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Financial Performance - Total revenues for the first quarter of 2025 were $0 million, unchanged from the same quarter in 2024[11] - Total expenses for the quarter ended September 30, 2024, were $5.8 million, a slight decrease from $5.9 million in the same quarter of 2023[12] - Research and development expenses for the quarter were $3.6 million, down from $4.4 million in the prior year[12] - The net loss attributable to shareholders for the quarter was $5.1 million, or $(0.48) per share, compared to a net loss of $6.6 million, or $(3.05) per share in the same quarter of 2023[13] - The company had $67.8 million in cash and cash equivalents as of September 30, 2024, an increase from $50.9 million at the end of June 2024[13] - Total stockholders' equity increased to $64.2 million as of September 30, 2024, compared to $47.2 million at the end of June 2024[14] Clinical Development - The first subject in the BB-301 clinical study experienced a 35% reduction in dysphagic symptoms, while the second subject achieved an 89% reduction in their total score[7][8] - No serious adverse events were reported for the three subjects treated with the low-dose of BB-301[9] - The third subject was treated in October 2024, with the fourth subject expected to receive treatment in December 2024[9] - The company plans to enroll additional subjects at a higher dose of BB-301 in 2025[2] - The company is in the clinical stage, with ongoing preclinical and clinical trials to evaluate the efficacy and safety of its product candidates[18] Strategic Focus - Benitec Biopharma is focused on developing novel genetic medicines, particularly for Oculopharyngeal Muscular Dystrophy (OPMD) using its proprietary "Silence and Replace" platform[17] - The BB-301 product utilizes a modified AAV9 capsid to co-express a functional version of PABPN1 while silencing the mutant version, aiming for effective treatment of OPMD[16] - The company emphasizes the importance of patient enrollment and dosing in clinical trials for the success of its product development[20] - The company is assessing the potential for a "one shot" cure through its innovative treatment approach, which could significantly alter the treatment landscape for chronic conditions[20] Market Considerations - Forward-looking statements indicate potential risks including the timing of clinical trial completions and regulatory approvals, which may impact future revenue and financing needs[19] - Benitec's intellectual property position and the duration of its patent portfolio are critical for its competitive advantage in the market[20] - Market conditions and the ability to secure additional financing are key factors influencing the company's operational strategy and capital needs[20] - The company acknowledges the impact of economic conditions and competition on its market acceptance and product sales[20] Investor Relations - Investor relations contact is available for further inquiries regarding the company's developments and financial performance[21]

