YASTEST
- Net cash used in operating and
investing activities was $18.3 million in the third quarter and
$94.8 million for the first nine months of 2017; quarter-end cash
and restricted cash position of $460.1 million, provides funding to
advance diverse pipeline
- Presented new research at HFSA
Annual Scientific Meeting on the important role of the cardiac
biomarker NT-proBNP in AL amyloidosis
- R&D Day planned for
Thursday, November 16th in New York,
NY
DUBLIN, Ireland , Nov. 07,
2017 (GLOBE NEWSWIRE) -- Prothena Corporation plc
(NASDAQ:PRTA), a late-stage clinical biotechnology company focused
on the discovery, development and commercialization of novel
protein immunotherapies, today reported financial results for the
third quarter and first nine months of 2017. In addition, the
Company provided an update on its R&D programs.
"As we look forward to topline
results from our Phase 2b PRONTO study and Phase 3 VITAL study of
NEOD001, we are focused on executing activities across our
clinical, regulatory and commercial functions," said Gene Kinney,
PhD, President and Chief Executive Officer of Prothena. "With
results from the PRONTO study expected in the second quarter of
2018, we continue to generate new research on the important role of
the cardiac biomarker NT-proBNP in AL amyloidosis. New data we
presented in September demonstrated that aggregated light chain
binds to cardiomyocytes, induces oxidative stress, and increases
the expression of the oxidative response marker heme oxygenase-1,
which in turn increases NT-proBNP secretion. These new insights
into the unique regulation of NT-proBNP in AL amyloidosis offer
further support that an amyloid targeting approach can provide
cardiac benefit with the potential to translate into improved
survival for patients with AL amyloidosis. Beyond NEOD001, our team
continues to advance a diverse pipeline of first-in-class
approaches for diseases that lack effective therapies including
PRX002 and PRX004, as well as several new targets in
discovery."
Third Quarter
2017 and Recent Highlights:
- Presented research at the Heart Failure Society
of America (HFSA) Annual Scientific Meeting that further supports
the important role of the cardiac biomarker NT-proBNP in both the
biology and clinical aspects of AL amyloidosis. Preclinical data
presented in a moderated poster talk and poster session at the
conference demonstrated the relationship between misfolded light
chain toxicity to heart cells and production of NT-proBNP.
- Announced clinical results of a Phase 1b multiple
ascending dose study in patients with psoriasis. Clinical data
demonstrated occupancy and downregulation of CD146 following
administration of PRX003 consistent with our previous Phase 1a
single ascending dose study. However, the clinical results in this
study did not meet the pre-specified criteria for evidence of a
well-defined relationship between biological activity and
meaningful clinical effects required to advance PRX003 into
mid-stage clinical development for psoriasis or psoriatic arthritis
as previously planned.
Upcoming Research
and Development Milestones
NEOD001 is a
monoclonal antibody for the potential treatment of AL
amyloidosis:
- Topline results in the Phase 2b PRONTO study
expected in the second quarter of 2018
PRX002/RG7935 is a monoclonal
antibody for the potential treatment of Parkinson's disease:
- The Phase 2 PASADENA study, initiated in the
second quarter of 2017, continues to enroll patients with early
Parkinson's disease
PRX004 is a
monoclonal antibody for the potential treatment of ATTR
amyloidosis:
- Clinical development expected to begin by
mid-2018
Third Quarter and First Nine
Months of 2017 Financial Results
Prothena reported a net loss of
$52.4 million and $105.5 million for the third quarter and first
nine months of 2017, respectively, as compared to a net loss of
$43.2 million and $111.2 million for the third quarter and first
nine months of 2016, respectively. Net loss per share for the third
quarter and first nine months of 2017 was $1.37 and $2.82,
respectively, as compared to a net loss per share of $1.26 and
$3.25 for the third quarter and first nine months of 2016,
respectively.
Prothena reported total revenue of
$0.2 million and $27.3 million for the third quarter and first nine
months of 2017, respectively, as compared to total revenue of $0.3
million and $0.9 million for the third quarter and first nine
months of 2016, respectively. The increase in revenue for the first
nine months of 2017 was primarily due to achievement of a clinical
milestone from Roche of $30.0 million (of which $26.6 million was
recognized as collaboration revenue and $3.4 million was recognized
as an offset to R&D expenses).
