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2016-02-18

Prothena Corporation plc: Prothena Reports Fourth Quarter and Full Year 2015 Financial Results; Provides Financial Guidance and R&D Update

* Net cash used in operating and investing activities was $20.7 million in
the fourth quarter and $63.8 million for the full year of 2015; net
proceeds of $128.6 million raised through January 2016 public equity
offering added to $370.6 million year-end cash position provides strong
foundation to advance a robust clinical pipeline
* Announced PRONTO, a global registration-directed Phase 2b trial of NEOD001
in previously-treated patients with AL amyloidosis and persistent cardiac
dysfunction
* Presented positive Phase 1/2 multiple ascending dose results for NEOD001 at
ASCO and EHA, and published the data in the Journal of Clinical Oncology;
expansion cohort data expected in 2Q16
* Presented Phase 1 single ascending dose results for PRX002 at MDS
demonstrating a robust, rapid, and dose- and time-dependent, statistically
significant mean reduction in levels of free serum alpha-synuclein of up to
96% after a single dose
* Initiated Phase 1 single ascending dose study of PRX003 in healthy
volunteers; results expected 2Q16

DUBLIN, Ireland, Feb. 18, 2016 (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 fourth quarter and
full year ended December 31, 2015. In addition, the Company provided 2016
financial guidance and an update on its R&D programs.

"Prothena had an exceptional 2015, driven by clinical advances in each of our
three lead protein immunotherapy programs and increased financial stability,"
said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. "We
continue to enroll patients in The VITAL Amyloidosis Study, our Phase 3
registrational trial of NEOD001, and announced PRONTO, a Phase 2b study to
potentially accelerate our pathway to patients with AL amyloidosis. We
reported encouraging clinical results from trials of both NEOD001 and PRX002,
while increasing awareness of both programs through presentations at major
international medical meetings and a peer-reviewed publication. We also
initiated clinical development of PRX003 and advanced a series of antibodies
in preclinical development against diseased forms of the transthyretin
protein, known as TTR."

Dr. Schenk continued, "We look forward to the year ahead with milestones
expected in each of our clinical stage programs, advancing our objective to
bring novel disease-modifying therapies to patients."

Full Year 2015 and Recent Highlights:

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

* Published results from the Phase 1/2 clinical trial of NEOD001 in patients
with AL amyloidosis and persistent organ dysfunction in the peer-reviewed
Journal of Clinical Oncology. The paper is entitled, "First-in-Human Phase
1/2 Study of NEOD001 in Patients with Light Chain Amyloidosis and
Persistent Organ Dysfunction".
* Announced plans to initiate PRONTO in October 2015, a randomized,
double-blind global registration-directed Phase 2b trial of NEOD001 in
previously-treated patients with AL amyloidosis and persistent cardiac
dysfunction.
* At oral presentations in June 2015 at the American Society for Clinical
Oncology Annual Meeting (ASCO) and the 20th Congress of the European
Hematology Association (EHA), reported clinical data from the multiple
ascending dose portion of a Phase 1/2 trial demonstrating NEOD001-treated
patients achieved more than double the cardiac and renal biomarker
responses when compared to historical data in patients treated solely with
off-label standard of care.

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:

* Added a high-dose cohort to the Phase 1 multiple ascending dose study of
PRX002 in patients with Parkinson's disease. The decision to add an
additional cohort of patients is intended to inform the design and dosing
levels of future PRX002 clinical studies.
* In a late-breaking session at the 19th International Congress of
Parkinson's Disease and Movement Disorders (MDS), presented clinical
results from a Phase 1 study of PRX002 in healthy volunteers demonstrating
that PRX002 was safe and well tolerated at all doses. In addition, PRX002
demonstrated robust, rapid, and dose- and time-dependent, statistically
significant mean reduction in levels of free serum alpha-synuclein of up to
96% after a single dose of PRX002.
* Announced an agreement with The Michael J. Fox Foundation for Parkinson's
Research to accelerate the discovery and development of novel biomarkers
for Parkinson's disease that facilitate therapeutic approaches targeting
alpha-synuclein, including PRX002.

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

* Initiated a Phase 1 single ascending dose study for PRX003 in healthy
volunteers.

Preclinical Programs:

* 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.

