Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical
company with expertise in protein dysregulation and a diverse
pipeline of investigational therapeutics for neurodegenerative and
rare peripheral amyloid diseases, today reported financial results
for the third quarter and first nine months of 2020. In addition,
the Company provided an update on its R&D programs.
“During the third quarter, Roche presented data
from the Phase 2 PASADENA study of prasinezumab in patients with
early Parkinson’s disease that demonstrated signals of efficacy
consistent with disease modification and recently, we announced
that prasinezumab will advance into a late-stage study,” said Gene
Kinney, Ph.D., President and Chief Executive Officer of Prothena.
“Moving into the fourth quarter, we are building on this momentum
with two new data presentations from our Alzheimer’s disease
portfolio at CTAD 2020 this week and additional data from our Phase
1 study of PRX004 in ATTR amyloidosis is expected later this
quarter. Looking ahead, we remain focused on advancing our R&D
pipeline towards key milestones.”
Third Quarter and Recent
Highlights
- Announced results from the Phase 2 PASADENA study of
prasinezumab in patients with early Parkinson’s disease that were
presented by Roche at the International Parkinson and Movement
Disorder Society’s MDS Virtual Congress 2020 (MDS Congress 2020) on
September 15, 2020. Prasinezumab is the first potentially
disease-modifying, anti-alpha-synuclein antibody to demonstrate
signs of efficacy on multiple pre-specified secondary and
exploratory clinical endpoints in patients with early Parkinson’s
disease. In the study, prasinezumab significantly reduced decline
in motor function by 35% (pooled dose levels) vs. placebo after one
year of treatment on the centrally rated assessment of Movement
Disorder Society-Unified Parkinson's Disease Rating Scale
(MDS-UPDRS) Part III, a clinical examination of motor function.
Prasinezumab-treated patients also demonstrated a significant delay
in time to clinically meaningful worsening of motor progression on
the site rated assessment of time to at least a 5-point progression
on MDS-UPDRS Part III vs. placebo over one year, with a hazard
ratio of 0.82 (pooled dose levels).
- Announced that Roche and Prothena will advance prasinezumab
into a late-stage (Phase 2b) study in patients with early
Parkinson’s disease. The study will be designed to further assess
the efficacy of prasinezumab by expanding upon the patient
population enrolled in PASADENA to include patients with early
Parkinson’s disease on stable levodopa therapy.
- Presented preclinical data from two programs in its Alzheimer’s
disease portfolio at the 13th Clinical Trials on Alzheimer’s
Disease Conference 2020 (CTAD 2020). First, a next generation anti-
Aβ antibody, PRX012, for more convenient subcutaneous
administration to improve patient access. Second, a multi-immunogen
vaccine that targets both Aβ and Tau, two main pathological
hallmarks of Alzheimer’s disease, for the prevention and treatment
of Alzheimer’s disease.
Upcoming Research and Development
Milestones
Prasinezumab (PRX002/RG7935), a
potential treatment for Parkinson’s disease, is a monoclonal
antibody designed to target alpha-synuclein and is the focus of the
worldwide collaboration with Roche
- Part 2 of the Phase 2 PASADENA study (a 52-week blinded
extension phase) is ongoing.
- Prothena will earn a $60 million clinical milestone payment
upon the first patient dosed in the Phase 2b study. Further details
are expected to be announced in the first half of 2021.
PRX004, a potential treatment
for ATTR amyloidosis, is a monoclonal antibody designed to deplete
the pathogenic, non-native forms of the TTR protein
-
Prothena expects to report new data in fourth quarter of this year
from the dose-escalation and available LTE portion of the
study.
-
Prothena continues to believe that the study has advanced
sufficiently to determine next steps for the program and has begun
further clinical development planning for next clinical studies in
patients with moderate-to-advanced ATTR cardiomyopathy (ATTR-CM).
Current therapies have not demonstrated efficacy in these patients
who are at high risk of early mortality.
Discovery and Preclinical
Development: Prothena is advancing an early-stage pipeline
of programs for a number of potential neurological indications
- Prothena continues to expect to advance IND-enabling activities
in 2020 for PRX005, our preclinical tau program, part of a global
neuroscience collaboration with Bristol-Myers Squibb, and expects
to file an IND in 2021.
- Prothena has initiated IND-enabling studies for PRX012, our
preclinical Aβ program, and expects to file an IND in 2021.
Upcoming Investor
Conferences
Members of the senior management team will
present and participate in investor meetings at the following
upcoming investor conferences:
- Stifel 2020 Virtual Healthcare Conference on Tuesday November
17, 2020 at 4:00 PM Eastern Time
- Jefferies Virtual London Healthcare Conference on Thursday
November 19, 2020 at 2:55 PM Eastern Time
A live webcast of the presentations can be
accessed through the Investors 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.