Research and development (R&D)
expenses totaled $41.3 million and $101.0 million for the third
quarter and first nine months of 2017, respectively, as compared to
$26.8 million and $79.7 million for the third quarter and first
nine months of 2016, respectively. The increase in R&D expenses
for the third quarter of 2017 was primarily due to higher product
manufacturing costs, and to a lesser extent higher personnel and
clinical trial costs. The increase in R&D expenses for the
first nine months of 2017 was primarily due to higher personnel
costs, and to a lesser extent higher clinical trial and product
manufacturing costs. R&D expenses included non-cash share-based
compensation expense of $2.8 million and $7.9 million for the third
quarter and first nine months of 2017, respectively, as compared to
$2.0 million and $5.2 million for the third quarter and first nine
months of 2016, respectively.
General and administrative
(G&A) expenses totaled $12.4 million and $34.2 million for the
third quarter and first nine months of 2017, respectively, as
compared to $16.1 million and $31.5 million for third quarter and
first nine months of 2016, respectively. The decrease in G&A
expenses for the third quarter of 2017 compared to the same period
in the prior year was primarily due to $6.5 million of share-based
compensation expense related to the accelerated vesting of stock
options upon the passing of the Company's former CEO in the third
quarter of 2016, offset in part by higher personnel costs in the
third quarter of 2017. The higher G&A expenses for the first
nine months of 2017 compared to the same period in the prior year
was primarily due to higher personnel costs, and to a lesser extent
higher consulting and other expenses, partially offset by a gain
recognized from the assignment of the Company's former South San
Francisco facility lease in January 2017 and the higher share-based
compensation expense related to the accelerated vesting of stock
options in the comparable period the prior year. G&A expenses
included non-cash share-based compensation expense of $4.3 million
and $11.5 million in the third quarter and first nine months of
2017, respectively, as compared to $9.5 million and $14.5 million
in the third quarter and first nine months of 2016,
respectively.
Total non-cash share-based
compensation expense was $7.1 million and $19.4 million for the
third quarter and first nine months of 2017, respectively, as
compared to $11.4 million and $19.7 million for the third quarter
and first nine months of 2016, respectively.
As of September 30, 2017,
Prothena had $460.1 million in cash, cash equivalents and
restricted cash and no debt.
As of October 20, 2017,
Prothena had approximately 38.4 million ordinary shares
outstanding.
The Company is updating its
projected full year 2017 net cash burn from operating and investing
activities, and expects it to be $142 to $152 million, representing
a decrease of approximately $18 million based on a combination of
savings related to the decision not to advance PRX003 and other
favorability from development, manufacturing and taxes. The Company
now expects to end the year with approximately $409 million in
cash, cash equivalents and restricted cash (midpoint). The cash
increase of $34 million results from the $18 million in operating
and investing burn savings described above and an additional $16
million in financing proceeds from employee stock option exercises
which occurred in the first three quarters of 2017 (primarily
related to our former CEO's options, which were fully exercised by
the end of the third quarter of 2017). The updated estimated full
year 2017 net cash burn from operating and investing activities is
primarily driven by the updated estimated net loss of $150 to $164
million, which includes an estimated $27 million of non-cash
share-based compensation expense.
Upcoming Investor
Event
Prothena will host an R&D Day
on Thursday, November 16th from 12:00 -
2:00 PM in New York, NY. During R&D Day, Prothena management
will discuss the Company's clinical development programs and
highlight new discovery efforts.
A live webcast of the presentation
can be accessed through the Investors section of the Company's
website at www.prothena.com. Following the live presentations, a
replay of the webcast will be available on the Company's website
for at least 90 days following the presentation date.
About
Prothena
Prothena Corporation plc is a
global, late-stage clinical biotechnology company establishing
fully-integrated research, development and commercial capabilities.
