Prothena(US:PRTA)2025-11-06 21:28Investigational Therapeutics - Prothena's investigational therapeutic pipeline includes prasinezumab for Parkinson's disease, BMS-986446 for Alzheimer's disease, and coramitug for ATTR amyloidosis, with potential milestone payments totaling up to $1.23 billion from Novo Nordisk[175]. - Prasinezumab is advancing into Phase 3 development with Roche, targeting approximately 900 participants in the PARAISO trial, focusing on motor progression over at least 104 weeks[165]. - The Phase 2b PADOVA trial for prasinezumab showed a 30-40% relative reduction in motor progression compared to placebo, with a hazard ratio of 0.79 in the levodopa-treated subgroup[166]. - Coramitug has completed a Phase 1 trial demonstrating safety and tolerability, with Novo Nordisk initiating the Phase 3 CLEOPATTRA trial involving approximately 1,280 participants[173][176]. - BMS-986446 received Fast Track designation from the FDA for Alzheimer's disease, with potential milestone payments of up to $563 million and tiered royalties on worldwide net sales[179]. - The Phase 2 TargetTau-1 trial for BMS-986446 will evaluate its efficacy in approximately 310 participants with early Alzheimer's disease, focusing on tau deposition changes over 76 weeks[180]. - Prothena's partnership with Roche for prasinezumab aims to address the underlying causes of Parkinson's disease, which affects approximately 10 million people globally[163]. - The ATTR amyloidosis market includes an estimated 400,000 to 1.4 million patients with wild-type ATTR cardiomyopathy, highlighting the significant unmet medical need[168]. - Prothena's collaboration with Bristol Myers Squibb for BMS-986446 includes an $80 million option exercise fee and a subsequent $55 million fee under a global license agreement[179]. - The Phase 1 clinical trial for BMS-986446 showed a favorable safety profile with no serious treatment-emergent adverse events reported[181]. Financial Performance - Total revenue for the three months ended September 30, 2025, was $2.4 million, a 149% increase from $1.0 million in the same period of 2024[193]. - Collaboration revenue for the nine months ended September 30, 2025, was $9.6 million, a 93% decrease from $133.0 million in the same period of 2024[194]. - Research and development expenses decreased by $21.8 million or 43% for the three months ended September 30, 2025, compared to the same period in 2024[202]. - Total operating expenses for the three months ended September 30, 2025, were $42.7 million, a 37% decrease from $67.5 million in the same period of 2024[198]. - The company incurred restructuring costs of approximately $33.1 million for the nine months ended September 30, 2025, primarily due to the discontinuation of birtamimab development[206]. - Interest income for the three months ended September 30, 2025, was $3.4 million, a 50% decrease from $6.7 million in the same period of 2024[208]. - Interest income decreased by $8.9 million or 44% for the nine months ended September 30, 2025, primarily due to lower cash balances and yields[209]. - Total other income, net decreased by $9.0 million or 45% for the nine months ended September 30, 2025[209]. - The company recorded a benefit from income taxes of $(371,000) for the three months ended September 30, 2025, a decrease of 56% compared to the prior year[211]. - The company expects full year 2025 net cash used in operating and investing activities to be approximately $170 million to $178 million[229]. Cash and Liquidity - Working capital was $288.5 million as of September 30, 2025, a decrease of $148.4 million from $436.9 million as of December 31, 2024[215]. - Cash and cash equivalents decreased to $330.8 million as of September 30, 2025, from $471.4 million as of December 31, 2024[216]. - Net cash used in operating activities was $140.3 million for the nine months ended September 30, 2025, primarily due to ongoing research and development activities[221]. - As of September 30, 2025, the company has $2.7 million of deferred revenue related to the PRX019 Global License Agreement[196]. - The company received an option exercise fee of $80.0 million related to the PRX019 license agreement[185]. Workforce and Restructuring - The company announced a 63% reduction in workforce in June 2025 to reduce operating costs[189]. - The company has contractual obligations totaling $30.9 million as of September 30, 2025, including operating leases and restructuring plan obligations[229]. Credit and Risk Management - The company has not experienced any losses on deposits of cash and cash equivalents[235]. - Cash and cash equivalents are placed with high credit quality financial institutions[234]. - The company limits credit exposure with any one financial institution according to its investment policy[234]. - Deposits held with banks have exceeded federally insured limits[234]. - The company is exposed to credit risk in the event of a default by financial institutions holding its cash and cash equivalents[235]. - Credit risk exposure is recorded on the Condensed Consolidated Balance Sheets[235]. Foreign Exchange and Other Losses - Foreign exchange losses from transactions with vendors denominated in euros amounted to $306,000 for the nine months ended September 30, 2025[210]. - Total liabilities were $57.6 million as of September 30, 2025, compared to $60.2 million as of December 31, 2024[214].