Prothena Reports Third Quarter 2016 Financial Results and Provides R&D Update
(Thomson Reuters ONE) -
* 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, Nov. 01, 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 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 other
related synucleinopathies (PRX002), inflammatory diseases, including psoriasis
and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). For
moreinformation, 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 ability of our cash position to support advancement
of a diverse pipeline and commercial capabilities; our contemplated Phase 2
clinical study of PRX003 in psoriatic arthritis; the timing of completing
enrollment in the Phase 3 VITAL study and reporting results from the Phase 2b
PRONTO study for NEOD001; the timing of reporting results from the Phase 1b
multiple ascending dose study for PRX002; the timing of reporting interim data
and full results from the Phase 1b multiple ascending dose study for PRX003; the
timing of advancing PRX004 into clinical development; our anticipated net cash
burn from operating and investing activities for 2016 and expected cash balance
at the end of 2016; and our estimated net loss and non-cash share-based
compensation expense for 2016. 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 25, 2016 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 Nine Months Ended
September 30, September 30,
--------------------------- ---------------------------
2016 2015 2016 2015
------------- ------------- -------------- ------------
Collaboration revenue $ 286 $ 429 $ 884 $ 1,300
------------- ------------- -------------- ------------
Total revenue 286 429 884 1,300
Operating expenses:
Research and
development 26,838 17,185 79,690 40,549
General and
administrative 16,136 5,905 31,452 16,476
------------- ------------- -------------- ------------
Total operating
expenses 42,974 23,090 111,142 57,025
------------- ------------- -------------- ------------
Loss from operations (42,688 ) (22,661 ) (110,258 ) (55,725 )
------------- ------------- -------------- ------------
Other expense, net (130 ) (77 ) (156 ) (31 )
------------- ------------- -------------- ------------
Loss before income
taxes (42,818 ) (22,738 ) (110,414 ) (55,756 )
Provision for income
taxes 421 238 791 699
------------- ------------- -------------- ------------
Net loss $ (43,239 ) $ (22,976 ) $ (111,205 ) $ (56,455 )
------------- ------------- -------------- ------------
Basic and diluted net
loss per share $ (1.26 ) $ (0.73 ) $ (3.25 ) $ (1.89 )
Shares used to
compute basic and
diluted net loss per
share 34,413 31,441 34,266 29,893
PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
September December
30, 31,
2016 2015
------------- ------------
Assets
Cash and cash equivalents $ 408,574 $ 370,586
Other current assets 7,064 6,817
------------- ------------
Total current assets 415,638 377,403
Property and equipment, net 51,738 3,862
Restricted cash 4,056 -
Other assets 8,150 3,971
------------- ------------
Total non-current assets 63,944 7,833
------------- ------------
Total assets $ 479,582 $ 385,236
------------- ------------
Liabilities and Shareholders' Equity
Accrued research and development 16,937 12,794
Other current liabilities 19,971 9,422
------------- ------------
Total current liabilities 36,908 22,216
Non-current liabilities: 41,574 2,351
------------- ------------
Total liabilities 78,482 24,567
Total shareholders' equity 401,100 360,669
------------- ------------
Total liabilities and shareholders' equity $ 479,582 $ 385,236
------------- ------------
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: 01.11.2016 - 21:05 Uhr
Sprache: Deutsch
News-ID 504255
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Kategorie:
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