Prothena(PRTA)

Search documents
Prothena (PRTA) Reports Q2 Loss, Lags Revenue Estimates
ZACKS· 2025-08-04 22:51
Prothena (PRTA) came out with a quarterly loss of $1.86 per share versus the Zacks Consensus Estimate of a loss of $1.11. This compares to earnings of $1.22 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -67.57%. A quarter ago, it was expected that this drug developer would post a loss of $0.92 per share when it actually produced a loss of $1.12, delivering a surprise of -21.74%.Over the last four quarters, the company has su ...
Prothena(PRTA) - 2025 Q2 - Quarterly Report
2025-08-04 20:21
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q _____________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-35676 ______________________________________ PROTHENA CORPORATION PUBLIC LIMITED COMP ...
Prothena(PRTA) - 2025 Q2 - Quarterly Results
2025-08-04 20:15
Exhibit 99.1 PRESS RELEASE Prothena Reports Second Quarter 2025 Financial Results and Business Highlights DUBLIN, Ireland, August 4, 2025 -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today reported financial results for the second quarter and first six months of 2025 and provided business highlights. "We are excited that our partner Roche is advancing prasinezumab into P ...
PRTA Dives 53.5% YTD: Will the Restructuring Effort Boost Prospects?
ZACKS· 2025-07-04 18:56
Core Viewpoint - Prothena Corporation (PRTA) has faced significant challenges, including a 53.5% decline in shares year-to-date, primarily due to pipeline setbacks and a major workforce reduction of 63% to cut operating costs [1][2]. Financial Outlook - PRTA has revised its annual guidance, expecting a net cash burn of $170-$178 million for 2025, with an estimated cash position of approximately $298 million [3]. - The company anticipates a net loss between $240 million and $248 million for 2025, an increase from previous estimates of $197-$205 million [3]. - The estimated loss includes $105-$110 million in operating expenses related to the discontinued birtamimab program and reorganization costs [4]. Pipeline Developments - The discontinuation of birtamimab, a key pipeline candidate, followed the failure of the phase III AFFIRM-AL study to meet its primary endpoint [6][7]. - Despite the setback with birtamimab, partner Roche is advancing the pipeline candidate prasinezumab into phase III development for early-stage Parkinson's disease, which could provide financial benefits to PRTA through royalties and milestone payments [11][12]. Future Programs - PRTA is expecting initial data from a phase I study on its PRX012 program for Alzheimer's disease in August [13]. - The company is also collaborating with Novo Nordisk on Coramitug for ATTR amyloidosis and with Bristol Myers on several early-stage neurological programs, including BMS-986446 for Alzheimer's disease [13][14][15].
Prothena Corporation (PRTA) Earnings Call Presentation
2025-07-03 12:00
Pipeline and Milestones - Prothena has multiple clinical programs ongoing, including one partnered Phase 3 program, two partnered Phase 2 programs, one partnered Phase 1 program, and one wholly-owned Phase 1 program[13] - Prothena is eligible to receive up to $1.23 billion in total consideration from Novo Nordisk for coramitug and the broader ATTR amyloidosis program[13, 16] - Prothena anticipates up to $105 million in clinical milestones in 2026, including completion of Phase 3 development for prasinezumab and initial data from the Phase 1 ASCENT trial for PRX012[18] Partnerships and Financials - Prothena's partnerships are expected to generate meaningful value, with up to $755 million in total milestones and royalties for prasinezumab, up to $1.23 billion for coramitug, and up to $1.55 billion across two clinical-stage programs (BMS-986446 and PRX019)[20] - Bristol Myers Squibb (BMS) owns approximately 2.2% of Prothena's outstanding shares as of March 3, 2025[21] Alzheimer's Disease Programs - PRX012, Prothena's