– Substantially Bolstered Balance Sheet
Through a Three-Tranche Private Placement Totaling Up to
$240 Million, Extending Cash Runway
Into the Third Quarter of 2025, Based on Initial $80 Million Tranche –
– Received Fourth U.S. Patent Directed to Use
of Vidofludimus Calcium in Multiple Sclerosis; Multilayered
Intellectual Property Strategy Provides Protection Into 2041 in
the United States –
– Twin Phase 3 ENSURE Trials in Relapsing
Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive
Multiple Sclerosis Remain Underway –
– Webcast to be Held Today, May 8, 2024, at 8:00 am
ET –
NEW
YORK, May 8, 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 first quarter
ended March 31, 2024, and provided a
corporate update.
"During the first quarter and subsequent period, we have
continued to advance both the phase 2 CALLIPER trial in patients
with progressive multiple sclerosis (PMS) and the twin phase 3
ENSURE trials in relapsing multiple sclerosis (RMS), for our
potentially groundbreaking, orally available lead asset, nuclear
receptor related 1 (Nurr1) activator, vidofludimus calcium
(IMU-838)," stated Daniel Vitt,
Ph.D., Chief Executive Officer and President of Immunic. "Just last
month, we hosted a Multiple Sclerosis (MS) R&D Day,
highlighting the latest developments in the MS landscape as well as
our highly encouraging preclinical and clinical data supporting the
neuroprotective potential and reduced disability-worsening
associated with vidofludimus calcium, which represent important
distinctions compared to currently available MS therapies. We also
shared our strong belief that vidofludimus calcium could elevate
today's standard of care by providing a holistic solution for the
full spectrum of MS patients, given that it is designed to
selectively manage all three components of smoldering MS with its
neuroprotective, anti-inflammatory and antiviral effects.
Importantly, the clear separation from placebo in serum
neurofilament light chain (NfL) levels in patients with PMS and
non-relapsing secondary progressive multiple sclerosis (SPMS),
which was observed in the recent interim analysis from our phase 2
CALLIPER trial, is significant, and, if this separation is also
evident in the top-line CALLIPER data expected in April of next
year, we may also be able to position vidofludimus calcium as the
first oral treatment option for non-relapsing SPMS. Additionally,
as it relates to our phase 3 ENSURE program, we expect to read-out
the first of the ENSURE trials in the second quarter of 2026 and
anticipate reading out the second ENSURE trial in the second half
of 2026."
"We are well capitalized to execute on our upcoming MS
milestones, following our successful January
2024, three-tranche private placement of up to $240 million, with a group of top-tier new and
existing investors, which we believe reflects the enormous
potential of our clinical programs. In addition to strengthening
our capital position, we also continued to build on the several
layers of patents, currently protecting vidofludimus calcium into
2041 in the United States, with
the United States Patent and Trademark Office's (USPTO) Notice of
Allowance last month for our fourth patent application covering a
key composition-of-matter of a specific polymorph of vidofludimus
calcium and related production of the material."
Dr. Vitt concluded, "Our second program, IMU-856, an orally
available, systemically acting small molecule modulator that
targets Sirtuin 6 ("SIRT6"), a protein which serves as a
transcriptional regulator of intestinal barrier function and
physiological regeneration of bowel epithelium, also shows great
promise. As we have noted previously, based on initial clinical
proof-of-concept data, we believe that IMU-856 could be an entirely
new therapeutic approach to treating gastrointestinal disorders by
restoring a healthy gut through renewal of the bowel wall. In
particular, the data from our phase 1b clinical trial in celiac disease patients
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. We are currently
preparing clinical phase 2 testing of IMU-856 in patients with
ongoing active celiac disease (OACD) despite gluten-free diet,
while also exploring the possibility of additional clinical uses in
other gastrointestinal conditions."
First Quarter 2024 and Subsequent Highlights
- April 2024: Hosted an MS R&D
Day, during which management discussed the latest developments in
the MS landscape, along with recent preclinical and clinical data
supporting the neuroprotective potential of vidofludimus
calcium.
- March 2024: Received Notice of
Allowance from the USPTO for patent application 16/981,122
entitled, "Calcium salt polymorphs as anti-inflammatory,
immunomodulatory and anti-proliferative agents," covering the
composition-of-matter of a specific polymorph of vidofludimus
calcium and a related method of production of the material.
- February 2024: Presented data
from the company's phase 2 CALLIPER and CALVID-1 clinical trials of
vidofludimus calcium, in two poster presentations at the Americas
Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) Forum 2024.
- January 2024: Announced a
three-tranche private placement totaling up to $240 million, with participation from select new
and existing investors. These included lead investor BVF Partners,
alongside Avidity Partners, Janus Henderson Investors, Soleus
Capital, RTW Investments and Adage Capital Partners. The initial
tranche successfully closed on January 8,
2024, with Immunic securing $80
million in gross proceeds.
