– Positive Interim Analysis from Phase 2
CALLIPER Trial Showed Improvements in Serum Neurofilament Light
Chain for Vidofludimus Calcium, Consistent Throughout the Overall
Progressive Multiple Sclerosis Population and All Subtypes
–
– Notice of Allowance for United
States Patent Protecting the Treatment of Relapsing Multiple
Sclerosis with Vidofludimus and Its Salts Bolsters Multilayered
Intellectual Property Position –
– $59.7 Million
in Cash and Cash Equivalents as of September
30, 2023 Expected to Fund Immunic Into September of 2024
–
– Webcast to be Held Today, November 14, 2023, at 8:00
am ET –
NEW
YORK, Nov. 14, 2023 /PRNewswire/
-- Immunic, Inc. (Nasdaq: IMUX), a
biotechnology company developing a clinical pipeline of orally
administered, small molecule therapies for chronic inflammatory and
autoimmune diseases, today announced financial results for the
third quarter ended September 30,
2023, and provided a corporate update.
"We have continued to make tangible progress on the clinical
development of our lead asset, nuclear receptor related 1 (Nurr1)
activator, vidofludimus calcium (IMU-838). Of particular
importance, we completed enrollment of our phase 2 CALLIPER trial
in patients with progressive multiple sclerosis (PMS) and most
recently reported a stronger than expected, positive interim
biomarker analysis of this trial. Notably, the clear separation
observed in serum neurofilament light chain (NfL) over placebo in
this patient population represents another key milestone for
what could potentially be a first-in-class Nurr1 activator for
PMS," stated Daniel Vitt, Ph.D.,
Chief Executive Officer and President of Immunic. "Serum NfL
responses were consistently observed for vidofludimus calcium
across progressive MS disease as well as all subpopulations and
even in non-active SPMS, a population where the medical need for
new therapies is particularly high. We believe that the data set
provides biomarker evidence that vidofludimus calcium's activity
extends beyond the previously observed anti-inflammatory effects,
further reinforcing its neuroprotective potential and bolstering
our view that it may be associated with the reduced
disability-worsening events we already observed in multiple
sclerosis (MS) patients."
"Assuming that the top-line CALLIPER data, which we plan to
report in April 2025, continues to
show a neuroprotective effect, we may be able to position
vidofludimus calcium as the first oral treatment for non-active
secondary progressive MS. We also think that the drug's potential
first-in-class ability to activate Nurr1 may meaningfully benefit
our ongoing phase 3 ENSURE program in relapsing MS (RMS). To that
end, we continue to enroll patients in our twin phase 3 ENSURE
trials and currently expect to report an interim futility analysis
in late 2024, with the read-out of the first of the ENSURE trials
expected at the end of 2025. If ultimately approved, we continue to
believe that vidofludimus calcium, with combined neuroprotective,
anti-inflammatory, and antiviral effects, could potentially offer a
unique treatment option targeted to the complex pathophysiology of
MS."
Dr. Vitt continued, "In October and November, respectively, we
presented the previously reported positive results from our phase
1b clinical trial of our second key
program, IMU-856, an orally available and systemically acting
small molecule modulator that targets SIRT6 (Sirtuin 6), in
patients with celiac disease, at two prestigious medical
conferences. The results, gathered during periods of gluten-free
diet and gluten challenge, demonstrated positive effects for
IMU-856 over placebo in four key dimensions of celiac disease
pathophysiology: protection of the gut architecture, improvement of
patients' symptoms, biomarker response and enhancement of nutrient
absorption. IMU-856 was also observed to be safe and well-tolerated
in this trial. We believe that this highly encouraging data
provides initial clinical proof-of-concept for a potential new
therapeutic approach to gastrointestinal disorders by promoting
regeneration of bowel architecture. That said, we are currently
preparing for clinical phase 2 testing of IMU-856 in ongoing active
celiac disease (OACD), while also considering further potential
clinical applications in other gastrointestinal disorders."
