ENTX (Entera Bio) FY2025 Earnings & Business Update

Price: ~$4.50 Market Cap: ~$55M Stage: Clinical (Phase 3 ready) Focus: Oral peptide platform. Lead asset EB613, first oral bone-building tablet for osteoporosis

The Numbers

• Revenue: Zero. Pre-revenue clinical stage

• R&D FY2025: $6.0M (up from $4.5M, Phase 3 prep and collaboration costs)

• G&A FY2025: $5.5M (up from $5.1M)

• Net Loss FY2025: $11.4M (up from $9.5M)

• Cash: $14.9M including $7.8M restricted for the OPKO collaboration

• Unrestricted cash: ~$7.1M. Runway through mid-Q3 2026

That cash number is the elephant in the room. $7.1M unrestricted with a 750-patient multinational Phase 3 to fund. They need to raise before the trial starts in late 2026. At a $55M market cap that raise matters a lot.

Pipeline

• EB613 (oral PTH for osteoporosis): Phase 3 protocol submitted to FDA March 2026, feedback expected late April. FDA already aligned on BMD as primary endpoint (Type A meeting July 2025). 750-patient multinational trial in postmenopausal women. Single-tablet formulation bridged successfully from multi-tablet. Phase 3 initiation late 2026, topline results H2 2028. Phase 2 data showed bone strengthening comparable to injectable teriparatide and abaloparatide at just 6 months

• EB612 (oral long-acting PTH for hypoparathyroidism): OPKO partnership, 50/50 cost share. Single oral tablet achieved sustained calcium elevation for 3+ days in preclinical. IND filing late 2026. Funded through Phase 1 with existing cash

• EB618 (oral GLP-1/Glucagon for obesity): OPKO partnership. Preclinical plasma levels matched the highest approved dose of Wegovy. Phase 1 injectable data from OPKO expected year-end 2026, then oral tablet enters Phase 1

• GLP-2 (oral, for short bowel syndrome): 18x half-life improvement over Gattex (the only approved GLP-2). Daily tablet vs daily injection. Rare disease, clear unmet need

The Thesis

The N-Tab oral peptide platform is the value here. Every major peptide therapy today is an injection. Forteo, Wegovy, Gattex, all needles. Entera is trying to turn each of those into a daily tablet. If the platform works across multiple peptides, the value isn't in any single drug, it's in the platform.

EB613 is the proof of concept. The osteoporosis market is massive. Injectable anabolics (teriparatide, abaloparatide) are underutilized because patients don't want daily injections. An oral tablet with comparable bone-building data changes the treatment paradigm. FDA alignment on BMD as a surrogate endpoint with a 12-month primary readout (instead of 24) cuts the Phase 3 timeline significantly.

The GLP-1/Glucagon oral tablet is the sleeper. If OPKO's injectable Phase 1 data looks good and Entera can replicate Wegovy-level plasma exposure in an oral tablet, the obesity angle alone could be worth multiples of the current market cap.

Catalysts

• FDA feedback on Phase 3 protocol (late April 2026)

• EB612 IND filing (late 2026)

• Phase 3 initiation for EB613 (late 2026)

• OPKO Phase 1 injectable data for OXM (year-end 2026)

• EB613 Phase 3 topline results (H2 2028)

The Risk

Cash. $7.1M unrestricted doesn't fund a 750-patient Phase 3. They're going to need a significant raise or a partnership deal before late 2026. The OPKO collaboration covers EB612 and EB618 but not EB613. At $55M cap the dilution risk is real.

The capital efficiency has been impressive though. $11.5M total opex for a company running four programs with FDA alignment on a Phase 3. They're lean. The question is whether the raise happens at a premium after the FDA protocol feedback, or at a discount if they wait too long.

Bottom Line

Platform story with multiple shots on goal. The oral peptide tech is the prize. EB613 osteoporosis data is strong, FDA pathway is aligned, and the Phase 3 design is streamlined. The GLP-1 oral tablet angle adds significant optionality. Cash is the near-term risk. Watch for the raise and the April FDA feedback.

When does Entera need to raise capital before Phase 3 starts?Could OPKO partnership fund EB613 Phase 3 trial costs?How much dilution might a capital raise cause at current valuation?What happens to stock if FDA feedback in April is negative?