Full Press Release Details
Immunic, Inc. Reports Third
Quarter 2022 Financial Results
and Provides Corporate Update
$72.8 Million in Cash and Cash Equivalents as of September 30, 2022, Plus $56.4 Million of Net Cash Raised in October 2022 Expected to
Fund Immunic Into the Fourth Quarter of 2024 -
Webcast to be Held Today, November 3, 2022, at 8:00 am ET -
November 3, 2022 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage
biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune
diseases, today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.
"Going forward, we are on sound financial
footing, having significantly bolstered our balance sheet in October with the closing of a $60 million private placement, providing runway
through multiple value inflection points into the fourth quarter of 2024," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "As reported last month, we conducted an interim analysis of our phase 1b clinical trial of IMU-935 in patients
with moderate-to-severe psoriasis. Unfortunately, the group-level data did not show a benefit of the first two active doses tested compared
to placebo. These results both disappointed and surprised us at the same time. That said, due to the volume of evidence generated, thus
far, for the potential efficacy of IMU-935, we continue to believe that IMU-935 has the potential to be a safe, efficacious and important
treatment option for patients with psoriasis and other chronic inflammatory and autoimmune diseases. We look forward to a full and final
analysis of data from this trial, which should allow us to better understand these early observations and to determine the best next steps
for this key program."
Dr. Vitt continued, "Our next clinical milestone
will be for IMU-856, our orally available and systemically acting small molecule modulator shown preclinically to regulate intestinal
barrier function and regenerate bowel epithelium, which is currently in an ongoing phase 1 clinical trial. During the recent quarter,
we reported positive unblinded safety, tolerability and pharmacokinetic (PK) results from Part A (single ascending doses, SAD) and Part
B (multiple ascending doses, MAD) of the trial in healthy human subjects and look forward to reporting initial clinical activity data
from the Part C portion in celiac disease patients next year. It is worth noting that, during the quarter, we received notice of allowance
from the U.S. Patent and Trademark Office for a key composition-of-matter patent for IMU-856, significantly strengthening the intellectual
property portfolio around this asset by providing protection into at least 2038."
"We also continue to progress the development
of our lead asset, selective oral DHODH inhibitor, vidofludimus calcium (IMU-838) in multiple sclerosis (MS). Specifically, our phase
2 CALLIPER trial in progressive MS continues to enroll patients and we expect data from the interim analysis to be available in the second
half of 2023, and top-line data at the end of 2024. Importantly, the CALLIPER trial is designed to corroborate the neuroprotective potential
of vidofludimus calcium and could, therefore, be an additional differentiator for the drug in the MS market. We also anticipate data from
the first of our phase 3 ENSURE trials in relapsing MS by the end of 2025. Based on the strong clinical activity observed thus far and
vidofludimus calcium's well-established safety and tolerability profile, to date, we strongly believe that the design of the ENSURE
program provides a straightforward path towards potential regulatory approval in relapsing MS."
Third Quarter 2022 and Subsequent Highlights
Anticipated Clinical Milestones
Financial and Operating Results
For the nine months ended September
30, 2022, R&D expenses were $50.5 million, as compared to $42.7 million for the same period ended September 30, 2021. The $7.8 million
increase reflects (i) a $14.0 million increase in external development costs related to the ongoing clinical programs of vidofludimus
calcium in relapsing and progressive MS, as well as IMU-935 and IMU-856, and (ii) a $2.3 million increase in personnel expense in research
and development. The increases were partially offset by (i) a decrease of $8.0 million in external development costs related to the phase
2 clinical trials of vidofludimus calcium in ulcerative colitis, COVID-19 and relapsing-remitting MS, and (ii) a decrease of $0.5 million
in external development costs across numerous categories.
For the nine months ended September
30, 2022, G&A expenses were $11.6 million, as compared to $10.0 million for the same period ended September 30, 2021. The $1.6 million
increase was primarily due to (i) a $1.3 million increase in personnel expense in general and administrative, and (ii) a $0.3 million
increase across numerous categories.
For the nine months ended September
30, 2022, other income (expense) was ($1.8 million), as compared to ($1.8 million) for the same period ended September 30, 2021, substantially
unchanged in net total. However, the company had a $1.2 million increase in the loss on an intercompany loan between Immunic, Inc. and
Immunic AG. This was offset by currency transaction gains, interest income due to higher interest rates, tax incentives for clinical trials
in Australia, and an increase in grants received.
Net loss for the nine months ended
September 30, 2022, was approximately $63.9 million, or $2.16 per basic and diluted share, based on 29,655,946 weighted average common
shares outstanding, compared to a net loss of approximately $71.8 million, or $3.33 per basic and diluted share, based on 21,559,964 weighted
average common shares outstanding for the same period ended September 30, 2021.
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_g6raQxUTRQuuryWUU4Umig
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 clinical-stage
biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune
diseases. The company is developing three small molecule products: its lead development program, vidofludimus calcium (IMU-838), a selective
immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based
antiviral effect, is currently being developed as a treatment option for multiple sclerosis. IMU-935, a selective inverse agonist of the
transcription factor ROR /ROR t, is targeted for development in psoriasis, and castration-resistant prostate cancer. IMU-856,
which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction.
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 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 three 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, particularly following the recent substantial decrease in the Company's market capitalization, 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, 2021, filed with the SEC on February 24, 2022, 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.
Head of Investor Relations and Communications
Rx Communications Group