Nes-Ziona, Israel, April 21, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company")), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and treated in the Phase II stage.   Oren Hershkovitz, Ph.D, CEO of Enlivex, co ...

Temporomandibular joint (TMJ) osteoarthritis is a degenerative, debilitating and progressive disease, the second most common musculoskeletal condition affecting five to 12% of the population globallyTMJ causes pain and stiffness in the jaw, making it difficult to chewTMJ osteoarthritis currently has no long-term effective treatments Ness-Ziona, Israel, April 03, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company" or "Enlivex")), a clinical-stage macrophage reprogramming immunother ...

Nes-Ziona, Israel, March 17, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for patent application number 2020800620493. Once issued, the resulting patent will provide Enlivex with added intellectual property protection in China through at least 2040 with claims covering methods of using Allocetra ...

Core Insights - Enlivex Therapeutics Ltd. is hosting a live investor webinar on March 5, 2025, to discuss positive interim six-month data from its Phase I/II Allocetra™ trial for knee osteoarthritis [1][4] Group 1: Trial Results - The interim results from the Allocetra™ trial showed a statistically significant 47.0% average reduction in reported pain (P=0.0001) and a 46% improvement in joint function at six months post-treatment [2] - 83% of treated patients were still considered responders to treatment at six months, indicating the durability and sustained efficacy of Allocetra™ [2][3] - No serious adverse events were reported, reinforcing the favorable safety profile of Allocetra™ [2] Group 2: Company Commitment - The CEO of Enlivex expressed excitement about the promising interim results, highlighting Allocetra™'s potential to provide meaningful and sustained pain relief for patients with moderate to severe knee osteoarthritis [3] - The company remains committed to advancing this innovative therapy to unlock its full potential for millions of patients worldwide [3] Group 3: Webinar Details - The webinar will feature a detailed review of the interim results and will include a live Q&A session [4] - Interested investors can register for the free webinar through the provided link [4]

Core Insights - Enlivex Therapeutics Ltd. announced positive interim six-month efficacy data from the Phase I stage of its Allocetra™ trial for knee osteoarthritis, showing significant pain reduction and improved functionality [1][2][4] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune balance [6] Clinical Trial Details - The Phase I/II trial consists of two stages: the completed Phase I safety run-in and the ongoing Phase II double-blind, randomized, placebo-controlled trial [1][3] - The Phase I stage demonstrated a 47.0% average reduction in reported pain and significant improvements in functionality and stiffness, with 83% of patients still responding to treatment after six months [2][4] Efficacy Results - The six-month interim results showed a 51.2% reduction in WOMAC pain, a 46% improvement in WOMAC function, and a 40% improvement in WOMAC stiffness, indicating durable efficacy [2][4] - The safety profile of Allocetra™ remained consistent, with no serious adverse events reported [2][4] Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and projected to reach 78 million by 2040, highlighting the critical need for effective treatments [4][5]

Core Viewpoint - Enlivex Therapeutics Ltd. has denied false claims made by Tipranks.com regarding the suspension of its stock trading due to an internal investigation, asserting that the company continues to operate normally and its shares are trading regularly on both the Tel Aviv Stock Exchange and NASDAQ [1][2]. Company Operations - The company emphasizes that it is executing its operating plan and is optimistic about the potential of its product Allocetra™ to provide treatment solutions for osteoarthritis patients, who currently have limited options [3]. - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, which aims to reset non-homeostatic macrophages to their homeostatic state, crucial for immune system rebalancing [4]. Legal Actions - The CEO of Enlivex has stated that the company will pursue legal actions against those responsible for the false report, including the publishers and hosting service of Tipranks.com [3]. Investor Communication - The company urges investors to rely solely on official communications, including press releases and filings with the U.S. Securities and Exchange Commission, for accurate information [2].

Core Viewpoint - Enlivex Therapeutics Ltd. has received authorization from the Israeli Ministry of Health to initiate a Phase I trial for Allocetra™ in patients with temporomandibular joint (TMJ) osteoarthritis, aiming to evaluate its safety, tolerability, and initial efficacy [1][3]. Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal, off-the-shelf cell therapy designed to restore macrophages to their homeostatic state [4][6]. - The company aims to address unmet medical needs in various conditions, including solid cancers and sepsis, by reprogramming non-homeostatic macrophages [4][6]. Industry Context - TMJ disorders are the second most common musculoskeletal condition, affecting 5% to 12% of the global population, with an estimated annual health cost of $4 billion [5]. - TMJ osteoarthritis is the most prevalent form of arthritis in the TMJ, leading to significant pain and functional impairment, and currently lacks effective long-term treatment options [5]. Clinical Trial Details - The Phase I trial will be conducted by the Rheumatology Unit at Sheba Medical Center, which is recognized among the top 10 hospitals globally [2]. - The trial aims to recruit six patients who have not responded adequately to conventional treatments, with primary endpoints focusing on safety and secondary endpoints assessing pain and joint functionality over 12 months [3].

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].