-- Subcutaneous Phase 1/2 Proof-of-Concept Clinical Trial of High Potency Factor IX CB 2679d/ISU304 in individuals with Hemophilia B to Commence in the First Quarter of 2017 --
-- Subcutaneous Prophylaxis Clinical Trial of Next-Generation Coagulation Factor VIIa Variant marzeptacog alfa (activated) (formerly CB 813d) in individuals with Hemophilia A or B and an Inhibitor to Commence in 2017 --
-- Sale of Additional Neuronal Nicotinic Receptor Asset Earns Company $750,000 Up-Front Payment --
SOUTH SAN FRANCISCO, Calif., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ:CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced financial results for the third quarter ended September 30, 2016.
“During the third quarter, we refocused the Company on developing our highly potent next-generation Factor VIIa and IX programs using subcutaneous dosing. We and our collaborator ISU Abxis of South Korea remain on track to initiate a Phase 1/2 clinical trial for our next-generation Factor IX CB 2679d/ISU304 in the first quarter of 2017,” said Nassim Usman, Ph.D., Catalyst’s President and Chief Executive Officer. “Since all currently approved hemophilia drugs are infused intravenously, they have significant limitations regarding convenient dosing and the ability to maintain suitable levels of factor activity. We believe that a subcutaneously injected therapy that consistently maintains high factor levels may provide a simpler dosing method and improved long-term clinical outcomes for patients.”
Recent Highlights
• Refocused the Company on development stage programs Factor VIIa and IX to provide convenient subcutaneous prophylaxis to individuals with hemophilia.
• Demonstrated the feasibility of subcutaneous dosing of Factor IX CB 2679d/ISU304 and marzeptacog alfa (activated) in multiple hemophilia animal models.
• Entered into a definitive sales agreement to sell an additional neuronal nicotinic receptor (“NNR”) asset that represents a portion of the NNR assets that were under development by Targacept prior to its 2015 merger with Catalyst; earned a $750,000 upfront payment and the potential for future milestones and royalties.
Anticipated Milestones
• CB 2679d/ISU304, the Company’s high potency Factor IX for hemophilia B, is expected to enter a Phase 1/2 proof of concept subcutaneous trial in the first quarter of 2017.
o The trial will be conducted by Catalyst’s collaborator, ISU Abxis (KOSDAQ: 086890) in South Korea.
• Marzeptacog alfa (activated), the Company’s next-generation coagulation Factor VIIa variant, for individuals with hemophilia A or B and an inhibitor, is expected to enter a subcutaneous efficacy of prophylaxis trial in 2017.
Financial Results for the Third Quarter Ended September 30, 2016
• Contract revenue for the three months ended September 30, 2016 and 2015 was $0.1 million.
• Research and development expense for the three months ended September 30, 2016 was $3.4 million, compared to $1.5 million for the prior year period. The increase was due primarily to increased manufacturing expenses for marzeptacog alfa (activated), personnel costs related to the Company’s September 2016 reduction in workforce and an increase in lab supply costs and costs related to preclinical third-party R&D service contracts.
• General and administrative expense for the three months ended September 30, 2016 was $2.4 million, compared to $2.5 million for the prior year period. The decrease was due primarily to a decrease in the cost of professional services.
• Interest and other income for the three months ended September 30, 2016 was $0.9 million, compared to $0.3 million for the comparable period in the prior year. The increase was due primarily to the gain related to the sale of NNR assets.
• Net loss for the three months ended September 30, 2016 was $4.8 million, or ($0.40) per basic and diluted share, compared to $5.1 million, or ($0.93) per basic and diluted share for the prior year period.
• Cash, cash equivalents and short-term investments as of September 30, 2016 were $19.5 million. The Company believes that its existing capital resources will be sufficient to meet its projected operating requirements for at least the next 12 months.
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications. Catalyst is focused on the field of hemostasis, including the subcutaneous prophylaxis of hemophilia and facilitating surgery in individuals with hemophilia. Catalyst’s most advanced program is an improved next-generation coagulation Factor VIIa variant, marzeptacog alfa (activated), that has successfully completed an intravenous Phase 1 clinical trial in individuals with severe hemophilia A or B. Catalyst is also developing a next-generation Factor IX variant, CB 2679d/ISU304, that is in advanced preclinical development. For more information, please visit www.catalystbiosciences.com.
