NEW YORK, Aug. 6, 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
second quarter ended June 30, 2021
and highlighted recent activity.
"So far this year, we have made outstanding progress with both
our selective oral DHODH inhibitor, IMU-838, as well as IMU-935, a
highly potent and selective inverse agonist of the transcription
factor RORγt, enabling what we believe will be an eventful and
potentially transformative first half of 2022. In particular, we
anticipate five data read-outs from clinical trials within the next
twelve months, and expect to begin our first phase 3 program very
soon. I want to congratulate our entire team for this remarkable
momentum," stated Daniel Vitt,
Ph.D., Chief Executive Officer and President of Immunic. "In June,
we received U.S. Food and Drug Administration (FDA) clearance for
our Investigational New Drug (IND) application for the phase 3
ENSURE program of IMU-838 in patients with relapsing-remitting
multiple sclerosis (RRMS), and the supportive phase 2 CALLIPER
trial in patients with progressive multiple sclerosis (PMS).
Initiation of these trials in the second half of this year will
mark a major milestone for our lead program. Additionally, we look
forward to completing recruitment of our ongoing phase 2 CALDOSE-1
trial of IMU-838 in patients with ulcerative colitis (UC) during
the second half of 2021, and reporting top-line data for this
potential second key indication for IMU-838 in the first half of
2022."
"At our virtual R&D Day just last month, we presented very
encouraging in vitro data showing that IMU-935 may inhibit
both the generation of Th17 cells and the production of IL-17
cytokines that are responsible for the development of autoimmune
diseases, without impairing thymocyte development, thereby avoiding
a potential risk for lymphoma that has complicated third-party
programs in this space. We also detailed highly encouraging new
preclinical data which suggests that IMU-935 can affect
castration-resistant prostate cancer (CRPC) both directly by
reducing androgen receptor (AR) expression via RORγ and inhibiting
tumor growth, and indirectly by inhibiting tumorigenesis-promoting
Th17 and IL-17. Based on the strength of this data, we are
preparing a phase 1 trial in metastatic CRPC (mCRPC) patients 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. We expect this trial to commence during the
fourth quarter of this year and also anticipate availability of
initial human data from moderate-to-severe psoriasis patients from
our phase 1 trial of IMU-935 during the second quarter of
2022."
Dr. Vitt added, "As previously announced, at the end of the
first quarter of 2021, we settled our remaining royalty obligation
to 4SC AG for both IMU-838 and IMU-935, for $17.3 million, which was paid 50% in cash and 50%
in shares of Immunic's common stock during the second quarter. This
strategic decision provides us with 100% of the future sales
potential of our two lead programs and should drive significant
value for our shareholders. Last month, we were able to offset this
payment by bolstering our balance sheet with a $45.0 million financing, providing us with
anticipated runway through multiple value inflection points into
2023."
Second Quarter 2021 and Subsequent Highlights
- 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, including:
-
- Based on preclinical studies performed by Immunic, as well as
third-party research, the company believes that IMU-935's observed
selectivity may enable it to inhibit the generation of Th17 cells
and the production of IL-17 cytokines without impairing RORγt
function required for normal thymocyte development and may,
therefore, avoid the risk of T cell malfunction and potential
lymphoma formation seen in third-party RORγt programs.
- In preclinical studies, IMU-935 was observed to suppress the
expression of mutated AR-V7 in prostate cancer cell lines, thus
potentially inhibiting tumor growth in CRPC patients who are
insensitive to androgen-targeted therapies. By suppressing the
expression of pro-tumorigenic IL-17, IMU-935 may also inhibit
tumorigenesis in an indirect fashion. Based on these results, the
company is currently preparing an open-label phase 1 dose
escalation trial designed to establish a recommended phase 2 dose
and to assess safety, tolerability, anti-tumor activity, biomarkers
and pharmacokinetics (PK) of IMU-935 in patients with progressive
mCRPC.
- The full PK and blinded safety data from the completed single
ascending dose (SAD) part of the phase 1 trial of IMU-935 was made
available. The data set revealed dose-linear PK and a blood
half-life that may be appropriate for once or twice daily dosing.
Although the trial is still blinded, no significant safety findings
have been detected in the SAD cohorts, to date.
- June 2021: Announced FDA
clearance of the company's IND application to begin the phase 3
ENSURE program, comprised of two multicenter, randomized,
double-blind trials designed to evaluate the efficacy, safety, and
tolerability of IMU-838 versus placebo in RRMS patients.
Additionally, announced FDA clearance of a separate IND application
to initiate the supportive, multicenter, randomized, double-blind,
placebo-controlled phase 2 CALLIPER trial of IMU-838 in patients
with PMS, which will run concurrently with the phase 3 program in
RRMS and which is designed to corroborate IMU-838's neuroprotective
potential.
