NEW YORK, Nov. 4, 2021 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a clinical-stage
biopharmaceutical company developing a pipeline of selective oral
immunology therapies focused on treating chronic inflammatory and
autoimmune diseases, today announced financial results for the
third quarter ended September 30,
2021 and highlighted recent activity.
"During the quarter, we continued to make extraordinary progress
advancing multiple programs through the clinic, including our
selective oral DHODH inhibitor, IMU-838, as well as IMU-935, a
highly potent and selective oral IL-17 inhibitor, setting the stage
for an exciting year ahead with several upcoming value creating
data readouts," stated Daniel Vitt,
Ph.D., Chief Executive Officer and President of Immunic. "Major
milestones achieved in lead program, IMU-838, included enrollment
of the final patient in our phase 2 CALDOSE-1 trial of IMU-838 in
patients with moderate-to-severe ulcerative colitis (UC), for which
we expect top-line data to be available in the first half of 2022,
and enrollment of the first patients in our phase 2 CALLIPER trial
in progressive multiple sclerosis (PMS)."
"We also made significant headway in the development of our
second key asset, IMU-935, and expect unblinded safety,
pharmacodynamic and pharmacokinetic data from the healthy volunteer
portions of our ongoing phase 1 trial to be available in the fourth
quarter of this year. We also initiated the patient part of the
phase 1 trial in moderate-to-severe psoriasis and anticipate
initial data from this patient population during the second quarter
of 2022. Additionally, at our virtual R&D Day in July, we
presented compelling new preclinical data highlighting the
therapeutic potential of IMU-935 to affect metastatic castration
resistant prostate cancer (mCRPC). We expect to initiate an
open-label phase 1 dose escalation trial in mCRPC during the fourth
quarter of this year, with Johann Sebastian
de Bono, M.D., Ph.D., Regius Professor of Cancer Research
and Professor in Experimental Cancer Medicine, The Institute of
Cancer Research and The Royal Marsden NHS Foundation Trust,
London, United Kingdom, acting as
the Principal Investigator."
Dr. Vitt added, "Our rapid pace of growth has necessitated an
expansion of our management team and we were pleased to welcome
Patrick Walsh as Chief Business
Officer. We look forward to leveraging his experience in business
development and strategic partnering as we seek to realize the full
potential of our clinical programs. On the financial front, in
July, we bolstered our balance sheet with a $45.0 million financing, extending our runway
through multiple clinical readouts and value inflection points into
2023."
Third Quarter 2021 and Subsequent Highlights
- October 2021: Enrolled and
randomized the last patient in the phase 2 CALDOSE-1 trial in
patients with moderate-to-severe UC. At completion of patient
recruitment, the trial has randomized a total of 263 patients into
four arms: three active dosing arms of 10 mg, 30 mg and 45 mg, as
well as placebo.
- October 2021: Dosed the first
patient with moderate-to-severe psoriasis in part C of the ongoing
phase 1 trial of IMU-935, representing the first-time patients have
been treated with the company's potentially best-in-class RORγt
inverse agonist.
- October 2021: Appointed Patrick
Walsh to the newly created role of Chief Business Officer.
- September 2021: Enrolled the
first patient in the phase 2 CALLIPER trial of IMU-838 in patients
with PMS.
- September 2021: Signed an
in-license agreement with the University Medical Center Göttingen,
Germany, covering the combination
of DHODH inhibitors and nucleoside analogues to treat viral
infections (COVID-19 and Influenza). Additionally, announced
remarkable preclinical data showing that certain DHODH inhibitors,
including IMU-838, strongly synergize with selected nucleoside
analogues to inhibit SARS-CoV-2 replication in vitro.
- July 2021: Completed a
$45.0 million underwritten public
offering of common stock.
- July 2021: Hosted a virtual
R&D Day to provide an update on the preclinical and clinical
development of IMU-935.
Anticipated Clinical Milestones
- IMU-838 in relapsing multiple sclerosis: The twin,
multicenter, randomized, double-blind, phase 3 ENSURE-1 and
ENSURE-2 trials of 30 mg daily IMU-838 or placebo will run
concurrently. Dosing of the first patient is expected in the fourth
quarter of 2021.
- IMU-838 in UC: Top-line data of the induction phase of
the phase 2 CALDOSE-1 trial of IMU-838 in patients with
moderate-to-severe UC is expected to be available in the second
quarter of 2022.
- IMU-935 phase 1 program in healthy volunteers and psoriasis
patients: The experimental phase of the multiple ascending dose
(MAD) part of the phase 1 trial of IMU-935 has recently been
completed. Unblinded safety, pharmacodynamic and pharmacokinetic
(PK) data from the single ascending dose (SAD) and MAD parts in
healthy volunteers is expected to be available in the fourth
quarter of 2021. Initial human data from the third portion of the
phase 1 trial in patients with moderate-to-severe psoriasis is
expected to be available in the second quarter of 2022.
