Prothena Reports Third Quarter 2017 Financial Results and Provides R&D Update
(Thomson Reuters ONE) -
* 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 16(th) 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 16(th) 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 Nine Months Ended September
September 30, 30,
2017 2016 2017 2016
Collaboration $ 219 $ 286 $ 27,290 $ 884
revenue
Total revenue 219 286 27,290 884
Operating expenses:
Research and 41,315 26,838 101,045 79,690
development
General and 12,438 16,136 34,182 31,452
administrative
Total operating 53,753 42,974 135,227 111,142
expenses
Loss from operations (53,534 ) (42,688 ) (107,937 ) (110,258 )
Other expense, net (565 ) (130 ) (2,195 ) (156 )
Loss before income (54,099 ) (42,818 ) (110,132 ) (110,414 )
taxes
Provision for (1,705 ) 421 (4,653 ) 791
(benefit from)
income taxes
Net loss $ (52,394 ) $ (43,239 ) $ (105,479 ) $ (111,205 )
Basic and diluted $ (1.37 ) $ (1.26 ) $ (2.82 ) $ (3.25 )
net loss per share
Shares used to 38,292 34,413 37,384 34,266
compute basic and
diluted net loss per
share
PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
September December
30, 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(at)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
Unternehmensinformation / Kurzprofil:
Datum: 07.11.2017 - 22:05 Uhr
Sprache: Deutsch
News-ID 567109
Anzahl Zeichen: 17226
contact information:
Town:
DUBLIN
Kategorie:
Business News
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