52 Weeks Make A Year

Centessa Pharmaceuticals to Present Additional 52-Weeks of Continuous Treatment Data from Third Year of Ongoing Phase 2a Study of SerpinPC for the Treatment of Hemophilia at American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Thursday, November 2, 2023

SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.

Key Points: 
  • SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.
  • The Phase 2a study (AP-0101) is a first-in-human open-label multicenter study to investigate the safety, tolerability, pharmacokinetics and efficacy of subcutaneous doses of SerpinPC in male participants with severe hemophilia.
  • The Company has reported results from Parts 1-4, with results from Parts 3 and 4 shared during an oral presentation at ASH on December 10, 2022 .
  • Centessa plans to make the poster available at https://investors.centessa.com/events-presentations after the session concludes and in accordance with ASH’s embargo policy.

Tenaya Therapeutics Announces FDA Clearance to Begin Clinical Testing of TN-401 Gene Therapy for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy

Retrieved on: 
Thursday, October 26, 2023

SOUTH SAN FRANCISCO, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of the company’s Investigational New Drug (IND) application to initiate clinical testing of TN-401.

Key Points: 
  • TN-401 is Tenaya’s adeno-associated virus serotype 9 (AAV9)-based investigational gene therapy product candidate for the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by mutations in the plakophilin-2 (PKP2) gene.
  • Tenaya is currently conducting the RIDGE™ global non-interventional natural history and serotype study of PKP2-associated ARVC.
  • ARVC, also known as arrhythmogenic cardiomyopathy (ACM), is a chronic, progressive, familial disease that typically presents before age 40.
  • People with ARVC experience symptoms related to ventricular arrhythmias, including palpitations, lightheadedness and fainting, and are at increased risk of sudden cardiac death.

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.

Hibbett Reports Fourth Quarter and Fiscal 2023 Results

Retrieved on: 
Friday, March 3, 2023

Hibbett, Inc. (Nasdaq/GS: HIBB), an athletic-inspired fashion retailer, provided financial results for its fourth quarter and full year ended January 28, 2023 (“Fiscal 2023”) and business updates.

Key Points: 
  • Hibbett, Inc. (Nasdaq/GS: HIBB), an athletic-inspired fashion retailer, provided financial results for its fourth quarter and full year ended January 28, 2023 (“Fiscal 2023”) and business updates.
  • Mike Longo, President and Chief Executive Officer, stated, “Hibbett delivered a solid performance for the fourth quarter of Fiscal 2023, highlighted by strong top line growth.
  • Comparable sales improved 15.5% over the fourth quarter last year, marking a positive finish to Fiscal 2023.
  • ET on Friday, March 3, 2023, to discuss the Company’s fourth quarter and full year results.

Utz Brands Reports Fourth Quarter and Full Year 2022 Results

Retrieved on: 
Thursday, March 2, 2023

Net sales in the quarter increased 17.9% to $354.7 million compared to $300.9 million in the fourth quarter of 2021.

Key Points: 
  • Net sales in the quarter increased 17.9% to $354.7 million compared to $300.9 million in the fourth quarter of 2021.
  • Power Brands’ sales growth versus the prior-year period was led by Utz®, On The Border®, Zapp’s®, Hawaiian®, Boulder Canyon®, and TGI Fridays®.
  • (1) IRI Total US MULO-C, custom Utz Brands hierarchy, on a pro forma basis.
  • (2) IRI does not include certain Partner Brands and Private Label sales that are not assigned to Utz Brands.

Goodfood Achieves Significant Gross Margin Expansion, Improves Adjusted EBITDA(1) by 89% Year-over-Year and Reaffirms Expectation of Positive Adjusted EBITDA(1) in First Half of FY2023

Retrieved on: 
Friday, December 2, 2022

Goodfoods core purpose is to create experiences that spark joy and help our community live longer on a healthier planet.

