– Preclinical Data Published in the Journal of
Medicinal Chemistry Identifies Vidofludimus Calcium as a Potent
Nurr1 Activator, Reinforcing Neuroprotective Potential in Multiple
Sclerosis –
– Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease
Provide Proof-of-Concept for a New Therapeutic Approach to Treat
Gastrointestinal Diseases by Promoting Regeneration of Bowel
Architecture –
– Interim Results From Phase 2 CALLIPER Trial
of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected
in the Fall of 2023 –
– $77.3 Million
in Cash, Cash Equivalents and Investments Expected to Fund Immunic
Into the Fourth Quarter of 2024 –
– Webcast to be Held Today, August 3, 2023, at 8:00 am
ET –
NEW
YORK, Aug. 3, 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 second quarter
ended June 30, 2023, and provided a
corporate update.
"During the second quarter, we reported important clinical and
preclinical data from our two, lead pipeline programs, including
the most advanced drug candidate, vidofludimus calcium (IMU-838),
as well as IMU-856," stated Daniel
Vitt, Ph.D., Chief Executive Officer and President of
Immunic. "Importantly, we announced publication, in the
peer-reviewed Journal of Medicinal Chemistry, of preclinical
evidence showing that vidofludimus calcium acts as a potent nuclear
receptor related 1 (Nurr1) activator, which may be associated with
both its hypothesized neuroprotective effects and the reduced
disability-worsening events observed in multiple sclerosis (MS)
patients. In the fall of this year, we expect to report an interim
biomarker analysis of our phase 2 CALLIPER trial in progressive MS,
designed to corroborate the neuroprotective potential of
vidofludimus calcium, which could become a distinguishing factor in
the MS market. Based on the substantial clinical activity seen thus
far, along with the already known favorable safety and tolerability
profile, we remain confident that vidofludimus calcium can
potentially be a unique therapeutic approach for managing the
multifaceted pathophysiology of MS."
Dr. Vitt continued, "In May, we reported stronger than expected
positive results from the part C portion of our phase 1 clinical
trial of IMU-856 in patients with celiac disease, showing the first
clinical evidence of its ability, as observed preclinically, to
regenerate the gut wall. In particular, the phase 1b data showed that IMU-856 was effective
compared to placebo in improving four crucial aspects of celiac
disease: histology, disease symptoms, biomarkers and nutrient
absorption. This was followed by our announcement, at Digestive
Disease Week, of the molecular mode of action of IMU-856 as a
potent modulator of Sirtuin 6 (SIRT6), which works to restore and
regenerate the architecture of the intestinal wall. As a result, we
now have clinical evidence to suggest IMU-856's activity and its
potential to treat various gastrointestinal disorders with a novel
therapeutic approach. Based on these findings, preparations for a
phase 2 clinical trial in ongoing active celiac disease (OACD) are
currently underway."
"The maintenance phase of our CALDOSE-1 trial of vidofludimus
calcium in moderate-to-severe ulcerative colitis (UC) patients,
announced during the quarter, delivered very promising results,
demonstrating statistically significant activity in comparison to
placebo. Moreover, this data reconfirmed the excellent safety and
tolerability profile for vidofludimus calcium found in prior
trials," concluded Dr. Vitt.
Second Quarter 2023 and Subsequent Highlights
- 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 recently announced, positive phase 1b trial results in celiac disease patients.
- May 2023: Published preclinical
data in the peer-reviewed, high impact Journal of Medicinal
Chemistry, confirming that vidofludimus calcium acts as a potent
Nurr1 activator, in addition to its known mode of action as a
dihydroorotate dehydrogenase (DHODH) inhibitor, in a paper
entitled, "Development of a potent Nurr1 agonist tool for in vivo
applications." Data showed that activation of Nurr1 could be
responsible for the drug's postulated neuroprotective effects and
may contribute to the previously reported reduction of confirmed
disability worsening events in MS patients.
- May 2023: Presented clinical and
preclinical data for IMU-856, including, for the first time, its
molecular mode of action as a highly selective and potent small
molecule modulator of SIRT6, a protein which serves as a
transcriptional regulator of intestinal barrier function and
regeneration of bowel epithelium, in a virtual e-poster at
Digestive Disease Week (DDW) 2023.
