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Prothena Q1 Earnings Miss Estimates, Focus on Key Readouts in 2025
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Prothena Corporation (PRTA - Free Report) reported first-quarter 2025 loss per share of $1.12, much wider than the Zacks Consensus Estimate of a loss of 92 cents. In the year-ago quarter, the company posted a loss of $1.34 per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
The bottom line improved year over year due to higher revenues and lower expenses.
Revenues totaled $2.8 million, which missed the Zacks Consensus Estimate of $21 million. PRTA recorded revenues of $0.1 million in the first quarter of 2024.
The company’s shares have lost 48.7% year to date compared with the industry’s decline of 7.4%.
Image Source: Zacks Investment Research
PRTA’s Q1 Results in Detail
Research and development (R&D) expenses decreased 20.7% year over year to $50.8 million, primarily due to lower clinical trial expenses and lower manufacturing costs.
General and administrative expenses amounted to $17.6 million, down from $17.5 million in the year-ago quarter.
As of March 31, 2025, Prothena had $418.8 million in cash, cash equivalents and restricted cash, and no debt.
Prothena Corporation plc Price, Consensus and EPS Surprise
Prothena is evaluating PRX012 — a wholly owned single-injection once-monthly antibody delivered subcutaneously targeting a key epitope at the N-terminus of amyloid beta (Aβ) — for treating Alzheimer’s Disease (AD). It has currently enrolled approximately 260 patients in the ASCENT clinical trials and expects to report multiple clinical readouts from the ongoing ASCENT studies beginning mid-2025.
PRTA is advancing an early-stage pipeline of programs for several potential neurological indications with Bristol Myers (BMY - Free Report) .
BMS-986446 (formerly PRX005) is a best-in-class anti-tau, MTBR-specific antibody for the potential treatment of AD.
Bristol Myers continues to enroll approximately 475 patients with early AD in the ongoing phase II study on BMS-986446. The study is expected to be completed in 2027.
The company is responsible for all the development, manufacturing and commercialization of BMS-986446.
PRX019, a potential treatment for neurodegenerative diseases with an undisclosed target, is also being developed in collaboration with BMY, which obtained the exclusive global license for the candidate in 2024.
PRTA has initiated a phase I first-in-human clinical trial on PRX019 to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of single ascending and multiple doses in healthy adults. The phase I study is expected to be completed in 2026.
Prothena is also developing a dual Aβ-Tau vaccine, PRX123, which is a potential preventive and therapeutic treatment for AD. It 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 has cleared an Investigational New Drug Application for PRX123.
The regulatory body granted Fast Track designation to PRX123 for the treatment of AD. Prothena expects to update plans for the phase I study by year-end 2025.
The company is also evaluating prasinezumab, in collaboration with Roche (RHHBY - Free Report) , for the treatment of Parkinson’s disease (PD).
Roche had earlier reported that data from the Phase IIb PADOVA study in patients with early-stage Parkinson’s disease showed that it missed the primary endpoint, but demonstrated a numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints, suggesting a possible clinical benefit.
The totality of the data presented in two oral presentations at AD/PD 2025 suggests a possible benefit in early-stage Parkinson’s disease, including consistent positive trends across primary, secondary, and exploratory clinical endpoints. A possible biological effect of prasinezumab on MRI biomarkers was also observed.
Roche will continue to evaluate data from PADOVA. It will also collaborate with health authorities to determine the next steps by mid-year 2025.
Roche is currently conducting the Open Label Extensions (OLEs) of the phase II PASADENA and phase IIb PADOVA clinical studies.
Prothena is also evaluating birtamimab, a wholly-owned potential treatment for AL amyloidosis. It reached a Special Protocol Assessment agreement with the FDA and initiated a confirmatory phase III AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis. Top-line results from the study are expected in the second quarter of 2025.
Novo Nordisk (NVO - Free Report) had earlier acquired Prothena’s clinical-stage antibody, Coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy.
NVO is conducting an ongoing phase II study in patients with ATTR cardiomyopathy. The study has completed enrollment of approximately 99 patients. Results are expected in the second half of 2025.
PRTA Reiterates 2025 Guidance
The company expects 2025 net cash burn from operating and investing activities to be in the range of $168-$175 million. It expects year-end cash, cash equivalents and restricted cash midpoint to be approximately $301 million. Net loss for 2025 is projected to be in the $197-$205 million range.
