Annonce • Jun 01
Benitec Biopharma Inc. Announces Board Changes, Effective May 22, 2026 Benitec Biopharma Inc. announced that on May 22, 2026, the Board of Directors appointed David Friedman to serve as a director of the Board, effective as of such date. Mr. Friedman was appointed as a Class III member of the Board with a term lasting until the Company's 2028 annual meeting of stockholders Benitec Biopharma Inc. also announced that on May 22, 2026, Megan Boston, the Company's chief financial officer and secretary and a member of the Board since 2016, notified the Board of her decision to resign solely from the Board and rotated off the Board as part of the Company's ongoing Board composition and governance review. Ms. Boston will continue in her capacity as chief financial officer and secretary. The resignation from the Board was effective as of May 22, 2026. Ms. Boston's departure from the Board was not the result of any dispute or disagreement with the Company regarding any matter relating to the Company's operations, policies, practices or otherwise. 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). Annonce • 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. New Risk • Jan 22
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (46% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$19m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Annonce • Jan 12
Benitec Biopharma Inc. Provides Positive Long-Term Clinical Study Results for BB-301 Phase 1b/2a Clinical Trial Demonstrating Robust Efficacy and Continued Durability of Response Benitec Biopharma Inc. announced that the first patient treated in Cohort 1 of the BB-301 Phase 1b/2a clinical study (NCT06185673) evaluating BB-301 for the treatment of dysphagia in oculopharyngeal muscular dystrophy (OPMD) has completed the 24-month post-treatment assessment. At the 24-month follow-up timepoint, Patient 1 continued to demonstrate robust, disease-modifying outcomes. At the 24-month follow-up timepoint, Patient 1 demonstrated deepening improvements in post-swallow pharyngeal residue as compared to the final pre-treatment timepoint and the 12-month post-treatment follow-up timepoint as assessed by x-ray-based swallowing studies. Additionally, Patient 1 experienced deepening improvements in total dysphagic symptom burden as assessed by the Sydney Swallow Questionnaire (SSQ). The first 4 patients in Cohort 1 have now completed the 12-month statistical follow-up period for the Phase 1b/2a study, and all 4 Completers continued to demonstrate durable response to BB-301. All 4 Cohort 1 Completers met the pre-specified statistical criteria for response to BB-301 defined by Benitec which require improvement across 2 or more of the 5 categories of assessment comprising the Responder Analysis. At the 24-month post-treatment follow-up, Patient 1 exhibited significant improvements in various swallowing metrics. Specifically, the patient demonstrated a 27% improvement in Pharyngeal Area at Maximum Constriction (PhAMPC) at both the 12-month and 24-month follow-up points, indicating durable functional improvement in throat closure. Additionally, the Normalized Residue Ratio Scale-Valleculae (NRRSv) showed a 60% improvement at the 24-month mark, reflecting enhanced throat-emptying ability. The Total Pharyngeal Residue (TPR) also improved by 39% at the 24-month follow-up. Furthermore, the Sydney Swallow Questionnaire (SSQ) total score indicated a 78% reduction in total dysphagic symptom burden at the 24-month follow-up. The Responder Analysis revealed that all four Cohort 1 Completers were formal Responders to BB-301, demonstrating a durable response at the conclusion of the 12-month statistical follow-up period. Price Target Changed • Nov 18
Price target increased by 9.3% to US$27.17 Up from US$24.86, the current price target is an average from 6 analysts. New target price is 101% above last closing price of US$13.53. Stock is up 41% over the past year. The company is forecast to post a net loss per share of US$2.34 next year compared to a net loss per share of US$1.05 last year. New Risk • Nov 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 46% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (46% 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$66m net loss in 3 years). Annonce • Nov 06
Benitec Biopharma Inc. has filed a Follow-on Equity Offering. Benitec Biopharma Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Board Change • Nov 04
Less than half of directors are independent Following Director Sharon Mates' arrival on 01 November 2025, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Ed Smith was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annonce • Oct 15
