Prothena Reports Third Quarter 2024 Financial Results and Business Highlights
Prothena reported Q3 2024 financial results with a net loss of $59.0 million ($1.10 per share) and revenue of $1.0 million. The company ended Q3 with $520.1 million in cash and restricted cash. Net cash used in operating and investing activities was $45.2 million for Q3. Key pipeline updates include: expected clinical readouts for PRX012 (Alzheimer's) starting mid-2025, Phase 2b PADOVA trial results for prasinezumab (Parkinson's) in Q4 2024, and Phase 3 AFFIRM-AL trial results for birtamimab (AL amyloidosis) in 1H 2025. The company maintains its 2024 guidance for net cash used in operating and investing activities at $148-160 million.
Prothena ha riportato i risultati finanziari del terzo trimestre 2024, con una perdita netta di 59,0 milioni di dollari (1,10 dollari per azione) e un fatturato di 1,0 milione di dollari. L'azienda ha chiuso il terzo trimestre con 520,1 milioni di dollari in cassa e cassa ristretta. Il flusso di cassa netto utilizzato in attività operative e di investimento è stato di 45,2 milioni di dollari per il terzo trimestre. Gli aggiornamenti principali sul pipeline includono: letture cliniche previste per PRX012 (Alzheimer) a partire dalla metà del 2025, risultati della sperimentazione di fase 2b PADOVA per prasinezumab (Parkinson) nel quarto trimestre del 2024 e risultati della sperimentazione di fase 3 AFFIRM-AL per birtamimab (amiloidosi AL) nella prima metà del 2025. L'azienda mantiene le sue previsioni per il 2024 relative al flusso di cassa netto utilizzato in attività operative e di investimento a 148-160 milioni di dollari.
Prothena reportó los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 59,0 millones de dólares (1,10 dólares por acción) y ingresos de 1,0 millón de dólares. La empresa cerró el tercer trimestre con 520,1 millones de dólares en efectivo y efectivo restringido. El efectivo neto utilizado en actividades operativas e inversiones fue de 45,2 millones de dólares para el tercer trimestre. Las actualizaciones clave del pipeline incluyen: la lectura clínica esperada para PRX012 (Alzheimer) iniciando a mediados de 2025, resultados del ensayo de fase 2b PADOVA para prasinezumab (Parkinson) en el cuarto trimestre de 2024 y resultados del ensayo de fase 3 AFFIRM-AL para birtamimab (amiloidosis AL) en la primera mitad de 2025. La empresa mantiene su guía para 2024 sobre el efectivo neto utilizado en actividades operativas e inversiones en 148-160 millones de dólares.
Prothena는 2024년 3분기 금융 결과를 보고하였으며, 5,900만 달러(주당 1.10달러)의 순손실과 100만 달러의 수익을 기록하였습니다. 회사는 3분기를 5억 201만 달러의 현금 및 제한 현금으로 마감하였습니다. 운영 및 투자 활동에 사용된 순현금은 3분기 동안 4,520만 달러였습니다. 주요 파이프라인 업데이트에는 PRX012(알츠하이머)의 예상 임상 결과가 2025년 중반부터 시작되며, prasinezumab(파킨슨)의 2b상 PADOVA 시험 결과가 2024년 4분기에, birtamimab(AL 아밀로이드증)의 3상 AFFIRM-AL 시험 결과가 2025년 상반기에 발표될 예정입니다. 또한, 회사는 운영 및 투자 활동에 사용되는 순현금에 대한 2024년 전망을 1억 4,800만 달러에서 1억 6,000만 달러로 유지합니다.
Prothena a rendu compte des résultats financiers du troisième trimestre 2024, affichant une perte nette de 59,0 millions de dollars (1,10 dollar par action) et des revenus de 1,0 million de dollars. La société a terminé le troisième trimestre avec 520,1 millions de dollars en espèces et en espèces restreintes. La trésorerie nette utilisée dans les activités d'exploitation et d'investissement s'élevait à 45,2 millions de dollars pour le troisième trimestre. Les mises à jour clés du pipeline comprennent : des résultats cliniques attendus pour PRX012 (Alzheimer) à partir de la mi-2025, des résultats de l'essai de phase 2b PADOVA pour prasinezumab (Parkinson) au quatrième trimestre 2024, et des résultats de l'essai de phase 3 AFFIRM-AL pour birtamimab (amyloïdose AL) dans la première moitié de 2025. L'entreprise maintient son orientation pour 2024 concernant l'utilisation de la trésorerie nette dans les activités d'exploitation et d'investissement entre 148 et 160 millions de dollars.
