New Risk • Aug 10
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$44m Forecast net loss in 3 years: US$54m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$54m net loss in 3 years). Share price has been volatile over the past 3 months (8.0% average weekly change). Reported Earnings • Aug 07
Second quarter 2026 earnings released: US$0.36 loss per share (vs US$2.34 loss in 2Q 2025) Second quarter 2026 results: US$0.36 loss per share (improved from US$2.34 loss in 2Q 2025). Revenue: US$1.01m (down 77% from 2Q 2025). Net loss: US$18.6m (loss narrowed 85% from 2Q 2025). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings. Tillkännagivande • Jul 31
Prothena Corporation plc to Report Q2, 2026 Results on Aug 06, 2026 Prothena Corporation plc announced that they will report Q2, 2026 results After-Market on Aug 06, 2026 New Risk • Jun 25
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 8.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. This is currently the only risk that has been identified for the company. Board Change • Jun 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 2 experienced directors. 5 highly experienced directors. Independent Chairman Dan Welch was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Breakeven Date Change • May 20
Forecast to breakeven in 2026 The 6 analysts covering Prothena expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$2.42m in 2026. Earnings growth of 72% is required to achieve expected profit on schedule. Tillkännagivande • May 01
Prothena Corporation plc to Report Q1, 2026 Results on May 07, 2026 Prothena Corporation plc announced that they will report Q1, 2026 results After-Market on May 07, 2026 Tillkännagivande • Apr 29
Prothena Corporation plc Announces Novo Nordisk Obtains Fast Track Designation for Coramitug in ATTR Amyloidosis with Cardiomyopathy Prothena Corporation plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to coramitug, a potential best-in-class amyloid depleter antibody currently in Phase 3 development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Fast Track Designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and fill an unmet medical need. Coramitug is a potential best-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy. Coramitug is being evaluated by Novo Nordisk in the ongoing Phase 3 CLEOPATTRA clinical trial in approximately 1,280 participants with ATTR-CM; primary completion expected in 2029. ATTR-CM is a progressive disease caused by the deposition of transthyretin as amyloid in the myocardium. Current therapies may slow disease progression but do not clear existing deposits. Coramitug is a humanized monoclonal antibody that targets misfolded transthyretin, designed to promote clearance of transthyretin amyloid through antibody-mediated phagocytosis. Novo Nordisk is evaluating coramitug in the ongoing Phase 3 CLEOPATTRA clinical trial in approximately 1,280 participants with ATTR-CM with primary completion expected in 2029. Novo Nordisk gained full worldwide rights to the intellectual property and related rights of the ATTR amyloidosis business and pipeline it acquired from Prothena in July 2021. Under the terms of the acquisition agreement, Prothena is eligible to receive up to $1,200 million including an upfront payment and upon achievement of clinical development and sales milestones, with $150 million earned to date. Coramitug is an investigational antibody designed to deplete amyloid associated with disease pathology in hereditary and wild type ATTR amyloidosis, without affecting the native, normal tetrameric form of the protein. Coramitug’s proposed mechanism of action is to deplete both the deposited amyloid to improve organ function and circulating non-native TTR to prevent further organ deposition. This differentiated depleter mechanism of action could be developed as a monotherapy approach to ATTR amyloidosis and might also complement existing therapeutic approaches which either stabilize or reduce production of the native TTR tetramer. In a Phase 2 clinical trial conducted by Novo Nordisk, coramitug 60 mg/kg significantly reduced and improved NT-proBNP from baseline, in a patient population in which the vast majority (>80%) were already receiving standard of care treatment for ATTR-CM. Furthermore, compared with placebo, coramitug was associated with improvements in multiple echocardiographic parameters of cardiac function, and was well-tolerated in participants with ATTR-CM. These findings support the potential of coramitug as an amyloid-clearing immunotherapy for ATTR-CM and provide a rationale for additional clinical investigation of coramitug for the treatment of patients with ATTR-CM. Tillkännagivande • Apr 11
Prothena Corporation plc Announces Executive Changes Prothena Corporation plc announced updates to its leadership team. Annie Kingston is being promoted to Chief Strategy Officer and Michael Isaacs is being promoted to General Counsel and Corporate Secretary. Mr. Isaacs succeeds Michael Malecek who will be departing from the company. Ms. Kingston and Mr. Isaacs will join it’s leadership team and will report to Gene Kinney, Ph.D., President and Chief Executive Officer. Ms. Kingston’s promotion is effective immediately and Mr. Isaacs’ promotion will take effect following Mr. Malecek’s departure in June. Ms. Kingston will lead the Company’s growth strategy aimed at driving sustainable value creation and Mr. Isaacs will be the Company’s most senior legal officer, overseeing the corporate legal function. Tran Nguyen, who previously served as Chief Financial Officer and Chief Strategy Officer, continues to serve as the Company’s Chief Financial Officer. Ms. Kingston joined Prothena in 2023, serving most recently as Vice President, Corporate Strategy and Chief of Staff. Prior to joining Prothena, Ms. Kingston was an Associate Principal and Project Leader at ClearView Healthcare Partners (a life sciences strategy consultancy), where she advised pharmaceutical and biotechnology companies on both product-level and corporate strategy from 2017 to 2023. Prior to that role, she was a consultant at The Dedham Group. She earned her B.A. in Biology and Psychology from Fairfield University. Mr. Isaacs joined Prothena in 2020, serving most recently as Deputy General Counsel. Prior to joining Prothena, he was a Corporate Associate at Arnold & Porter Kaye Scholer LLP from 2015 to 2020. Prior to entering the legal profession, he held multiple research positions, including at the Salk Institute for Biological Studies and Biogen Idec. Mr. Isaacs earned his B.S. in Biology (Microbiology) and his M.S. in Biology (Biochemistry and Biophysics) both from the University of California, San Diego, and his J.D. from Santa Clara University School of Law. Tillkännagivande • Mar 30
Prothena Corporation plc, Annual General Meeting, May 14, 2026 Prothena Corporation plc, Annual General Meeting, May 14, 2026. Location: at the merrion hotel, upper merrion street, ireland., d02 kf79, dublin 2, United States Tillkännagivande • Mar 02
Prothena Corporation plc (NasdaqGS:PRTA) announces an Equity Buyback for $100 million worth of its shares. Prothena Corporation plc (NasdaqGS:PRTA) announces a share repurchase program. Under the program, the company will repurchase up to $100 million worth of its shares. The share repurchase plan will expire on December 31, 2026 Tillkännagivande • Feb 13
Prothena Corporation plc to Report Q4, 2025 Results on Feb 19, 2026 Prothena Corporation plc announced that they will report Q4, 2025 results After-Market on Feb 19, 2026 Tillkännagivande • Dec 13
Prothena Corporation plc Announces Resignation of Paula Cobb from Board of Directors and Member of Compensation and Audit Committee, Effective December 31, 2025 On December 10, 2025, Paula Cobb notified Prothena Corporation plc (Company) of her decision to resign from the Board of Directors of the Company (Board) to join Manifold Bio as its Chief Operating Officer, effective as of December 31, 2025. Ms. Cobb will continue to serve on the Board, the Compensation Committee of the Board, and the Audit Committee of the Board through December 31, 2025. During her six-year tenure, Ms. Cobb played a significant role in which she made key contributions to the Company’s vision and strategy. Her decision to resign was not because of a disagreement with the Company on any matter relating to the Company’s operations, policies, or practices. Tillkännagivande • Nov 20