Key Points: 
  • Goodfoods core purpose is to create experiences that spark joy and help our community live longer on a healthier planet.
  • As a result, we are reconfirming our expected path to return to positive quarterly Adjusted EBITDA1 in the first half of 2023 with continued growth thereafter.
  • Adjusted gross margin is defined as the percentage of adjusted gross profit to net sales.
  • EBITDA, Adjusted EBITDA & Adjusted EBITDA margin: EBITDA is defined as net income or loss before net finance costs, depreciation and amortization and income taxes.

Viston United Swiss AG provides CFIUS Update in Connection with All-Cash Offer to Acquire Petroteq Energy Inc.

Retrieved on: 
Wednesday, August 24, 2022

On May 16, 2022, the Offeror and Petroteq formally submitted to CFIUS a voluntary notice (the Notice) in connection with the transactions contemplated by the Offer.

Key Points: 
  • On May 16, 2022, the Offeror and Petroteq formally submitted to CFIUS a voluntary notice (the Notice) in connection with the transactions contemplated by the Offer.
  • On August 22, 2022, the United States Department of the Treasury notified the Offeror and Petroteq that CFIUS has rejected the Notice.
  • The time for acceptance of the Offer is 5:00 p.m. (Toronto time) on September 9, 2022 (the Expiry Time).
  • The Offer is expressed in Canadian dollars but Shareholders may elect to receive their consideration in the U.S. dollar equivalent amount.

CinCor Reports Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Monday, August 8, 2022

WALTHAM, Mass., Aug. 08, 2022 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (NASDAQ: CINC) today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update.

Key Points: 
  • We look forward to continuing the clinical momentum with topline data for HALO expected to read out in the second half of 2022.
  • In July 2022, CinCor completed enrollment in the Phase 2 HALO trial with 249 patients randomized.
  • CinCor, founded in 2018, is a clinical-stage biopharmaceutical company with a mission to bring innovation to the pharmaceutical treatment of cardio-renal diseases.
  • CinCor undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Viston United Swiss AG Provides Update on Recent Discussions With Petroteq Energy Inc.

Retrieved on: 
Friday, June 10, 2022

Viston United Swiss AG (Viston), together with its indirect, wholly-owned subsidiary, 2869889 Ontario Inc. (the Offeror) is providing an update on the Offerors all-cash offer (the Offer) to acquire all of the issued and outstanding common shares (Common Shares) of Petroteq Energy Inc. (Petroteq) (TSX-V: PQE; OTC: PQEFF; FSE: PQCF).

Key Points: 
  • Viston United Swiss AG (Viston), together with its indirect, wholly-owned subsidiary, 2869889 Ontario Inc. (the Offeror) is providing an update on the Offerors all-cash offer (the Offer) to acquire all of the issued and outstanding common shares (Common Shares) of Petroteq Energy Inc. (Petroteq) (TSX-V: PQE; OTC: PQEFF; FSE: PQCF).
  • Petroteq has confirmed to Viston the following:
    Petroteqs continued support for the Offer and recommendation to Petroteq shareholders to tender their Common Shares to the Offer.
  • The Offeror is an indirect, wholly-owned subsidiary of Viston, a Swiss company limited by shares (AG) established in 2008 under the laws of Switzerland.
  • Subject to future developments, Viston (and, if applicable, Petroteq) may file additional documents with the Securities and Exchange Commission (the SEC).

Viston United Swiss AG provides CFIUS Update in Connection with All-Cash Offer to Acquire Petroteq Energy Inc.

Retrieved on: 
Wednesday, May 18, 2022

Further to the Declaration filed by the Offeror, the Notice includes additional required information in respect of Petroteq provided by Petroteq.

Key Points: 
  • Further to the Declaration filed by the Offeror, the Notice includes additional required information in respect of Petroteq provided by Petroteq.
  • After responding to comments and questions from CFIUS on the pre-filing materials, the Offeror and Petroteq formally submitted the Notice to CFIUS on May 16, 2022.
  • Viston and the Offeror expect to issue a further update once the Offeror receives notice from CFIUS that the 45-day notice review period has commenced.
  • Subject to future developments, Viston (and, if applicable, Petroteq) may file additional documents with the Securities and Exchange Commission (the SEC).