Full Press Release Details
Immunic, Inc. Reports Second Quarter 2021
and Highlights Recent Activity
Received FDA Clearance to Initiate Twin IMU-838 Phase 3 ENSURE Trials in Relapsing-Remitting Multiple Sclerosis and Supportive Phase 2
CALLIPER Trial in Progressive Multiple Sclerosis -
Reported In Vitro Data Showing That IMU-935 May Inhibit the Generation of Th17 Cells and Production of IL-17 Cytokines Without
Impairing ROR t Function Required for Normal
Thymocyte Development -
Reported Preclinical Data Establishing IMU-935 as a Potential Treatment for Castration-Resistant Prostate
Cancer; Preparing for a Phase 1 Clinical Trial -
$87.2 Million in Cash and Cash Equivalents as of June 30, 2021 and the Additional $45.0 Million Raised in July are Expected to Fund Immunic
August 6, 2021 - 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 second quarter ended June 30, 2021 and highlighted recent activity.
"So far this year, we have made outstanding
progress with both our selective oral DHODH inhibitor, IMU-838, as well as IMU-935, a highly potent and selective inverse agonist of the
transcription factor ROR t, enabling what we believe will be an eventful and potentially transformative first half of 2022. In particular,
we anticipate five data read-outs from clinical trials within the next twelve months, and expect to begin our first phase 3 program very
soon. I want to congratulate our entire team for this remarkable momentum," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "In June, we received U.S. Food and Drug Administration (FDA) clearance for our Investigational New Drug (IND)
application for the phase 3 ENSURE program of IMU-838 in patients with relapsing-remitting multiple sclerosis (RRMS), and the supportive
phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS). Initiation of these trials in the second half of this year
will mark a major milestone for our lead program. Additionally, we look forward to completing recruitment of our ongoing phase 2 CALDOSE-1
trial of IMU-838 in patients with ulcerative colitis (UC) during the second half of 2021, and reporting top-line data for this potential
second key indication for IMU-838 in the first half of 2022."
"At our virtual R&D Day just last month,
we presented very encouraging in vitro data showing that IMU-935 may inhibit both the generation of Th17 cells and the production
of IL-17 cytokines that are responsible for the development of autoimmune diseases, without impairing thymocyte development, thereby avoiding
a potential risk for lymphoma that has complicated third-party programs in this space. We also detailed highly encouraging new preclinical
data which suggests that IMU-935 can affect castration-resistant prostate cancer (CRPC) both directly by reducing androgen receptor (AR)
expression via ROR and inhibiting tumor growth, and indirectly by inhibiting tumorigenesis-promoting Th17 and IL-17. Based on the
strength of this data, we are preparing a phase 1 trial in metastatic CRPC (mCRPC) patients with Johann Sebastian de Bono, M.D., Ph.D.,
Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine, The Institute of Cancer Research and The Royal Marsden
NHS Foundation Trust, London, United Kingdom, acting as the Principal Investigator. We expect this trial to commence during the fourth
quarter of this year and also anticipate availability of initial human data from moderate-to-severe psoriasis patients from our phase
1 trial of IMU-935 during the second quarter of 2022."
Dr. Vitt added, "As previously announced,
at the end of the first quarter of 2021, we settled our remaining royalty obligation to 4SC AG for both IMU-838 and IMU-935, for $17.3
million, which was paid 50% in cash and 50% in shares of Immunic's common stock during the second quarter. This strategic decision
provides us with 100% of the future sales potential of our two lead programs and should drive significant value for our shareholders.
Last month, we were able to offset this payment by bolstering our balance sheet with a $45.0 million financing, providing us with anticipated
runway through multiple value inflection points into 2023."
Second Quarter 2021 and Subsequent Highlights
Anticipated Clinical Milestones
Financial and Operating Results
For the six months ended June 30, 2021,
R&D expenses were $27.3 million, as compared to $16.4 million for the same period ended June 30, 2020. The $10.9 million increase
was primarily attributable to (i) a $2.9 million increase in preparation costs related to the phase 3 program of IMU-838 in multiple sclerosis,
(ii) a $2.4 million increase in preparation costs related to the phase 2 trial of IMU-838 in PMS, (iii) a $2.2 million increase in external
development costs related to the phase 2 clinical trial of IMU-838 in patients with UC, (iv) a $1.4 million increase in external development
costs related to the phase 2 clinical trial in patients with COVID-19 as trials did not start until the second quarter of 2020, (v) a
$0.8 million increase in external development costs related to the phase 1 clinical trial of IMU-856, (vi) a $0.7 million increase in
external development costs related to the phase 1 clinical trial of IMU-935, (vii) a $1.0 million increase in personnel expenses in research
and development and (viii) $1.0 million related to increased costs across numerous categories. The increases were partially offset by
a decrease of $1.5 million in drug supply costs for IMU-856.
For the six months ended June 30, 2021,
G&A expenses were $7.1 million, as compared to $4.8 million for the same period ended June 30, 2020. The $2.3 million increase was
primarily due to (i) a $1.7 million increase related to non-cash stock compensation expense and (ii) a $0.6 million increase across numerous
categories, primarily for legal and consultancy services.
For the six months ended June 30, 2021,
other income was $(1.0) million, as compared to $1.3 million for the same period ended June 30, 2020. The $2.3 million decrease was primarily
attributable to (i) a $1.9 million foreign exchange loss on the Intercompany Loan and (ii) a $1.0 million decrease in recognized deferred
income attributable to reimbursements of research and development expenses in connection with the Daiichi Sankyo Agreement realized in
the first six months of 2020. The decrease was partially offset by a $0.6 million increase in research and development tax incentives
for clinical trials in Australia as a result of increased spending on clinical trials in Australia.
Net loss for the six months ended June
30, 2021 was approximately $52.5 million, or $2.44 per basic and diluted share, based on 21,463,656 weighted average common shares outstanding,
compared to a net loss of approximately $19.9 million, or $1.70 per basic and diluted share, based on 11,722,725 weighted average common
shares outstanding for the same period ended June 30, 2020.
(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, 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, ulcerative colitis, Crohn's
disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR t, is targeted
for development in psoriasis, castration-resistant prostate cancer and Guillain-Barr syndrome. 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, prospects,
plans and objectives of management are forward-looking statements. Examples of such 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
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, 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 resources to meet business objectives and operational requirements, the fact that the results of earlier studies and 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, 2020, filed with the SEC on February
26, 2021, 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.