Entera Bio(ENTX) - 2024 Q3 - Quarterly Report

Financial Performance - Total revenues for the nine months ended September 30, 2024, were $99 million, compared to$0 for the same period in 2023[16] - Gross profit for the nine months ended September 30, 2024, was $9 million, with a gross margin of approximately 9.1$7.248 million, compared to $6.928 million for the same period in 2023[16] - Net loss for the nine months ended September 30, 2024, was$7.183 million, compared to $6.894 million for the same period in 2023[16] - Revenue for the three months ended September 30, 2024, was$42 thousand, a 100% increase from $0 in the same period in 2023, attributed to a research services agreement[109][115] - For the nine months ended September 30, 2024, the company reported revenues of$99 thousand, a 100% increase from $0 in the same period in 2023[115] Cash and Assets - Cash and cash equivalents decreased to$6.915 million as of September 30, 2024, from $11.019 million as of December 31, 2023[13] - Total current assets decreased to$7.340 million as of September 30, 2024, from $11.257 million as of December 31, 2023[13] - As of September 30, 2024, the company had cash and cash equivalents of$6.9 million, which is expected to meet projected operating requirements into the third quarter of 2025[92] - As of September 30, 2024, other current assets increased to $383,000 from$238,000 as of December 31, 2023, representing a 60.5% increase[56] - Cash and cash equivalents stood at $6.9 million as of September 30, 2024, with primary cash uses being research and development, general and administrative expenses, and working capital[124] Liabilities and Equity - Total liabilities decreased to$1.289 million as of September 30, 2024, from $1.379 million as of December 31, 2023[13] - Shareholders' equity decreased to$6.452 million as of September 30, 2024, from $10.386 million as of December 31, 2023[13] - Accrued expenses and other payables decreased to$765,000 as of September 30, 2024, down from $874,000 as of December 31, 2023, a reduction of 12.5$3.298 million, compared to $3.510 million for the same period in 2023[16] - The company has incurred significant expenses related to research and development, which are expected to continue impacting its financial position[27] - Research and development expenses for the three months ended September 30, 2024, were$1.5 million, an 8% increase from $1.4 million in the same period in 2023[102][111] - Research and development expenses for the nine months ended September 30, 2024, were$3.3 million, a 6% decrease from $3.5 million in the same period in 2023[117] Future Plans and Financing - The company plans to initiate a Phase 3 registrational study for its product candidate EB613, which is aimed at treating post-menopausal women with low bone mineral density and high-risk osteoporosis[25] - Entera Bio Ltd. is evaluating various financing alternatives to support future research and development activities, with no certainty of obtaining necessary funding[27] - The company anticipates needing to raise additional capital to fund further operations, which may not be available on favorable terms[93] - The company plans to finance future research and development activities through public or private equity markets or collaborations, but there is no certainty about obtaining such funding[129] Operational Viability - As of September 30, 2024, Entera Bio Ltd. has an accumulated deficit of$111.6 million and negative cash flows from operating activities[27] - There is substantial doubt regarding the company's ability to continue as a going concern due to recurring losses and negative cash flows[122] - The company has not derived significant income from its activities and has incurred an accumulated deficit since inception, raising concerns about its operational viability[131] Product Development - The company is developing EB612 as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism[26] - The company’s most advanced product candidate, EB613, is being developed as the first oral, osteoanabolic tablet treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis[70] - The FDA has concurred that a 2-year, placebo-controlled phase 3 study with Total Hip BMD as the primary endpoint could support a new drug application for EB613[70] - The company has safely administered its proprietary PTH tablets to a total of 255 subjects across Phase 1 and Phase 2 studies[73] Impact of External Factors - The company has not experienced material impacts on its business operations due to ongoing regional conflicts, and it does not expect delays in its programs[31] - The ongoing geopolitical situation in Israel has not materially impacted the company's business or operations to date[87] Stock and Securities - Entera Bio Ltd. has issued a total of 236,126 ordinary shares under the Leerink ATM Program for net proceeds of $601 at a weighted average price of$2.54 per share during the nine months ended September 30, 2024[43] - The company issued 143,049 ordinary shares to non-executive members of the Board in lieu of cash board fees, with a fair value of $263 based on the market price at the grant date[53] - The board of directors granted 25,000 restricted stock units (RSUs) to a consulting firm for services rendered, with vesting occurring in four monthly installments starting August 31, 2024[158] - The RSUs were not registered under the Securities Act and were offered in reliance on exemptions from registration requirements[159] - There were no defaults upon senior securities during the reporting period[160] - No officers or directors adopted or terminated any trading plans intended to satisfy Rule 10b5-1(c) during the quarter ended September 30, 2024[162] Compliance and Certifications - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required under the Sarbanes-Oxley Act[163]