BNTC
Benitec Biopharma Inc.12.41
+0.23+1.89%
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
420.23MP/E (TTM)
-Basic EPS (TTM)
-1.09Dividend Yield
0%Recent Filings
8-K
8-K
FDA Fast Track for BB-301
Benitec Biopharma appointed Dr. Sharon Mates, ex-CEO of Intra-Cellular Therapies, to its board effective November 3, 2025, granting her options worth $450,000 vesting by the 2026 annual meeting. Meanwhile, the FDA awarded Fast Track Designation to BB-301 for OPMD treatment after positive Phase 1b/2a interim data showing a 100% response rate in Cohort 1, with significant dysphagia improvements like a 328-point SSQ score drop. Cohort 2 dosing started in Q4 2025; FDA pivotal study talks loom in 2026. No severe adverse events reported.
8-K
Financial restatement announced
Benitec Biopharma disclosed on September 10, 2025, that it must restate its unaudited financial statements for the quarters ended December 31, 2024, and March 31, 2025, due to underrecorded non-cash share-based compensation from a faulty equity data system migration in November 2023. The errors materially understated net loss and accumulated deficit in those periods, though immaterial earlier. Restatements will appear in the timely filed 2025 Form 10-K. This fix exposes deeper accounting vulnerabilities.
8-K
BB-301 trial advances safely
Benitec Biopharma completed dosing the sixth and final subject in Cohort 1 of its Phase 1b/2a BB-301 study for OPMD in April 2025, with the treatment deemed safe via direct intramuscular delivery. The Data Safety Monitoring Board reviewed safety data for all six subjects and recommended proceeding, paving the way for Cohort 2 enrollment in Q4 2025. This advances BB-301's silence-and-replace mechanism. Yet risks like enrollment delays loom.
8-K
Q3 loss widens on R&D
Benitec Biopharma reported a $10.2 million operating loss for the fiscal quarter ended March 31, 2025, up from $4.1 million a year earlier, driven by $6.0 million in R&D costs for BB-301's OPMD clinical trial. Cash reserves swelled to $103.6 million, fueled by recent equity raises. The final Cohort 1 patient received low-dose BB-301 in April 2025. Higher-dose enrollment starts later this year, but trial delays loom as a key risk.
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