Entera Bio(US:ENTX)2026-03-27 20:20Financial Performance - Entera Bio Ltd. reported revenues of $42,000 for the year ended December 31, 2025, a decrease of 76.6% compared to $181,000 in 2024[514]. - The company incurred a net loss of $11,439,000 in 2025, compared to a net loss of $9,541,000 in 2024, reflecting an increase in losses of approximately 19.9%[514]. - The company reported a net loss of $11,439,000 for the year ended December 31, 2025, compared to a net loss of $9,541,000 for 2024, indicating an increase in losses of approximately 20%[522]. - The total revenues were $42,000, a decrease of 76.8% compared to $181,000 in 2024[609]. - The net loss for the year ended December 31, 2025, was $11,439,000, compared to a net loss of $9,541,000 in 2024, representing a 19.9% increase in losses[609]. Expenses and Liabilities - Research and development expenses rose to $6,004,000 in 2025, up 33.4% from $4,499,000 in 2024[514]. - Total liabilities increased to $2,892,000 in 2025 from $1,310,000 in 2024, representing a significant increase of 120.5%[513]. - The company incurred share-based compensation expenses of $2,750,000 in 2025, up from $2,556,000 in 2024, reflecting an increase of approximately 8%[522]. - The severance payment expenses were $181,000 and $144,000 for the years ended December 31, 2025 and 2024, respectively[548]. - The operating lease cost for the year ended December 31, 2025, was $240,000, compared to $198,000 for the year ended December 31, 2024[573]. Assets and Cash Flow - Total current assets increased to $15,298,000 as of December 31, 2025, compared to $8,972,000 in 2024, marking a growth of 70.5%[513]. - Total cash and cash equivalents, including restricted cash and deposits, increased to $14,973,000 at the end of 2025 from $8,740,000 at the end of 2024, representing a growth of approximately 71%[522]. - The company reported a net cash used in operating activities of $7,370,000 for 2025, compared to $6,818,000 for 2024, indicating an increase of approximately 8% in cash outflows[522]. - The balance of carryforward losses for Entera Bio Ltd. as of December 31, 2025, was approximately $91.8 million, an increase from $83.5 million in 2024[612]. Capital and Funding - The company is highly dependent on raising additional capital or entering into agreements with collaborators to support its product development and commercialization efforts[27]. - The company issued 2,731,574 ordinary shares under the ATM program in 2025, raising $6,067,000, compared to $3,960,000 raised from 2,236,126 shares in 2024, reflecting a 53% increase in funds raised[522]. - The Company issued 3,685,226 ordinary shares to OPKO for a total purchase price of $8.0 million, at approximately $2.17 per share[581]. - As of December 31, 2025, approximately $29.95 million of ordinary shares remained available for sale under the Leerink ATM Program[592]. Regulatory and Development Activities - The company plans to submit a final protocol to the FDA and initiate a Phase 3 registrational study for its product candidate EB613, which is aimed at treating post-menopausal women with low bone mineral density[525]. - The company is developing EB612 as the first oral PTH(1-34) tablet for hypoparathyroidism, with a collaboration agreement with OPKO Biologics, Inc. to advance this product[526]. - The company is also developing EB618, a proprietary dual agonist GLP-1/glucagon peptide for obesity and metabolic disorders, in collaboration with OPKO[527]. - Under the 2025 Collaboration Agreement with OPKO, the Company will retain 40% of all proceeds and be responsible for 40% of the Program's development costs[580]. Concerns and Uncertainties - The company has substantial doubt about its ability to continue as a going concern due to recurring losses and cash outflows from operating activities[503]. - The ongoing Israel-Hamas conflict and its implications for operations and workforce remain uncertain and could impact the company's business[27]. Royalties and Obligations - The Company is committed to pay royalties to the Israel Innovation Authority on proceeds from sales of products developed with government grants, contingent on successful project development[574]. - As of December 31, 2025, the total royalty amount payable by the Company to the IIA was approximately $460,000[576]. - The Company is obligated to pay Oramed royalties equal to 3% of its net revenues as per the patent transfer agreement[577]. Stock Options and Compensation - The total fair value of options granted during the year ended December 31, 2025 was $2,943,000[602]. - As of December 31, 2025, the Company had 2,989,046 unvested options outstanding with a total unrecognized compensation cost of $1,735,000[601]. - The total unrecognized compensation cost of employee RSUs as of December 31, 2025, was $57,000, expected to be recognized over a weighted average period of 0.33 years[605]. - The total vesting-date value of equity classified RSUs that vested during 2025 was $676,000[606]. - The aggregate intrinsic value of the outstanding options as of December 31, 2025, was $3,121,000[603].