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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]

Summary of Prothena's Conference Call Company Overview - **Company**: Prothena - **Industry**: Biotechnology, specifically focused on neurodegenerative diseases and amyloidosis Key Points and Arguments 1. **Pipeline Updates**: Prothena has made significant progress in its pipeline, with Roche advancing prasinezumab for Parkinson's disease into a phase three study and Novo moving Kuramitug for ATTR cardiomyopathy into a phase three study as well [4][5] 2. **Restructuring**: The company underwent a restructuring to align its resources with ongoing partnership obligations and to focus on shareholder-friendly activities [13][14] 3. **Financial Milestones**: Prothena anticipates up to $105 million in clinical milestone payments in 2026, contingent on the progress of its partnered programs with Novo and Bristol Myers Squibb [8][16] 4. **Shareholder Returns**: Plans for a share repurchase program are in place, supported by the establishment of distributable reserves through an extraordinary general meeting [11][20] 5. **PRXO12 Data**: The recent data for PRXO12 indicated higher than expected ARIA events, prompting consideration of a transferrin-based approach to mitigate these issues while retaining the drug's efficacy [21][24] 6. **Partnerships**: Prothena has four partnership programs, with two in phase three and one in phase two, which are crucial for the company's future value creation [12][19] 7. **Roche Partnership**: The deal with Roche is valued at $755 million, with $135 million received to date. Roche sees a peak sales opportunity for prasinezumab exceeding $4 billion [32][33] 8. **Novo Partnership**: The partnership with Novo for Kuramitug is valued at $1.23 billion, with $100 million received so far. The next milestone payment is expected to be around $50 million [60][63] 9. **Clinical Development**: Prothena is focused on the clinical development of its partnered assets, with expectations for data releases from ongoing studies [39][70] Additional Important Content 1. **Market Potential**: The market for treatments targeting neurodegenerative diseases and amyloidosis is significant, with increasing demand for effective therapies [43][58] 2. **Competitive Landscape**: The competitive environment is intensifying, with multiple companies developing similar therapies, which could impact Prothena's market positioning [21][22] 3. **Regulatory Considerations**: The timeline for potential partnerships and clinical trials is uncertain, with ongoing discussions expected to take time [29][30] 4. **Scientific Insights**: Prothena's approach to targeting alpha-synuclein in Parkinson's disease is based on empirical data, focusing on the carboxy terminus of the protein for better efficacy [44][46] This summary encapsulates the critical insights from Prothena's conference call, highlighting the company's strategic direction, financial outlook, and ongoing clinical developments.

Core Viewpoint - Prothena's recent earnings report indicates significant losses and revenue misses, but the company is focusing on key pipeline developments that could drive future growth [2][12]. Financial Performance - Prothena reported a second-quarter adjusted loss per share of $1.86, which was wider than the Zacks Consensus Estimate of a loss of $1.11 [2]. - Revenues for the quarter totaled $4.4 million, missing the Zacks Consensus Estimate of $21 million, compared to $132 million in the previous year [2]. - Research and development expenses decreased by 29.5% year-over-year to $40.5 million, attributed to lower clinical trial and manufacturing costs [3]. - General and administrative expenses were slightly reduced to $15.9 million from $16.1 million in the prior year [3]. - As of June 30, 2025, Prothena had $372.3 million in cash and equivalents, with no debt [3]. Pipeline Developments - Prothena is collaborating with Roche on prasinezumab for Parkinson's disease, with phase III development expected to start by the end of 2025 [4]. - The company is evaluating PRX012 for Alzheimer's disease, which has received Fast Track designation from the FDA, with initial data from phase I trials expected soon [5]. - Prothena is advancing several early-stage programs in collaboration with Bristol Myers, including BMS-986446 for Alzheimer's disease [6]. - PRX019, a potential treatment for neurodegenerative diseases, is undergoing a phase I clinical trial, expected to complete in 2026 [8]. - The dual Aβ-Tau vaccine, PRX123, has also received Fast Track designation and is being advanced through efficient funding structures [9][10]. Guidance and Estimates - Prothena expects a net cash burn of $170 to $178 million for 2025, with a projected year-end cash balance of approximately $298 million [12]. - The company anticipates a net loss in the range of $240 to $248 million for 2025 [12]. - Since the earnings release, consensus estimates have shifted upward by 29.35% [13]. Market Position - Prothena holds a Zacks Rank of 3 (Hold), indicating an expectation of in-line returns in the coming months [15]. - The company has an average Growth Score of C, a Momentum Score of A, but a low value score of F, placing it in the bottom 20% for value investors [14].

Company Performance - Prothena reported a quarterly loss of $1.86 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.11, and a significant decline from earnings of $1.22 per share a year ago, indicating an earnings surprise of -67.57% [1] - The company posted revenues of $4.42 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 79.2%, and a stark decrease from year-ago revenues of $132.01 million [2] - Over the last four quarters, Prothena has only surpassed consensus EPS estimates once and has not beaten consensus revenue estimates during the same period [2] Stock Performance - Prothena shares have declined approximately 50.8% since the beginning of the year, contrasting with the S&P 500's gain of 6.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.96 on revenues of $24.8 million, and for the current fiscal year, it is -$3.94 on revenues of $39.34 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Prothena belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, suggesting that the industry outlook could negatively impact stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could be a useful metric for investors [5]