SAN FRANCISCO, Nov. 5, 2020 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ: NKTR) today reported financial results for
the third quarter ended September 30,
2020.
Cash and investments in marketable securities at September 30, 2020 were approximately
$1.2 billion as compared to
$1.6 billion at December 31, 2019.
"In Q3, we've continued to successfully advance our late-stage
registrational and early stage studies for our immune-oncology
pipeline of candidates while navigating challenges in the current
COVID-19 environment," said Howard W.
Robin, President and CEO of Nektar. "Enrollment in our five
registrational trials of bempegaldesleukin in combination with
nivolumab is going well and our partner BMS recently initiated a
new clinical study in renal cell carcinoma to evaluate the doublet
therapy with a TKI agent. We are also pleased to report that we are
ahead of our enrollment targets for the Phase 2 PROPEL study of
bempegaldesleukin with pembrolizumab in patients with metastatic
non-small cell lung cancer and we look forward to sharing the
initial data from this important study in the first part of
2021."
"Next week's 2020 SITC meeting will feature data presentations
that showcase the strength of Nektar's immune-oncology pipeline,
including an oral presentation of 2 1/2 year data for metastatic
melanoma patients treated with bempegaldesleukin plus nivolumab,
and promising early data for NKTR-255, our IL-15 cytokine, as well
as NKTR-262, our TLR agonist program," continued Robin. "In
immunology, we presented positive new data at ACR 2020 this week
highlighting the disease activity observed in lupus patients with
NKTR-358, our T regulatory cell agent. We are exceptionally
pleased that our partner Lilly is undertaking a broad clinical
development program for NKTR-358 with two Phase 1b studies in atopic dermatitis and psoriasis, a
Phase 2 study underway in patients with systemic lupus
erythematosus and a new Phase 2 study being planned in ulcerative
colitis."
Summary of Q3 2020 Financial Results
Revenue in the third quarter of 2020 was $30.0 million compared to $29.2 million in the third quarter of 2019.
Year-to-date revenue for 2020 was $129.5
million compared to $80.8
million for the first nine months of 2019. Revenue was
higher due to the recognition of $50.0
million in total milestones from Bristol-Myers Squibb
related to the start of two new registrational trials of
bempegaldesleukin plus Opdivo® in adjuvant melanoma and
muscle-invasive bladder cancer.
Total operating costs and expenses in the third quarter of 2020
were $133.1 million compared to
$128.0 million in the third quarter
of 2019. Total operating costs and expenses in the first nine
months of 2020 were $443.8 million
compared to $411.2 million in the
first nine months of 2019. Year-to-date operating costs and
expenses increased primarily as a result of $45.2 million in impairment charges in the first
quarter of 2020 resulting from the discontinuation of the NKTR-181
program, partially offset by a decrease in R&D expense.
R&D expense in the third quarter of 2020 was $100.5 million compared to $99.0 million for the third quarter of 2019. For
the first nine months of 2020, R&D expense was $306.0 million compared to $324.2 million in the first nine months of 2019.
Excluding pre-commercial manufacturing costs for NKTR-181 incurred
during 2019, research and development expense increased for the
third quarter and the first nine months of 2020 primarily due to
increases in clinical development costs, partially offset by a
decrease in manufacturing costs for clinical trial materials.
Net loss for the third quarter of 2020 was $108.6 million or $0.61 basic and diluted loss per share compared
to a net loss of $98.6 million or
$0.56 basic and diluted loss per
share in the third quarter of 2019. Net loss in the first nine
months of 2020 was $327.2 million or
$1.84 basic and diluted loss per
share compared to a net loss of $328.5
million or $1.88 basic and
diluted loss per share in the first nine months of 2019.
Third Quarter 2020 and Recent Business Highlights
- In November 2020, Nektar
presented new data from its NKTR-358 program at the American
College of Rheumatology (ACR) virtual meeting. Data from the Phase
1b study in patients with mild to
moderate systemic lupus erythematosus (SLE) showed that NKTR-358
produced a dose-dependent increase in expression of Treg activation
markers, providing a rationale for continued development in SLE and
other inflammatory indications.
- In October 2020, Nektar received
IND clearance and began site initiation activities for a Phase 1/2
study of NKTR-255 in patients with solid tumors. The study will
evaluate NKTR-255 in combination with cetuximab in two distinct
groups of highly refractory patients with colorectal cancer or head
and neck cancer.
- In October 2020, Nektar initiated
a Phase 1b clinical study of
bempegaldesleukin in adult patients with mild COVID-19 infection.
The randomized, double-blind, placebo-controlled trial is designed
to assess the safety, tolerability, and pharmacokinetic and
pharmacodynamic profile of bempegaldesleukin in adult patients with
mild COVD-19.
