NEW YORK, May 6, 2021 /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 first quarter
ended March 31, 2021 and highlighted
recent activity.
"Our clinical program activities have continued unabated, with
significant progress having recently been achieved for our lead
asset, selective oral DHODH inhibitor, IMU-838," stated
Daniel Vitt, Ph.D., Chief Executive
Officer and President of Immunic. "Last month, we announced key
interim data from our phase 2 EMPhASIS Cohort 2 sub-trial of
IMU-838 in patients with relapsing-remitting multiple sclerosis
(RRMS), confirming 30 mg as the most appropriate dose for our
envisaged phase 3 program. We will now move directly to the filing
of an Investigational New Drug (IND) application in the United States and are currently working to
complete the package, with the expectation of initiating the phase
3 program in the second half of this year."
"Beyond RRMS, during the first quarter, we reported positive
top-line data from the investigator-sponsored, open-label phase 2
proof-of-concept trial of IMU-838 in primary sclerosing cholangitis
(PSC), conducted in collaboration with the Mayo Clinic. Results
confirmed safety and tolerability and provided encouraging activity
signals. In order to find the optimized dose for future clinical
activities in PSC, we plan to initiate a phase 1 trial in hepatic
impaired patients. Backed by the promising results from our phase 2
CALVID-1 trial of IMU-838 which underlined its broad antiviral
activity, our phase 2 trial in ulcerative colitis (UC) has seen
recent strong recruitment which we expect to be completed in the
second half of this year."
Dr. Vitt added, "With the ongoing accumulation of robust data
for IMU-838, including repeated confirmation of safety and efficacy
across multiple indications, we made a strategic decision during
the first quarter to settle our remaining royalty obligation to 4SC
AG, giving us full rights to our most advanced asset and securing
our ability to unlock its future potential."
First Quarter 2021 and Subsequent Highlights
- April 2021: Announced EMPhASIS
interim analysis of 10 mg Cohort 2 confirming IMU-838's dose
response in RRMS and supporting phase 3 dose selection. Previously
published data from Cohort 1, together with Cohort 2 data from 59
randomized patients who completed week 12 magnetic resonance
imaging assessments, confirmed that 30 mg once daily IMU-838
is the most appropriate dose for the company's planned phase 3
program in RRMS.
- March 2021: Announced the signing
of an agreement with 4SC AG to settle the remaining obligation of a
4.4% royalty on net sales of IMU-838, for $17.25 million. The payment was made 50% in cash
and 50% in shares of Immunic's common stock. No further payment
obligations remain between Immunic and 4SC AG.
- 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, 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. The data showed
clinical activity based on multiple secondary endpoints and
confirmed IMU-838 to be safe and well-tolerated in this patient
population.
Meanwhile, additional available data from the full analysis of
all 223 randomized patients support the conclusions made in the
main analysis and have provided data on a few additional endpoints.
Notably, the rate and timing of anti-SARS-CoV-2 antibodies patients
are developing in response to the infection was found to be
identical between the IMU-838 and placebo treatment arms. The full
analysis was also able to detect a relationship between drug trough
levels in blood plasma and the clinical recovery endpoint.
With the progressing rollout of vaccines in many countries,
however, the company believes that the opportunity to execute a
phase 3 program as a monotherapy and to benefit from any potential
commercialization in this indication within a reasonable time frame
is no longer viable.
Anticipated Clinical Milestones
- IMU-838 in RRMS: As previously announced, Immunic
remains in discussions with regulatory authorities, including the
FDA and the European Medicines Agency, regarding the planned phase
3 program in RRMS. At the FDA's request, the company is proceeding
directly to submission of an IND application, instead of holding an
end-of-phase 2 meeting. Feasibility and other preparatory
activities for the phase 3 program are ongoing and initiation is
expected in the second half of 2021.
- IMU-838 in 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-838 in PSC: Immunic plans to perform a phase 1 trial
in hepatic impaired patients which will allow for dose optimization
of IMU-838 for potential future clinical activities in PSC.
- IMU-935 phase 1 program: Based on a positive outcome of
the single ascending dose (SAD) cohort of the phase 1 trial of
IMU-935, the company received approval from the Ethics Committee in
Australia, during first quarter of
2021, to proceed with the multiple ascending dose (MAD) portion of
the trial and subjects in the first cohort are currently being
dosed. Unblinded safety, pharmacodynamics and pharmacokinetics data
from the SAD and MAD parts in healthy volunteers is expected to be
available in the second half of 2021. Initiation of a third portion
of the phase 1 trial in patients with mild-to-moderate psoriasis is
expected in the third quarter of 2021 and is anticipated to last
approximately 12 months.
- IMU-856 phase 1 program: The SAD part of the ongoing
phase 1 trial of IMU-856 has been completed. Based on the favorable
data available, the company expects to receive clearance from the
Ethics Committee in Australia to
proceed to the MAD part in healthy volunteers, in the near future.
