Prothena Reports First Quarter 2017 Financial Results and Provides R&D Update
(Thomson Reuters ONE) -
* Net cash used in operating and investing activities was $40.2 million in the
first quarter; quarter-end cash and restricted cash position of $510.6
million, including net proceeds of $150.3 million raised through March 2017
public equity offering, provides funding to advance R&D pipeline
* Completed enrollment in the Phase 2b PRONTO study evaluating NEOD001 in
previously treated patients with AL amyloidosis and persistent cardiac
dysfunction
* Presented results from the Phase 1b study of PRX002/RG7935 in an oral
session at the 13(th) International Conference on Alzheimer's and
Parkinson's Disease (AD/PD)
DUBLIN, Ireland, May 09, 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 first quarter of 2017. In addition, the
Company provided an update on its R&D programs.
"Enrollment is now complete in our Phase 2b PRONTO study evaluating NEOD001 for
the potential treatment of AL amyloidosis and we expect topline results from
this study in the second quarter of 2018," said Gene Kinney, PhD, President and
Chief Executive Officer of Prothena. "Later this month, we also expect to meet
an important milestone by completing over-enrollment of our Phase 3 VITAL
Amyloidosis Study evaluating NEOD001 in newly diagnosed, treatment naïve
patients with AL amyloidosis and cardiac dysfunction. Our balance sheet enables
us to progress our clinical programs through key milestones and we are steadily
advancing a diverse pipeline of protein immunotherapies across multiple
therapeutic categories while strengthening our organization to plan for
commercialization of our lead program, NEOD001."
First Quarter 2017 and Recent Highlights:
* Completed enrollment in the Phase 2b PRONTO study evaluating NEOD001 in
previously treated patients with AL amyloidosis and persistent cardiac
dysfunction. Based on the high level of patient interest, there are 129
patients randomized in the study, representing over-enrollment by 29
patients. The PRONTO study is a global, double-blind, placebo-controlled,
registration-directed study with a primary endpoint of best response over
12 months of the cardiac functional biomarker NT-proBNP, defined by the
consensus criteria of NT-proBNP change. Secondary endpoints include quality
of life, functional and biomarker measures.
* Expect to complete over-enrollment by mid-May in our 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 has been met, and patients who are currently in
screening have an opportunity to complete this process and based on their
eligibility will be randomized into the study. The study will therefore be
over-enrolled, with the last patient randomized in the coming weeks. 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
13(th) 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 support advancing PRX002/RG7935 into a Phase 2 study,
PASADENA, which is expected to begin in the second quarter of 2017.
* Completed a successful public offering that raised aggregate net proceeds of
$150.3 million through the issuance of 2.7 million ordinary shares in March
2017.
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:
* Complete enrollment in the Phase 3 VITAL Amyloidosis Study expected by mid-
May 2017
* Topline results in the Phase 2b PRONTO study expected in the second quarter
of 2018
PRX002/RG7935 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:
* Phase 2 clinical study, PASADENA, expected to begin in the second quarter of
2017
PRX003 is a monoclonal antibody for the potential treatment of inflammatory
diseases, including psoriasis and psoriatic arthritis:
* Topline results from the Phase 1b multiple ascending dose, safety and proof-
of-biology study in 32 patients (8 patients per dose-level cohort,
randomized 3:1) with psoriasis expected in the third quarter of 2017
PRX004 is a monoclonal antibody for the potential treatment of ATTR amyloidosis:
* Clinical development expected to begin in early 2018
First Quarter 2017 Financial Results and Updated 2017 Financial Guidance
Prothena reported a net loss of $35.4 million for the first quarter of 2017, as
compared to a net loss of $27.5 million for the first quarter of 2016. Net loss
per share for the first quarter of 2017 was $0.99, as compared to a net loss per
share for the first quarter of 2016 of $0.81.
Prothena reported total revenue of $0.3 million for the first quarter of 2017,
as compared to total revenue of $0.3 million for the first quarter of 2016.
