RNA-dependent RNA polymerase

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

Retrieved on: 
Thursday, November 30, 2023

BB-301 is the Company’s first gene therapy candidate employing the Silence and Replace approach and is being developed for the treatment of Oculopharyngeal Muscular Dystrophy-related Dysphagia.

Key Points: 
  • BB-301 is the Company’s first gene therapy candidate employing the Silence and Replace approach and is being developed for the treatment of Oculopharyngeal Muscular Dystrophy-related Dysphagia.
  • Dosing of the first subject marks the beginning of the 52-week follow-up period designed to facilitate conclusive evaluation of the primary and secondary endpoints of the BB-301 Phase 1b/2a Clinical Treatment Study.
  • 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 the BB-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.

Benitec Biopharma Releases Full Year 2023 Financial Results and Provides Operational Update

Retrieved on: 
Thursday, September 21, 2023

HAYWARD, Calif., Sept. 21, 2023 (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 DNA-directed RNA interference ("ddRNAi") platform, today announced financial results for its Fiscal Year ended June 30, 2023. The Company has filed its annual report on Form 10-K for the quarter ended June 30, 2023, with the U.S. Securities and Exchange Commission.

Key Points: 
  • The Company has filed its annual report on Form 10-K for the quarter ended June 30, 2023, with the U.S. Securities and Exchange Commission.
  • Dosing with BB-301: 1-day of BB-301 dosing to initiate participation in the Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study.
  • In December 2022, Benitec began screening OPMD subjects at the lead clinical study site in the United States.
  • In January 2023, Benitec announced the enrollment of the first OPMD subject into the OPMD NH Study in the United States.

Benitec Biopharma Inc. Announces Closing of $30 Million Underwritten Public Offering

Retrieved on: 
Friday, August 11, 2023

The pre-funded warrants are immediately exercisable until exercised in full at an exercise price of $0.0001 per share of common stock.

Key Points: 
  • The pre-funded warrants are immediately exercisable until exercised in full at an exercise price of $0.0001 per share of common stock.
  • The common warrants are immediately exercisable at an exercise price of $3.86 per share of common stock and will expire on the fifth anniversary of such initial exercisable date.
  • In addition, Benitec has granted the underwriter a 30-day option to purchase an additional 2,331,606 shares of common stock and/or common warrants to purchase up to an additional 2,331,606 shares of common stock at the public offering price, less discounts and commissions.
  • The aggregate gross proceeds to Benitec from the public offering were approximately $30.9 million (after giving effect to the 458,134 additional shares of common stock and 458,134 additional common warrants sold pursuant to the underwriter’s partial exercise of its over-allotment option), prior to deducting underwriting discounts, commissions and other estimated offering expenses.

Benitec Biopharma Inc. Announces Pricing of $30 Million Underwritten Public Offering

Retrieved on: 
Wednesday, August 9, 2023

The pre-funded warrants, if any, will be immediately exercisable until exercised in full at an exercise price of $0.0001 per share of common stock.

Key Points: 
  • The pre-funded warrants, if any, will be immediately exercisable until exercised in full at an exercise price of $0.0001 per share of common stock.
  • The offering is expected to close on August 11, 2023, subject to customary closing conditions.
  • In addition, Benitec has granted the underwriter a 30 day option to purchase an additional 2,331,606 shares of common stock and/or common warrants to purchase up to an additional 2,331,606 shares of common stock at the public offering price, less discounts and commissions.
  • The aggregate gross proceeds to Benitec from the public offering are expected to be approximately $30 million, prior to deducting underwriting discounts, commissions and other estimated offering expenses.

Benitec Biopharma Receives FDA Clearance of the IND for BB-301 for the Treatment of Oculopharyngeal Muscular Dystrophy

Retrieved on: 
Monday, June 26, 2023

Oculopharyngeal Muscular Dystrophy (OPMD) is a chronic, life-threatening genetic disorder affecting approximately 15,000 patients in the United States, Canada, Western Europe, and Israel.

Key Points: 
  • Oculopharyngeal Muscular Dystrophy (OPMD) is a chronic, life-threatening genetic disorder affecting approximately 15,000 patients in the United States, Canada, Western Europe, and Israel.
  • OPMD patients lose the ability to swallow liquids and solids, resulting in chronic malnutrition, aspiration, and fatal episodes of aspiration pneumonia.
  • Currently, there are no approved therapeutic agents for the treatment of OPMD.
  • “The FDA’s clearance of our IND for BB-301 is a significant milestone for OPMD patients and for Benitec as a Company,” said Jerel A.

