– Significantly Strengthened Balance Sheet in
January 2024 with Execution of
Three-Tranche Private Placement of up to $240 Million, Extending Cash Runway Into the
Third Quarter of 2025 Based on Initial $80
Million Tranche –
– Evidence for Neuroprotective Activity of
Vidofludimus Calcium from Phase 2 CALLIPER Interim Analysis,
Consistent Across the Entire Progressive Multiple Sclerosis
Population and All Subtypes; Top-Line CALLIPER Data Expected in
April 2025 –
– Phase 3 ENSURE Program in Relapsing Multiple
Sclerosis Ongoing –
– Expanded Vidofludimus Calcium Patent
Portfolio with Additional New Patents Granted;
Exclusivity Protection Expected Into 2041 in the United States, Unless Extended
Further –
– Webcast to be Held Today, February 22, 2024, at 8:00
am ET –
NEW
YORK, Feb. 22, 2024 /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
fourth quarter and year ended December 31,
2023, and provided a corporate update.
"Immunic made remarkable progress throughout 2023, and these
achievements were punctuated by the successful three-tranche
private placement of up to $240
million, which we announced last month. Our ability to
execute this transaction, with a group of top-tier, existing and
new investors, we believe affirms the enormous value inherent in
our two advanced clinical programs" stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic.
"During the fourth quarter, we reported an interim biomarker
analysis from our phase 2 CALLIPER trial of our lead asset, nuclear
receptor related 1 (Nurr1) activator, vidofludimus calcium. The
highly encouraging results demonstrated clear separation from
placebo in serum neurofilament light chain (NfL) levels in patients
with progressive multiple sclerosis (PMS). Notably, this effect was
observed across all subpopulations, including advanced secondary
progressive multiple sclerosis (SPMS), which we believe is a
segment of very high unmet need in multiple sclerosis (MS).
Further, if the top-line CALLIPER data, expected in April 2025, continues to show a neuroprotective
effect, we may be able to position vidofludimus calcium as the
first oral treatment option for advanced SPMS. This eagerly
anticipated data is fully funded by the first $80 million tranche of our recent financing,
which extended our cash runway into the third quarter of 2025. An
interim futility analysis for our phase 3 ENSURE program is
expected late this year, and the read-out of the first of the
ENSURE trials is anticipated in the second quarter of 2026. If
approved, we believe that vidofludimus calcium has the potential to
be a unique treatment option targeted to the complex
pathophysiology of MS, based on its combined neuroprotective,
anti-inflammatory, and antiviral effects. It is important to note
that we continue to build on the multiple layers of patent
protection around vidofludimus and its salt and free acid forms. In
November, we were granted two fundamental new patents in
the United States covering the
specific dose strength used in clinical trials for the treatment of
relapsing multiple sclerosis (RMS), as well as the dosing regimens
associated with the treatment of MS. As a result, our extensive
patent portfolio now provides protection into 2041 in the United States, unless extended
further."
Dr. Vitt continued, "During the fourth quarter, we presented the
previously reported positive results from our phase 1b clinical trial of our second key clinical
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 demonstrated meaningful improvements over placebo in four
key dimensions of celiac disease pathophysiology: histology,
disease symptoms, biomarkers and nutrient absorption. We believe
this data provides initial clinical proof-of-concept for a
potentially new, oral therapeutic approach to a multitude of
gastrointestinal disorders through the regeneration of bowel
architecture, rather than the traditional immunomodulatory
approaches used in many gastrointestinal indications, today. We are
currently preparing for phase 2 testing in ongoing active celiac
disease (OACD) and are considering additional clinical applications
in other gastrointestinal disorders."
Fourth Quarter 2023 and Subsequent Highlights
- January 2024: Announced a
three-tranche private placement of up to $240 million, with participation from select new
and existing investors, including lead investor BVF Partners, as
well as Avidity Partners, Janus Henderson Investors, Soleus
Capital, RTW Investments and Adage Capital Partners. A total of
$80 million in gross proceeds was
received by Immunic in the first tranche, which closed on
January 8, 2024.
- November 2023: Received a Notice
of Allowance from the United States Patent and Trademark Office
(USPTO) for patent application 17/992,162, covering the dosing
regimens associated with vidofludimus calcium and other salt as
well as free acid forms for the treatment of MS, including all
regimens tested in the MS clinical program.
- November 2023: Received a Notice
of Allowance from the USPTO for patent application 17/391,442,
covering a daily dose of about 10 mg to 45 mg of vidofludimus
calcium and other salt as well as free acid forms, including the 30
mg dosage used in the ongoing twin phase 3 ENSURE trials, for the
treatment of RMS. The claims are expected to provide protection
into 2041, unless extended further.
- November 2023: Presented data
from the 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 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 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 improvements were consistently observed
for vidofludimus calcium across PMS and all disease subtypes, as
well as in patients who showed or did not show disease and/or
magnetic resonance imaging (MRI) activity. Immunic believes that
this data illustrates biomarker evidence that vidofludimus
calcium's activity extends beyond the previously observed
anti-inflammatory effects, further reinforcing its neuroprotective
potential. Enrollment of the trial was completed in August. In
total, 467 patients with primary PMS, or active or non-active SPMS,
were randomized to either 45 mg of vidofludimus calcium or
placebo.
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 2025. An interim futility
analysis of the ENSURE program is expected in late 2024. The
read-out of the first of the ENSURE trials is currently anticipated
in the second quarter of 2026; and the second ENSURE trial in the
second half of 2026.