Prothena hat die finanziellen Ergebnisse des 3. Quartals 2024 gemeldet, mit einem Nettverlust von 59,0 Millionen Dollar (1,10 Dollar pro Aktie) und Einnahmen von 1,0 Millionen Dollar. Das Unternehmen schloss das 3. Quartal mit 520,1 Millionen Dollar in Bargeld und beschränktem Bargeld ab. Der in Betrieb und Investitionen verwendete Nettobargeldbetrag betrug im 3. Quartal 45,2 Millionen Dollar. Wichtige Pipeline-Updates umfassen: erwartete klinische Ergebnisse für PRX012 (Alzheimer) ab Mitte 2025, Ergebnisse der Phase 2b PADOVA-Studie für prasinezumab (Parkinson) im 4. Quartal 2024 und Ergebnisse der Phase 3 AFFIRM-AL-Studie für birtamimab (AL-Amyloidose) in der ersten Jahreshälfte 2025. Das Unternehmen hält seine Prognose für 2024 über die Verwendung von Nettobargeld in Betriebs- und Investitionstätigkeiten zwischen 148 und 160 Millionen Dollar aufrecht.
- Strong cash position of $520.1 million with no debt
- Multiple late-stage clinical trials with readouts expected in 2024-2025
- FDA Fast Track designations for key pipeline products
- Net loss increased to $59.0 million in Q3 2024 vs net income of $21.9 million in Q3 2023
- Revenue decreased to $1.0 million in Q3 2024 from $84.9 million in Q3 2023
- Increased cash burn with $45.2 million used in Q3 2024 operations
Insights
The Q3 2024 results reveal significant financial dynamics.
R&D expenses decreased to
The pipeline progress shows strong momentum across multiple programs. Key catalysts include birtamimab's Phase 3 AFFIRM-AL results in 1H 2025, PRX012's multiple readouts starting mid-2025 and prasinezumab's Phase 2b PADOVA results in Q4 2024. The Nature Medicine publication of PASADENA OLE results validates the potential clinical benefit in Parkinson's disease.
The diverse portfolio targeting Alzheimer's, Parkinson's and rare amyloidosis demonstrates strategic positioning in high-value neurodegenerative markets. Fast Track designations for PRX012 and PRX123 could accelerate development timelines. The collaboration with major partners like Roche, Bristol Myers Squibb and Novo Nordisk provides additional validation and resources.
-
Net cash used in operating and investing activities was
$45.2 million $102.5 million $520.1 million - PRX012, a potential single-injection once-monthly subcutaneous treatment, is designed to address the unmet need of millions of patients with presymptomatic or early symptomatic Alzheimer's disease; Prothena expects to report multiple clinical readouts starting in mid-2025 and continuing throughout the year from the ongoing Phase 1 ASCENT clinical trials
- Results from partner Roche evaluating prasinezumab in patients with early Parkinson’s disease from the Phase 2 PASADENA OLE clinical trial published in Nature Medicine
- In collaboration with Bristol Myers Squibb, Prothena has initiated a Phase 1 clinical trial for PRX019, a potential treatment for neurodegenerative diseases
- With partner Novo Nordisk, Phase 1 clinical trial results for coramitug (formerly PRX004) in patients with ATTR amyloidosis published in Amyloid, the official journal of the ISA
- Prothena appointed Chad J. Swanson, Ph.D., as Chief Development Officer
“Within the next several quarters we expect meaningful data readouts on four clinical programs in our robust R&D pipeline that have the potential to significantly improve the lives of millions of individuals with neurodegenerative or rare peripheral amyloid diseases and their families,” said Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. “From our wholly-owned programs we expect to complete our confirmatory Phase 3 AFFIRM-AL clinical trial evaluating birtamimab, which is being conducted under a SPA agreement with the FDA at a significance level of 0.10, in 1H 2025. We also expect to announce multiple clinical readouts from our ongoing Phase 1 ASCENT clinical trials evaluating PRX012 for Alzheimer’s disease starting in mid-2025 and continuing throughout the year. In collaboration with Roche, we expect results from the Phase 2b
Third Quarter, Recent Business Highlights and Upcoming Milestones
Neurodegenerative Diseases Portfolio
Alzheimer’s Disease
PRX012, a wholly-owned potential best-in-class, single-injection once-monthly antibody delivered subcutaneously for the treatment of Alzheimer’s disease that targets a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency. The
- Designed as a potential single-injection once-monthly subcutaneous treatment to address the unmet need of millions of patients with presymptomatic or early symptomatic Alzheimer's disease, Prothena expects to report multiple clinical readouts starting in mid-2025 and continuing throughout the year from the ongoing Phase 1 ASCENT clinical trials
- Prothena has currently enrolled approximately 260 patients in the ASCENT clinical trials
- Poster presentation at CTAD 2024 highlighted the clinical trial design and patient demographic diversity of the ongoing ASCENT clinical trials
BMS-986446 (formerly PRX005), a potential best-in-class antibody for the treatment of Alzheimer’s disease that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in the causal pathophysiology of Alzheimer’s disease.
