Exhibit 99.2
Catalyst Biosciences Hosts Research & Development Day Focused on Factor VIIa and Factor IX Hemophilia Programs
SOUTH SAN FRANCISCO, Calif., Dec. 18, 2018 — Catalyst Biosciences, Inc. (NASDAQ: CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, is hosting a Research & Development (R&D) Day today in New York to provide updates on its Factor IX (FIX) dalcinonacog alfa (DalcA) and Factor VIIa (FVIIa) marzeptacog alfa (activated) (MarzAA) hemophilia programs.
Members of the Catalyst management team, including, Nassim Usman, Ph.D., chief executive officer; Howard Levy, M.B.B.Ch., Ph.D., M.M.M., chief medical officer; Fletcher Payne, chief financial officer; and Grant Blouse, Ph.D., vice president of translational research, will be presenting beginning at 12:00 p.m. EST. A live and archived webcast of the event may be accessedhere and on theEvents and Presentations section of the Catalyst website.
“The results of our extensive DalcA immunogenicity risk assessment revealed a similar low immunogenicity potential compared with BeneFIX and other commercial wildtype FIXs; therefore, we will be moving forward with the clinical development of DalcA,” said Dr. Usman. “We plan to initiate a Phase 2b trial that will include 28 days of daily subcutaneous dosing in the first quarter of 2019. Based on the efficacy data that we have previously shown in which subjects achieved high mild hemophilia FIX activity, we believe that DalcA has the potential to provide a conveniently-dosed subcutaneous prophylactic treatment option for those suffering from hemophilia B.”
Dr. Usman continued, “Given the promising interim results from our Phase 2/3 study of MarzAA, in which all five subjects that have completed dosing experienced clinically significant reductions in their annualized bleed rates, and the results of our commercial assessment, showing a several hundred million dollar revenue forecast globally, we believe that MarzAA has significant clinical and commercial potential.”
Select R&D Day Highlights
DalcA
| • | | A comprehensive immunogenicity risk assessment to investigate the development of neutralizing antidrug antibodies in Cohort 6 of the Phase 1/2 program concluded: |
| • | | The DalcA drug product does not appear to be inherently immunogenic. |
| • | | In silico, in vitroandex vivoanalyses indicate that the immunogenicity risk for DalcA is similar to commercial wildtype recombinant FIX products. |
| • | | The DalcA drug product quality is similar to marketed FIX products. |
| • | | 7-day subcutaneousnon-human primate toxicology studies showed that DalcA subcutaneous injections were well tolerated. |