Catalyst Biosciences, Inc. - CBIO STOCK NEWS

Catalyst Biosciences (NASDAQ: CBIO) recently presented at the International Conference on Complement Therapeutics (ICCT) from September 8-13, 2021. The focus was on the engineered Complement Factor I (CFI), particularly CB 4332, demonstrating improved pharmacokinetics and efficacy compared to plasma-derived CFI in preclinical models. This first-in-class product aims for weekly subcutaneous administration in patients with CFI deficiency. Catalyst has initiated the ConFIrm study to confirm CFI deficiencies, supporting future IND submissions and global clinical trials for CB 4332.

Catalyst Biosciences (NASDAQ: CBIO) announced the appointment of Jeanne Jew to its Board of Directors, bringing over 25 years of corporate development experience. CEO Nassim Usman expressed excitement regarding her expertise to support the advancement of the company’s Protease Medicines pipeline. Jew has held significant roles in various biopharmaceutical companies, enhancing strategic planning and business development. Catalyst focuses on addressing unmet medical needs in rare disorders with its protease engineering platform, which includes late-stage clinical programs like MarzAA.

Catalyst Biosciences, Inc. (CBIO) announced its second-quarter financial results for 2021, reporting a net loss of $19.9 million, or $0.64 per share, compared to $17.2 million, or $0.96 per share, in 2020. The company had cash reserves of $86.5 million. R&D expenses increased by 19% to $15.4 million, driven by higher clinical and personnel costs. Catalyst continues to advance its complement and hemostasis programs, notably with the launch of the ConFIrm study for CB 4332 and ongoing trials for MarzAA. The company outlined its expected milestones for future development.

Catalyst Biosciences (NASDAQ: CBIO) announced the launch of the ConFIrm study, screening patients for Complement Factor I (CFI) deficiencies to develop CB 4332, an enhanced CFI treatment. The first patient has been screened, aiming for a Phase 1/2 trial in mid-2022. This study will evaluate CFI levels and disease manifestations linked to CFI deficiency, which can lead to severe immune disorders. Catalyst's complement portfolio also includes CB 2782-PEG for dry age-related macular degeneration, licensed to Biogen, with a focus on addressing rare complement-related disorders.

Catalyst Biosciences (NASDAQ: CBIO) presented four key posters at the ISTH 2021 Virtual Congress from July 17-21, highlighting significant findings on Marzeptacog Alfa (MarzAA) and Dalcinonacog Alfa (DalcA). The studies demonstrated MarzAA's effectiveness in treating bleeding in FVII deficient rats and outlined dosage selection strategies for clinical trials, particularly in children with Hemophilia. Additionally, research into DalcA addressed injection site reactions with optimizations in formulation buffers. Catalyst is advancing MarzAA in Phase 3 and Phase 1/2 trials.

Catalyst Biosciences (NASDAQ: CBIO) has announced key management changes, promoting Grant Blouse, Ph.D., to chief scientific officer and Tom Knudsen, DVM, Ph.D., to senior vice president of corporate development. Howard Levy, M.B.B.Ch, Ph.D., M.M.M., will retire as chief medical officer, transitioning to a senior clinical advisor role. These changes aim to strengthen the leadership team as Catalyst advances its SQ hemophilia programs, including SQ MarzAA and SQ DalcA, now in late-stage clinical trials. The company focuses on rare disorders of the coagulation and complement systems.

Catalyst Biosciences (NASDAQ: CBIO) announced four poster presentations at the International Society on Thrombosis and Haemostasis Virtual Congress from July 17-21, 2021. The presentations will focus on marzaptacog alfa (MarzAA) and dalcinanonog alfa (DalcA), highlighting various dose selection strategies and efficacy in treating bleeding disorders. These insights aim to advance the understanding of their engineered proteases, which target rare coagulation disorders. Access to presentation materials will be available on the Catalyst website once the congress begins.

Catalyst Biosciences (NASDAQ: CBIO) will host an R&D day on July 19, 2021, focusing on its protease medicines platform, particularly CB 4332, which addresses complement disorders. Key speaker, Dr. Filomeen Haerynck, will discuss CFI deficiency and unmet medical needs. Catalyst plans to initiate screening studies for CFI deficiency in mid-2021, leading to a Phase 1/2 study for CB 4332 in 2022. The company’s complement pipeline also includes CB 2782-PEG, in development for dry AMD. Registration for the event is available online.

Catalyst Biosciences announced that the FDA has granted a second Fast Track Designation for Marzeptacog alfa (MarzAA), an engineered coagulation Factor VIIa for treating episodic bleeding in patients with Factor VII deficiency.

This designation allows for expedited development and review, facilitating greater access and priority review by the FDA. Catalyst is currently enrolling patients in a Phase 1/2 open-label study for MarzAA and conducting a Phase 3 registration trial for Hemophilia A or B with inhibitors.