Clinical-stage company
Prothena Corporation
PRTA
reported first-quarter 2022 loss of 78 cents per share, narrower than the Zacks Consensus Estimate of a loss of 85 cents per share. In the year-ago quarter, the company reported a loss of 91 cents.
Total revenues came in at $1.15 million in the quarter, beating the Zacks Consensus Estimate by 401.3%. Revenues in the quarter included collaboration revenues from
Bristol Myers Squibb
BMY
. In the year-ago quarter, the company generated revenues of $0.2 million from collaboration and license revenue from
Roche
RHHBY
.
The company’s shares have slumped 50.4% in the year so far compared with the
industry
’s decline of 26.8%.
Image Source: Zacks Investment Research
Quarter in Detail
R&D expenses were $27.3 million, up from $21.1 million in the year-ago quarter, primarily due to higher manufacturing costs, primarily related to the birtamimab program, higher personnel-related expenses, and increased clinical trial expenses primarily related to the PRX012, birtamimab and PRX005 programs.
General and administrative (G&A) expenses were $11.8 million, up from $11.1 million in the year-ago quarter.
As of Mar 31, 2022, Prothena had $544.3 million in cash, cash equivalents and restricted cash and no debt.
Pipeline Updates
Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications with Bristol Myers. PRX005 — a potential treatment for Alzheimer’s disease (AD) — is an investigational antibody that targets tau, a protein implicated in diseases including AD, frontotemporal dementia, progressive supranuclear palsy, chronic traumatic encephalopathy and other tauopathies. A phase I study was initiated in 2021, and top-line data is expected in 2022.
Prothena is also evaluating PRX012, an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) for the treatment of AD. The company obtained FDA clearance for the Investigational New Drug (IND) application for the same. A phase I single ascending dose (SAD) study, a randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, immunogenicity and pharmacokinetics in healthy volunteers and patients with AD has been initiated, and a phase I multiple ascending dose (MAD) study initiation is expected by year-end 2022.
The company is also developing a dual Aβ-Tau vaccine — a potential prevention and treatment for AD — to target key epitopes within Aβ and tau proteins to promote amyloid clearance and block pathogenic tau interaction. An IND for the vaccine is anticipated in 2023.
The company is also evaluating prasinezumab in collaboration with Roche for the treatment of Parkinson’s disease. PRTA earned a $60 million milestone payment in 2021 upon dosing the first patient in the global phase IIb PADOVA study for prasinezumab from Roche, and study results are expected in 2024.
It is also evaluating birtamimab, a potential treatment for AL amyloidosis. It reached a Special Protocol Assessment agreement with FDA and initiated a confirmatory phase III AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis in 2021, and results are expected in 2024.
Novo Nordisk
NVO
has acquired Prothena’s clinical-stage antibody, PRX004, and broader ATTR amyloidosis program. Prothena is eligible to receive a total aggregate of up to $1.23 billion and has received $60 million upfront payment from NVO in 2021. Novo Nordisk is expected to initiate a phase II trial in the second quarter on PRX004 for the treatment of ATTR cardiomyopathy.
Our Take
The company reported a narrower loss and revenues beat estimates in the first quarter. The pipeline progress with its AD candidates is impressive and promises potential.
Prothena 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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