Product Development - 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[145]. - The silence and replace approach aims to permanently silence disease-causing genes while simultaneously replacing them with wildtype genes, potentially improving treatment outcomes for patients[145]. - The company plans to utilize its proprietary ddRNAi technology to achieve sustained gene silencing and gene replacement, which may reduce the frequency of drug administration traditionally required for chronic disease management[120]. - The proprietary AAV vector technology enhances the endosomal escape capability of the virus, broadening its application in AAV-based gene therapies[149]. - The silence and replace technology is designed to chronically express RNAi molecules and restore native intracellular biological processes following a single administration[138]. - BB-301 is a first-in-class genetic medicine utilizing a "silence and replace" approach for treating OPMD, targeting the PABPN1 gene mutation[154]. - BB-301's mechanism of action involves the simultaneous expression of a codon-optimized, siRNA-resistant version of the wild type PABPN1 gene alongside shmiRs targeting both mutant and wild type forms[161]. - The BB-301 clinical development program includes a 76-week follow-up with a 6-month pre-treatment observation period and 52 weeks of post-dosing evaluation[186]. Clinical Trials - The first study subject for the BB-301 Phase 1b/2a clinical trial was treated in November 2023, with subsequent subjects treated in February, October, and December 2024[150]. - In the A17 mouse model, a single intramuscular injection of BB-301 resulted in 75% silencing of PABPN1 and 26% replacement of wild type PABPN1 activity, leading to full restoration of muscle strength[166]. - The BB-301 Pilot Dosing Study in Beagle dogs confirmed transduction efficiency with an average of 5.12 copies per cell in hypopharyngeal muscle and 5.66 copies per cell in thyropharyngeal muscle at the highest dose[177]. - The BB-301 Pilot Dosing Study was designed to evaluate safety and biological activity across three distinct doses, confirming the method's efficacy for OPMD treatment[172]. - BB-301 demonstrated an average of 83% inhibition of wtPABPN1 in hypopharyngeal muscle and 82% in thyropharyngeal muscle at high volume dosing[183]. - Following methodological improvements, BB-301 transduction in HP muscle improved by 248-fold (+24,650%) and in TP muscle by 111-fold (+11,027%) compared to previous studies[184]. - Subject 1 showed a 35% reduction in SSQ Total Score and a 33% reduction in VFSS TPR after 270 days post-BB-301 treatment[191]. - Subject 2 experienced an 89% reduction in SSQ Total Score and a 92% reduction in low-volume sequential swallows after 180 days post-BB-301 treatment[193]. - As of January 2024, 23 subjects had enrolled in the NH study, with no significant adverse events reported for the lowest dose of BB-301[188]. - The primary endpoint of the Phase 1b/2a study is safety, with secondary endpoints assessing swallowing efficiency and muscle function[188]. Financial Overview - Benitec requires additional financing to advance its product candidates through key inflection points, including the Phase 1b/2a BB-301 treatment study[121]. - The company closed a public offering on August 11, 2023, raising net proceeds of approximately $27.9 million from the sale of 875,949 shares of common stock and warrants[215]. - As of December 31, 2024, the company reported accumulated losses of $203 million and cash and cash equivalents of approximately $78.3 million[232][234]. - Research and development expenses for the three months ended December 31, 2024, were $5.1 million, a slight decrease from $5.1 million in the same period in 2023[228]. - General and administrative expenses increased to $3.5 million for the three months ended December 31, 2024, compared to $1.8 million for the same period in 2023, primarily due to increased share-based compensation[229]. - The company did not generate any revenues from product sales during the three and six months ended December 31, 2024, and December 31, 2023[219]. - The company incurred total operating expenses of $8.6 million for the three months ended December 31, 2024, compared to $6.9 million for the same period in 2023[227]. - The company reported a total other income of $1.3 million for the three months ended December 31, 2024, compared to $129,000 for the same period in 2023, driven by gains on extinguishment of liabilities[231]. - The company anticipates an increase in general and administrative expenses due to compliance with SEC requirements and other related costs[224]. - The company has no borrowings as of December 31, 2024, and does not currently have a credit facility[233]. - Net cash used in operating activities for the six months ended December 31, 2024, was $12.3 million, compared to $9.9 million in 2023, primarily due to net loss and changes in working capital[236]. - Net cash used in investing activities was $12 thousand for the six months ended December 31, 2024, related to the purchase of lab equipment, while there were no investing activities in 2023[237]. - Net cash provided by financing activities increased to $39.5 million in the six months ended December 31, 2024, from $28.0 million in 2023, primarily from the issuance of common stock[238]. - The company does not have any products approved for sale and has not generated revenue from product sales, with no expected significant revenue until regulatory approval is obtained[240]. - The company anticipates continued losses for the foreseeable future as it develops product candidates and prepares for commercialization, estimating cash and cash equivalents will fund operations for at least the next twelve months[241]. - Future funding requirements will depend on various factors, including clinical trial costs, regulatory approvals, and potential collaborations[242]. Strategic Partnerships and Intellectual Property - The company aims to explore partnerships with global biopharmaceutical companies to co-develop and commercialize its ddRNAi-based products[142]. - Benitec's intellectual property portfolio is expected to protect its technologies and product candidates through at least 2036, with potential extensions to 2040[149]. - The company is actively seeking licensing partners for its ddRNAi technology but cannot guarantee successful arrangements or terms[239]. - The company has collaborated with leading experts in medicine and surgery for the development and execution of the BB-301 studies[172]. - The company is exploring long-term manufacturing alliances to support future commercialization efforts for its gene therapy products[198]. Market and Competition - The biopharmaceutical industry is characterized by intense competition, with potential competitors having greater resources and experience in product development and commercialization[203]. - The company entered into a Sales Agreement on October 11, 2024, allowing for the sale of up to $75 million of common stock through at-the-market offerings[218]. - The company records research and development expenses primarily related to clinical and preclinical trials, with significant judgments made in estimating accrued liabilities[248]. - 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[251].