- May 2023: Announced positive
results from the part C portion of the phase 1 clinical trial of
IMU-856 in patients with celiac disease. Data 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. Immunic believes this data
provides initial clinical proof-of-concept for an entirely new
therapeutic approach to gastrointestinal disorders by promoting
regeneration of bowel architecture. The data also provides first
clinical evidence that IMU-856's ability, observed in preclinical
studies, to re-establish proper gut cell renewal, translates into
clinical benefits for patients with celiac disease. Most
importantly, the observed protection of intestinal villi from
gluten-induced destruction, independent of targeting immune
mechanisms involved specifically in celiac disease, appears to be
unique among proposed therapeutic approaches and may be applicable
to other gastrointestinal disorders.
- April 2023: Strengthened Board of
Directors with the addition of Richard
Rudick, M.D., a thought-leader in multiple sclerosis with
decades of experience in the clinic, academia and industry,
effective April 26, 2023. Also
announced that Vincent Ossipow,
Ph.D., would step down from the Board, effective June 28, 2023.
- April 2023: Reported positive
data from the maintenance phase of the phase 2b CALDOSE-1 trial of vidofludimus calcium in
patients with moderate-to-severe ulcerative colitis. Data showed a
dose-linear increase in clinical remission compared to placebo at
week 50. An exploratory statistical analysis confirmed the 30 mg
dose of vidofludimus calcium to be statistically superior
(p=0.0358) in achieving clinical remission at week 50, with a 33.7%
absolute improvement over placebo. Moreover, a dose-linear increase
in endoscopic healing was observed, with the 30 mg dose of
vidofludimus calcium being associated with a 37.8% absolute
improvement over placebo while also achieving statistical
significance in an exploratory statistical analysis (p=0.0259).
Administration of vidofludimus calcium was observed to be safe and
well-tolerated.
Anticipated Clinical Milestones
- Vidofludimus calcium in MS: Data from the interim
analysis of the phase 2 CALLIPER trial of vidofludimus calcium in
progressive MS, previously guided for the second half of 2023, is
now expected to be available in the fall of 2023. The top-line data
read-out for the trial is expected at the end of 2024. Data from
the interim 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
$21.2 million for the three months
ended June 30, 2023, as compared to
$16.5 million for the three months
ended June 30, 2022. The $4.7 million increase reflects (i) a $6.1 million increase in external development
costs related to the ongoing clinical programs of vidofludimus
calcium in relapsing and progressive MS, as well as the IMU-856
program, (ii) a $0.6 million increase
in personnel expense in research and development related to an
increase in headcount, $0.1 million
of which was due to non-cash stock based compensation and (iii) a
$0.7 million increase related costs
across numerous categories. The increases were partially offset by
(i) a decrease of $1.4 million in
external development costs related to the phase 2 clinical trial of
vidofludimus calcium in ulcerative colitis and (ii) a decrease of
$1.3 million related to the IMU-935
psoriasis program.
For the six months ended June 30,
2023, R&D expenses were $44.1
million, as compared to $34.0
million for the same period ended June 30, 2022. The $10.1
million increase reflects (i) a $12.1
million increase in external development costs related to
the ongoing clinical programs of vidofludimus calcium in relapsing
and progressive MS, as well as the IMU-856 program, (ii) a
$1.1 million increase in personnel
expense in research and development related to an increase in
headcount, $0.2 million of which was
due to non-cash stock based compensation and (iii) a $0.5 million increase related costs across
numerous categories. The increases were partially offset by (i) a
decrease of $2.0 million in external
development costs related to the phase 2 clinical trial of
vidofludimus calcium in ulcerative colitis and (ii) a decrease of
$1.6 million related to the IMU-935
psoriasis program.
- General and Administrative (G&A) Expenses were
$3.8 million for the three months
ended June 30, 2023, as compared to
$4.1 million for the same period
ended June 30, 2022. The $0.3 million decrease was primarily due to a
$0.4 million decrease for non-cash
stock-based compensation, which was offset by increased costs
across numerous categories.
For the six months ended June 30,
2023, G&A expenses were $8.1
million, as compared to $8.0
million for the same period ended June 30, 2022. The $0.1
million increase was primarily due to (i) a $0.6 million increase across numerous categories,
partially offset by a decrease of $0.5
million in personnel expense in general and administrative
which was primarily due to non-cash stock-based compensation
decrease.
- Other Income (Expense) was $1.0
million for the three months ended June 30, 2023, as compared to ($1.3 million) for the same period ended
June 30, 2022. The $2.3 million increase was primarily attributable
to (i) a $1.7 million decrease in
foreign exchange losses, (ii) a $0.9
million increase in interest income as a result of higher
interest rates and (iii) a $0.1
million increase for grants received. The increase was
partially offset by a $0.4 million
decrease in research and development tax incentives for clinical
trials in Australia as a result of
decreased spending on clinical trials in Australia.
