Prothena Reports Second Quarter 2022 Financial Results and Business
Highlights
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 and provided business highlights for the
second quarter and first six months of 2022.
“We are closing the first half of 2022 from a
position of strength, with multiple clinical programs advancing and
a solid cash position supporting a robust set of milestones
anticipated in 2022 and beyond. We are grateful for the opportunity
to quickly progress the development of PRX012, a next-generation
anti-Aβ antibody, under FDA’s Fast Track designation, further
reinforcing our commitment to Alzheimer’s disease patients and
their families,” said Gene Kinney, Ph.D., President and Chief
Executive Officer of Prothena. “We believe our anticipated progress
in the second half of the year will continue to validate our
biology-directed R&D strategy, with antibodies that have been
engineered to target pathogenic proteins in a manner we believe
will be most impactful for the treatment of disease. We expect to
achieve multiple milestones, including topline Phase 1 data for
PRX005, the initiation of a Phase 1 multiple ascending dose study
of PRX012 and the continued advancement of the Phase 2 study of
PRX004 by Novo Nordisk. Additionally, we remain focused on our
confirmatory Phase 3 AFFIRM-AL study of birtamimab, the first
potential therapy to show survival benefit in Mayo Stage IV
patients with AL amyloidosis.”
Second Quarter and Recent Business
Highlights and Upcoming Milestones
Neurodegenerative Diseases
Portfolio
Alzheimer’s Disease (AD)
PRX012, a potential
best-in-class, next-generation 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
- In April, the U.S. Food and Drug
Administration (FDA) granted Fast Track designation for PRX012 for
the treatment of AD
- Phase 1 multiple ascending dose
(MAD) study initiation expected by year-end 2022
- Topline data from Phase 1 study
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 data from Phase 1 study
expected in 2022
PRX123, a potential
first-in-class dual Aβ/tau vaccine 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
- 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
- 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
- Abstract accepted for poster
presentation on Monday September 5, 2022 at the XVIII International
Symposium on Amyloidosis (ISA) titled: Birtamimab in Patients with
Mayo Stage IV AL Amyloidosis: Rationale for Confirmatory AFFIRM-AL
Phase 3 Study (Poster P040)
- Confirmatory Phase 3 AFFIRM-AL
study results expected in 2024
ATTR Amyloidosis
NNC6019 (previously 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 transthyretin (TTR) protein, that is being
developed by Novo Nordisk for the treatment of ATTR
cardiomyopathy
- Phase 2 trial of NNC6019 in
patients with ATTR cardiomyopathy is being conducted by Novo
Nordisk (NCT05442047)
Second Quarter and First Six Months of
2022 Financial Results
For the second quarter and first six months of
2022, Prothena reported a net loss of $41.2 million and $77.5
million, as compared to a net income of $27.6 million and a net
loss of $9.1 million for the second quarter and first six months of
2021. Net loss per share for the second quarter of 2022 and first
six months of 2022 was $0.88, and $1.66, respectively, as compared
to net income per share on a diluted basis of $0.58 and net loss
per share of $0.21 for the second quarter and first six months of
2021, respectively.
Prothena reported total revenue of $1.3 million
and $2.5 million for the second quarter and first six months of
2022, respectively, primarily from collaboration revenue from BMS.
As compared to total revenue of $60.1 million and $60.2 million for
the second quarter and first six months of 2021, from collaboration
and license revenue from Roche.
Research and development (R&D) expenses
totaled $31.6 million and $58.8 million for the second quarter and
first six months of 2022, respectively, as compared to $21.1
million and $42.2 million for the second quarter and first six
months of 2021, respectively. The increase in R&D expense for
the second quarter and first six months of 2022 compared to the
same periods in the prior year was primarily due to higher
personnel related expenses, higher clinical trial expenses
primarily related to the PRX012 and birtamimab programs, higher
manufacturing costs primarily related to the birtamimab, PRX019 and
PRX123 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 and lower manufacturing expenses related to the NNC6019/PRX004
and PRX005 programs. R&D expenses included non-cash share-based
compensation expense of $3.8 million and $7.1 million for the
second quarter and first six months of 2022, respectively, as
compared to $2.2 million and $4.2 million for the second quarter
and first six months of 2021, respectively.
General and administrative (G&A) expenses
totaled $13.0 million and $24.8 million for the second quarter and
first six months of 2022, respectively, as compared to $11.0
million and $22.2 million for the second quarter and first six
months of 2021, respectively. The increase in G&A expenses for
the second quarter and first six months of 2022 compared to the
same periods in the prior year was primarily related to higher
personnel related expenses and higher consulting expenses; offset
in part by lower legal expenses. G&A expenses included non-cash
share-based compensation expense of $4.5 million and $8.8 million
for the second quarter and first six months of 2022, respectively,
as compared to $3.3 million and $7.5 million for the second quarter
and first six months of 2021, respectively.
