Prothena Reports Second Quarter 2017 Financial Results and Provides R&D Update
(Thomson Reuters ONE) -
* Net cash used in operating and investing activities was $36.3 million in the
second quarter and $76.5 million for the first six months of 2017; quarter-
end cash and restricted cash position of $475.8 million, provides funding to
advance diverse pipeline
* Initiated, with Roche, the global Phase 2 PASADENA study of PRX002/RG7935 in
patients with early Parkinson's disease, triggering a $30 million milestone
payment from Roche to Prothena
* Completed enrollment in the Phase 3 VITAL Amyloidosis Study evaluating
NEOD001 in newly diagnosed, treatment naïve patients with AL amyloidosis and
cardiac dysfunction
* Strengthened management team with appointments of Sarah Noonberg, MD, PhD as
Chief Medical Officer and Wagner Zago, PhD as Chief Scientific Officer
DUBLIN, Ireland, Aug. 08, 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 second quarter and first six months of
2017. In addition, the Company provided an update on its R&D programs.
"During the quarter, we achieved two important milestones in our first-in-class
protein immunotherapy pipeline, completing enrollment of our Phase 3 VITAL
Amyloidosis Study evaluating NEOD001 in newly diagnosed, treatment naïve
patients with AL amyloidosis and cardiac dysfunction, and initiating the Phase
2 PASADENA study of PRX002/RG7935 in patients with early Parkinson's disease,"
said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. "We
also appointed two exceptionally talented leaders into key roles to further
expand our ability to advance our R&D pipeline. Looking ahead, we expect topline
results from our Phase 1b MAD study of PRX003 in patients with psoriasis in
October, and topline results from our Phase 2b PRONTO study of NEOD001 in
patients with AL amyloidosis in the second quarter of 2018. With both the PRONTO
and VITAL studies now fully enrolled, our team is focused on activities to
support registration submissions for NEOD001."
Second Quarter 2017 and Recent Highlights:
* Initiated the Phase 2 PASADENA study of PRX002/RG7935 in patients with early
Parkinson's disease, triggering a $30 million milestone payment from Roche
to Prothena. PASADENA is a global two-part clinical study that is being
conducted by Roche. The primary endpoint of this study is the comparison of
change from baseline in the Movement Disorder Society-Unified Parkinson's
Disease Rating Scale (MDS-UPDRS) total score (parts 1, 2 and 3) at week 52
in each of the two treatment groups vs. the placebo group.
* Completed enrollment in the Phase 3 VITAL Amyloidosis Study evaluating
NEOD001 in newly diagnosed, treatment naïve patients with AL amyloidosis and
cardiac dysfunction. The original target enrollment of 236 patients was
exceeded and 260 patients have been randomized into the study. The VITAL
study is a global, double-blind, placebo-controlled, registrational study
with an event-based composite primary endpoint of all-cause mortality or
cardiac hospitalizations as qualifying events. Secondary endpoints include
biomarker, quality of life and functional measures.
* In a late-breaking therapeutic strategies session at the
13(th) International Conference on Alzheimer's and Parkinson's Diseases
(AD/PD), Dr. Joseph Jankovic of Baylor College of Medicine presented
clinical data from the 80-patient Phase 1b multiple ascending dose study of
PRX002/RG7935 in patients with Parkinson's disease. The positive results
supported advancing PRX002/RG7935 into a Phase 2 study, PASADENA.
* Appointed Sarah Noonberg, MD, PhD as Chief Medical Officer to define and
advance Prothena's product pipeline and lead its clinical and medical
organizations. Dr. Noonberg has extensive drug development experience across
several therapeutic categories and has led large, global organizations
across several phases of drug development.
* Appointed Wagner Zago, PhD as Chief Scientific Officer to define and execute
Prothena's research strategy and advance its drug discovery pipeline. Dr.
Zago had been Prothena's Head of Research since 2015 and has led teams that
have advanced four programs based on novel mechanisms into clinical
development.
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 (129 patients) expected in the
second quarter of 2018
PRX003 is a monoclonal antibody for the potential treatment of inflammatory
diseases, including psoriasis and psoriatic arthritis:
* Topline results from the Phase 1b multiple ascending dose, safety and proof-
of-biology study in 32 patients (8 patients per dose-level cohort,
randomized 3:1) with psoriasis expected in October 2017
PRX004 is a monoclonal antibody for the potential treatment of ATTR amyloidosis:
* Clinical development expected to begin by mid-2018
Second Quarter and First Six Months of 2017 Financial Results
Prothena reported a net loss of $17.7 million and $53.1 million for the second
quarter and first six months of 2017, respectively, as compared to a net loss of
$40.4 million and $68.0 million for the second quarter and first six months of
2016, respectively. Net loss per share for the second quarter and first six
months of 2017 was $0.46 and $1.44, respectively, as compared to a net loss per
share of $1.18 and $1.99 for the second quarter and first six months of 2016,
respectively.
