Entera Bio (ENTX) investor relations material

Pipeline and clinical evidence

• EB613 is an oral teriparatide peptide with the same amino acid sequence as Forteo; development is pursuing a 505(b)(2) application. Three Phase I studies compared EB613 and Forteo in the same participants at separate visits.

• A placebo-controlled, dose-ranging Phase II study in postmenopausal women with low bone mass or osteoporosis tested 0.5–2.5 mg daily and met biomarker and BMD endpoints; 270 subjects have received EB613 to date.

• Phase II data showed 1.34%–1.56% total hip BMD gains at six months; the planned Phase III program will use a 12-month placebo-controlled study followed by a 12-month extension for safety and durability data.

• FDA alignment on the placebo-controlled total hip BMD endpoint followed discussions dating to 2022; the FDA agreed to the 12-month study and extension in June 2026. A Forteo scientific bridge analysis is based on PK exposure.

Osteoporosis market and positioning

• Management characterized osteoporosis as a widely diagnosed but undertreated condition affecting 200 million women globally; it cited no new drug approval in seven years and no Phase III trial for close to a decade.

• Antiresorptives account for an estimated 80% of prescriptions, while management said they do not rebuild bone; injectable anabolic options offer bone-building effects but reach a minority due to cost, administration and access barriers.

• The oral EB613 opportunity is to broaden access to anabolic treatment; management cited ~60% starting bisphosphonates, ~50% discontinuing within 12 months, and fewer than 15% receiving an anabolic.

• Management cited U.S. annual prices of $14,000–$16,000 for teriparatide injectables and ~$24,000 for romosozumab; it expects bisphosphonate step-through requirements and views Prolia as a separate treatment segment.

Broader pipeline and outlook

• EB612, an acylated oral PTH(1-34) peptide co-developed with OPKO for hypoparathyroidism, is planned to enter a Phase I single-ascending-dose PK study in 2027 after IND-enabling work.

• A $27.5 million PIPE announced July 27, 2026, was intended to fund EB613 through PDUFA; stated cash runway extends into 2030. Phase I SAD and MAD results for EB612 are also expected during that period.

• Management said the July financing and planned EB613 Phase III transition brought increased attention to platform discussions; its pipeline also includes GLP-1/glucagon and GLP-2 programs.