Image: Bigstock
Prothena Q1 Earnings Miss Estimates, Focus on Key Readouts in 2025
Prothena Corporation (PRTA - Free Report) reported first-quarter 2025 loss per share of $1.12, much wider than the Zacks Consensus Estimate of a loss of 92 cents. In the year-ago quarter, the company posted a loss of $1.34 per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
The bottom line improved year over year due to higher revenues and lower expenses.
Revenues totaled $2.8 million, which missed the Zacks Consensus Estimate of $21 million. PRTA recorded revenues of $0.1 million in the first quarter of 2024.
The company’s shares have lost 48.7% year to date compared with the industry’s decline of 7.4%.
Image Source: Zacks Investment Research
PRTA’s Q1 Results in Detail
Research and development (R&D) expenses decreased 20.7% year over year to $50.8 million, primarily due to lower clinical trial expenses and lower manufacturing costs.
General and administrative expenses amounted to $17.6 million, down from $17.5 million in the year-ago quarter.
As of March 31, 2025, Prothena had $418.8 million in cash, cash equivalents and restricted cash, and no debt.
Prothena Corporation plc Price, Consensus and EPS Surprise
Prothena Corporation plc price-consensus-eps-surprise-chart | Prothena Corporation plc Quote
PRTA’s Pipeline Updates
Prothena is evaluating PRX012 — a wholly owned single-injection once-monthly antibody delivered subcutaneously targeting a key epitope at the N-terminus of amyloid beta (Aβ) — for treating Alzheimer’s Disease (AD). It has currently enrolled approximately 260 patients in the ASCENT clinical trials and expects to report multiple clinical readouts from the ongoing ASCENT studies beginning mid-2025.
PRTA is advancing an early-stage pipeline of programs for several potential neurological indications with Bristol Myers (BMY - Free Report) .
BMS-986446 (formerly PRX005) is a best-in-class anti-tau, MTBR-specific antibody for the potential treatment of AD.
Bristol Myers continues to enroll approximately 475 patients with early AD in the ongoing phase II study on BMS-986446. The study is expected to be completed in 2027.
The company is responsible for all the development, manufacturing and commercialization of BMS-986446.
PRX019, a potential treatment for neurodegenerative diseases with an undisclosed target, is also being developed in collaboration with BMY, which obtained the exclusive global license for the candidate in 2024.
PRTA has initiated a phase I first-in-human clinical trial on PRX019 to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of single ascending and multiple doses in healthy adults. The phase I study is expected to be completed in 2026.
Prothena is also developing a dual Aβ-Tau vaccine, PRX123, which is a potential preventive and therapeutic treatment for AD. It 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 has cleared an Investigational New Drug Application for PRX123.
The regulatory body granted Fast Track designation to PRX123 for the treatment of AD. Prothena expects to update plans for the phase I study by year-end 2025.
The company is also evaluating prasinezumab, in collaboration with Roche (RHHBY - Free Report) , for the treatment of Parkinson’s disease (PD).
Roche had earlier reported that data from the Phase IIb PADOVA study in patients with early-stage Parkinson’s disease showed that it missed the primary endpoint, but demonstrated a numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints, suggesting a possible clinical benefit.
The totality of the data presented in two oral presentations at AD/PD 2025 suggests a possible benefit in early-stage Parkinson’s disease, including consistent positive trends across primary, secondary, and exploratory clinical endpoints. A possible biological effect of prasinezumab on MRI biomarkers was also observed.
Roche will continue to evaluate data from PADOVA. It will also collaborate with health authorities to determine the next steps by mid-year 2025.
Roche is currently conducting the Open Label Extensions (OLEs) of the phase II PASADENA and phase IIb PADOVA clinical studies.
Prothena is also evaluating birtamimab, a wholly-owned potential treatment for AL amyloidosis. It reached a Special Protocol Assessment agreement with the FDA and initiated a confirmatory phase III AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis. Top-line results from the study are expected in the second quarter of 2025.
Novo Nordisk (NVO - Free Report) had earlier acquired Prothena’s clinical-stage antibody, Coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy.
NVO is conducting an ongoing phase II study in patients with ATTR cardiomyopathy. The study has completed enrollment of approximately 99 patients. Results are expected in the second half of 2025.
PRTA Reiterates 2025 Guidance
The company expects 2025 net cash burn from operating and investing activities to be in the range of $168-$175 million. It expects year-end cash, cash equivalents and restricted cash midpoint to be approximately $301 million. Net loss for 2025 is projected to be in the $197-$205 million range.
PRTA currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.