Prothena Reports Second Quarter 2016 Financial Results; Provides R&D Update
(Thomson Reuters ONE) -
* Net cash used in operating and investing activities was $32.3 million in the
second quarter and $57.7 million for the first six months of 2016; strong
quarter-end cash and restricted cash position of $447.0 million supports
advancement of multiple clinical development programs
* Presented new clinical data from NEOD001 Phase 1/2 dose-escalation and
expansion study, demonstrating improvement in three organ systems (cardiac,
renal, and peripheral nerve) in previously-treated patients with AL
amyloidosis
* Presented clinical results from PRX003 Phase 1 single ascending dose study,
demonstrating target engagement of novel anti-MCAM antibody for inflammatory
diseases
DUBLIN, Ireland, Aug. 02, 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 second quarter and first six months of
2016. In addition, the Company provided an update on its R&D programs and 2016
financial guidance.
"During the second quarter, we demonstrated positive momentum in our pipeline
with oral presentations on new clinical data from two of our lead programs,
NEOD001 and PRX003, at medical conferences," said Dale Schenk, PhD, President
and Chief Executive Officer of Prothena. "The new clinical data from our NEOD001
Phase 1/2 dose-escalation and expansion study gives us continued confidence in
the design and powering of the Phase 2b PRONTO and Phase 3 VITAL studies, which
remain on track to our previously guided timelines. We continue to invest in our
pipeline, and our financial position enables us to advance our programs through
key milestones. During the coming 12 months we expect to announce topline
results from the Phase 1b study of PRX002 in patients with Parkinson's disease,
share interim results from the Phase 1b proof-of-biology study of PRX003 in
patients with psoriasis, complete enrollment in the VITAL Amyloidosis Study of
NEOD001, and advance PRX004 targeting transthyretin amyloid towards clinical
development."
Recent Highlights and Program Updates:
* In an oral session at the 15th International Symposium on Amyloidosis (ISA),
Morie A. Gertz, MD, of Mayo Clinic, presented new interim clinical data as
of May 9, 2016 from 69 patients enrolled in 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.
These cardiac and renal best response rates are consistent with results from
the interim analysis of the dose-escalation phase of the Phase 1/2 study
published in the Journal of Clinical Oncology in February 2016. In addition,
improvement in peripheral neuropathy in patients in the prospectively
defined peripheral neuropathy expansion cohort (n=11) was demonstrated by a
mean 35% (median 23%) decrease in the Neuropathy Impairment Score-Lower Limb
(NIS-LL) measured at month 10, leading to an 82% response rate and
indicating improvement to a third organ system in NEOD001-treated patients.
Two patients in this cohort demonstrated complete resolution of their
peripheral neuropathy, as measured by NIS-LL. NEOD001 continued to be safe
and well tolerated.
* Also at ISA, presented preclinical research from Prothena's newest pipeline
program, PRX004 for the potential treatment of TTR amyloidosis. An
additional 7 posters and 1 oral session at ISA included research on new
amyloid targets, and data on quality of life in AL amyloidosis.
* In an oral session at the European League Against Rheumatism (EULAR)
17th Annual European Congress of Rheumatology, presented positive
results from a Phase 1 clinical study of PRX003 in healthy volunteers that
demonstrated PRX003 was safe and well-tolerated following a single infusion,
up to and including the highest dose level tested of 30 mg/kg. Results from
this study showed that administration of PRX003 led to greater than 95
percent neutralization of MCAM at saturating drug exposures. The data also
demonstrated a statistically significant (p<0.0001) dose-dependent duration
of downregulation of MCAM, or CD146, on Th17 cells.
* In poster and e-poster sessions at the European Hematology Association's
21st Congress, presented new quality of life data for patients with AL
amyloidosis. These studies included data on the relative burden of AL
amyloidosis on health-related quality of life for patients, the impact of
treatment-related symptoms on treatment compliance, impact on absenteeism,
job productivity and loss, and validity of psychometric properties of the
SF-36v2® Health Survey.
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 late 2017 - 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 the fourth quarter of 2016
PRX003 is a monoclonal antibody for the potential treatment of inflammatory
diseases, including psoriasis:
* Expect to provide update on Phase 2 development strategy in September 2016
* 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 TTR amyloidosis:
* Expect to advance PRX004 into clinical development in late 2017 - early 2018
Second Quarter and First Six Months of 2016 Financial Results and Updated 2016
Financial Guidance
Prothena reported a net loss of $40.4 million and $68.0 million for the second
quarter and first six months of 2016, respectively, as compared to a net loss of
$18.3 million and $33.5 million for the second quarter and first six months of
2015, respectively. Net loss per share for the second quarter and first six
months of 2016 was $1.18 and $1.99, respectively, as compared to a net loss per
share of $0.59 and $1.15 for the second quarter and first six months of 2015,
respectively.
Prothena reported total revenue of $0.3 million and $0.6 million for the second
quarter and first six months of 2016, respectively, as compared to total revenue
of $0.3 million and $0.9 million for the second quarter and first six months of
2015, respectively. The decrease in revenue for the second quarter and first six
months of 2016 was primarily due to lower revenue from Prothena's collaboration
agreement with Roche.
