Entera Bio (ENTX) investor relations material

Business overview and pipeline updates

• Focus on developing first-in-class oral peptide tablets, with four main programs in the pipeline.

• Lead candidate EB613 targets osteoporosis in postmenopausal women, with a successful FDA Type A meeting enabling a de-risked path to phase three.

• Preclinical data for long-acting PTH variants expected by end of 2025; GLP-1/glucagon tablet IND filing planned for H1 2026.

• GLP-2 tablet program under evaluation for broader indications beyond short bowel syndrome.

Regulatory and clinical development

• EB613 benefits from FDA's acceptance of total hip bone mineral density as a surrogate endpoint, streamlining innovation in osteoporosis.

• Multiple productive FDA meetings since 2022 clarified requirements for NDA submission.

• Phase three trial for EB613 will use the same 2.5 mg dose as in phase two, with a titrated regimen.

• The 24-month phase three trial is mandated by FDA, with 20% U.S. patient representation and global enrollment.

• Study start targeted for the first half of 2026.

Clinical data and differentiation

• Phase two data showed significant gains in bone mineral density at spine, hip, and femoral neck.

• EB613 demonstrates a unique anabolic window with increased P1NP and suppressed CTX, indicating strong bone formation and minimal cortical porosity.

• Early onset of action at cortical sites and conservative effect size modeling for 24-month outcomes.

• Non-human primate studies support continuous bone mass increases.