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]

Clinical Development - The company completed the development of the frozen formulation of Allocetra™ twelve months ahead of schedule, which is expected to have a shelf life spanning multiple years, improving scalability and reducing production costs [19]. - The Phase II trial for sepsis is integrating the frozen formulation of Allocetra™, expanding the study population to include patients with higher SOFA scores, with top-line data readouts expected in Q1 2024 [20][21]. - The company initiated a Phase I/II trial for Allocetra™ in combination with chemotherapy for patients with peritoneal metastases, with data readouts expected by Q2 2024 [23]. - A second Phase I/II trial is evaluating Allocetra™ combined with anti-PD-1 checkpoint inhibitors, with enrollment completion expected by the end of Q2 2023 [24]. - The company received positive recommendations from the Data and Safety Monitoring Board to continue its clinical trials, indicating progress in its research efforts [23][24]. Financial Performance and Projections - The company has not generated any revenue from Allocetra™ or any other product candidate, and it may never be profitable [32]. - The company expects to incur additional losses in the future and will need substantial additional capital to continue operations [32]. - The company has incurred losses of $31 million and $14.4 million for the years ended December 31, 2022, and 2021, respectively, with an accumulated deficit of approximately $83 million as of December 31, 2022 [41]. - The company expects research and development expenses to increase due to planned pre-clinical studies and clinical trials, leading to continued significant operating losses [42]. - The company anticipates needing substantial additional capital to fund operations and develop product candidates, particularly Allocetra™, with a potential cash runway extending into 2025 [50]. - The company has no current source of revenue and does not expect to generate revenue until regulatory approval and successful commercialization of its product candidates [56]. Regulatory and Compliance Challenges - The company has not received regulatory clearance to conduct necessary clinical trials for Allocetra™ in the U.S. or other countries [60]. - The clinical trial process is expensive and subject to delays due to various factors, including regulatory requirements and patient recruitment challenges [67]. - Even if clinical trials are successful, obtaining regulatory approval is lengthy and uncertain, with potential for delays or denials [69]. - Approval in one jurisdiction does not guarantee approval in others, which may impair the ability to develop foreign markets for Allocetra™ [62]. - Changes in regulatory requirements during clinical trials may increase costs and delay timelines [73]. - Non-compliance with regulatory requirements could lead to sanctions, including fines, product recalls, and operational restrictions [80]. Manufacturing and Operational Risks - The company completed construction of its cGMP Allocetra™ manufacturing plant on schedule, but the move into the new facility has been deferred for approximately three years as part of a cost-cutting program [26]. - Manufacturing processes are complex and susceptible to contamination, which could impact the availability of raw materials and finished products [74]. - The company faces risks of write-offs and costs due to the complex nature of blood and potential contamination of product candidates [77]. - Regulatory compliance is critical, as failure to meet manufacturing regulations could adversely affect financial results and operations [78]. - The company may incur additional costs and face integration difficulties if it acquires or in-licenses new technologies or product candidates [100]. Market and Competitive Landscape - The company faces intense competition from larger pharmaceutical and biotechnology companies, which may have more resources and experience [112]. - Market acceptance of Allocetra™ will depend on factors such as clinical safety, efficacy, and the willingness of patients to pay out of pocket [97]. - The company may face significant regulatory hurdles even after receiving marketing approval, which could impact commercialization [92]. - Obtaining coverage and reimbursement approval from third-party payors is a time-consuming and costly process that may impact the commercialization of future products [108]. Intellectual Property Risks - The company faces risks related to intellectual property, including the uncertainty of obtaining and maintaining patents [149]. - There is no guarantee that pending patent applications will result in issued patents, which could significantly affect the company's competitive advantage [150]. - The company may face litigation related to intellectual property rights, which can be costly and time-consuming [167]. - There is a risk that third parties may claim infringement of their patents, potentially halting the company's operations [168]. Shareholder and Market Considerations - Approximately 19.47% of the company's outstanding ordinary shares are owned by principal shareholders, directors, and officers, allowing them to exert significant influence over shareholder decisions [178]. - The company does not intend to declare cash dividends in the foreseeable future, meaning shareholders must rely on capital appreciation for returns on their investment [182]. - The trading price of the company's ordinary shares is likely to be volatile, influenced by factors such as clinical trial results and regulatory approvals [175]. Geographic and Political Risks - The company operates in Israel, where political and military instability could adversely affect its business operations and financial results [186]. - The company's ordinary shares are traded on both the Nasdaq Capital Market and the Tel Aviv Stock Exchange, which may lead to price variations due to different currencies and trading times [185]. - The company’s operations may be adversely affected by Israeli government policies and military service obligations, which could disrupt business continuity [191].