Product Development and Technology - Benitec Biopharma is developing BB-301, an AAV-based gene therapy for Oculopharyngeal Muscular Dystrophy (OPMD), which has received Orphan Drug Designation in both the United States and the European Union[84]. - The silence and replace approach aims to permanently silence disease-causing genes while simultaneously replacing them with wildtype genes, potentially improving treatment outcomes for chronic diseases[86]. - The proprietary ddRNAi technology allows for sustained silencing of disease-causing genes through a single administration, reducing the frequency of drug administration typically required for chronic disease management[84]. - Benitec's technology could facilitate the development of therapeutics for over 20,000 human genes, addressing significant unmet medical needs in genetic disorders[87]. - The silence and replace technology combines RNAi with gene therapy to overcome limitations of traditional gene silencing approaches, enhancing the efficacy of treatments for genetic disorders[91]. - Benitec's proprietary AAV vector technology improves the delivery of genetic constructs, enhancing the potential for effective gene therapy applications[94]. - BB-301 employs a "silence and replace" mechanism, achieving 75% silencing of mutant PABPN1 and 26% replacement of wild type PABPN1 activity in preclinical models[104]. - BB-301 demonstrated robust intracellular silencing of PABPN1 protein production and restoration of muscle strength in the A17 mouse model[104]. - BB-301 is designed to be administered via direct intramuscular injection, enhancing the precision of treatment delivery[108]. - The BB-301 Pilot Dosing Study in Beagle dogs confirmed dose-dependent transduction efficiency and gene expression levels, with significant biological activity observed[108]. - BB-301 demonstrated a 248-fold improvement (+24,650%) in transduction of the HP muscle and a 111-fold improvement (+11,027%) in transduction of the TP muscle compared to previous studies[112]. Clinical Development and Regulatory Progress - BB-301 is in clinical development for Oculopharyngeal Muscular Dystrophy (OPMD) with the first study subject treated in November 2023 and subsequent subjects treated in February and October 2024[101]. - The Investigational New Drug (IND) application for BB-301 was approved by the U.S. FDA in June 2023, indicating regulatory progress[101]. - The BB-301 clinical development program includes approximately 76 weeks of follow-up, with a 6-month pre-treatment observation period for evaluating baseline dysphagia[113]. - The primary endpoint of the Phase 1b/2a study is safety, with secondary endpoints evaluating swallowing efficiency and muscle function[114]. - Subject 1 experienced a 35% reduction in SSQ Total Score and a 33% reduction in VFSS TPR for thin liquids post-BB-301 treatment[118]. - Subject 2 showed an 89% reduction in SSQ Total Score and a 92% reduction in the frequency of low-volume sequential swallows post-BB-301 treatment[120]. - The NH Study has enrolled 23 subjects as of January 2024, assessing dysphagia progression through quantitative measures[114]. Financial Performance and Funding - The Company raised approximately $27.9 million in net proceeds from an underwritten public offering on August 11, 2023, selling 875,949 shares of common stock and warrants[132]. - For the three months ended September 30, 2024, the Company incurred research and development expenses of $3.6 million, a decrease from $4.4 million in the same period in 2023[145]. - General and administrative expenses increased to $2.2 million for the three months ended September 30, 2024, compared to $1.6 million in the same period in 2023[146]. - The Company reported total other income of $732 thousand for the three months ended September 30, 2024, compared to a loss of $80 thousand in the same period in 2023[147]. - As of September 30, 2024, the Company had accumulated losses of $195 million since inception[148]. - The Company had cash and cash equivalents of approximately $67.8 million as of September 30, 2024[150]. - Net cash used in operating activities was $4.6 million for both the three months ended September 30, 2024 and 2023[152]. - The Company provided $21.7 million in net cash from financing activities for the three months ended September 30, 2024, down from $27.9 million in the same period in 2023[153]. - The Company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained[155]. - The Company entered into a Sales Agreement on October 11, 2024, allowing for the sale of up to $75 million of common stock[135]. - The company anticipates continued losses for the foreseeable future, with expectations that losses will increase as product candidates are developed and prepared for commercialization[156]. - Cash and cash equivalents are estimated to be sufficient to fund operations for at least the next twelve months[156]. - Future funding requirements will depend on various factors, including clinical trial costs and regulatory approval outcomes[157]. Corporate Strategy and Partnerships - The company plans to utilize its cash reserves for advancing BB-301 and other product candidates, as well as for general corporate purposes and strategic growth opportunities[92]. - The company aims to establish partnerships with global biopharmaceutical companies to co-develop and commercialize its ddRNAi-based products, leveraging its unique scientific platform[95]. - Manufacturing of gene therapy products is complex, and the company is exploring long-term alliances for production[121]. - The company has not yet established sales or marketing operations, pending clinical trial results and regulatory approvals[123]. Internal Controls and Compliance - A material weakness in internal control over financial reporting has been identified, affecting the ability to process complex transactions[171]. - The company plans to retain additional accounting experts to assist in remediating the identified material weakness[171]. - No changes in internal controls over financial reporting have materially affected the company during the quarter ended September 30, 2024[173]. - The company is currently evaluating the impact of recently issued accounting standards on its financial disclosures[167].

-Positive 270-day Interim Clinical Study Data for the First Subject and Positive 180-day Interim Clinical Study Data for the Second Subject Treated with the Low-Dose of BB-301 in the Phase 1b/2a Clinical Treatment Study Reported in October as a Late-Breaking Oral Presentation at the 29th Annual Congress of the World Muscle Society- -Third Subject Safely Treated with the Low-Dose of BB-301 in October 2024, and Fourth Subject Expected to Receive Treatment with the Low-Dose of BB-301 in December 2024 HAYWARD, ...

Core Insights - Benitec Biopharma Inc. is a clinical-stage biotechnology company focused on developing novel genetic medicines using its proprietary "Silence and Replace" DNA-directed RNA interference platform [3] Group 1: Company Overview - Benitec is headquartered in Hayward, California and specializes in gene therapy aimed at chronic and life-threatening conditions, including Oculopharyngeal Muscular Dystrophy (OPMD) [3] - The "Silence and Replace" platform combines RNA interference with gene therapy to enable sustained silencing of disease-causing genes while delivering wildtype replacement genes in a single administration [3] Group 2: Upcoming Events - CEO Jerel A. Banks will participate in the Guggenheim Securities Healthcare Conference in Boston from November 11-13, 2024 [1] - The presentation will include a fireside chat and one-on-one meetings, with a live webcast available for interested parties [2]

Group 1 - Benitec Biopharma Inc. (NASDAQ: BNTC) reported positive results from its phase 1b/2a clinical study using BB-301 for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD) [1] - The positive interim results were reported at two time points during the study [1] Group 2 - The article is authored by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace [1] - The Biotech Analysis Central service offers a deep-dive analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [1]

-Management plans to host an investor webcast on October 14th at 8:30 am EDT to provide an update for the BB-301 Phase 1b/2a Clinical Study, details below- -The webcast access information has been revised from the conference call information provided on October 12th- HAYWARD, Calif., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "Company"), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary "Silenc ...

-Subject 1 and Subject 2 experienced durable, clinically meaningful improvements in swallowing at 9-months and 6-months post-BB-301 treatment, respectively, with Subject 2 achieving a Sydney Swallow Questionnaire Score Representative of Clinically Normal Swallowing- -Management plans to host a conference call on October 14 at 8:30 am EDT to discuss the interim results, details below- HAYWARD, Calif., Oct. 12, 2024 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "Company"), a clinical ...