Benitec Biopharma to Present at the JMP Securities Life Sciences Conference

Retrieved on: 
Monday, May 8, 2023

HAYWARD, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference ("ddRNAi") platform, today announced that Jerel A.

Key Points: 
  • HAYWARD, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference ("ddRNAi") platform, today announced that Jerel A.
  • Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec will present at the JMP Securities Life Sciences Conference on Tuesday, May 16th, 2023 at 2:00 pm ET.
  • A live webcast of the presentation will be accessible from the Investor section of Benitec’s website at ir.benitec.com .
  • An archived version of the webcast will be available in the Events section of the Investors page of Benitec’s website for 90 days following the event.

Benitec Biopharma to Present at the OPMD International Conference

Retrieved on: 
Monday, May 8, 2023

HAYWARD, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference ("ddRNAi") platform, today announced that Jerel A.

Key Points: 
  • HAYWARD, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference ("ddRNAi") platform, today announced that Jerel A.
  • Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec will present virtually on the BB-301 Clinical Development Program at the Oculopharyngeal Muscular Dystrophy (OPMD) International Conference in Tel Aviv, Israel, on Tuesday, May 16th, 2023 at 12:50 pm Israel Daylight Time.
  • Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec.
  • “Enrollment of OPMD subjects into the Natural History Study at the U.S. clinical trial site is proceeding at a rapid pace, with 9 subjects enrolled to date.

New Data Showcasing Favorable Profile of Bemnifosbuvir for Treatment of COVID-19 and Hepatitis C Presented at 2023 International Conference on Antiviral Research

Retrieved on: 
Tuesday, March 14, 2023

BOSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral direct acting therapeutics for serious viral diseases, today announced the presentation of new Phase 1, in vitro and in vivo data that demonstrate key profile attributes of Atea’s lead drug candidate, bemnifosbuvir, for the treatment of COVID-19 and hepatitis C (HCV). Additionally, new data for AT-752 for dengue and a nucleotide analogue are being presented. These results are being presented at the 36th International Conference on Antiviral Research (ICAR 2023) taking place March 13-17, 2023 in Lyon, France.

Key Points: 
  • Additionally, new data for AT-752 for dengue and a nucleotide analogue are being presented.
  • These results are being presented at the 36th International Conference on Antiviral Research (ICAR 2023) taking place March 13-17, 2023 in Lyon, France.
  • These advantages include a higher barrier to resistance and maintenance of antiviral activity in the presence of COVID-19 variants.
  • Additionally, the combination of bemnifosbuvir and ruzasvir for the treatment of HCV demonstrated potent in vitro synergistic antiviral activity and in vivo preclinical safety without adverse interactions.

Enanta Pharmaceuticals to Present New Data for EDP-235, its 3CL Protease Inhibitor, in Development as an Oral, Once-Daily Treatment for COVID-19, at the 36th International Conference on Antiviral Research

Retrieved on: 
Tuesday, March 14, 2023

Additional preclinical data show EDP-235’s targeted tissue penetration and potential to mitigate rebound in COVID-19 patients.

Key Points: 
  • Additional preclinical data show EDP-235’s targeted tissue penetration and potential to mitigate rebound in COVID-19 patients.
  • Additional preclinical data demonstrate that EDP-235’s optimized tissue targeting may help to minimize viral rebound.
  • To evaluate the impact of EDP-235 treatment on SARS-CoV-2 transmission, infected source animals were co-housed with uninfected contact animals 60 hours post-infection.
  • This high throughput screen identified multiple, structurally diverse, non-nucleoside SARS-CoV-2 RdRp inhibitors as potential starting points for hit optimization.

Ligand Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Wednesday, February 22, 2023

Total revenues for the fourth quarter of 2022 were $50.4 million, compared with $56.4 million for the same period in 2021.

Key Points: 
  • Total revenues for the fourth quarter of 2022 were $50.4 million, compared with $56.4 million for the same period in 2021.
  • Core Captisol sales were $3.3 million for the fourth quarter of 2022, compared with $7.1 million for the same period in 2021.
  • Captisol sales related to COVID-19 were $23.5 million for the fourth quarter of 2022, compared with $28.3 million for the same period in 2021.
  • Contract revenue was $1.5 million for the fourth quarter of 2022, compared with $3.5 million for the same period in 2021.