- In September 2020, a Phase 1/2
study was initiated by Nektar partner BMS in patients with clear
cell renal cell carcinoma to evaluate the triplet combination of
bempegaldesleukin with nivolumab in combination with a
tyrosine-kinase inhibitor.
- In August 2020, Vaccibody AS and
Nektar announced that the first patient had been dosed in the Phase
1/2a study evaluating bempegaldesleukin with VB10.NEO, Vaccibody's
personalized neoantigen cancer vaccine, in patients with advanced
squamous cell carcinoma of the head and neck.
The company also announced upcoming presentations at the
following scientific congress:
2020 Society for Immunotherapy of Cancer (SITC) Annual
Meeting:
- Oral Presentation: "REVEAL: Phase 1 dose-escalation
study of NKTR-262, a novel TLR7/8 agonist, plus bempegaldesleukin:
local innate immune activation and systemic adaptive immune
expansion for treating solid tumors"
-
- Presenter: Dr. Adi
Diab, MD Anderson Cancer Center
- Session: Session 102: Combinatorial Therapies
- Date and Time: Wednesday, November 11; 11:15 a.m. – 1:10 p.m.
Eastern Standard Time
- Oral Presentation: "Progression-free survival
and biomarker correlates of response with BEMPEG plus NIVO in
previously untreated patients with metastatic melanoma: results
from the PIVOT-02 study"
-
- Presenter: Dr. Adi
Diab, MD Anderson Cancer Center
- Session: Session 104: Concurrent Rapid Oral
Abstract Presentation: Clinical
- Date and Time: Wednesday, November 11; 1:30 p.m. – 2:00 p.m.
Eastern Standard Time
- Poster Presentation: "First-in-human phase I
study of NKTR-255 in patients with relapsed/refractory hematologic
malignancies", Shah, N., et al.
-
- Session: Virtual Poster Hall
- Date and Time: Poster presentations will be
available beginning November 9,
2020
- Poster Presentation: "Bempegaldesleukin (BEMPEG;
CD122-preferential IL-2 pathway agonist)) and NKTR-262 (TLR7/8
agonist) combination treatment pairs local innate immune activation
with systemic CD8+ T cell expansion to enhance anti-tumor
immunity", Rolig, A., et al.
-
- Session: Virtual Poster Hall
- Date and Time: Poster presentations will be
available beginning November 9,
2020
Conference Call to Discuss Third Quarter Financial
Results
Nektar management will host a conference call to review the
results beginning at 5:00 p.m. Eastern
Time/2:00 p.m. Pacific Time,
today, Thursday, November 5,
2020.
This press release and a live audio-only Webcast of the
conference call can be accessed through a link that is posted on
the Home Page and Investors section of the Nektar website:
https://ir.nektar.com/. The web broadcast of the conference call
will be available for replay through Tuesday, December 1, 2020.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970)
315-0453 (international)
Conference ID: 5192707 (Nektar Therapeutics is the host)
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in oncology, immunology, and virology, as well as a portfolio
of approved partnered medicines. Nektar is headquartered in
San Francisco, California, with
additional operations in Huntsville,
Alabama and Hyderabad,
India. Further information about the company and its drug
development programs and capabilities may be found online at
http://www.nektar.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which
can be identified by words such as: "may," "design," "potential,"
"evaluate," "plan," "will," and similar references to future
periods. Examples of forward-looking statements include, among
others, statements we make regarding the therapeutic potential of,
and future development plans for, our clinical drug candidates, and
the timing of the initiation of clinical studies for our clinical
drug candidates. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based
only on our current beliefs, expectations and assumptions regarding
the future of our business, future plans and strategies,
anticipated events and trends, the economy and other future
conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results may differ
materially from those indicated in the forward-looking statements.