Prothena Corporation plc Announces Poster Presentation on its TDP-43 CYTOPE Program At Neuroscience 2025 Prothena Corporation plc announced a scientific presentation at Neuroscience 2025, hosted by the Society for Neuroscience (SfN) in San Diego, CA. CYTOPE is a novel drug delivery modality enabling cytosolic delivery of macromolecules in the brain and periphery through an efficient endosomal escape mechanism that preserves membrane and vesicle integrity following systemic administration. This technology potentially allows for targeting of previously undruggable intracellular disease targets. To demonstrate this, the company developed and investigated company developed and investigated company TDP-43 program in multiple preclinical models. Preclinical data from in vivo transgenic mouse model of ALS expressing human mutant TDP-43: Systemically-administered TDP-43 CYTOPE rapidly and efficiently distributed to the brain, internalized into the cytosol and colocalized with intracellular pTDP-43 pathology in rNLS8 mice Systemically-administered T DP-43 CYTOPE significantly reduced intracellular pTDP -43 pathology in rNLS 8 mice; Systemically-administering TDP-43 CYTope significantly reduced intracellular p TDP-43 pathology in r NLS8 mouse motor cortex and neuromuscular junction. Preclinical in vitro data from rat and human-derived neuronal cell lines and human iPSC motor neurons: TDP-43 CYT EUR rapidly and efficiently internalized into the cytosOL and colocalized with pre-formed cytosolic pTDP-43 aggregates; TDP-43 CYTOP promoted significant clearance of cytosolic pTDP -43 aggregates and meaningfully reduced RNA dysregulation driven by cryptic exon inclusions, defining pathogenic features of ALS and other TDP-43 proteinopathies. These results demonstrate the potential of CYTOPE technology as a novel modality for delivering large molecules into cells, enabling precise targeting of intracellular disease pathways. Tillkännagivande • Nov 12
Prothena Corporation plc Highlights Phase 2 Data for Coramitug (Formerly PRX004) Published in Circulation, Official Journal of AHA Prothena Corporation plc announced the publication of Phase 2 clinical trial data for coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody, for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM), in the American Heart Association's journal, Circulation. The Phase 2 clinical trial results were presented during a late-breaking session at the American Heart Association (AHA) Scientific Sessions on November 10, 2025 and simultaneously published in AHA journal, Circulation. Novo Nordisk recently initiated the Phase 3 CLEOPATTRA clinical trial evaluating the effects of coramitug versus placebo on cardiovascular outcomes in participants with ATTR-CM (NCT07207811). Novo Nordisk gained full worldwide rights to the intellectual property and related rights of the ATTR amyloidosis business and pipeline it acquired from Prothena in July 2021. Under the terms of the acquisition agreement, Prothena is eligible to receive up to $1.2 billion dollars upon achievement of clinical development and sales milestones, including $100 million earned to date. Prothena is eligible to earn a clinical milestone payment when prespecified enrollment criteria are met in the CLEOPATTRA Phase 3 clinical trial. Coramitug (formerly PR X004) is an investigational antibody designed to deplete amyloid associated with disease pathology in hereditary and wild type ATTR amyloidosis, without affecting the native, normal tetrameric form of the protein. Coramitug's proposed mechanism of action is to deplete both the deposited amyloid to improve organ function and circulating non-native TTR to prevent further organ deposition. This differentiated mechanism of action could be developed as a monotherapy approach to ATTR amyloidosis and might also complement existing therapeutic approaches which either stabilize or reduce production of the native TTR tetramer. Tillkännagivande • Oct 31
Prothena Corporation plc to Report Q3, 2025 Results on Nov 06, 2025 Prothena Corporation plc announced that they will report Q3, 2025 results After-Market on Nov 06, 2025 Tillkännagivande • Aug 28
Prothena Corporation plc Provides Update on PRX012 and Announces Results from the Phase 1 ASCENT Clinical Program Prothena Corporation plc announced results from the Phase 1 ASCENT clinical program in participants with early symptomatic Alzheimer's disease (AD). As previously communicated, Prothena plans to explore potential partnership interest to advance PRX012 and its preclinical PRX012-TfR (transferrin receptor) antibody. The Phase 1 ASCENT clinical program results demonstrated PRX012 as a potential once-monthly, subcutaneous anti-amyloid beta (Ab) antibody with stable pharmacokinetics, low anti-drug antibodies, low injection site reactions, and dose- and time-dependent reductions in amyloid plaque. At the 400 mg dose level, PRX012 demonstrated a mean reduction in amyloid PET to 27.47 centiloids (CL) at month 12; FDA approved anti-Ab antibodies have defined amyloid negativity thresholds of 30 CL or 24.1 CL. However, PRX012 was associated with higher overall ARIA-E rates relative to FDA approved anti-Ab antibodies, making PRX012 less appropriate for the patients studied in the ASCENT clinical program. When ARIA-E did occur, the characteristics were similar to those reported following treatment with other anti-Ab antibodies. Based on the profile observed in the ASCENT clinical program and feasibility work already completed on its preclinical Ab-transferrin receptor antibody surrogate, Prothena believes this approach may represent an opportunity to significantly lower the risk of ARIA and quickly reduce amyloid plaque with a once-monthly subcutaneous administration. Initial preclinical studies have demonstrated substantially increased brain exposure and facilitated rapid targeting of Ab plaques in an APP/PS1 transgenic mouse model. Prothena does not plan to publicly share additional data from the ASCENT clinical program while it expects to explore potential partnership interest to advanced PRX012 and PRX012-Tf R. The Phase 1 ASCENT Clinical program includes ASCENT-1: a randomized, double-blind, placebo-controlled single-ascending-dose trial; ASCENT-2: a randomized, double- blind, placebo-controlled six-month multiple-dose trial; and ASCENT-3: a twelve-month open-label extension trial. The objectives of the ASCENT clinical program were to determine the safety, tolerability, immunogenicity, and pharmacokinetics of PRX012. The ASCENT-2 and ASCENT-3 trials also evaluated the pharmacodynamics of PRX012, including amyloid plaque deposition as measured by positron emission tomography (PET), in participants with early symptomatic AD. The results include data from the five ASCENT-2 Group A cohorts in 228 participants with early symptomatic AD who are either APOe4 non-carriers or heterozygous carriers ranging in doses of PRX012 from 45 mg to 400 mg, randomized to PRX012 or placebo in a 3:1 ratio. Additional amyloid plaque reduction data from an interim read-out of ASCENT-3, the open-label extension (OLE) trial, was included. ASCENT-2 Group A: Adverse Events1: Placebo 45 mg 70 mg 200 mg2 400 mg (n=57) (n=25) (n=24) (n=24) ("n=97) (n=24) and Treatment Emergent 33 (57.9%) 10 (40.0%) 13 (54.2%) 66 (68.0%) 66 (68.0%). Tillkännagivande • Aug 05
Prothena Corporation plc Provides Earnings Guidance for the Year 2025 Prothena Corporation plc provided earnings guidance for the year 2025. The estimated full year 2025 net cash used from operating and investing activities is primarily driven by an estimated net loss of $240 to $248 million, which includes an estimated $36 million of non-cash share-based compensation expense and a $44.9 million non-cash income tax expense to book a full valuation allowance against its federal deferred tax assets. Tillkännagivande • Jul 29
Prothena Corporation plc to Report Q2, 2025 Results on Aug 04, 2025 Prothena Corporation plc announced that they will report Q2, 2025 results After-Market on Aug 04, 2025 Tillkännagivande • May 24
Prothena Corporation plc Announces Phase 3 AFFIRM-AL Clinical Trial for Birtamimab in Patients with AL Amyloidosis Did Not Meet Primary Endpoint Prothena Corporation plc announced the Phase 3 AFFIRM-AL clinical trial evaluating birtamimab in patients with AL amyloidosis did not meet its primary endpoint (HR=0.915, p-value=0.7680). Based on these results, the Company will discontinue the development of birtamimab, including stopping the open label extension of the AFFIRM-ALclinical trial. In the Phase 3 AFFIR M-AL clinical trial, the primary endpoint of time to all-cause mortality was not met for patients treated with birtamimab. In addition, neither of the secondary endpoints were met: 6-minute walk test distance (nominal p-value=0.5288) and Short Form-36 version 2 Physical Component Score (nominal p-value =0.9597). The Phase 3 AFFIRM -AL clinical trial was a global, double-blind, placebo-controlled, time-to-event clinical trial that enrolled 207 newly diagnosed, treatment naive patients with Mayo Stage IV AL amyloidosis. Birtamimab was given to the active arm every 28 days at a dose level of 24 mg/kg (maximum dose not to exceed 2,500 mg). Tillkännagivande • May 02
Prothena Corporation plc to Report Q1, 2025 Results on May 08, 2025 Prothena Corporation plc announced that they will report Q1, 2025 results After-Market on May 08, 2025 Tillkännagivande • Mar 31
Prothena Corporation plc, Annual General Meeting, May 13, 2025 Prothena Corporation plc, Annual General Meeting, May 13, 2025. Location: at the merrion hotel, upper merrion street, d02 kf79, ireland, dublin United States Tillkännagivande • Feb 21
Prothena Corporation plc Provides Financial Guidance for the Fiscal Year 2025 Prothena Corporation plc provided financial guidance for the fiscal year 2025. For the period, the company expects net loss of $197 million to $205 million. Tillkännagivande • Feb 14
Prothena Corporation plc to Report Q4, 2024 Results on Feb 20, 2025 Prothena Corporation plc announced that they will report Q4, 2024 results After-Market on Feb 20, 2025 Tillkännagivande • Dec 31
