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 ...

Core Insights - Enlivex Therapeutics Ltd. announced positive interim data from a Phase I/II clinical trial of AllocetraTM for patients with end-stage knee osteoarthritis, indicating a potential alternative to knee replacement surgery [1][3]. Clinical Trial Results - In a three-month follow-up, only 1 out of 9 patients (11%) opted for knee replacement surgery, while 8 patients (89%) chose not to proceed with the surgery [2][7]. - Patients reported an average pain reduction of 64% from baseline, with 33% of patients experiencing complete pain relief, reducing their average pain level from 9 to 0 on a scale of 0 to 10 [7][8]. - The trial demonstrated a favorable safety profile, with no severe adverse events related to AllocetraTM reported [7][16]. Background on Osteoarthritis - Osteoarthritis affects over 32.5 million Americans and more than 300 million individuals globally, with projections indicating that 78 million Americans will have the condition by 2040 [5]. - The disease leads to over one million hospitalizations annually in the U.S., primarily for total joint replacement, highlighting the critical need for effective treatments [5]. About Allocetra™ - Allocetra™ is designed as a universal, off-the-shelf cell therapy aimed at reprogramming macrophages into their homeostatic state, which is essential for immune system rebalancing [12][18]. - The therapy is being explored for various conditions, including solid cancers and sepsis, addressing significant unmet medical needs [18]. Future Directions - The ongoing study aims to enroll a total of 18 patients, with assessments for safety and pain/function responses extending up to 12 months post-injection [17].

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 ...

Core Insights - Enlivex Therapeutics has received authorization from the Israeli Ministry of Health to initiate a Phase I/II trial for Allocetra™ targeting thumb osteoarthritis, a condition with no FDA-approved therapies [1][4] - The trial will be led by Dr. Amir Oron, focusing on the role of macrophages in osteoarthritis and the potential of Allocetra™ as a disease-modifying treatment [2][4] - Allocetra™ is designed to reprogram macrophages into their homeostatic state, potentially addressing unmet medical needs in various diseases [5][8] Company Overview - Enlivex Therapeutics is a clinical-stage company specializing in macrophage reprogramming immunotherapy, with Allocetra™ as its primary product [8] - The company aims to develop novel therapies that can improve the quality of life for patients suffering from osteoarthritic conditions [4] Trial Details - The Phase I/II trial will recruit up to 46 patients, consisting of a safety run-in phase followed by a randomized, placebo-controlled stage [3] - The primary safety endpoint will assess adverse events, while efficacy will be measured through changes in pain and function over 12 months [3] Disease Context - Basal thumb osteoarthritis is a chronic condition that significantly impacts daily activities, with a prevalence of 5.8% in 50-year-old males and 7.3% in females, increasing to 33.1% and 39.0% in those aged 80 [6][7] - Current treatments for thumb osteoarthritis are limited, and the condition often progresses despite conservative management [7]

The potential gross proceeds from the warrants, if fully exercised on a cash basis, will be approximately $10.0 million. No assurance can be given that any of the warrants will be exercised. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. The securities described above were offered and sold by the Company in a registered direct offering pursuant to a "shelf" regist ...

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 ...

Single healthcare-focused institutional investor $5 million upfront with up to an additional $10 million of gross proceeds upon the exercise in full of clinical milestone-linked warrants Nes-Ziona, Israel, May 28, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale in a ...

Nes-Ziona, Israel, May 28, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale in a registered direct offering of an aggregate of 3,571,429 ordinary shares (or ordinary share equivalents in lieu thereof) and clinical milestone-linked warrants, composed of Series A warran ...

