Full Press Release Details
Immunic, Inc. Reports Third Quarter 2020
and Provides Corporate Update
Released Very Positive Phase 2 Data for IMU-838 in Relapsing-Remitting Multiple Sclerosis; Company to Submit End-of-Phase 2 Meeting
Requests to Regulatory Authorities at the End of Q1 2021 -
200 Patients Randomized in Phase 2 Trial of IMU-838 for the Treatment of Moderate COVID-19; Top-Line Data From Main Phase 2 Efficacy
Analysis Expected in Q1 2021 -
Readout of 18 Patients From Phase 2, Investigator-Sponsored Proof-of-Concept Clinical Trial of IMU-838 in Primary Sclerosing Cholangitis,
Being Conducted at the Mayo Clinic, Expected During Q4 2020 -
With Approximately $133 Million in Cash and Cash Equivalents, Immunic is Funded Through Key Value Inflection Points into the Second
YORK, November 5, 2020 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing
a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced
financial results for the third quarter ended September 30, 2020 and provides corporate update.
"The third quarter was marked by
a significant achievement for our lead asset, selective oral DHODH inhibitor, IMU-838, with the release of top-line data from our
phase 2 EMPhASIS trial in patients with relapsing-remitting multiple sclerosis, and subsequent publication of the full unblinded
data set. IMU-838 demonstrated robust efficacy, through the achievement of all primary and key secondary endpoints, combined with
an outstanding safety and tolerability profile. We believe that the phase 2 results emphasize the game-changing potential of IMU-838
as a once-daily oral therapy for this indication," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.
"On the heels of this overwhelmingly positive data, we completed a successful common stock offering, raising $103.5 million
in gross proceeds, significantly bolstering our balance sheet. We are currently preparing our end-of-phase 2 submission for IMU-838
in relapsing-remitting multiple sclerosis to regulatory authorities, anticipated in the first quarter of next year, after which
we look forward to scheduling our end-of-phase 2 meetings, during which we will have the opportunity to discuss our plans for a
Dr. Vitt continued, "We have also
made notable strides in our development of IMU-838 in patients with moderate COVID-19, most recently securing a financing agreement
of up to 24.5 million (approximately $29 million) with the European Investment Bank for the ongoing development of our phase
2 CALVID-1 trial, a potential expansion into a confirmatory phase 3 trial and commercial-scale manufacturing of IMU-838. Additionally,
we reported that an Independent Data Monitoring Committee recommended the continuation, without changes, of the CALVID-1 trial
after an interim safety analysis. Recruitment has accelerated due to the spread of disease within the countries included in the
trial and, at the beginning of November, we reached the enrollment goal of 200 patients, pre-specified in the protocol as sufficient
to perform the main efficacy analysis of the phase 2 part of the CALVID-1 trial. The data of this unblinded main analysis of all
available efficacy, biomarker and virus titer data is expected to be available in the first quarter of next year."
The company's current cash position
of approximately $133.2 million, at September 30, 2020, is expected to fund activities into the second half of 2022, and specifically
through key value inflection points including those for the COVID-19 phase 2 trial with IMU-838; preparation for, and initiation
of, a phase 3 trial of IMU-838 in relapsing-remitting multiple sclerosis (RRMS); the phase 2 readouts of IMU-838 in patients with
ulcerative colitis (UC) and primary sclerosing cholangitis (PSC); as well as completion of the phase 1 trials of IMU-935 and IMU-856,
respectively, including pharmacodynamic evaluations in patients for both of these trials.
Third Quarter 2020 and Subsequent Highlights
Update on Activities Relating to the Preparation of a Phase
3 Program for IMU-838 in RRMS
As previously announced, the full unblinded
clinical data set from the company's phase 2 trial of IMU-838 in patients with RRMS showed achievement of all primary and
key secondary endpoints, with high statistical significance. Notably, both doses (30 and 45 mg/day) appeared to be equally safe
and efficacious, reducing the number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24, as
compared to placebo. Based on this phase 2 data as well as established regulatory guidance that the lowest effective dose should
be considered for future clinical trials, Immunic may propose the dose of 30 mg/day of IMU-838 for investigation in a phase 3 program.
Given the relative equal performance of
the two doses tested, however, and to allow for pharmacodynamic modeling of the dose-response relationship, data from a lower dose
in the effective dose range would be beneficial to complete a dose-effect assessment of IMU-838 in RRMS. For this reason, Immunic
has already started an additional, small Cohort 2 sub-trial to obtain exploratory data on the expanded dose response of IMU-838.
