Full Press Release Details
Immunic, Inc. Reports Second
Quarter 2023 Financial Results
and Provides Corporate Update
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 -
August 3, 2023 - 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
"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."
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."
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
Second Quarter 2023 and Subsequent Highlights
Anticipated Clinical Milestones
Financial and Operating Results
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.
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.
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 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.
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.
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.
Statement Regarding Forward-Looking Statements
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