- June 2021: Announced the
appointment of Inderpal Singh as
General Counsel. Mr. Singh is responsible for legal and compliance
matters and has become part of the management team of the
company.
- April 2021: Announced interim
data from the 10 mg Cohort 2 of the EMPhASIS trial of IMU-838 in
RRMS confirming, along with previously published data from Cohort
1, that the 30 mg once daily dosing of IMU-838 is the most
appropriate dose for the company's phase 3 program in RRMS. The
experimental part of double-blind treatment in Cohort 2 has
meanwhile been completed.
Anticipated Clinical Milestones
- IMU-838 in RRMS: 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 second half of 2021.
- IMU-838 in PMS: The multicenter, randomized,
double-blind, phase 2 CALLIPER trial of 45 mg daily IMU-838 or
placebo is intended to run concurrently with and to complement the
phase 3 program in RRMS. Dosing of the first patient is expected in
the third quarter 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-935 phase 1 program in healthy volunteers and psoriasis
patients: The multiple ascending dose (MAD) part of the phase 1
trial of IMU-935 is ongoing and progressing. Unblinded safety,
pharmacodynamic and PK 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 moderate-to-severe psoriasis is expected in the third quarter
of 2021 and initial human data from this patient population is
expected to be available in the second quarter of 2022.
- IMU-935 phase 1 trial in CRPC patients: 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.
- 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 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 first quarter of 2022. Initiation of the third
portion of the phase 1 trial in patients with several diseases
involving bowel barrier dysfunction is expected in the first half
of 2022.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$15.7 million for the three months
ended June 30, 2021, as compared to
$10.0 million for the same period
ended June 30, 2020. The $5.7 million increase was primarily due to (i) a
$2.6 million increase in preparation
costs related to the phase 3 program of IMU-838 in multiple
sclerosis, (ii) a $1.8 million
increase in external development costs related to the phase 2
clinical trial of IMU-838 in patients with UC, (iii) a $1.7 million increase in preparation costs
related to the phase 2 trial of IMU-838 in PMS, (v) a $0.6 million increase in external development
costs related to the phase 1 clinical trial of IMU-935, (vi) a
$0.5 million increase in external
development costs related to the phase 1 clinical trial of IMU-856,
(vii) a $0.7 million increase in
personnel expenses in research and development and (viii)
$0.1 million related to increased
costs across numerous categories. The increases were partially
offset by a decrease of $2.3 million
related to drug supply costs for IMU-838, IMU-935 and IMU-856.
For the six months ended June 30,
2021, R&D expenses were $27.3
million, as compared to $16.4
million for the same period ended June 30, 2020. The $10.9
million increase was primarily attributable to (i) a
$2.9 million increase in preparation
costs related to the phase 3 program of IMU-838 in multiple
sclerosis, (ii) a $2.4 million
increase in preparation costs related to the phase 2 trial of
IMU-838 in PMS, (iii) a $2.2 million
increase in external development costs related to the phase 2
clinical trial of IMU-838 in patients with UC, (iv) a $1.4 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,
(v) a $0.8 million increase in
external development costs related to the phase 1 clinical trial of
IMU-856, (vi) a $0.7 million increase
in external development costs related to the phase 1 clinical trial
of IMU-935, (vii) a $1.0 million
increase in personnel expenses in research and development and
(viii) $1.0 million related to
increased costs across numerous categories. The increases were
partially offset by a decrease of $1.5
million in drug supply costs for IMU-856.
- General and Administrative (G&A) Expenses were
$3.4 million for the three months
ended June 30, 2021, as compared to
$2.2 million for the same period
ended June 30, 2020. The $1.2 million increase was primarily due to (i) a
$0.7 million increase related to
non-cash stock compensation expense, (ii) a $0.3 million increase of legal and consultancy
costs and (iii) a $0.2 million
increase across numerous categories.
For the six months ended June 30,
2021, G&A expenses were $7.1
million, as compared to $4.8
million for the same period ended June 30, 2020. The $2.3
million increase was primarily due to (i) a $1.7 million increase related to non-cash stock
compensation expense and (ii) a $0.6
million increase across numerous categories, primarily for
legal and consultancy services.
- 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 was $1.2
million for the three months ended June 30, 2021, as compared to $0.8 million for the same period ended
June 30, 2020. The $0.4 million increase was primarily attributable
to (i) a $0.6 million foreign
exchange gain on a $52.0 million
intercompany loan between Immunic, Inc. and Immunic AG (the
"Intercompany Loan") and (ii) a $0.3
million increase in research and development tax incentives
for clinical trials in Australia
as a result of increased spending on clinical trials in
Australia. The increase was
partially offset by a $0.5 million
decrease in recognized deferred income attributable to
reimbursements of research and development expenses in connection
with the option agreement with Daiichi Sankyo Co., Ltd. realized in
the second quarter of 2020.