- IMU-935 phase 1 trial in CRPC: An open-label phase 1
dose escalation trial designed to establish a potential recommended
phase 2 dose and to assess safety, tolerability, anti-tumor
activity, biomarkers and PK of IMU-935 in patients with progressive
mCRPC, is expected to commence in the fourth quarter of 2021. The
trial was recently approved by the Medicines and Healthcare
products Regulatory Agency (MHRA), the Research Ethics Committee
(REC) and the Health Research Authority (HRA) in the United Kingdom.
- 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 so far, the Ethics Committee in Australia has agreed to proceed to the MAD
part and the first cohort is currently being dosed. Unblinded
safety data from the SAD and MAD parts in healthy volunteers is
expected to be available in the third quarter of 2022. Initiation
of the third portion of the phase 1 trial in patients with
intestinal barrier function associated diseases is expected in the
first half of 2022.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$15.5 million for the three months
ended September 30, 2021, as compared
to $11.0 million for the same period
ended September 30, 2020. The
$4.4 million increase reflects (i) a
$3.8 million increase in preparation
costs related to the phase 3 program of IMU-838 in RMS, (ii) a
$2.3 million increase in costs
related to the phase 2 trial of IMU-838 in PMS, (iii) a
$0.8 million increase in external
development costs related to the phase 2 clinical trial of IMU-838
in UC, (iv) a $1.1 million increase
in external development costs related to the phase 1 clinical trial
of IMU-935, (v) a $0.6 million
increase in personnel expenses in research and development due to
an increase in headcount, and (vi) $0.2
million related to increased costs across numerous
categories. The increases were partially offset by (i) a
$3.5 million decrease in external
development costs related to the phase 2 clinical trial in COVID-19
as trials were finished in the first quarter of 2021, and (ii) a
decrease of $0.9 million in drug
supply costs for IMU-856.
For the nine months ended September 30,
2021, R&D expenses were $42.7
million, as compared to $27.5
million for the same period ended September 30, 2020. The $15.3 million increase was primarily attributable
to (i) a $6.9 million increase in
preparation costs related to the phase 3 program of IMU-838 in RMS,
(ii) a $4.7 million increase in
preparation costs related to the phase 2 trial of IMU-838 in PMS,
(iii) a $3.0 million increase in
external development costs related to the phase 2 clinical trial of
IMU-838 in UC, (iv) a $1.7 million
increase in personnel expenses in research and development related
to an increase in headcount, (v) a $1.2
million increase in external development costs related to
the phase 1 clinical trial of IMU-935, (vi) a $1.3 million increase in external costs for
IMU-856, and (vii) $0.7 million
related to increased costs across numerous categories. The
increases were partially offset by (i) a decrease of $2.1 million in drug supply costs for IMU-856,
and (ii) a $2.1 million decrease in
external development costs related to the phase 2 clinical trial in
COVID-19.
- General and Administrative (G&A) Expenses were
$2.9 million for the three months
ended September 30, 2021, as compared
to $2.5 million for the same period
ended September 30, 2020. The
$0.4 million increase was primarily
due to a $0.5 million increase
related to non-cash stock compensation expense offset by a
$0.1 million decrease in costs across
numerous categories.
For the nine months ended September 30,
2021, G&A expenses were $10.0
million, as compared to $7.3
million for the same period ended September 30, 2020. The $2.6 million increase was primarily due to (i) a
$2.2 million increase related to
non-cash stock compensation expense, and (ii) a $0.4 million increase across numerous
categories.
- 4SC Royalty Settlement: On March
31, 2021, Immunic AG and 4SC AG entered into a Settlement
Agreement, pursuant to which Immunic AG settled its 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.
- Other Income (Expense) was $(0.9)
million for the three months ended September 30, 2021, as compared to $0.6 million for the same period ended
September 30, 2020. The $1.5 million decrease was primarily attributable
to (i) a $1.2 million foreign
exchange loss on a $52.0 million
intercompany loan between Immunic, Inc. and Immunic AG, (ii) a
$0.2 million decrease related to
lower research and development tax incentives for clinical trials
in Australia as a result of
decreased spending on clinical trials in Australia year over year, and (iii)
$0.1 million related to a 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 third quarter of 2020.
For the nine months ended September 30,
2021, Other Income was $(1.8)
million, as compared to $1.9
million for the same period ended September 30, 2020. The $3.7 million decrease was primarily attributable
to (i) a $3.2 million foreign
exchange loss on a $52.0 million
intercompany loan between Immunic, Inc. and Immunic AG, and (ii) a
$1.0 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 nine months of 2020. The decrease was
partially offset by a $0.5 million
increase in research and development 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 September 30, 2021, was approximately
$19.3 million, or $0.76 per basic and diluted share, based on
25,320,091 weighted average common shares outstanding, compared to
a net loss of approximately $12.9
million, or $0.70 per basic
and diluted share, based on 18,405,840 weighted average common
shares outstanding for the same period ended September 30, 2020.
