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Prothena (PRTA) Investor Presentation - Slideshow
2023-08-21 16:22
15 PRX012 0.070a >67b Data represent KD values from SPRa (nM) or IC50 from ELISAb (nM). • How does binding to protofibrils compare? PRX012s Binds Aβ Protofibrils With Very High Affinity SPR Binding Kinetics Greater affinity is driven largely by a slower binding dissociation Culture time 72 hours at 37°C PRX012s facilitates concentration-dependent clearance of pyroglutamate-modified Aβ (N3pE-Aβ) at concentrations that may be relevant for PRX012 clinical exposure PRX012s Promotes Simultaneous Microglia-Mediat ...
Prothena(PRTA) - 2023 Q2 - Quarterly Report
2023-08-03 20:14
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, 2023 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 ...
CORPORATE OVERVIEW
2023-05-12 17:11
Ab Tau ✓ Avoids T-cell response observed in other vaccines Rare Peripheral Amyloid Diseases PATHOGENIC PATHWAY Protein Misfolding KIDNEY Proteinuria Kidney failure SOLUBLE AGGREGATES AMYLOID FIBRILS CLONAL PLASMA CELLS INVOLVED IMMUNOGLOBU LIN LIGHT CHAIN HEART Restrictive cardiomyopathy Heart failure The four stages (Mayo Stages I–IV) of AL amyloidosis: life expectancy decreases as the disease progresses4,5 1 American Cancer Society. Available from: https://www.cancer.org/cancer/multiple-myeloma/treating/c ...
Prothena(PRTA) - 2023 Q1 - Quarterly Report
2023-05-04 20:32
Investigational Therapies - Prothena's investigational therapeutic birtamimab has shown a significant survival benefit in patients with Mayo Stage IV AL amyloidosis, a rare disease affecting approximately 200,000 to 400,000 patients globally, with 30% categorized as Mayo Stage IV[156][155]. - The confirmatory Phase 3 AFFIRM-AL study for birtamimab is expected to enroll around 150 newly diagnosed patients, with topline data anticipated in 2024[158][157]. - Prasinezumab, an investigational antibody for Parkinson's disease, is part of a collaboration with Roche, with a Phase 2b PADOVA study enrolling 575 patients and topline data expected in 2024[163][160]. - PRX005, an anti-tau antibody for Alzheimer's disease, has advanced to a Phase 1 study, with topline data from the multiple ascending dose portion expected in 2023[174][173]. - PRX012, targeting Amyloid Beta for Alzheimer's disease, is part of Prothena's pipeline aimed at addressing the underlying causes of neurodegenerative diseases[176]. - The lead candidate PRX012 is advancing through a Phase 1 clinical trial, with topline data expected in 2023[181]. - PRX123, a dual Aβ-tau vaccine, is in preclinical development, with an IND filing anticipated in 2023[186]. Financial Performance - Total revenue for the three months ended March 31, 2023, was $2.2 million, an increase of 88% compared to $1.2 million for the same period in 2022[190]. - Collaboration revenue from BMS for US development services related to the Tau/PRX005 program was $2.1 million for the three months ended March 31, 2023, up from $1.1 million in 2022, representing a 92% increase[191]. - Research and development (R&D) expenses increased by $17.5 million, or 64%, to $44.8 million for the three months ended March 31, 2023, compared to $27.3 million in the prior year[193][196]. - General and administrative (G&A) expenses rose by $1.9 million, or 16%, to $13.7 million for the three months ended March 31, 2023, compared to $11.8 million in 2022[200]. - Interest income surged by $6.6 million, or 12,523%, to $6.7 million for the three months ended March 31, 2023, primarily due to higher interest rates and money market balances[202][203]. - The benefit from income taxes increased to $(2.9) million for the three months ended March 31, 2023, compared to $(1.7) million in 2022, reflecting adjustments to deferred tax assets[204]. Cash Flow and Capital - As of March 31, 2023, working capital decreased to $651.5 million from $668.9 million as of December 31, 2022, primarily due to cash use of $58.5 million for operating expenses[206]. - Cash and cash equivalents stood at $686.2 million as of March 31, 2023, with expectations that this will be sufficient to meet