anti-Aβ candidate, has approximately 10X greater binding potency to fibrillar Aβ vs aducanumab and approximately 20X greater binding potency against protofibrils vs lecanemab[24] - BMS-986446 (formerly PRX005), an anti-tau candidate, has the potential to reduce pathogenic tau spread in Alzheimer's disease[27] - PRX123, a dual Aβ/tau vaccine candidate, is designed for both treatment and prevention of Alzheimer's disease, and its IND has been cleared[27] Parkinson's Disease Program - Roche will initiate Phase 3 development for prasinezumab in early-stage Parkinson's disease[15, 111] - The Parkinson's disease affects >10 million people worldwide and represents an overall economic burden of $52 billion in the US[5] ATTR Amyloidosis Program - Coramitug (formerly PRX004) is in Phase 2 development for ATTR amyloidosis with cardiomyopathy (ATTR-CM)[15, 142] - An estimated 450,000 patients worldwide have wtATTR or ATTRv[8]
Prothena's Late-Stage Study for AL Amyloidosis Fails, Stock Down
ZACKS· 2025-05-27 15:21
Core Viewpoint - Prothena (PRTA) shares fell 22.5% after the company announced the discontinuation of birtamimab development due to the failure of the AFFIRM-AL clinical study to meet its primary endpoint [1][5]. Group 1: Birtamimab Development - Birtamimab was a potential best-in-class anti-amyloid antibody aimed at treating AL amyloidosis, evaluated in a phase III global clinical trial with 207 newly diagnosed patients [3][4]. - The primary endpoint of time to all-cause mortality was not met, nor were the secondary endpoints, including the 6-minute walk test and Short Form-36 Physical Component Score [5]. - Despite the failure, birtamimab was reported to be generally safe and well-tolerated [5]. Group 2: Future Plans and Pipeline - Following the discontinuation of birtamimab, Prothena will reduce ongoing operating expenses and organizational size, with further updates expected in June [6]. - The company is also evaluating prasinezumab for Parkinson's disease in collaboration with Roche, which has reported mixed results from the phase IIb PADOVA study [7][8]. - Prothena is advancing early-stage programs for neurological indications, including BMS-986446 for Alzheimer's disease and PRX019 for neurodegenerative diseases, with ongoing clinical trials expected to complete in 2027 and 2026, respectively [9][10].
Why Is Prothena Stock Trading Lower On Tuesday?
Benzinga· 2025-05-27 11:43
Core Viewpoint - Prothena Corporation plc announced disappointing results from the Phase 3 AFFIRM-AL clinical trial for birtamimab, leading to the decision to discontinue its development [3][4]. Group 1: Clinical Trial Details - The Phase 3 AFFIRM-AL trial involved 207 newly diagnosed patients, with birtamimab administered every 28 days at a dose of 24 mg/kg, not exceeding 2500 mg [2]. - Both active and control groups received a bortezomib-containing chemotherapy regimen, with the use of daratumumab permitted [2]. Group 2: Trial Outcomes - The trial did not meet its primary endpoint of time to all-cause mortality (HR=0.915, p-value=0.7680) [3][4]. - Secondary endpoints, including the 6-minute walk test distance (nominal p-value=0.5288) and Short Form-36 version 2 Physical Component Score (nominal p-value=0.9597), were also not met [5]. Group 3: Company Response and Future Plans - Prothena's CEO expressed surprise and disappointment at the trial results, stating that discontinuing birtamimab's development was the most appropriate action [4]. - The company plans to reduce spending, including a substantial workforce reduction, and will evaluate business options to benefit shareholders [6]. - Upcoming data from the Phase 1 ASCENT clinical trials on PRX012 in Alzheimer's disease is expected in August, with additional program updates from partners anticipated in the coming years [6]. Group 4: Market Reaction - Following the announcement, Prothena's stock (PRTA) fell by 26.80%, trading at $4.82 during the premarket session [7].