Exhibit 99.1 LOGO Benitec Biopharma Releases Full Year 2024 Financial Results and Provides Operational Update -Positive 90-day and 180-day Interim Clinical Trial Data for the First Oculopharyngeal Muscular Dystrophy (OPMD) Subject Dosed with the Low-Dose of BB-301 in the Phase 1b/2a Clinical Treatment Study Reported in April and July- -Second Subject Dosed with the Low-Dose of BB-301 in February 2024, and Third Subject Expected to Receive the Low-Dose of BB-301 in Calendar Quarter Four of 2024 -Closed an Ov ...

Revenue and Sales - In the fiscal year ended June 30, 2024, the company generated no revenues from product sales, compared to $75 thousand in the fiscal year ended June 30, 2023, indicating a decrease in licensing revenue [373][374]. - The Company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for its product candidates [389]. - The company reported no revenues from customers for the year ended June 30, 2024, down from $75,000 in the previous year [419]. - The company recognized no licensing revenue for the fiscal year ended June 30, 2024, as performance obligations were not satisfied [467]. Financial Performance - The company incurred net losses of $21.8 million and $19.6 million for the years ended June 30, 2024, and 2023, respectively, with cumulative losses reaching $190.3 million as of June 30, 2024 [383]. - The net loss for the year ended June 30, 2024, was $21,751,000, compared to a net loss of $19,562,000 in 2023, reflecting a 11% increase in losses [419]. - The company anticipates continued losses as it develops product candidates, with expected losses increasing as commercialization efforts begin [390]. - The company has not established a source of revenue to cover its full operating costs and is dependent on capital financing activities [464]. Expenses - Research and development expenses for the year ended June 30, 2024, were $15.6 million, up from $12.8 million in the previous year, primarily due to ongoing clinical development of BB-301 for OPMD [380][381]. - Total expenses for the year ended June 30, 2024, were $22.5 million, compared to $19.2 million for the year ended June 30, 2023, reflecting increased research and development and general administrative costs [380][381]. - Total operating expenses rose to $22,490,000 in 2024, an increase of 17% from $19,156,000 in 2023 [419]. - The company anticipates an increase in general and administrative expenses as it continues to develop its clinical programs and comply with regulatory requirements [378]. Cash and Financing - As of June 30, 2024, the company had cash and cash equivalents of $50.9 million, with net cash used in operating activities amounting to $19.4 million for the year [384][385]. - Net cash provided by financing activities was $68.0 million for the year ended June 30, 2024, significantly higher than $16.0 million for the previous year, driven by capital raises [387]. - The company completed an underwritten public offering in August 2023, raising gross proceeds of approximately $30.9 million, and another in April 2024, raising approximately $40.0 million [371][372]. - The Company closed a private investment in public equity (PIPE) financing on April 22, 2024, resulting in net proceeds of $37.1 million [388]. Assets and Equity - Total current assets increased significantly to $51,674,000 as of June 30, 2024, compared to $3,729,000 in the previous year, representing a growth of 1,284% [417]. - Total stockholders' equity increased to $47,248,000 as of June 30, 2024, from $202,000 in the previous year, indicating a significant rise in equity [418]. - Cash and cash equivalents at the end of the year were $50,866,000, a substantial increase from $2,477,000 in the previous year, marking a growth of 1,952% [421]. Research and Development - BB-301, a silence and replace-based genetic medicine, is under development for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD) and has received Orphan Drug Designation in the U.S. and EU [364]. - Research and development expenses increased to $15,609,000 in 2024, up from $12,774,000 in 2023, representing a growth of 22% [419]. - Research and development expenses primarily relate to clinical and pre-clinical trials, with accrued liabilities recorded for estimated costs [455][456]. Accounting and Compliance - The Company adopted ASU 2016-13 effective July 1, 2023, which requires immediate recognition of expected credit losses, with an immaterial impact on financial statements [402]. - The Company is evaluating the impact of recently issued accounting standards on its disclosures, including ASU No. 2023-09 and ASU No. 2023-07 [404]. - The Company adopted ASC 326 for estimating expected credit losses on trade and other receivables starting July 1, 2023 [443]. - The company’s financial statements are prepared in accordance with US GAAP and reflect the historical results of BBL and its subsidiaries [428]. Stock and Warrants - A 1-for-17 reverse stock split was executed on July 26, 2023, affecting the number of outstanding shares and stock options [427]. - The company had 1,182,140 stock options outstanding as of June 30, 2024, with a weighted average exercise price of $6.58 [488]. - The weighted-average grant-date fair value of stock options granted during the fiscal year ended June 30, 2024, was $4.39, compared to $3.34 for the fiscal year ended June 30, 2023 [489]. - The exercise price of the Series 2 Warrants was adjusted from $11.22 to $1.9299 due to a public offering on August 11, 2023, resulting in a deemed dividend of $618,987 [505]. Risks and Challenges - The company is subject to risks typical of early-stage biotechnology firms, including competition and regulatory approval challenges [434]. - Future funding requirements will depend on various factors, including clinical trial costs and regulatory approval timelines [391].