Benitec Biopharma Inc., Annual General Meeting, Dec 01, 2025 Benitec Biopharma Inc., Annual General Meeting, Dec 01, 2025. Annonce • Jul 09
Benitec Biopharma Inc. Provides Operational Updates Benitec Biopharma Inc. announced the recommendation of the independent Data Safety Monitoring Board (DSMB) to continue enrollment of the Phase 1b/2a Clinical Treatment Study (NCT06185673) following completion of the comprehensive review of safety information for all six Subjects enrolled into Cohort 1. In accordance with the Protocol for the BB-301 Phase 1b/2a clinical Treatment Study, a meeting of the DSMB was concluded following the completion of the 28-day post BB-301 dosing visit for the sixth Subject enrolled into Cohort 1. The DSMB recommended the continuation of Subject enrollment for the Phase 1b/2 a Clinical Treatment Study. The DSMB recommended the continued safety profile of BB-301 associated with local route of direct intramuscular delivery, as this method of administration enables the use of lower doses of gene therapy agent relative to the doses employed for other gene therapy programs which rely on systemic routes of administration. Additional clinical study updates for Subjects enrolled in Cohort 1 are planned for the fourth calendar quarter of this year. Price Target Changed • Apr 10
Price target increased by 7.1% to US$25.71 Up from US$24.00, the current price target is an average from 7 analysts. New target price is 115% above last closing price of US$11.94. Stock is up 92% over the past year. The company is forecast to post a net loss per share of US$1.43 next year compared to a net loss per share of US$5.51 last year. Annonce • Mar 28
Benitec Biopharma Inc. has completed a Follow-on Equity Offering. Benitec Biopharma Inc. has completed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 900,000
Price\Range: $13
Security Name: Pre-Funded Warrant
Security Type: Equity Warrant
Securities Offered: 900,000
Transaction Features: Registered Direct Offering Annonce • Mar 25
Benitec Biopharma Inc. has filed a Follow-on Equity Offering in the amount of $37.50357 million. Benitec Biopharma Inc. has filed a Follow-on Equity Offering in the amount of $37.50357 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,443,000
Price\Range: $13
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,443,000
Price\Range: $12.99 Annonce • Mar 19
Benitec Biopharma Reports Positive Interim Clinical Results for Three Subjects Treated with BB-301 in Phase 1b/2a Study to Be Presented at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference Benitec Biopharma Inc. announced continued durable improvements in swallowing function and reductions in total dysphagic symptom burden following administration of the low-dose of BB-301 in the first three Subjects treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD). Interim clinical study results will be presented in an oral late-breaking podium presentation at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference, taking place in Dallas, Texas. The interim clinical study update to be presented at the 2025 Muscular Dy Strophy Association Clinical & Scientific Conference will detail the 12-month (365-day) post-treatment results for the first Subject, the 12-month (365-day) post- treatment results for the second Subject, and the 3- month (90-day) post-treatment Results for the third Subject, each of whom have been safely treated with BB-301. Subjects Enrolled into the BB-301 Clinical Development Program are Impacted by Two Discrete Drivers of Total Dysphagic Symptom Burden: OPMD Subjects enrolled into the OPMD Natural History Study and the BB-301 Phase 1ss/2a Clinical Treatment Study can be impacted by the post swallow accumulation of food and liquid. OPMD Subjects enrolled in the OPMD Natural history Study and the BB-301 phase 1b/2a Clinical treatment Study can be impacted by pathologic sequential swallowingows comprising rapid involuntary contractions of thepharyngeal muscles without restoration of the resting pharyngeal diameter between pharyngeal contractions ("Inefficient Swallowing"). Clinical Utility, Sensitivity, and Specificity of the Key Assessment Methods: In the BB-301 Phase1b/2a Clinical Treatment Study, Radiologists and Speech Language Pathologists employ serial VFSS to objectively characterize the nature and severity of anatomical and functional abnormalities present in each Subject during the pre-treatment period and the post-treatment period. Recent Insider Transactions Derivative • Mar 04
