- Net cash used in operating and investing activities was $47.5
million in the first quarter of 2023; quarter-end cash and
restricted cash position was $688.4 million
- Data reported in an oral presentation at AD/PD 2023 that
PRX012, a potential best-in-class anti-amyloid beta antibody,
demonstrated higher affinity binding to amyloid beta soluble
protofibrils and greater clearance of pyroglutamate-modified
amyloid beta plaques compared to other approved and investigational
molecules
- Topline data reported from Phase 1 SAD study of PRX005, a novel
anti-MTBR-tau antibody, meeting the primary study objective
Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical
biotechnology company with a robust pipeline of investigational
therapeutics built on protein dysregulation expertise, today
reported financial results for the first quarter of 2023 and
provided business highlights.
“Recent positive clinical study results and FDA approvals have
now established that reduction of amyloid beta plaque is directly
related to clinical benefit. These results are positive for the
Alzheimer’s disease community, especially for the patients,
families and caregivers who fight everyday against this devastating
disease. Prothena is committed to furthering these efforts by
developing patient-centric, next-generation Alzheimer’s disease
treatments,” said Gene Kinney, Ph.D., President and Chief Executive
Officer, Prothena. “We showcased our potential best-in-class
Alzheimer’s disease portfolio in the first quarter of 2023 with new
preclinical data presented at AD/PD which adds to the scientific
foundation for our PRX012 program. These data demonstrated higher
affinity binding to amyloid beta soluble protofibrils and greater
clearance of pyroglutamate-modified amyloid beta plaques compared
to other approved and investigational molecules. In addition, we
released topline data from the Phase 1 SAD study of PRX005 which
demonstrated that single doses of PRX005 across three dose cohorts
were generally safe and well tolerated.
“We look forward to making meaningful advances in our
Alzheimer’s disease portfolio this year. We also continue to focus
on enrolling our confirmatory Phase 3 AFFIRM-AL study of
birtamimab, the first potential therapy to observe a significant
survival benefit in patients with Mayo Stage IV AL amyloidosis,”
added Kinney.
First Quarter, Recent Business Highlights and Upcoming
Milestones
Neurodegenerative Diseases Portfolio
Alzheimer’s Disease (AD)
PRX012, a wholly-owned potential best-in-class,
next-generation subcutaneous antibody for the treatment of AD,
targets a key epitope at the N-terminus of amyloid beta (Aβ) with
high binding potency. The U.S. Food and Drug Administration (FDA)
has granted Fast Track Designation for PRX012 for the treatment of
AD.
- Multiple presentations at International Conference on
Alzheimer’s and Parkinson’s Diseases 2023 (AD/PD) highlighted by an
oral presentation of preclinical data showing superior binding
characteristics of PRX012, demonstrated 20-fold higher affinity to
Aβ soluble protofibrils when compared to lecanemab; PRX012 also
cleared pyroglutamate-modified Aβ at lower concentrations when
compared to donanemab
- Partnered with Walgreens to accelerate patient identification
and recruitment for ongoing ASCENT-2 multiple ascending dose (MAD)
clinical trial evaluating safety and tolerability
- Ongoing Phase 1 single ascending dose (SAD) and MAD studies;
topline data expected year end 2023
PRX005, a potential best-in-class antibody for the
treatment of AD, 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 a global neuroscience
research and development collaboration with Bristol Myers
Squibb.
- Topline data from Phase 1 SAD study announced January 2023
showing single doses of PRX005 across three dose cohorts were
generally safe and well tolerated, meeting the primary study
objective; results expected from the Phase 1 SAD study at an
upcoming medical conference
- Ongoing Phase 1 MAD study; topline data expected by year end
2023
PRX123, a wholly-owned potential first-in-class dual
Aβ/tau vaccine for the treatment and prevention of AD, 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
- Investigational new drug (IND) application filing expected by
year end 2023
Parkinson’s Disease (PD)
Prasinezumab, a potential first-in-class antibody for the
treatment of PD, is designed to target a key epitope within the
C-terminus of alpha-synuclein and is the focus of a worldwide
collaboration with Roche
- Poster and oral presentations at AD/PD highlighted aspects of
the Phase 2 PASADENA study of prasinezumab for the treatment of
PD
- In Q1 2023, Roche completed enrollment for the Phase 2b PADOVA
trial in patients with early PD (NCT04777331); topline data
expected in 2024
Rare Peripheral Amyloid Diseases
Portfolio
AL Amyloidosis
Birtamimab, a wholly-owned potential best-in-class
amyloid depleter antibody for the treatment of AL amyloidosis, is
designed to directly neutralize soluble toxic 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 advanced
disease (i.e. Mayo Stage IV) are at the highest risk for early
death. Birtamimab has been granted Fast Track Designation by the
FDA for the treatment of patients with Mayo Stage IV AL amyloidosis
to reduce the risk of mortality and has been granted Orphan Drug
Designation by both the FDA and European Medicines Agency.