Oleg Nodelman to Step Down as Board of Director of Prothena Corporation plc Prothena Corporation plc announced that Oleg Nodelman will step down from Prothena’s Board of Directors to create time to focus on existing and new endeavors. During his five-year tenure, Mr. Nodelman played a pivotal role in which he made significant contributions to the Company’s current strategy. Tillkännagivande • Dec 19
Roche's Phase IIb Study of Prasinezumab Missed Primary Endpoint, But Suggests Possible Clinical Benefit in Early-Stage Parkinson's Disease Prothena Corporation plc announced results from the Phase IIb PADOVA study conducted by partner Roche investigating prasinezumab in 586 people with early-stage Parkinson's disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical effect in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01] and p=0.0657. The effect of prasinezumab was more pronounced in a pre-specified analysis in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99] and nominal p=0.0431. Pre-specified supplemental analyses of these endpoints demonstrated nominally significant effects on the primary endpoint (HR=0.81 [0.67-0.98; nominal p=0.0334) and in the levodopa subgroup (HR=0.76 [0.61-0.95; nominal p=0.0175). Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Prasinezumab continues to be well tolerated and no new safety signals were observed in the study. The Phase IIb PADOVA results along with prior clinical study results will inform future clinical development, including study design, statistical analysis, and appropriate evaluation of patient sub-groups, of prasinezumab as a potential first-in-class disease-modifying treatment for patients with Parkinson's disease. The Phase II PASADENA and Phase IIb PADOVA open-label extension studies will continue in order to explore the observed effects in both studies. Roche will continue to evaluate the data and work together with health authorities to determine next steps. Full results from the PADOVA study will be presented at an upcoming medical meeting. Prasinezumab is an investigational monoclonal antibody designed to selectively bind aggregated a-syn and reduce neuronal toxicity. Parkinson's disease is characterized by the gradual loss of neurons that make dopamine and other nerve cells, and the development of motor and non-motor symptoms that may appear years before diagnosis. Symptoms can vary widely between individuals and disease progression is not predictable, in which symptoms can develop gradually over time or suddenly. Clinical diagnosis of Parkinson's disease is late in the disease course and currently based only on motor symptoms, with non-motor symptoms often preceding diagnosis by up to 20 years. Reported Earnings • Nov 14
Third quarter 2024 earnings released: US$1.10 loss per share (vs US$0.41 profit in 3Q 2023) Third quarter 2024 results: US$1.10 loss per share (down from US$0.41 profit in 3Q 2023). Revenue: US$970.0k (down 99% from 3Q 2023). Net loss: US$59.0m (down 369% from profit in 3Q 2023). Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 35 percentage points per year, which is a significant difference in performance. Tillkännagivande • Nov 06
Prothena Corporation plc to Report Q3, 2024 Results on Nov 12, 2024 Prothena Corporation plc announced that they will report Q3, 2024 results After-Market on Nov 12, 2024 Tillkännagivande • Sep 30
Prothena Corporation plc Announces Appointment of Chad Swanson as Chief Development Officer Prothena Corporation plc announced that Chad Swanson, Ph.D., has been appointed Chief Development Officer and will assume leadership of clinical development and medical functions. Chad will join Prothena’s executive leadership team and will report to Gene Kinney, Ph.D., President and Chief Executive Officer. Hideki Garren, M.D., Ph.D., will pursue an opportunity at a large pharmaceutical company to lead a global product development division. Prothena will initiate a search for a world-class healthcare leader as next Chief Medical Officer. Dr. Swanson is a neuropharmacologist with over 20 years industry experience and joined Prothena as Senior Vice President and Head of Clinical Development in January 2023 from Eisai Inc. where he was the Executive Director of Clinical Research in the Alzheimer’s Disease Brain Health group. In that role, he served as the International Project Team Leader, responsible for all aspects of the lecanemab program. During his 11-year tenure at Eisai, Dr. Swanson delivered a highly innovative Phase 2 dose finding study that established proof of concept for lecanemab in treating early Alzheimer’s disease. Based on those Phase 2 results, he led regulatory submission activities that resulted in the accelerated approval of LEQEMBI™ in January 2023. Prior to his time at Eisai, Dr. Swanson was Senior Scientist and US Head of Neurochemistry, Target Discovery and Assessment at Lundbeck, Inc, where he led several discovery programs, and a laboratory devoted to discovery and preclinical research in psychiatric disease. Dr. Swanson received his Ph.D. from the Medical University of South Carolina in Physiology and Neuroscience, and his B.S. from the University of Wisconsin–Madison in Zoology with neurobiology emphasis. Reported Earnings • Aug 09
Second quarter 2024 earnings released: EPS: US$1.24 (vs US$1.03 loss in 2Q 2023) Second quarter 2024 results: EPS: US$1.24 (up from US$1.03 loss in 2Q 2023). Revenue: US$132.0m (up US$128.0m from 2Q 2023). Net income: US$66.9m (up US$121.5m from 2Q 2023). Profit margin: 51% (up from net loss in 2Q 2023). The move to profitability was driven by higher revenue. Revenue is forecast to grow 41% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 55% per year but the company’s share price has only fallen by 30% per year, which means it has not declined as severely as earnings. Tillkännagivande • Aug 09
Prothena Corporation plc Revises Financial Guidance for the Full Year of 2024 Prothena Corporation plc revised financial guidance for the full year of 2024. For the period, the company net cash used in operating and investing actives, and expects it to be $148 million to $160 million (versus prior guidance $208 million to $225 million) and expects to end the year with approximately $468 million (midpoint) in cash, cash equivalents and restricted cash, representing an increase of $63 million from prior guidance of $405 million (midpoint). This increase in cash position is primarily driven by Bristol Myers Squibb obtaining the $80 million exclusive worldwide rights for PRX019, offset by increased spend on company clinical stage programs including PRX019. The updated estimated full year 2024 net cash used from operating and investing activities is primarily driven by an updated estimated net loss of $120 million to $135 million (versus prior guidance of $229 million to $255 million), which includes an estimated $48 million of non-cash share-based compensation expense. Tillkännagivande • Aug 02
Prothena Corporation plc to Report Q2, 2024 Results on Aug 08, 2024 Prothena Corporation plc announced that they will report Q2, 2024 results After-Market on Aug 08, 2024 Reported Earnings • May 09
First quarter 2024 earnings released: US$1.35 loss per share (vs US$0.89 loss in 1Q 2023) First quarter 2024 results: US$1.35 loss per share (further deteriorated from US$0.89 loss in 1Q 2023). Revenue: US$50.0k (down 98% from 1Q 2023). Net loss: US$72.2m (loss widened 54% from 1Q 2023). Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 42% per year but the company’s share price has increased by 6% per year, which means it is well ahead of earnings. Tillkännagivande • May 03
Prothena Corporation plc to Report Q1, 2024 Results on May 08, 2024 Prothena Corporation plc announced that they will report Q1, 2024 results After-Market on May 08, 2024 Tillkännagivande • Mar 30
Prothena Corporation plc, Annual General Meeting, May 14, 2024 Prothena Corporation plc, Annual General Meeting, May 14, 2024, at 15:00 Coordinated Universal Time. Location: The Merrion Hotel, Upper Merrion Street Dublin 2 Ireland Agenda: To elect directors, to hold office until no later than the annual general meeting of shareholders in 2027; to ratify the appointment of KPMG LLP as the company's independent registered public accounting firm for its fiscal year ending December 31, 2024, and to authorize, in a binding vote, the company's Board of Directors, acting through its Audit Committee, to approve the remuneration of that auditor; to approve the compensation of the company's executive officers named in the Proxy Statement accompanying this Notice; to approve an amendment to the company's 2018 Long Term Incentive Plan to increase the number of ordinary shares available for issuance under that Plan by 2,000,000 ordinary shares; and to transact such other business as properly comes before the Annual Meeting or any adjournment or postponement thereof. Tillkännagivande • Mar 05
