Core Insights - Prothena Corporation plc announced the resignation of Paula Cobb from its Board of Directors as she will join Manifold Bio as Chief Operating Officer, marking a significant transition for the company [1][2] - Cobb has been a part of Prothena's board for six years, contributing to the company's vision and strategy, and her departure leaves the board with 8 directors [2] Company Overview - Prothena is a late-stage clinical biotechnology company specializing in protein dysregulation, with a pipeline of investigational therapeutics aimed at treating neurodegenerative and rare peripheral amyloid diseases [3] - The company leverages decades of scientific research to advance therapeutic candidates for various indications, including ATTR amyloidosis with cardiomyopathy, Alzheimer's disease, and Parkinson's disease [3]

Prothena Corporation FY Conference Summary Company Overview - **Company**: Prothena Corporation (NasdaqGS:PRTA) - **Focus**: Expertise in protein dysregulation with a robust pipeline in neurodegenerative diseases, including Alzheimer's, Parkinson's, and ATTR cardiomyopathy [2][22] Key Programs and Developments - **Phase 3 Programs**: - **Prasunezumab**: Targeting early Parkinson's disease in collaboration with Roche, expected to initiate in Q4 2025 [2][22] - **Coramitug**: Targeting ATTR cardiomyopathy in collaboration with Novo, which has already initiated Phase 3 [2][22] - **Phase 2 Program**: - **PRX019**: Targeting tau in Alzheimer's disease, partnered with Bristol Myers Squibb [2][22] - **Phase 1 Program**: - **PRX012**: An undisclosed target for neurodegeneration, also partnered with Bristol [2][22] Financial Outlook - Prothena anticipates earning up to **$105 million** in clinical milestones in 2026 related to coramitug and PRX019 [2][22] Shareholder Actions - Recently approved a share repurchase program for 2026 to support distributable reserves [2][22] Pipeline Insights - **Alzheimer's Program**: The company is exploring partnerships to advance its amyloid beta program, emphasizing the importance of collaboration for cost efficiency and bandwidth [4][5] - **Transferrin Technology**: Prothena is developing PRX012, which incorporates transferrin technology to enhance blood-brain barrier penetration. Preclinical data is expected in 2026 [7][17][18] Clinical Data and Efficacy - **Amyloid Reduction**: Over **80%** of patients treated with the amyloid beta molecule are reported to be amyloid negative after 18 months [5][6] - **ARIA Rates**: Reported around **40%** for the amyloid beta treatment, with ongoing efforts to mitigate these effects [6][7] - **Coramitug Data**: Recent presentations showed a **50%** difference from placebo in NT-proBNP levels, supporting the move to Phase 3 [24][25] Collaborations and Partnerships - Prothena has established strong collaborations with Roche, Novo, and Bristol Myers Squibb, focusing on scientific dialogue and clinical decision-making [22][26] - The company is actively supporting partner programs as they transition into Phase 3 [26] Regulatory Considerations - The company is preparing for potential IND submissions, with ongoing discussions with the FDA regarding preclinical toxicology requirements [8][9] Market Position and Future Directions - Prothena is positioning itself to leverage its unique constructs in the competitive landscape of Alzheimer's treatments, particularly with its transferrin-based technology [17][40] - The company is closely monitoring developments in the field, including Eli Lilly's studies, to inform its strategic direction [5][40] Conclusion - Prothena Corporation is advancing multiple promising programs in neurodegenerative diseases, with a strong focus on collaboration and innovative technologies to enhance treatment efficacy and patient outcomes [2][22][40]

Prothena Corporation (NasdaqGS:PRTA) FY Conference Summary Company Overview - Prothena Corporation is focused on developing therapies for neurodegenerative diseases, with a robust pipeline of partnered programs and a strategic approach to clinical milestones and business development opportunities [1][2][4]. Pipeline Strategy - The company has two late-stage programs in Phase 3: - **Prasinezumab** for early Parkinson's disease, partnered with Roche, with a trial initiation expected in Q4 2025 [2][6]. - **Coramitug** for ATTR cardiomyopathy, partnered with Novo, which has already initiated its Phase 3 trial [2][20]. - Prothena aims to achieve $105 million in clinical milestones from Coramitug and PRX019 in the near term [3][49]. Key Programs Prasinezumab - Prasinezumab targets alpha-synuclein, a protein implicated in the progression of Parkinson's disease, and aims to be the first disease-modifying therapy for this condition [6][7]. - The Phase 3 trial design incorporates learnings from previous Phase 2 studies, focusing on time to motor progression as the primary endpoint [10][11]. - Roche estimates a market opportunity of approximately $3.5 billion for this asset [12]. Coramitug - Coramitug targets the deposited forms of transthyretin in ATTR cardiomyopathy, differentiating itself from existing therapies that either inhibit synthesis or stabilize the protein [17][18]. - The Phase 2 data showed a significant reduction in NT-proBNP levels, indicating cardiac health improvement, and a potential for rapid effects [19][23]. - Novo has initiated a Phase 3 study with a primary endpoint focused on cardiovascular events [27][28]. PRX019 - This program targets Tau in Alzheimer's disease and is currently in Phase 1, with potential for significant market opportunity in the multi-billion dollar range [46][48]. Financial Aspects - Prothena has received $135 million in upfront and clinical milestone payments from Roche for Prasinezumab, with an additional $620 million in potential milestone payments remaining [15][34]. - The partnership with Novo includes $100 million in milestone payments, with a total remaining potential of $1.13 billion, structured to avoid future taxes [34][36]. Business Development and Future Outlook - Prothena is exploring unpartnered programs and technologies, such as CyTOPE, to enhance shareholder value through potential partnerships [4][50]. - The company plans to announce a share repurchase program in 2026, reflecting a commitment to financial prudence [4][49]. - The upcoming milestones and data readouts from ongoing studies are expected to create significant value for investors over the next few years [48][49]. Conclusion - Prothena Corporation is strategically positioned with a strong pipeline and partnerships, focusing on innovative therapies for neurodegenerative diseases. The company is set to achieve key clinical milestones and explore further business development opportunities, making it a compelling prospect for investors looking towards 2026 and beyond [1][4][50].