- Confirmatory Phase 3 AFFIRM-AL trial in patients with Mayo
Stage IV AL amyloidosis, which is under a Special Protocol
Assessment (SPA) with the FDA with a primary endpoint of all-cause
mortality at p≤0.10, is ongoing (NCT04973137); topline data
expected in 2024
ATTR Amyloidosis
NNC6019 (formerly PRX004), a potential first-in-class
amyloid depleter antibody for the treatment of ATTR cardiomyopathy,
is designed to deplete the pathogenic, non-native forms of the
transthyretin (TTR) protein and is being developed by Novo Nordisk
as part of their up to $1.2 billion acquisition of Prothena’s ATTR
amyloidosis business and pipeline
- Ongoing Phase 2 study in patients with ATTR cardiomyopathy is
being conducted by Novo Nordisk (NCT05442047); topline data
expected in 2024
First Quarter of 2023 Financial Results
For the first quarter of 2023, Prothena reported net loss of
$46.9 million, as compared to a net loss of $36.3 million for the
first quarter of 2022. Net loss per share was $0.89 for the first
quarter of 2023, as compared to net loss per share of $0.78 for the
first quarter of 2022.
Prothena reported total revenue of $2.2 million for the first
quarter of 2023, as compared to total revenue of $1.2 million for
the first quarter of 2022, primarily from collaboration revenue
from Bristol Myers Squibb.
Research and development (R&D) expenses totaled $44.8
million for the first quarter of 2023, as compared to $27.3 million
for the first quarter of 2022. The increase in R&D expense for
the first quarter of 2023 compared to the same period in the prior
year was primarily due to higher clinical trial expenses, higher
personnel related expenses, higher consulting and other R&D
expenses. R&D expenses included non-cash share-based
compensation expense of $4.4 million for the first quarter of 2023,
as compared to $3.3 million for the first quarter of 2022.
General and administrative (G&A) expenses totaled $13.7
million for the first quarter of 2023, as compared to $11.8 million
for the first quarter of 2022. The increase in G&A expenses for
the first quarter of 2023 compared to the same period in the prior
year was primarily related to higher personnel related and legal
expenses. G&A expenses included non-cash share-based
compensation expense of $4.4 million for the first quarter of 2023,
as compared to $4.3 million for the first quarter of 2022.
Total non-cash share-based compensation expense was $8.8 million
for the first quarter of 2023, as compared to $7.7 million for the
first quarter of 2022.
As of March 31, 2023, Prothena had $688.4 million in cash, cash
equivalents and restricted cash, and no debt.
As of April 28, 2023, Prothena had approximately 52.8 million
ordinary shares outstanding.
2023 Financial Guidance
The Company continues to expect the full year 2023 net cash used
in operating and investing activities to be $213 to $229 million
and expects to end the year with approximately $512 million in
cash, cash equivalents and restricted cash (midpoint). The
estimated full year 2023 net cash used in operating and investing
activities is primarily driven by an estimated net loss of $250 to
$275 million, which includes an estimated $46 million of non-cash
share-based compensation expense.
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, 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; the
continued advancement of our discovery, preclinical, and clinical
pipeline, and expected milestones in 2023 and beyond; the treatment
potential, designs, proposed mechanisms of action, and potential
administration of birtamimab, prasinezumab, NNC6019/PRX004, PRX005,
PRX012, and PRX123; plans for future clinical studies of
birtamimab, prasinezumab, NNC6019/PRX004, PRX005, PRX012, and
PRX123 (including the filing of an IND application); the expected
timing of reporting data from clinical studies of birtamimab,
prasinezumab, PRX005, and PRX012; our anticipated net cash burn
from operating and investing activities for 2023 and expected cash
balance at the end of 2023; and our estimated net loss and non-cash
share-based compensation expense for 2023. 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 May 4, 2023,
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
March 31,
2023
2022
Collaboration revenue
$
2,119
$
1,103
Revenue from license and intellectual
property
50
50
Total revenue
2,169
1,153
Operating expenses:
Research and development
44,756
27,262
General and administrative
13,738
11,835
Total operating expenses
58,494
39,097
Loss from operations
(56,325
)
(37,944
)
Other income (expense), net
6,549
(17
)
Loss before income taxes
(49,776
)
(37,961
)
Benefit from income taxes
(2,912
)
(1,671
)
Net loss
$
(46,864
)
$
(36,290
)
Basic net loss per ordinary share
$
(0.89
)
$
(0.78
)
Diluted net loss per ordinary share
$
(0.89
)
$
(0.78
)
Shares used to compute basic net loss per
share
52,501
46,704
Shares used to compute diluted net loss
per share
52,501
46,704
PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited - amounts in
thousands)
March 31,
December 31,
2023
2022
Assets
Cash and cash equivalents
$
686,184
$
710,406
Prepaid expenses and other current
assets
14,159
8,692
Total current assets
700,343
719,098
Property and equipment, net
1,924
1,731
Operating lease right-of-use assets
4,719
6,277
Restricted cash, non-current
2,212
2,212
Other non-current assets
32,388
28,717
Total non-current assets
41,243
38,937
Total assets
$
741,586
$
758,035
Liabilities and Shareholders’
Equity
Accrued research and development
14,156
10,794
Deferred revenue, current
9,323
11,442
Lease liability, current
4,885
6,473
Other current liabilities
20,520
21,438
Total current liabilities
48,884
50,147
Deferred revenue, non current
85,293
85,293
Other non-current liabilities
—
553
Total non-current liabilities
85,293
85,846
Total liabilities
134,177
135,993
Total shareholders’ equity
607,409
622,042
Total liabilities and shareholders’
equity
$
741,586
$
758,035
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230504005736/en/
Media and Investor Contact:
Media Michael Bachner, Senior Director, Corporate Communications
609-664-7308, michael.bachner@prothena.com
Investors IR@prothena.com
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