Entera Bio (ENTX) investor relations material

Technology and pipeline overview

• N-Tab platform enables oral delivery of native peptides by stabilizing them and enhancing GI absorption using excipients and SNAC.

• Pipeline includes both unmodified and acylated peptides, targeting osteoporosis, hypoparathyroidism, and metabolic syndrome.

• EB613, based on teriparatide, is the lead candidate for osteoporosis, aiming to induce bone formation via a short, pulsatile PK profile.

Clinical development and regulatory alignment

• Phase III for EB613 will enroll about 750 post-menopausal women, using a 12-month placebo-controlled design with total hip BMD as the primary endpoint.

• FDA alignment allows for a streamlined 12-month study, with an open-label extension to 24 months for safety and durability data.

• Phase II data showed EB613 achieved 1.34–1.57% increase in total hip BMD at six months, supporting the goal of 1.7–2% at 12 months.

• Additional studies include PK comparability with FORTEO and bone turnover marker analysis.

Osteoporosis market landscape and unmet need

• Osteoporosis affects about 200 million globally, with 10–12 million diagnosed in the US; 80% are women.

• Less than 40% of diagnosed US patients receive treatment, mainly due to tolerability and administration issues.

• Oral bisphosphonates dominate first-line therapy but have high discontinuation rates due to side effects.

• Injectable anabolics treat less than 15% of patients, leaving a large gap for oral anabolic options.