Core Insights - Enlivex Therapeutics Ltd. has received a notice of allowance from the Japanese Patent Office for a patent application related to therapeutic apoptotic cells for the treatment of osteoarthritis, which will enhance its intellectual property protection until at least 2040 [1][2] - The company aims to develop Allocetra™ as a next-generation cell therapy for osteoarthritis, addressing a significant unmet medical need in a market with limited treatment options [2] Industry Overview - Osteoarthritis is the most prevalent form of arthritis, affecting over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [3] - Symptomatic knee osteoarthritis is particularly common, with 40% of men and 47% of women likely to develop it in their lifetimes, leading to over one million hospitalizations annually in the U.S. primarily for total joint replacement [3] - Currently, there are no FDA or EMA approved medications that can effectively halt, slow, or reverse the structural damage associated with osteoarthritis [3] Company Profile - Enlivex is focused on macrophage reprogramming immunotherapy, specifically developing Allocetra™, a universal, off-the-shelf cell therapy aimed at restoring macrophages to their homeostatic state, which is essential for immune system balance [4]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [4] Clinical Trial Progress - The independent Data and Safety Monitoring Board (DSMB) has completed an interim data review of the Phase I safety run-in stage of the Phase I/II clinical trial for Allocetra™ in up to 160 patients with moderate to severe knee osteoarthritis [1] - No serious adverse reactions were reported during the Phase I safety run-in, allowing the company to proceed to the Phase II stage, which will be a double-blind, randomized evaluation of Allocetra™ injections compared to placebo [1][2] - The Phase I/II trial consists of two stages: the Phase I safety run-in to assess safety and tolerability, followed by the Phase II stage to evaluate efficacy and safety in a controlled setting [2] Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [3] - The condition leads to significant disability, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes, and it accounts for over one million hospitalizations annually in the U.S. [3] Treatment Landscape - Currently, there are no FDA or EMA approved medications that can arrest, slow, or reverse the progression of structural damage in osteoarthritis, highlighting the critical need for effective treatments [3]

