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Further Trial Data Analyses 'Reinforce' Profile of Biopharma's Multiple Sclerosis Drug
Research Report

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The confirmatory results concerning Immunic's lead drug candidate IMU-838 are presented in an H.C. Wainwright & Co. report.

In a Sept. 14 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Immunic Inc.'s (IMUX:NASDAQ) re-analyses of the data from the EMPhASIS Phase 2 trial 'reinforced IMU-838's profile." The study evaluated this immune modulator in patients with relapsing-remitting multiple sclerosis.

H.C. Wainwright has a $56 per share target price on Immunic, the developer of IMU-838, and the stock's current share price is around $18.17.

In his report, Selvaraju presented the takeaways from Immunic's additional examination of the EMPhASIS Phase 2 study results, which the biopharma had reported at the ACTRIMS-ECTRIMS conference last week.

For one, all EMPhASIS trial subgroups showed lesion suppression as evidenced on MRI, and this occurred whether or not patients had prior treatment, despite the number of pre-trial relapses they experienced and regardless of their enrollment country.

Two, lesion reduction occurred by six weeks, which indicates that a stable therapeutic drug level was achieved quickly, a characteristic for which IMU-838 is known.

Three, the IMU-838 groups did better than the placebo cohort in terms of the secondary endpoints of time to first relapse and annualized relapse rate. These, however, could not be evaluated officially given the trial's short, 24-week duration.

"These data reinforce the value proposition for IMU-838 in relapsing-remitting multiple sclerosis and may increase the interest level of potential strategic partners in licensing the compound within the context of the multiple sclerosis indication," Selvaraju commented.

He highlighted that the serum biomarker data from EMPhASIS also are "intriguing." By the end of the study, serum neurofilament dropped significantly below baseline figures in both treated groups but increased by 6.5% in the placebo group.

"We believe that IMU-838's impact on this biomarker may constitute a key component of the drug's mechanism of action," Selvaraju wrote, adding that over the past few years, this biomarker has become one of the most important for central nervous system tissue damage related to multiple sclerosis.

Selvaraju indicated the additional EMPhASIS data analyses also confirmed IMU-838's robust safety profile. During the study, the drug did not cause hepatotoxicity, raise serum uric acid levels or increase the incidence of hematuria. In addition, fewer treated patients, about 4.3%, withdrew from the trial than placebo patients, 7.2%.

Looking forward, Selvaraju pointed out that Immunic has two potential stock-moving events likely to happen in the near term. One is interim clinical data from the CALVID-1 trial that shows IMU-838 weakens viral load in COVID-19-infected patients. The other is the outlicensing of IMU-838 for relapsing-remitting multiple sclerosis.

H.C. Wainwright has a Buy rating on Immunic.


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Disclosures from H.C. Wainwright & Co., Immunic, Inc., Company Update, September 14, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Immunic, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of August 31, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Immunic, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did not receive compensation from Immunic, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report

The Firm does not make a market in Immunic, Inc. as of the date of this research report.

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