New Risk • May 11
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 19% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (34% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$65m net loss in 2 years). New Risk • May 05
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$44m Forecast net loss in 3 years: US$10m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (34% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$10m net loss in 3 years). Announcement • Mar 10
Benitec Biopharma Inc. Announces Positive Interim Phase 1b/2a Results For High Dose BB-301 And Continued Durable Improvements For Low Dose BB-301 Treatment Benitec Biopharma Inc. announced promising interim clinical results from the BB-301 Phase 1b/2a first-in-human study (NCT06185673) evaluating low dose and high dose BB-301 treatment for Oculopharyngeal Muscular Dystrophy (OPMD) with moderate dysphagia. Interim and long-term clinical results for patients enrolled into Cohort 1 (low dose BB-301), and interim clinical results for the first patient enrolled into Cohort 2 (high dose BB-301) in the ongoing clinical trial will be presented as a late-breaking poster presentation at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference in Orlando, Florida on March 9, 2026. BB-301 Phase 1b/2a Clinical Treatment Study Background: The BB-301 Phase 1b/2a clinical study (NCT06185673) is an open-label, dose escalation study evaluating the safety and clinical activity of intramuscular doses of BB-301 to treat moderate dysphagia in patients with OPMD. The following parameters represent the core assessments of BB-301 efficacy for each study participant: Sydney Swallow Questionnaire (SSQ), pharyngeal area at maximum constriction (PhAMPC), total pharyngeal residue (TPR) and normalized residue ratio scale-valleculae (NRRSv). The SSQ is a validated 17-item patient-reported outcome instrument that assesses the total dysphagic symptom burden experienced by a patient. The PhAMPC is assessed by videofluoroscopic swallowing studies (VFSS) and serves as a surrogate for the functional capacity of the pharyngeal constrictor muscles during the swallowing cycle. The TPR is assessed by VFSS and represents the quantity of food and liquid material (residue) remaining in the throat upon completion of a swallow (post-swallow residue). The NRRSv is assessed by VFSS and represents the quantity of food and liquid material (residue) remaining in the vallecular region of the throat upon completion of a swallow (post-swallow residue). Key interim clinical study results to be presented at the 2026 MDA Clinical & Scientific Conference include: Interim Clinical Results for High Dose BB-301 (Cohort 2): High dose BB-301 is being evaluated for the potential to facilitate more rapid clinical improvements and/or greater magnitudes of clinical improvements across the core functional, anatomical, and symptom-focused elements of the dysphagic symptom burden experienced by OPMD patients. Patient B (Cohort 2, high dose BB-301) safely received the high dose of BB-301 with no treatment-related SAEs. Patient B (Cohort 2, high dose BB-301) and Patient A (Cohort 1, low dose BB-301) had comparable baseline functional, anatomical, and symptom-focused deficits prior to the administration of BB-301. When comparing 3-month post-BB-301-treatment clinical results for Patient A and Patient B, Patient B experienced a significant improvement in depth of response to high dose BB-301. Patient B, the first OPMD Patient treated with high dose BB-301, experienced an extraordinarily robust dose-response at an early interim follow-up time-point, indicating the continued potential for BB-301 to achieve disease-modifying outcomes for OPMD patients with dysphagia. When comparing the interim clinical results for the low dose BB-301 treatment and the high dose BB-301 treatment at the 3-month post-treatment time-point in Patients with comparable pre-treatment baseline deficits, the high dose BB-301 treatment demonstrated significantly improved results across all radiographic and patient-reported assessments employed in the BB-301 Phase 1b/2a Clinical Treatment Study: Significantly differentiated levels of dysphagic symptom burden reduction were observed, with a ~7% reduction in total dysphagic symptom burden (SSQ) achieved with low dose BB-301 as compared to a ~68% reduction in SSQ achieved with high dose BB-301. Significantly differentiated levels of throat closure were observed, with an ~8% improvement in throat closure (PhAMPC) achieved with low dose BB-301 as compared to a ~19% improvement in PhAMPC achieved with high dose BB-301. Significantly differentiated levels of overall throat emptying were observed, with a ~6% worsening in overall throat emptying (TPR) observed with low dose BB-301 as compared to a ~44% improvement in TPR achieved with high dose BB-301. Significantly differentiated levels of throat emptying from the vallecular region were observed, with a ~3% improvement in throat emptying from the vallecular region (NRRSv) achieved with low dose BB-301 as compared to a ~57% improvement in NRRSv with high dose BB-301. Interim Clinical Results for Low Dose BB-301 (Cohort 1): All Study Completers in Cohort 1 (low dose BB-301) are formal Responders to BB-301. Completers are Patients that have reached the 12-month post-BB-301-treatment assessment time-point in the BB-301 Phase 1b/2a Clinical Treatment Study. Long-term efficacy trends for low dose BB-301 at 24-months post BB-301 treatment continue to demonstrate robust disease-modifying outcomes for throat closure, throat emptying, and total dysphagic symptom burden. 
