Benitec Biopharma Inc.
BNTC evidence brief
What we can confirm
- BioSniper Score:
- 6.4 / 10
- Market Cap:
- $419.8M
- Lead Asset:
- bb-301 (Phase 1/Phase 2)
What it means
What to watch
Prepared research question
What matters most for BNTC—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · BNTC
Benitec Biopharma Inc. is a clinical-stage biotechnology company developing a silence-and-replace AAV-based gene therapy (BB-301) for Oculopharyngeal Muscular Dystrophy (OPMD), with headquarters in Hayward, California [sec · filed 2026-09-14].
Key risk: No approved products
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Market Cap
$419.8M
Cash Runway
—
Lead Asset
bb-301 (Phase 1/Phase 2)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 1 clinical trial for Benitec Biopharma Inc..
Benitec Biopharma Inc. is a clinical-stage biotechnology company developing a silence-and-replace AAV-based gene therapy (BB-301) for Oculopharyngeal Muscular Dystrophy (OPMD), with headquarters in Hayward, California [sec · filed 2026-09-14].
- Benitec is a clinical-stage biotechnology company focused on novel genetic medicines, with headquarters in Hayward, California [sec · filed 2026-09-14].
- Its lead product candidate, BB-301, is an AAV-based gene therapy designed to silence and replace the mutant PABPN1 gene for the treatment of OPMD [sec · filed 2026-09-14].
- BB-301 has received Orphan Drug Designation in the European Union and Orphan Drug Designation and Fast Track Designation in the United States [sec_mda · as of 2026-09-14].
- The Phase 1b/2a clinical trial (NCT06185673) for BB-301 is ongoing; all Cohort 1 patients have completed the 12-month follow-up, and Cohort 2 is fully enrolled [news · published 2026-09-14].
- As of 2026-06-30, the company reported cash and equivalents of $180.0M and shareholders' equity of $177.0M [latest reported financials].
What works
- BB-301 has received Orphan Drug Designation in both the EU and US, as well as Fast Track Designation in the US, which may provide development and commercialization advantages [sec_mda · as of 2026-09-14].
- The company has a strong cash position of $180.0M as of 2026-06-30, providing a runway to advance its clinical programs [latest reported financials].
- The silence-and-replace platform is designed to provide a permanent, single-administration therapy, potentially reducing patient non-compliance [sec_mda · as of 2026-09-14].
- Geographical clustering of OPMD patients may simplify clinical development and global commercialization efforts [sec_mda · as of 2026-05-14].
What to weigh
- Benitec does not expect to generate significant revenue from product sales unless and until regulatory approval is obtained, and anticipates continued losses as development progresses [sec_mda · as of 2026-09-14].
- The company is subject to risks inherent in gene therapy development, including the timing and sufficiency of patient enrollment and clinical trial outcomes [sec · filed 2026-09-14].
- The company has no approved products and its sole clinical-stage candidate, BB-301, is still in Phase 1b/2a, with no guarantee of eventual regulatory approval [sec_mda · as of 2026-05-14].
From the filings
Quoted directly from source documents.
Benitec is a clinical-stage biotechnology company focused on genetic medicines for OPMD.
“Benitec Biopharma Inc. ("Benitec" or the "Company" or in the first person, "we" or "our") is a clinical-stage biotechnology company focused on the advancement of novel genetic medicines with headquarters in Hayward, California.”
SEC filings · September 14, 2026
BB-301 is an AAV-based gene therapy using a silence-and-replace mechanism.
“BB-301 is an adeno associated viral (AAV)-based gene therapy designed to perman”
SEC filings · September 14, 2026
BB-301 has received Orphan Drug and Fast Track designations.
“BB-301 has been granted Orphan Drug Designation in the European Union and Orphan Drug Designation and Fast Track Designation in the United States.”
SEC MD&A · September 14, 2026
All Cohort 1 patients completed 12-month follow-up; Cohort 2 fully enrolled.
“All six Cohort 1 (low dose BB-301) patients have completed the full 12-month post-treatment follow-up period, and Cohort 2 (high dose BB-301) is fully enrolled with all three patients having been safely treated”
News · September 14, 2026
Catalyst timeline
- 2023-11-28 · Phase 1b/2a clinical trial start for BB-301 — The Phase 1b/2a open-label, dose-escalation study evaluating BB-301 in OPMD subjects with dysphagia began on this date.
Risks & what to watch (3)›
Key risks
- No approved products — Benitec has no approved products and relies solely on BB-301, which is still in Phase 1b/2a [sec_mda · as of 2026-05-14].
- Revenue uncertainty — The company does not expect significant revenue until regulatory approval, and losses are expected to increase [sec_mda · as of 2026-09-14].
- Clinical trial risks — Risks include patient enrollment, dosing, and trial outcomes, which could delay or derail development [sec · filed 2026-09-14].
What to watch
- Anticipated FDA Type C meeting minutes in October 2026 regarding BB-301 pivotal study design [news · published 2026-09-14].
- Additional interim clinical results from the BB-301 Phase 1b/2a trial accepted for late-breaking presentation [news · published 2026-09-14].
- Progress of Cohort 2 patients through the 12-month follow-up period [news · published 2026-09-14].
Sources: Catalysts · News · SEC filings · SEC MD&A · Generated October 8, 2026 · How we verify sources →
Run Benitec Biopharma Inc. through your own thesis
Use the pipeline, catalyst, financial, FDA, and market facts on this page as inputs to a protocol you control.
Your protocol can:
- Turn available Benitec Biopharma Inc. facts into screen rules or deeper checks
- Show cited findings, blockers, and unresolved evidence together
- Save the logic and rerun it as the company evidence changes
Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.03
Lead: Phase 1/Phase 2
1 candidate
No upcoming catalysts tracked
No insider transactions in the last 180 days
Pipeline
Regulatory
Financials
Short Interest
as of May 20, 2026- % of float
- 11.9%
- Days to cover
- 21.4
- Shares short
- 2,318,612
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
BNTC short interestGovernance
Frequently asked questions
What is the AI investment thesis for Benitec Biopharma Inc.?
Benitec Biopharma Inc. is a clinical-stage biotechnology company developing a silence-and-replace AAV-based gene therapy (BB-301) for Oculopharyngeal Muscular Dystrophy (OPMD), with headquarters in Hayward, California [sec · filed 2026-09-14].
What is Benitec Biopharma Inc.'s lead drug candidate?
Benitec Biopharma Inc.'s most advanced tracked candidate is bb-301 (Phase 1/Phase 2) for Oculopharyngeal Muscular Dystrophy (OPMD).
Who is the CEO of Benitec Biopharma Inc.?
Dr. Jerel A. Banks M.D., Ph.D. is the chief executive officer of Benitec Biopharma Inc. (BNTC).
Where is Benitec Biopharma Inc. headquartered?
Benitec Biopharma Inc. (BNTC) is headquartered in Hayward, CA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.