Independent Non-Executive Director exercised options to buy US$620k worth of stock. On the 27th of February, J. Buchi exercised options to buy 52k shares at a strike price of around US$3.86, costing a total of US$200k. This transaction amounted to 99% of their direct individual holding at the time of the trade. Since September 2024, Buchi has owned 52.10k shares directly. This was the only transaction from an insider over the last 12 months. New Risk • Feb 14
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (over 7x increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$58m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Annonce • Feb 14
Benitec Biopharma Announces Acceptance of Late- Breaking Oral Abstract for the BB-301 Phase 1b/2a Clinical Study at the Muscular Dystrophy Association Clinical and Scientific Conference Benitec Biopharma Inc. announced the acceptance of a late-breaking oral abstract for the BB-301 Phase 1b/2a Clinical Treatment Study ongoing in Subjects diagnosed with Oculopharyngeal Muscular Dystrophy (OPMD) with moderate dysphagia. Interim clinical study updates for the first three Subjects will be discussed in an oral presentation at the Muscular Dystrophy Association Clinical and Scientific Conference on March 19, 2025 at 1:15 pm Central Time. An interim study update for the Phase 1b/2a Clinical Treatment Study of BB-301 in OPMD subjects with moderate dysphagia will be presented in a late-breaking oral presentation entitled “Interim Study Update for the BB-301 Gene Therapy Phase 1b/2a First in Human Trial in Subjects with Oculopharyngeal Muscular Dystrophy with Dysphagia” at 1:15 pm Central Time on March 19th at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference in room Coronado ABCD. BB-301 is a novel, modified AAV9 capsid expressing a unique, single bifunctional construct promoting co-expression of both codon-optimized Poly-A Binding Protein Nuclear-1 (PABPN1) and two small inhibitory RNAs (siRNAs) against mutant PABPN1 (the causative gene for OPMD). The two siRNAs are modeled into microRNA backbones to silence expression of faulty mutant PABPN1, while allowing expression of the codon-optimized PABPN1 to replace the mutant with a functional version of the protein. We believe the silence and replace mechanism of BB-301 is uniquely positioned for the treatment of OPMD by halting mutant expression while providing a functional replacement protein. Annonce • Oct 23
Benitec Biopharma Inc., Annual General Meeting, Dec 04, 2024 Benitec Biopharma Inc., Annual General Meeting, Dec 04, 2024. Location: meetnow.global/mxpauvl, United States New Risk • Oct 16
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 3.8% 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 3.8% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 6x increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$134m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Annonce • Oct 13
Benitec Biopharma Inc. Reports Positive Data from Two Subjects Treated with Low-Dose Bb-301 in Phase 1B/2A Study Presented At 29Th Annual Congress of the World Muscle Society Benitec Biopharma Inc. announced continued durable improvements in swallowing following administration of the low-dose of BB-301 in the study’s first two subjects treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD). Interim clinical study data were presented in an oral late-breaking podium presentation at the 29th Annual Congress of the World Muscle Society, taking place in Prague, Czech Republic by the study’s principal investigator, Professor Milan R. Amin, M.D., Department of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine, Director, New York University Langone Voice Center. The interim clinical study update presented at the Annual Congress of the World Muscle Society detailed the 9-month (270-day) post-dose results for the first subject and the 6-month (180-day) post-dose results for the second subject, both of whom have been safely treated with BB-301. Key efficacy endpoints presented included videofluoroscopic swallowing study (“VFSS”) assessments of Total Pharyngeal Residue (“TPR”, i.e., the amount of solid food or liquid material remaining in the pharynx after the first swallow) and the Subject-Reported Outcome Instrument (i.e., the Sydney Swallow Questionnaire or “SSQ”). The post-dose results were compared to the average pre-dose results for each subject as evaluated during the five clinical assessment visits conducted during their enrollment in the Benitec-sponsored OPMD Natural History (NH) Study. The post-dose results for each subject were also compared to the pre-dose result derived from the final pre-dose clinical visit prior to the administration of BB-301. Subject 1 (270 Days post-BB-301 dose): Global inefficiency of swallowing for solid food, thin liquid, and thick liquids drives