Net loss for the nine months ended September
30, 2021, was approximately $71.8
million, or $3.33 per basic
and diluted share, based on 21,559,964 weighted average common
shares outstanding, compared to a net loss of approximately
$32.9 million, or $2.35 per basic and diluted share, based on
13,966,690 weighted average common shares outstanding for the same
period ended September 30, 2020.
- Cash and Cash Equivalents as of September 30, 2021, were $110.4 million, which management expects to be
sufficient to fund operations into 2023.
Webcast Information
Immunic will host a webcast today
at 8:00 am ET. To participate, please
register in advance at:
https://imux.zoom.us/webinar/register/WN_VcZaYTP9RFqHZj7N5qMNJg or
on the "Events and Presentations" section of Immunic's website at
ir.imux.com/events-and-presentations. Registrants will receive a
confirmation email containing a link for online participation or a
telephone number for dial in access.
An archived replay of the webcast will be available
approximately one hour after completion on Immunic's website at
ir.imux.com/events-and-presentations.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a
clinical-stage biopharmaceutical company with a pipeline of
selective oral immunology therapies focused on 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, and primary
sclerosing cholangitis. IMU-935, a selective inverse agonist of the
transcription factor RORγt, is targeted for development in
psoriasis, castration-resistant prostate cancer 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 Immunic's development programs to safely and
effectively target diseases; preclinical and clinical data for
Immunic's development programs; the timing of current and future
clinical trials and anticipated clinical milestones; 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
September 30,
|
|
Nine
Months
Ended
September 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
15,480
|
|
|
$
|
11,040
|
|
|
$
|
42,737
|
|
|
$
|
27,461
|
|
General and
administrative
|
|
2,907
|
|
|
2,505
|
|
|
9,957
|
|
|
7,320
|
|
4SC Royalty
Settlement
|
|
—
|
|
|
—
|
|
|
17,250
|
|
|
—
|
|
Total operating
expenses
|
|
18,387
|
|
|
13,545
|
|
|
69,944
|
|
|
34,781
|
|
Loss from
operations
|
|
(18,387)
|
|
|
(13,545)
|
|
|
(69,944)
|
|
|
(34,781)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
10
|
|
|
20
|
|
|
51
|
|
|
48
|
|
Other income
(expense), net
|
|
(915)
|
|
|
612
|
|
|
(1,867)
|
|
|
1,875
|
|
Total other income
(expense)
|
|
(905)
|
|
|
632
|
|
|
(1,816)
|
|
|
1,923
|
|
Net loss
|
|
$
|
(19,292)
|
|
|
$
|
(12,913)
|
|
|
$
|
(71,760)
|
|
|
$
|
(32,858)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic
and diluted
|
|
$
|
(0.76)
|
|
|
$
|
(0.70)
|
|
|
$
|
(3.33)
|
|
|
$
|
(2.35)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding, basic
and diluted
|
|
25,320,091
|
|
|
18,405,840
|
|
|
21,559,964
|
|
|
13,966,690
|
|
Immunic,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(In thousands, except
share and per share amounts)
|
|
|
September 30,
2021
|
|
December 31,
2020
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
110,444
|
|
|
$
|
127,452
|
|
Other current assets
and prepaid expenses
|
12,051
|
|
|
6,293
|
|
Total current
assets
|
122,495
|
|
|
133,745
|
|
Property and
equipment, net
|
196
|
|
|
203
|
|
Goodwill
|
32,970
|
|
|
32,970
|
|
Right-of-use assets,
net
|
1,054
|
|
|
901
|
|
Other long-term
assets
|
42
|
|
|
42
|
|
Total
assets
|
$
|
156,757
|
|
|
$
|
167,861
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
3,241
|
|
|
$
|
3,700
|
|
Accrued
expenses
|
6,771
|
|
|
4,318
|
|
Other current
liabilities
|
579
|
|
|
379
|
|
Total current
liabilities
|
10,591
|
|
|
8,397
|
|
Long term
liabilities
|
|
|
|
Operating lease
liabilities
|
701
|
|
|
679
|
|
Total long-term
liabilities
|
701
|
|
|
679
|
|
Total
liabilities
|
11,292
|
|
|
9,076
|
|
Commitments and
contingencies (Note 4)
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.0001 par value; 20,000,000 authorized and no shares
issued or outstanding at September 30, 2021 and December 31,
2020
|
—
|
|
|
—
|
|
Common stock, $0.0001
par value; 130,000,000 shares authorized and
26,249,439 and 21,168,240 shares issued and outstanding as of
September
30, 2021 and December 31, 2020, respectively
|
3
|
|
|
2
|
|
Additional paid-in
capital
|
321,950
|
|
|
266,823
|
|
Accumulated other
comprehensive loss
|
(800)
|
|
|
(4,112)
|
|
Accumulated
deficit
|
(175,688)
|
|
|
(103,928)
|
|
Total stockholders'
equity
|
145,465
|
|
|
158,785
|
|
Total liabilities and
stockholders' equity
|
$
|
156,757
|
|
|
$
|
167,861
|
|
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SOURCE Immunic, Inc.