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Core Insights - Prothena Corporation (PRTA) reported a third-quarter 2025 adjusted loss per share of 67 cents, which was wider than the Zacks Consensus Estimate of a loss of 60 cents, compared to a loss of $1.10 per share in the same quarter last year [1][7] - Revenues for the quarter totaled $2.4 million, significantly missing the Zacks Consensus Estimate of $25 million, and up from $0.1 million in the year-ago quarter [1][7] Financial Performance - Research and development (R&D) expenses decreased by 42.9% year over year to $28.9 million, attributed to lower clinical trial, manufacturing, personnel, and consulting expenses [4] - General and administrative expenses were reported at $13.2 million, down 21% year over year [4] - As of September 30, 2025, Prothena had $331.7 million in cash, cash equivalents, and restricted cash, with no debt [4][7] Pipeline Developments - Prothena is collaborating with Roche to evaluate prasinezumab for the treatment of Parkinson's disease, with Roche set to initiate the late-stage PARAISO study by the end of 2025, expecting peak sales potential of over $3.5 billion [5] - Novo Nordisk has acquired Prothena's clinical-stage antibody, Coramitug, for treating ATTR amyloidosis with cardiomyopathy, and has initiated the late-stage CLEOPATTRA study [6] - Prothena is advancing an early-stage pipeline for neurological indications in collaboration with Bristol Myers Squibb (BMY), including BMS-986446, which has received Fast Track designation from the FDA for Alzheimer's disease [8][9] Future Expectations - Prothena anticipates earning a clinical milestone when enrollment criteria are met in the ongoing phase III study by Novo Nordisk [8] - The company expects a net cash burn from operating and investing activities in 2025 to be between $170 million and $178 million, with a projected year-end cash balance of approximately $298 million [12] - The projected net loss for 2025 is estimated to be in the range of $240 million to $248 million [12]

Core Insights - Prothena reported a quarterly loss of $0.67 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.60, but an improvement from a loss of $1.10 per share a year ago, indicating an earnings surprise of -11.67% [1] - The company generated revenues of $2.42 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 90.26%, compared to revenues of $0.97 million in the same quarter last year [2] - Prothena's shares have declined approximately 25.9% year-to-date, contrasting with the S&P 500's gain of 15.6% [3] Future Outlook - The future performance of Prothena's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4] - The current consensus EPS estimate for the upcoming quarter is -$0.42 on revenues of $36.25 million, and for the current fiscal year, it is -$4.45 on revenues of $38.26 million [7] - The Zacks Industry Rank places the Medical - Biomedical and Genetics sector in the top 41% of over 250 Zacks industries, suggesting a favorable industry outlook [8] Estimate Revisions - Prior to the earnings release, the estimate revisions trend for Prothena was favorable, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expectations of outperforming the market in the near future [6] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Investigational 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].

