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 ...

Nes-Ziona, Israel, April 16, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company"))), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Danish Medicines Agency (DKMA) authorized the expansion into Denmark of the Company's multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis. As previously announced, the Company received its first regulatory approval for ...

Enlivex Therapeutics (ENLV) is a clinical-stage pharmaceutical company focused on developing its lead pipeline candidate, Allocetra, an off-the-shelf cell therapy.Enlivex designed Allocetra to reprogram macrophages into their homeostatic state. The therapy is being evaluated in a mid-stage study for treating organ failure associated with sepsis.In the past week, the company’s stock lost 51.2%. This downside came after management came out with mixed results from the phase II study evaluating Allocetra over 2 ...

Nes-Ziona, Israel, April 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company"))), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will host a conference call and webcast on April 12, 2024, at 8:30am ET (15:30 IL time) to discuss topline results from its Phase II trial of Allocetra™ in patients with sepsis, in which 120 patients enrolled.  During the call, members of Enlivex's leadership team will discuss the results. A live Q&A session w ...

Nes-Ziona, Israel, April 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will host a conference call and webcast on April 12, 2024, at 8:30am ET (15:30 IL time) to discuss topline results from its Phase II trial of Allocetra™ in patients with sepsis, in which 120 patients enrolled.  During the call, members of Enlivex’s leadership team will discuss the results. A live Q&A session wi ...

Analysis of eligible1 patients from the sepsis Phase II study (NCT# NCT04612413) In accordance with the study protocol, the safety and efficacy topline analysis includes sequential organ failure assessment (SOFA) scores and mortality for the 28-day period post treatment.Efficacy: Stand-alone analysis of the Allocetra™-treated patients, of which 78% had septic shock and 65% had invasive ventilation at screening, demonstrated substantial reductions in SOFA scores and 65% reduction in overall mortality rate a ...

Nes-Ziona, Israel, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd., (NASDAQ:ENLV, the "Company"))), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the U.S. Patent and Trademark Office issued a new patent, number US 11,883,429, covering AllocetraTM, the Company's immunotherapy product candidate. The new patent is expected to provide added intellectual property protection in the United States for the product's composition and manufacturing method. ABOUT ENLIV ...