obligations for at least the next twelve months[207]. - Net cash used in operating activities was $47.5 million for the three months ended March 31, 2023, compared to $37.4 million for the same period in 2022[212][213]. - Net cash provided by financing activities was $23.3 million for the three months ended March 31, 2023, primarily from net proceeds of $20.7 million from the issuance of ordinary shares[216]. - The company expects full-year 2023 net cash used in operating and investing activities to be approximately $213 million to $229 million[226]. - The company anticipates requiring additional capital in the future for research and development of drug candidates, which may be raised through various financing methods[207]. Obligations and Expenses - Total contractual obligations as of March 31, 2023, amounted to $35.8 million, including $19.7 million in operating leases and $15.7 million in purchase obligations[220][225]. - A foreign currency exchange loss of approximately $141,000 was recorded for the three months ended March 31, 2023, compared to $70,000 in the same period in 2022[228]. - Cash used in investing activities was $48,000 for the three months ended March 31, 2023, primarily related to purchases of property and equipment[215]. Strategic Collaborations - Prothena has received approximately $100 million from Novo Nordisk for the acquisition of its ATTR amyloidosis business, with potential milestone payments totaling up to $1.23 billion[168]. - The global collaboration with Bristol Myers Squibb for neurodegenerative disease research has resulted in Prothena receiving a total of $230 million, with potential additional payments up to $2.2 billion[175]. - The Phase 1 study of NNC6019 for ATTR amyloidosis has shown safety and tolerability, with further studies being conducted by Novo Nordisk[166][169]. Research Focus - Prothena's pipeline includes multiple investigational therapies targeting neurodegenerative diseases, leveraging deep scientific expertise in protein dysregulation[151]. - The company is focusing on discovery programs that address significant unmet medical needs in neurological diseases, including AD and ALS[182].
Prothena(PRTA) - 2022 Q4 - Annual Report
2023-02-28 21:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Washington, D.C. 20549 For the transition period from to Commission file number: 001-35676 ______________________________________ PROTHENA CORPORATION PUBLIC LIMITED COMPANY (Exact name of registrant as specified in its charter) ______________________________________ Ireland 98-1111119 (State or other jurisdiction of incorporation or ...
Prothena(PRTA) - 2022 Q4 - Earnings Call Presentation
2023-02-24 05:38
Global Neuroscience Collaboration with Bristol Myers Squibb – This propagation of pathology is thought to be mediated by tau "seeds" containing the MTBR of tau2 • Phase 1 SAD data in HVs demonstrated dose-proportional PRX005 concentrations in plasma with robust CNS penetration and generally safe and well tolerated 1Ahmed, Z., Cooper, J.. et al. A novel in vivo model of tau propagation with rapid and progressive neurofibrillary tangle pathology: the pattern of spread is determined by connectivity, not proxim ...
Prothena(PRTA) - 2022 Q4 - Earnings Call Transcript
2023-02-24 05:33
Prothena Corporation plc (NASDAQ:PRTA) Q4 2022 Earnings Conference Call February 23, 2023 4:30 PM ET Company Participants Eric Endicott - Senior Vice President, Corporate Affairs and Communications Gene Kinney - President and Chief Executive Officer Hideki Garren - Chief Medical Officer Tran Nguyen - Chief Financial Officer and Chief Strategy Officer Wagner Zago - Chief Scientific Officer Conference Call Participants Michael Yee - Jefferies Neena Bitritto-Garg - Citi Charles Duncan - Cantor Fitzgerald Jay O ...
Prothena(PRTA) - 2022 Q3 - Quarterly Report
2022-11-03 20:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission file number: 001-35676 ______________________________________ 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 September 30, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 PROTHENA CORPORATION PUBLIC LIMITED ...
