In a June 1 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Enlivex Therapeutics Ltd.'s (ENLV:NASDAQ) Allocetra demonstrated multifaceted immune system rebalancing in sepsis patients during a Phase 1b trial.
Selvaraju relayed that these results were presented by Enlivex at the International Society for Cellular Therapy conference held last week virtually. Along with a recap of safety and efficacy data, the data included a new endpoint analysis that "demonstrated the potential of Allocetra to resolve cytokine storms with heterogeneous underlying pathologies," he wrote.
The analyst reviewed the findings presented at the conference. Enlivex's Phase 1b study compared the levels after receiving Allocetra to baseline of more than 30 immune modulators in the participants, all sepsis patients. Results showed that after treatment with Allocetra, abnormal immune modulators either returned to or toward homeostasis. For instance, white blood cells and neutrophils returned to within normal limits in all evaluated patients.
"The fact that trends towards normalization were observed not only across multiple inflammatory markers, spanning different categories, as well as immune cell counts, but across all patients assessed, gives us confidence that these data prove the hypothesis that Allocetra achieves broad resetting of the immune system," Selvaraju highlighted.
This return to homeostasis led to decreased or resolved inflammation, improvements in sequential organ failure assessment and reduced hospital and intensive care unit (ICU) stays. "We believe that the close relationship between observed reductions in inflammatory biomarkers and the clinical outcomes observed bodes very well for future development of Allocetra as a treatment for sepsis," commented Selvaraju.
In Q4/20, Enlivex intends to follow up its Phase 1b study with a controlled, randomized Phase 2b trial. If the study starts as planned, topline data could be available by late 2021.
"Positive data could prove sufficient to support regulatory approval, in our view, given the unmet need in severe sepsis, which carries a 50% mortality rate, accounting for the deaths of 270,000 Americans each year," indicated Selvaraju.
As such, an accelerated approval pathway for Allocetra in sepsis is likely as is the potential for "lucrative" pricing given that its use would decrease the time patients spent in a hospital intensive care unit.
Potential stock moving events for Enlivex in 2020 are the release of additional data on sepsis and graft versus host disease and results from its COVID-19 trial.
"We feel investors should consider investment in Enlivex given the context of the plethora of near- and medium-term clinical development-related catalysts for Allocetra," Selvaraju noted.
H.C. Wainwright & Co. has a Buy rating and a 12-month target price of $22 per share on Enlivex Therapeutics. The stock is currently trading at about $5.35 per share.
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Disclosures from H.C. Wainwright & Co., Enlivex Therapeutics Ltd., Company Update, June 1, 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 April 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 received compensation from Enlivex Therapeutics Ltd. for non-investment banking services in the previous 12 months.
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.
