Prothena Reports Second Quarter 2015 Financial Results and Provides R&D Update

(Thomson Reuters ONE) -


* Net cash used in operating activities was $11.1 million in the second
quarter and $25.9 million for first six months of 2015; completion of
successful public equity offering netting $131.4 million strengthened
quarter-end cash position of $402.4 million providing solid runway for
continued advancement of multiple programs
* Drs. Morie A. Gertz (Mayo Clinic) and Michaela Liedtke (Stanford University
School of Medicine) presented updated clinical data of NEOD001 in patients
with AL amyloidosis in oral sessions at ASCO and EHA, respectively,
demonstrating best cardiac response rate of 57% and best renal response rate
of 60%
* Presented clinical trial results as part of the late breaking session at the
19th International Congress of Parkinson's Disease and Movement Disorders
(MDS) demonstrating robust, rapid, and dose- and time-dependent mean
reduction in levels of free serum alpha-synuclein of up to 96% after a
single dose of PRX002, a novel protein immunotherapy for Parkinson's disease
* Announced successful dosing of the first subject in a Phase 1 single
ascending dose study for PRX003, a monoclonal antibody for psoriasis and
other inflammatory diseases

DUBLIN, Ireland, Aug. 4, 2015 (GLOBE NEWSWIRE) -- Prothena Corporation plc
(NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the
discovery, development and commercialization of novel protein immunotherapy
programs, today reported financial results for the second quarter and first six
months of 2015 and provided an update on its lead programs.

"We made significant progress during the second quarter, and we now have three
protein immunotherapy programs in clinical development. Specifically, we
presented positive clinical results for both NEOD001 and PRX002 at major
international medical meetings that continued to validate the use of disease-

modifying protein immunotherapies for the treatment of debilitating illnesses
including AL amyloidosis and Parkinson's disease," said Dale Schenk, PhD,
President and Chief Executive Officer of Prothena.

Dr. Schenk continued, "With a strong balance sheet and robust data from multiple
programs anticipated in the next 12 to 18 months, we move toward 2016 with
growing momentum for each of our clinical-stage programs. For NEOD001, in
addition to enrolling patients in the registrational Phase 3 VITAL Amyloidosis
Study, we expect to report new data from the expansion portion of the Phase 1/2
trial in the fourth quarter of this year. For PRX002, we expect to report data
from the Phase 1 multiple ascending dose study in the first half of 2016, and
for PRX003, we expect to report data from the Phase 1 single ascending dose
study in the first half of 2016."

Second Quarter 2015 Highlights:

* In April, successfully raised aggregate net proceeds of $131.4 million
through the issuance of 3,795,000 ordinary shares
* In May, announced an agreement with The Michael J. Fox Foundation for
Parkinson's Research to accelerate the discovery of novel biomarkers and
development of assays to measure Parkinson's disease progression to
facilitate therapeutic approaches, including PRX002, targeting alpha-
synuclein, a protein potentially involved in the onset and progression of
Parkinson's disease
* In June, at oral presentations during the 2015 American Society for Clinical
Oncology Annual Meeting and the 20(th) Congress of the European Hematology
Association (EHA), reported updated 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
* In June, at EHA and in collaboration with the Amyloidosis Research
Consortium, presented results from a systemic amyloidosis patient experience
survey identifying new opportunities to improve diagnosis and treatment of
amyloidoses and the need for safe, effective disease-modifying treatment
options for systemic amyloidosis
* In June, in a late-breaking session at MDS, presented clinical results from
a Phase 1 study of PRX002 demonstrating robust, rapid, and dose- and time-
dependent mean reduction in levels of free serum alpha-synuclein of up to
96% after a single dose of PRX002
* In June, successfully dosed the first subject in a Phase 1 single ascending
dose study for PRX003, a monoclonal antibody for the potential treatment of
psoriasis and other inflammatory diseases
* In June, expanded the Board of Directors with the appointment of a seasoned
executive, Anders Härfstrand, MD, PhD

Upcoming Research and Development Pipeline Milestones

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

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

* Enrolling patients with AL amyloidosis and cardiac dysfunction in The VITAL
Amyloidosis Study, a global Phase 3 registrational trial
* Expect additional data from the Phase 1/2 study in patients with AL
amyloidosis and persistent organ dysfunction to be shared at least once
annually at a medical conference

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 study in patients with
psoriasis in 2016

Second Quarter and First Six Months of 2015 Financial Results and Guidance

Prothena reported a net loss of $18.3 million and $33.5 million for the second
quarter and first six months of 2015, respectively, as compared to net income of
$1.3 million and $19.1 million for the second quarter and first six months of
2014, respectively. Net loss per share for the second quarter and first six
months of 2015 was $0.59 and $1.15, respectively, as compared to net income per
share of $0.06 and $0.83 on a fully diluted basis for the second quarter and
first six months of 2014, respectively.

