On May 5, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported financial results for the first quarter 2022 (Press release, Prothena, MAY 5, 2022, View Source [SID1234613796]).
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"We are excited to kick off 2022 with a strong first quarter, further reinforcing continued execution across our portfolio. We remain focused on the Phase 3 AFFIRM-AL trial of birtamimab being conducted under a SPA agreement with FDA. We also achieved multiple milestones in our PRX012 program, our next-generation, subcutaneous anti-amyloid beta antibody, having received FDA clearance of the IND, initiated a Phase 1 clinical study and received Fast Track designation from FDA. Additionally, we presented positive preclinical findings for our Alzheimer’s and Parkinson’s active vaccine candidates at AD/PD 2022, further highlighting the depth of our neurodegenerative pipeline," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "Later this year, we look forward to clinical data from our PRX005 Phase 1 study and the initiation of a Phase 1 multiple ascending dose study for PRX012. We will continue to drive meaningful growth this year across our portfolio and our strong capital position supports our leadership in protein dysregulation."
First Quarter and Recent Business Highlights and Upcoming Milestones
Neurodegenerative Diseases Portfolio
Alzheimer’s Disease (AD)
PRX012, a potential best-in-class treatment for AD, is an investigational monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency supporting subcutaneous administration
Received U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application
Received Fast Track designation for PRX012 from FDA for the treatment of AD
Initiated Phase 1 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 Alzheimer’s disease
Phase 1 multiple ascending dose (MAD) study initiation expected by year-end 2022
Topline Phase 1 data expected in 2023
PRX005, a potential best-in-class treatment for AD, is an investigational antibody that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE), and other tauopathies. PRX005 is part of the global neuroscience research and development collaboration with Bristol Myers Squibb
Topline Phase 1 data expected in 2022
Dual Aβ /tau vaccine, a potential first-in-class treatment and prevention therapy for AD, is a dual-target vaccine targeting key epitopes within the Aβ and tau proteins to promote amyloid clearance and blockade of pathogenic tau
Oral presentation on preclinical data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022) in March demonstrating that Prothena’s dual Aβ/tau vaccine generated anti-Aβ and anti-tau antibodies to enable phagocytosis of Aβ and to neutralize tau
IND filing expected in 2023
Parkinson’s Disease (PD)
Prasinezumab, a potential first-in-class treatment for PD, is a humanized monoclonal antibody designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche
Oral presentation by partner Roche at AD/PD 2022 on the Phase 2 PASADENA study of prasinezumab, further supports a potential effect on delaying motor progression in patients
Phase 2b PADOVA study results expected in 2024
Rare Peripheral Amyloid Diseases Portfolio
AL Amyloidosis
Birtamimab, a potential best-in-class amyloid depleter treatment for AL amyloidosis, is an investigational humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure
Confirmatory Phase 3 AFFIRM-AL study results expected in 2024
ATTR Amyloidosis
PRX004, a potential first-in-class treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein, that is being developed by Novo Nordisk for the treatment of ATTR cardiomyopathy
Novo Nordisk expects to initiate a Phase 2 study of PRX004 for the treatment of ATTR cardiomyopathy in 2Q 2022
Upcoming Investor Conferences
Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:
BofA Securities 2022 Healthcare Conference, May 10, 2022, at 9:20 AM PT/12:20 PM ET
H.C. Wainwright Global Investment Conference, May 24, 2022, on demand presentations available starting at 7:00 AM ET
First Quarter 2022 Financial Results
For the first quarter of 2022, Prothena reported a net loss of $36.3 million, as compared to a net loss of $36.7 million for the first quarter of 2021. Net loss per share for the first quarter of 2022 was $0.78, as compared to net loss per share of $0.91 for the first quarter of 2021.
Prothena reported total revenue of $1.2 million for the first quarter of 2022, primarily from collaboration revenue from Bristol Myers Squibb. As compared to total revenue of $0.2 million for the first quarter of 2021, from collaboration and license revenue from Roche.
Research and development (R&D) expenses totaled $27.3 million for the first quarter of 2022, as compared to $21.1 million for the first quarter of 2021. The increase in R&D expense for the first quarter of 2022 compared to the same period in the prior year was primarily due to higher manufacturing costs, primarily related to the birtamimab program, higher personnel related expenses, higher clinical trial expenses primarily related to the PRX012, birtamimab and PRX005 programs, and higher other R&D expense, offset in part by lower collaboration expenses related to the prasinezumab program with Roche as a result of the cost share opt-out exercised in May 2021. R&D expenses included non-cash share-based compensation expense of $3.3 million for the first quarter of 2022, as compared to $2.0 million for the first quarter of 2021.
General and administrative (G&A) expenses totaled $11.8 million for the first quarter of 2022, as compared to $11.1 million for the first quarter of 2021. The increase in G&A expenses for the first quarter of 2022 compared to the same period in the prior year was primarily related to higher personnel expense and higher consulting expenses, offset in part by lower legal expense and lower expense for our director and officer insurance premium. G&A expenses included non-cash share-based compensation expense of $4.3 million for the first quarter of 2022, as compared to $4.2 million for the first quarter of 2021.
Total non-cash share-based compensation expense was $7.7 million for the first quarter of 2022, as compared to $6.2 million for the first quarter of 2021.
As of March 31, 2022, Prothena had $544.3 million in cash, cash equivalents and restricted cash, and no debt.
As of April 28, 2022, Prothena had approximately 46.8 million ordinary shares outstanding.
2022 Financial Guidance
The Company continues to expect the full year 2022 net cash used in operating and investing activities to be $120 to $132 million, which includes an expected $40 million clinical milestone payment from Novo Nordisk and expects to end the year with approximately $454 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2022 net cash used in operating and investing activities is primarily driven by an estimated net loss of $154 to $170 million, which includes an estimated $32 million of non-cash share-based compensation expense. (Press release, Prothena, MAY 5, 2022, View Source [SID1234613796])