Entera Bio(US:ENTX)2023-05-04 16:00Financial Performance - As of March 31, 2023, Entera Bio Ltd. reported total assets of $11.606 million, a decrease of 11.6% from $13.127 million as of December 31, 2022[18]. - The company incurred a net loss of $2.190 million for the three months ended March 31, 2023, compared to a net loss of $3.784 million for the same period in 2022, representing a 42% improvement[20]. - The total shareholders' equity decreased to $10.080 million as of March 31, 2023, from $11.754 million at the end of 2022, reflecting a decline of 14.2%[18]. - Cash and cash equivalents at the end of Q1 2023 were $10.691 million, down from $12.309 million at the end of 2022, indicating a decrease of 13.1%[18]. - The company reported a basic and diluted loss per share of $0.08 for Q1 2023, compared to $0.13 for Q1 2022, showing a reduction in loss per share[20]. - For the three months ended March 31, 2023, the company reported operating losses of $2.2 million, a decrease of 42% compared to $3.8 million for the same period in 2022[91]. - The net cash used in operating activities for the three months ended March 31, 2023 was $1.6 million, a decrease of $3.2 million compared to $4.8 million for the same period in 2022[107][110]. - The company has raised a total of $84.7 million since inception, with $25.3 million from at-the-market offerings and $11.2 million from its IPO in 2018[100]. Research and Development - Research and development expenses for Q1 2023 were $0.931 million, down 44.9% from $1.690 million in Q1 2022[20]. - The company anticipates significant increases in research and development expenses as it advances product candidates EB613 and EB612 into later clinical stages[81]. - The company plans to conduct a pharmacokinetic study for a new formulation of EB612 in the first half of 2023, which may support regulatory approval[63]. - Entera Bio has two product candidates in clinical development: EB613 and EB612, both of which are first-in-class daily mini tablets of human parathyroid hormone[49]. - The Phase 2 study of EB613 in osteoporosis met its primary endpoint, showing significant improvement in bone mineral density at Month 6[54]. - EB612 has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of hypoparathyroidism[61]. - The company received approximately $0.5 million in grants from the Israeli Innovation Authority to partially fund research and development, with a royalty rate of 3% on revenues derived from products developed using these grants[67]. Financing and Capital Resources - The company plans to fund ongoing operations, including R&D and the completion of the Phase 1 study for the new formulation EB612, into Q3 2024[32]. - Entera Bio Ltd. is evaluating various financing alternatives to support future R&D activities and working capital needs[32]. - The company expects its existing capital resources to meet projected operating requirements into the third quarter of 2024, but additional funding will be necessary for future studies[102]. - There is substantial doubt about the company's ability to continue as a going concern without additional capital infusion[105]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained[76]. - The company has substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows[71]. - The company anticipates that any additional capital raised through equity or debt financing may dilute existing shareholders' interests[104]. Agreements and Collaborations - The company has entered into a collaboration with Amgen for drug delivery technology, which was terminated on May 2, 2023[33]. - Entera Bio terminated its research collaboration and license agreement with Amgen on May 2, 2023, as per the agreement's terms[66]. - The company has a patent transfer agreement with Oramed, which includes a royalty payment of 3% on net revenues generated from the assigned patent rights[64]. - Under the Amgen Agreement, the company received a total of $1.7 million from 2019 through March 31, 2023, with no revenue recognized for the three months ended March 31, 2023[77][92]. Expenses and Liabilities - General and administrative expenses decreased to $1.3 million for the three months ended March 31, 2023, from $2.2 million in the same period in 2022, reflecting a 40% reduction[91][96]. - As of March 31, 2023, accrued expenses and other payables totaled $1,296,000, an increase from $1,233,000 as of December 31, 2022[41]. - As of March 31, 2023, the company had tax loss carry-forwards of $69.2 million, which can be utilized indefinitely against future taxable income[89]. - Entera Bio Ltd. has an accumulated deficit of $97.687 million as of March 31, 2023, up from $95.497 million at the end of 2022[18].