Entera Bio(ENTX) - 2024 Q1 - Quarterly Report

Financial Performance - Total assets decreased to $10,239,000 as of March 31, 2024, down from $11,765,000 as of December 31, 2023, representing a decline of approximately 13.0%[24] - Net loss for the three months ended March 31, 2024, was $2,017,000, compared to a net loss of $2,190,000 for the same period in 2023, indicating a reduction of about 7.9%[27] - Operating expenses totaled $2,062,000 for Q1 2024, down from $2,212,000 in Q1 2023, reflecting a decrease of approximately 6.8%[27] - The accumulated deficit increased to $106,403,000 as of March 31, 2024, from $104,386,000 as of December 31, 2023, representing an increase of approximately 1.9%[24] - For the three months ended March 31, 2024, the company reported operating losses of $2.1 million, a decrease of 6.8% compared to $2.2 million in the same period of 2023[94] - General and administrative expenses for the three months ended March 31, 2024, were $1.3 million, showing a slight increase of 2.6% compared to the same period in 2023[94] - The company has an accumulated deficit of $106.4 million as of March 31, 2024, and expects to continue incurring significant expenses and losses in the foreseeable future[78] Cash Flow and Liquidity - Cash and cash equivalents at the end of Q1 2024 were $9,189,000, a decrease from $11,019,000 at the end of Q4 2023, marking a decline of about 16.6%[24] - The company incurred a net cash used in operating activities of $1,862,000 for Q1 2024, compared to $1,609,000 for Q1 2023, indicating an increase of approximately 15.7%[34] - Cash and cash equivalents as of March 31, 2024, were $9.2 million, which is expected to meet projected operating requirements into the third quarter of 2025[80] - The company reported a net decrease in cash and cash equivalents of $1.8 million for Q1 2024, compared to a decrease of $1.6 million in Q1 2023[110] - The company anticipates needing to raise additional capital to fund operations, which may not be available on favorable terms[81] - Management expresses substantial doubt about the company's ability to continue as a going concern due to recurring losses and negative cash flows[109] - The company has no committed external sources of funds other than the Leerink ATM Program, which may lead to shareholder dilution if additional capital is raised[108] Research and Development - The company plans to initiate a Phase 3 registrational study for its product candidate EB613, targeting post-menopausal women with low bone mineral density and high-risk osteoporosis[38] - The EB613 program, an oral PTH (1-34) tablet, met primary and secondary endpoints in a Phase 2 study with 161 participants, and a Phase 3 study is planned to support a new drug application[60] - Entera's proprietary PTH tablets have been safely administered to 102 healthy subjects in Phase 1 studies and 153 patients in Phase 2 studies, targeting osteoporosis and hypoparathyroidism[63] - The company is collaborating with OPKO Biologics to develop oral tablet formulations of GLP-2 and Oxyntomodulin, with positive in vivo pharmacokinetic results announced in March 2024[66] - The company is exploring the use of PTH(1-34) tablets for treating stress fractures in athletes, with a Phase 2 study expected to begin in the second half of 2024[64] - Research and development expenses for the three months ended March 31, 2024 were $0.7 million, down 21% from $0.9 million in the same period of 2023[95] - 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 from products developed using these grants[70] - As of March 31, 2024, the total royalty amount payable to the IIA is approximately $460 thousand, with $96,000 already paid related to collaboration agreements[71] Shareholder Information - The company reported a weighted average number of shares outstanding of 36,735,429 for Q1 2024, an increase from 28,809,922 in Q1 2023[27] - Diluted loss per share for the periods ended March 31, 2024, and 2023 excluded options, warrants, and RSUs exercisable into 16,484,665 shares and 7,116,583 shares, respectively, due to antidilutive effects[45] - In March 2024, the company granted 758,331 options to purchase ordinary shares at an exercise price of $0.60 per share, with a fair value of $295 at the date of grant[49] - The company issued 214,088 ordinary shares in April 2024 under the Leerink ATM Program for net proceeds of $545 at a weighted average price of $2.60 per share[53] - The company raised $30 thousand from financing activities in Q1 2024 through the issuance of ordinary shares[115] Strategic Initiatives - The company intends to license its N-Tab™ technology to biopharmaceutical companies for use with their proprietary compounds, indicating a strategy for market expansion[39] - The company is continuously evaluating financing alternatives to support future R&D and operational expenses[107] - The ongoing geopolitical situation in the Middle East has not materially impacted the company's business or operations to date[128] - There have been no material changes in contractual obligations and commitments since the 2023 Annual Report[116] - The company expects existing capital resources to fund operations into Q3 2025, including R&D and completion of Phase 1 PK study[104]