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 ...

Financial Performance - The net loss for the nine months ended September 30, 2023, was $19,973,000, compared to a net loss of $23,871,000 for the same period in 2022, indicating an improvement of about 16.0%[5]. - Basic and diluted loss per share improved from $(1.30) in the nine months ended September 30, 2022, to $(1.08) in the same period of 2023[5]. - The company reported a net cash (used in) provided by investing activities of $(30,103) thousand for the nine months ended September 30, 2023, compared to $65,400 thousand in the same period of 2022[12]. - The company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations[17]. - The company expects to continue incurring losses for at least the next several years and will need to raise additional financing to support its development activities[18]. Assets and Liabilities - Total assets decreased from $67,642,000 as of December 31, 2022, to $46,936,000 as of September 30, 2023, representing a decline of approximately 30.6%[4]. - Total shareholders' equity decreased from $56,841,000 as of December 31, 2022, to $38,779,000 as of September 30, 2023, a decline of approximately 31.8%[4]. - Total current liabilities decreased from $6,607,000 as of December 31, 2022, to $4,339,000 as of September 30, 2023, a reduction of about 34.3%[4]. - As of September 30, 2023, total financial assets amounted to $30,895,000, a decrease of 39.1% from $50,656,000 on December 31, 2022[53]. Cash and Cash Equivalents - Cash and cash equivalents significantly dropped from $49,945,000 in December 2022 to $1,971,000 in September 2023, a decrease of about 96.0%[4]. - Cash and cash equivalents decreased from $49,945,000 as of December 31, 2022, to $1,971,000 as of September 30, 2023, representing a decline of 96.1%[53]. - Net cash used in operating activities for the nine months ended September 30, 2023, was $18,246 thousand, slightly improved from $19,135 thousand in the same period of 2022[12]. - Cash used in operating activities increased to $700,000 for the nine months ended September 30, 2023, compared to $624,000 in the same period of 2022[40]. Research and Development - Research and development expenses for the nine months ended September 30, 2023, increased to $14,560,000, up from $12,993,000 for the same period in 2022, reflecting a rise of approximately 12.1%[5]. - The company is developing Allocetra, a universal cell therapy aimed at reprogramming macrophages, which is critical for immune system rebalancing[14]. Shareholder Information - The weighted average number of shares outstanding increased from 18,379,062 in the nine months ended September 30, 2022, to 18,566,383 in the same period of 2023[5]. - The company has a share repurchase program approved for up to $1.5 million of its outstanding Ordinary Shares, with a compliance deadline of 45 days following court approval on November 2, 2023[55]. Grants and Compensation - The gross amount of grants received from the Israeli Innovation Authority was approximately $9.7 million as of September 30, 2023, with no royalties paid to date[42]. - Share-based compensation expenses for the three months ended September 30, 2023, totaled $407,000, compared to $471,000 in the same period of 2022[52]. - The company recognized share-based compensation expenses related to stock options of $1,261,000 for the nine months ended September 30, 2023, compared to $1,385,000 in 2022[52]. - The total unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,347,000, expected to be recognized over a weighted average period of 1.07 years[50]. Operational Challenges - The company incurred an accumulated deficit of $102,998 thousand as of September 30, 2023, indicating ongoing financial challenges since inception[17]. - The company is currently unable to predict the impact of the ongoing conflict in Israel on its business operations[55].

Financial Performance - For the three months ended March 31, 2023, Enlivex reported a net loss of $7,218 thousand, compared to a net loss of $8,225 thousand for the same period in 2022, reflecting an improvement of approximately 12.2%[5] - The company's accumulated deficit increased to $90,243 thousand as of March 31, 2023, compared to $83,025 thousand at the end of 2022, marking a rise of approximately 8.7%[4] - Enlivex has not generated any revenues or product sales and has not achieved profitable operations since its inception[14] - The company expects to continue incurring losses for at least the next several years and will need to raise additional financing to support its research and development activities[15] Assets and Cash Position - As of March 31, 2023, Enlivex Therapeutics Ltd. reported total assets of $60,022 thousand, a decrease from $67,642 thousand as of December 31, 2022, representing a decline of approximately 11.5%[4] - The company had cash and cash equivalents of $13,138 thousand as of March 31, 2023, down from $49,945 thousand at the end of 2022, indicating a decrease of about 73.7%[4] - The company reported total financial assets of $43,636 thousand as of March 31, 2023, a decrease from $50,656 thousand as of December 31, 2022[51] - Total short-term deposits increased significantly to $22,839 thousand as of March 31, 2023, from $299 thousand as of December 31, 2022[32] Shareholder Equity and Financing - Enlivex's total shareholders' equity decreased to $50,574 thousand as of March 31, 2023, down from $56,841 thousand at the end of 2022, a decline of about 11.0%[4] - The company plans to finance its operations through equity securities issuances and, in the longer term, through revenues[16] - The company issued 110,115 Ordinary Shares under the ATM agreement for a gross consideration of $470 thousand during the three months ended March 31, 2023[44] - The company issued 10,190 Ordinary Shares under the ATM Agreement during the second quarter of 2023[53] Research and Development Expenses - Research and development expenses for the first quarter of 2023 were $5,176 thousand, an increase of 10.6% from $4,682 thousand in the same period of 2022[5] Share-Based Compensation - The company recognized $530 thousand in share-based compensation expenses related to stock options for the three months ended March 31, 2023, down from $565 thousand in the same period of 2022[50] - The total unrecognized estimated compensation cost related to outstanding non-vested stock options was $2,213 thousand, expected to be recognized over a weighted average period of 1.57 years[50] - Share-based compensation expenses related to restricted stock units amounted to $103 thousand for the three months ended March 31, 2023, compared to $223 thousand for the same period in 2022[50] - The company reported a total share-based compensation expense of $633 thousand for the three months ended March 31, 2023, down from $788 thousand in the same period of 2022[50] Liabilities and Expenses - The company had accrued expenses and other liabilities totaling $3,970 thousand as of March 31, 2023, down from $4,659 thousand as of December 31, 2022[36] - The company’s total operating lease liabilities were $4,677 thousand as of March 31, 2023, compared to $4,847 thousand as of December 31, 2022[39] - Depreciation expenses for the three months ended March 31, 2023, were $209 thousand, compared to $188 thousand for the same period in 2022[34] Stock Options and Warrants - As of March 31, 2023, the total number of outstanding options was 2,929,868 with a weighted average exercise price of $5.84, compared to 2,399,622 options at a weighted average exercise price of $5.95 as of March 31, 2022[47] - The number of exercisable options at the end of the period was 2,053,017, with a weighted average exercise price of $5.58[47] - The intrinsic value of options outstanding as of March 31, 2023, was $617 thousand[51] - The company had 202,251 warrants outstanding as of March 31, 2023, with an average exercise price of $23.31[43] Grants and Financial Support - The company has received approximately $9.3 million in grants from the Israeli Innovation Authority, with no royalties paid as of March 31, 2023[41] Interest Rates - The average interest rates for bank deposits were 4.29% for cash equivalents and 4.69% for short-term deposits as of March 31, 2023[31][32]