Total non-cash share-based compensation expense
was $8.3 million and $15.9 million for the second quarter and first
six months of 2022, respectively, as compared to $5.5 million and
$11.7 million for the second quarter and first six months of 2021,
respectively.
As of June 30, 2022, Prothena had $510.1
million in cash, cash equivalents and restricted cash, and no
debt.
As of July 29, 2022, Prothena had
approximately 46.9 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.
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 2022 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; and the expected timing of reporting
data from clinical studies of birtamimab, prasinezumab, PRX005, and
PRX012. 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 August 8, 2022, 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
PLCCONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited - amounts in thousands except
per share data)
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June
30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
1,312 |
|
|
$ |
60,071 |
|
|
$ |
2,415 |
|
|
$ |
60,181 |
|
Revenue from license and
intellectual property |
|
— |
|
|
|
— |
|
|
|
50 |
|
|
|
50 |
|
Total revenue |
|
1,312 |
|
|
|
60,071 |
|
|
|
2,465 |
|
|
|
60,231 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
31,569 |
|
|
|
21,090 |
|
|
|
58,831 |
|
|
|
42,234 |
|
General and administrative |
|
12,952 |
|
|
|
11,032 |
|
|
|
24,787 |
|
|
|
22,157 |
|
Total operating expenses |
|
44,521 |
|
|
|
32,122 |
|
|
|
83,618 |
|
|
|
64,391 |
|
Income (loss) from
operations |
|
(43,209 |
) |
|
|
27,949 |
|
|
|
(81,153 |
) |
|
|
(4,160 |
) |
Other income (expense), net |
|
637 |
|
|
|
(53 |
) |
|
|
620 |
|
|
|
(19 |
) |
Income (loss) before income
taxes |
|
(42,572 |
) |
|
|
27,896 |
|
|
|
(80,533 |
) |
|
|
(4,179 |
) |
Provision for (benefit from)
income taxes |
|
(1,328 |
) |
|
|
254 |
|
|
|
(2,999 |
) |
|
|
4,914 |
|
Net income (loss) |
$ |
(41,244 |
) |
|
$ |
27,642 |
|
|
$ |
(77,534 |
) |
|
$ |
(9,093 |
) |
Basic net income (loss) per
ordinary share |
$ |
(0.88 |
) |
|
$ |
0.62 |
|
|
$ |
(1.66 |
) |
|
$ |
(0.21 |
) |
Diluted net income (loss) per
ordinary share |
$ |
(0.88 |
) |
|
$ |
0.58 |
|
|
$ |
(1.66 |
) |
|
$ |
(0.21 |
) |
Shares used to compute basic
net income (loss) per share |
|
46,805 |
|
|
|
44,332 |
|
|
|
46,755 |
|
|
|
42,302 |
|
Shares used to compute diluted
net income (loss) per share |
|
46,805 |
|
|
|
47,414 |
|
|
|
46,755 |
|
|
|
42,302 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROTHENA CORPORATION
PLCCONSOLIDATED BALANCE
SHEETS(unaudited - amounts in
thousands)
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2022 |
|
|
2021 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
508,795 |
|
$ |
579,094 |
Prepaid expenses and other
current assets |
|
12,499 |
|
|
5,715 |
Total current assets |
|
521,294 |
|
|
584,809 |
Property and equipment, net |
|
1,861 |
|
|
2,012 |
Operating lease right-of-use
assets |
|
9,340 |
|
|
12,123 |
Restricted cash, non-current |
|
1,352 |
|
|
1,352 |
Other non-current assets |
|
15,742 |
|
|
9,070 |
Total non-current assets |
|
28,295 |
|
|
24,557 |
Total assets |
$ |
549,589 |
|
$ |
609,366 |
Liabilities and Shareholders’ Equity |
|
|
|
Accrued research and
development |
|
9,188 |
|
|
6,351 |
Deferred revenue, current |
|
9,822 |
|
|
7,657 |
Lease liability, current |
|
6,299 |
|
|
5,940 |
Other current liabilities |
|
14,798 |
|
|
13,504 |
Total current liabilities |
|
40,107 |
|
|
33,452 |
Deferred revenue, non
current |
|
98,352 |
|
|
102,933 |
Lease liability, non-current |
|
3,278 |
|
|
6,386 |
Other non-current
liabilities |
|
553 |
|
|
553 |
Total non-current liabilities |
|
102,183 |
|
|
109,872 |
Total liabilities |
|
142,290 |
|
|
143,324 |
Total shareholders’ equity |
|
407,299 |
|
|
466,042 |
Total liabilities and shareholders’ equity |
$ |
549,589 |
|
$ |
609,366 |
Contacts:InvestorsJennifer
Zibuda, Director, Investor Relations &
Communications650-837-8535, jennifer.zibuda@prothena.com
MediaEric Endicott, Senior Vice
President, Corporate Affairs650-448-3670, media@prothena.com
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