Therefore, you should not rely on any of these forward-looking
statements. Important factors that could cause our actual results
to differ materially from those indicated in the forward-looking
statements include, among others: (i) our statements regarding the
therapeutic potential of bempegaldesleukin in patients who have
been diagnosed with COVID-19 infection are based on data that is
evolving and do not include clinical testing of bempegaldesleukin
for this intended patient population, and there is no guarantee
that the clinical evaluation of bempegaldesleukin in COVID-19
patients will support the use of bempegaldesleukin in this patient
population; (ii) investigational agents and continued research
and development for these drug candidates are subject to
substantial risks, including negative safety and efficacy findings
in ongoing clinical studies (notwithstanding positive findings in
earlier preclinical and clinical studies); (iii) as our clinical
drug candidates are currently in development, the risk of
failure is high and failure can unexpectedly occur at any stage
prior to regulatory approval; (iv) the timing of the commencement
or end of clinical trials and the availability of clinical data may
be delayed or unsuccessful due to regulatory delays, slower than
anticipated patient enrollment, manufacturing challenges, changing
standards of care, evolving regulatory requirements, clinical trial
design, clinical outcomes, competitive factors, or delay or failure
in ultimately obtaining regulatory approval in one or more
important markets; (v) patents may not issue from our patent
applications for our drug candidates, patents that have issued may
not be enforceable, or additional intellectual property licenses
from third parties may be required; and (vi) certain other
important risks and uncertainties set forth in our Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on
August 7, 2020. Any forward-looking
statement made by us in this press release is based only on
information currently available to us and speaks only as of the
date on which it is made. We undertake no obligation to update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Contact:
For Investors:
Jerry
Isaacson of Nektar Therapeutics
628-895-0634
Vivian Wu of Nektar Therapeutics
628-895-0661
For Media:
Dan Budwick of 1AB
973-271-6085
Opdivo is a registered trademark of Bristol-Myers Squibb
Company.
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
September 30,
2020
|
|
December 31, 2019
(1)
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
$
55,843
|
|
$
96,363
|
|
Short-term
investments
|
|
|
|
900,163
|
|
1,228,499
|
|
Accounts
receivable
|
|
|
|
42,925
|
|
36,802
|
|
Inventory
|
|
|
|
|
12,892
|
|
12,665
|
|
Advance payments to
contract manufacturers
|
|
|
10,483
|
|
31,834
|
|
Other current
assets
|
|
|
|
21,550
|
|
15,387
|
|
|
Total current
assets
|
|
|
|
1,043,856
|
|
1,421,550
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
investments
|
|
|
|
197,715
|
|
279,119
|
Property, plant and
equipment, net
|
|
|
60,189
|
|
65,665
|
Operating lease
right-of-use assets
|
|
|
128,985
|
|
134,177
|
Goodwill
|
|
|
|
|
|
76,501
|
|
76,501
|
Other
assets
|
|
|
|
|
1,420
|
|
344
|
|
|
Total
assets
|
|
|
|
|
$
1,508,666
|
|
$
1,977,356
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Senior secured notes,
net and interest payable
|
|
|
$
-
|
|
$
252,891
|
|
Accounts
payable
|
|
|
|
15,484
|
|
19,234
|
|
Accrued
compensation
|
|
|
|
29,504
|
|
11,467
|
|
Accrued clinical
trial expenses
|
|
|
48,886
|
|
32,626
|
|
Accrued contract
manufacturing expenses
|
|
|
7,141
|
|
7,304
|
|
Other accrued
expenses
|
|
|
|
9,630
|
|
12,338
|
|
Operating lease
liabilities, current portion
|
|
|
15,348
|
|
12,516
|
|
Deferred revenue,
current portion
|
|
|
507
|
|
5,517
|
|
|
Total current
liabilities
|
|
|
|
126,500
|
|
353,893
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
liabilities, less current portion
|
|
|
139,022
|
|
142,730
|
Liability related to
the sale of future royalties, net
|
|
|
66,378
|
|
72,020
|
Deferred revenue,
less current portion
|
|
|
2,494
|
|
2,554
|
Other long-term
liabilities
|
|
|
|
3,291
|
|
768
|
|
|
Total
liabilities
|
|
|
|
337,685
|
|
571,965
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
|
|
-
|
|
-
|
|
Common
stock
|
|
|
|
|
18
|
|
17
|
|
Capital in excess of
par value
|
|
|
3,363,998
|
|
3,271,097
|
|
Accumulated other
comprehensive income (loss)
|
|
(1,080)
|
|
(1,005)
|
|
Accumulated
deficit
|
|
|
|
(2,191,955)
|
|
(1,864,718)
|
|
|
Total stockholders'
equity
|
|
|
1,170,981
|
|
1,405,391
|
|
Total liabilities and
stockholders' equity
|
|
|
$
1,508,666
|
|
$
1,977,356
|
|
|
|
|
|
|
|
|
|
|
|
(1) The consolidated
balance sheet at December 31, 2019 has been derived from the
audited financial statements at that date but does not include
all of the information and notes required by generally
accepted accounting principles in the United States for complete
financial statements.