For the six months ended June 30,
2023, other income was $3.0
million, as compared to ($0.7
million) for the same period ended June 30, 2022. The $3.7
million increase was primarily attributable to (i) a
$1.7 million increase in interest
income as a result of higher interest rates, (ii) a $1.4 million decrease in foreign exchange losses
and (iii) a $1.1 million research
allowance attributable for tax year 2021 from the German Federal
Ministry of Finance. The increase was partially offset by a
$0.5 million decrease in research and
development 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 June 30, 2023, was approximately $24.0 million, or $0.54 per basic and diluted share, based on
44,432,955 weighted average common shares outstanding, compared to
a net loss of approximately $21.9
million, or $0.72 per basic
and diluted share, based on 30,248,767 weighted average common
shares outstanding for the same period ended June 30, 2022.
Net loss for the six months ended June 30,
2023, was approximately $49.3
million, or $1.12 per basic
and diluted share, based on 44,036,352 weighted average common
shares outstanding, compared to a net loss of approximately
$42.7 million, or $1.49 per basic and diluted share, based on
28,686,910 weighted average common shares outstanding for the same
period ended June 30, 2022.
- Cash, Cash Equivalents and Investments as of
June 30, 2023 were $77.3 million. With these funds, Immunic expects
to be able to fund its operations into the fourth quarter 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_p1SCneOlThmUfjhnJ3AZ4g 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 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 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 June
30,
|
|
Six
Months
Ended June
30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$ 21,172
|
|
$ 16,538
|
|
$ 44,135
|
|
$ 33,983
|
General and
administrative
|
|
3,849
|
|
4,072
|
|
8,137
|
|
8,062
|
Total operating
expenses
|
|
25,021
|
|
20,610
|
|
52,272
|
|
42,045
|
Loss from
operations
|
|
(25,021)
|
|
(20,610)
|
|
(52,272)
|
|
(42,045)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
968
|
|
106
|
|
1,768
|
|
113
|
Other income
(expense), net
|
|
54
|
|
(1,397)
|
|
1,233
|
|
(777)
|
Total other income
(expense)
|
|
1,022
|
|
(1,291)
|
|
3,001
|
|
(664)
|
Net loss
|
|
$
(23,999)
|
|
$
(21,901)
|
|
$
(49,271)
|
|
$
(42,709)
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
(0.54)
|
|
$
(0.72)
|
|
$
(1.12)
|
|
$
(1.49)
|
|
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding, basic and diluted
|
|
44,432,955
|
|
30,248,767
|
|
44,036,352
|
|
28,686,910
|
Immunic,
Inc.
Condensed
Consolidated Balance Sheets
(In thousands, except
share and per share amounts)
(Unaudited)
|
|
|
June 30,
2023
|
|
December
31, 2022
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
77,294
|
|
$
106,745
|
Investments -
other
|
—
|
|
9,629
|
Other current assets
and prepaid expenses
|
9,257
|
|
9,490
|
Total current
assets
|
86,551
|
|
125,864
|
Property and equipment,
net
|
290
|
|
294
|
Right-of-use assets,
net
|
1,855
|
|
1,552
|
Other long-term
assets
|
43
|
|
43
|
Total assets
|
$
88,739
|
|
$
127,753
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
4,700
|
|
$
4,281
|
Accrued
expenses
|
12,613
|
|
7,986
|
Other current
liabilities
|
928
|
|
810
|
Total current
liabilities
|
18,241
|
|
13,077
|
Long term
liabilities
|
|
|
|
Operating lease
liabilities
|
1,214
|
|
992
|
Total long-term
liabilities
|
1,214
|
|
992
|
Total
liabilities
|
19,455
|
|
14,069
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.0001 par value; 20,000,000 authorized and no shares
issued
or outstanding as
of June 30, 2023 and December 31, 2022
|
—
|
|
—
|
Common stock, $0.0001
par value; 130,000,000 shares authorized and
44,488,371 and
39,307,286 shares issued and outstanding as of June 30,
2023
and December 31,
2022, respectively
|
4
|
|
4
|
Additional paid-in
capital
|
431,849
|
|
427,925
|
Accumulated other
comprehensive income
|
3,982
|
|
3,035
|
Accumulated
deficit
|
(366,551)
|
|
(317,280)
|
Total stockholders'
equity
|
69,284
|
|
113,684
|
Total liabilities and
stockholders' equity
|
$
88,739
|
|
$
127,753
|
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