Financial Performance - Prothena reported a net loss of $36.5 million for Q3 2025, compared to a net loss of $59.0 million in Q3 2024, and a net loss of $222.5 million for the first nine months of 2025, compared to $64.4 million in the same period of 2024[12]. - Total revenue for Q3 2025 was $2.4 million, up from $1.0 million in Q3 2024, and $9.7 million for the first nine months of 2025, down from $133.0 million in the same period of 2024[13]. - Collaboration revenue for Q3 2025 was $2,415,000, a significant increase from $970,000 in Q3 2024, representing a growth of 149.4%[24]. - Total revenue for the nine months ended September 30, 2025, was $9,663,000, down from $133,034,000 in the same period of 2024, indicating a decline of 92.7%[24]. - The net loss for Q3 2025 was $36,541,000, an improvement from a net loss of $59,001,000 in Q3 2024, showing a reduction of 38.0%[24]. - Basic and diluted net loss per ordinary share for Q3 2025 was $0.68, an improvement from $1.10 in Q3 2024[24]. Expenses - Research and development (R&D) expenses decreased to $28.9 million in Q3 2025 from $50.7 million in Q3 2024, and to $120.3 million for the first nine months of 2025 from $172.3 million in the same period of 2024[14]. - General and administrative (G&A) expenses decreased to $13.2 million in Q3 2025 from $16.8 million in Q3 2024, and to $46.7 million for the first nine months of 2025 from $50.4 million in the same period of 2024[15]. - Research and development expenses for Q3 2025 were $28,938,000, compared to $50,723,000 in Q3 2024, reflecting a decrease of 42.9%[24]. - The company reported restructuring costs of $479,000 in Q3 2025, while there were no such costs reported in Q3 2024[24]. Cash Position - Prothena's cash position at the end of Q3 2025 was $331.7 million, with no debt[17]. - Cash and cash equivalents decreased to $330,843,000 as of September 30, 2025, compared to $471,388,000 at the end of 2024, a decline of 29.8%[25]. - The company expects to end 2025 with approximately $298 million in cash, driven by an estimated net loss of $240 to $248 million for the year[19]. Assets and Liabilities - Total assets decreased to $352,628,000 as of September 30, 2025, down from $547,108,000 at the end of 2024, a decline of 35.5%[25]. - Total liabilities were $57,639,000 as of September 30, 2025, slightly down from $60,182,000 at the end of 2024, a decrease of 2.6%[25]. - Total current liabilities increased to $51,436,000 as of September 30, 2025, compared to $48,501,000 at the end of 2024, an increase of 4.0%[25]. Clinical Developments - Prothena has the potential to earn up to $105 million in aggregate clinical milestone payments by the end of 2026 related to the advancement of coramitug and PRX019[4]. - Novo Nordisk initiated the Phase 3 CLEOPATTRA clinical trial for coramitug, and Roche plans to initiate the Phase 3 PARAISO clinical trial for prasinezumab by the end of 2025[4]. - Bristol Myers Squibb obtained Fast Track designation from the U.S. FDA for BMS-986446, currently in a Phase 2 trial with primary completion expected in the first half of 2027[4]. Corporate Actions - Prothena will convene an Extraordinary General Meeting on November 19, 2025, to seek shareholder approval for a proposal to reduce share capital to support a potential share redemption program in 2026[20].

Core Insights - Prothena Corporation (PRTA) announced that Bristol-Myers Squibb (BMS) received Fast Track Designation from the FDA for BMS-986446, an anti-tau antibody currently in Phase 2 trials for Alzheimer's disease [1] Company Summary - Prothena Corporation is involved in the development of therapies for neurodegenerative diseases, with a focus on Alzheimer's disease [1] - The Fast Track Designation is a significant regulatory milestone that may expedite the development and review process for BMS-986446 [1] Industry Summary - The Alzheimer's disease treatment market is seeing increased interest and investment, particularly in innovative therapies targeting tau proteins [1] - Fast Track Designation by the FDA is a critical factor that can enhance the competitive positioning of companies developing treatments for Alzheimer's disease [1]

Core Insights - Prothena Corporation's shares have decreased by 40% year-to-date, contrasting with a 6.6% gain in the industry, primarily due to pipeline setbacks [1][8] - The company is working to advance other pipeline projects after halting the development of birtamimab, but challenges persist [1] Pipeline Updates - Prothena provided an update on PRX012, a candidate for early symptomatic Alzheimer's disease, showing promising results in a phase I program [3][4] - PRX012 demonstrated a mean reduction in amyloid PET to 27.47 centiloids at the 400 mg dose level after 12 months, which is favorable compared to FDA-approved anti-Aβ antibodies [4] - However, PRX012 exhibited higher overall ARIA-E rates, raising concerns about its suitability for the studied patient population [5] - The company plans to seek partnerships to advance PRX012 and its preclinical PRX012-TfR antibody, which may reduce ARIA risks and enhance amyloid clearance [6][8] Recent Developments - Novo Nordisk will advance coramitug, an amyloid depleter antibody, into a phase III program for ATTR amyloidosis with cardiomyopathy in 2025, which Prothena initially developed [9] - Prothena is eligible for up to $1.2 billion in milestone payments from Novo Nordisk, having already earned $100 million [10] Setbacks and Workforce Changes - The discontinuation of birtamimab's development was announced in May 2025 after it failed to meet primary endpoints in a late-stage study [11] - Following this, Prothena implemented a 63% workforce reduction to streamline costs and support ongoing programs [12] Partnered Programs - Roche is advancing prasinezumab into phase III development for early-stage Parkinson's disease, with initiation expected by the end of 2025 [13][14] - Prothena will receive double-digit teen royalties on net sales of prasinezumab [14] - Bristol Myers is conducting phase II and phase I trials for potential Alzheimer's treatments, with Prothena collaborating on several early-stage programs [15][16] Overall Outlook - Despite progress in partnered programs, setbacks in wholly owned programs present significant challenges for Prothena [17]