ENTX
Entera Bio Ltd.2.0900
+0.0100+0.48%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
95.84MP/E (TTM)
-Basic EPS (TTM)
-0.24Dividend Yield
0%Recent Filings
10-Q
8-K
10-Q
Q2 FY2025 results
Entera Bio posted a Q2 operating loss of $2.7M, up 23% y/y from $2.2M, driven by higher R&D spending on EB613 phase 3 preparations and the OPKO collaboration, while revenues dropped to zero after completing a research services deal. For the half-year, the net loss widened 25% y/y to $5.2M on $42K in revenues, with gross profit flat at zero; diluted EPS of $0.12 aligns with 45.1M weighted shares, though anti-dilution from 16.6M options persisted. Cash climbed to $18.9M (including $8.0M restricted for OPKO), bolstered by $13.3M in financing like the March 2025 OPKO deal for 3.7M shares at $2.17 each and $6.0M from ATM sales, funding ops through mid-2026 but not EB613's phase 3 start. The OPKO pact splits costs 40/60 and proceeds 40/60 for oral OXM in obesity, with an opt-out post-phase 1. Free cash flow not disclosed in the 10-Q. Geopolitical tensions in Israel pose operational risks.
8-K
Entera Bio Q2 results and FDA milestone
Entera Bio reported Q2 2025 net loss of $2.7 million, up from $2.1 million last year, driven by $1.5 million in R&D expenses for EB613 Phase 3 planning. FDA's pivotal agreement on BMD as primary endpoint clears a streamlined path for the first oral anabolic osteoporosis treatment, while OPKO collaboration shows promising obesity program data. Cash stands at $18.9 million, funding operations through mid-2026. Regulatory risks could delay timelines.
8-K
FDA greenlights BMD endpoint for EB613
Entera Bio secured FDA agreement on July 28, 2025, for its EB613 Phase 3 study in postmenopausal osteoporosis women, designating total hip BMD change as the primary endpoint over traditional fracture incidence. This single 24-month, randomized, placebo-controlled trial supports the NDA filing, bypassing delays from the pending SABRE qualification. EB613 advances as the first oral anabolic tablet. Prior FDA waivers on nonclinical studies streamline development.
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