dysphagia for Subject 1. Subject 1 displayed continued clinically meaningful reductions (i.e., improvements) in SSQ Total Score (35% reduction) and SSQ Sub-Scores (42% reduction for Thin Liquid, 16% reduction for Solid Food, and 22% reduction for Thick Liquids). Subject 1 displayed correspondingly significant reductions (i.e., improvements) in VFSS TPR (33% reduction for Thin Liquid, 18% reduction for Solid Food, and 30% reduction for Thick Liquids) following the administration of the low-dose of BB-301 as compared to the average values recorded for Subject 1 during the pre-dose period. Subject 2 (180 Days post-BB-301-dose): Pathologic low-volume sequential swallowing for thin liquid drives dysphagia for Subject 2. Pathologic low-volume sequential swallows are experienced by the subject as multiple swallows and are detected during VFSS as a series of rapid contractions of the pharyngeal muscles interrupting the discrete peristaltic contraction pattern typically observed during swallows of low volumes of thin liquids. Subject 2 displayed clinically meaningful reductions (i.e., improvements) in SSQ Total Score (89% reduction) and the SSQ Sub-Score for the necessity of repeat swallows during consumption (84% reduction) as compared to the average values recorded for Subject 2 during the pre-dose period. The average post-dose SSQ Total Score of 82 is representative of a clinically normal swallowing profile for Subject 2. Subject 2 displayed correspondingly significant reductions (i.e., improvements) in the post-dose frequency of low-volume sequential swallows as evaluated by VFSS (92% reduction) following the administration of the low-dose of BB-301 as compared to the pre-dose values recorded for Subject 2 during the pre-dose period. All study Subjects are blinded to their SSQ Total Scores and VFSS TPR assessment results, and the Central Reader for the VFSS assessments is blinded to the SSQ Total Scores and SSQ Sub-Scores for all Study Subjects. Annonce • Oct 12
Benitec Biopharma Inc. has filed a Follow-on Equity Offering in the amount of $75 million. Benitec Biopharma Inc. has filed a Follow-on Equity Offering in the amount of $75 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annonce • Jul 15
Benitec Biopharma Reports Continued Durable Improvements in the Radiographic Assessments of Swallowing Efficiency and the Subject-Reported Outcome Instrument at the 180-Day Timepoint for First OPMD Subject Treated with Low-Dose BB-Dose BB-301 in Phase 1b/2a Study Benitec Biopharma Inc. announced continued durable improvements in the radiographic assessments of swallowing efficiency and the subject-reported outcome instrument as assessed at the 180-day timepoint following the administration of the low-dose of BB-301 to the study’s first subject (Subject 1) treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD). BB-301 has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). The current interim clinical study update focuses principally on the 180-day results of the videofluoroscopic swallowing study (“VFSS”) assessments of Total Pharyngeal Residue (“TPR”, i.e., the amount of solid food or liquid material remaining in the pharynx after the first swallow) and the Subject-Reported Outcome Instrument (i.e., the Sydney Swallow Questionnaire or “SSQ”) as the Key Opinion Leaders (KOLs) participating in the recent BB-301 Research and Development Day webcast in April 2024 highlighted the Total Pharyngeal Residue and the SSQ as the central markers of value for the long-term evaluation of clinically meaningful improvement in subjects diagnosed with OPMD. Additionally, as the formal statistical plan for the BB-301 Phase 1b/2a clinical study comprises comparisons of the average pre-dose assessments to the respective average 365-day post-dose assessments for each subject, the interim clinical study update focuses on these specific quantitative comparisons. Benitec plans to provide additional analyses of the interim clinical study data at upcoming medical conferences and company-sponsored Research and Development-focused webcasts in the first quarter of calendar 2025. Previously Announced 90-Day Post-Dose Interim Clinical Study Results: At the 90-day post-dose assessment following the administration of the low-dose of BB-301, Subject 1 demonstrated improvements in key VFSS assessments which correlated with the observation of similar levels of improvement in the SSQ as compared to the pre-dose average values recorded for Subject 1 during the OPMD Natural History Study, indicating an improvement in swallowing function as reported by Subject 1. Newly Reported 180-Day Post-Dose Interim Clinical Study Results: The post-dose average values