Prothena reported total revenue of $0.3 million and $0.9 million for the second
quarter and first six months of 2015, respectively, as compared to total revenue
of $15.1 million and $47.4 million for the second quarter and first six months
of 2014, respectively. The decrease was primarily due to $15.0 million and $47.1
million in collaboration revenue recognized in relation to the PRX002
collaboration with Roche in the second quarter and first six months of 2014,
compared to $0.3 million and $0.9 million in collaboration revenue recognized in
the second quarter and first six months of 2015, respectively.

Research and development (R&D) expenses totaled $12.8 million and $23.4 million
for the second quarter and first six months of 2015, respectively, as compared
to $8.6 million and $18.0 million for the second quarter and first six months of
2014, respectively. The increase in R&D expenses was primarily due to increased
external expenses related to clinical trials, offset in part by lower external
product manufacturing expenses. R&D expenses included non-cash share-based
compensation expense of $1.0 million and $1.7 million for the second quarter and
first six months of 2015, respectively, as compared to $0.6 million and $1.0
million for the second quarter and first six months of 2014, respectively.

General and administrative (G&A) expenses totaled $5.5 million and $10.6 million
for the second quarter and first six months of 2015, respectively, as compared
to $4.9 million and $9.8 million for second quarter and first six months of
2014, respectively. The increase in G&A expenses was primarily due to increases
in personnel costs. G&A expenses included non-cash share-based compensation
expense of $1.4 million and $2.4 million in the second quarter and first six
months of 2015, respectively and $0.9 million and $1.7 million in the second
quarter and first six months of 2014, respectively.

Total non-cash share-based compensation expense was $2.4 million and $4.1
million for the second quarter and first six months of 2015, respectively, as
compared to $1.4 million and $2.8 million for the second quarter and first six
months of 2014.

As of June 30, 2015, Prothena had $402.4 million in cash and cash equivalents
and no outstanding debt. As of July 24, 2015, Prothena had 31,379,986 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.

Upcoming Investor Conferences

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

* 7th Annual Citi Biotech on Wheels Bus Tour on August 5, 2015 at 12:30 p.m.
ET in South San Francisco, CA
* 2015 Wedbush PacGrow Healthcare Conference on August 12, 2015 at 1:20 p.m.
ET at Le Parker Meridien in New York, NY

A live webcast of the Wedbush presentation can be accessed through the investor
relations section of the Company's website at www.prothena.com. Following the
live presentation, replays of the webcast will be available on the Company's
website for 90 days following the presentation date.

About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company focused
on the discovery, development and commercialization of novel protein
immunotherapy programs 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 programs to be disease-
modifying; the enrollment for our VITAL Amyloidosis Study for NEOD001; the
timing of reporting additional data from our ongoing Phase 1/2 study for
NEOD001; the timing of reporting data from our Phase 1 multiple ascending dose
study for PRX002; the timing of reporting data for our Phase 1 single ascending
does study and 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 Six Months Ended
June 30, June 30,

  2015 2014 2015 2014

Collaboration revenue $ 278 $ 14,984 $ 871 $ 47,080

Revenue-related party - 137 - 275

Total revenue 278 15,121 871 47,355

Operating expenses:

Research and development 12,791 8,615 23,364 17,957

General and administrative 5,522 4,937 10,571 9,810

Total operating expenses 18,313 13,552 33,935 27,767

Income (loss) from operations (18,035) 1,569 (33,064) 19,588

Other income (expense), net (47) 17 46 1

Income (loss) before income taxes (18,082) 1,586 (33,018) 19,589

Provision for income taxes 195 296 461 447

Net income (loss) $ (18,277) $ 1,290 $ (33,479) $ 19,142

Net income (loss) per share
attributable to holders of ordinary
shares

Basic $ (0.59) $ 0.06 $ (1.15) $ 0.87

Diluted $ (0.59) $ 0.06 $ (1.15) $ 0.83

Shares used to compute net income
(loss) per share attributable to
holders of ordinary shares

Basic 30,792 21,959 29,106 21,922

Diluted 30,792 22,898 29,106 22,927

PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)

  June 30, December 31,

  2015 2014

Assets

Cash and cash equivalents $ 402,389 $ 293,579

Other current assets 3,811 5,696

Total current assets 406,200 299,275

Property and equipment, net 2,816 3,121

Other assets 2,148 1,720

Total non-current assets 4,964 4,841

Total assets $ 411,164 $ 304,116

Liabilities and Shareholders' Equity

Accrued research and development 6,399 2,285

Other current liabilities 7,057 9,754

Total current liabilities 13,456 12,039

Non-current liabilities: 2,488 2,188

Total liabilities 15,944 14,227

Total shareholders' equity 395,220 289,889

Total liabilities and shareholders' equity $ 411,164 $ 304,116

CONTACT: Investors: Tran Nguyen, CFO
650-837-8535, IR(at)prothena.com

Media: Angela Bitting
925-202-6211, angela.bitting(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#1943662]

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