Prothena Reports Third Quarter 2015 Financial Results and Provides R&D Update
(Thomson Reuters ONE) -
* Net cash used in operating activities was $16.9 million in the third quarter
and $42.8 million for first nine months of 2015; quarter-end cash position
of $387.8 million provides solid runway for continued advancement of
multiple programs
* Recently, announced plans to initiate PRONTO, a global trial of NEOD001 in
patients with AL Amyloidosis with primary endpoint of cardiac functional
biomarker NT-proBNP best response
* Completed enrollment in expansion cohort of Phase 1/2 trial of NEOD001 in
patients with AL amyloidosis and persistent organ dysfunction; data expected
in second quarter of 2016
DUBLIN, Nov. 02, 2015 (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
2015 and provided an update on its R&D programs.
"We've made important additions to our protein immunotherapy programs in order
to optimize and accelerate development timelines, capture relevant data for
engagement with regulatory agencies, and advance new programs toward the
clinic," said Dale Schenk, PhD, President and CEO of Prothena. "We recently
announced PRONTO, a global trial of NEOD001 that will evaluate the cardiac
functional biomarker NT-proBNP as its primary endpoint, to provide an additional
opportunity to engage with European regulators in a dialogue around conditional
approval. In addition to a strong focus on our clinical pipeline, our
exceptional research team continues to advance novel antibodies for our
development pipeline, including preclinical candidates that selectively bind to
amyloidogenic forms of the transthyretin (ATTR) protein."
Dr. Schenk continued, "We have a strong balance sheet to advance our pipeline of
novel protein immunotherapies and look forward to reporting data on several of
our clinical-stage programs in 2016 as part of our effort to bring innovative
therapies to patients."
Recent Highlights and Program Updates:
* In October, announced plans to initiate PRONTO, a randomized, double-blind
global registration-directed Phase 2b trial of NEOD001 in previously-treated
patients with AL amyloidosis and persistent cardiac dysfunction. The primary
endpoint is the cardiac functional biomarker NT-proBNP as measured by best
response over a 12-month period. Secondary endpoints include evaluations of
Short Form 36 (SF-36, quality of life measure), six-minute walk test (6MWT),
and renal function as assessed by proteinuria. When combined with data from
the ongoing NEOD001 Phase 1/2 trial, the PRONTO trial is intended to provide
a foundation for discussions with European regulatory agencies around the
potential for conditional approval.
* In October, announced the completion of enrollment for the expansion cohort
of the Phase 1/2 study of NEOD001 to treat patients with AL amyloidosis and
persistent organ dysfunction. Based on strong interest from patients and
physicians, enrollment in this trial was increased to 42 from the originally
planned 25 and topline results are expected in the second quarter of 2016.
* On November 2, presented preclinical results from a series of novel,
conformation-specific protein immunotherapy antibodies that selectively bind
to amyloidogenic (diseased) forms of the transthyretin (ATTR) protein at the
First European Congress on Hereditary TTR Amyloidosis in Paris, France.
These data suggest that Prothena's antibodies can prevent deposition, and
enhance clearance of, ATTR in patients with wild type and hereditary TTR-
mediated amyloidosis.
Upcoming Research and Development Milestones
Prothena's clinical development pipeline includes three lead protein
immunotherapy programs.
NEOD001 is a monoclonal antibody for the potential treatment of AL amyloidosis:
* Expect to provide an update on enrollment timeline for The VITAL Amyloidosis
Study in February 2016
* Expect topline results from the expansion cohort of the Phase 1/2 study in
the second quarter of 2016
PRX002 is a monoclonal antibody for the potential treatment of Parkinson's
disease and other related synucleinopathies, and is the primary focus of
Prothena's worldwide collaboration with Roche:
* Expect topline data from Phase 1 multiple ascending dose study in patients
with Parkinson's disease in the first half of 2016
PRX003 is a monoclonal antibody for the potential treatment of psoriasis and
other inflammatory diseases:
* Expect topline data from Phase 1 single ascending dose study in healthy
volunteers in the first half of 2016
* Expect to initiate Phase 1 multiple ascending dose, proof-of-biology study
in patients with psoriasis in 2016
Third Quarter and First Nine Months of 2015 Financial Results and Guidance
Prothena reported a net loss of $23.0 million and $56.5 million for the third
quarter and first nine months of 2015, respectively, as compared to a net loss
of $13.2 million for the third quarter of 2014 and net income of $6.0 million
for the first nine months of 2014. Net loss per share for the third quarter and
first nine months of 2015 was $0.73 and $1.89, respectively, as compared to a
net loss per share for the third quarter of 2014 of $0.48 and net income per
share for the first nine months of 2014 of $0.24 on a fully diluted basis.
Prothena reported total revenue of $0.4 million and $1.3 million for the third
quarter and first nine months of 2015, respectively, as compared to total
revenue of $1.5 million and $48.8 million for the third quarter and first nine
months of 2014, respectively. The decrease in revenue for the third quarter and
first nine months was primarily due to lower revenue from our collaboration
agreement with Roche.
