-
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 13th 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:
PRX003 is a monoclonal
antibody for the potential treatment of inflammatory diseases,
including psoriasis and psoriatic arthritis:
PRX004 is a monoclonal
antibody for the potential treatment of ATTR amyloidosis:
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
June 30, |
|
Six Months Ended
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 development |
|
34,032 |
|
|
32,359 |
|
|
59,730 |
|
|
52,852 |
|
|
General and administrative |
|
10,912 |
|
|
8,134 |
|
|
21,744 |
|
|
15,316 |
|
| Total
operating expenses |
|
44,944 |
|
|
40,493 |
|
|
81,474 |
|
|
68,168 |
|
| Loss from
operations |
|
(18,132 |
) |
|
(40,160 |
) |
|
(54,403 |
) |
|
(67,570 |
) |
| Other
expense, net |
|
(856 |
) |
|
(96 |
) |
|
(1,630 |
) |
|
(26 |
) |
| Loss before income
taxes |
|
(18,988 |
) |
|
(40,256 |
) |
|
(56,033 |
) |
|
(67,596 |
) |
| Provision for (benefit
from) income taxes |
|
(1,287 |
) |
|
189 |
|
|
(2,948 |
) |
|
370 |
|
| Net
loss |
|
$ |
(17,701 |
) |
|
$ |
(40,445 |
) |
|
$ |
(53,085 |
) |
|
$ |
(67,966 |
) |
| Basic and diluted net
loss per share |
|
$ |
(0.46 |
) |
|
$ |
(1.18 |
) |
|
$ |
(1.44 |
) |
|
$ |
(1.99 |
) |
| Shares used to compute
basic and diluted net loss per share |
|
38,073 |
|
|
34,358 |
|
|
36,922 |
|
|
34,192 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
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@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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