Full Press Release Details
Enlivex Initiates Design and Construction Process
for a New cGMP Allocetra Manufacturing Plant
New cGMP manufacturing plant designed to
support additional clinical- and initial commercial-scale production of Allocetra
Nes Ziona, Israel, July 12, 2021 (GLOBE NEWSWIRE) -- Enlivex
Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced
that it has initiated the design and construction process for a new wholly owned manufacturing plant in Israel. Upon completion, this
cGMP plant will provide additional manufacturing capacity for AllocetraTM, the Company's immunotherapy product candidate.
Enlivex intends to use the additional manufacturing capacity to support
ongoing clinical trials, future clinical trials and initial commercial production of AllocetraTM that may occur if Enlivex
receives applicable regulatory approvals. The planned new facility will initially be approximately 17,000 square feet, and will have the
ability to be expanded to approximately 21,500 square feet in the future.
"The planned expansion of our manufacturing capacity represents
an important milestone that we expect will position Enlivex at a different level of readiness for larger clinical trials and potential
initiation of commercial activities," said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex. "It will allow us
to remain well prepared as we continue to advance AllocetraTM towards regulatory approval in sepsis and COVID-19 and work to
leverage its broadly applicable mechanism of action to expand our planned clinical pipeline into solid tumors. We are very pleased with
the progress these programs have been making and look forward to the construction of our new facility, which will be a critical component
of the infrastructure needed to support their continued advancement."
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 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.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
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