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Catalyst Biosciences (NASDAQ: CBIO) has appointed Charles Democko as Senior Vice President of Regulatory Affairs, bringing over 20 years of experience in the field. He will spearhead the regulatory strategy for the company’s portfolio targeting rare hematologic and systemic complement-mediated disorders. Democko's previous leadership role at CytomX and his track record in successful marketing applications are expected to bolster Catalyst’s regulatory efforts as it prepares for key milestones. The company’s advanced product candidates include SQ MarzAA and subcutaneous dalcinonacog alfa (DalcA), with Phase 3 trials planned for late 2020.
Catalyst Biosciences (NASDAQ: CBIO) presented preclinical data on its hemophilia B gene therapy, CB 2679d-GT, at the World Federation of Hemophilia Virtual Summit. The therapy demonstrated a 4-fold reduction in blood loss and an 8-fold decrease in bleeding time compared to the Padua variant in mice. Additionally, a pilot study showed stable FIX expression levels above baseline in non-human primates. Catalyst's innovative gene therapy could offer advantages over existing AAV-based options. Future studies, including a Phase 3 trial for SQ MarzAA, are planned for late 2020.
Catalyst Biosciences (NASDAQ: CBIO) announced a public offering of its common stock, subject to market conditions. The company plans to grant underwriters a 30-day option to purchase an additional 15% of shares. Proceeds will support general corporate purposes, including research, development activities for marzeptacog alfa and dalcinonacog alfa, and working capital needs. The offering is based on a previously effective shelf registration statement with the SEC. Raymond James & Associates acts as the sole book-running manager.
Catalyst Biosciences (NASDAQ: CBIO) plans to present a corporate overview at the Raymond James Human Health Innovation Conference on June 18, 2020. CEO Nassim Usman, Ph.D. will lead the presentation at 3:00 PM ET. A live webcast and a recorded version will be accessible for 90 days thereafter. Catalyst is focused on developing treatments for rare hematologic disorders with advanced programs in hemophilia and partnerships including a gene therapy project for age-related macular degeneration with Biogen. More details can be found on their website.
Catalyst Biosciences (NASDAQ: CBIO) announced the completion of its Phase 1 MAA-102 study for Marzeptacog alfa (MarzAA), demonstrating its potential as a subcutaneous treatment for episodic bleeding in hemophilia patients. The company plans to start a Phase 3 trial evaluating MarzAA in 2020. The Phase 1 study results highlighted safety and pharmacokinetic profiles, with positive interim data presented earlier this year. The successful advancement positions Catalyst to address unmet needs in the hemophilia market, expected to disrupt multi-billion dollar treatment paradigms.
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