In an Oct. 2 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Enlivex Therapeutics Ltd. (ENLV:NASDAQ) reported "intriguing initial COVID-19 clinical data."
The analyst relayed the top-line results, which are from the study of Enlivex's immunotherapeutic Allocetra in five COVID-19 patients, two of which were in severe condition and the other three were in critical condition.
All of the five patients enrolled in the study experienced complete recovery after receiving Allocetra and were discharged from the hospital. Patients in severe condition were released an average of 5.5 days later, and those in critical condition, an average of 8.5 days later. At the time of discharge, all five patients had a negative COVID-19 PCR test.
In terms of safety, all of the study participants tolerated Allocetra well, and no adverse events were reported.
"Enlivex believes that Allocetra, if ultimately approved, could bridge the gap that currently exists in treating severe or critical COVID-19 patients," Selvaraju noted. He added that the U.S. Food and Drug Administration has said it will grant emergency use authorization to therapeutics that have an impact on this particular COVID-19 patient population.
The Israel-based company's plan now is to obtain regulatory approval for a larger Phase 2 trial of COVID-19 patients in severe or critical condition. Once approval is received, patient recruitment will start.
In other news, Selvaraju reported, Enlivex is preparing and intends to commence a Phase 2b trial of Allocetra in severe sepsis. Should this study get underway before year-end 2020, top-line data could be available late next year.
About the company overall, Selvaraju wrote that "investors should consider investment in Enlivex given the context of the plethora of near- and medium-term clinical development-related catalysts for Allocetra."
H.C. Wainwright has a Buy rating and a $22 per share target price on Enlivex, the stock of which is currently trading at about $13.34 per share.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., Enlivex Therapeutics Ltd., Company Update, October 2, 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 Enlivex Therapeutics Ltd. (including, without limitation, any option, right, warrant, future, long or short position).
As of September 30, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Enlivex Therapeutics Ltd.
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 receive compensation from Enlivex Therapeutics Ltd. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Enlivex Therapeutics Ltd. during the past 12 months.
The Firm does not make a market in Enlivex Therapeutics Ltd. as of the date of this research report.