Trial of the century

Benitec Biopharma Releases Full Year 2022 Financial Results and Provides Operational Update

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Friday, September 2, 2022
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HAYWARD, Calif., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (Benitec or the 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 financial results for its Fiscal Year ended June 30, 2022.

Key Points: 
  • HAYWARD, Calif., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (Benitec or the 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 financial results for its Fiscal Year ended June 30, 2022.
  • The Company has filed its annual report on Form 10-K for the quarter ended June 30, 2022, with the U.S. Securities and Exchange Commission.
  • Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma.
  • 52-weeks of post-dosing follow-up for conclusive evaluation of the primary and secondary endpoints of the Phase 1b/2a BB-301 treatment study.

DGAP-News: ABIVAX: Abivax announces successful oversubscribed EUR 49.2M cross-over financing with top-tier US and European Biotech investors

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Friday, September 2, 2022
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Abivax is highly committed to fully exploit the anti-inflammatory potential of our lead compound obefazimod across different indications, starting with moderate to severe ulcerative colitis.

Key Points: 
  • Abivax is highly committed to fully exploit the anti-inflammatory potential of our lead compound obefazimod across different indications, starting with moderate to severe ulcerative colitis.
  • Didier Blondel, CFO of Abivax, added: We are pleased that Abivax could attract new top-tier US biotech investors, TCGX, Venrock and Deep Track Capital, as well as our existing US and European biotech investors, for the capital increase and royalty certificates.
  • EUR 5.5M split between EUR 4.8M paid under the Kreos loans and EUR 0.7M paid under the OCEANE convertible bonds).
  • Therefore, an additional non-dilutive and/or dilutive financing of EUR 154M is required to complement the EUR 46M proceeds of the Transaction.

Exagen Inc. Collaboration Leads to Characterization of Broad Autoreactivity in Severe COVID-19 Patients

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Thursday, September 1, 2022
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Exagens clinical test offerings, run on samples from severe COVID-19 patients, helped researchers from Emory characterize the autoimmune profiles induced by SARS-CoV-2 infection.

Key Points: 
  • Exagens clinical test offerings, run on samples from severe COVID-19 patients, helped researchers from Emory characterize the autoimmune profiles induced by SARS-CoV-2 infection.
  • These efforts will assess the importance of long-term autoimmune monitoring in those patients experiencing lasting symptoms following acute pulmonary infection, including those caused by SARS-CoV-2.
  • Mathew Woodruff, PhD is a researcher at the Lowance Center for Human Immunology and the Division of Rheumatology at Emory School of Medicine.
  • We are excited to have partnered with Exagen on this important work investigating the origins of emerging self-targeted antibody responses in severe COVID-19.

SYNAPS Dx Honors Researchers, Providers, Patients and Families During World Alzheimer’s Month

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Thursday, September 1, 2022
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SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimers disease (AD), recognizes World Alzheimers Month and the extraordinary progress in diagnosing the disease.

Key Points: 
  • SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimers disease (AD), recognizes World Alzheimers Month and the extraordinary progress in diagnosing the disease.
  • "One of the challenges in managing patients with AD is getting an accurate, early diagnosis.
  • SYNAPS Dx is a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer's disease (AD).
  • SYNAPS Dx's laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity clinical laboratory testing.

Sernova Receives Second Tranche Equity Investment from Evotec of $6.8 Million at a Price of $2.50 Per Share

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Thursday, September 1, 2022
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Upon completion of the second tranche, Evotecs strategic investment in Sernova totals $27,098,000.

Key Points: 
  • Upon completion of the second tranche, Evotecs strategic investment in Sernova totals $27,098,000.
  • Evotecs investment at $2.50 per share, significantly more than double yesterdays closing price, reflects the value our strategic partner places on Sernova relative to the current trading price on the TSX, commented Dr. Philip Toleikis, President and CEO of Sernova Corp.
  • The dedication and synergy of our mutual teams to advance the iPSC diabetes program expeditiously has been impressive.
  • In May 2022, Sernova and Evotec entered into a global strategic collaboration to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy.

Immusoft Announces FDA Clearance of IND Application for ISP-001 for MPS I, the First Engineered B Cell Therapy to Enter into Clinical Trials

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Thursday, September 1, 2022
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The open IND enables Immusoft to initiate a Phase 1 clinical study.

