Full Press Release Details
Announces Third Quarter 2022 Financial Results and Provides a Business Update
Nes-Ziona, Israel, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Enlivex
Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, on December
2, 2022 filed with the SEC its financial results and related management's discussion for the third quarter ended September 30,
are continuing to execute our stated operating plan across the different clinical verticals," said Oren Hershkovitz, Ph.D., Chief
Executive Officer of Enlivex. "Our oncology program now includes two clinical trials that have initiated patient enrollment. These
trials were initiated following a set of preclinical studies that provided strong a scientific rationale for the potential effect of
Allocetra , alone and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors who have poor treatment
Hershkovitz continued, "The IND clearance by the FDA of frozen-formulation Allocetra for treatment of patients with advanced
solid tumors enables Enlivex to potentially add U.S.-based solid tumor patients to our ongoing study, as well as allow oncology investigators
in the United States who are excited about the potential therapeutic effect of Allocetra in solid tumor patients to initiate investigator-initiated
clinical trials in the United States subject to FDA's clearance of cross-referencing INDs, thereby allowing Enlivex to potentially
observe the potential clinical effect of Allocetra in a variety of different cancers and patient populations. Alongside our progress
in oncology, we are pleased to have received clearance by several European regulatory agencies for the incorporation of Allocetra's
frozen formulation into our Phase II sepsis trial, alongside the expansion of the study's target patient population to include
various causes of sepsis in order to potentially accelerate Allocetra's development and optimize our commercial prospects.
In addition, we expect that our cash runway will extend beyond the various planned data readouts from our clinical trials, allowing us
to focus on proper execution of our operating plan."
Quarter 2022 Financial Results:
and development expenses were $4.2 million for the three months ended September 30, 2022, as compared to $2.7 million for the same period
in 2021. 56% of the increase was associated with expenses relating to clinical studies, pre-clinical studies, an increase in the number
of Allocetra doses that were manufactured and inventoried, and lease payments and overhead expenses with respect to our new manufacturing
plant. 23% of the increase was associated with an increase in salaries as a result of hiring additional R&D personnel and certain
pay increases for existing R&D personnel.
and administrative expenses were $1.5 million for the three months ended September 30, 2022, as compared to $1.1 million for the same
period in 2021. 31% of the increase was associated with expenses relating to salaries of newly recruited management team members, 21%
to an increase in intellectual property regulatory expenses, and 9% in non-cash share-based compensation expense. For the nine month
period ending September 30, 2022, compensation paid to executive and non-executive board members, in the aggregate, decreased by $346,000
loss for the three months ended September 30, 2022 was $5.7 million, as compared to a net loss of $3.4 million for the three months ended
September 30, 2021. This increase resulted primarily from clinical studies, pre-clinical studies and an increase in the number of Allocetra
TM doses that were manufactured and inventoried, as well as from an increase in salaries as a result of hiring additional
R&D personnel and certain pay increases for existing R&D personnel. Additionally, net loss increased for the three months ended
September 30, 2022 due to non-operating losses associated with changes in the fair value of marketable securities and currency fluctuations
on cash and cash equivalents and deposits denominated in New Israeli Shekels, as compared to a non-operating gain for the three months
ended September 30, 2021.
of September 30, 2022, Enlivex had cash and cash equivalents of $57.7 million. The Company believes its existing cash and cash equivalents
will be sufficient to fund its operating expenses and capital expenditure requirements through the third quarter of 2024.
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, 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, Allocetra 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.
is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra , 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.
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.