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
$11.5 million for the three months
ended March 31, 2021, as compared to
$6.4 million for the same period
ended March 31, 2020. The
$5.1 million increase was primarily
due to (i) a $1.7 million increase in
external development costs related to the phase 2 clinical trial in
patients with COVID-19 as trials did not start until the second
quarter of 2020, (ii) a $1.4 million
increase in drug supply costs related to IMU-838 to support the
company's ongoing and future clinical trials, (iii) a $0.9 million increase in preparation costs
related to the phase 3 program of IMU-838 in multiple sclerosis,
(iv) $0.4 million related to
increased cost for the ulcerative colitis trial, and (v)
$0.7 million related to increased
costs across numerous categories.
- General and Administrative (G&A) Expenses were
$20.9 million for the three months
ended March 31, 2021, as compared to
$2.6 million for the same period
ended March 31, 2020. The
$18.3 million increase was primarily
due to (i) a $17.3 million settlement
of royalty obligations to 4SC AG, and (ii) a $1.3 million increase in personnel expenses of
which $1.2 million is related to
non-cash stock compensation expense, partially offset by a
$0.3 million decrease in travel
related costs.
- Other Income (Expense) was $(2.1)
million for the three months ended March 31, 2021, as compared to $0.5 million for the same period ended
March 31, 2020. The $2.6 million decrease was primarily attributable
to (i) a $2.5 million foreign
exchange loss on a $52.0 million
intercompany loan between Immunic, Inc. and Immunic AG, and (ii) a
$0.4 million decrease in recognized
deferred income attributable to reimbursements of R&D expenses
in connection with the option agreement with Daiichi Sankyo Co.,
Ltd. realized in the first quarter of 2020. The decrease was
partially offset by a $0.2 million
increase in R&D tax incentives for clinical trials in
Australia as a result of increased
spending on clinical trials in Australia.
- Net Loss for the three months ended March 31, 2021 was approximately $34.5 million, or $1.63 per basic and diluted share, based on
21,174,698 weighted average common shares outstanding, compared to
a net loss of approximately $8.5
million, or $0.79 per basic
and diluted share, based on 10,749,460 weighted average common
shares outstanding for the same period ended March 31, 2020.
- Cash and Cash Equivalents as of March 31, 2021 were $114.8
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 relating to Immunic's three development programs and the
targeted diseases; the potential for Immunic's development programs
to safely and effectively target diseases; clinical data for
Immunic's development programs; the timing of current and future
clinical trials; the nature, strategy and focus of the company and
further updates with respect thereto; the development and
commercial potential of any product candidates of the company; and
the company's expected cash runway. 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.
|
Condensed
Consolidated Statements of Operations
|
(In thousands, except share and per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Three
Months
Ended March
31,
|
|
|
2021
|
|
2020
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
$
|
11,519
|
|
$
|
6,434
|
General and
administrative
|
|
20,868
|
|
2,580
|
Total operating
expenses
|
|
32,387
|
|
9,014
|
Loss from
operations
|
|
(32,387)
|
|
(9,014)
|
Other income
(expense):
|
|
|
|
|
Interest
income
|
|
28
|
|
24
|
Other income
(expense), net
|
|
(2,175)
|
|
503
|
Total other income
(expense)
|
|
(2,147)
|
|
527
|
Net loss
|
|
$
|
(34,534)
|
|
$
|
(8,487)
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(1.63)
|
|
$
|
(0.79)
|
|
|
|
|
|
Weighted-average
common shares outstanding, basic and diluted
|
|
21,174,698
|
|
10,749,460
|
Immunic,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(In thousands, except
share and per share amounts)
|
|
|
|
|
|
March
31, 2021
|
|
December
31, 2020
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
114,839
|
|
$
|
127,452
|
Other current assets
and prepaid expenses
|
5,441
|
|
6,293
|
Total current
assets
|
120,280
|
|
133,745
|
Property and
equipment, net
|
190
|
|
203
|
Goodwill
|
32,970
|
|
32,970
|
Right-of-use assets,
net
|
1,242
|
|
901
|
Other long-term
assets
|
42
|
|
42
|
Total
assets
|
$
|
154,724
|
|
$
|
167,861
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
10,048
|
|
$
|
3,700
|
Accrued
expenses
|
5,827
|
|
4,318
|
Other current
liabilities
|
481
|
|
379
|
Total current
liabilities
|
16,356
|
|
8,397
|
Long term
liabilities
|
|
|
|
Operating lease
liabilities
|
922
|
|
679
|
Total long-term
liabilities
|
922
|
|
679
|
Total
liabilities
|
17,278
|
|
9,076
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.0001 par value; 20,000,000 authorized and
no shares issued or outstanding at March 31, 2021 and December 31,
2020
|
—
|
|
—
|
Common stock, $0.0001
par value; 130,000,000 shares authorized and
21,749,439 and 21,168,240 shares issued and outstanding as of March
31,
2021 and December 31, 2020, respectively
|
2
|
|
2
|
Additional paid-in
capital
|
277,027
|
|
266,823
|
Accumulated other
comprehensive loss
|
(1,121)
|
|
(4,112)
|
Accumulated
deficit
|
(138,462)
|
|
(103,928)
|
Total stockholders'
equity
|
137,446
|
|
158,785
|
Total liabilities and
stockholders' equity
|
$
|
154,724
|
|
$
|
167,861
|
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SOURCE Immunic, Inc.