Core Viewpoint - Benitec Biopharma Inc. is actively participating in several upcoming conferences to showcase its advancements in gene therapy and its proprietary "Silence and Replace" platform [1][2]. Group 1: Upcoming Conferences - Benitec will participate in the Muscular Dystrophy Association Gene Therapy Summit from January 28 to 30, 2025, in Tucson, AZ [2]. - The company will also attend the Guggenheim SMID Cap Biotech Conference on February 5, 2025, in New York, NY, which will include 1x1 meetings [2]. - Additionally, Benitec will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, at 2:00 PM EST, with a format that includes both a presentation and 1x1 meetings [2]. Group 2: Company Overview - Benitec Biopharma Inc. is a clinical-stage biotechnology company based in Hayward, California, focusing on novel genetic medicines [4]. - The company utilizes its proprietary "Silence and Replace" DNA-directed RNA interference platform, which combines RNA interference with gene therapy to target disease-causing genes while delivering wildtype replacement genes [4]. - Benitec is developing therapeutics based on this platform for chronic and life-threatening conditions, including Oculopharyngeal Muscular Dystrophy (OPMD) [4].

Company Insights - Benitec Biopharma Inc. (BNTC) is currently experiencing solid earnings estimate revision activity, indicating a positive outlook from analysts [1][3] - Over the past month, current quarter estimates for Benitec Biopharma have improved from a loss of $1.25 per share to a loss of $1.00 per share, while current year estimates have risen from a loss of $4.33 per share to a loss of $3.58 per share [4] - The company has earned a Zacks Rank 2 (Buy), highlighting its strong position in the market [4] Industry Overview - The Medical - Biomedical and Genetics industry has a Zacks Industry Rank of 63 out of more than 250 industries, indicating a favorable position compared to other segments [2] - The overall positive trends in the industry suggest that a rising tide may benefit multiple securities within this segment [2][5] - Benitec Biopharma is positioned well within a strong industry, making it an intriguing choice for investors [5]

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Exhibit 99.1 Benitec Biopharma Releases First Quarter 2025 Financial Results and Provides Operational Update -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 ...

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 ...