For the six months ended June 30,
2021, other income was $(1.0)
million, as compared to $1.3
million for the same period ended June 30, 2020. The $2.3
million decrease was primarily attributable to (i) a
$1.9 million foreign exchange loss on
the Intercompany Loan and (ii) a $1.0
million decrease in recognized deferred income attributable
to reimbursements of research and development expenses in
connection with the Daiichi Sankyo Agreement realized in the first
six months of 2020. The decrease was partially offset by a
$0.6 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 June 30, 2021, was approximately $17.9 million, or $0.82 per basic and diluted share, based on
21,749,439 weighted average common shares outstanding, compared to
a net loss of approximately $11.5
million, or $0.90 per basic
and diluted share, based on 12,695,989 weighted average common
shares outstanding for the same period ended June 30, 2020.
Net loss for the six months ended June 30,
2021 was approximately $52.5
million, or $2.44 per basic
and diluted share, based on 21,463,656 weighted average common
shares outstanding, compared to a net loss of approximately
$19.9 million, or $1.70 per basic and diluted share, based on
11,722,725 weighted average common shares outstanding for the same
period ended June 30, 2020.
- Cash and Cash Equivalents as of June 30, 2021, were $87.2
million, which does not include the approximately
$42.2 million raised in the equity
offering on July 19, 2021. Management
expects its current cash and cash equivalents to be sufficient to
fund operations into 2023.
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 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 June
30,
|
|
Six
Months
Ended June
30,
|
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
15,738
|
|
$
|
9,987
|
|
$
|
27,257
|
|
$
|
16,421
|
|
General and
administrative
|
|
3,432
|
|
2,235
|
|
7,050
|
|
4,815
|
|
4SC Royalty
Settlement
|
|
—
|
|
—
|
|
17,250
|
|
—
|
|
Total operating
expenses
|
|
19,170
|
|
12,222
|
|
51,557
|
|
21,236
|
|
Loss from
operations
|
|
(19,170)
|
|
(12,222)
|
|
(51,557)
|
|
(21,236)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
13
|
|
4
|
|
41
|
|
28
|
|
Other income
(expense), net
|
|
1,223
|
|
760
|
|
(952)
|
|
1,263
|
|
Total other income
(expense)
|
|
1,236
|
|
764
|
|
(911)
|
|
1,291
|
|
Net loss
|
|
$
|
(17,934)
|
|
$
|
(11,458)
|
|
$
|
(52,468)
|
|
$
|
(19,945)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.82)
|
|
$
|
(0.90)
|
|
$
|
(2.44)
|
|
$
|
(1.70)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding,
basic and diluted
|
|
21,749,439
|
|
12,695,989
|
|
21,463,656
|
|
11,722,725
|
|
Immunic,
Inc.
Condensed
Consolidated Balance Sheets
(In thousands, except
share and per share amounts)
|
|
|
June 30,
2021
|
|
December 31,
2020
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
87,175
|
|
|
$
|
127,452
|
|
Other current assets
and prepaid expenses
|
14,512
|
|
|
6,293
|
|
Total current
assets
|
101,687
|
|
|
133,745
|
|
Property and
equipment, net
|
194
|
|
|
203
|
|
Goodwill
|
32,970
|
|
|
32,970
|
|
Right-of-use assets,
net
|
1,165
|
|
|
901
|
|
Other long-term
assets
|
42
|
|
|
42
|
|
Total
assets
|
$
|
136,058
|
|
|
$
|
167,861
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
4,182
|
|
|
$
|
3,700
|
|
Accrued
expenses
|
6,175
|
|
|
4,318
|
|
Other current
liabilities
|
4,130
|
|
|
379
|
|
Total current
liabilities
|
14,487
|
|
|
8,397
|
|
Long term
liabilities
|
|
|
|
Operating lease
liabilities
|
829
|
|
|
679
|
|
Total long-term
liabilities
|
829
|
|
|
679
|
|
Total
liabilities
|
15,316
|
|
|
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 June 30, 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 June
30, 2021
and December 31, 2020, respectively
|
2
|
|
|
2
|
|
Additional paid-in
capital
|
278,534
|
|
|
266,823
|
|
Accumulated other
comprehensive loss
|
(1,398)
|
|
|
(4,112)
|
|
Accumulated
deficit
|
(156,396)
|
|
|
(103,928)
|
|
Total stockholders'
equity
|
120,742
|
|
|
158,785
|
|
Total liabilities and
stockholders' equity
|
$
|
136,058
|
|
|
$
|
167,861
|
|
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SOURCE Immunic, Inc.