Prothena Q1 Earnings Miss Estimates, Focus on Key Readouts in 2025
ZACKS· 2025-05-09 18:30
Core Viewpoint - Prothena Corporation reported a wider-than-expected loss per share for Q1 2025, despite improvements in year-over-year performance due to higher revenues and lower expenses [1][5]. Financial Performance - The loss per share for Q1 2025 was $1.12, compared to the Zacks Consensus Estimate of a loss of $0.92, and an improvement from a loss of $1.34 per share in the same quarter last year [1]. - Revenues for Q1 2025 totaled $2.8 million, significantly missing the Zacks Consensus Estimate of $21 million, and a notable increase from $0.1 million in Q1 2024 [2]. - Research and development (R&D) expenses decreased by 20.7% year over year to $50.8 million, attributed to lower clinical trial and manufacturing costs [5]. - General and administrative expenses were $17.6 million, slightly down from $17.5 million in the previous year [5]. - As of March 31, 2025, Prothena had $418.8 million in cash and equivalents, with no debt [5]. - The company expects a net cash burn of $168-$175 million for 2025, with a projected year-end cash balance of approximately $301 million [15]. Stock Performance - Prothena's shares have declined by 48.7% year to date, in contrast to a 7.4% decline in the industry [4]. Pipeline Developments - Prothena is evaluating PRX012, a single-injection antibody for Alzheimer's Disease, with approximately 260 patients enrolled in the ASCENT clinical trials, expecting multiple readouts starting mid-2025 [6]. - The company is advancing BMS-986446, an anti-tau antibody for Alzheimer's, with about 475 patients enrolled in a phase II study expected to complete in 2027 [7]. - PRX019, a potential treatment for neurodegenerative diseases, is in phase I trials, expected to complete in 2026 [8]. - Prothena is developing PRX123, a dual Aβ-Tau vaccine for Alzheimer's, which has received Fast Track designation from the FDA [9][10]. - The company is also evaluating prasinezumab for Parkinson's disease in collaboration with Roche, which is conducting ongoing studies [10][12]. - Prothena is assessing birtamimab for AL amyloidosis, with a phase III study initiated and top-line results expected in Q2 2025 [13]. Guidance - Prothena projects a net loss for 2025 in the range of $197-$205 million [15].
Prothena (PRTA) Reports Q1 Loss, Misses Revenue Estimates
ZACKS· 2025-05-08 22:50
分组1 - Prothena reported a quarterly loss of $1.12 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.92, and an improvement from a loss of $1.34 per share a year ago, indicating an earnings surprise of -21.74% [1] - The company generated revenues of $2.83 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 86.72%, compared to revenues of $0.05 million in the same quarter last year [2] - Prothena's shares have declined approximately 47.4% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] 分组2 - The earnings outlook for Prothena is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.94 on revenues of $21.05 million, and for the current fiscal year at -$3.60 on revenues of $80.55 million [7] - The Medical - Biomedical and Genetics industry, to which Prothena belongs, is currently ranked in the top 33% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]
Prothena(PRTA) - 2025 Q1 - Quarterly Report
2025-05-08 20:15
Clinical Trials and Investigational Therapies - Prothena's investigational therapeutic birtamimab has shown a statistically significant survival benefit of 74% for Mayo Stage IV AL amyloidosis patients treated with birtamimab plus standard of care compared to 49% for placebo plus standard of care at 9 months [165]. - The Phase 3 AFFIRM-AL clinical trial for birtamimab is expected to enroll up to 220 newly diagnosed, treatment-naïve patients with Mayo Stage IV AL amyloidosis, with topline results anticipated in Q2 2025 [164]. - Prasinezumab, an investigational antibody for Parkinson's disease, demonstrated a potential clinical effect with a hazard ratio of 0.84 in the primary endpoint of time to confirmed motor progression in the Phase 2b PADOVA trial [169]. - In the PADOVA trial, prasinezumab showed a more pronounced effect in the levodopa-treated subgroup with a hazard ratio of 0.79, indicating a significant reduction