Clinical Development Programs
- 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
$18.7 million for the three months
ended March 31, 2024, as compared to
$22.9 million for the three months
ended March 31, 2023. The
$4.2 million decrease reflects (i) a
decrease of $2.4 million from
deprioritizing the izumerogant program in psoriasis and
castration-resistant prostate cancer and (ii) a $2.5 million decrease in external development
costs related to the vidofludimus calcium and IMU-856 programs. The
decreases were partially offset by a $0.7
million increase in personnel costs, $0.3 million of which is related to non-cash
stock compensation and the remainder of which is due to an increase
in headcount.
- General and Administrative (G&A) Expenses were
$5.1 million for the three months
ended March 31, 2024, as compared to
$4.2 million for the same period
ended March 31, 2023. The
$0.9 million increase was primarily
due to (i) a $0.8 million increase in
personnel expense in general and administrative, $0.5 million of which is related to non-cash
stock compensation expense and the remainder of which is related to
an increase in headcount and (ii) $0.1
million in legal and consultancy expenses.
- Interest Income was $1.2
million for the three months ended March 31, 2024, as compared to $0.8 million for the same period ended
March 31, 2023. The $0.4 million increase was due to higher interest
rates.
- The Change in Fair Value of the Tranche Rights of
$4.8 million for the three months
ended March 31, 2024 was a non-cash
charge related to the change in value of the tranche rights
associated with the future tranches 2 and 3 of the January 2024 private placement.
- Other Income (Expense) was ($2.1
million) for the three months ended March 31, 2024, as compared to $1.2 million for the same period ended
March 31, 2023. The $3.3 million decrease was primarily attributable
to (i) a $1.7 million expense related
to the portion of deal costs from the January 2024 private placement related to the
tranche rights that were established at the time of the closing of
tranche 1, (ii) the German Federal Ministry of Finance grant of
$1.1 million being recognized in the
fourth quarter of 2023 which was one quarter earlier than in the
prior year when the grant was recognized in the first quarter of
2023 and (iii) 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 March 31, 2024, was approximately $29.6 million, or $0.30 per basic and diluted share, based on
97,299,955 weighted average common shares outstanding, compared to
a net loss of approximately $25.3
million, or $0.58 per basic
and diluted share, based on 43,664,783 weighted average common
shares outstanding for the same period ended March 31, 2023.
- Cash and Cash Equivalents as of March 31, 2024 were $97.3
million. With these funds, 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_K6jgjaMURFiJjgA5i9-M8g 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 including the
ability to satisfy the conditions required to receive funding in
tranche 2 and 3 of the January 2024
private placement, 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.
Condensed
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
|
|
|
|
Three
Months
Ended March
31,
|
|
|
2024
|
|
2023
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
$ 18,736
|
|
$ 22,963
|
General and
administrative
|
|
5,145
|
|
4,288
|
Total operating
expenses
|
|
23,881
|
|
27,251
|
Loss from
operations
|
|
(23,881)
|
|
(27,251)
|
Other income
(expense):
|
|
|
|
|
Interest
income
|
|
1,187
|
|
800
|
Change in fair value
of the tranche rights
|
|
(4,796)
|
|
—
|
Other income
(expense), net
|
|
(2,094)
|
|
1,179
|
Total other income
(expense)
|
|
(5,703)
|
|
1,979
|
Net loss
|
|
$
(29,584)
|
|
$
(25,272)
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
(0.30)
|
|
$
(0.58)
|
|
|
|
|
|
Weighted-average common
shares outstanding, basic and diluted
|
|
97,299,955
|
|
43,664,783
|
Immunic,
Inc.
Condensed
Consolidated Balance Sheets
(In thousands, except
share and per share amounts)
(Unaudited)
|
|
|
March 31,
2024
|
|
December 31,
2023
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
97,312
|
|
$
46,674
|
Other current assets
and prepaid expenses
|
5,303
|
|
5,860
|
Total current
assets
|
102,615
|
|
52,534
|
Property and equipment,
net
|
442
|
|
466
|
Right-of-use assets,
net
|
1,098
|
|
1,299
|
Total assets
|
$ 104,155
|
|
$
54,299
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
6,767
|
|
$
5,099
|
Accrued
expenses
|
12,419
|
|
18,664
|
Other current
liabilities
|
960
|
|
966
|
Total current
liabilities
|
20,146
|
|
24,729
|
Long-term
liabilities
|
|
|
|
Operating lease
liabilities
|
433
|
|
639
|
Total long-term
liabilities
|
433
|
|
639
|
Total
liabilities
|
20,579
|
|
25,368
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock,
$0.0001 par value; 20,000,000 authorized and no shares issued or
outstanding as of March 31, 2024 and December 31, 2023
|
—
|
|
—
|
Common stock, $0.0001
par value; 500,000,000 and 130,000,000 shares authorized as of
March 31, 2024 and December 31, 2023, respectively,
and 90,079,016 and 45,177,730 shares issued and outstanding as of
March 31, 2024 and December 31, 2023, respectively
|
8
|
|
4
|
Additional paid-in
capital
|
519,757
|
|
436,060
|
Accumulated other
comprehensive income
|
4,287
|
|
3,759
|
Accumulated
deficit
|
(440,476)
|
|
(410,892)
|
Total stockholders'
equity
|
83,576
|
|
28,931
|
Total liabilities and
stockholders' equity
|
$ 104,155
|
|
$
54,299
|
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SOURCE Immunic, Inc.