Bli medlem
Bli medlem

Du är här

2016-11-01

Prothena Reports Third Quarter 2016 Financial Results and Provides R&D Update

cial Results and Provides R&D Update

-- Net cash used in operating and investing activities was $39.1 million in
the third quarter and $96.8 million for the first nine months of 2016;
quarter-end cash and restricted cash position of $412.6 million supports
advancement of a diverse pipeline and commercial capabilities
-- Appointed Gene G. Kinney, PhD President and Chief Executive Officer,
following the passing of Prothena Co-founder, President and Chief Executive
Officer Dale B. Schenk, PhD
-- Announced strategy to advance a Phase 2 clinical trial for PRX003 in
psoriatic arthritis

DUBLIN, Ireland, 2016-11-01 21:05 CET (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
2016. In addition, the Company provided an update on its R&D programs and 2016
financial guidance.

“With the continued expansion of our team and capabilities, we are advancing
our vision of establishing a fully-integrated biotechnology company that can
take a potential new therapy from discovery to patients,” stated Gene Kinney,
PhD, President and Chief Executive Officer of Prothena. “During the next 18
months, we expect to achieve significant milestones for each of our clinical
programs. Later this month, we plan to report topline data from the Phase 1b
multiple ascending dose study for PRX002 in patients with Parkinson’s disease,
and in 2017 we expect both interim and full results from the Phase 1b
proof-of-biology study of PRX003 in patients with psoriasis. For our lead
program NEOD001, the VITAL study is on track to be fully enrolled by the second
quarter of 2017 and based on the current status of the PRONTO study enrollment,
we expect topline results from this study in early 2018.”

Recent Highlights and Program Updates:

-- Announced that Gene Kinney, PhD was appointed as President and Chief
Executive Officer. Dr. Kinney succeeded Prothena Co-founder, President and
Chief Executive Officer Dale Schenk, PhD, who passed away on September 30,
2016. Dr. Kinney was also appointed to Prothena's Board of Directors.
-- During a webcast, announced strategy to advance a Phase 2 clinical study of
PRX003 in psoriatic arthritis, based on certain pre-specified criteria
being met in an ongoing Phase 1b proof-of-biology study in patients with
psoriasis. PRX003 targets CD146, also known as melanoma cell adhesion
molecule (MCAM), a cellular adhesion molecule expressed on the surface of
Th17 cells, and is designed to block pathogenic Th17 cells from
infiltrating into tissue and releasing multiple cytokines that contribute
to inflammatory disease pathology.
-- In an oral session at the 6th International Charcot-Marie-Tooth and Related
Neuropathy Consortium (CMTR) meeting, presented preclinical data from a
series of novel, conformation-specific protein immunotherapy antibodies
that selectively bind to amyloidogenic (diseased) forms of the
transthyretin (ATTR) protein in tissues from ATTR amyloidosis patients.
-- Published a paper in the journal Amyloid that further supports the proposed
mechanism of action of NEOD001. The publication features preclinical data
demonstrating the binding and phagocytosis clearance properties of NEOD001
and the related murine form of the antibody in tissue samples from multiple
organs of patients with AL amyloidosis.
-- In an oral session at the 15th International Symposium on Amyloidosis
(ISA), Morie A. Gertz, MD, of Mayo Clinic, presented clinical data from the
NEOD001 Phase 1/2 dose-escalation and expansion study, demonstrating best
response rates of 53% and 63% for cardiac- (n=36) and renal- (n=35)
evaluable patients, respectively. Improvement in peripheral neuropathy, a
third organ system, was demonstrated by a mean 35% (median 23%, n=11)
decrease in the Neuropathy Impairment Score- Lower Limb (NIS-LL) as a
change from baseline to month 10, leading to an 82% response rate. NEOD001
continued to be generally safe and well tolerated. These data were also
presented in poster sessions at the 2016 European Society of Cardiology
Congress, the Heart Failure Society of America 2016 Annual Meeting, and the
American Neurological Association's 141st Annual Meeting.

Upcoming Research and Development Milestones

Prothena’s pipeline includes four protein immunotherapy programs.

