Benitec Biopharma — First Quarter 2027 Fiscal-Year Earnings Summary

Financial Performance:

• Total expenses for the quarter ended September 30, 2026, were $14.5 million, an increase from $9.8 million in the same quarter of the prior year.
• Research and development expenses totaled $8.6 million for the quarter, compared to $3.4 million in the prior year quarter.
• General and administrative expenses were $5.9 million for the quarter, down from $6.4 million in the prior year quarter.
• Net loss for the quarter ended September 30, 2026, was $12.9 million, compared to a net loss of $9.0 million in the prior year quarter.
• Net loss per basic and diluted share was $(0.26) for the quarter ended September 30, 2026, compared to $(0.22) in the prior year quarter.
• Cash and cash equivalents stood at $176.5 million as of September 30, 2026, down from $179.972 million as of June 30, 2026.
• Total assets were $179.1 million as of September 30, 2026, compared to $182.6 million as of June 30, 2026.
• Total liabilities were $9.5 million as of September 30, 2026, compared to $5.6 million as of June 30, 2026.
• Stockholders' equity was $169.6 million as of September 30, 2026, compared to $177.0 million as of June 30, 2026.
• Interest income, net, was $1.6 million for the quarter, up from $1.0 million in the prior year quarter.

Guidance and Future Outlook:

• The pivotal study design for BB-301 is expected to be finalized in the first calendar quarter of 2027.
• The company remains on track to begin the BB-301 pivotal trial in mid-2027.
• Operational and program guidance is presented on a calendar-year (CY) basis, while historical financial guidance is presented on a June 30 fiscal-year (FY) basis.

Business Segments and Product Lines:

• BB-301, a disease-modifying genetic medicine for Oculopharyngeal Muscular Dystrophy (OPMD)-related dysphagia, is the company's lead candidate.
• Interim clinical results from the Phase 1b/2a study presented at the ESGCT Annual Congress showed a 100% responder rate across all patients in Cohort 1 (low dose) and Cohort 2 (high dose).
• There have been no Serious Adverse Events reported in any patient treated with BB-301 to date.
• BB-301 received Orphan Drug Designation from the EMA and Orphan Drug and Fast Track Designations from the FDA.
• BB-301 is a modified AAV9 capsid utilizing a "Silence and Replace" mechanism to silence mutant PABPN1 and replace it with a functional protein.

Market and Competitive Landscape:

• BB-301 is described as the first and only disease-modifying genetic medicine in clinical development for the treatment of OPMD-related dysphagia.
• The company operates in the clinical-stage biotechnology sector focusing on genetically defined diseases.

Risks and Challenges:

• Forward-looking statements are subject to risks including the success of product development, timing of clinical trials, patient enrollment, regulatory approvals, and potential for unsuccessful clinical results.
• Risks include the potential for significant losses, uncertainty in achieving profitability, and dependence on third-party manufacturers and suppliers.
• Potential risks involve intellectual property protection, market acceptance, and changes in regulatory frameworks or government operations.

Management Commentary and Tone:

• Executive Chairman and CEO Jerel A. Banks, M.D., Ph.D., described the period as productive with continued clinical progress for BB-301.
• Management expressed strengthened conviction in the potential of BB-301 to alter the course of OPMD-related dysphagia based on the consistency and durability of observed clinical benefits.
• The company thanked patients, families, and investigators for enabling progress.

Other Key Points:

• The company announced a plan to transition its fiscal year-end from June 30 to December 31, commencing with its first periodic report following the Form 10-Q for the quarter ended September 30, 2026.
• The company is well-capitalized with approximately $176 million in cash as of September 30, 2026.
• The BB-301 study is a first-in-human, open-label dose escalation study (NCT06185673) evaluating intramuscular doses for OPMD subjects.