Paradigm Biopharmaceuticals Ltd (ASX:PAR) has remained funded with A$83.9 million past near-term inflection points in its osteoarthritis program, says a study conducted by Edison Investment Research.
The company has revealed a net cash outflow of A$7.8 million in operating activities during the December quarter, including a A$7.4 million R&D tax incentive rebate, and no capital expenditure.
In the analyst's view, demonstrating that an injectable formulation of PPS (iPPS, Zilosul) has a disease-modifying profile, which current clinical biomarker data and animal studies suggest it could, is key to maximising the commercial impact of the drug.
The R&D expenditure increased to A$13.2 million, up 54% from the previous quarter, corresponding with the ongoing recruitment and site identification for the pivotal PARA_OA_002 Phase 3 trial of iPPS in knee osteoarthritis and an increase in other clinical activities.
Looking ahead, the management estimates that operations are funded into 2024, past important clinical milestones in Paradigm’s osteoarthritis program in 2023.
About Paradigm
Paradigm Biopharmaceuticals is an Australia-based, late-stage pharmaceutical company focused on the development of an injectable formulation of iPPS for the treatment of knee osteoarthritis (kOA) and mucopolysaccharidosis types I and VI.
The company is currently conducting a comprehensive clinical program in kOA for which the global pivotal Phase 3 PARA_OA_002 trial and completed the first formal safety review in December 2022.
The management expects the clinical program in kOA to support an NDA filing with the US Food and Drug Administration at the end of 2025.