for TPR remained meaningfully reduced (i.e., smaller amounts of solid food and liquid material remained in the pharynx after the completion of the first swallow) at the 180-day post-dose assessment following the administration of the low-dose of gene therapy BB-301 as compared to the pre-dose average values recorded for Subject 1 during the OPMD Natural History Study. Critically, for three of the four food types evaluated during the radiographic swallowing study assessments for Subject 1, the post-dose average TPR values were lower at the 180-day post-dose assessments than at any point during the 9-month pre-dose observation period comprising the OPMD Natural History Study, with the post-dose average TPR value for the fourth food type being similar to the lowest TPR value observed at any point during the 9-month pre-dose observation period of the OPMD Natural History Study. The Total Score recorded for the Subject-Reported SSQ also demonstrated continued reductions in the Subject’s dysphagic symptoms (i.e., improvements in the Subject’s ability to swallow) at the 180-day post-dose timepoint, with the Total SSQ Score continuing to decline and remaining meaningfully reduced as compared to the pre-dose average value recorded for Subject 1 during the OPMD Natural History Study, indicating a greater improvement in swallowing function as reported by Subject 1. Importantly, similar to the results observed for the VFSS assessments of TPR, the post-dose average Total SSQ Score was lower at the 180-day post-dose timepoint than at any point during the 9-month pre-dose assessment period of the OPMD Natural History Study. Annonce • Jul 01
Benitec Biopharma Inc. Announces Appointment of Kishen Mehta to Its Board of Directors Benitec Biopharma Inc. announced the appointment of Kishen Mehta to the board of directors (BOD) of the Company, effective June 26, 2024. Mr. Mehta’s appointment follows the $40.0 million private investment in public equity (PIPE) financing announced on April 18th, led by long-term investor Suvretta Capital, where he serves as portfolio manager.Mr. Mehta has over 15 years of experience in the financial industry and is currently a Portfolio Manager at Suvretta Capital Management, LLC, where he is focused on its healthcare investment strategies. Mr. Mehta currently sits on the Board of Directors of Biohaven Pharmaceuticals, where he was a strategic adviser on various business development, capital structure and communication strategies. Prior to Biohaven, Mr. Mehta was a portfolio manager at Surveyor Capital, a Citadel LLC strategy, focused on global small-, mid- and large-capitalization biotechnology, pharmaceutical, specialty pharmaceutical, medical device and healthcare services companies. Prior to Surveyor, Mr. Mehta was an analyst at Adage Capital where he evaluated and participated in numerous mezzanine and pre-IPO private healthcare investments. Mr. Mehta held a similar role at Apothecary Capital and started his career as a mergers and acquisitions analyst at Evercore Partners, where he focused on life sciences. Mr. Mehta graduated from New York University with a degree in finance and accounting. Reported Earnings • May 13
Third quarter 2024 earnings released: US$1.64 loss per share (vs US$2.67 loss in 3Q 2023) Third quarter 2024 results: US$1.64 loss per share (improved from US$2.67 loss in 3Q 2023). Net loss: US$4.28m (loss narrowed 2.7% from 3Q 2023). Revenue is expected to decline by 172% p.a. on average during the next 2 years, while revenues in the Biotechs industry in the US are expected to grow by 18%. Over the last 3 years on average, earnings per share has increased by 62% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Annonce • Apr 27
Benitec Biopharma Inc. announced that it has received $40.000019 million in funding from a group of investors On April 25, 2024, Benitec Biopharma Inc. closed the transaction. The company has received $40,000,018 from 17 investors pursuant to exemption provided under Regulation D. The company has paid placement agent fee of $2,400,001. New Risk • Apr 19
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 39% per year over the past 5 years. Shareholders have been substantially diluted in the past year (58% increase in shares outstanding). Revenue is less than US$1m (US$61k revenue). Minor Risk Market cap is less than US$100m (US$17.7m market cap). Annonce • Apr 19