Key Points: 
  • The open IND enables Immusoft to initiate a Phase 1 clinical study.
  • This milestone is both significant for Immusoft and historic in the field of cell and gene therapies, as ISP-001 will be the first engineered B cell therapy to enter into human clinical trials.
  • Children with MPS I require frequent infusions, which impacts quality of life and is expensive.
  • We are pleased with the FDAs clearance of our IND application for our lead candidate ISP-001 in MPS I.

Ibex Reports Excellent Outcomes for AI-supported Diagnosis of Breast Cancer

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Thursday, September 1, 2022
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TEL AVIV, Israel, Sept. 1, 2022 /PRNewswire/ -- Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, today announced outstanding outcomes for the Galen™ Breast solution in diagnosing multiple cancer types and further expansion of its AI portfolio for breast cancer diagnosis. The CE-Marked AI solution is generally available as Ibex partners with laboratories, hospitals and health systems across Europe to deploy Galen™ Breast into their routine workflow, supporting improved quality and efficiency in the diagnosis of breast biopsies.

Key Points: 
  • TEL AVIV, Israel, Sept. 1, 2022 /PRNewswire/ -- Ibex Medical Analytics , the leader in AI-powered cancer diagnostics, today announced outstanding outcomes for the Galen Breast solution in diagnosing multiple cancer types and further expansion of its AI portfolio for breast cancer diagnosis.
  • Breast cancer is the most common malignant disease in women worldwide, with over two million new cases each year.
  • Over the last several years, rapid advances in personalized medicine have resulted in a growing complexity of cancer diagnosis.
  • Galen Breast demonstrated excellent outcomes in a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel.

Vyluma Completes Last Patient Visit for Primary Analysis of Pivotal Phase III CHAMP Study Evaluating NVK002 for the Treatment of Myopia Progression in Children

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Thursday, September 1, 2022
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The CHAMP study has been designed, in collaboration with FDA, to evaluate whether NVK002 eye drops are safe and effective as a treatment for the progression of myopia in children.

Key Points: 
  • The CHAMP study has been designed, in collaboration with FDA, to evaluate whether NVK002 eye drops are safe and effective as a treatment for the progression of myopia in children.
  • With this milestone, Vyluma remains on track for primary analysis readout later this year and regulatory submission in 2023.
  • NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly, which, if approved, would be the first-in-class pharmaceutical treatment for myopia progression in children.
  • Vylumas pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to treat the progression of myopia in children.

DGAP-News: Mainz Biomed to Present at the H.C. Wainwright Annual Global Investment Conference

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Thursday, September 1, 2022
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Mainz Biomed to Present at the H.C. Wainwright Annual Global Investment Conference

Key Points: 
  • Mainz Biomed to Present at the H.C. Wainwright Annual Global Investment Conference
    The issuer is solely responsible for the content of this announcement.
  • BERKELEY, US MAINZ, Germany SEPTEMBER 01, 2022 Mainz Biomed N.V. (NASDAQ:MYNZ) (Mainz Biomed or the Company), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that Bill Caragol, Chief Financial Officer, will present at the H.C. Wainwright Annual Global Investment Conference taking place from September 12-14, 2022.
  • The in-person conference is being held at the Lotte New York Palace Hotel in New York City.
  • To access Mainzs presentation at the Annual Global Investment Conference, please visit https://hcwevents.com/annualconference/ to register for the event.

Mainz Biomed to Present at the H.C. Wainwright Annual Global Investment Conference

Retrieved on: 
Thursday, September 1, 2022
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BERKELEY, Calif. and MAINZ, Germany, Sept. 01, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (Mainz Biomed or the Company), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that Bill Caragol, Chief Financial Officer, will present at the H.C. Wainwright Annual Global Investment Conference taking place from September 12-14, 2022.

Key Points: 
  • BERKELEY, Calif. and MAINZ, Germany, Sept. 01, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (Mainz Biomed or the Company), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that Bill Caragol, Chief Financial Officer, will present at the H.C. Wainwright Annual Global Investment Conference taking place from September 12-14, 2022.
  • The in-person conference is being held at the Lotte New York Palace Hotel in New York City.
  • To access Mainzs presentation at the Annual Global Investment Conference, please visit https://hcwevents.com/annualconference/ to register for the event.
  • The product is commercially available in a selection of countries in the European Union and in the United Arab Emirates.