Enlivex Therapeutics .(US:ENLV)2021-11-18 16:00Financial 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]