Fueled by its deep scientific understanding built over decades of
research in protein misfolding and cell adhesion - the root causes
of many serious or currently untreatable amyloid and inflammatory
diseases - Prothena seeks to fundamentally change the course of
progressive diseases associated with this biology. The Company's
pipeline of antibody therapeutic candidates targets a number of
indications including AL amyloidosis (NEOD001), Parkinson's disease
and other related synucleinopathies (PRX002/RG7935) and ATTR
amyloidosis (PRX004). The Company continues discovery of additional
novel therapeutic candidates where its deep scientific
understanding of disease pathology can be leveraged. For more
information, please visit the Company's website
at www.prothena.com
Forward-looking
Statements
This press
release contains forward-looking statements. These statements
relate to, among other things, whether an amyloid targeting
approach can provide cardiac benefit with the potential to
translate into improved survival for AL amyloidosis patients; the
role of NT-proBNP in the biology and clinical aspects of AL
amyloidosis; the relationship between misfolded light chain
toxicity in heart cells and production of NT-proBNP; our ability to
advance a diverse pipeline, including new targets in discovery; the
timing of announcing topline results from the Phase 2b study of
NEOD001; the timing of initiating clinical development of PRX004;
our expected net cash burn from operating and investing activities
for 2017 and cash balance at the end of 2017; and our estimated net
loss and non-cash share-based compensation expense for 2017. 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 the
risks, uncertainties and other factors described in the "Risk
Factors" sections of our Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on February 27, 2017 and
our subsequent Quarterly Reports on Form 10-Q filed with the SEC.
Prothena undertakes 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 Prothena's
expectations.
PROTHENA CORPORATION
PLC
CONSOLIDATED STATEMENTS OF
OPERATIONS
(unaudited - amounts in thousands except per share
data)
|
|
Three Months
Ended September 30, |
|
Nine Months
Ended September 30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Collaboration revenue |
|
$ |
219 |
|
|
$ |
286 |
|
|
$ |
27,290 |
|
|
$ |
884 |
|
Total
revenue |
|
219 |
|
|
286 |
|
|
27,290 |
|
|
884 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
41,315 |
|
|
26,838 |
|
|
101,045 |
|
|
79,690 |
|
General
and administrative |
|
12,438 |
|
|
16,136 |
|
|
34,182 |
|
|
31,452 |
|
Total
operating expenses |
|
53,753 |
|
|
42,974 |
|
|
135,227 |
|
|
111,142 |
|
Loss from
operations |
|
(53,534 |
) |
|
(42,688 |
) |
|
(107,937 |
) |
|
(110,258 |
) |
Other expense, net |
|
(565 |
) |
|
(130 |
) |
|
(2,195 |
) |
|
(156 |
) |
Loss
before income taxes |
|
(54,099 |
) |
|
(42,818 |
) |
|
(110,132 |
) |
|
(110,414 |
) |
Provision
for (benefit from) income taxes |
|
(1,705 |
) |
|
421 |
|
|
(4,653 |
) |
|
791 |
|
Net
loss |
|
$ |
(52,394 |
) |
|
$ |
(43,239 |
) |
|
$ |
(105,479 |
) |
|
$ |
(111,205 |
) |
Basic and
diluted net loss per share |
|
$ |
(1.37 |
) |
|
$ |
(1.26 |
) |
|
$ |
(2.82 |
) |
|
$ |
(3.25 |
) |
Shares
used to compute basic and diluted net loss per share |
|
38,292 |
|
|
34,413 |
|
|
37,384 |
|
|
34,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROTHENA CORPORATION
PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
|
September 30, |
|
December 31, |
|
2017 |
|
2016 |
Assets |
|
|
|
Cash and
cash equivalents |
$ |
456,061 |
|
|
$ |
386,923 |
|
Other
current assets |
13,003 |
|
|
4,439 |
|
Total
current assets |
469,064 |
|
|
391,362 |
|
Property
and equipment, net |
55,384 |
|
|
56,452 |
|
Restricted cash |
4,056 |
|
|
4,056 |
|
Other
assets |
9,176 |
|
|
8,106 |
|
Total
non-current assets |
68,616 |
|
|
68,614 |
|
Total
assets |
$ |
537,680 |
|
|
$ |
459,976 |
|
Liabilities and Shareholders' Equity |
|
|
|
Accrued
research and development |
$ |
18,482 |
|
|
$ |
19,073 |
|
Other
current liabilities |
20,776 |
|
|
22,002 |
|
Total
current liabilities |
39,258 |
|
|
41,075 |
|
Non-current liabilities: |
52,168 |
|
|
53,498 |
|
Total
liabilities |
91,426 |
|
|
94,573 |
|
Total
shareholders' equity |
446,254 |
|
|
365,403 |
|
Total
liabilities and shareholders' equity |
$ |
537,680 |
|
|
$ |
459,976 |
|
Media & Investor
Contact:
Ellen Rose, Head of
Communications
650-922-2405, ellen.rose@prothena.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Prothena Corporation plc via Globenewswire
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