|
|
|
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands, except
per share information)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
|
|
|
$
5,691
|
|
$
5,558
|
|
$
14,620
|
|
$
14,302
|
Royalty
revenue
|
|
|
|
|
12,289
|
|
10,275
|
|
31,411
|
|
29,008
|
Non-cash royalty
revenue related to sale of future royalties
|
|
10,422
|
|
10,264
|
|
28,001
|
|
27,585
|
License,
collaboration and other revenue
|
|
|
1,631
|
|
3,121
|
|
55,421
|
|
9,860
|
Total
revenue
|
|
|
|
|
30,033
|
|
29,218
|
|
129,453
|
|
80,755
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
5,570
|
|
4,927
|
|
15,154
|
|
15,385
|
Research and
development
|
|
|
|
100,531
|
|
99,048
|
|
305,954
|
|
324,197
|
General and
administrative
|
|
|
|
26,982
|
|
23,983
|
|
77,546
|
|
71,570
|
Impairment of assets
and other costs for terminated program
|
|
-
|
|
-
|
|
45,189
|
|
-
|
Total operating costs
and expenses
|
|
|
133,083
|
|
127,958
|
|
443,843
|
|
411,152
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
(103,050)
|
|
(98,740)
|
|
(314,390)
|
|
(330,397)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
|
|
-
|
|
(5,425)
|
|
(6,851)
|
|
(15,882)
|
Non-cash interest
expense on liability related to sale of future royalties
|
|
(8,425)
|
|
(5,813)
|
|
(22,084)
|
|
(17,853)
|
Interest income and
other income (expense), net
|
|
|
2,910
|
|
11,492
|
|
16,453
|
|
35,964
|
Total non-operating
income (expense), net
|
|
|
(5,515)
|
|
254
|
|
(12,482)
|
|
2,229
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
|
(108,565)
|
|
(98,486)
|
|
(326,872)
|
|
(328,168)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
21
|
|
99
|
|
365
|
|
335
|
Net loss
|
|
|
|
|
|
$
(108,586)
|
|
$
(98,585)
|
|
$
(327,237)
|
|
$
(328,503)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
$
(0.61)
|
|
$
(0.56)
|
|
$
(1.84)
|
|
$
(1.88)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
|
179,090
|
|
175,402
|
|
178,203
|
|
174,609
|
|
|
|
|
|
|
|
|
|
|
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
|
2020
|
|
2019
|
Cash flows from
operating activities:
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
$
(327,237)
|
|
$
(328,503)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Non-cash royalty
revenue related to sale of future royalties
|
|
(28,001)
|
|
(27,585)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
|
22,084
|
|
17,853
|
Stock-based
compensation
|
|
|
72,274
|
|
74,787
|
Depreciation and
amortization
|
|
|
10,937
|
|
9,582
|
Impairment of
advance payments to contract manufacturers and equipment for
terminated program
|
|
20,351
|
|
-
|
Accretion of premiums
(discounts), net and other non-cash transactions
|
|
1,150
|
|
(9,147)
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
Accounts
receivable
|
|
|
|
(6,123)
|
|
2,008
|
Inventory
|
|
|
|
|
(227)
|
|
(2,339)
|
Operating leases,
net
|
|
|
|
4,316
|
|
11,550
|
Other
assets
|
|
|
|
|
(5,588)
|
|
18,127
|
Accounts
payable
|
|
|
|
(3,337)
|
|
16,109
|
Accrued
compensation
|
|
|
|
20,478
|
|
13,164
|
Other accrued
expenses
|
|
|
|
9,340
|
|
10,401
|
Deferred
revenue
|
|
|
|
(5,070)
|
|
(9,465)
|
Net cash used in
operating activities
|
|
|
(214,653)
|
|
(203,458)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
Purchases of
investments
|
|
|
(791,445)
|
|
(1,028,883)
|
Maturities of
investments
|
|
|
|
1,158,722
|
|
1,122,902
|
Sales of
investments
|
|
|
|
41,700
|
|
-
|
Purchases of
property, plant and equipment
|
|
|
(5,504)
|
|
(22,614)
|
Net cash provided by
investing activities
|
|
|
403,473
|
|
71,405
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
Proceeds from shares
issued under equity compensation plans
|
|
20,651
|
|
18,449
|
Repayment of Senior
Notes
|
|
|
(250,000)
|
|
-
|
Net cash provided by
(used in) financing activities
|
|
(229,349)
|
|
18,449
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
|
9
|
|
(77)
|
Net decrease in cash
and cash equivalents
|
|
|
(40,520)
|
|
(113,681)
|
Cash and cash
equivalents at beginning of period
|
|
96,363
|
|
194,905
|
Cash and cash
equivalents at end of period
|
|
|
$
55,843
|
|
$
81,224
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash flow information:
|
|
|
|
|
Cash paid for
interest
|
|
|
|
$
9,742
|
|
$
14,299
|
Operating lease
right-of-use asset recognized in exchange for lease
liabilities
|
|
$
2,133
|
|
$
56,025
|
|
|
|
|
|
|
|
|
|
|
|
View original
content:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-third-quarter-2020-financial-results-301167517.html
SOURCE Nektar Therapeutics