NEOD001 is a monoclonal antibody for the potential treatment of AL amyloidosis:

-- Expect to complete enrollment in the Phase 3 VITAL Amyloidosis Study in the
second quarter of 2017
-- Expect topline results from the Phase 2b PRONTO study in early 2018

PRX002 is a monoclonal antibody for the potential treatment of
Parkinson's disease and related synucleinopathies, and is the primary focus
of Prothena's worldwide collaboration with Roche:

-- Expect topline results from Phase 1b multiple ascending dose study in
patients with Parkinson's disease in November 2016

PRX003 is a monoclonal antibody for the potential treatment of inflammatory
diseases, including psoriasis and psoriatic arthritis:

-- Expect interim data from the Phase 1b multiple ascending dose,
proof-of-biology study in patients with psoriasis by mid-2017
-- Expect full topline results from the Phase 1b multiple ascending dose,
proof-of-biology study in patients with psoriasis in the second half of
2017

PRX004 is a monoclonal antibody for the potential treatment of ATTR amyloidosis:

-- Expect to advance PRX004 into clinical development in late 2017 - early
2018

Third Quarter and First Nine Months of 2016 Financial Results

Prothena reported a net loss of $43.2 million and $111.2 million for the third
quarter and first nine months of 2016, respectively, as compared to a net loss
of $23.0 million and $56.5 million for the third quarter and first nine months
of 2015, respectively. Net loss per share for the third quarter and first nine
months of 2016 was $1.26 and $3.25, respectively, as compared to a net loss per
share of $0.73 and $1.89 for the third quarter and first nine months of 2015,
respectively.

Prothena reported total revenue of $0.3 million and $0.9 million for the third
quarter and first nine months of 2016, respectively, as compared to total
revenue of $0.4 million and $1.3 million for the third quarter and first nine
months of 2015, respectively. The decrease in revenue for the third quarter and
first nine months of 2016 was primarily due to lower revenue from Prothena's
collaboration agreement with Roche.

Research and development (R&D) expenses totaled $26.8 million and $79.7 million
for the third quarter and first nine months of 2016, respectively, as compared
to $17.2 million and $40.5 million for the third quarter and first nine months
of 2015, respectively. The increase in R&D expenses for the third quarter and
first nine months was primarily due to increased expenses for product
manufacturing, clinical trials and personnel cost. R&D expenses included
non-cash share-based compensation expense of $2.0 million and $5.2 million for
the third quarter and first nine months of 2016, respectively, as compared to
$1.2 million and $3.0 million for the third quarter and first nine months of
2015, respectively.

General and administrative (G&A) expenses totaled $16.1 million and $31.5
million for the third quarter and first nine months of 2016, respectively, as
compared to $5.9 million and $16.5 million for third quarter and first nine
months of 2015, respectively. The increase in G&A expenses for the third
quarter and first nine months was primarily due to increases in personnel costs
(including $7.7 million of non-cash share-based compensation expense related to
the accelerated vesting of stock options and payments due to the estate of our
former CEO, Dr. Schenk, upon his passing). G&A expenses included non-cash
share-based compensation expense of $9.5 million and $14.5 million in the third
quarter and first nine months of 2016, respectively (including $6.5 million of
non-cash share-based compensation expense related to the accelerated vesting of
stock options upon the passing of our former CEO), as compared to $1.8 million
and $4.2 million in the third quarter and first nine months of 2015,
respectively.

Total non-cash share-based compensation expense was $11.4 million and $19.7
million for the third quarter and first nine months of 2016, respectively, as
compared to $3.0 million and $7.1 million for the third quarter and first nine
months of 2015, respectively.

As of September 30, 2016, Prothena had $412.6 million in cash, cash equivalents
and restricted cash and no debt.

As of October 21, 2016, Prothena had approximately 34.5 million ordinary shares
outstanding.

Based on build-to-suit accounting, the Company will recognize reimbursements of
tenant improvement allowances (TIAs) from our landlord as financing activities
rather than operating activities in our cash flow statement. Although this
presentation change to financing from operating activities will increase
projected full year 2016 net cash burn from operating and investing activities
by approximately $14 million (landlord reimbursements of TIAs) to $132 to $142
million, it will not impact our previous guidance of year end cash, cash
equivalents and restricted cash of $376 million (midpoint). The updated
estimated full year 2016 net cash burn from operating and investing activities
is primarily driven by a net loss of $152 to $169 million, which includes an
estimated $24 million of non-cash share-based compensation expense. The net
loss estimate has been increased by approximately $7.7 million (including $6.5
million in non-cash share-based compensation expense) primarily driven by
expenses recognized in the third quarter upon the passing of our former CEO.

About Prothena

Prothena Corporation plc is a global, late-stage clinical biotechnology company
seeking to fundamentally change the course of progressive diseases with its
clinical pipeline of novel therapeutic antibodies. 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 is establishing a fully integrated
research, development and commercial focus and has advanced several drug
candidates into clinical studies while pursuing discovery of additional novel
therapies. Our pipeline of antibody-based product candidates targets a number
of potential indications including AL amyloidosis (NEOD001), Parkinson's
disease and oth...

Författare SSE

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.