Third Quarter 2023 and Subsequent Highlights
- November 2023: Received a Notice
of Allowance from the United States Patent and Trademark Office for
patent application 17/391,442, entitled, "Treatment of Multiple
Sclerosis Comprising DHODH Inhibitors," covering a daily dose of
about 10 mg to 45 mg of vidofludimus calcium and other salt as well
as free acid forms for the treatment of RMS. The claims are
expected to provide protection into 2041, unless extended
further.
- November 2023: Presented data
from the company's phase 1b clinical
trial of IMU-856 in patients with celiac disease in a poster
presentation at the Association of European Coeliac Societies
(AOECS) 35th General Assembly Conference 2023.
- October 2023: Presented data from
the phase 1b clinical trial of
IMU-856 in patients with celiac disease in a moderated poster
session; along with data from the company's phase 2 CALDOSE-1 trial
of vidofludimus calcium in moderate-to-severe ulcerative colitis
(UC) in an oral presentation, both at the United European
Gastroenterology Week (UEGW) 2023.
- October 2023: Presented data from
the company's phase 2 EMPhASIS trial of vidofludimus calcium in
relapsing-remitting MS in an ePoster at MSMilan2023: The 9th Joint
ECTRIMS-ACTRIMS Meeting.
- October 2023: Reported positive
interim data from the phase 2 CALLIPER trial of vidofludimus
calcium in PMS. Serum NfL responses were consistently observed for
vidofludimus calcium across PMS disease and all subtypes, as well
as in patients that show or do not show disease and/or magnetic
resonance imaging (MRI) activity. The Company believes that this
data showed biomarker evidence that vidofludimus calcium's activity
extends beyond the previously observed anti-inflammatory effects,
thereby further reinforcing its neuroprotective potential.
- August 2023: Announced the
completion of enrollment of the phase 2 CALLIPER trial of
vidofludimus calcium in PMS. In total, 467 patients with primary
PMS, or active or non-active secondary PMS were randomized to
either 45 mg of vidofludimus calcium or placebo.
- July 2023: Hosted a virtual
celiac disease expert roundtable to discuss the substantial unmet
medical need for new therapeutic solutions. Immunic's management
also provided an overview of the company's IMU-856 program,
including the positive results from the phase 1b clinical trial in patients with celiac
disease.
Anticipated Clinical Milestones
- Vidofludimus calcium in MS: Top-line data from the phase
2 CALLIPER trial of vidofludimus calcium in PMS is expected in
April of 2025. An interim futility analysis of the ENSURE program
is expected in late 2024, with the read-out of the first of the
ENSURE trials at the end of 2025.
- IMU-856 in celiac disease: Based on the positive data
from the phase 1b clinical trial,
testing IMU-856 in celiac disease patients during periods of
gluten-free diet and gluten challenge, the company is actively
preparing for clinical phase 2 testing of IMU-856 in OACD
patients.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$19.8 million for the three months
ended September 30, 2023, as compared
to $16.5 million for the three months
ended September 30, 2022. The
$3.3 million increase reflects (i) a
$2.8 million increase in external
development costs related to the phase 3 clinical program of
vidofludimus calcium in RMS, (ii) a $1.2
million increase in drug supply costs for vidofludimus
calcium to support our ongoing trials, (iii) a $1.0 million increase in external development
costs related to the phase 2 clinical trial of vidofludimus calcium
in PMS, (iv) a $0.5 million increase
in personnel expense in R&D related to an increase in headcount
and (v) a $0.9 million increase in
related costs across numerous categories. The increases were
partially offset by (i) a decrease of $2.5
million resulting from deprioritizing the izumerogant
program in psoriasis and castration-resistant prostate cancer and
(ii) a $0.6 million decrease in
external development costs related to the phase 1 clinical trial of
IMU-856.