- IMU-856 in celiac disease: Based on the positive data
from the phase 1b clinical trial, the
company is preparing for clinical phase 2 testing of IMU-856 in
OACD patients despite gluten-free diet.
Financial and Operating Results
- Research and Development (R&D) Expenses were
$83.2 million for the twelve months
ended December 31, 2023, as compared
to $71.2 million for the twelve
months ended December 31, 2022. The
$12.0 million increase reflects (i) a
$19.1 million increase in external
development costs related to the ongoing clinical programs of
vidofludimus calcium in RMS and PMS, the ongoing IMU-856 clinical
program as well as increased drug supply costs for vidofludimus
calcium to support ongoing trials and (ii) a $2.2 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. The increases were partially
offset by (i) a decrease of $6.5
million from deprioritizing the izumerogant program in
psoriasis and castration-resistant prostate cancer, (ii) a decrease
of $2.5 million in external
development costs related to the phase 2 clinical trial of
vidofludimus calcium in ulcerative colitis and (iii) a $0.3 million increase in related costs across
numerous categories.
- General and Administrative (G&A) Expenses were
$16.0 million for the twelve months
ended December 31, 2023, as compared
to $15.3 million for the same period
ended December 31, 2022. The
$0.7 million increase was primarily
due to (i) a $0.9 million increase in
legal and consultancy expense, travel expense and facility expenses
and (ii) a $0.3 million increase
across numerous categories. The increases were 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 $5.6
million for the twelve months ended December 31, 2023, as compared to ($0.9 million) for the same period ended
December 31, 2022. The $6.5 million increase was primarily attributable
to (i) a $3.9 million decrease in
foreign exchange losses, (ii) a $2.3
million research allowance attributable to tax year 2021 and
2022 from the German Federal Ministry of Finance and (iii) a
$2.0 million increase in interest
income as a result of higher interest rates. The increase was
partially offset by (i) a $1.6
million decrease in research and development tax incentives
for clinical trials in Australia
as a result of decreased spending on clinical trials in
Australia and (ii) a $0.1 million decrease across numerous
categories.
- Net Loss for the twelve months ended December 31, 2023, was approximately $93.6 million, or $2.11 per basic and diluted share, based on
44,320,050 weighted average common shares outstanding, compared to
a net loss of approximately $120.4
million, or $3.78 per basic
and diluted share, based on 31,819,006 weighted average common
shares outstanding for the same period ended December 31, 2022.
- Cash, Cash Equivalents and Investments as of
December 31, 2023 were $46.7 million. With these funds and the
approximately $75.0 million in net
proceeds raised in the first tranche of the January 2024 private placement, Immunic expects
to be able to fund its operations into the third quarter of
2025.
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_NCQiFCMpTJ2WEqAc2FnB3A 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, for which 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 and cash
runway, 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,
2023, filed with the SEC on February
22, 2024, 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
Vice President 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. Consolidated Statements of Operations (In
thousands, except share and per share amounts)
(Unaudited)
|
|
|
Years Ended December
31,
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
Research and
development
|
$
83,215
|
|
$
71,255
|
General and
administrative
|
16,008
|
|
15,263
|
Goodwill
impairment
|
—
|
|
32,970
|
Total operating
expenses
|
99,223
|
|
119,488
|
Loss from
operations
|
(99,223)
|
|
(119,488)
|
Other income
(expense):
|
|
|
|
Interest
income
|
3,075
|
|
1,041
|
Other income
(expense), net
|
2,536
|
|
(1,960)
|
Total other income
(expense), net
|
5,611
|
|
(919)
|
Net loss
|
$
(93,612)
|
|
$
(120,407)
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(2.11)
|
|
$
(3.78)
|
|
|
|
|
Weighted-average common
shares outstanding, basic and diluted
|
44,320,050
|
|
31,819,006
|
Immunic,
Inc. Consolidated Balance Sheets (In thousands,
except share and per share amounts)
(Unaudited)
|
|
|
December
31,
|
|
2023
|
|
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
46,674
|
|
$
106,745
|
Investments -
other
|
—
|
|
9,629
|
Prepaid expenses and
other current assets
|
5,860
|
|
9,490
|
Total current
assets
|
52,534
|
|
125,864
|
Property and equipment,
net
|
466
|
|
294
|
Right of use asset,
net
|
1,299
|
|
1,552
|
Other long-term
assets
|
—
|
|
43
|
Total assets
|
$
54,299
|
|
$
127,753
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
5,099
|
|
$
4,281
|
Accrued
expenses
|
18,664
|
|
7,986
|
Other current
liabilities
|
966
|
|
810
|
Total current
liabilities
|
24,729
|
|
13,077
|
Long-term
liabilities:
|
|
|
|
Operating lease
liabilities
|
639
|
|
992
|
Total long-term
liabilities
|
639
|
|
992
|
Total
liabilities
|
25,368
|
|
14,069
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.0001 par value; 20,000,000 authorized and no shares issued
or outstanding at December 31, 2023 and 2022
|
—
|
|
—
|
Common stock, $0.0001
par value; 130,000,000 shares authorized and 45,177,730
and 39,307,286 shares issued and outstanding at December 31,
2023 and 2022,
respectively
|
4
|
|
4
|
Additional paid-in
capital
|
436,060
|
|
427,925
|
Accumulated other
comprehensive income
|
3,759
|
|
3,035
|
Accumulated
deficit
|
(410,892)
|
|
(317,280)
|
Total stockholders'
equity
|
28,931
|
|
113,684
|
Total liabilities and
stockholders' equity
|
$
54,299
|
|
$
127,753
|
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SOURCE Immunic, Inc.