'We have made a strategic decision to stop the clinical development of MarzAA (engineered FVIIa) and focus solely on our complement programs and protease medicines platform. Based on several factors including a recently updated feasibility assessment, we determined that we cannot continue to develop MarzAA through completion of the ongoing trials. Enrollment in our MarzAA clinical trials has been adversely impacted by several factors, including pandemic-related logistical challenges, competition for subjects, and increasing availability of prophylaxis therapy globally. Given these factors, it is no longer feasible for us to deliver topline data in 2022. We will report on the data obtained in the Crimson-1 trial to date showing that we have successfully treated bleeds with subcutaneous (SQ) MarzAA and have not observed any treatment-related adverse or thrombotic events,' said
'Candidates from our protease platform offer a differentiated approach to complement regulation by rapidly engaging and degrading high abundancy targets in a way antibodies and small molecule inhibitors cannot. We believe that investing in novel solutions for complement-mediated disease will open opportunities in multiple settings ranging from ultra-orphan to large markets with significant unmet needs, including nephrology, inflammation and ophthalmology. We will advance the clinical development of CB 4332, an SQ-dosed enhanced complement Factor I (CFI), as swiftly as possible and continue to generate development candidates from our protease platform that we will either license out or develop on our own. We believe that the complement therapeutics market holds tremendous potential and that investing our resources in these programs is the optimal strategy going forward,' concluded
Complement Program Updates
Presented positive preclinical data on CB 4332 at the
Presented preclinical data on the ProTUNE platform at the
Enrolled the first two CFI deficient subjects in the ConFIdence study, Catalyst's global natural history study designed to assess the clinical outcomes of patients with CFI deficiency and support the CB 4332 development program.
Expected Milestones
Submit an IND for CB 4332.
Announce a development candidate from Catalyst's ProTUNE platform that leverages the Company's knowledge of CFI.
Complete transfer of CBIO supported activities to Biogen for CB 2782-PEG, the C3 degrader for the potential treatment of dry AMD.
Third Quarter 2021 Results and Financial Highlights:
Cash, cash equivalents and, investments, as of
Research and development expenses were
General and administrative expenses were
Interest and other income (expense), net was
Net loss attributable to common stockholders for the three months ended
As of
Conference call
Company management will host a call today,
About
Catalyst is a research and clinical development biopharmaceutical company focused on developing protease therapeutics to address unmet medical needs in disorders of the complement system. Proteases are natural regulators of this biological system. We engineer proteases to create improved or novel molecules to treat diseases that result from dysregulation of the complement cascade. Our complement pipeline consists of a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration (dAMD), an improved Complement Factor I protease CB 4332 for SQ replacement therapy in patients with Complement Factor I (CFI) deficiency and proteases from our ProTUNE C3b/C4b degrader and ImmunoTUNE C3a/C5a degrader platforms designed to target specific disorders of the complement or inflammatory pathways.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include, without limitation, those regarding swiftly moving forward with clinical development of CB 4332, the continued generation of candidates from the protease platform that will either be licensed or self-developed, reduction of burn rate, the potential that complement will open opportunities in multiple disease settings, submitting an IND for CB 4332, announcing a development candidate from our ProTUNE platform that leverages our knowledge of CFI, and successfully completing the transfer of CBIO supported activities to Biogen for CB 2782-PEG, as well as statements about the benefits of our protease engineering platform. 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 clinical trials and preclinical studies may be delayed as a result of COVID-19, competitive products, and other factors, that Biogen could terminate our agreement for the development of CB 2782-PEG, that the Company's complement degraders are not yet in human clinical trials and will require additional manufacturing validation and preclinical testing before entering human clinical trials, that the Company may need to raise additional capital, and other risks described in the 'Risk Factors' section of the Company's Annual Report on Form 10-K filed with the
Contact:
E: investors@catbio.com
(C) 2021 Electronic News Publishing, source