Catalyst Biosciences, Inc. - CBIO STOCK NEWS

Catalyst Biosciences (NASDAQ: CBIO) has initiated dosing in its Phase 1/2 trial (MAA-202) for MarzAA, a novel subcutaneous treatment for bleeding disorders including FVII deficiency and Hemophilia A. This open-label study will assess the pharmacokinetics, safety, and efficacy of MarzAA. CEO Nassim Usman emphasized the significance of MarzAA as a unique bypassing agent for rapid bleeding treatment. The ongoing Phase 3 study (MAA-304) complements this effort, targeting hemophilia patients on Hemlibra prophylaxis. Updates on the clinical program are expected later this year.

Catalyst Biosciences (NASDAQ: CBIO) will participate in a fireside chat at the Truist Securities Life Sciences Summit on May 17, 2021, at 1:00 PM ET.

Investors can access a live webcast of the presentation through the company’s website, with an archived version available for 90 days post-event. Catalyst focuses on rare disorders, utilizing its engineered protease platform to develop therapies like MarzAA for bleeding disorders and a preclinical C3-degrader program licensed to Biogen for age-related macular degeneration.

Catalyst Biosciences (NASDAQ: CBIO) reported its financial and operational results for Q1 2021, highlighting advances in their Protease Medicines platform. The company plans to initiate a trial for its CFI deficiency candidate, CB 4332, by mid-2021 and has started dosing patients in the Phase 3 trial of MarzAA for hemophilia. Financially, Catalyst had $107 million in cash but reported a net loss of $22.4 million, significantly higher than the prior year's loss of $4.1 million. Research and development expenses rose 28% to $17 million, largely due to increased preclinical costs.

Catalyst Biosciences, Inc. (NASDAQ: CBIO) has commenced dosing in the Crimson 1 Study, a Phase 3 trial for Marzeptacog alfa (activated) – MarzAA, a subcutaneous treatment for bleeding events in congenital Hemophilia A or B patients with inhibitors. This trial is a pivotal step, especially amid the challenges posed by the COVID-19 pandemic. MarzAA is the only subcutaneously administered therapy in development for this purpose. The study's primary goal is to evaluate the efficacy and safety of MarzAA in episodic bleeding treatment, anticipating updates later this year.

Catalyst Biosciences disclosed promising preclinical data for its gene therapy candidate CB 2679d-GT in hemophilia B, published in Blood. The study showed that CB 2679d-GT outperformed the R338L-Padua variant, demonstrating enhanced efficacy with significantly reduced bleeding times. Conducted by Vrije Universiteit Brussel, the findings suggest CB 2679d-GT may allow for lower vector doses in future human trials. This advancement supports further clinical development of CB 2679d-GT as a leading option for hemophilia B treatment.

Catalyst Biosciences (NASDAQ: CBIO) has announced the extension of its patent protection for the lead candidate CB 2782-PEG until at least 2038, following the issuance of U.S. Patent Number 10,954,501 B2. This patent secures intellectual property related to modified proteases that target complement factor 3 (C3), supporting the company’s ongoing work in treating dry age-related macular degeneration (AMD). Catalyst's CEO emphasized the importance of a robust patent estate for future development, aiming to enhance shareholder value through various protease medicine assets.

Catalyst Biosciences (NASDAQ: CBIO) will present a corporate overview at the 20th Annual Needham Virtual Healthcare Conference on April 15, 2021, at 3:00 PM ET. Interested parties can access a live webcast and an archived version available for 90 days. The company focuses on developing treatments for rare disorders, featuring their protease engineering platform, which includes MarzAA, a next-generation coagulation Factor VIIa for episodic bleeding. Additionally, they are collaborating with Biogen on a pre-clinical C3-degrader program for dry age-related macular degeneration.

Catalyst Biosciences (NASDAQ: CBIO) reported fourth quarter and full-year 2020 results on March 4, 2021. The company achieved Fast Track designation for MarzAA, a treatment for hemophilia. Catalyst raised approximately $49.3 million in net proceeds from a financing round, enhancing its total capital to over $130 million. The firm reported a net loss of $18.9 million for Q4 and $56.2 million for the full year. R&D expenses increased to $53 million annually, driven by personnel and research costs. Cash and investments stood at $81.9 million as of year-end 2020.

Catalyst Biosciences, Inc. (NASDAQ: CBIO) will participate in a fireside chat at the Raymond James 42^nd Annual Institutional Investors Conference on March 3, 2021, at 2:10 pm ET. Investors can access a live webcast of the event here. Catalyst focuses on rare disorders related to the complement and coagulation systems, with late-stage programs like MarzAA for bleeding disorders.