This additional, double-blind assessment includes a cohort of 60 patients who receive 10 mg/day of IMU-838 or placebo for 24 weeks.
The still-active sites of the phase 2 trial of IMU-838 in RRMS continue to be used and, as a result, the company expects that this
assessment can be executed in an accelerated fashion. This additional sub-trial is not expected to change any conclusions for dosing
of IMU-838 in a future phase 3 program. Rather, it is expected to provide additional data to address any potential regulatory requests
in the context of the design of a phase 3 program. Management believes that this strategy will enable risk reduction for end-of-phase
2 discussions with regulatory agencies.
The company intends to separate formal
end-of-phase 2 meeting preparations from regulatory advice for non-clinical phase 3 related topics to be submitted to regulatory
authorities in the near future. Subsequently, the company intends to submit formal end-of-phase 2 meeting requests with a sole
focus on the phase 2 data, including the Cohort 2 interim data, and a proposed phase 3 program to regulatory authorities at the
end of the first quarter 2021. The end-of-phase 2 meetings are expected to be held in or about May 2021.
In parallel to the preparation and execution
of the regulatory discussions, Immunic has begun performing formal feasibility activities for a phase 3 program of IMU-838 in RRMS,
including country and site selection, as well as other preparatory activities. The company also believes that this feasibility
assessment will help ensure an expeditious execution of the development strategy for IMU-838.
Additional Anticipated Clinical Milestones
Financial and Operating Results
For the nine months ended September
30, 2020, R&D expenses were $27.5 million, as compared to $16.5 million for the same period ended September 30, 2019. The $11.0
million increase was primarily attributable to (i) a $4.8 million increase in external development costs for IMU-838, related to
the phase 2 clinical trial in patients with COVID-19, (ii) a $4.5 million increase in license fees, drug supply and phase 1 costs
related to IMU-856, (iii) a $1.4 million increase in drug supply costs related to IMU-935, (iv) a $1.2 million increase in drug
supply costs related to IMU-838, and (v) a $0.6 million increase in personnel costs. The increases were partially offset by a decrease
of $1.5 million related to the phase 2 clinical trial of IMU-838 in patients with RRMS.
For the nine months ended September
30, 2020, G&A expenses were $7.3 million, as compared to $12.4 million for the same period ended September 30, 2019. The $5.0
million decrease was primarily due to (i) non-recurring costs related to the transaction with Vital Therapies including $6.4 million
of stock-based compensation for company executives, key employees and members of the board of directors, and (ii) $2.1 million
of non-recurring investment banking and legal fees in the first nine months of 2019. The decrease was partially offset by (i) a
$2.3 million increase in personnel expenses, (ii) $1.0 million of increased legal, accounting and consultancy costs, and (iii)
$0.2 million of increased costs across numerous categories primarily due to becoming a public company and expanding operations
in the United States.
For the nine months ended September
30, 2020, other income was $1.9 million, as compared to $1.6 million for the same period ended September 30, 2019. The $0.3 million
increase was primarily attributable to $0.7 million of R&D tax incentives for clinical trials in Australia as a result of increased
spending on clinical trials in Australia, partially offset by a decrease attributable to (i) the $0.4 million difference between
the face value and fair value of the promissory note collected in full in September 2019 in connection with the sale of ELAD Assets
offset by the $0.1 million write-off of the investment in VTL China included in the ELAD Assets sale, and (ii) a $0.1 million decrease
of recognized income attributable to reimbursements of R&D expenses in connection with the option agreement with Daiichi Sankyo
Net loss for the nine months
ended September 30, 2020 was approximately $32.9 million, or $2.35 per basic and diluted share, based on 13,966,690 weighted average
common shares outstanding, compared to a net loss of approximately $27.2 million, or $3.96 per basic and dilutes share, based on
6,880,057 weighted average common shares outstanding for the same period ended September 30, 2019.
(Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating
chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's
disease, and psoriasis. Immunic is developing three small molecule products: its lead development program, IMU-838, is 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; IMU-935 is an inverse agonist of ROR t; and IMU-856 targets the restoration of the intestinal
barrier function. Immunic announced positive results from its phase 2 EMPhASIS trial of IMU-838 in patients with relapsing-remitting
multiple sclerosis, reporting achievement of both primary and key secondary endpoints with high statistical significance. IMU-838