Prothena Corporation PRTA reported fourth-quarter 2024 loss per share of $1.08, wider than the Zacks Consensus Estimate of a loss of $1.02.  In the year-ago quarter, the company posted a loss of $1.26 cents per share.

The bottom line improved year over year due to higher revenues and lower expenses.

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Revenues totaled $2.1 million, which missed the Zacks Consensus Estimate of $14 million. PRTA recorded revenues of $316,000 for the fourth quarter of 2023.

The company’s shares have lost 43.6% in the past year compared with the industry’s decline of 5.5%.

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PRTA’s Q4 Results in Detail

Research and development (R&D) expenses decreased 19% year over year to $50.2 million, primarily due to lower clinical trial expenses and lower manufacturing costs.

General and administrative expenses amounted to $16.8 million, down from $16.9 million in the year-ago quarter.

As of Dec. 31, 2024, Prothena had $472.2 million in cash, cash equivalents and restricted cash, and no debt.

Pipeline Updates

Prothena is evaluating PRX012 — a wholly owned investigational next-generation subcutaneous, 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.

BMS-986446 (formerly PRX005) is designed to be 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. 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, a potential prevention and 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 cleared an investigational new drug application.

The regulatory body granted Fast Track designation to PRX123 for the treatment of AD. Prothena expects to update plans for the phase I study in 2025.

The company is evaluating prasinezumab, in collaboration with Roche RHHBY, for the treatment of Parkinson’s disease (PD).

Roche 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 showed a numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints, suggesting possible clinical benefit. It will continue to evaluate the data and collaborate with health authorities to determine the next steps.

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 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, expected to be completed in 2025, has completed enrollment of approximately 99 patients.

PRTA’s 2024 Results

Revenues totaled $135.1 million, up from $91.4 million in 2023. Collaboration revenues from BMY were primarily recognized from the license agreement for PRX019.

Loss per share was $2.27 in 2024, marking an improvement from a loss of $2.76 in 2023.

PRTA’s 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 #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

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