On December 5, 2022 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported on December 2, 2022 filed with the SEC its financial results and related management’s discussion for the third quarter ended September 30, 2022 (Press release, Enlivex Therapeutics, DEC 5, 2022, View Source [SID1234624782]).
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"We 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 alternatives."
Dr. 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."
Third Quarter 2022 Financial Results:
Research 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.
General 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
Net 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.
As 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.
ABOUT ALLOCETRA
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.