Prothena(PRTA) - 2022 Q2 - Quarterly Report
2022-08-08 20:37
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) The company reported a net loss of $77.5 million for the six months ended June 30, 2022, a significant increase from a net loss of $9.1 million in the same period of 2021, driven by decreased collaboration revenue and increased operating expenses [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $549.6 million as of June 30, 2022, from $609.4 million at year-end 2021, primarily due to a reduction in cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $508,795 | $579,094 | | Total current assets | $521,294 | $584,809 | | Total assets | $549,589 | $609,366 | | Total current liabilities | $40,107 | $33,452 | | Total liabilities | $142,290 | $143,324 | | Total shareholders' equity | $407,299 | $466,042 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported net losses of $41.2 million and $77.5 million for Q2 and H1 2022, respectively, driven by a sharp decline in collaboration revenue and increased operating expenses Statements of Operations Summary (in thousands, except per share data) | Metric | Q2 2022 | Q2 2021 | H1 2022 | H1 2021 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $1,312 | $60,071 | $2,465 | $60,231 | | Research and development | $31,569 | $21,090 | $58,831 | $42,234 | | General and administrative | $12,952 | $11,032 | $24,787 | $22,157 | | Net income (loss) | $(41,244) | $27,642 | $(77,534) | $(9,093) | | Diluted net income (loss) per share | $(0.88) | $0.58 | $(1.66) | $(0.21) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $72.7 million for H1 2022, a significant shift from cash provided in H1 2021, leading to a $70.3 million decrease in cash and equivalents Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $(72,678) | $2,953 | | Net cash used in investing activities | $(183) | $(48) | | Net cash provided by financing activities | $2,562 | $101,546 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(70,299) | $104,451 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, financial position, and significant collaboration agreements, confirming sufficient cash for the next twelve months despite an accumulated deficit - As of June 30, 2022, the company had an accumulated deficit of **$793.6 million** and cash and cash equivalents of **$508.8 million**[33](index=33&type=chunk) - Management believes the company's cash and cash equivalents as of June 30, 2022, are sufficient to meet its obligations for at least the next twelve months[34](index=34&type=chunk) - The company has significant collaboration agreements with Roche, Bristol Myers Squibb (BMS), and is entitled to potential milestone payments from Novo Nordisk[31](index=31&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a 98% revenue decrease in Q2 2022 due to a non-recurring milestone, increased operating expenses, and the sufficiency of $508.8 million in cash for future operations [Overview](index=29&type=section&id=Overview) Prothena is a late-stage clinical biotechnology company focused on neurodegenerative and rare amyloid diseases, with wholly-owned and partnered programs in its pipeline - Birtamimab is in a confirmatory **Phase 3 AFFIRM-AL study** for AL amyloidosis under a Special Protocol Assessment (SPA) with the FDA[173](index=173&type=chunk) - Prasinezumab, partnered with Roche, is being evaluated in a **Phase 2b PADOVA study** for early Parkinson's disease[177](index=177&type=chunk) - The company's Alzheimer's portfolio includes PRX012 (anti-Aβ antibody), with an IND cleared in March 2022, and PRX005 (anti-tau antibody), partnered with Bristol Myers Squibb[184](index=184&type=chunk)[190](index=190&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Total revenue for Q2 2022 decreased by 98% to $1.3 million due to a non-recurring milestone, while R&D expenses increased by 50% to $31.6 million Revenue Comparison (in thousands) | Period | Q2 2022 | Q2 2021 | H1 2022 | H1 2021 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $1,312 | $60,071 | $2,415 | $60,181 | | Total revenue | $1,312 | $60,071 | $2,465 | $60,231 | Operating Expense Comparison (in thousands) | Period | Q2 2022 | Q2 2021 | H1 2022 | H1 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $31,569 | $21,090 | $58,831 | $42,234 | | General and administrative | $12,952 | $11,032 | $24,787 | $22,157 | | Total operating expenses | $44,521 | $32,122 | $83,618 | $64,391 | - The increase in R&D expenses for Q2 2022 was primarily due to higher personnel costs, increased clinical trial expenses for PRX012 and birtamimab, and higher manufacturing costs for birtamimab, PRX019, and PRX123 programs[207](index=207&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Working capital decreased by $70.2 million to $481.2 million, with $508.8 million in cash deemed sufficient for the next twelve months, despite $72.7 million net cash used in operations Key Liquidity Metrics (in thousands) | Metric | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Working capital | $481,187 | $551,357 | | Cash and cash equivalents | $508,795 | $579,094 | - Net cash used in operating activities was **$72.7 million** for the six months ended June 30, 2022, compared to net cash provided by operating activities of **$3.0 million** in the prior year period[222](index=222&type=chunk)[223](index=223&type=chunk) - The company expects full year 2022 net cash used in operating and investing activities to be approximately **$120 million to $132 