Presented positive clinical and pre-clinical data from its MarzAA and DalcA hemophilia programs

Announced a global license and collaboration agreement with Biogen to develop and commercialize pegylated CB 2782 for Dry AMD

SOUTH SAN FRANCISCO, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (CBIO), today announced its operating and financial results for the fourth quarter and full-year ending December 31, 2019 and provided a corporate update.

We made exceptional progress in both our subcutaneously-dosed (SQ) MarzAA (FVIIa) and SQ DalcA (FIX) programs this past year. Earlier this month at EAHAD, positive data was presented in an oral presentation from the Companys Phase 2b SQ DalcA trial in subjects with hemophilia B clearly demonstrating efficacy and safety. We also presented data from MarzAA and Factor IX gene therapy programs in three posters, said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. Catalysts therapies have demonstrated the potential to effectively treat hemophilia subcutaneously in a $3.4 billion market.

Dr. Usman continued, "Additionally, our February 2020 financing combined with our current cash provides funding through several major milestones for our lead Phase 3 ready MarzAA and Phase 2b DalcA product candidates, as well as our FIX gene therapy and complement inhibitor programs."

Recent Milestones:

Expected Milestones

Fourth Quarter and Full-year 2019 Results and Financial Highlights

About Catalyst Biosciences

Catalyst is a clinical-stage biopharmaceutical company focused on addressing unmet needs in rare diseases and systemic complement mediated disorders. Our protease engineering platform includes development programs in hemophilia and a research program on subcutaneous (SQ) systemic complement inhibitors. Our engineered coagulation factors are designed to overcome the significant limitations of current IV treatment options, facilitate prophylaxis, and ultimately deliver substantially better outcomes for patients using SQ dosing. Our lead asset, MarzAA has completed Phase 2 development having met its primary endpoint of significantly reducing the annualized bleed rate (ABR) in individuals with hemophilia A or B with inhibitors. Our second hemophilia asset, DalcA is completing a Phase 2b clinical trial and is being developed for the treatment of hemophilia B. We also have a global license and collaboration agreement with Biogen for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy associated dry age-related macular degeneration.

For more information, please visit http://www.catalystbiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about the potential uses and benefits of MarzAA and DalcA to effectively and therapeutically treat hemophilia subcutaneously, the potential market opportunity for MarzAA and DalcA, plans to start a Phase 3 trial of MarzAA in second half of 2020 and report final data in the second quarter of 2020 from a MarzAA Phase 1 pharmacokinetic and pharmacodynamic study to support future SQ treatment of bleed studies, to announce final Phase 2b trial data for DalcA in the second quarter of 2020, plans to announce primate data for Factor IX gene therapy in the second quarter of 2020, and potential future milestone and royalty payments from Biogen. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may be delayed and may not have satisfactory outcomes, that additional human trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of DalcA, or MarzAA, including the generation of antibodies, which has been observed in patients previously treated with DalcA, the risk that costs required to develop or manufacture the Companys products will be higher than anticipated, the risk that Biogen will terminate our agreement with them, competition and other risks described in the Risk Factors section of the Companys quarterly report filed with the Securities and Exchange Commission on November 7, 2019, and in other filings with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements, except as required by law.

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Contact:

Ana KaporCatalyst Biosciences, Inc.investors@catbio.com

Catalyst Biosciences, Inc.Consolidated Balance Sheets(In thousands, except shares and per share amounts)

Catalyst Biosciences, Inc.Consolidated Statements of Operations(In thousands, except share and per share amounts)

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Catalyst Biosciences Reports Fourth Quarter and Full-Year 2019 Operating & Financial Results and Provides a Corporate Update - Yahoo Finance

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