Core Viewpoint - Enlivex Therapeutics Ltd. (ENLV) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Rising earnings estimates for Enlivex Therapeutics suggest an improvement in the company's underlying business, likely leading to increased stock prices [5][10]. Recent Earnings Estimate Revisions - Enlivex Therapeutics is projected to earn -$0.70 per share for the fiscal year ending December 2024, reflecting a year-over-year change of 55.1% [8]. - Over the past three months, the Zacks Consensus Estimate for Enlivex has increased by 13.6%, indicating a positive trend in earnings expectations [8]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The upgrade of Enlivex Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Financial Performance - The net loss for the three months ended June 30, 2024, was $3.096 million, compared to a net loss of $6.792 million for the same period in 2023, indicating an improvement of about 54%[6] - The net loss for the six months ended June 30, 2024, was $7,236 thousand, compared to a net loss of $14,010 thousand for the same period in 2023[11] - The company reported operating loss of $2.986 million for the three months ended June 30, 2024, compared to an operating loss of $6.649 million for the same period in 2023, reflecting a reduction of about 55%[6] - Basic and diluted loss per share improved to $(0.16) for the three months ended June 30, 2024, compared to $(0.37) for the same period in 2023[6] Assets and Liabilities - As of June 30, 2024, total assets decreased to $31.902 million from $36.831 million as of December 31, 2023, representing a decline of approximately 13.5%[4] - Total current liabilities decreased to $2.841 million from $6.061 million, a reduction of approximately 53%[4] - Total shareholders' equity decreased to $28.562 million from $30.084 million, a decline of approximately 5.1%[4] - The company reported total accrued expenses and other liabilities of $2,538,000 as of June 30, 2024, down from $4,001,000 as of December 31, 2023, indicating a reduction of about 37%[34] Cash Flow and Financing - Cash and cash equivalents increased significantly to $3.747 million from $0.813 million, marking a growth of over 360%[4] - The company reported a net cash used in operating activities of $6,307 thousand for the six months ended June 30, 2024, down from $12,807 thousand in the prior year[11] - Cash and cash equivalents at the end of the period were $4,166 thousand, an increase from $3,862 thousand at the end of June 30, 2023[11] - The company raised $4,943 thousand from the issuance of shares and warrants during the six months ended June 30, 2024[11] Research and Development - Research and development expenses for the three months ended June 30, 2024, were $1.999 million, down from $5.035 million in the same period of 2023, a decrease of approximately 60%[6] - Research and development expenses for the three months ended June 30, 2024, were $145 thousand, compared to $122 thousand for the same period in 2023, reflecting an increase of approximately 18.9%[56] Share-Based Compensation - The company incurred share-based compensation expenses of $771 thousand for the six months ended June 30, 2024[11] - For the three months ended June 30, 2024, the company recognized share-based compensation expenses of $388 thousand, compared to $511 thousand for the same period in 2023, reflecting a decrease of approximately 24%[56] - For the six months ended June 30, 2024, total share-based compensation expenses amounted to $771 thousand, down from $1,144 thousand in the same period of 2023, indicating a decline of about 32.5%[56] Future Outlook - The company expects to continue incurring losses for the foreseeable future and will need to raise additional financing to support its development activities[16] - The company plans to finance its operations through equity securities issuances and, in the longer term, revenues[17] - The company’s management believes that current financial resources will be sufficient for at least twelve months following the filing of the financial statements[17] Other Financial Information - The company has not generated any revenues or product sales and has not achieved profitable operations since its inception[15] - The company has not paid any royalties to the Israeli Innovation Authority as of June 30, 2024, despite receiving approximately $9.9 million in grants[38] - The company entered into a securities purchase agreement on May 27, 2024, for the issuance of 2,060,000 Ordinary Shares at a price of $1.40 per share[39] - The total unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,061 thousand, expected to be recognized over a weighted average period of 1.36 years[50]

First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatments Ness-Ziona, Israel, June 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company"))), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated, randomi ...

Ness-Ziona, Israel, June 20, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company" or "Enlivex"))), a clinical-stage macrophage reprogramming immunotherapy company, is pleased to invite investors to a webinar on June 25, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature Enlivex's Chief Executive Officer, Dr. Oren Hershkovitz, who will share insight into the Company's leading product candidate, Allocetra™. Enlivex's Chief Executive Officer will discuss the r ...

Ness-Ziona, Israel, June 17, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today released a positive interim data readout from a Phase I/II investigator-initiated clinical trial of AllocetraTM in patients with endstage knee osteoarthritis who had been indicated for knee replacement surgery. During the three-month period post injection of AllocetraTM, only a single patient (1/9, 11%) decided to move forward w ...

Key Highlights Enrolled patients with severe knee osteoarthritis who were indicated for knee-replacement surgery received a single local injection of AllocetraTM into the knee as a "last resort" Three-month data readout showed a significant reduction in pain and a favorable safety profile Pain reduction: patients reported an average pain reduction of 64% from baseline Complete Pain Resolution: 33% of patients reported complete pain relief, from an average pain level of 9 to a pain level of 0; pain scale use ...

●First study of AllocetraTM in thumb osteoarthritis, a debilitating disease that affects millions of people in the U.S., and has no FDA-approved therapy ● Third study of AllocetraTM in osteoarthritis, following the on-going Phase I/II trial in pre-surgery, endstage knee osteoarthritis, and the on-going randomized, placebo-controlled Phase I/II trial in up to 160 moderately to severely symptomatic knee osteoarthritis patients Ness-Ziona, Israel, June 03, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NA ...

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein or any other securities, nor shall there be any sale of the securities described herein or any other securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Nes-Ziona, Israel, May 29, 2024 (GLOBE NEWSWIRE) -- Enlive ...