- Bristol Myers Squibb continues to enroll the ongoing Phase 2 clinical trial in approximately 475 patients with early Alzheimer’s disease; primary completion expected in 2027 (NCT06268886)
- Bristol Myers Squibb is responsible for all development, manufacturing, and commercialization
- Oral encore presentation by partner Bristol Myers Squibb at CTAD 2024 highlighted the design of the ongoing Phase 2 TargetTau-1 clinical trial
PRX123, a wholly-owned potential first-in-class dual Aβ/tau vaccine designed for the treatment and prevention of Alzheimer’s disease, is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau designed to promote amyloid clearance and block the transmission of pathogenic tau. The FDA cleared the investigational new drug (IND) application and granted Fast Track designation for PRX123 for the treatment of Alzheimer’s disease.
- Continuing to optimize capital allocation across our robust R&D pipeline, Prothena expects to update plans for Phase 1 clinical trial in 2025
Parkinson’s Disease
Prasinezumab, a potential first-in-class antibody for the treatment of Parkinson’s disease that is designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of a worldwide collaboration with Roche.
- PASADENA Open Label Extension Phase 2 clinical trial results published in Nature Medicine showed a continued reduction in motor and functional progression compared to real-world data after 4 years
-
Topline results from Phase 2b
PADOVA clinical trial in patients with early Parkinson’s disease, which has completed enrollment of 586 patients, expected in 4Q 2024 (NCT04777331)
Neurodegenerative Diseases
PRX019, a potential treatment of neurodegenerative diseases in development in collaboration with Bristol Myers Squibb.
- Prothena has initiated a Phase 1 first-in-human clinical trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of single ascending and multiple doses in healthy adults
Rare Peripheral Amyloid Diseases Portfolio
AL Amyloidosis
Birtamimab, a wholly-owned potential best-in-class anti-amyloid antibody for the treatment of AL amyloidosis designed to directly neutralize soluble toxic light chain aggregates and promote clearance of amyloid that causes organ dysfunction and failure. Among patients with AL amyloidosis, a rare, progressive, and fatal disease, newly diagnosed individuals with cardiac involvement are at the highest risk for early death. Birtamimab has been granted Fast Track designation by the FDA and has been granted Orphan Drug Designation by both the FDA and European Medicines Agency. A significant survival benefit was observed in the post hoc analysis of birtamimab-treated patients categorized as Mayo Stage IV at baseline in the previous Phase 3 VITAL clinical trial (Blood 2023).
- The ongoing confirmatory Phase 3 AFFIRM-AL clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA with a primary endpoint of all-cause mortality (time-to-event) at a significance level of 0.10
- Topline results from confirmatory AFFIRM-AL Phase 3 clinical trial expected in 1H 2025 (NCT04973137)
ATTR Amyloidosis
Coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM) designed to deplete the pathogenic, non-native forms of the transthyretin (TTR) protein, is being developed by Novo Nordisk as part of its up to
- Phase 1 clinical trial results for coramitug in patients with ATTR amyloidosis published in Amyloid, the official journal of the International Society of Amyloidosis
- Ongoing Phase 2 signal-detection clinical trial in patients with ATTR-CM is being conducted by Novo Nordisk
- Phase 2 clinical trial has completed enrollment of approximately 99 patients with topline data expected in 1H 2025 (NCT05442047)
Corporate Highlight
- Prothena announced the appointment of Chad J. Swanson, Ph.D., as Chief Development Officer in September 2024, leading all clinical development and medical functions. 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.
Third Quarter and First Nine Months of 2024 Financial Results
For the third quarter and first nine months of 2024, Prothena reported net loss of
Prothena reported total revenue of
Research and development (R&D) expenses totaled
General and administrative (G&A) expenses totaled
Total non-cash share-based compensation expense was
As of September 30, 2024, Prothena had
As of November 6, 2024, Prothena had approximately 53.8 million ordinary shares outstanding.
2024 Financial Guidance
The Company continues to expect full year 2024 net cash used in operating and investing actives to be
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of a broad pipeline and completion of our ongoing clinical trials; the continued advancement of our discovery, preclinical, and clinical pipeline, and expected milestones in 2024, 2025, and beyond; the treatment potential, designs, proposed mechanisms of action, and potential administration of PRX012, BMS-986446/PRX005, PRX123, prasinezumab, PRX019, birtamimab, and coramitug/PRX004; plans for ongoing and future clinical trials of PRX012, BMS-986446/PRX005, PRX123, prasinezumab, PRX019, birtamimab, and coramitug/PRX004; the expected timing of reporting data from clinical trials, including multiple clinical readouts starting in mid- 2025 and continuing throughout the year from our ongoing Phase 1 clinical trials evaluating PRX012 and topline study results for our Phase 3 AFFIRM-AL clinical trial between in 1H 2025; our anticipated net cash burn from operating and investing activities for 2024 and expected cash balance at the end of 2024; and our estimated net loss and non-cash share-based compensation expense for 2024. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.
