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Interim Readout for Pharma Trial 'Delivers Home Run'
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An H.C. Wainwright & Co. report discussed the implications of data indicating "overwhelming evidence of efficacy" for this company's nonantibiotic anti-infective for treatment of catheter-related bloodstream infections.

In a July 26 research note, analyst Ram Selvaraju reported that H.C. Wainwright & Co. raised its price target on Buy-rated CorMedix Inc. (CRMD:NYSE.MKT) to $3 per share from $2 following "best case scenario" news from the Data and Safety Monitoring Board (DSMB) regarding the LOCK-IT-100 Phase 3 trial. CorMedix's current share price is around $0.55.

The DSMB recommended the study be stopped "due to overwhelming evidence of efficacy seen in the predefined interim analysis," Selvaraju relayed.

In LOCK-IT-100, CorMedix's lead candidate Neutrolin, a nonantibiotic anti-infective, was being evaluated against a Heparin catheter lock-flush solution as treatment of catheter-related bloodstream infections. The interim analysis was performed after 28 such infections occurred among the study patients who had central venous catheters and were on hemodialysis. The primary endpoint was fewer catheter-related bloodstream infections.

The DSMB's conclusion is "particularly impressive given such a small number of events and leads us to believe that perhaps only one or two infections—or even none at all—occurred in the Neutrolin arm."

Selvaraju noted that interim analysis results will likely be sent to the FDA within the next few weeks. "We feel that the FDA could prove amenable to considering fast-tracked submission of Neutrolin for review and accelerated approval for the product in the U.S.," he added. This is due to the significant unmet need with respect to treatment for patients who develop catheter-related bloodstream infections and the potential severity of these infections, which lead to death in 20% or more of patients.

The analyst also indicated that with the LOCK-IT-100 pivotal trial being cut short, filing with the FDA could take place by the end of 2018, and FDA approval could happen by 2019. This is sooner than the initial target for a commercial release in the U.S., which was no earlier than 2020. The DSMB's determination of clear efficacy could accelerate commercial sales outside of the U.S. as well.

Further, were Neutrolin to be approved, CorMedix could choose to launch the product itself, could pursue a licensing or partnering arrangement with a more established firm to sell the product, or could seek an acquisition deal. "We believe that the strength of the LOCK-IT-100 data—even from an interim analysis readout—is such that Neutrolin should now be regarded as a valuable potential asset for any company seeking to develop or maintain a presence in the U.S. hospital-based products market," Selvaraju purported.

As for CorMedix's finances, Selvaraju wrote, "We consider the existing resources sufficient to fund operations near term."


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Disclosures from H.C. Wainwright & Co., CorMedix Inc., July 26, 2018

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 CorMedix, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of June 30, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of CorMedix, 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 and/or the research analyst’s household has a financial interest in and own the securities of Iovance Biotherapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

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 CorMedix, 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 CorMedix, Inc. as of the date of this research report.

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