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Jun 30, 2021
Gyre Therapeutics Q2 2021 Earnings Report
Catalyst Biosciences reported results for the second quarter of 2021 and provided a corporate update.
Key Takeaways
Catalyst Biosciences reported a net loss of $19.9 million for the second quarter of 2021. The company is advancing its complement and hemostasis programs, with key milestones including the initiation of the ConFIrm study for CFI deficiency and progress in the Crimson 1 Phase 3 registrational study of MarzAA.
Advanced the development of CB 4332, an SQ enhanced CFI development candidate, and screened the first patient in the ConFIrm study for CFI deficiency.
Disclosed new proteases from ProTUNE™ and ImmunoTUNE™ platforms targeting specific disorders of the complement or inflammatory pathways.
Continued progress in the Crimson 1 Phase 3 registrational study of MarzAA in hemophilia A or B with inhibitors and in the Phase 1/2 trial in other rare bleeding disorders.
The FDA granted Fast Track Designation for MarzAA for treatment of episodic bleeding in subjects with Factor FVII deficiency in June 2021.
Gyre Therapeutics
Gyre Therapeutics
Gyre Therapeutics Revenue by Segment
Revenue by Segment
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CapyFin.com Forward Guidance
Catalyst Biosciences expects to advance its CB 2782-PEG program, provide additional preclinical data for the C4b degrader program, submit an IND and initiate a global clinical trial of CB 4332, announce development candidates in lead discovery programs, and present PK and biomarker data for CB 4332. The company also plans to continue enrolling the Crimson 1 Phase 3 registrational and Phase 1/2 trials, submit the first Crimson 1 report to the DSMB, and present PK data from the Phase 1/2 trial.
Positive Outlook
- Advance CB 2782-PEG, the C3 degrader for the potential treatment of dry AMD in collaboration with Biogen towards the clinic
- Provide additional preclinical data supporting continued development of the C4b degrader program and other complement assets
- Submit an IND and initiate global clinical trial of CB 4332
- Announce development candidates in lead discovery programs
- Present PK and biomarker data for CB 4332
Challenges Ahead
- Trials and studies may be delayed as a result of COVID-19, competitive products and other factors
- Trials may not have satisfactory outcomes
- The ConFIrm and ConFIdence trials will not validate the potential market for CB 4332
- Catalyst may elect to terminate or postpone ongoing development programs, including development of MarzAA or any of the Company’s complement assets
- The Company will need to raise additional capital, which may not be available on favorable terms if at all