Strategic Focus and Clinical Development - The company announced a strategic reprioritization plan in September 2023, increasing focus on inflammatory and autoimmune indications, particularly sepsis and osteoarthritis, which represent a multibillion commercial market opportunity [18]. - The ongoing Phase II trial for Allocetra in sepsis has enrolled 120 patients, with topline results expected in April 2024, showing a 65% reduction in overall mortality rate compared to expected mortality based on real-world data [22]. - In the Phase II trial, Allocetra-treated patients demonstrated a 90% reduction in SOFA scores for urinary tract infection-related sepsis, indicating a significant potential market opportunity, as up to 31% of sepsis cases start as urinary tract infections [22]. - The company initiated a clinical program in osteoarthritis, with the first patient dosed in a Phase I/II trial, targeting to receive topline readout by Q3 2025 [26]. - The Phase I/II trial for knee osteoarthritis will evaluate joint pain and function compared to placebo at three, six, and twelve months [26]. - The company aims to leverage preclinical evidence of Allocetra's mechanism of action to address chronic low-grade inflammation in osteoarthritis patients [27]. - The company has a favorable safety profile for Allocetra, as demonstrated in previous trials, addressing a high unmet medical need in sepsis [24]. - The company has focused substantially all efforts on Allocetra™, which is currently under development for specific indications, and may not obtain regulatory approval [44]. - The company has suspended internal clinical development of various oncology indications to focus on inflammatory and autoimmune indications [69]. Financial Performance and Capital Requirements - The company reported a loss attributable to holders of ordinary shares of $29 million for the year ended December 31, 2023, compared to a loss of $31 million for 2022, with an accumulated deficit of approximately $112.1 million as of December 31, 2023 [43]. - The company has not generated any revenue from its product candidates, including Allocetra™, and may never achieve profitability [45]. - Significant additional capital will be required in the future to fund operations and develop product candidates, with no committed external sources of funds currently available [52]. - The company anticipates that existing resources will be sufficient to maintain operations through the end of 2025, but may require significant additional funds for the FDA and EMA approval processes [52]. - Due to recurring operating losses, the company may require additional financial support to continue operations beyond the end of 2025 [59]. - The company expects long-term capital requirements to depend on factors such as commercialization costs, revenue from approved products, and expenses to attract skilled personnel [56]. Regulatory and Compliance Risks - The clinical trial process is complex and expensive, with potential delays or failures that could significantly impair the company's ability to generate revenues [35]. - The company has not yet obtained regulatory clearance to conduct confirmatory clinical trials necessary for filing a Biologics License Application (BLA) with the FDA [63]. - The approval process for Allocetra™ may vary significantly across jurisdictions, impacting the timeline for commercialization [64]. - Regulatory authorities may suspend clinical trials if participants are exposed to unacceptable health risks, which could delay regulatory approval and adversely affect product development and revenue generation [75]. - Obtaining approval for a BLA or similar regulatory application is a lengthy and uncertain process, with potential delays due to various factors including trial design and data interpretation [76]. - Regulatory approvals may come with significant limitations, including restrictions on intended uses and post-marketing study requirements, impacting commercialization efforts [79]. - The company faces numerous risks and uncertainties, including geopolitical tensions and market conditions that could adversely affect its business and financial condition [34]. Market and Competitive Landscape - The commercial success of product candidates will depend on broad market acceptance, which is influenced by factors such as clinical safety, ease of administration, and pricing [101][103]. - The company faces significant competition in seeking collaboration arrangements for product development, which may not be successful and could adversely affect its ability to commercialize products [104][105]. - The company anticipates increasing competition as new drugs enter the market and advanced technologies become available, which could render its products obsolete [121]. - Allocetra™ must demonstrate superior efficacy, safety, and cost-effectiveness compared to existing treatments for knee osteoarthritis to achieve market success [123]. Intellectual Property and Legal Risks - The company faces risks related to intellectual property, including the potential failure to obtain or maintain patents, which could impact its competitive position [148]. - The complexity and uncertainty of patent protection may hinder the company's ability to secure adequate protection for its technologies and products [158]. - The company may encounter significant costs and uncertainties related to patent litigation, which could adversely affect its business operations [157]. - Legal challenges from third parties claiming patent infringement could hinder the company's operations and lead to costly litigation [168]. Operational and Management Challenges - The company relies on third parties for clinical trials and may face challenges in collaboration arrangements that could impact the development and commercialization of its product candidates [35]. - The company relies heavily on a small number of senior executive officers, and the loss of key personnel could adversely affect its business execution [135]. - The complexity of internal controls over financial reporting may lead to deficiencies that could materially misstate financial statements, harming investor confidence [139]. - The company currently lacks a sales force and distribution capabilities, limiting its ability to market products directly in the near future [146]. External Factors and Economic Conditions - The ongoing military conflict in Israel, including the recent escalation in October 2023, could disrupt the company's operations and financial conditions [197]. - Economic and geopolitical conditions may adversely affect the company's business and financial condition, impacting capital raising efforts and market conditions [61]. - The healthcare industry is facing increased limitations on reimbursement, which could affect the company's product sales and market acceptance [112][115].

Nes-Ziona, Israel, April 29, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company" or "Enlivex"))), a clinical-stage macrophage reprogramming immunotherapy company, today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz. Dear fellow shareholders, I have been serving as the Chief Executive Officer of Enlivex for the last four and a half years. During that period, we have been working diligently to develop our drug product candidate, Allocetra ...