Prothena Appoints David Ford to Newly Created Chief People Officer Prothena Corporation plc announced that it has named David Ford to a newly created position of Chief People Officer, reporting to Prothena President and Chief Executive Officer Gene Kinney, PhD. In this role, Mr. Ford will be responsible for people, culture, and human resources strategy to drive the company’s vision and overall growth strategy. Mr. Ford brings over 25 years of experience in a variety of human resources roles across the United States, Europe, Latin America and New Zealand. Most recently, Mr. Ford served as the Chief Human Resources Officer at Intercept Pharmaceuticals from May 2017 to December 2023, leading the company through several transformational periods, including significant expansion of the company's commercial resources and recruiting outstanding talent across the company. Prior to that, Mr. Ford spent nearly 15 years at Sanofi. Mr. Ford holds a master’s degree in business administration from INSEAD, Fontainebleau (France). Reported Earnings • Feb 25
Full year 2023 earnings released: US$2.76 loss per share (vs US$2.47 loss in FY 2022) Full year 2023 results: US$2.76 loss per share (further deteriorated from US$2.47 loss in FY 2022). Revenue: US$91.4m (up 70% from FY 2022). Net loss: US$147.0m (loss widened 26% from FY 2022). Products in clinical trials Phase I: 2 Phase II: 2 Phase III: 1 Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 22% per year but the company’s share price has increased by 8% per year, which means it is well ahead of earnings. New Risk • Feb 24
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings are forecast to decline by an average of 1.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$180m net loss in 3 years). Shareholders have been diluted in the past year (2.1% increase in shares outstanding). Tillkännagivande • Feb 23
Prothena Corporation plc has filed a Follow-on Equity Offering in the amount of $250 million. Prothena Corporation plc has filed a Follow-on Equity Offering in the amount of $250 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Tillkännagivande • Feb 22
Prothena Corporation plc Announces Board Changes Prothena Corporation plc announced the appointment of Daniel G. Welch to its Board of Directors as an independent director and Chair Designate following a comprehensive search process in connection with the board’s regular succession planning. Upon election by the shareholders at Prothena’s Annual General Meeting later this year, the Board intends to appoint Mr. Welch as Chair of the Board. The planned transition is in anticipation of the conclusion of Dr. Lars Ekman’s successful 11-year tenure as Chair during which he made significant contributions to the Company’s growth and success. Dr. Ekman will step down as Chair and continue to serve on the board as Chair Emeritus, following the anticipated appointment of Mr. Welch. The entire Prothena Board expresses their sincere gratitude for Dr. Ekman’s valuable service as Chair. Additionally, Dr. Anders Harfstrand, whose current board term will expire at the Annual Meeting, is not standing for re-election at the Annual Meeting. Mr. Welch serves as the chair of the boards of Structure Therapeutics Inc., Nuvation Bio Inc., and Ultragenyx Pharmaceuticals Inc. He recently served as a director of Seagen Inc. which was acquired by Pfizer in December 2023. He previously served as chair of the board of AveXis Inc. (acquired by Novartis in 2018), and as a director of Intercept Pharmaceuticals Inc. and Hyperion Therapeutics (acquired by Horizon Pharma in 2015). Prior to these roles he served as an executive partner at Sofinnova Ventures, as CEO and president of InterMune Inc. (acquired by Roche Holdings in 2014), as chair of the board of InterMune, as chair of the board and CEO of Triangle Pharmaceuticals Inc. (acquired by Gilead Sciences in 2003), and as president of the pharmaceutical division of Elan Corporation, PLC. Mr. Welch earned his B.A. from the University of Miami and his M.B.A. from the University of North Carolina. With Dr. Anders Harfstrand not standing for re-election at the Annual Meeting, the Board plans to reduce the size of the Board to ten members immediately after the Annual Meeting. Dr. Harfstrand has been a director since 2015 and the entire Prothena Board acknowledges and appreciates his positive impact during his service. Reported Earnings • Feb 16
Full year 2023 earnings released: US$2.76 loss per share (vs US$2.47 loss in FY 2022) Full year 2023 results: US$2.76 loss per share (further deteriorated from US$2.47 loss in FY 2022). Revenue: US$91.4m (up 70% from FY 2022). Net loss: US$147.0m (loss widened 26% from FY 2022). Revenue is forecast to grow 42% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 22% per year but the company’s share price has increased by 10% per year, which means it is well ahead of earnings. Tillkännagivande • Feb 16
Prothena Corporation plc Provides Earnings Guidance for the Year 2024 Prothena Corporation plc provided earnings guidance for the year 2024. The company expects full year 2024 net cash used in operating and investing activities to be between $208 million and $225 million. The estimated full year 2024 net cash used in operating and investing activities is primarily driven by an estimated net loss of $229 million to $255 million, which includes an estimated $51 million of noncash share-based compensation expense. Tillkännagivande • Feb 09
Prothena Corporation plc to Report Q4, 2023 Results on Feb 15, 2024 Prothena Corporation plc announced that they will report Q4, 2023 results After-Market on Feb 15, 2024 New Risk • Nov 04
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.9% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 1.9% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$152m net loss in 3 years). Share price has been volatile over the past 3 months (7.0% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Reported Earnings • Nov 03
Third quarter 2023 earnings released: EPS: US$0.41 (vs US$0.97 loss in 3Q 2022) Third quarter 2023 results: EPS: US$0.41 (up from US$0.97 loss in 3Q 2022). Revenue: US$84.9m (up US$83.3m from 3Q 2022). Net income: US$21.9m (up US$67.7m from 3Q 2022). Profit margin: 26% (up from net loss in 3Q 2022). The move to profitability was driven by higher revenue. Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 5% per year but the company’s share price has increased by 45% per year, which means it is well ahead of earnings. Tillkännagivande • Oct 27
Prothena Corporation plc to Report Q3, 2023 Results on Nov 02, 2023 Prothena Corporation plc announced that they will report Q3, 2023 results After-Market on Nov 02, 2023 New Risk • Oct 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.1% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$163m net loss in 3 years). Share price has been volatile over the past 3 months (6.1% average weekly change). Shareholders have been diluted in the past year (14% increase in shares outstanding). Tillkännagivande • Oct 18
Prothena Reportedly Prepares for Potential Sale The company has been speaking to advisers as it prepares to explore options that may include a sale or partnership, the report said. Ireland, Dublin-based Prothena could attract interest from larger drugmakers if it decides to go ahead, according to the report. Prothena said it does not comment on market speculation, when contacted by Reuters. The Bloomberg report said the deliberations are in early stage and Prothena could opt to remain independent for longer, especially if the data from its Alzheimer's trial is negative. Reported Earnings • Aug 04
Second quarter 2023 earnings released: US$1.03 loss per share (vs US$0.88 loss in 2Q 2022) Second quarter 2023 results: US$1.03 loss per share (further deteriorated from US$0.88 loss in 2Q 2022). Revenue: US$4.02m (up 206% from 2Q 2022). Net loss: US$54.6m (loss widened 32% from 2Q 2022). Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has remained flat but the company’s share price has increased by 80% per year, which means it is well ahead of earnings. Tillkännagivande • Jul 29
Prothena Corporation plc to Report Q2, 2023 Results on Aug 03, 2023 Prothena Corporation plc announced that they will report Q2, 2023 results After-Market on Aug 03, 2023 Tillkännagivande • Jul 18
