Full Press Release Details
Enlivex Announces Reprioritization Plan and
Second Quarter 2023 Financial Results
Nes-Ziona, Israel, Sept. 11, 2023 (GLOBE NEWSWIRE) - Enlivex
Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company announced
today a strategic reprioritization plan and its financial results for the second quarter ended June 30, 2023.
The Company plans to increase its existing focus on inflammatory and
autoimmune indications. The Company, since its inception, considered the inherent properties of AllocetraTM as a new, highly-differentiated
modality for immune resolution across a wide variety of inflammatory and auto-immune indications with unmet medical needs that received
strong interest from large pharma, physicians and patients.
In addition to the ongoing Phase II trial of AllocetraTM
in patients with sepsis, the Company has initiated a clinical program in osteoarthritis, a degenerative disease with low grade inflammation,
and an indication with a substantial unmet medical need that potentially represents a multibillion commercial market. Within the osteoarthritis
program, the Company recently dosed the first patient in a Phase I/II investigator-initiated clinical trial enrolling patients with severe
knee osteoarthritis who had been scheduled for knee replacement surgeries and are offered to inject AllocetraTM locally into
the diseased knee as a potential alternative for pain resolution and knee functionality in lieu of replacement surgery. The Company is
planning, in addition to this Phase I/II trial, to initiate a randomized, controlled Phase II clinical trial in patients with moderate
knee osteoarthritis in early 2024. That clinical trial is expected to enroll 120-150 patients and would be double-blinded, controlled
and statistically powered to evaluate efficacy as well as safety, and potentially allow the Company to design and initiate a Phase III
registrational trial upon its completion.
The Company's revised strategy is targeted at obtaining topline
data readouts from two advanced-stage clinical indications by mid-2025 - (a) a randomized, controlled Phase II trial in 120 patients
with sepsis with a targeted topline data readout by the end of Q1 2024, and (b) a randomized, controlled Phase II trial in 120-150 patients
with moderate knee osteoarthritis, with a targeted topline data readout by the end of Q2 2025; as well as a targeted topline data readout
by the end of Q3 2024 from the Phase I/II investigator-initiated clinical trial in 12 patients with severe knee osteoarthritis who had
been scheduled for knee replacement surgeries.
In the two ongoing oncology clinical trials, 15 patients with advanced
malignancies of different origins that were heavily pre-treated with multiple lines of therapy prior to the study, were treated with repeat
doses of AllocetraTM given intravenously or intraperitoneally. Most patients received monotherapy treatment and lower doses
of AllocetraTM. Results demonstrated tolerability and safety, allowing the program to proceed to assess the efficacy of AllocetraTM
in solid tumor indications in combination with other therapies and at higher doses. Pursuant to the strategic reprioritization plan, and
in light of the new guidelines and regulatory initiatives set by the FDA for drug development in oncology that may result in longer clinical
development cycles as foundations for regulatory approvals, the Company will cease the internal clinical development of our various oncology
indications and plans to seek external collaborations or out-licensing opportunities for its oncology assets.
As a result of the Company's reprioritization of its clinical
indications and focus on the inflammatory and auto-immune verticals, the Company intends to reduce its workforce by approximately 50%.
The workforce reductions and the savings associated with the reclassification of the oncology indications as candidates for external collaborations
or out-licensing opportunities in lieu of internal development are expected to result in a substantial extension of the Company's
cash runway through the end of 2025. The revised, extended cash runway is expected to support the timeline for the topline data readouts
of the two advanced-stage, randomized, controlled Phase II clinical trials in sepsis and osteoarthritis.
The initiation of the clinical program in osteoarthritis followed preclinical
evidence of the potential applicability of Allocetra'sTM mechanism of action to resolve chronic low grade inflammation
of joints with osteoarthritis, as well as a substantial recovery in a case of a 70-year old patient who suffered for many years from vanishing
bone disease (Gorham-Stout syndrome), which is a rare disease characterized by destruction of osseous matrix and proliferation of vascular
structures, resulting in complete destruction and absorption of the patient's shoulder joint. Despite exhaustive therapeutic attempts,
the patient's disease remained refractory to treatment and continued to deteriorate, with continuous production of synovial fluid,
necessitating permanent drainage of the shoulder and, as a consequence, requiring extended hospitalization for a duration of nine months
prior to compassionate treatment with AllocetraTM to the shoulder joint. Following five intra-articular AllocetraTM
injections, substantial improvement was documented in multiple clinical parameters, including pain and inflammatory cytokines, and the
patient was successfully discharged from the hospital. At a two-year follow-up, the improvement in the afflicted shoulder was maintained
and no subsequent hospital re-admissions were required.
"Patient well-being and advancing medical science have always
been at the heart of our mission," said Oren Hershkovitz, Ph.D., CEO of Enlivex. "While we have made significant progress in
our oncology research and the clinical results to date have confirmed the favorable safety profile of AllocetraTM, coupled
with the previously demonstrated preclinical evidence of efficacy, additional clinical development in more defined solid tumor populations
evaluating higher doses and different combinations of AllocetraTM is necessary. Given the recent changes in the regulatory
landscape for drug development in oncology, which may result in longer clinical development cycles, we believe that, by focusing on inflammatory
and autoimmune indications, we can better address the urgent needs of a broader patient population and contribute to the development of
transformative treatments. Our reprioritization includes an anticipated workforce reduction of approximately 50% of the Company's
employees, comprising a remarkable team that contributed significantly to our substantial progress in recent years. We appreciate their
efforts and commitment, and we wish them continued success in their individual paths forward. Our reprioritization is expected to decrease
the overall expenses and increase our cash runway through the end of 2025, which is in line with the estimated timeline for the expected
data readouts, starting with end of the first quarter 2024 for the ongoing randomized controlled Phase II in sepsis and end of second
quarter 2025 for the planned randomized controlled Phase II in osteoarthritis."
Second Quarter 2023 Financial Results
Research and development expenses were $10.2 million for the six months
ended June 30, 2023, as compared to $8.8 million for the same period in 2022. The increase of 16% 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 $3.2
million for the six months ended June 30, 2023, as compared to $3.5 million for the same period in 2022. The decrease of 8% was primarily
due to a decrease in stock-based compensation expense with respect to equity granted to employees and directors, a decrease in insurance
expenses, a decrease in professional fees and a decrease in payroll expenses, offset by an increase in rent and maintenance expenses.
Net loss for the six months ended June 30, 2023 was $14.0 million,
as compared to a net loss of $18.1 million for the six months ended June 30, 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 June 30, 2023, Enlivex had cash and cash equivalents, short term
bank deposits and long term interest-bearing bank deposits of approximately $36 million. The Company believes its existing cash and cash
equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through the end of 2025.
Allocetra is being developed as a universal, off-the-shelf cell
therapy designed to reprogram macrophages into their homeostatic state. Inflammatory and autoimmune diseases 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
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