Benitec Biopharma Inc. Reports Positive Interim Clinical Trial Data for First OPMD Subject Treated with BB-301 in Phase 1b/2a Study Benitec Biopharma Inc. announced positive interim clinical data from the 90-day timepoint following the administration of BB-301 to the study's first subject (Subject 1) treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD). BB-301 has been granted Orphan Drug designation by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). BB-301 Interim Clinical Study Results: During the OPMD Natural History Study, which represents the pre-dose observational period for each subject, Subject 1 experienced progressive worsening of dysphagia as demonstrated by the results of the videofluoroscopic swallowing studies (VFSS), the cold water timed drinking test, and the key subject-reported outcome measure (the Sydney Swallow Questionnaire). Videofluoroscopic swallowing studies represent the gold standard analytical method for the quantitative assessment of dysphagia (swallowing difficulty) in the clinical setting. At the 90-day timepoint following the administration of BB-301, Subject 1 demonstrated improvements in key videofluoroscopic assessments which correlated with the observation of similar improvement in the key subject-reported outcome measure as compared to the average values for the respective assessments completed during the pre-dose observational period. Notably, the results of many assessments completed at the 90-day timepoint demonstrated improvements over the initial measurements assessed at the subject’s first visit for the natural history observational study which occurred more than 12 months prior to the 90-day assessment. The most significant VFSS improvements at Day 90 were observed for swallowing tasks centered on the evaluation of pharyngeal constrictor muscle function and swallowing efficiency in the context of the consumption of thin liquids, solid foods and thick, non-solid foods (yogurt or pudding). The VFSS improvements correlated with an improvement in the key subject-reported outcome measure the Sydney Swallow Questionnaire, indicating an improvement in swallowing function as reported by Subject 1. Regarding the BB-301 safety profile observed to date, no Serious Adverse Events have been observed for the two subjects that have received BB-301. Transient Grade 2 Gastroesophageal Reflux Disease or “GERD” (“acid reflux” or “heartburn”) was observed for the two subjects that received BB-301. For both subjects, the GERD resolved following the completion of a short course of common prescription medications approved for the treatment of GERD. OPMD is a rare progressive muscle-wasting disease caused by a mutation in the poly(A)-binding protein nuclear 1 (PABPN1) gene, for which there is currently no effective drug therapy. The disease is characterized by swallowing difficulties (dysphagia), limb weakness and eyelid drooping (ptosis). Dysphagia worsens over time and can lead to chronic choking, regurgitation, aspiration pneumonia, and in severe cases, death. Available clinical and surgical interventions are limited in scope and effectiveness and do not address the underlying progressive muscle weakness. New Risk • Jan 18
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Earnings have declined by 41% per year over the past 5 years. Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Revenue is less than US$1m (US$75k revenue). Market cap is less than US$10m (US$8.27m market cap). Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). Annonce • Nov 30
Benitec Biopharma Announces First Subject Dosed in Phase 1B/2A Clinical Trial for Gene Therapy Candidate BB-301 for the Treatment of Oculopharyngeal Muscular Dystrophy Benitec Biopharma Inc. announced the first subject has been dosed in the BB-301 Phase 1b/2a Clinical Treatment Study. Dosing of the first subject marks the beginning of the 52-week follow-up period designed to facilitate inclusive evaluation of the primary and secondary endpoints of the BB-301 Phase 1ss/2a Clinical Treatment Study". Subjects enrolled in Benitec's ongoing OPMD Natural History (NH) study will become eligible to roll over into the BB-301 Phase 1 b/2a Clinical Treatment Study for the treatment of OPMD-related dysphagia after 6 months of baseline data collection. Currently, there are 19 subjects enrolled into the NH study at the U.S. clinical trial site, with each subject having the potential to roll over into theBB-301 Phase 1b/2a Clinical Treatment Study. Interim safety and efficacy data are expected to become available from the BB-301 Phase 1B/2a Clinical Treatment Study in mid-2024. New Risk • Nov 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$19m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Earnings have declined by 41% per year over the past 5 years. Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m (US$75k revenue). Market cap is less than US$10m (US$9.37m market cap). Annonce • Oct 21
