
proof-of-concept clinical trial of IMU-935 in Guillain-Barré
syndrome. This orphan approach may allow for an accelerated path to
approval, in parallel to IMU-935's previously planned development
in psoriasis. The company plans to announce additional details as
soon as design and timing of the envisaged trial are defined.
- IMU-856 phase 1 program: The current, SAD part of the
ongoing phase 1 trial of IMU-856 is planned to be followed by a MAD
portion in healthy volunteers, which is expected to start in the
first quarter of 2021. Unblinded safety data from the SAD and MAD
parts in healthy volunteers is expected to be available in the
second half of 2021. Initiation of the third portion of the phase 1
trial in patients with several diseases involving bowel barrier
dysfunction is expected in the second half of 2021.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$38.6 million for the twelve months
ended December 31, 2020, as compared
to $22.5 million for the same period
ended December 31, 2019. The
$16.1 million increase was primarily
due to (i) a $9.6 million increase in
external development costs for IMU-838 related to the phase 2
clinical trial in patients with COVID-19 since the trial was
started in 2020, (ii) a $5.0 million
increase in license fees, drug supply and phase 1 costs related to
IMU-856 since this trial ramped up in 2020, (iii) a $2.1 million increase in drug supply, phase 1 and
preclinical costs related to IMU-935 since this trial ramped up in
2020, (iv) a $1.5 million increase in
personnel costs, (v) a $0.7 million
increase in drug supply costs related to IMU-838, and (vi) a
$0.7 million increase for a
bioequivalence study related to IMU-838. The increases were
partially offset by (i) a $2.0
million decrease related to the phase 2 clinical trial of
IMU-838 in patients with RRMS as the clinical trial came to an end
in 2020, and (ii) a $1.5 million
decrease in costs related to a phase 2 clinical trial in patients
with Crohn's disease.
- General and Administrative (G&A) Expenses were
$10.3 million for the twelve months
ended December 31, 2020, as compared
to $14.5 million for the same period
ended December 31, 2019. The
$4.2 million decrease was primarily
due to (i) $5.1 million lower stock
compensation expense as a result of non-recurring costs recorded in
2019 related to the transaction with Vital Therapies, (ii)
$0.9 million of decreased legal,
accounting and consultancy costs, and (iii) a $0.7 million decrease in travel costs due to
worldwide travel restrictions in connection with the COVID-19
pandemic. The decrease was partially offset by (i) a $2.2 million increase in personnel expenses, and
(ii) $0.3 million of increased costs
across numerous categories.
- Other Income was $5.0
million for the twelve months ended December 31, 2020, as compared to $2.1 million for the same period ended
December 31, 2019. The $2.9 million increase was primarily attributable
to (i) a $2.5 million foreign
exchange gain on a $68.0 million
intercompany loan between Immunic, Inc. and Immunic AG, and (ii) a
$0.9 million increase in R&D tax
incentives for clinical trials in Australia as a result of increased spending on
clinical trials in Australia. This
increase was partially offset by (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 certain assets of Vital Therapies (ELAD Assets), offset by
the $0.1 million write-off of the
investment in Vital Therapies (Beijing) Company Limited included in the ELAD
Assets sale, and (ii) a $0.2 million
decrease of recognized income attributable to reimbursements of
R&D expenses in connection with the option and licensing
agreement with Daiichi Sankyo Co., Ltd.
- Net Loss for the twelve months ended December 31, 2020 was approximately $44.0 million, or $2.81 per basic and diluted share, based on
15,663,826 weighted average common shares outstanding, compared to
a net loss of approximately $35.0
million, or $4.52 per basic
and diluted share, based on 7,722,269 weighted average common
shares outstanding for the same period ended December 31, 2019.
- Cash and Cash Equivalents, as of December 31, 2020, were $127.5 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. 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 RORγt, is targeted for
development in psoriasis and Guillain-Barré 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.
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 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, 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.
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
Paula Schwartz
+1-917-322-2216
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
Financials
|
Immunic,
Inc.
Consolidated
Statements of Operations
(In thousands, except share and per share amounts)
|
|
|
Years Ended
December 31,
|
|
2020
|
|
2019
|
Operating
expenses:
|
|
|
|
Research and
development
|
$
|
38,637
|
|
|
$
|
22,512
|
|
General and
administrative
|
10,334
|
|
|
14,520
|
|
Total operating
expenses
|
48,971
|
|
|
37,032
|
|
Loss from
operations
|
(48,971)
|
|
|
(37,032)
|
|
Other
income:
|
|
|
|
Interest
income
|
58
|
|
|
107
|
|
Other income,
net
|
4,896
|
|
|
1,992
|
|
Total other
income
|
4,954
|
|
|
2,099
|
|
Net loss
|
$
|
(44,017)
|
|
|
$
|
(34,933)
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
|
(2.81)
|
|
|
$
|
(4.52)
|
|
|
|
|
|
Weighted-average
common shares outstanding, basic and diluted
|
15,663,826
|
|
|
7,722,269
|
|
Immunic,
Inc.
Consolidated
Balance Sheets
(In thousands,
except share and per share amounts)
|
|
|
December
31,
|
|
2020
|
|
2019
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
127,452
|
|
|
$
|
29,369
|
|
Other current assets
and prepaid expenses
|
6,293
|
|
|
2,861
|
|
Total current
assets
|
133,745
|
|
|
32,230
|
|
Property and
equipment, net
|
203
|
|
|
80
|
|
Goodwill
|
32,970
|
|
|
32,970
|
|
Right of use asset,
net
|
901
|
|
|
633
|
|
Other long-term
assets
|
42
|
|
|
42
|
|
Total
assets
|
$
|
167,861
|
|
|
$
|
65,955
|
|
Liabilities
and Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
3,700
|
|
|
$
|
2,423
|
|
Accrued
expenses
|
4,318
|
|
|
3,298
|
|
Other current
liabilities
|
379
|
|
|
1,351
|
|
Total current
liabilities
|
8,397
|
|
|
7,072
|
|
Long-term
liabilities:
|
|
|
|
Operating lease
liabilities
|
679
|
|
|
520
|
|
Total long-term
liabilities
|
679
|
|
|
520
|
|
Total
liabilities
|
9,076
|
|
|
7,592
|
|
Commitments and
contingencies (note 6)
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.0001 par value; 20,000,000 authorized and no shares issued or
outstanding at December 31, 2020 and 2019
|
—
|
|
|
—
|
|
Common stock, $0.0001
par value; 130,000,000 shares authorized and 21,168,240 and
10,744,806 shares issued and outstanding at December 31, 2020
and 2019, respectively
|
2
|
|
|
1
|
|
Additional paid-in
capital
|
266,823
|
|
|
119,646
|
|
Accumulated other
comprehensive loss
|
(4,112)
|
|
|
(1,373)
|
|
Accumulated
deficit
|
(103,928)
|
|
|
(59,911)
|
|
Total stockholders'
equity
|
158,785
|
|
|
58,363
|
|
Total liabilities and
stockholders' equity
|
$
|
167,861
|
|
|
$
|
65,955
|
|
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SOURCE Immunic, Inc.