For the nine months ended September 30,
2023, R&D expenses were $63.9
million, as compared to $50.5
million for the same period ended September 30, 2022. The $13.4 million increase reflects (i) a
$10.1 million increase in external
development costs related to the phase 3 clinical program of
vidofludimus calcium in RMS, (ii) a $2.9 million increase in external development
costs related to the phase 2 clinical trial of vidofludimus
calcium in PMS, (iii) a $2.3
million increase in drug supply costs for
vidofludimus calcium to support our ongoing trials,
(iv) a $1.8 million
increase in external development costs related to the phase 1
clinical trial of IMU-856, (v) a $1.6 million increase in personnel expense in
R&D related to an increase in headcount, $0.2 million of which was due to non-cash stock
based compensation and (vi) a $0.5 million increase in related costs across
numerous categories. The increases were partially offset by
(i) a decrease of $4.0
million resulting from deprioritizing
the izumerogant program in psoriasis and
castration-resistant prostate cancer and (ii) a decrease of
$1.8 million in external development
costs related to the phase 2 clinical trial of vidofludimus
calcium in UC.
- General and Administrative (G&A) Expenses were
$3.8 million for the three months
ended September 30, 2023, as compared
to $3.6 million for the same period
ended September 30, 2022. The
$0.2 million increase was spread
across numerous categories.
For the nine months ended September 30,
2023, G&A expenses were $11.9
million, as compared to $11.6
million for the same period ended September 30, 2022. The $0.3 million increase was primarily due to
(i) a $0.2 million increase in
travel expense, (ii) a $0.2 million
increase in legal and consultancy expense and (iii) a
$0.5 million increase across numerous
categories. The increases were partially offset by a decrease of
$0.6 million in personnel expenses in
G&A, which was primarily due to non-cash stock-based
compensation decrease.
- Other Income (Expense) was $0.8 million for the three months ended
September 30, 2023, as compared to
($1.1 million) for the same period
ended September 30, 2022. The
$1.9 million increase was primarily
attributable to (i) a $1.8
million decrease in foreign exchange losses and (ii) a
$0.5 million increase in interest
income as a result of higher interest rates. The increase was
partially offset by a $0.4 million
decrease in R&D tax incentives for clinical trials in
Australia as a result of decreased
spending on clinical trials in Australia primarily for IMU-856.
For the nine months ended September 30,
2023, other income was $3.8
million, as compared to ($1.8
million) for the same period ended September 30, 2022. The $5.6 million increase was primarily attributable
to (i) a $2.2 million increase in
interest income as a result of higher interest rates, (ii) a
$3.2 million decrease in foreign
exchange losses and (iii) a $1.1
million research allowance attributable to tax year 2021
from the German Federal Ministry of Finance. The increase was
partially offset by a $0.9 million
decrease in R&D tax incentives for clinical trials in
Australia as a result of decreased
spending on clinical trials in Australia.
- Net Loss for the three months ended September 30, 2023, was approximately
$22.8 million, or $0.51 per basic and diluted share, based on
44,574,377 weighted average common shares outstanding, compared to
a net loss of approximately $21.2
million, or $0.69 per basic
and diluted share, based on 30,564,995 weighted average common
shares outstanding for the same period ended September 30, 2022.
Net loss for the nine months ended September
30, 2023, was approximately $72.0
million, or $1.63 per basic
and diluted share, based on 44,227,264 weighted average common
shares outstanding, compared to a net loss of approximately
$63.9 million, or $2.16 per basic and diluted share, based on
29,655,946 weighted average common shares outstanding for the same
period ended September 30, 2022.
- Cash, Cash Equivalents and Investments as of
September 30, 2023 were $59.7 million. With these funds Immunic expects
to be able to fund its operations into September of 2024.
Webcast Information
Immunic will host a webcast today
at 8:00 am ET. To participate in the
webcast, please register in advance at:
https://imux.zoom.us/webinar/register/WN_AxIAE0pCQ12oMZIiehNKDg 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
biotechnology company developing a clinical pipeline of orally
administered, small molecule therapies for chronic inflammatory and
autoimmune diseases. The company's lead development program,
vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2
clinical trials for the treatment of relapsing and progressive
multiple sclerosis, respectively, and has shown therapeutic
activity in phase 2 clinical trials in patients suffering from
relapsing-remitting multiple sclerosis, progressive multiple
sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus
calcium combines neuroprotective effects, through its mechanism as
a first-in-class nuclear receptor related 1 (Nurr1) activator, with
additional anti-inflammatory and anti-viral effects, by selectively
inhibiting the enzyme dihydroorotate dehydrogenase (DHODH).
IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended
to restore intestinal barrier function and regenerate bowel
epithelium, which could potentially be applicable in numerous
gastrointestinal diseases, such as celiac disease, where it is
currently in preparations for a phase 2 clinical trial. IMU-381,
which currently is in preclinical testing, is a next generation
molecule being developed to specifically address the needs of
gastrointestinal diseases. 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, sufficiency of cash, expected
timing, development and results of clinical trials, 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 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 substantial 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, increasing inflation, impacts of the
Ukraine – Russia conflict and the conflict in the
Middle East on planned and ongoing
clinical trials, 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 financial and other resources to meet
business objectives and operational requirements, the fact that the
results of earlier preclinical studies and clinical 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,
2022, filed with the SEC on February
23, 2023, 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
+1 917 633 7790
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
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,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$ 19,796
|
|
$ 16,537
|
|
$ 63,931
|
|
$ 50,520
|
General and
administrative
|
|
3,774
|
|
3,579
|
|
11,911
|
|
11,641
|
Total operating
expenses
|
|
23,570
|
|
20,116
|
|
75,842
|
|
62,161
|
Loss from
operations
|
|
(23,570)
|
|
(20,116)
|
|
(75,842)
|
|
(62,161)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
766
|
|
230
|
|
2,534
|
|
343
|
Other income
(expense), net
|
|
35
|
|
(1,338)
|
|
1,268
|
|
(2,115)
|
Total other income
(expense)
|
|
801
|
|
(1,108)
|
|
3,802
|
|
(1,772)
|
Net loss
|
|
$
(22,769)
|
|
$
(21,224)
|
|
$
(72,040)
|
|
$
(63,933)
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
(0.51)
|
|
$
(0.69)
|
|
$
(1.63)
|
|
$
(2.16)
|
|
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding, basic and diluted
|
|
44,574,377
|
|
30,564,995
|
|
44,227,264
|
|
29,655,946
|
Immunic,
Inc.
Condensed
Consolidated Balance Sheets
(In thousands, except
share and per share amounts)
(Unaudited)
|
|
|
September 30,
2023
|
|
December 31,
2022
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
59,689
|
|
$
106,745
|
Investments -
other
|
—
|
|
9,629
|
Other current assets
and prepaid expenses
|
5,545
|
|
9,490
|
Total current
assets
|
65,234
|
|
125,864
|
Property and equipment,
net
|
288
|
|
294
|
Right-of-use assets,
net
|
1,412
|
|
1,552
|
Other long-term
assets
|
43
|
|
43
|
Total assets
|
$
66,977
|
|
$
127,753
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
3,199
|
|
$
4,281
|
Accrued
expenses
|
13,659
|
|
7,986
|
Other current
liabilities
|
923
|
|
810
|
Total current
liabilities
|
17,781
|
|
13,077
|
Long term
liabilities
|
|
|
|
Operating lease
liabilities
|
789
|
|
992
|
Total long-term
liabilities
|
789
|
|
992
|
Total
liabilities
|
18,570
|
|
14,069
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.0001 par value; 20,000,000 authorized and no shares
issued
or outstanding at
September 30, 2023 and December 31, 2022
|
—
|
|
—
|
Common stock, $0.0001
par value; 130,000,000 shares authorized and 44,595,383
and 39,307,286 shares
issued and outstanding as of September 30, 2023 and
December 31, 2022,
respectively
|
4
|
|
4
|
Additional paid-in
capital
|
433,818
|
|
427,925
|
Accumulated other
comprehensive income
|
3,905
|
|
3,035
|
Accumulated
deficit
|
(389,320)
|
|
(317,280)
|
Total stockholders'
equity
|
48,407
|
|
113,684
|
Total liabilities and
stockholders' equity
|
$
66,977
|
|
$
127,753
|
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SOURCE Immunic, Inc.