Prothena Corporation plc Presents New Research in the Treatment of Alzheimer's Disease At Alzheimer's Association International Conference®? 2023 Prothena Corporation plc shared data on three investigational product programs for the treatment and prevention of Alzheimer's disease, PRX005, PRX012 and PRX123, at the Alzheimer's Association International Conference®? 2023 (AAIC®?) being held July 16-20, 2023 in Amsterdam, Netherlands and virtually. PRX005 Phase 1 Clinical Trial, Single Ascending Dose (SAD) Portion: Prothena: PRX005, A Novel Anti-MTBR Tau Humanized Monoclonal Antibody: Results from the Single Ascending Dose Portion of a First-in-Human Double-Blind, Placebo-Controlled, Phase 1 Clinical Trial: The results of the Phase 1 clinical trial SAD portion showed that all three dose level cohorts (low, medium, high) of PRX005 were considered generally safe and well tolerated, meeting the Phase 1 clinical trial S AD portion primary objective and supporting evaluation of doses in the MAD portion of the ongoing Phase 1 clinical trial. PRX005 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints. Plasma drug concentrations of PRX005 increased in a dose-proportional manner. As planned, cerebral spinal fluid (CSF) drug levels were measured in the high dose cohort and reached sufficient CSF concentrations to predict pharmacological targeting of MTBR tau in the central nervous system (CNS) (day 29 CSF:plasma ratio=0.2%). On July 10, 2023, Prothena announced that Bristol Myers Squibb exercised its $55 million option under the global neuroscience research and development collaboration to obtain the exclusive worldwide commercial rights for PRX005. PRX123, a potential first-in-class investigational dual Ab/tau vaccine designed for the treatment and prevention of disease, is a dual-target vaccine targeting key epitopes within the N-terminus of Ab and MTBR-tau to simultaneously promote amyloid clearance and blockade of pathogenic tau. PRX012, an investigational next-generation anti-Ab antibody, was designed as a subcutaneous IgG1 mAb to target aggregated forms of Ab, including protofibrils and plaques, with high binding affinity. PRX012 is currently being investigated in a Phase 1 clinical trial for the treatment of Alzheimer’s disease. Preclinical data have demonstrated binding of PRX012 to beta amyloid plaques and oligomers with high affinity, allowing effective Aß plaque occupancy and removal at relatively lower dose ranges, optimal for subcutaneous delivery. Preclinical data have also demonstrated clearance of both pyroglutamate modified and unmodified Aß plaque in brain tissue at concentrations of PRX012 estimated to be clinically achievable in the central nervous system with subcutaneous delivery. Tillkännagivande • Jun 28
Prothena C Corporation plc Announces Phase VITAL Clinical Trial Results Published in Blood Showing Survival Benefit in Patients with Mayo Stage IV Al Amyloidosis Treated with Birtamimab Pthena C Corporation plc announced the publication of the Phase 3 VITAL clinical trial in Blood, a journal of the American Society of Hematology (ASH). Based on the totality of data generated to date, including results from the VITAL clinical trial, Prothena has advanced birtamimab into the confirmatory Phase 3 AFFIRM-AL clinical trial in patients with Mayo Stage IV AL amyloidosis under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) with a primary endpoint of all-cause mortality at a significance level of 0.10. Phase 3 AFFIRM -AL topline data is expected in 2024. Birtamimab has also been granted orphan drug designation for AL amyloidosis by both the FDA and the European Medicines Agency and has been granted Fast Track designation by the FDA. Tillkännagivande • May 17
Prothena Corporation plc Appoints Billy Dunn to its Board of Directors Prothena Corporation plc announced the appointment of Billy Dunn, M.D., to its Board of Directors. Dr. Dunn is the founding and former Director of the Office of Neuroscience, Center for Drug Evaluation and Research (CDER), at the U.S. Food and Drug Administration (FDA). During his tenure at FDA, Dr. Dunn had a significant impact on how drugs are developed for a range of serious neurological diseases, including many that previously had only limited treatment options. His work and leadership contributed to major therapeutic advances in neuro-immunological diseases such as multiple sclerosis and myasthenia gravis, advances in rare neurological disorders, advances in migraine treatment, advances in the range of complex seizure disorders, and advances in therapies for Alzheimer’s disease, among many other neurological disorders. Dr. Dunn is the founding director of the Office of Neuroscience, CDER, at the FDA, a position he held since the founding of the office in 2019 through February 2023. He was responsible for the regulatory oversight of all research conducted to support neuroscience drug development, including the regulation and review of investigational new drug applications and marketing applications for drug and biologic products. From 2005 to 2019, he held positions of increasing seniority in the Division of Neurology Products, CDER, including his role as director of that division. Dr. Dunn is a trained neurologist and vascular neurologist with experience in basic research, clinical research, and clinical care. He earned his B.A. from the University of Virginia and his M.D. from the F. Edward Hébert School of Medicine in Bethesda, Maryland. Tillkännagivande • May 06
Prothena Corporation plc Provides Earnings Guidance for the Year 2023 Prothena Corporation plc provided earnings guidance for the year 2023. The company continues to expect the full-year 2023 net cash used in operating and investing activities to be $213 million to $229 million and expects to end the year with approximately $512 million in cash, cash equivalents and restricted cash (midpoint). The estimated full-year 2023 net cash used in operating and investing activities is primarily driven by an estimated net loss of $250 million to $275 million, which includes an estimated $46 million of non-cash share-based compensation expense. Reported Earnings • May 05
First quarter 2023 earnings released: US$0.89 loss per share (vs US$0.78 loss in 1Q 2022) First quarter 2023 results: US$0.89 loss per share (further deteriorated from US$0.78 loss in 1Q 2022). Revenue: US$2.17m (up 88% from 1Q 2022). Net loss: US$46.9m (loss widened 29% from 1Q 2022). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has increased by 85% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • Feb 25
Full year 2022 earnings released: US$2.47 loss per share (vs US$1.51 profit in FY 2021) Full year 2022 results: US$2.47 loss per share (down from US$1.51 profit in FY 2021). Revenue: US$53.9m (down 73% from FY 2021). Net loss: US$116.9m (down 275% from profit in FY 2021). Revenue is forecast to grow 41% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has increased by 71% per year, which means it is tracking significantly ahead of earnings growth. Tillkännagivande • Feb 17
Prothena Corporation plc to Report Q4, 2022 Results on Feb 23, 2023 Prothena Corporation plc announced that they will report Q4, 2022 results After-Market on Feb 23, 2023 Tillkännagivande • Feb 01
Prothena Corporation plc Reports Topline Phase 1 Single Ascending Dose Study Results of PRX005 Prothena Corporation plc announced positive topline Phase 1 single ascending dose (SAD) study results for PRX005, a potentially best-in-class investigational tri-epitopic antibody for the treatment of Alzheimer’s disease that specifically binds with high affinity to the R1, R2, and R3 repeats within the microtubule binding region (MTBR) of tau and targets both 3R and 4R tau isoforms. PRX005 is one of three programs in the global neuroscience research and development collaboration between Prothena and Bristol Myers Squibb. In this first-in-human, randomized, placebo controlled, SAD study, healthy volunteers (n=19) were enrolled into three PRX005 dose level cohorts (low, medium or high dose) and randomized in a 3:1 drug to placebo ratio. Study participants received a single dose of PRX0005 or placebo intravenously (IV) and were followed for up to two months. The results of the study found all three dose level cohorts of PRX005 to be generally safe and well tolerated, meeting the Phase 1 SAD study primary objective. None of the treatment emergent adverse events (TEAE) were serious. No clinically relevant changes were observed in other safety parameters. PRX005 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints. Plasma drug concentrations of PRX005 increased in a dose-proportional manner. Furthermore, PRX005 exposure in cerebrospinal fluid (CSF) was measured in the high dose cohort and based on the robust exposure of PRX005 in the CSF (day 29 CSF:Plasma ratio=0.2%), substantial target engagement is expected in the CNS. PRX005 had a desirable immunogenicity profile with no persistent PRX005-induced antidrug antibodies (ADAs) observed. Prothena plans to present results from the Phase 1 SAD study at an upcoming medical conference. These results support the ongoing Phase 1 MAD trial of PRX005 in patients with Alzheimer’s disease. Topline results from the Phase 1 MAD trial are expected by year end 2023. Tau is a microtubule associated protein, which aggregates and hyper-phosphorylates in the brains of individuals with Alzheimer’s disease to form pathological neurofibrillary tangles. Tau tangles, along with amyloid beta plaques represent the pathological hallmarks of Alzheimer’s disease. The presence of tau pathology strongly correlates with neurodegeneration and cognitive impairment in Alzheimer’s disease and its pattern of progression throughout the brain suggests that tau pathology spreads through anatomically connected pathways through cell-to-cell transmission, a hypothesis supported by multiple preclinical studies. This propagation of pathology is thought to be mediated by MTBR-tau “seeds”. PRX005 has demonstrated superior ability to bind, intercept and block cellular internalization of pathogenic tau, and mitigate downstream neurotoxicity compared to other anti-tau antibodies in multiple preclinical studies. PRX005 is designed to be a best-in-class anti-tau antibody that specifically binds with high affinity the R1, R2, and R3 repeats within the MTBR of tau and targets both 3R and 4R tau isoforms. MTBR tau has been shown in preclinical