Entera Bio(ENTX) - 2023 Q2 - Quarterly Report

Financial Performance - As of June 30, 2023, Entera Bio Ltd. reported total assets of $10.445 million, a decrease from $13.127 million as of December 31, 2022, representing a decline of approximately 20.6%[22] - The company incurred a net loss of $4.515 million for the six months ended June 30, 2023, compared to a net loss of $6.969 million for the same period in 2022, reflecting a reduction of approximately 35.5%[25] - The loss per share for the six months ended June 30, 2023, was $0.16, compared to $0.24 for the same period in 2022, reflecting an improvement of approximately 33.3%[25] - For the three months ended June 30, 2023, the company reported an operating loss of $2.33 million, a decrease of 28% compared to an operating loss of $3.25 million for the same period in 2022[93] - The net loss for the six months ended June 30, 2023 was $4.5 million, a reduction of 35% from a net loss of $7.0 million in the same period of 2022[100] Cash and Assets - Cash and cash equivalents decreased to $9.135 million as of June 30, 2023, from $12.309 million at the end of 2022, a decline of about 25.5%[22] - As of June 30, 2023, the company had cash and cash equivalents of $9.1 million, down from $12.3 million at the end of the previous period[109] - The company recorded prepaid expenses of $296,000 and other current assets of $354,000 as of June 30, 2023, compared to $86,000 and $208,000 respectively as of December 31, 2022[48] Liabilities and Deficits - Total current liabilities increased to $1.865 million as of June 30, 2023, from $1.341 million at the end of 2022, marking an increase of approximately 39.0%[22] - The company's accumulated deficit reached $100.012 million as of June 30, 2023, up from $95.497 million at the end of 2022, indicating an increase of approximately 4.0%[22] - The accumulated deficit as of June 30, 2023 was $100.0 million, indicating significant ongoing financial challenges[107] Research and Development - Research and development expenses for the six months ended June 30, 2023, were $2.140 million, down from $3.084 million in the same period of 2022, indicating a decrease of about 30.6%[25] - The company expects to increase research and development expenses significantly as it advances EB613 and EB612 into later stages of clinical development[85] - Research and development expenses for the three months ended June 30, 2023, were $1.21 million, a 13% decrease from $1.39 million in the same period of 2022[93] Funding and Capital - Entera Bio Ltd. plans to fund ongoing operations, including R&D and the completion of the Phase 1 study for EB612, with available funds expected to last into Q3 2024[37] - The company has raised a total of $84.7 million since inception from various sources, including public and private equity offerings[76] - The company anticipates needing to raise additional capital to fund further operations, which may include private or public equity offerings and strategic collaborations[81] - The company has substantial doubt about its ability to continue as a going concern without additional capital[108] Clinical Development - Entera Bio has two product candidates, EB613 and EB612, currently in clinical development, with EB613 being positioned as a potential first oral anabolic treatment for post-menopausal osteoporosis[56] - The company has completed two Phase 1 clinical trials and a Phase 2, 161-patient study for EB613, showing positive results in increasing bone mineral density[62] - On April 3, 2023, the FDA indicated it would not oppose Entera initiating the Phase 3 study for EB613 under the proposed FNIH BQP pathway[66] Legal and Compliance - No material legal proceedings are currently ongoing against the company[131] - There have been no material changes in risk factors since the 2022 Annual Report[132] - No unregistered sales of equity securities occurred during the reporting period[133] - The company has not experienced any defaults upon senior securities[134] - No mine safety disclosures are applicable to the company[135] - During the quarter ended June 30, 2023, no contracts or trading plans were adopted or terminated by officers or directors[136] - The report includes various certifications under the Sarbanes-Oxley Act of 2002[137]