Third Quarter and First Nine Months of
2020 Financial Results
For the third quarter and first nine months of
2020, Prothena reported a net loss of $30.6 million and $80.4
million, respectively, as compared to a net loss of $19.4 million
and $56.1 million for the third quarter and first nine months of
2019, respectively. The third quarter and first nine months of 2019
included a restructuring credit of nil and $0.1 million,
respectively, which resulted from an adjustment in previously
recorded employee termination benefits associated with the
discontinuation of the NEOD001 program. Net loss per share for the
third quarter and first nine months of 2020 was $0.77 and $2.02,
respectively, as compared to a net loss per share of $0.49 and
$1.41 for the third quarter and first nine months of 2019,
respectively.
Prothena reported total revenue, primarily from
its collaboration with Roche, of $0.2 million and $0.5 million for
the third quarter and first nine months of 2020, respectively as
compared to total revenue of $0.2 million and $0.6 million for the
third quarter and first nine months of 2019, respectively.
Research and development (R&D) expenses
totaled $21.6 million and $54.1 million for the third quarter and
first nine months of 2020, respectively, as compared to $12.5
million and $35.4 million for the third quarter and first nine
months of 2019, respectively. The increase in R&D expense for
the third quarter and first nine months of 2020 compared to the
same periods in the prior year was primarily due to higher
manufacturing costs, higher collaboration expense with Roche
related to the prasinezumab program and higher R&D consulting
expense. R&D expenses included non-cash share-based
compensation expense of $2.1 million and $6.2 million for the third
quarter and first nine months of 2020, respectively, as compared to
$2.0 million and $6.2 million for the third quarter and first nine
months of 2019, respectively.
General and administrative (G&A) expenses
totaled $9.4 million and $28.8 million for the third quarter and
first nine months of 2020, respectively, as compared to $8.7
million and $27.7 million for the third quarter and first nine
months of 2019, respectively. The increase in G&A expenses for
the third quarter and first nine months of 2020 compared to the
same periods in the prior year was primarily related to higher
costs for our director and officer insurance premiums offset in
part by lower share-based compensation expense. G&A expenses
included non-cash share-based compensation expense of $3.5 million
and $10.6 million for the third quarter and first nine months of
2020, respectively, as compared to $3.9 million and $12.1 million
for the third quarter and first nine months of 2019,
respectively.
Total non-cash share-based compensation expense
was $5.6 million and $16.8 million for the third quarter and first
nine months of 2020, respectively, as compared to $5.8 million and
$18.3 million for the third quarter and first nine months of 2019,
respectively.
As of September 30, 2020, Prothena had
$317.2 million in cash, cash equivalents and restricted cash and no
debt.
As of October 30, 2020, Prothena had
approximately 39.9 million ordinary shares outstanding.
The Company continues to expect its full year
2020 net cash burn from operating and investing activities to be
$75-$85 million and expects to end the year with approximately $299
million in cash, cash equivalents and restricted cash (midpoint).
The estimated full year 2020 net cash burn from operating and
investing activities is primarily driven by estimated net loss of
$101-$118 million, which includes an estimated $23 million of
non-cash share-based compensation expense.
Inducement Grant Under NASDAQ Listing
Rule 5635(C)(4)
In connection with hiring two new employees, the
compensation committee of the Company’s board of directors granted
the individuals hired by the Company, in the aggregate, options to
purchase 90,000 ordinary shares of the Company. The options have an
exercise price per share equal to $11.03, which was the closing
trading price on November 2, 2020, the date of the grants. The
inducement awards will vest over four years, with 25% of the
underlying shares vesting on the one-year anniversary of the date
of grants and 1/48th of the underlying shares vesting monthly
thereafter over 36 months. The options were granted pursuant to the
Company’s 2020 Employment Inducement Incentive Plan, which was
approved by the Company’s board of directors under Rule 5635(c)(4)
of The Nasdaq Global Market for equity grants to induce new
employees to enter into employment with the Company.
About ProthenaProthena
Corporation plc is a late-stage clinical company with expertise in
protein dysregulation and a diverse pipeline of novel
investigational therapeutics with the potential to change the
course of devastating neurodegenerative and rare peripheral amyloid
diseases. Fueled by its deep scientific expertise built over
decades of research, Prothena is advancing a pipeline of
therapeutic candidates for a number of indications and novel
targets for which its ability to integrate scientific insights
around neurological dysfunction and the biology of misfolded
proteins can be leveraged. Prothena’s partnered programs include
prasinezumab (PRX002/RG7935), in collaboration with Roche for the
potential treatment of Parkinson’s disease and other related
synucleinopathies, and programs that target tau (PRX005), TDP-43,
and an undisclosed target in collaboration with Bristol-Myers
Squibb for the potential treatment of Alzheimer’s disease,
amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD)
or other neurodegenerative diseases. Prothena’s proprietary
programs include PRX004 for the potential treatment of ATTR
amyloidosis, and a portfolio of programs for the potential
treatment of Alzheimer’s disease including PRX012 that targets Aβ
(Amyloid beta). For more information, please visit the Company’s
website at www.prothena.com and follow the Company on Twitter
@ProthenaCorp.