studies to be involved in the pathological spread of tau. Neurofibrillary tangles composed of misfolded tau proteins, along with amyloid beta plaques, are pathological hallmarks of Alzheimer’s disease. Cell-to-cell transmission of pathogenic extracellular tau and the accumulation of pathogenic tau also correlate with the progression of symptomatology and clinical decline in patients with Alzheimer’s disease. Recent publications suggest that during the course of Alzheimer’s disease progression, tau appears to spread throughout the brain via synaptically-connected pathways; this propagation of pathology is thought to be mediated by tau “seeds” containing the MTBR of tau. Additionally, it has been recently reported that the presence of MTBR fragments in cerebrospinal fluid correlate with dementia stages and tau tangles in Alzheimer’s disease to a higher degree than fragments of other tau regions. In preclinical research, antibodies targeting this region of tau were superior in blocking tau uptake and neurotoxicity, which has been associated with efficacy in Alzheimer’s disease animal models. In these preclinical models, PRX005 demonstrated significant reduction of intraneuronal tau pathology and protection against behavioral deficit in a tau transgenic mouse model and complete blockade of neuronal tau internalization in vitro. Alzheimer’s disease is a fatal disease and the most common form of dementia causing increasingly serious symptoms, including confusion, disorientation, mood and behavioral changes, and difficulty speaking, swallowing, and walking. Approximately 50 million people worldwide are estimated to be living with Alzheimer’s disease or other dementias. Alzheimer’s disease is the most common neurodegenerative disorder. There is an urgent need for therapies that slow the progression and ultimately prevent Alzheimer’s disease to address this global healthcare crisis. Prothena’s Alzheimer’s disease portfolio spans next generation antibody immunotherapy, small molecule, and vaccine approaches, all geared toward building upon first generation treatments to advance the treatment paradigm. Tillkännagivande • Dec 13
Prothena Corporation plc Presents Data Demonstrating Consistent Survival Benefit Observed with Birtamimab in Mayo Stage IV AL Amyloidosis Patients in Phase 3 VITAL Study at ASH 2022 Prothena Corporation plc presented data from the completed phase 3 VITAL study demonstrating that in a post hoc analysis of patients with Mayo Stage IV AL amyloidosis, a statistically significant survival benefit was observed in those treated with birtamimab at 9 months. The survival benefit of birtamimab in VITAL remained consistent across all key baseline variables in patients with Mayo Stage IV AL amyloidosis. The data were presented in an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, LA. Birtamimab is a potential best-in-class amyloid depleter treatment for AL amyloidosis. Based on the totality of the VITAL study data, Prothena has advanced birtamimab into the confirmatory Phase 3 AFFIRM-AL study in patients with Mayo Stage IV AL amyloidosis under a Special Protocol Assessment (SPA) agreement with the U.S. FDA with a primary endpoint of all-cause mortality at p<=0.10. Confirmatory Phase 3 AFFIRM-AL topline data is expected in 2024. A post hoc analysis of patients with Mayo Stage IV AL amyloidosis showed a statistically significant survival benefit of 74 percent in patients treated with birtamimab versus a survival benefit of 49% in patients on placebo at 9 months (HR 0.413, p=0.021). The survival benefit of birtamimab in VITAL remained consistent across all key baseline variables in Mayo Stage IV patients, reinforcing the strength of the survival data in these patients at high risk of early mortality. The significant and consistent survival benefits of birtamimab in the VITAL study's post hoc analysis of patients with Mayo Stage IV AL amyloidosis offers hope that the removal of amyloid deposits leads to a survival benefit and affirms the potential of birtamimab as a safe, well-tolerated and meaningful therapy. The sensitivity analysis was performed as part of the post hoc analysis of patients with Mayo Stage IV AL amyloidosis. After adjusting for baseline demographic, clinical, and laboratory variables, the adjusted hazard ratios ranged from 0.336 to 0.465, with no upper bounds of the 90% confidence interval crossing 1, indicating a consistent survival benefit with birtamimab at 9 months. Birtamimab also demonstrated statistically significant improvement over placebo in post hoc analyses of quality of life (assessed with the Short Form-36 version 2 physical component score, SF-36v2 PCS) and cardiac function (assessed with the 6-minute walk test). Patients treated with birtamimab showed a mean difference of 4.65 in the SF-36v2 PCS over placebo at 9 months (p=0.046). Mayo Stage IV patients treated with birtamimab after 9 months demonstrated an increase of 15.22 meters in the 6-minute walk test, whereas patients treated with placebo had a decrease of 21.15 meters (a difference of 36.37; p=0.022). Birtamimab was generally safe and well tolerated in the overall patient population and in Mayo Stage IV patients. The rates of treatment emergent adverse events (TEAEs) were balanced between treatment arms. The rates of treatment related TEAEs were similar or lower with birtamimab than in the placebo arm of both the overall population and in Mayo Stage IV patients. Consistent with AL amyloidosis, cardiac disorder was the most common class of fatal TEAEs. There were no fatal TEAEs that were considered treatment related. VITAL was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of birtamimab plus standard of care versus placebo plus standard of care in newly diagnosed, treatment-naïve patients with AL amyloidosis. The study was terminated early based on a futility analysis. The primary endpoint in the full study population was the composite of time to all-cause mortality and cardiac hospitalization in patients with AL amyloidosis. The primary endpoint in the overall study population favored birtamimab over placebo, but the difference was not statistically significant at the time of early study termination. The primary study population included 260 patients with AL amyloidosis, of which patients who received birtamimab and placebo were evenly split. Approximately one-third of patients in the study had Mayo Stage IV AL amyloidosis (n=77). Patient demographics were generally balanced between the birtamimab and placebo groups in the study population and the Mayo Stage IV sub population. Birtamimab is an investigational monoclonal antibody designed to specifically and selectively target and clear the amyloid that accumulates and causes organ dysfunction and failure in patients with AL amyloidosis. Birtamimab specifically binds to a defined epitope on kappa and lambda AL protein involved in the disease process. Birtamimab is the only investigational therapeutic that has shown a significant survival benefit in patients with Mayo Stage IV AL amyloidosis post-hoc in a placebo-controlled study. Birtamimab has been granted orphan drug designation for AL Amyloidosis by both the U.S. FDA and the European Medicines Agency and has been granted Fast Track designation by the FDA. A SPA was agreed to between Prothena and the FDA for the AFFIRM-AL trial which represents FDA's agreement that the design and planned analysis for the primary endpoint of time to all-cause mortality adequately address the objectives necessary to support a regulatory submission. Results from the AFFIRM-AL trial are anticipated in 2024. Final marketing approval is predicated upon FDA's complete review of the entire application. Reported Earnings • Nov 05
Third quarter 2022 earnings released: US$0.97 loss per share (vs US$2.39 profit in 3Q 2021) Third quarter 2022 results: US$0.97 loss per share (down from US$2.39 profit in 3Q 2021). Net loss: US$45.8m (down 142% from profit in 3Q 2021). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 39% per year but the company’s share price has increased by 93% per year, which means it is tracking significantly ahead of earnings growth. Tillkännagivande • Oct 28
Prothena Corporation plc to Report Q3, 2022 Results on Nov 03, 2022 Prothena Corporation plc announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 03, 2022 Tillkännagivande • Sep 02
Prothena Corporation plc Appoints Helen S. Kim to its Board of Directors Prothena Corporation plc announced the appointment of Helen S. Kim, MBA, to its Board of Directors. Ms. Kim has over 27 years of experience in leadership roles in biotechnology, including her previous role as Executive Vice President of Business Development at Kite Pharma Inc. where she led all business and corporate development initiatives, leading to a successful acquisition by Gilead in 2017. With the appointment of Ms. Kim, Prothena will expand its Board to 10 directors. Currently, Ms. Kim serves as a Senior Managing Director at Vida Ventures, LLC, a position which she has held since April 2019. Prior to her current role, Ms. Kim was a Partner at the Column Group from 2018-2019 and the Executive Vice President, Business Development at Kite Pharma Inc. from 2014-2018. Previously, Ms. Kim held positions as Chief Business Officer (2009-2012) and then Strategic Advisor (2012-2014) of NGM Biopharmaceuticals Inc. Prior to NGM, she was the Chief Executive Officer and President of Kosan Biosciences, where she restructured and repositioned the company prior to a successful transaction with Bristol Myers Squibb in 2008. Ms. Kim’s additional industry experience includes executive and leadership positions at Affymax Inc., Onyx Pharmaceuticals Inc., Protein Design Labs Inc., and Chiron Corporation. Ms. Kim currently serves on the Board of Directors for A2 Biotherapeutics Inc., ReCode Therapeutics Inc., IconOVir Bio Inc., Aktis Oncology, PACT Pharma, Protego Therapeutics, and InduPro Labs. Ms. Kim received a B.S. in Chemical Engineering from Northwestern University and an MBA from the University of Chicago. Reported Earnings • Aug 10
