Financial Performance - The company reported a net loss of $2,602,000 for the three months ended September 30, 2024, compared to a net loss of $5,963,000 for the same period in 2023, indicating a 56.4% improvement[11]. - Basic and diluted loss per share improved to $(0.12) for the three months ended September 30, 2024, compared to $(0.32) for the same period in 2023, showing a 62.5% improvement[11]. - For the nine months ended September 30, 2023, the net loss was $19,973 thousand, compared to a net loss of $9,838 thousand for the same period in 2024[22]. - As of September 30, 2024, the company had an accumulated deficit of $121,931 thousand, indicating significant ongoing financial challenges[32]. - The company expects to continue incurring losses for the foreseeable future and may need to raise additional debt or equity financing[33]. Assets and Liabilities - Total current assets decreased to $27,111,000 as of September 30, 2024, down from $33,764,000 as of December 31, 2023, representing a decline of approximately 19.6%[8]. - The total liabilities decreased to $3,210,000 as of September 30, 2024, from $6,747,000 as of December 31, 2023, a reduction of approximately 52.5%[8]. - The company’s total shareholders' equity as of September 30, 2024, was $26,587,000, down from $30,084,000 as of December 31, 2023, representing a decrease of about 11.7%[8]. - Total financial assets as of September 30, 2024, amounted to $24,929,000, a decrease from $27,733,000 as of December 31, 2023, reflecting a decline of 10.1%[89]. Cash and Cash Equivalents - Cash and cash equivalents increased to $2,772,000 as of September 30, 2024, compared to $813,000 as of December 31, 2023, marking a significant increase of 241.5%[8]. - The company reported a cash balance of $3,196 thousand at the end of the period, an increase of $1,970 thousand from the beginning of the period[22]. - As of September 30, 2024, total cash and cash equivalents amounted to $2,772,000, a significant increase from $813,000 as of December 31, 2023[49]. Research and Development - Research and development expenses for the nine months ended September 30, 2024, were $7,204,000, down from $14,560,000 in the same period of 2023, reflecting a reduction of 50.6%[11]. - The company plans to continue focusing on research and development to enhance its product pipeline and market presence[11]. - Research and development expenses for the three months ended September 30, 2024, were $162,000, compared to $97,000 for the same period in 2023, representing a 67% increase[88]. Shareholder Equity and Compensation - The weighted average number of shares outstanding increased to 21,278,081 for the three months ended September 30, 2024, compared to 18,597,313 for the same period in 2023, an increase of approximately 9.1%[11]. - Share-based compensation for the nine months ended September 30, 2023, amounted to $1,148 thousand, down from $1,551 thousand in the previous year[22]. - For the nine months ended September 30, 2024, the Company recognized $1,261 thousand in share-based compensation expenses related to stock options[80]. - The total unrecognized estimated compensation cost related to outstanding non-vested stock options was $746 thousand, expected to be recognized over a weighted average period of 3.5 years[80]. - The Company recognized $466 thousand in share-based compensation expense related to restricted stock units for the nine months ended September 30, 2024[85]. Financing and Capital Management - Enlivex Therapeutics Ltd. plans to finance its operations through equity securities issuances and anticipates needing additional funding to support its research and development activities[32]. - The net proceeds from the Offering were approximately $4.5 million after deducting fees and expenses, intended for working capital and general corporate purposes[71]. - The company entered into a securities purchase agreement on May 27, 2024, issuing 2,060,000 Ordinary Shares at a price of $1.40 per share[65]. - The Board of Directors approved the purchase of up to $1 million of Bitcoin as part of its cash management strategy during the fourth quarter of 2024[91]. Grants and Other Income - The gross amount of grants received from the Israeli Innovation Authority was approximately $9.9 million as of September 30, 2024, with no royalties paid to date[64].

Core Insights - Enlivex Therapeutics Ltd. has completed the dosing and initial follow-up for the first patient in its Phase I clinical trial of Allocetra™ for psoriatic arthritis, with no safety concerns reported [1] - The trial aims to recruit six patients who have not adequately responded to conventional therapies, focusing on safety and disease activity parameters over 12 months [2] - The CEO highlighted the potential market opportunity for Allocetra™ in treating psoriatic arthritis, a condition with limited treatment options [3] Company Overview - Enlivex is a clinical-stage company developing Allocetra™, a macrophage reprogramming immunotherapy designed to restore macrophages to their homeostatic state, which is essential for immune system balance [4] Industry Insights - The global market for psoriatic arthritis treatments was valued at approximately $10.8 billion in 2023 and is projected to grow to $20.5 billion by 2032, with a CAGR of 7.4% from 2024 to 2032 [3] - Alternative projections suggest the market could increase from $9.97 billion in 2023 to $24.87 billion by 2031, representing a CAGR of 12.1% from 2024 to 2031 [3] - The current treatment landscape for psoriatic arthritis faces challenges such as limited efficacy, side effects, high costs, and underdiagnosis, necessitating ongoing research for better treatment options [3]

Core Viewpoint - Enlivex Therapeutics Ltd. (ENLV) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which are crucial for stock price movements [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, particularly influenced by institutional investors [4][6]. - For the fiscal year ending December 2024, Enlivex is expected to earn -$0.70 per share, reflecting a 55.1% change from the previous year [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 Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 5% of Zacks-covered stocks receive a 'Strong Buy' rating, highlighting their superior earnings estimate revision features [9][10].

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 ...