in motor progression [169]. - Coramitug, designed for the treatment of ATTR amyloidosis, targets non-native TTR to improve organ function and has shown promise in preclinical studies for inhibiting amyloid fibril formation [172][177]. - The Phase 3 VITAL clinical trial results indicated that birtamimab-treated patients had a mean decrease of 0.75 in quality of life compared to a mean decrease of 5.40 for placebo, demonstrating a significant quality of life advantage [166]. - A Phase 2 clinical trial for BMS-986446 is being conducted with approximately 475 participants with early Alzheimer's disease, initiated in Q1 2024 [186]. - PRX123, a dual Aβ-tau vaccine, is in development for the potential treatment and prevention of Alzheimer's disease, with preclinical studies showing promising results [190]. - The Phase 1 clinical trial for PRX019 was initiated in November 2024 to evaluate its safety and pharmacokinetics in healthy adults [195]. Financial Performance - Total revenue for the three months ended March 31, 2025, was $2.8 million, a significant increase from $0.1 million in the same period of 2024, representing a 5,556% growth [200]. - Collaboration revenue for the three months ended March 31, 2025, was $2.8 million, compared to nil for the same period in 2024, attributed to the PRX019 Phase 1 Clinical Trial [201]. - Total operating expenses for the three months ended March 31, 2025, were $81.6 million, a decrease of 16% from $68.4 million in the same period of 2024 [205]. - Research and development expenses decreased by $13.3 million for the three months ended March 31, 2025, primarily due to lower clinical trial expenses related to PRX012 [208]. - R&D expenses totaled $50.8 million for the three months ended March 31, 2025, a decrease of 20.6% from $64.1 million in the same period of 2024 [209]. - Interest income decreased by $2.8 million to $4.3 million, a decline of 39% compared to $7.2 million in the prior year, primarily due to lower yields and cash balances [210]. - The benefit from income taxes decreased by $1.0 million or 46%, from $2.2 million in 2024 to $1.2 million in 2025, mainly due to a decrease in capitalized deferred tax assets [212]. Cash and Liabilities - Working capital decreased by $49.2 million to $387.7 million as of March 31, 2025, primarily due to cash used in operating activities of $53.4 million [214]. - Cash and cash equivalents were $417.9 million as of March 31, 2025, sufficient to meet obligations for at least the next twelve months [215]. - Net cash used in operating activities was $53.4 million for the three months ended March 31, 2025, with total operating expenses of $68.4 million [221]. - Total liabilities were $57.7 million as of March 31, 2025, a slight decrease from $60.2 million as of December 31, 2024 [214]. - Contractual obligations included minimum cash payments under operating leases of $11.3 million and purchase obligations of $15.6 million as of March 31, 2025 [226]. - The company expects full year 2025 net cash used in operating and investing activities to be approximately $168 million to $175 million [229]. Regulatory Designations and Collaborations - The company has received Fast Track Designation and Orphan Drug Designation from the FDA for birtamimab, emphasizing its potential as a critical treatment option for AL amyloidosis [159]. - Prothena's partnered programs include prasinezumab for Parkinson's disease in collaboration with Roche, and BMS-986446 for Alzheimer's disease in collaboration with Bristol Myers Squibb [156]. - The FDA granted Fast Track designation for PRX012 in April 2022, aimed at expediting its development for Alzheimer's disease [189]. - The FDA cleared the IND application for PRX019 in December 2023, with potential milestone payments of up to $617.5 million [194]. Investment and Credit Risk - The company places cash and cash equivalents with high credit quality financial institutions [234]. - The investment policy limits credit exposure with any one financial institution [234]. - Deposits held with banks exceed federally insured limits [234]. - The company has not experienced any losses on deposits of cash and cash equivalents [234]. - Credit risk exposure is recorded on the Condensed Consolidated Balance Sheets [234].