Second quarter 2022 earnings released: US$0.88 loss per share (vs US$0.62 profit in 2Q 2021) Second quarter 2022 results: US$0.88 loss per share (down from US$0.62 profit in 2Q 2021). Revenue: US$1.31m (down 98% from 2Q 2021). Net loss: US$41.2m (down 249% from profit in 2Q 2021). Over the next year, revenue is expected to shrink by 73% compared to a 15% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 63% per year whereas the company’s share price has increased by 62% per year. Tillkännagivande • Aug 10
Prothena Corporation plc Provides Earnings Guidance for the Year 2022 Prothena Corporation plc provided earnings guidance for the year 2022. For the year, the company estimated full year 2022 net cash used in operating and investing activities is primarily driven by an estimated net loss of $154 to $170 million, which includes an estimated $32 million of non-cash share-based compensation expense. Tillkännagivande • Aug 02
Prothena Corporation plc to Report Q2, 2022 Results on Aug 08, 2022 Prothena Corporation plc announced that they will report Q2, 2022 results After-Market on Aug 08, 2022 Valuation Update With 7 Day Price Move • Jul 08
Investor sentiment improved over the past week After last week's 15% share price gain to €29.32, the stock trades at a trailing P/E ratio of 21.3x. Average forward P/E is 31x in the Biotechs industry in Europe. Total returns to shareholders of 243% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €18.24 per share. Tillkännagivande • Jun 26
Prothena Corporation plc(NasdaqGS:PRTA) dropped from Russell Microcap Value Index Prothena Corporation plc(NasdaqGS:PRTA) dropped from Russell Microcap Value Index Valuation Update With 7 Day Price Move • Jun 15
Investor sentiment deteriorated over the past week After last week's 17% share price decline to €21.67, the stock trades at a trailing P/E ratio of 15.9x. Average forward P/E is 31x in the Biotechs industry in Europe. Total returns to shareholders of 148% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €15.93 per share. Reported Earnings • May 06
First quarter 2022 earnings released: US$0.78 loss per share (vs US$0.91 loss in 1Q 2021) First quarter 2022 results: US$0.78 loss per share (up from US$0.91 loss in 1Q 2021). Revenue: US$1.15m (up US$993.0k from 1Q 2021). Net loss: US$36.3m (loss narrowed 1.2% from 1Q 2021). Over the next year, revenue is expected to shrink by 71% compared to a 28% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 59% per year but the company’s share price has only increased by 47% per year, which means it is significantly lagging earnings growth. Tillkännagivande • Apr 27
Prothena Corporation plc Receives FDA Fast Track Designation for PRX012, a Next-Generation Anti-Amyloid Beta Antibody Under Investigation for the Treatment of Alzheimer's Disease Prothena Corporation plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PRX012, a potential best-in-class anti-amyloid beta (A<BETA>) antibody therapy currently being investigated in a Phase 1 clinical study for the treatment of Alzheimer's disease. The FDA's Fast Track designation program is designed to expedite the development and review of drugs intended to treat a serious condition, such as Alzheimer's disease, with evidence demonstrating the potential to address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the drug candidate's development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review. About PRX012 PRX012 is currently being investigated in a Phase 1 clinical study for the treatment of Alzheimer's disease. Preclinical data have demonstrated binding of PRX012 to beta amyloid plaques and oligomers with high avidity, allowing effective A<BETA> plaque occupancy at relatively lower dose ranges, optimal for subcutaneous delivery. Preclinical data have also demonstrated clearance of both pyroglutamate modified and unmodified A<BETA> plaque in brain tissue at concentrations of PRX012 estimated to be clinically achievable in the central nervous system with subcutaneous delivery. The Phase 1 PRX012 SAD study is a randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics in healthy volunteers and patients with Alzheimer's disease. In this Phase 1 SAD study, healthy volunteers and patients will be randomized to receive a single subcutaneous injection of either PRX012 or placebo. Tillkännagivande • Mar 29
Prothena Corporation plc Announces U.S. Food and Drug Administration Clearance of IND for PRX012, A Subcutaneous Anti-Amyloid Beta Antibody Under Investigation for the Treatment of Alzheimer’s Disease Prothena Corporation plc announced that the U.S. Food and Drug Administration has cleared the investigational new drug application for PRX012, a potential best-in-class anti-amyloid beta (Aß) antibody in development for the treatment of Alzheimer’s disease. Prothena has initiated the Phase 1 single ascending dose (SAD) study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of PRX012 in both healthy volunteers and patients with AD. Prothena expects to initiate the Phase 1 multiple ascending dose study by year-end 2022. PRX012 is a next-generation, high binding potency antibody, designed to enable subcutaneous dosing on a patient-friendly, convenient administration schedule, potentially providing greater accessibility for patients and caregivers. Preclinical data have shown that PRX012 binds to beta amyloid plaques and oligomers with high avidity, enabling effective levels of Aß plaque occupancy at relatively lower dose ranges, which are optimal for subcutaneous delivery. Additional preclinical data demonstrated clearance of both pyroglutamate modified and unmodified Aß plaque in brain tissue at concentrations of PRX012 estimated to be clinically achievable in the central nervous system with subcutaneous delivery. Compared to first generation anti-Aß antibodies, PRX012 is expected to result in less variance of antibody concentrations in the brain. About the Phase 1 SAD Study for PRX012. The Phase 1 single ascending dose (SAD) study of PRX012 is a randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics in healthy volunteers and patients with Alzheimer’s disease. In this Phase 1 SAD study, healthy volunteers and patients will be randomized to receive a single subcutaneous injection of either PRX012 or placebo. Valuation Update With 7 Day Price Move • Mar 22
Investor sentiment improved over the past week After last week's 18% share price gain to €35.40, the stock trades at a trailing P/E ratio of 26.3x. Average forward P/E is 39x in the Biotechs industry in Europe. Total returns to shareholders of 231% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €17.88 per share. Reported Earnings • Feb 18
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: EPS: US$1.51 (up from US$2.79 loss in FY 2020). Revenue: US$200.6m (up US$199.7m from FY 2020). Net income: US$67.0m (up US$178.1m from FY 2020). Profit margin: 33% (up from net loss in FY 2020). The move to profitability was driven by higher revenue. Revenue missed analyst estimates by 2.4%. Over the next year, revenue is expected to shrink by 76% compared to a 63% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 49% per year but the company’s share price has only increased by 40% per year, which means it is significantly lagging earnings growth. Tillkännagivande • Feb 18
Prothena Corporation plc Provides Earnings Guidance for the Year 2022 Prothena Corporation plc provided earnings guidance for the year 2022. The estimated full year 2022 net cash used in operating and investing activities is primarily driven by an estimated net loss of $154 to $170 million, which includes an estimated $32 million of non-cash share-based compensation expense. Tillkännagivande • Feb 11
Prothena Corporation plc to Report Q4, 2021 Results on Feb 17, 2022 Prothena Corporation plc announced that they will report Q4, 2021 results After-Market on Feb 17, 2022 Buying Opportunity • Jan 14
Now 22% undervalued after recent price drop Over the last 90 days, the stock is down 42%. The fair value is estimated to be US$41.49, however is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 158% per annum over the last 3 years. The company has become profitable over the last year. Valuation Update With 7 Day Price Move • Jan 11
