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Enlivex Announces First Quarter 2023 Financial Results and Provides a Business Update Enrollment of patients in the Phase I/II evaluating Allocetra in combination with chemotherapy in patients with peritoneal metastases

Key Takeaway: Enlivex Therapeutics reported its financial results for the first quarter of 2023, detailing a decrease in net loss to $7.2 million. The company's research and development expenses rose due to clinical study costs, while its general and administrative expenses saw a slight decline. Enlivex emphasized its innovative cell therapy, Allocetra, aimed at reprogramming macrophages to combat severe health conditions, and indicated strong cash reserves to support operations through 2025.

Market Sentiment Analysis

POSITIVE FACTORS

  • The net loss decreased to $7.2 million from $8.2 million year-over-year.
  • Enlivex has sufficient cash to fund operations potentially into 2025.
  • Allocetra is designed as a novel therapy with potential applications in severe diseases.

CONCERNS & RISKS

  • Research and development expenses increased by 11% compared to the previous year.
  • The company's products in development may not achieve expected results or effectiveness.
  • Results of early-stage trials can differ significantly from later-stage trials.

Full Press Release Details

Enlivex Announces First Quarter 2023 Financial
Results and Provides a Business Update
Nes-Ziona, Israel, June 26, 2023 (GLOBE NEWSWIRE)
-- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy
company, on June 16, 2023, filed with the SEC its financial results and related management's discussion for the first quarter ended
First Quarter 2023 Financial Results:
Research and development expenses were $5.2 million for the three months
ended March 31, 2023, as compared to $4.7 million for the same period in 2022. The increase of 11% was primarily due to an increase in
expenses for clinical studies and pre-clinical studies, offset by a decrease in lease payments and overhead expenses related to our plant
General and administrative expenses were $1.6
million for the three months ended March 31, 2023, as compared to $1.7 million for the same period in 2022. The decrease of 7% was primarily
due to decrease in stock-based compensation expense with respect to equity granted to employees and directors, and decrease in professional
Net loss for the three months ended March 31, 2023 was $7.2 million,
as compared to a net loss of $8.2 million for the three months ended March 31, 2022. This decrease resulted primarily from a decrease
in other expenses, net, which was partially offset by an increase in the costs of clinical and pre-clinical studies and material consumption.
As of March 31, 2023, Enlivex had cash and cash equivalents, short
term bank deposits and long term interest-bearing bank deposits of $43.2 million. The Company believes its existing cash and cash equivalents
will be sufficient to fund its operating expenses and capital expenditure requirements potentially into 2025.
Allocetra 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.
Enlivex 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.
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.
INVESTOR RELATIONS CONTACT

Frequently Asked Questions

What were Enlivex's Q1 2023 research expenses?

$5.2 million in research and development expenses were reported.

How much cash did Enlivex have as of March 31, 2023?

Enlivex had $43.2 million in cash and equivalents.

What is Allocetra developed by Enlivex?

Allocetra is a universal cell therapy aimed at reprogramming macrophages.

What was Enlivex's net loss for Q1 2023?

The net loss for Q1 2023 was $7.2 million.

What is the purpose of reprogramming macrophages?

Reprogramming macrophages aims to restore immune balance and address severe diseases.

Last updated: Jun 26, 2023