Benitec Biopharma Inc., Annual General Meeting, Dec 06, 2023 Benitec Biopharma Inc., Annual General Meeting, Dec 06, 2023, at 14:00 Pacific Standard Time. Agenda: To consider The election of one Class I director to hold office until our 2026 Annual Meeting of Stockholders or until his successor is elected and qualified; to consider Ratification of the appointment of the Company’s independent registered public accounting firm for the fiscal year ending June 30, 2024; to consider non-binding advisory vote on the compensation of the Company’s named executive officers as disclosed in the attached proxy statement; to approve an amendment to the Company’s 2020 Equity and Incentive Compensation Plan previously approved by the Company’s Board of Directors. Reported Earnings • Sep 22
Full year 2023 earnings released: US$14.12 loss per share (vs US$37.88 loss in FY 2022) Full year 2023 results: US$14.12 loss per share. Net loss: US$19.6m (loss widened 7.4% from FY 2022). Annonce • Aug 11
Benitec Biopharma Regains Compliance with the Bid Price Rule As previously reported, on September 6, 2022, Benitec Biopharma Inc. (the “Company”) received a letter from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that the minimum bid price per share for its common stock fell below $1.00 for a period of 30 consecutive business days and that therefore the Company did not meet the minimum bid price requirement (the “Bid Price Rule”) set forth in Nasdaq Listing Rule 5550(a)(2). On August 9, 2023, the Company received written notice from the Listing Qualifications Department of Nasdaq informing the Company that it has regained compliance with the Bid Price Rule based on the closing price of the Company’s common stock having been at $1.00 per share or greater for 10 consecutive trading days and that the matter is now closed. Annonce • Jul 26
Benitec Biopharma Provides Nasdaq Compliance Update Benitec Biopharma Inc. a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference (“ddRNAi”). “Silence and Replace” platform, announced that it will effect a 1-for-17 reverse stock split (“Reverse Stock Split”) of its common stock, par value $0.0001 per share (“Common Stock”), that will become effective on July 26, 2023, at 12:01 a.m., Eastern Time. Benitec’s Common Stock will continue to trade on The Nasdaq Capital Market (“Nasdaq”) under the existing symbol “BNTC” and will begin trading on a split-adjusted basis when the market opens on July 26, 2023. The new CUSIP number for the Common Stock following the Reverse Stock Split will be 08205P209. The Reverse Stock Split is primarily intended to bring the Company into compliance with the $1.00 minimum bid price requirement for maintaining its listing on Nasdaq. There is no guarantee the Company will meet the minimum bid price requirement. New Risk • Jun 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 26% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings have declined by 38% per year over the past 5 years. Shareholders have been substantially diluted in the past year (242% increase in shares outstanding). Revenue is less than US$1m (US$68k revenue). Minor Risk Market cap is less than US$100m (US$10.1m market cap). Board Change • May 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 2 highly experienced directors. Independent Non-Executive Director Ed Smith was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Annonce • Jan 24
Benitec Biopharma Enrolls First OPMD Subject into the Clinical Development Program Benitec Biopharma Inc. announced the enrollment of the first oculopharyngeal muscular dystrophy (OPMD) patient into the OPMD natural history phase of the BB-301 clinical development program. The OPMD Natural History (NH) Study represents the 6-month pre-treatment observation period for each OPMD subject prior to the administration of BB-301 for the treatment of OPMD-related dysphagia. Upon the completion of 6-months of radiographic and clinical assessments required for the NH Study, participants will be eligible for enrollment into the BB-301 Phase 1b/2a treatment study in which BB-301 will be administered. The OPMD NH Study will facilitate the characterization of OPMD patient disposition at baseline and assess subsequent rates of progression of dysphagia via the use of the following quantitative radiographic measures (i.e., videofluoroscopic swallowing studies or "VFSS"), with the VFSS outlined below collectively providing objective assessments of swallowing safety, swallowing efficiency, and the functional capacity of the specific pharyngeal constrictor muscles underlying the progression of dysphagia in OPMD patients: Total Phaharyngeal Residue %(C2-4)2, Pharyngeal Area at Maximum Constriction (PhAMPC), Dynamic Imagining Grade of Swallowing Toxicity Scale (DIGEST), Vallecular Residue %(C2-4)2, Pyriform Sinus Residue %(C2-4)2, and Other Pharyngeal Residue %(C2-4). Normalized Residue Ratio Scale (NRRSv, NRRSp). Pharyngeal Construction Ratio (PCR). The study will also employ clinical measures of global swallowing capacity and oropharyngeal dyspgia, along with two distinct patient-reported outcome instruments targeting the assessment of oropharyngeal dysphagia. Upon the achievement of 6-months of follow-up in the NH Study, participants will be eligible for enrollment into theplanned BB-301 Phase 1b/2a treatment study. Reported Earnings • Sep 03