PROTHENA CORPORATION PLC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited - amounts in thousands except per share data) |
||||||||||||||||
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Collaboration revenue |
|
$ |
970 |
|
|
$ |
84,866 |
|
|
$ |
132,984 |
|
|
$ |
91,004 |
|
Revenue from license and intellectual property |
|
|
— |
|
|
|
— |
|
|
|
50 |
|
|
|
50 |
|
Total revenue |
|
|
970 |
|
|
|
84,866 |
|
|
|
133,034 |
|
|
|
91,054 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
|
50,723 |
|
|
|
57,913 |
|
|
|
172,347 |
|
|
|
158,680 |
|
General and administrative |
|
|
16,760 |
|
|
|
16,645 |
|
|
|
50,351 |
|
|
|
44,895 |
|
Total operating expenses |
|
|
67,483 |
|
|
|
74,558 |
|
|
|
222,698 |
|
|
|
203,575 |
|
Income (loss) from operations |
|
|
(66,513 |
) |
|
|
10,308 |
|
|
|
(89,664 |
) |
|
|
(112,521 |
) |
Total other income, net |
|
|
6,677 |
|
|
|
8,507 |
|
|
|
20,235 |
|
|
|
22,659 |
|
Income (loss) before income taxes |
|
|
(59,836 |
) |
|
|
18,815 |
|
|
|
(69,429 |
) |
|
|
(89,862 |
) |
Benefit from income taxes |
|
|
(835 |
) |
|
|
(3,092 |
) |
|
|
(5,075 |
) |
|
|
(10,310 |
) |
Net income (loss) |
|
$ |
(59,001 |
) |
|
$ |
21,907 |
|
|
$ |
(64,354 |
) |
|
$ |
(79,552 |
) |
Basic net income (loss) per ordinary share |
|
$ |
(1.10 |
) |
|
$ |
0.41 |
|
|
$ |
(1.20 |
) |
|
$ |
(1.50 |
) |
Diluted net income (loss) per ordinary share |
|
$ |
(1.10 |
) |
|
$ |
0.38 |
|
|
$ |
(1.20 |
) |
|
$ |
(1.50 |
) |
Shares used to compute basic net income (loss) per share |
|
|
53,790 |
|
|
|
53,559 |
|
|
|
53,757 |
|
|
|
53,064 |
|
Shares used to compute diluted net income (loss) per share |
|
|
53,790 |
|
|
|
58,004 |
|
|
|
53,757 |
|
|
|
53,064 |
|
PROTHENA CORPORATION PLC CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited - amounts in thousands) |
|||||
|
September 30, |
|
December 31, |
||
|
|
2024 |
|
|
2023 |
Assets |
|
|
|
||
Cash and cash equivalents |
$ |
519,262 |
|
$ |
618,830 |
Restricted cash, current |
|
— |
|
|
1,352 |
Prepaid expenses and other current assets |
|
15,722 |
|
|
19,100 |
Total current assets |
|
534,984 |
|
|
639,282 |
Property and equipment, net |
|
3,254 |
|
|
3,836 |
Operating lease right-of-use assets |
|
11,400 |
|
|
12,162 |
Restricted cash, non-current |
|
860 |
|
|
860 |
Other non-current assets |
|
44,756 |
|
|
40,242 |
Total non-current assets |
|
60,270 |
|
|
57,100 |
Total assets |
$ |
595,254 |
|
$ |
696,382 |
Liabilities and Shareholders’ Equity |
|
|
|
||
Accrued research and development |
|
10,340 |
|
|
14,724 |
Deferred revenue, current |
|
8,832 |
|
|
— |
Lease liability, current |
|
2,613 |
|
|
1,114 |
Other current liabilities |
|
24,637 |
|
|
41,053 |
Total current liabilities |
|
46,422 |
|
|
56,891 |
Deferred revenue, non-current |
|
5,589 |
|
|
67,405 |
Lease liability, non-current |
|
8,881 |
|
|
10,721 |
Total non-current liabilities |
|
14,470 |
|
|
78,126 |
Total liabilities |
|
60,892 |
|
|
135,017 |
Total shareholders’ equity |
|
534,362 |
|
|
561,365 |
Total liabilities and shareholders’ equity |
$ |
595,254 |
|
$ |
696,382 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112238826/en/
Investors
Mark Johnson, CFA, Vice President, Investor Relations
650-417-1974, mark.johnson@prothena.com
Media
Michael Bachner, Senior Director, Corporate Communications
609-664-7308, michael.bachner@prothena.com
Source: Prothena Corporation plc
FAQ
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