Entera Bio Ltd. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $15.6 million ($0.11 per share) for the three months ended September 30, 2026, compared to a net loss of $3.2 million ($0.07 per share) for the same period in 2025.
• Research and development expenses increased to $4.9 million for the quarter ended September 30, 2026, from $1.6 million in the prior year period, driven by Phase 3 program startup activities and the OPKO collaboration.
• General and administrative expenses rose to $2.3 million for the quarter ended September 30, 2026, compared to $1.6 million in the prior year period.
• Cash and cash equivalents totaled $265.9 million as of September 30, 2026, with restricted cash of $6.5 million designated for the OPKO collaboration.
• Total assets increased to $277.0 million as of September 30, 2026, from $16.0 million as of December 31, 2025.
• Total shareholders' equity reached $274.3 million as of September 30, 2026, compared to $13.1 million as of December 31, 2025.
• The increase in net loss was primarily attributed to a $7.5 million non-cash fair value remeasurement of pre-funded warrants issued in April and July 2026, which were reclassified to equity in August 2026.
• No revenue was generated during the three months ended September 30, 2026, or September 30, 2025.

Guidance and Future Outlook:

• Cash resources are expected to be sufficient to fully fund the planned Phase 3 registrational program for EB613 through topline results and the anticipated NDA submission, as well as to support operations into 2030.
• First site activation for the EB613 Phase 3 study is expected in late 2026, with topline results anticipated in the second half of 2028.
• IND-enabling activities for EB612 are ongoing, with a Phase 1 single ascending dose study planned to initiate in 2027.

Business Segments and Product Lines:

• EB613 (Osteoporosis): A new post-hoc analysis of Phase 2 data presented at ASBMR 2026 showed enhanced bone formation and suppression of bone resorption in women with T-scores of -2.5 or lower. The planned Phase 3 study will enroll approximately 900 postmenopausal women (randomized 2:1 to EB613 or placebo) with a primary endpoint of percent change in total hip BMD at Month 12. The study design includes a potential extension through Month 24 and utilizes the 505(b)(2) regulatory pathway, incorporating a scientific bridging analysis with Forteo®.
• EB612 (Hypoparathyroidism): Developed in collaboration with OPKO Health, this first-in-class oral acylated PTH(1-34) replacement tablet is currently in IND-enabling stages.
• Pipeline Expansion: The company is also developing an oral oxyntomodulin tablet for obesity/metabolic syndromes and an oral GLP-2 tablet for short bowel syndrome in collaboration with OPKO Health.
• Leadership Appointments: The company expanded its clinical and early development teams with the appointment of Riccardo Paolo Camisasca (CMO), Michele McDermott (SVP Medical Affairs), Ofer Spiegelstein (VP Head of Early Clinical Development), and Graziella Soulban (VP Clinical Development).
• Board Appointments: Laura Hamill and Juan Camilo Arjona Ferreira, M.D., were appointed to the Board of Directors effective December 1, 2026.

Market and Competitive Landscape:

• EB613 is positioned as the first oral anabolic treatment for osteoporosis, aiming to transform the standard of care compared to existing injectable therapies like Forteo®.
• The Phase 3 study targets patients with the largest need for bone density gains, specifically postmenopausal women with T-scores ≤ -2.5.

Risks and Challenges:

• Forward-looking statements highlight risks including the timing, design, and results of the EB613 Phase 3 study, FDA review interpretations, and the ability to obtain regulatory approvals.
• Risks include reliance on third parties for clinical trials, potential changes in market size, intellectual property protection, and the company's ability to continue as a going concern without access to liquidity.
• The company faces risks related to compliance with Nasdaq listing standards and the interpretation of clinical data.

Management Commentary and Tone:

• CEO Miranda Toledano stated that the third quarter transitioned the company into "late-stage clinical execution mode," expressing excitement regarding the opportunity to evaluate EB613 as the first oral anabolic treatment for osteoporosis.
• Management emphasized a focus on ensuring a seamless trial launch and highlighted the expansion of human capital with senior clinical and board appointments.

Other Key Points:

• In July 2026, the company completed an oversubscribed private placement raising approximately $275.0 million in gross proceeds, led by BVF Partners L.P. with participation from new investors including Longitude Capital, Vivo Capital, TCGX, Spruce Street Capital, Venrock, RA Capital Management, Perceptive Advisors, Driehaus Capital Management, Logos Capital, and Catalio Capital Management.
• The FDA accepted the proposed registrational development plan for EB613 in June 2026.
• The company leverages its proprietary N-Tab® technology platform for developing oral peptide and protein replacement therapies.