million**[232](index=232&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risks are minimal, primarily related to foreign currency exposure in Euros, interest rate fluctuations on money market funds, and credit risk managed through high-quality financial institutions - The company's business is primarily conducted in U.S. dollars, with some foreign currency exposure through agreements denominated in Euros and other currencies[233](index=233&type=chunk) - Interest rate risk is limited as cash equivalents are held in money market funds, where interest income fluctuates with short-term market conditions[234](index=234&type=chunk) - Credit risk is managed by placing cash with high-credit-quality financial institutions and limiting exposure per institution[236](index=236&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of June 30, 2022, the company's disclosure controls and procedures were effective to provide reasonable assurance of timely information recording, processing, and reporting[237](index=237&type=chunk) - No changes in internal control over financial reporting occurred during the second fiscal quarter that materially affected, or are reasonably likely to materially affect, internal controls[238](index=238&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[242](index=242&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a history of losses, need for capital, COVID-19 impacts, R&D program dependence, reliance on partners, regulatory challenges, and intellectual property protection - The company anticipates incurring losses for the foreseeable future and may never achieve profitability, with an accumulated deficit of **$793.6 million** as of June 30, 2022[244](index=244&type=chunk) - The COVID-19 pandemic has adversely affected business, including delaying clinical trial site initiations for the Phase 3 birtamimab trial, and could continue to disrupt clinical development programs[252](index=252&type=chunk) - The company's success is highly dependent on its research programs and collaborations with Roche and BMS, which are subject to risks such as partners not committing sufficient resources or terminating agreements[269](index=269&type=chunk)[275](index=275&type=chunk) - The company relies on third parties for conducting clinical trials and for all manufacturing of its drug candidates, creating risks related to performance, compliance, and supply chain continuity[352](index=352&type=chunk)[357](index=357&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=73&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the reporting period - None[432](index=432&type=chunk) [Item 3. Defaults Upon Senior Securities](index=73&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reporting period - None[432](index=432&type=chunk) [Item 4. Mine Safety Disclosures](index=73&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not Applicable[434](index=434&type=chunk) [Item 5. Other Information](index=74&type=section&id=Item%205.%20Other%20Information) No other material information is reported for the period - None[435](index=435&type=chunk) [Item 6. Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including CEO and CFO certifications and XBRL data files - Exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906, and XBRL interactive data files[437](index=437&type=chunk)
Prothena(PRTA) - 2022 Q1 - Quarterly Report
2022-05-05 20:26
PART I. FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Prothena reported a net loss of $36.3 million in Q1 2022, with total assets decreasing to $581.4 million primarily due to reduced cash and increased R&D expenses [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $581.4 million as of March 31, 2022, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $542,994 | $579,094 | | Total current assets | $555,620 | $584,809 | | Total assets | $581,412 | $609,366 | | Total current liabilities | $36,496 | $33,452 | | Total liabilities | $142,525 | $143,324 | | Total shareholders' equity | $438,887 | $466,042 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2022 total revenue increased to $1.2 million, operating expenses rose to $39.1 million, resulting in a net loss of $36.3 million Q1 2022 vs Q1 2021 Statement of Operations (in thousands, except per share data) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Total revenue | $1,153 | $160 | | Research and development | $27,262 | $21,144 | | General and administrative | $11,835 | $11,125 | | Total operating expenses | $39,097 | $32,269 | | Loss from operations | ($37,944) | ($32,109) | | Net loss | ($36,290) | ($36,735) | | Basic and diluted net loss per share | ($0.78) | ($0.91) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $37.4 million in Q1 2022, leading to a $36.1 million net decrease in cash Q1 2022 vs Q1 2021 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,415) | ($33,666) | | Net cash used in investing activities | ($22) | ($48) | | Net cash provided by financing activities | $1,337 | $81,327 | | Net (decrease) increase in cash | ($36,100) | $47,613 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, collaboration agreements, and commitments, with $543.0 million cash deemed sufficient for 12 months - The company believes its cash and cash equivalents of **$543.0 million** as of March 31, 2022, are sufficient to meet its obligations for at least the next twelve months[34](index=34&type=chunk)[35](index=35&type=chunk) - As of March 31, 2022, the company had non-cancelable purchase commitments of **$16.8 million** and