Research and development (R&D) expenses totaled $32.4 million and $52.9 million
for the second quarter and first six months of 2016, respectively, as compared
to $12.8 million and $23.4 million for the second quarter and first six months
of 2015, respectively. The increase in R&D expenses for the second quarter was
primarily due to increased expenses for product manufacturing and personnel
cost. The increase in R&D expense for the first six months was primarily due to
increased expenses related to product manufacturing, clinical trials and
personnel costs. R&D expenses included non-cash share-based compensation expense
of $1.8 million and $3.2 million for the second quarter and first six months of
2016, respectively, as compared to $1.0 million and $1.7 million for the second
quarter and first six months of 2015, respectively.
General and administrative (G&A) expenses totaled $8.1 million and $15.3 million
for the second quarter and first six months of 2016, respectively, as compared
to $5.5 million and $10.6 million for second quarter and first six months of
2015, respectively. The increase in G&A expenses for the second quarter and
first six months was primarily due to increases in personnel costs. G&A expenses
included non-cash share-based compensation expense of $2.7 million and $5.0
million in the second quarter and first six months of 2016, respectively, as
compared to $1.4 million and $2.4 million in the second quarter and first six
months of 2015, respectively.
Total non-cash share-based compensation expense was $4.5 million and $8.3
million for the second quarter and first six months of 2016, respectively, as
compared to $2.4 million and $4.1 million for the second quarter and first six
months of 2015, respectively.
As of June 30, 2016, Prothena had $447.0 million in cash, cash equivalents and
restricted cash and no debt.
As of July 22, 2016, Prothena had approximately 34.4 million ordinary shares
outstanding.
The Company is updating its projected full year 2016 net cash burn from
operating and investing activities, and expects it to be $118 to $128 million,
representing an increase of approximately $13 million, and expects to end the
year with approximately $376 million in cash, cash equivalents and restricted
cash (midpoint). Based on the new clinical data from the NEOD001 Phase 1/2 study
presented at ISA, the Company accelerated manufacturing expenses into the
current fiscal year in order to increase its supply of NEOD001. Accelerating
these manufacturing expenses into the 2016 operating year offers an opportunity
to support NEOD001 investigator-sponsored trials, and to prepare to scale for
potential commercial launch. The updated estimated full year 2016 net cash burn
from operating and investing activities is primarily driven by an updated
estimated net loss of $144 to $161 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 2016 Wedbush Pacgrow Healthcare Conference on August 16, 2016 at
10:20 AM ET in New York, NY.
A live webcast of the presentation can be accessed through the investor
relations section of the Company's website at www.prothena.com. Following the
live presentation, 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
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 has advanced several drug candidates into
clinical trials 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
(PRX003), and TTR amyloidosis (PRX004).
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 multiple clinical development programs through key milestones; our confidence
in the design and powering of the Phase 2b PRONTO and Phase 3 VITAL studies; 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 providing
an update on the Phase 2 development strategy and reporting interim data and
full results from the Phase 1b multiple ascending dose study for PRX003; the
timing of advancing PRX004 into clinical development; the opportunity to support
NEOD001 investigator-sponsored trials and to prepare to scale for commercial
launch; 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 Six Months Ended
June 30, June 30,
--------------------------- --------------------------
2016 2015 2016 2015
------------- ------------- ------------- ------------
Collaboration revenue $ 333 $ 278 $ 598 $ 871
------------- ------------- ------------- ------------
Total revenue 333 278 598 871
Operating expenses:
Research and
development 32,359 12,791 52,852 23,364
General and
administrative 8,134 5,522 15,316 10,571
------------- ------------- ------------- ------------
Total operating
expenses 40,493 18,313 68,168 33,935
------------- ------------- ------------- ------------
Loss from operations (40,160 ) (18,035 ) (67,570 ) (33,064 )
------------- ------------- ------------- ------------
Other expense (96 ) (47 ) (26 ) 46
------------- ------------- ------------- ------------
Loss before income
taxes (40,256 ) (18,082 ) (67,596 ) (33,018 )
Provision for income
taxes 189 195 370 461
------------- ------------- ------------- ------------
Net loss $ (40,445 ) $ (18,277 ) $ (67,966 ) $ (33,479 )
------------- ------------- ------------- ------------
Basic and diluted net
loss per share $ (1.18 ) $ (0.59 ) $ (1.99 ) $ (1.15 )
Shares used to compute
basic and diluted net
loss per share 34,358 30,792 34,192 29,106
PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
December
June 30, 31,
2016 2015
------------- ------------
Assets
Cash and cash equivalents $ 442,948 $ 370,586
Other current assets 7,650 6,817
------------- ------------
Total current assets 450,598 377,403
Property and equipment, net 41,852 3,862
Restricted cash 4,056 -
Other assets 6,056 3,971
------------- ------------
Total non-current assets 51,964 7,833
------------- ------------
Total assets $ 502,562 $ 385,236
------------- ------------
Liabilities and Shareholders' Equity
Accrued research and development 16,650 12,794
Other current liabilities 16,806 9,422
------------- ------------
Total current liabilities 33,456 22,216
Non-current liabilities: 38,241 2,351
------------- ------------
Total liabilities 71,697 24,567
Total shareholders' equity 430,865 360,669
------------- ------------
Total liabilities and shareholders' equity $ 502,562 $ 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 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#2032419]
Unternehmensinformation / Kurzprofil:
Datum: 02.08.2016 - 22:05 Uhr
Sprache: Deutsch
News-ID 486935
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