Full year 2022 earnings: EPS and revenues miss analyst expectations Full year 2022 results: US$2.23 loss per share. Net loss: US$18.2m (loss widened 31% from FY 2021). Revenue missed analyst estimates by 24%. Earnings per share (EPS) also missed analyst estimates by 23%. Over the next year, revenue is expected to shrink by 100% compared to a 41% growth forecast for the Biotechs industry in the US. Reported Earnings • May 18
Third quarter 2022 earnings released: US$0.40 loss per share (vs US$0.82 loss in 3Q 2021) Third quarter 2022 results: US$0.40 loss per share (up from US$0.82 loss in 3Q 2021). Net loss: US$3.28m (loss narrowed 16% from 3Q 2021). Over the next year, revenue is expected to shrink by 100% compared to a 45% growth forecast for the industry in the US. Reported Earnings • Feb 15
Second quarter 2022 earnings: EPS and revenues miss analyst expectations Second quarter 2022 results: US$0.59 loss per share (up from US$0.76 loss in 2Q 2021). Net loss: US$4.82m (loss widened 48% from 2Q 2021). Revenue missed analyst estimates by 97%. Earnings per share (EPS) also missed analyst estimates by 5.7%. Over the last 3 years on average, earnings per share has fallen by 41% per year but the company’s share price has fallen by 53% per year, which means it is performing significantly worse than earnings. Reported Earnings • Nov 17
First quarter 2022 earnings released: US$0.62 loss per share (vs US$2.45 loss in 1Q 2021) First quarter 2022 results: Net loss: US$5.05m (loss widened 86% from 1Q 2021). Over the last 3 years on average, earnings per share has fallen by 42% per year but the company’s share price has fallen by 53% per year, which means it is performing significantly worse than earnings. Reported Earnings • Sep 21
Full year 2021 earnings released: US$3.23 loss per share (vs US$8.10 loss in FY 2020) Full year 2021 results: Net loss: US$13.9m (loss widened 68% from FY 2020). Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has fallen by 53% per year, which means it is performing significantly worse than earnings. Reported Earnings • May 14
Third quarter 2021 earnings released: US$0.82 loss per share (vs US$1.96 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$3.91m (loss widened 86% from 3Q 2020). Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. Is New 90 Day High Low • Mar 05
New 90-day low: US$2.59 The company is down 6.0% from its price of US$2.76 on 04 December 2020. The American market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. Is New 90 Day High Low • Feb 10
New 90-day high: US$4.71 The company is up 56% from its price of US$3.01 on 11 November 2020. The American market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 23% over the same period. Is New 90 Day High Low • Jan 21
New 90-day high: US$3.88 The company is up 32% from its price of US$2.93 on 22 October 2020. The American market is up 14% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 27% over the same period. Is New 90 Day High Low • Jan 05
New 90-day high: US$3.34 The company is up 9.0% from its price of US$3.07 on 06 October 2020. The American market is up 13% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 11% over the same period. Reported Earnings • Nov 15
First quarter 2021 earnings released: US$2.45 loss per share First quarter 2021 results: Net loss: US$2.72m (loss widened 71% from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 58% per year, which means it is significantly lagging earnings. Is New 90 Day High Low • Oct 28
New 90-day low: US$2.76 The company is down 63% from its price of US$7.50 on 30 July 2020. The American market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. Is New 90 Day High Low • Oct 01
New 90-day low: US$4.79 The company is down 38% from its price of US$7.72 on 02 July 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. Reported Earnings • Sep 25
Full year earnings released - US$8.10 loss per share Over the last 12 months the company has reported total losses of US$8.27m, with earnings decreasing by US$8.28m from the prior year.