Research and development (R&D) expenses totaled $25.7 million for the first
quarter of 2017, as compared to $20.5 million for the first quarter of 2016. The
increase in R&D expenses for the first quarter of 2017 was primarily due to
increased personnel cost, and higher expenses for product manufacturing and
clinical trials. R&D expenses included non-cash share-based compensation expense
of $2.3 million for the first quarter of 2017, as compared to $1.4 million for
the first quarter of 2016.
General and administrative (G&A) expenses totaled $10.8 million for the first
quarter of 2017, as compared to $7.2 million for first quarter of 2016. The
increase in G&A expenses for the first quarter of 2017 was primarily due to
increases in personnel costs, consulting expense and other expenses, partially
offset by a gain recognized from the assignment of our former South San
Francisco facility lease. G&A expenses included non-cash share-based
compensation expense of $3.3 million in the first quarter of 2017, as compared
to $2.3 million in the first quarter of 2016.
Total non-cash share-based compensation expense was $5.6 million for the first
quarter of 2017, as compared to $3.7 million for the first quarter of 2016.
As of March 31, 2017, Prothena had $510.6 million in cash, cash equivalents and
restricted cash, and no debt.
As of April 21, 2017, Prothena had approximately 38.0 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, including an expected milestone
payment from Roche 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), which has been updated to include the recent $150.3
million from the March 2017 public equity offering. 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.
Upcoming Investor Conferences
Members of the senior management team will present and participate in investor
meetings at the following upcoming investor conferences:
* Bank of America Merrill Lynch 2017 Healthcare Conference on May 18, 2017 at
8:00 AM PT/11:00 AM ET in Las Vegas, NV
* UBS 2017 Global Healthcare Conference on May 23, 2017 at 8:30 AM ET in New
York, NY
* Jefferies 2017 Global Healthcare Conference on June 8, 2017 at 11:30 AM ET
in New York, NY
A live webcast of the presentations can be accessed through the investor
relations section of the Company's website at www.prothena.com. Following the
live presentations, a replay of the webcast will be available on the Company's
website for at least 90 days following the presentation date.
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 cash position to advance our R&D
pipeline through key milestones; the timing of completing enrollment in the
Phase 3 study and announcing topline results from the Phase 2b study of NEOD001;
the timing of initiating a Phase 2 study of PRX002/RG7935; the timing of
announcing topline results from the Phase 1b study of PRX003; the timing of
initiating clinical development of PRX004; our anticipated net cash burn from
operating and investing activities for 2017 and expected 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
March 31,
2017 2016
Collaboration revenue $ 259 $ 265
Total revenue 259 265
Operating expenses:
Research and development 25,698 20,493
General and administrative 10,832 7,182
Total operating expenses 36,530 27,675
Loss from operations (36,271 ) (27,410 )
Other income (expense), net: (774 ) 70
Loss before income taxes (37,045 ) (27,340 )
Provision for (benefit from) income taxes (1,661 ) 181
Net loss $ (35,384 ) $ (27,521 )
Basic and diluted net loss per share $ (0.99 ) $ (0.81 )
Shares used to compute basic and diluted net loss 35,758 34,026
per share
PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
March 31, December
31,
2017 2016
Assets
Cash and cash equivalents $ 506,550 $ 386,923
Other current assets 7,654 4,439
Total current assets 514,204 391,362
Property and equipment, net 56,084 56,452
Restricted cash 4,056 4,056
Other assets 7,606 8,106
Total non-current assets 67,746 68,614
Total assets $ 581,950 $ 459,976
Liabilities and Shareholders' Equity
Accrued research and development $ 21,710 $ 19,073
Other current liabilities 11,970 22,002
Total current liabilities 33,680 41,075
Non-current liabilities: 52,022 53,498
Total liabilities 85,702 94,573
Total shareholders' equity 496,248 365,403
Total liabilities and shareholders' equity $ 581,950 $ 459,976
Contacts
Investors: Tran Nguyen, CFO
650-837-8535, IR(at)prothena.com
Media: Ellen Rose, Head of Communications
650-922-2405, ellen.rose(at)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
Unternehmensinformation / Kurzprofil:
Datum: 09.05.2017 - 22:05 Uhr
Sprache: Deutsch
News-ID 541383
Anzahl Zeichen: 16192
contact information:
Town:
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Kategorie:
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