Entera Bio reported its third‑quarter 2025 financial results, posting a net loss of $3.2 million and an earnings‑per‑share figure of $‑0.07. The loss beat analysts’ consensus estimate of $‑0.09, giving the company a modest EPS beat of $0.02 per share.
Operating expenses for the quarter rose to $3.3 million, driven by research and development costs of $1.6 million and general and administrative expenses of $1.6 million. The company’s cash and cash equivalents stood at $16.6 million as of September 30, 2025, of which $8.0 million is restricted for its collaboration with OPKO Health.
Management cautioned that the current cash position will support operations only through the middle of the third quarter of 2026. The company will need additional financing to launch the pivotal Phase 3 trial for its lead candidate, EB613, a first‑in‑class oral peptide for osteoporosis.
A key milestone announced in the release was the U.S. Food and Drug Administration’s agreement to accept bone mineral density as the primary endpoint for EB613’s Phase 3 study. The agreement de‑risks the clinical development pathway and is expected to reduce both the timeline and cost of the trial.
CEO Miranda Toledano said, “Our achievements this quarter are testament to Entera’s leadership position in oral peptide innovation and our team’s unrelenting mission to deliver transformative treatments to patients, starting with post‑menopausal women with osteoporosis.” She added that the FDA agreement “underscores the strength of our data and the promise for EB613 to close the treatment chasm in osteoporosis.”
The market reacted positively to the earnings beat and the regulatory milestone. Investors highlighted the EPS beat and the FDA agreement as the primary drivers of the favorable response, reflecting confidence in the company’s clinical strategy and the potential upside of its N‑Tab™ platform.
The results underscore the company’s need for new capital to fund the upcoming Phase 3 trial, while also demonstrating progress in its pipeline and regulatory strategy. The cash runway constraint remains a near‑term challenge, but the FDA agreement and the company’s continued investment in its N‑Tab™ technology position Entera Bio for future growth if it can secure the necessary financing.
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