Product Development and Trials - Enlivex 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 production costs [21]. - The Phase II sepsis trial will now utilize the frozen formulation of Allocetra™, with protocol amendments expected to be submitted to regulators in Q2 2022, potentially deferring trial completion by 6-8 months [23]. - The Phase Ib trial of Allocetra™ demonstrated a favorable safety profile and improved clinical outcomes, with over 1.7 million adults in the U.S. developing sepsis annually, leading to more than 270,000 deaths [24]. - Enlivex plans to initiate a Phase Ib trial for Allocetra™ in combination with chemotherapy for solid peritoneal tumors in Q3 2022, and a Phase I/II trial with an immune checkpoint inhibitor in late 2022 [27]. - The company is de-prioritizing Allocetra's clinical development for COVID-19 due to regulatory challenges and resource reallocation towards sepsis and oncology [25]. Financial Performance and Projections - Enlivex has not generated any revenue from Allocetra™ or other product candidates and anticipates incurring additional losses in the future [37]. - The company has incurred losses of $14.4 million and $11.8 million for the years ended December 31, 2021, and 2020, respectively, with an accumulated deficit of approximately $51.9 million as of December 31, 2021 [48]. - The company expects research and development expenses to increase due to planned pre-clinical studies, clinical trials, and the construction of a new manufacturing facility [49]. - The company anticipates significant additional capital will be required to fund operations and develop product candidates, particularly Allocetra™ [60]. - The company has sustained operating losses and expects these losses to continue for the foreseeable future, with a substantial doubt about continuing operations beyond Q3 2024 without additional financing [69]. Regulatory and Market Challenges - The company is subject to extensive regulatory requirements and potential future development difficulties even if Allocetra™ receives marketing approval [48]. - The company has not received regulatory clearance to conduct necessary clinical trials for filing a Biologics License Application (BLA) with the FDA, which could delay commercialization efforts [75]. - Regulatory approval processes are lengthy and uncertain, with various factors that could delay or deny approval for product candidates [90]. - Even if regulatory approval is obtained, it may come with significant limitations that could hinder the commercialization of Allocetra™ or other product candidates [93]. - The company faces risks related to the acceptance and reimbursement of its products by government agencies and third-party payors, which could affect commercial viability [79]. Manufacturing and Operational Risks - Construction of the new cGMP Allocetra™ manufacturing plant in Israel is on schedule, with an initial size of approximately 17,000 square feet, expandable to 21,500 square feet, expected to be completed in Q4 2022 [28]. - The manufacturing process for Allocetra™ is complex and must adhere to stringent cGMP requirements, with any non-compliance potentially resulting in product destruction or recalls [100]. - The company must ensure the safety of its blood supply against transmissible diseases, as risks remain despite existing safeguards, which could impair product manufacturing and distribution [109]. - The company has invested almost all its resources in Allocetra™, indicating a high dependency on the success of this single product candidate [74]. - The company faces potential write-offs and costs due to the complex nature of blood and its processes, which could lead to material fluctuations in liquidity and operational results [101]. Competition and Market Dynamics - The company faces intense competition from larger pharmaceutical and biotechnology companies, which may have more resources and experience in drug development and commercialization [145]. - Sales in Europe and other countries will depend on the availability of reimbursement from third-party payors, who are increasingly challenging pricing and cost-effectiveness [133]. - The company anticipates that government authorities and third-party payors will impose strict requirements for reimbursement, which may limit off-label use of higher-priced drugs [137]. - Obtaining coverage and reimbursement approval is a time-consuming and costly process, and the company cannot guarantee that adequate reimbursement will be available for future products [138]. Intellectual Property and Legal Risks - The company faces risks related to the failure to obtain or maintain patents, which could impact its competitive position [191]. - The company may infringe on the intellectual property rights of others, which could delay product development and increase commercialization costs [210]. - The company’s success is heavily dependent on intellectual property, particularly patents, which are costly and time-consuming to obtain and enforce [206]. - The company may not be able to enforce its intellectual property rights globally, particularly in developing countries where patent laws are less favorable [201]. - The company may be subject to significant costs and litigation to defend intellectual property rights licensed from third parties [208]. Management and Operational Structure - The company relies heavily on its ability to attract and retain qualified senior executive officers, with a particular emphasis on scientific and technical experience, which is critical for its business operations [160]. - The company has incurred significant costs due to its status as a public company, including legal and accounting expenses, which may hinder its ability to comply with regulatory requirements [162][163]. - The company faces intense competition for qualified personnel in the pharmaceutical field, which may affect its ability to recruit and retain necessary staff [160]. - The company does not currently carry "key person" insurance for its senior management, which could pose risks if key personnel are lost [160]. Economic and Geopolitical Factors - The company is operating in a period of economic uncertainty and capital markets disruption, significantly impacted by geopolitical instability [37]. - The ongoing military conflict between Russia and Ukraine has created economic uncertainty and capital market disruptions, which may materially adversely affect the company's business and financial condition [71]. - The COVID-19 pandemic has caused delays in the development of clinical programs and manufacturing of Allocetra™, impacting the company's operations and financial condition [186][187].