Research and development (R&D) expenses totaled $17.2 million and $40.5 million
for the third quarter and first nine months of 2015, respectively, as compared
to $10.4 million and $28.3 million for the third quarter and first nine months
of 2014, respectively. The increase in R&D expenses for the third quarter was
primarily due to increased external expenses related to clinical trials and
increased personnel cost. The increase in R&D expense for the first nine months
was primarily due to increased external expenses related to clinical trials and
increased personnel costs, offset in part by lower external product
manufacturing expenses. R&D expenses included non-cash share-based compensation
expense of $1.2 million and $3.0 million for the third quarter and first nine
months of 2015, respectively, as compared to $0.6 million and $1.7 million for
the third quarter and first nine months of 2014, respectively.
General and administrative (G&A) expenses totaled $5.9 million and $16.5 million
for the third quarter and first nine months of 2015, respectively, as compared
to $4.2 million and $14.0 million for third quarter and first nine months of
2014, respectively. The increase in G&A expenses for the third quarter and first
nine months was primarily due to increases in personnel costs. G&A expenses
included non-cash share-based compensation expense of $1.8 million and $4.2
million in the third quarter and first nine months of 2015, respectively, as
compared to $0.8 million and $2.5 million in the third quarter and first nine
months of 2014, respectively.
Total non-cash share-based compensation expense was $3.0 million and $7.1
million for the third quarter and first nine months of 2015, respectively, as
compared to $1.4 million and $4.2 million for the third quarter and first nine
months of 2014, respectively.
As of September 30, 2015, Prothena had $387.8 million in cash and cash
equivalents and no outstanding debt. As of October 23, 2015, Prothena had
31,522,750 ordinary shares outstanding.
The Company continues to expect the full year 2015 net cash burn from operating
and investing activities to be $66 to $72 million, ending the year with
approximately $356 million in cash (mid-point). The estimated full year 2015 net
cash burn from operating and investing activities is primarily driven by an
estimated net loss of $77 to $83 million, which includes an estimated $9 million
of non-cash share-based compensation expense.
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company focused
on the discovery, development and commercialization of novel protein
immunotherapies for the potential treatment of diseases that involve amyloid or
cell adhesion. The Company is developing antibody-based product candidates that
target a number of potential indications including AL amyloidosis (NEOD001),
Parkinson's disease and other related synucleinopathies (PRX002), and psoriasis
and other inflammatory diseases (PRX003). For more information, please visit the
Company's web site at www.prothena.com.
Forward-looking Statements
This press release contains forward-looking statements. These statements relate
to, among other things, the ability of our cash position to fund continued
advancement of multiple programs; the potential for our PRONTO trial to provide
an additional opportunity to engage with European regulators on conditional
approval of NEOD001; the potential for our antibodies to prevent deposition and
enhance clearance of TTR amyloid; the timing of providing an update on the
enrollment timeline for our VITAL Amyloidosis Study; the timing of reporting
data from the expansion cohort of our Phase 1/2 study for NEOD001, from our
Phase 1 multiple ascending dose study for PRX002 and from our Phase 1 single
ascending dose study for PRX003; the timing of initiating our Phase 1 multiple
ascending dose study for PRX003; our anticipated net cash burn from operating
and investing activities for 2015 and expected cash balance at the end of 2015;
and our estimated net loss and non-cash share-based compensation expense for
2015. 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 March 13, 2015 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2015 2014 2015 2014
Collaboration revenue $ 429 $ 1,349 $ 1,300 $ 48,429
Revenue-related party - 137 - 412
Total revenue 429 1,486 1,300 48,841
Operating expenses:
Research and 17,185 10,388 40,549 28,345
development
General and 5,905 4,230 16,476 14,040
administrative
Total operating 23,090 14,618 57,025 42,385
expenses
Income (loss) from (22,661 ) (13,132 ) (55,725 ) 6,456
operations
Other income (expense), (77 ) 191 (31 ) 192
net
Income (loss) before (22,738 ) (12,941 ) (55,756 ) 6,648
income taxes
Provision for income 238 241 699 688
taxes
Net income (loss) $ (22,976 ) $ (13,182 ) $ (56,455 ) $ 5,960
Net income (loss) per
share attributable to
holders of ordinary
shares
Basic $ (0.73 ) $ (0.48 ) $ (1.89 ) $ 0.25
Diluted $ (0.73 ) $ (0.48 ) $ (1.89 ) $ 0.24
Shares used to compute
net income (loss) per
share attributable to
holders of ordinary
shares
Basic 31,441 27,370 29,893 23,758
Diluted 31,441 27,370 29,893 24,722
PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
September December
30, 31,
2015 2014
Assets
Cash and cash equivalents $ 387,802 $ 293,579
Other current assets 5,774 5,696
Total current assets 393,576 299,275
Property and equipment, net 2,930 3,121
Other assets 2,424 1,720
Total non-current assets 5,354 4,841
Total assets $ 398,930 $ 304,116
Liabilities and Shareholders' Equity
Accrued research and development 9,522 2,285
Other current liabilities 9,036 9,754
Total current liabilities 18,558 12,039
Non-current liabilities: 2,419 2,188
Total liabilities 20,977 14,227
Total shareholders' equity 377,953 289,889
Total liabilities and shareholders' equity $ 398,930 $ 304,116
Contact
Investors: Tran Nguyen, CFO
650-837-8535, IR(at)prothena.com
Media: Ellen Rose, Head of Communications
650-922-2405, ellen.rose(at)prothena.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Prothena Corporation plc via GlobeNewswire
[HUG#1963490]
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Datum: 02.11.2015 - 22:05 Uhr
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