Enlivex Announces Third Quarter 2021 Financial Results and Provides a Business Update
Initiated dosing in placebo-controlled Phase IIb clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients with ARDS
Received authorization to expand ongoing sepsis and COVID-19 trials into Spain
Initiated design and construction process for a new cGMP AllocetraTM manufacturing plant
Nes Ziona, Israel, Nov. 22, 2021 (GLOBE NEWSWIRE) -- -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it filed its financial results and related discussion for the third quarter ended September 30, 2021 with the SEC on November 19, 2021.
“We are advancing towards 2022 with a strong balance sheet, expanded leadership team, and compelling clinical and preclinical data that we believe demonstrate Allocetra’s potential as a next generation cell therapy for infectious, inflammatory and oncologic diseases,” said Oren Hershkovitz, Ph.D., CEO of Enlivex. “Our ongoing sepsis and COVID-19 trials were recently granted authorization for expansion into sites in Spain, which positions us to broaden our therapeutic impact while also providing important regulatory validation for our study designs and manufacturing process. To support these and our other programs, we also initiated the design and construction process for a new cGMP manufacturing plant. This plant will importantly allow us to be prepared for larger clinical trials and the potential commencement of commercial activities.”
Dr. Hershkovitz continued, “Alongside this recent regulatory and corporate progress, we have continued to advance our solid tumor program towards the initiation of two planned clinical trials. Through the advancement of these trials, we aim to clinically demonstrate Allocetra’s potential to combine synergistically with currently available cancer therapies and improve response rates for difficult-to-treat cancer patients. Looking ahead, we expect our solid tumor, sepsis, and COVID-19 programs to gain momentum as we work to address life-threatening conditions through Allocetra’s clinical development.”
Business Highlights and Upcoming Milestones
Third Quarter 2021 Financial Results
AllocetraTM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.
Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "could," "intends," "estimates," "suggests," "has the potential to" and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex's business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex's filings with the Securities and Exchange Commission, including in the Company's most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
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