Prothena Reports First Quarter 2015 Financial Results and Provides R&D Update
(Thomson Reuters ONE) -
* Net cash used in operating activities was $14.7 million in the first
quarter; net proceeds of $131.4 million raised through April 2015 public
equity offering added to $279.9 million quarter-end cash position provide
solid runway for continued advancement of multiple programs
* Reported positive results from a Phase 1 single ascending dose study of
PRX002, a novel protein immunotherapy for Parkinson's disease, demonstrating
robust, rapid and dose-dependent mean reduction of free serum alpha-
synuclein of up to 96% after single dose
DUBLIN, Ireland - May 5, 2015 - 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 first quarter ended March 31, 2015 and provided an
update on its lead programs.
"During the first quarter, we reported positive Phase 1 data confirming that
PRX002 was safe and well tolerated, and importantly, that a single dose of
PRX002 resulted in robust, rapid and dose-dependent mean reduction of free serum
alpha-synuclein of up to 96%. Reducing alpha-synuclein may translate into a
delay or reversal of disease progression in patients with Parkinson's disease,"
said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. "Taken
in combination with the Phase 1/2 results for NEOD001 that drove the initiation
of The VITAL Amyloidosis Study, our global Phase 3 registrational trial, today
we have a multi-product pipeline of potentially disease-modifying
immunotherapies."
Dr. Schenk continued, "Further, PRX003 is expected to enter the clinic in the
first half of this year, and we believe we are exceptionally well capitalized
for sustainable development growth and for becoming a commercial company in the
years ahead."
First Quarter 2015 and Recent Highlights
· In March, reported positive results from the Phase 1 single ascending
dose study for PRX002 in healthy volunteers
-- PRX002 was safe and well tolerated at all doses, meeting the primary
objective of the study
-- PRX002 demonstrated favorable pharmacokinetic properties, supporting the
current dosing frequency in the ongoing Phase 1 multiple ascending dose study in
patients with Parkinson's disease
-- Results showed that a single administration of PRX002 leads to a robust,
rapid and dose-dependent mean reduction of free serum alpha-synuclein levels of
up to 96% (p<0.00001)
· In April, 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 and development of novel
biomarkers for Parkinson's disease that facilitate therapeutic approaches
targeting alpha-synuclein, including PRX002
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 to share further details on positive results from Phase 1
single ascending dose study at a medical conference in 2015
· 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 to initiate Phase 1 single ascending dose trial in healthy
volunteers in the second quarter of 2015
· Expect to initiate Phase 1 multiple ascending dose study in patients
with psoriasis in 2016
First Quarter 2015 Financial Results and Guidance
Prothena reported a net loss of $15.2 million for the first quarter of 2015 as
compared to net income of $17.9 million for the first quarter of 2014. Net loss
per share was $0.55 for the first quarter of 2015 as compared to net income per
share of $0.78 on a fully diluted basis for the first quarter of 2014.
Prothena reported total revenue of $0.6 million for the first quarter of 2015 as
compared to total revenue of $32.2 million for the first quarter of 2014. The
decrease was primarily due to $32.1 million in collaboration revenue recognized
in relation to the PRX002 collaboration with Roche in the first quarter of 2014
compared to $0.6 million in collaboration revenue recognized in the first
quarter of 2015.
Research and development (R&D) expenses totaled $10.6 million for the first
quarter of 2015 as compared to $9.3 million for the first quarter of 2014. The
increase in R&D expenses was primarily due to increased external expenses
related to clinical trials, and higher personnel costs offset by lower external
product manufacturing expenses and higher net expense reimbursements from Roche.
R&D expenses included non-cash share-based compensation expense of $0.8 million
for the first quarter of 2015 as compared to $0.5 million for the first quarter
of 2014.
General and administrative (G&A) expenses totaled $5.0 million for the first
quarter of 2015 as compared to $4.9 million for first quarter of 2014. 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 $0.9 million in
both the first quarter of 2015 and the first quarter of 2014.
Total non-cash share-based compensation expense was $1.7 million for the first
quarter of 2015 as compared to $1.3 million for the first quarter of 2014.
As of March 31, 2015, Prothena had $279.9 million in cash and cash equivalents
and no outstanding debt. In April 2015, Prothena raised net proceeds of $131.4
million through a public offering of 3.8 million ordinary shares. After
completion of that offering and as of April 24, 2015, Prothena had 31.3 million
ordinary shares outstanding.
The Company expects 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:
· Credit Suisse's Antibody Day on Wednesday, May 6, 2015 at 12:05 p.m.
EDT in New York, NY
· Bank of America Merrill Lynch 2015 Health Care Conference on
Wednesday, May 13, 2015 at 1:40 p.m. PDT at Encore at the Wynn in Las Vegas, NV
· UBS 2015 Global Healthcare Conference on Monday, May 18, 2015 at
10:00 a.m. EDT at Sheraton Times Square Hotel in New York, NY
Live webcasts of the above presentations can be accessed through the investor
relations section of the Company's website at www.prothena.com. Following the
live presentations, replays of the webcasts 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 our program and becoming a commercial company; the potential for
PRX002 to impact Parkinson's disease progression; 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 further data from our Phase 1 single
ascending dose study and initial data from our Phase 1 multiple ascending dose
study for PRX002; the timing of initiating our Phase 1 single ascending dose and
multiple ascending dose studies 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
March 31,
-------------------------
2015 2014
------------- -----------
Collaboration revenue $ 593 $ 32,096
Revenue-related party - 138
------------- -----------
Total revenue 593 32,234
Operating expenses:
Research and development 10,573 9,342
General and administrative 5,049 4,873
------------- -----------
Total operating expenses 15,622 14,215
------------- -----------
Income (loss) from operations (15,029 ) 18,019
Other income (expense), net 93 (16 )
------------- -----------
Income (loss) before income taxes (14,936 ) 18,003
Provision for income taxes 266 151
------------- -----------
Net income (loss) $ (15,202 ) $ 17,852
------------- -----------
Net income (loss) per share attributable to holders
of ordinary shares
Basic $ (0.55 ) $ 0.82
Diluted $ (0.55 ) $ 0.78
Shares used to compute net income (loss) per share
attributable to holders of ordinary shares
Basic 27,401 21,884
Diluted 27,401 22,942
PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
December
March 31, 31,
2015 2014
------------- ------------
Assets
Current assets:
Cash and cash equivalents $ 279,857 $ 293,579
Receivable from Roche 1,357 1,729
Receivable from related party 30 30
Deferred tax assets 163 167
Prepaid expenses and other current assets 3,012 3,770
------------- ------------
Total current assets 284,419 299,275
Non-current assets:
Property and equipment, net 2,956 3,121
Deferred tax assets, non-current 2,093 1,720
Other assets 117 -
------------- ------------
Total non-current assets 5,166 4,841
------------- ------------
Total assets $ 289,585 $ 304,116
------------- ------------
Liabilities and Shareholders' Equity
Accrued research and development 3,662 2,285
Other current liabilities 5,882 9,754
------------- ------------
Total current liabilities 9,544 12,039
Non-current liabilities 2,615 2,188
------------- ------------
Total liabilities 12,159 14,227
Total shareholders' equity 277,426 289,889
------------- ------------
Total liabilities and shareholders' equity $ 289,585 $ 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#1919062]
Unternehmensinformation / Kurzprofil:
Datum: 05.05.2015 - 22:26 Uhr
Sprache: Deutsch
News-ID 391184
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