contractual obligations under license agreements of **$0.4 million**[69](index=69&type=chunk) - Share-based compensation expense was **$7.7 million** for Q1 2022, up from **$6.2 million** in Q1 2021. The total unearned share-based compensation to be expensed through 2026 is estimated at **$83.6 million**[156](index=156&type=chunk)[158](index=158&type=chunk) - The company recorded an income tax benefit of **$1.7 million** in Q1 2022, compared to a provision of **$4.7 million** in Q1 2021, primarily due to an increase in deferred tax assets related to Section 174 R&D Capitalization requirements[161](index=161&type=chunk)[213](index=213&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A highlights a 29% increase in R&D expenses to $27.3 million in Q1 2022, with $543.0 million cash deemed sufficient for 12 months [Overview of Business and Pipeline](index=29&type=section&id=Overview%20of%20Business%20and%20Pipeline) Prothena, a late-stage biotech, focuses on neurodegenerative and amyloid diseases with wholly-owned and partnered clinical programs - Birtamimab is in a confirmatory **Phase 3 AFFIRM-AL study** for Mayo Stage IV AL amyloidosis patients, under a Special Protocol Assessment (SPA) with the FDA[173](index=173&type=chunk) - Prasinezumab, partnered with Roche for Parkinson's disease, is being evaluated in a **Phase 2b PADOVA study**[177](index=177&type=chunk) - PRX012, a next-generation antibody for Alzheimer's disease, received FDA clearance for its IND in March 2022, initiating a **Phase 1 study**, and was granted Fast Track designation in April 2022[189](index=189&type=chunk) - PRX005, an anti-tau antibody for Alzheimer's, is part of a collaboration with Bristol Myers Squibb (BMS). BMS exercised its U.S. license option in June 2021 for an **$80 million payment**, and a **Phase 1 study** is ongoing[184](index=184&type=chunk)[185](index=185&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Q1 2022 total revenue increased to $1.2 million, while R&D expenses rose 29% to $27.3 million due to program advancements Operating Expenses Comparison (in thousands) | Expense Category | Q1 2022 | Q1 2021 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $27,262 | $21,144 | 29% | | General and administrative | $11,835 | $11,125 | 6% | | **Total operating expenses** | **$39,097** | **$32,269** | **21%** | R&D Expenses by Major Program (in thousands) | Program | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Birtamimab (NEOD001) | $12,432 | $6,510 | | Prasinezumab (PRX002/RG7935) | $82 | $4,876 | | PRX005 | $3,048 | $2,602 | | Other R&D | $11,536 | $5,687 | - The increase in R&D expenses was primarily due to higher manufacturing costs for the birtamimab program, increased personnel expenses, and higher clinical trial costs for the PRX012, birtamimab, and PRX005 programs[205](index=205&type=chunk) - The decrease in prasinezumab program costs was a result of the cost-share opt-out exercised in May 2021 with Roche[205](index=205&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Working capital decreased to $519.1 million, with $543.0 million cash deemed sufficient for 12 months, though future capital needs are anticipated Key Liquidity Metrics (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Working capital | $519,124 | $551,357 | | Cash and cash equivalents | $542,994 | $579,094 | - The company believes its existing cash and cash equivalents are sufficient to meet obligations for at least the next twelve months[216](index=216&type=chunk) - As of March 31, 2022, the company had contractual obligations totaling **$28.6 million**, including **$11.4 million** in operating leases and **$16.8 million** in purchase obligations[228](index=228&type=chunk)[231](index=231&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks include foreign currency, interest rate, and credit risks, all managed with minimal impact in Q1 2022 - Foreign currency risk arises from agreements with contract manufacturers denominated in Euros and other currencies, resulting in a net loss of approximately **$70,000** in Q1 2022[232](index=232&type=chunk) - Interest rate risk is considered minimal as cash equivalents are held in money market funds, where interest income fluctuates with prevailing rates[233](index=233&type=chunk) - Credit risk is managed by placing cash with high-credit-quality financial institutions and limiting exposure, although deposits may exceed insured amounts[235](index=235&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal controls - The CEO and CFO concluded that as of March 31, 2022, the company's disclosure controls and procedures were effective to provide reasonable assurance that required information is recorded, processed, summarized, and reported in a timely manner[236](index=236&type=chunk)[237](index=237&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the first fiscal quarter ended March 31, 2022[238](index=238&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though routine litigation may occur - Prothena is not currently a party to any material legal proceedings[243](index=243&type=chunk) [Risk Factors](index=40&type=page&id=Item%201A.