Entera Bio (ENTX) investor relations material

Technology platform and pipeline

• N-Tab technology enables oral delivery of large, linear hydrophilic peptides by inhibiting enzymatic degradation and enhancing epithelial permeability.

• Lead asset EB613 is the only oral peptide in development for osteoporosis, with additional pipeline assets in hypoparathyroidism, metabolic/obesity, and GI inflammation.

• Partnership with OPKO focuses on developing a dual GLP-1/glucagon agonist tablet, with IND filing expected in early 2026.

• Oral GLP-2 tablet for short bowel syndrome shows prolonged systemic exposure and is under strategic review.

• Cash runway extends into Q3 2026.

Clinical development and data

• EB613 demonstrated a dual mechanism: stimulating bone formation and suppressing bone resorption, with favorable bone modeling profile in phase 2.

• Phase 2 results showed rapid onset and greater increases in hip bone mineral density compared to Forteo, with early effects on both trabecular and cortical bone.

• Safety profile of EB613 is similar to Forteo, with no serious adverse events in phase 2.

• FDA agreement allows a single phase III registrational study using total hip BMD as the primary endpoint, with secondary endpoints including fracture risk reduction.

• Phase III study planning is underway, with supplemental data to be presented at the American Society for Bone Mineral Research in September.

Market need and access

• Osteoporosis affects 200 million women globally, with high fracture risk and low treatment rates; less than 25% receive adequate medication post-fracture.

• Injectable anabolic drugs treat less than 15% of patients due to access and administration barriers.

• EB613 aims to expand access by providing a daily oral alternative, addressing compliance and access issues, especially in community and gynecology settings.

• Surveys show strong clinician and patient interest in oral bone-building treatments, with 55% of patients interested and 37% discontinuing injectables due to side effects.

• EB613 may offer significant price advantages over injectable anabolic drugs.