Corporate:

* Executed two public offerings that raised aggregate net proceeds of $131.5
million through the issuance of 3,795,000 ordinary shares in April 2015 as
well as aggregate net proceeds of $128.6 million through the issuance of
2,587,500 ordinary shares in January 2016.
* Expanded the Board of Directors with the appointment of a seasoned
executive, Anders Härfstrand, MD, PhD, who brings strategic expertise in
leading both entrepreneurial and large commercial organizations.

Upcoming Research and Development Milestones

Prothena's clinical development pipeline includes three lead protein
immunotherapy programs.

NEOD001

* Expect topline results from the expansion cohort of the Phase 1/2 study in
the second quarter of 2016.
* 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 trial in late 2017 - early
2018.

PRX002

* Expect topline results from Phase 1 multiple ascending dose study in
patients with Parkinson's disease in the fourth quarter of 2016. The study
will remain blinded to us until completion, which we expect to occur
following completion of the newly added dose cohort follow-up period.

PRX003

* Expect topline results from Phase 1 single ascending dose study in healthy
volunteers in the second quarter of 2016.
* Expect to initiate Phase 1 multiple ascending dose, proof-of-biology study
in patients with psoriasis in the second quarter of 2016.

Fourth Quarter and Full Year of 2015 Financial Results and 2016 Financial
Guidance

Prothena reported a net loss of $24.2 million and $80.6 million for the fourth
quarter and full year of 2015, respectively, as compared to a net loss of
$13.1 million and $7.2 million for the fourth quarter and full year of 2014,
respectively. Net loss per share for the fourth quarter and full year of 2015
was $0.76 and $2.66, respectively, as compared to a net loss per share for
the fourth quarter and full year of 2014 of $0.48 and $0.29, respectively, on
a fully diluted basis.

Prothena reported total revenue of $0.3 million and $1.6 million for the
fourth quarter and full year of 2015, respectively, as compared to total
revenue of $2.0 million and $50.9 million for the fourth quarter and full
year of 2014, respectively. The decrease in revenue for the fourth quarter
and full year was primarily due to lower revenue from Prothena's
collaboration agreement with Roche.

Research and development (R&D) expenses totaled $17.9 million and $58.4
million for the fourth quarter and full year of 2015, respectively, as
compared to $10.1 million and $38.5 million for the fourth quarter and full
year of 2014, respectively. The increase in R&D expenses was primarily due to
increased external expenses related to clinical trials and increased
personnel cost. R&D expenses included non-cash share-based compensation
expense of $1.3 million and $4.3 million for the fourth quarter and full year
of 2015, respectively, as compared to $0.6 million and $2.3 million for the
fourth quarter and full year of 2014, respectively.

General and administrative (G&A) expenses totaled $6.6 million and $23.1
million for the fourth quarter and full year of 2015, respectively, as
compared to $5.0 million and $19.1 million for fourth quarter and full year
of 2014, respectively. The increase in G&A expenses for the fourth quarter
and full year was primarily due to increases in personnel costs and legal
expenses. G&A expenses included non-cash share-based compensation expense of
$1.9 million and $6.1 million in the fourth quarter and full year of 2015,
respectively, as compared to $0.8 million and $3.3 million in the fourth
quarter and full year of 2014, respectively.

Total non-cash share-based compensation expense was $3.3 million and $10.4
million for the fourth quarter and full year of 2015, respectively, as
compared to $1.4 million and $5.6 million for the fourth quarter and full
year of 2014, respectively.

As of December 31, 2015, Prothena had $370.6 million in cash and cash
equivalents, which does not include the $128.6 million in net proceeds
received through the January 2016 equity offering, and no debt.

As of February 12, 2016, Prothena had approximately 34.3 million ordinary
shares outstanding, which includes the issuance of approximately 2.6 million
ordinary shares as part of the January 2016 offering.

The Company expects the full year 2016 net cash burn from operating and
investing activities to be $105 to $115 million, ending the year with
approximately $388 million in cash (mid-point). The estimated full year 2016
net cash burn from operating and investing activities is primarily driven by
an estimated net loss of $132 to $149 million, which includes an estimated
$18 million of non-cash share-based compensation expense.

Upcoming Investor Conferences

Members of the senior management team will present and participate in investor
meetings at the following upcoming investor conferences:

* RBC Capital Markets 2016 Global Healthcare Conference on February 23, 2016
at 10:00 AM ET in New York, NY.
* Cowen and Company 36th Annual Health Care Conference on March 9, 2016 at
9:20 AM ET in Boston, MA.
* Future Leaders in the Biotech Industry on March 11, 2016 at 10:00 ...

Författare WKR

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