%20Risk%20Factors) The company outlines significant risks including financial sustainability, drug development uncertainty, reliance on third parties, and intellectual property challenges [Risks Relating to Financial Position and Business](index=40&type=section&id=Risks%20Relating%20to%20Financial%20Position%20and%20Business) The company faces risks from anticipated losses, the need for additional capital, potential COVID-19 disruptions, and challenges in retaining personnel - The company expects to incur substantial losses for the foreseeable future and may never sustain profitability[245](index=245&type=chunk) - Additional capital will be required to fund operations; if unavailable, the company may have to delay or terminate clinical trials or cease operations[246](index=246&type=chunk)[252](index=252&type=chunk) - The COVID-19 pandemic has already disrupted clinical trials and could materially adversely affect liquidity, operations, and development programs[253](index=253&type=chunk) [Risks Related to Discovery, Development, and Regulatory Approval](index=45&type=section&id=Risks%20Related%20to%20Discovery%2C%20Development%2C%20and%20Regulatory%20Approval) Success depends on R&D programs prone to failure, with clinical trials facing delays and an unpredictable, costly regulatory approval process - The company's success depends on its ability to discover, develop, obtain regulatory approval for, and commercialize its drug candidates, which are in various stages of development and face significant risks of failure[270](index=270&type=chunk) - Clinical trials can be delayed, suspended, or terminated due to factors like slow enrollment, insufficient drug supply, unexpected side effects, or failure to meet endpoints[282](index=282&type=chunk)[285](index=285&type=chunk) - Although an SPA agreement is in place with the FDA for the Phase 3 AFFIRM-AL trial of birtamimab, this does not guarantee regulatory approval, as the FDA can revoke or alter the agreement under certain circumstances[296](index=296&type=chunk)[298](index=298&type=chunk) [Risks Related to Commercialization](index=51&type=section&id=Risks%20Related%20to%20Commercialization) Approved drug candidates may lack market acceptance, success depends on collaborations, and reimbursement uncertainty and intense competition pose risks - Approved products may not gain market acceptance among physicians, payers, and patients, which would limit revenues[308](index=308&type=chunk) - The success of prasinezumab is highly dependent on the collaboration with Roche, which has significant control over development and commercialization and can terminate the agreement with notice[312](index=312&type=chunk)[314](index=314&type=chunk) - Sales will depend on the availability of reimbursement from third-party payers, who are increasingly focused on cost containment, creating uncertainty around coverage and pricing[326](index=326&type=chunk)[327](index=327&type=chunk) [Risks Related to Dependence on Third Parties](index=58&type=section&id=Risks%20Related%20to%20Dependence%20on%20Third%20Parties) Prothena relies heavily on third-party CROs for clinical trials and manufacturers for supplies, posing risks if they fail to perform or comply with regulations - The company relies on third parties like CROs to conduct clinical trials and may be delayed if these parties do not perform satisfactorily or meet deadlines[353](index=353&type=chunk) - Prothena has no manufacturing capacity and depends on third-party manufacturers for all nonclinical and clinical trial supplies. Any failure by these manufacturers could delay or suspend production and development[358](index=358&type=chunk)[361](index=361&type=chunk) [Risks Related to Intellectual Property](index=61&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Success depends on uncertain patent enforcement, with risks of costly litigation, difficulty protecting trade secrets, and potential license terminations - The ability to obtain, maintain, and enforce patents is uncertain and involves complex legal and scientific questions; issued patents may not provide sufficient protection[368](index=368&type=chunk) - The company may face expensive and time-consuming litigation regarding patents and proprietary rights, which could cause delays and harm its ability to operate[392](index=392&type=chunk) - The company relies on trade secrets and confidentiality agreements, which may not effectively prevent disclosure of proprietary information[402](index=402&type=chunk) [Risks Related to Our Ordinary Shares](index=69&type=section&id=Risks%20Related%20to%20Our%20Ordinary%20Shares) Ordinary share price may fluctuate due to clinical results and market conditions, with dilution risk and complexities from Irish incorporation and stamp duty - The market price of ordinary shares is subject to wide fluctuation based on clinical trial results, regulatory news, competitor actions, and general market conditions[407](index=407&type=chunk) - Being an Irish-incorporated company means it is governed by the Irish Companies Act, which differs from U.S. corporate law and may offer less protection to shareholders in areas like director duties and shareholder lawsuits[419](index=419&type=chunk)[421](index=421&type=chunk) - Transfers of ordinary shares may be subject to Irish stamp duty (currently **1%**), which could adversely affect the share price[426](index=426&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=73&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[434](index=434&type=chunk) [Other Information](index=74&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item - None[437](index=437&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and XBRL data files - The exhibits filed include certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002, along with XBRL interactive data files[439](index=439&type=chunk)