Prothena reported total revenue of $26.8 million and $27.1 million for the
second quarter and first six months of 2017, respectively, as compared to total
revenue of $0.3 million and $0.6 million for the second quarter and first six
months of 2016, respectively. The increase in revenue for the second quarter and
first six 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 $34.0 million and $59.7 million
for the second quarter and first six months of 2017, respectively, as compared
to $32.4 million and $52.9 million for the second quarter and first six months
of 2016, respectively. The increase in R&D expenses for the second quarter and
first six months of 2017 was primarily due to higher clinical trial and
personnel cost offset in part by lower external expenses for product
manufacturing. R&D expenses included non-cash share-based compensation expense
of $2.7 million and $5.0 million for the second quarter and first six months of
2017, respectively, as compared to $1.8 million and $3.2 million for the second
quarter and first six months of 2016, respectively.
General and administrative (G&A) expenses totaled $10.9 million and $21.7
million for the second quarter and first six months of 2017, respectively, as
compared to $8.1 million and $15.3 million for second quarter and first six
months of 2016, respectively. The increase in G&A expenses for the second
quarter was primarily due to increases in personnel costs. The increase in G&A
expenses for the first six months was primarily due to increases in personnel,
consulting and other expenses partially offset by a gain recognized in the first
quarter of 2017 from the assignment of our former South San Francisco facility
lease. G&A expenses included non-cash share-based compensation expense of $3.9
million and $7.2 million in the second quarter and first six months of 2017,
respectively, as compared to $2.7 million and $5.0 million in the second quarter
and first six months of 2016, respectively.
Total non-cash share-based compensation expense was $6.7 million and $12.3
million for the second quarter and first six months of 2017, respectively, as
compared to $4.5 million and $8.3 million for the second quarter and first six
months of 2016, respectively.
As of June 30, 2017, Prothena had $475.8 million in cash, cash equivalents and
restricted cash and no debt.
As of July 21, 2017, Prothena had approximately 38.3 million ordinary shares
outstanding.
The Company expects the full year 2017 net cash burn from operating and
investing activities to be $160 to $170 million, which includes the milestone
from Roche earned in the second quarter of 2017 upon initiation of the Phase 2
study of PRX002/RG7935, and to end the year with approximately $375 million in
cash, cash equivalents and restricted cash (mid-point). The estimated full year
2017 net cash burn from operating and investing activities is primarily driven
by an estimated net loss of $177 to $191 million, which includes an estimated
$26 million of non-cash share-based compensation expense.
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), inflammatory diseases,
including psoriasis and psoriatic arthritis (PRX003), 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, the sufficiency of our funding to advance our diverse
pipeline; the timing of announcing topline results from the Phase 2b study of
NEOD001; the timing of announcing topline results from the Phase 1b study of
PRX003; 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 Six Months Ended
June 30, June 30,
2017 2016 2017 2016
Collaboration revenue $ 26,812 $ 333 $ 27,071 $ 598
Total revenue 26,812 333 27,071 598
Operating expenses:
Research and 34,032 32,359 59,730 52,852
development
General and 10,912 8,134 21,744 15,316
administrative
Total operating 44,944 40,493 81,474 68,168
expenses
Loss from operations (18,132 ) (40,160 ) (54,403 ) (67,570 )
Other expense, net (856 ) (96 ) (1,630 ) (26 )
Loss before income (18,988 ) (40,256 ) (56,033 ) (67,596 )
taxes
Provision for (benefit (1,287 ) 189 (2,948 ) 370
from) income taxes
Net loss $ (17,701 ) $ (40,445 ) $ (53,085 ) $ (67,966 )
Basic and diluted net $ (0.46 ) $ (1.18 ) $ (1.44 ) $ (1.99 )
loss per share
Shares used to compute
basic and diluted net 38,073 34,358 36,922 34,192
loss per share
PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
June 30, December 31,
2017 2016
Assets
Cash and cash equivalents $ 471,729 $ 386,923
Other current assets 39,991 4,439
Total current assets 511,720 391,362
Property and equipment, net 55,843 56,452
Restricted cash 4,056 4,056
Other assets 7,381 8,106
Total non-current assets 67,280 68,614
Total assets $ 579,000 $ 459,976
Liabilities and Shareholders' Equity
Accrued research and development $ 20,799 $ 19,073
Other current liabilities 18,800 22,002
Total current liabilities 39,599 41,075
Non-current liabilities: 52,425 53,498
Total liabilities 92,024 94,573
Total shareholders' equity 486,976 365,403
Total liabilities and shareholders' equity $ 579,000 $ 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: 08.08.2017 - 22:05 Uhr
Sprache: Deutsch
News-ID 555756
Anzahl Zeichen: 16353
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Town:
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Kategorie:
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