Investor sentiment deteriorated over the past week After last week's 16% share price decline to €36.40, the stock trades at a trailing P/E ratio of 28.1x. Average forward P/E is 35x in the Biotechs industry in Europe. Total returns to shareholders of 257% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €30.10 per share. Reported Earnings • Nov 06
Third quarter 2021 earnings released: EPS US$2.39 (vs US$0.77 loss in 3Q 2020) The company reported a strong third quarter result with improved earnings, revenues and profit margins. Third quarter 2021 results: Revenue: US$139.2m (up US$139.0m from 3Q 2020). Net income: US$109.2m (up US$139.8m from 3Q 2020). Profit margin: 79% (up from net loss in 3Q 2020). The move to profitability was primarily driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has increased by 63% per year, which means it is tracking significantly ahead of earnings growth. Breakeven Date Change • Sep 23
Forecast to breakeven in 2021 The 7 analysts covering Prothena expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$68.4m in 2021. Reported Earnings • Aug 08
Second quarter 2021 earnings released: EPS US$0.62 (vs US$0.66 loss in 2Q 2020) The company reported a strong second quarter result with improved earnings, revenues and profit margins. Second quarter 2021 results: Revenue: US$60.1m (up US$59.9m from 2Q 2020). Net income: US$27.6m (up US$53.9m from 2Q 2020). Profit margin: 46% (up from net loss in 2Q 2020). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has increased by 55% per year, which means it is tracking significantly ahead of earnings growth. Breakeven Date Change • Aug 08
Forecast to breakeven in 2021 The 4 analysts covering Prothena expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$63.5m in 2021. Breakeven Date Change • Jul 16
Forecast to breakeven in 2021 The 7 analysts covering Prothena expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$5.74m in 2021. Reported Earnings • May 13
First quarter 2021 earnings released: US$0.91 loss per share (vs US$0.59 loss in 1Q 2020) First quarter 2021 results: Net loss: US$36.7m (loss widened 56% from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has only increased by 12% per year, which means it is significantly lagging earnings growth. Tillkännagivande • May 12
Prothena Corporation plc Provides Earnings Guidance for the Year 2021 Prothena Corporation plc provided earnings guidance for the year 2021. The company provided that the estimated full year 2021 net cash used in operating and investing activities is primarily driven by an estimated net loss of $79 to $111 million, which includes an estimated $20 million of non-cash share-based compensation expense. Reported Earnings • Mar 01
Full year 2020 earnings released: US$2.79 loss per share (vs US$1.95 loss in FY 2019) Full year 2020 results: Net loss: US$111.1m (loss widened 43% from FY 2019). Products in clinical trials Phase I: 1 Phase II: 1 Phase III: 1 Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Mar 01
Revenue beats expectations Revenue exceeded analyst estimates by 33%. Over the next year, revenue is forecast to grow 10,196%, compared to a 50% growth forecast for the Biotechs industry in Germany. Tillkännagivande • Feb 25
Prothena Corporation plc Announces Promising New Preclinical and Clinical Data from Its Neurodegenerative Programs Selected for Oral Presentations At AD/PD 2021 Prothena Corporation plc announced three oral presentations and participation in a live forum at The 15thInternational Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2021). Prothena will present new preclinical data demonstrating that targeting a novel epitope with PRX005, an anti-tau antibody, resulted in superior attributes for the potential treatment of Alzheimer’s disease. PRX005 is being developed as part of the Company’s global neuroscience collaboration with Bristol Myers Squibb. In addition, Roche will present new pre-specified exploratory subgroup analyses from Part 1 of the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease and, separately, new digital biomarker data from its remote monitoring technology used in the study. Prasinezumab is being developed as part of the Company’s worldwide collaboration with Roche. Neurofibrillary tangles composed of misfolded tau proteins, along with A plaques, are pathological hallmarks of Alzheimer’s disease. Antibodies targeting various tau epitopes are currently being investigated for their ability to disrupt this pathogenic process and treat Alzheimer’s disease. Preclinical research indicates that antibodies developed to target key epitopes within the microtubule binding region (MTBR) of tau may result in superior attributes. Prothena has employed its unbiased epitope mapping and selection strategy to define this critical region of the tau protein involved in the pathological spread in Alzheimer’s disease. Antibodies targeting epitopes along the tau protein were developed and tested in a variety of in vitro and in vivo models. Among these, the murine precursor of PRX005, an antibody targeting an epitope within the MTBR of tau, demonstrated significant inhibition of cell-to-cell transmission and neuronal internalization in vitro and in vivo, and slowed pathological progression in a tau transgenic mouse model. New pre-specified exploratory subgroup analyses from the PASADENA study as well as results from the digital biomarker mobile application used in PASADENA to continuously monitor symptoms of Parkinson’s disease will be presented by Roche at AD/PD. Is New 90 Day High Low • Feb 18
New 90-day high: €21.00 The company is up 116% from its price of €9.70 on 20 November 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 15% over the same period. Reported Earnings • Feb 13
Full year 2020 earnings released: US$2.79 loss per share (vs US$1.95 loss in FY 2019) Full year 2020 results: Net loss: US$111.1m (loss widened 43% from FY 2019). Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Feb 13
Revenue beats expectations Revenue exceeded analyst estimates by 33%. Over the next year, revenue is forecast to grow 9,654%, compared to a 79% growth forecast for the Biotechs industry in Germany. Tillkännagivande • Feb 05
Prothena Corporation plc to Report Q4, 2020 Results on Feb 11, 2021 Prothena Corporation plc announced that they will report Q4, 2020 results Pre-Market on Feb 11, 2021 Is New 90 Day High Low • Feb 04
New 90-day high: €12.00 The company is up 6.0% from its price of €11.30 on 06 November 2020. The German market is up 16% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 9.0% over the same period. Tillkännagivande • Feb 02
Prothena Corporation plc Announces Confirmatory Phase 3 AFFIRM-AL Study of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis under SPA Agreement with FDA Prothena Corporation plc announced that following further analyses by the Company and multiple in-depth discussions with the U.S. Food and Drug Administration (FDA) regarding the previous analysis of patients categorized as Mayo Stage IV at baseline in the VITAL study, Prothena is advancing birtamimab into the confirmatory Phase 3 AFFIRM-AL study in this category of patients with AL amyloidosis. This registration-enabling study will be conducted with a primary endpoint of all-cause mortality at p<0.10 under a Special Protocol Assessment (SPA) agreement with FDA. Birtamimab is the only investigational therapeutic that has shown a significant survival benefit in Mayo Stage IV patients with AL amyloidosis in a placebo-controlled study, with 74% of birtamimab-treated patients alive at 9 months versus 49% of patients in the control group in VITAL (hazard ratio (HR)=0.413, p=0.025, over 9 months). AFFIRM-AL is expected to initiate mid-2021. The significant survival benefit observed in VITAL with birtamimab was further supported by evidence of clinical benefit on secondary endpoints, including significant changes observed on both the Short Form-36 version 2 Physical Component Score (SF-36v2 PCS), a measure of quality of life (p=0.026), and 6 Minute Walk Test (6MWT) distance, an assessment of functional capacity (p=0.046). Is New 90 Day High Low • Nov 06
New 90-day high: €11.80 The company is up 15% from its price of €10.30 on 07 August 2020. The German market is down 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Tillkännagivande • Nov 06
Prothena Corporation plc Provides Updates on Upcoming Research and Development Milestones Prothena Corporation plc provides updates on Upcoming Research and Development Milestones. Prasinezumab,is a monoclonal antibody designed to target alpha-synuclein and is the focus of the worldwide collaboration with Roche Part 2 of the Phase 2 PASADENA study is ongoing. Prothena will earn a $60 million clinical milestone payment upon the first patient dosed in the Phase 2b study. Further details are expected to be announced in the first half of 2021 and PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein. Prothena expects to report new data in fourth quarter of this year from the dose-escalation and available LTE portion of the study. Prothena continues to believe that the study has advanced sufficiently to determine next steps for the program and has begun further clinical development planning for next clinical studies in patients with moderate-to-advanced ATTR cardiomyopathy. Current therapies have not demonstrated efficacy in these patients who are at high risk of early mortality.