Financial Performance - The net loss for 2022 was $31,060,000, compared to a net loss of $14,468,000 in 2021, indicating an increase in losses of approximately 114.5%[17]. - Basic and diluted loss per share increased to $1.69 in 2022, compared to $0.81 in 2021, representing a rise of approximately 108.6%[17]. - Total comprehensive loss for 2022 was $31,060,000, compared to a total comprehensive loss of $14,344,000 in 2021, an increase of approximately 116.5%[17]. - For the year ended December 31, 2022, Enlivex Therapeutics Ltd. reported a net loss of $31.06 million, an increase of 114% compared to a net loss of $14.47 million in 2021[21]. - The company incurred net cash used in operating activities of $23.95 million in 2022, compared to $17.54 million in 2021, reflecting a 36.6% increase[21]. Assets and Equity - Total assets decreased to $67,642,000 as of December 31, 2022, down from $95,146,000 in 2021, representing a decline of approximately 29.1%[16]. - Total shareholders' equity decreased to $56,841,000 in 2022 from $85,039,000 in 2021, a decline of approximately 33.3%[16]. - Enlivex's accumulated deficit reached $83.2 million as of December 31, 2022, indicating ongoing financial challenges since the company has not generated any revenues or product sales[27]. - As of December 31, 2022, the company had total financial assets of $50,656 thousand, a decrease from $84,564 thousand in 2021[134]. Cash and Cash Equivalents - Cash and cash equivalents increased significantly to $49,945,000 in 2022, compared to $11,202,000 in 2021, marking an increase of approximately 345.5%[16]. - Cash, cash equivalents, and restricted cash at the end of 2022 totaled $50.36 million, a significant increase from $11.64 million at the end of 2021[21]. - Total cash and cash equivalents increased to $49,945 thousand in 2022 from $11,202 thousand in 2021, representing a growth of 345%[80]. - Total cash, cash equivalents, and restricted cash shown in the statement of cash flows reached $50,357 thousand in 2022, up from $11,636 thousand in 2021, marking a 332% increase[80]. Research and Development - Research and development expenses rose to $18,693,000 in 2022, up from $12,881,000 in 2021, reflecting a growth of approximately 45.3%[17]. - Research and development expenses for the year ended December 31, 2022, totaled $19,900 thousand, an increase from $13,901 thousand in 2021[135]. - Enlivex's research and development activities are expected to require additional cash investment for preclinical studies and clinical trials, necessitating further financing[28]. - Research and development expenses include costs directly attributable to R&D programs, with all costs expensed as incurred[54]. Operating Expenses - Operating expenses totaled $25,797,000 in 2022, up from $19,288,000 in 2021, which is an increase of approximately 33.9%[17]. - General and administrative expenses for the year ended December 31, 2022, amounted to $7,104 thousand, compared to $6,407 thousand in 2021[136]. - Operating lease expenses for 2022 amounted to $1,037 thousand, up from $698 thousand in 2021, representing a 49% increase[96]. Financing and Capital Structure - The company plans to finance its operations through equity securities issuances and anticipates continuing to incur losses for several years[28]. - The Company entered into an ATM Agreement on December 30, 2022, allowing for the sale of Ordinary Shares with an aggregate offering price of up to $100 million[109]. - The Company sold 476,983 Ordinary Shares under the Former ATM Agreement, resulting in a gross aggregate offering price of $8,557 thousand at an average price of $17.94 per share[108]. - The net proceeds from the February 2021 Offering were $47,023 thousand after deducting fees and expenses[108]. Shareholder Information - The number of shares outstanding increased to 18,421,852 as of December 31, 2022, from 18,331,507 in 2021, reflecting a growth of approximately 0.5%[19]. - As of December 31, 2022, the Company had 202,251 warrants outstanding with a weighted average exercise price of $23.31[114]. - The total unrecognized estimated compensation cost related to non-vested stock options was $2,746 thousand, expected to be recognized over a weighted average period of 1.61 years[119]. - The Company granted 860,492 stock options in 2022 at a weighted average exercise price of $5.49[118]. Tax and Regulatory Matters - The Company has not paid income taxes since its incorporation, with a statutory tax rate of 23%[126]. - As of December 31, 2022, the Company recorded a liability of $705 thousand for uncertain tax positions[61]. Other Financial Metrics - The company reported interest income of $835 thousand for the year ended December 31, 2022, significantly up from $120 thousand in 2021[137]. - The Company recorded charges related to patent costs of approximately $536 thousand, $373 thousand, and $374 thousand for the years ended December 31, 2022, 2021, and 2020, respectively[58]. - The intrinsic value of options exercised during 2022 was $0[120]. - The weighted average risk-free interest rate for stock options was 3.41% in 2022[117].