Prothena(US:PRTA)2023-05-04 20:32Investigational Therapies - Prothena's investigational therapeutic birtamimab has shown a significant survival benefit in patients with Mayo Stage IV AL amyloidosis, a rare disease affecting approximately 200,000 to 400,000 patients globally, with 30% categorized as Mayo Stage IV[156][155]. - The confirmatory Phase 3 AFFIRM-AL study for birtamimab is expected to enroll around 150 newly diagnosed patients, with topline data anticipated in 2024[158][157]. - Prasinezumab, an investigational antibody for Parkinson's disease, is part of a collaboration with Roche, with a Phase 2b PADOVA study enrolling 575 patients and topline data expected in 2024[163][160]. - PRX005, an anti-tau antibody for Alzheimer's disease, has advanced to a Phase 1 study, with topline data from the multiple ascending dose portion expected in 2023[174][173]. - PRX012, targeting Amyloid Beta for Alzheimer's disease, is part of Prothena's pipeline aimed at addressing the underlying causes of neurodegenerative diseases[176]. - The lead candidate PRX012 is advancing through a Phase 1 clinical trial, with topline data expected in 2023[181]. - PRX123, a dual Aβ-tau vaccine, is in preclinical development, with an IND filing anticipated in 2023[186]. Financial Performance - Total revenue for the three months ended March 31, 2023, was $2.2 million, an increase of 88% compared to $1.2 million for the same period in 2022[190]. - Collaboration revenue from BMS for US development services related to the Tau/PRX005 program was $2.1 million for the three months ended March 31, 2023, up from $1.1 million in 2022, representing a 92% increase[191]. - Research and development (R&D) expenses increased by $17.5 million, or 64%, to $44.8 million for the three months ended March 31, 2023, compared to $27.3 million in the prior year[193][196]. - General and administrative (G&A) expenses rose by $1.9 million, or 16%, to $13.7 million for the three months ended March 31, 2023, compared to $11.8 million in 2022[200]. - Interest income surged by $6.6 million, or 12,523%, to $6.7 million for the three months ended March 31, 2023, primarily due to higher interest rates and money market balances[202][203]. - The benefit from income taxes increased to $(2.9) million for the three months ended March 31, 2023, compared to $(1.7) million in 2022, reflecting adjustments to deferred tax assets[204]. Cash Flow and Capital - As of March 31, 2023, working capital decreased to $651.5 million from $668.9 million as of December 31, 2022, primarily due to cash use of $58.5 million for operating expenses[206]. - Cash and cash equivalents stood at $686.2 million as of March 31, 2023, with expectations that this will be sufficient to meet obligations for at least the next twelve months[207]. - Net cash used in operating activities was $47.5 million for the three months ended March 31, 2023, compared to $37.4 million for the same period in 2022[212][213]. - Net cash provided by financing activities was $23.3 million for the three months ended March 31, 2023, primarily from net proceeds of $20.7 million from the issuance of ordinary shares[216]. - The company expects full-year 2023 net cash used in operating and investing activities to be approximately $213 million to $229 million[226]. - The company anticipates requiring additional capital in the future for research and development of drug candidates, which may be raised through various financing methods[207]. Obligations and Expenses - Total contractual obligations as of March 31, 2023, amounted to $35.8 million, including $19.7 million in operating leases and $15.7 million in purchase obligations[220][225]. - A foreign currency exchange loss of approximately $141,000 was recorded for the three months ended March 31, 2023, compared to $70,000 in the same period in 2022[228]. - Cash used in investing activities was $48,000 for the three months ended March 31, 2023, primarily related to purchases of property and equipment[215]. Strategic Collaborations - Prothena has received approximately $100 million from Novo Nordisk for the acquisition of its ATTR amyloidosis business, with potential milestone payments totaling up to $1.23 billion[168]. - The global collaboration with Bristol Myers Squibb for neurodegenerative disease research has resulted in Prothena receiving a total of $230 million, with potential additional payments up to $2.2 billion[175]. - The Phase 1 study of NNC6019 for ATTR amyloidosis has shown safety and tolerability, with further studies being conducted by Novo Nordisk[166][169]. Research Focus - Prothena's pipeline includes multiple investigational therapies targeting neurodegenerative diseases, leveraging deep scientific expertise in protein dysregulation[151]. - The company is focusing on discovery programs that address significant unmet medical needs in neurological diseases, including AD and ALS[182].