Forward-looking Statements
This press release contains forward-looking
statements. These statements relate to, among other things, the
sufficiency of our cash position to fund advancement of a broad
pipeline; the treatment potential and proposed mechanisms of action
of prasinezumab, PRX004, PRX005 and PRX012; plans for the ongoing
Phase 2 clinical study of prasinezumab and the Phase 1 clinical
study of PRX004; the expected timing of reporting data from the
Phase 1 clinical study of PRX004; plans for future clinical studies
of prasinezumab and PRX004; amounts we might receive under our
collaboration with Roche; the continued advancement of our
discovery and preclinical pipeline; the timing of IND-enabling
activities from our tau and Aβ programs; our anticipated
net cash burn from operating and investing activities for 2020 and
expected cash balance at the end of 2020; and our estimated net
loss and non-cash share-based compensation expense for 2020. 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
effects on our business of the worldwide COVID-19 pandemic and 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 3, 2020, as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings 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 PLCCONSOLIDATED
STATEMENTS OF OPERATIONS(unaudited - amounts in
thousands except per share data)
|
|
Three months ended September 30, |
|
Nine Months Ended September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Collaboration revenue |
|
$ |
157 |
|
|
|
$ |
205 |
|
|
|
$ |
443 |
|
|
|
$ |
558 |
|
|
License revenue |
|
— |
|
|
|
— |
|
|
|
50 |
|
|
|
— |
|
|
Total revenue |
|
157 |
|
|
|
205 |
|
|
|
493 |
|
|
|
558 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
21,605 |
|
|
|
12,486 |
|
|
|
54,124 |
|
|
|
35,365 |
|
|
General and administrative |
|
9,398 |
|
|
|
8,691 |
|
|
|
28,795 |
|
|
|
27,677 |
|
|
Restructuring credits |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(61 |
) |
|
Total operating expenses |
|
31,003 |
|
|
|
21,177 |
|
|
|
82,919 |
|
|
|
62,981 |
|
|
Loss from operations |
|
(30,846 |
) |
|
|
(20,972 |
) |
|
|
(82,426 |
) |
|
|
(62,423 |
) |
|
Other income, net |
|
54 |
|
|
|
1,992 |
|
|
|
1,362 |
|
|
|
6,810 |
|
|
Loss before income taxes |
|
(30,792 |
) |
|
|
(18,980 |
) |
|
|
(81,064 |
) |
|
|
(55,613 |
) |
|
Provision for (benefit from)
income taxes |
|
(215 |
) |
|
|
468 |
|
|
|
(636 |
) |
|
|
510 |
|
|
Net loss |
|
$ |
(30,577 |
) |
|
|
$ |
(19,448 |
) |
|
|
$ |
(80,428 |
) |
|
|
$ |
(56,123 |
) |
|
Basic and diluted net loss per
share |
|
$ |
(0.77 |
) |
|
|
$ |
(0.49 |
) |
|
|
$ |
(2.02 |
) |
|
|
$ |
(1.41 |
) |
|
Shares used to compute basic
and diluted net loss per share |
|
39,917 |
|
|
|
39,897 |
|
|
|
39,912 |
|
|
|
39,877 |
|
|
PROTHENA CORPORATION PLCCONSOLIDATED
BALANCE SHEETS(unaudited - amounts in
thousands)
|
September 30, |
|
December 31, |
|
2020 |
|
2019 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
314,525 |
|
|
$ |
375,723 |
|
Accounts receivable |
22 |
|
|
68 |
|
Prepaid expenses and other
current assets |
4,586 |
|
|
2,584 |
|
Restricted cash, current |
1,352 |
|
|
— |
|
Total current assets |
320,485 |
|
|
378,375 |
|
Property and equipment, net |
2,899 |
|
|
3,874 |
|
Operating lease right-of-use
assets |
19,197 |
|
|
23,274 |
|
Restricted cash, non-current |
1,352 |
|
|
2,704 |
|
Other non-current assets |
11,851 |
|
|
11,041 |
|
Total non-current assets |
35,299 |
|
|
40,893 |
|
Total assets |
$ |
355,784 |
|
|
$ |
419,268 |
|
Liabilities and Shareholders’ Equity |
|
|
|
Accrued research and
development |
$ |
7,617 |
|
|
$ |
5,826 |
|
Lease liability, current |
5,408 |
|
|
5,101 |
|
Other current liabilities |
8,697 |
|
|
6,787 |
|
Total current liabilities |
21,722 |
|
|
17,714 |
|
Deferred revenue, non
current |
110,242 |
|
|
110,242 |
|
Lease liability, non-current |
13,753 |
|
|
17,838 |
|
Other non-current
liabilities |
553 |
|
|
553 |
|
Total
non-current liabilities |
124,548 |
|
|
128,633 |
|
Total liabilities |
146,270 |
|
|
146,347 |
|
Total shareholders’ equity |
209,514 |
|
|
272,921 |
|
Total liabilities and shareholders’ equity |
$ |
355,784 |
|
|
$ |
419,268 |
|
Contacts:
MediaEllen Rose, Head of
Communications650-922-2405, ellen.rose@prothena.com
InvestorsJennifer Zibuda,
Director, Investor Relations & Communications650-837-8535,
jennifer.zibuda@prothena.com
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