Product Development - Enlivex completed the development of the frozen formulation Allocetra™ twelve months ahead of schedule in Q1 2022, significantly improving shelf-life and scalability[2] - The frozen formulation is expected to lower production costs and increase profitability upon potential commercialization, with a shelf life spanning multiple years compared to the liquid formulation's 96 hours[3] - Enlivex plans to integrate the frozen formulation into its ongoing Phase II sepsis trial, which may defer trial completion by approximately six to eight months but shorten the overall timeline for regulatory approval[4] - Enlivex plans to initiate two clinical trials for Allocetra™ in solid tumor patients in 2022, including a Phase Ib trial in Q3 2022 and a Phase I/II trial in late 2022[8] Clinical Trials - The company is de-prioritizing Allocetra's clinical development in COVID-19 due to emerging variants and a more stringent regulatory environment, reallocating resources to sepsis and oncology[6] - Enlivex's Phase IIb COVID-19 trial has seen slow recruitment, with only 11 patients enrolled, leading to the decision to cease recruitment[7] Financial Performance - The company's cash runway is expected to extend to Q3 2024 due to the re-prioritization of resources, with cash and marketable securities totaling $84.1 million as of December 31, 2021[11][14] - Research and development expenses for 2021 were $12.8 million, up from $6.0 million in 2020, while general and administrative expenses increased to $6.4 million from $3.7 million[13] - The net loss for 2021 was $14.4 million, compared to a net loss of $11.8 million in 2020[13] Manufacturing - The construction of Enlivex's new cGMP manufacturing plant in Israel is on schedule, with an initial size of approximately 17,000 square feet and potential expansion to 21,500 square feet[9]

Financial Performance - Operating loss for the three months ended September 30, 2021, was $3,864,000, compared to $1,959,000 for the same period in 2020, indicating an increase in losses of 97.1%[10] - Net loss for the nine months ended September 30, 2021, was $9,732,000, compared to $5,960,000 in 2020, an increase of 63.2%[10] - Total comprehensive loss for the nine months ended September 30, 2021, was $(9,608,000), compared to $(5,861,000) for the same period in 2020, an increase of 63.5%[10] - The company reported a net loss of $9,732 thousand for the nine months ended September 30, 2021, compared to a net loss of $5,960 thousand for the same period in 2020, indicating an increase in losses[21] - 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[31] Assets and Liabilities - Total current assets increased to $90,281,000 as of September 30, 2021, compared to $38,121,000 as of December 31, 2020, representing an increase of 136.5%[7] - Total liabilities increased to $10,084,000 as of September 30, 2021, from $4,871,000 as of December 31, 2020, a rise of 106.5%[7] - Shareholders' equity grew to $88,083,000 as of September 30, 2021, compared to $35,487,000 as of December 31, 2020, an increase of 148.5%[7] - Cash and cash equivalents rose to $22,146,000 from $5,673,000, a growth of 289.5%[7] - Cash and cash equivalents at the end of the period were $23,327 thousand, up from $6,397 thousand at the beginning of the period, showing a significant increase in liquidity[21] Research and Development - Research and development expenses for the nine months ended September 30, 2021, totaled $7,715,000, up from $3,642,000 in 2020, reflecting a 112.8% increase[10] - The company is developing Allocetra, a universal cell therapy aimed at reprogramming macrophages, which is critical for treating conditions like solid tumors and COVID-19[25] - The Phase IIb clinical trial for Allocetra in patients with severe sepsis is expected to yield interim results in the first or second quarter of 2022, with top-line results anticipated in the fourth quarter of 2022[35] Financing Activities - The company issued shares and warrants for cash consideration of $57,629,000 net of issuance costs during the reporting period[13] - The company raised a net amount of $53.2 million from the issuance of 2,848,629 ordinary shares and an additional $7.7 million from the exercise of warrants and options during the first quarter of 2021[31] - The company plans to finance its operations through equity securities issuances and expects to require additional capital to support its long-term development[34] Stock Options and Compensation - As of September 30, 2021, the total unrecognized estimated compensation cost related to outstanding nonvested stock options was $2,822 thousand, expected to be recognized over a weighted average period of 3.96 years[90] - The Company authorized an increase of 1,800,000 ordinary shares for issuance to employees, directors, and consultants, totaling 4,150,704 shares authorized under the 2019 Equity Incentive Plan[86] - The Company recognized share-based compensation expenses of $336 thousand and $1,114 thousand for the three and nine months ended September 30, 2021, respectively[90] Grants and Other Income - The Company received approximately $8 million in grants from the Israeli Innovation Authority (IIA) as of September 30, 2021, with no royalties paid to the IIA yet[66] - The Company was approved for a new grant from the IIA amounting to NIS 3.8 million ($1.16 million) for its clinical development program related to sepsis[67] Miscellaneous - The company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations[30] - The company does not expect any material impact on its liquidity due to the COVID-19 pandemic, although clinical trial timelines may be extended[35]

United States Securities and Exchange Commission Washington, D.C. 20549 Title of each class Trading symbol Name of each exchange on which registered Ordinary Shares, par value of NIS 0.40 ENLV Nasdaq Capital Market FORM 20-F ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 Commission file number 001-36578 Enlivex Therapeutics Ltd. (Exact name of Registrant as specified in its charter) State of Israel (Jurisdiction of incorporati ...

Ticker: ENLV | --- | --- | --- | |--------------|---------------------------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | Life-saving | | | | October 2020 | immunomodulating cell therapies | | Forward-Looking Statements These slides and the accompanying oral presentation contain forward-looking statements and information. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels or activ ...

United States Securities and Exchange Commission Washington, D.C. 20549 Title of each class Trading symbol Name of each exchange on which registered Ordinary Shares, par value of NIS 0.40 ENLV Nasdaq Capital Market FORM 20-F ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 Commission file number 001-36578 Enlivex Therapeutics Ltd. (Exact name of Registrant as specified in its charter) State of Israel (Jurisdiction of incorporati ...

United States Securities and Exchange Commission Washington, D.C. 20549 FORM 20-F ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 Commission file number: 001-36578 Enlivex Therapeutics Ltd. (Exact name of Registrant as specified in its charter) State of Israel (Jurisdiction of incorporation or organization) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal executive offices) Mr. Shmuel Hess Tel: +972.2.6708072 ...