SAN
FRANCISCO, Nov. 7, 2023 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported financial results for
the third quarter ended September 30,
2023.
Cash and investments in marketable securities at September 30, 2023, were $372.7 million as compared to $505.0 million at December
31, 2022. Nektar's cash and marketable securities are
expected to support strategic development activities and operations
into the middle of 2026.
"We've made significant progress across our pipeline, including
initiating a Phase 2b atopic
dermatitis study in October and completing plans to start a Phase
2b alopecia areata study in early
2024," said Howard W. Robin, President and CEO of Nektar.
"These two studies position us for important and transformative
data readouts for rezpegaldesleukin in the first half of 2025. In
September, we signed a new clinical study collaboration with cell
therapy leader, Cellular Biomedicine Group, who will evaluate
NKTR-255 in combination with CBMG's tumor-infiltrating lymphocyte
therapy in advanced non-small cell lung cancer. This study is an
example of the potential of NKTR-255 in combination with a range of
cell therapies in liquid and solid tumors. Finally, we will end
this year in a strong financial position with at least
$320 million in cash and
investments which provides us with a cash runway into the middle of
2026."
Summary of Financial Results
Revenue in the third quarter of 2023 was $24.1 million as compared to $23.6 million in the third quarter of 2022.
Revenue for the first nine months of 2023 was $66.2 million as compared to $70.0 million in the first nine months of
2022.
Total operating costs and expenses in the third quarter of 2023
were $69.0 million as compared to
$77.9 million in the third quarter of
2022. Total operating costs and expenses in the first nine months
of 2023 were $296.4 million as
compared to $393.7 million in the
first nine months of 2022. The reduction in operating costs and
expenses for both the third quarter and the first nine months of
2023 were due to decreases in research and development expenses,
general and administrative expense and restructuring, impairment
and costs of terminated program. For the first nine months of 2023,
these decreases were partially offset by $76.5 million in non-cash goodwill
impairment.
R&D expense in the third quarter of 2023 was $24.1 million as compared to $33.6 million for the third quarter of 2022. For
the first nine months of 2023, R&D expense was $84.2 million as compared to $183.6 million in the first nine months of 2022.
R&D expense decreased for both the third quarter and first nine
months of 2023 due to the wind down of the bempegaldesleukin
program.
G&A expense was $21.1 million
in the third quarter of 2023 as compared to $22.5 million in the third quarter of 2022. For
the first nine months of 2023, G&A expense was $60.1 million as compared to $70.4 million in the first nine months of 2022.
G&A expense decreased for both the third quarter and first nine
months of 2023 due to the wind down of the bempegaldesleukin
program.
Restructuring, impairment and costs of terminated program were
$11.4 million in the third quarter of
2023 as compared to $16.8 million in
the third quarter of 2022. The amount for the third quarter of 2023
includes $10.2 million in non-cash
lease and equipment impairment charges, $0.7
million for the wind down of the bempegaldesleukin program
and $0.5 million in severance. The
amount for the third quarter of 2022 includes $8.5 million for the wind down of the
bempegaldesleukin program, $5.0
million for contract termination and other restructuring
costs, $2.1 million in severance and
$1.2 million in non-cash lease
impairment charges.
For the first nine months of 2023, restructuring, impairment and
costs of terminated program were $49.1
million. This amount includes $36.6
million in non-cash lease and equipment impairment charges,
$8.0 million in severance and
$3.6 million for the wind down of the
bempegaldesleukin program.
For the first nine months of 2022, restructuring, impairment and
costs of terminated program were $124.4
million. This amount includes $58.5
million in non-cash lease and equipment impairment charges,
$29.8 million in severance,
$28.9 million for the wind down of
the bempegaldesleukin program and $7.1
million in contract termination and other restructuring
costs.
Net loss for the third quarter of 2023 was $45.8 million or $0.24 basic and diluted loss per share as
compared to a net loss of $59.0
million or $0.31 basic and
diluted loss per share in the third quarter of 2022. Net loss in
the first nine months of 2023 was $234.0
million or $1.23 basic and
diluted loss per share as compared to a net loss of $308.5 million or $1.65 basic and diluted loss per share in the
first nine months of 2022. Excluding the $10.2 million in non-cash impairment charges, net
loss, on a non-GAAP basis, for the third quarter of 2023 was
$35.7 million or $0.19 basic and diluted loss per
share. Excluding the $113.1
million in non-cash goodwill and other impairment charges,
net loss, on a non-GAAP basis, for the first nine months of 2023
was $120.8 million or $0.64 basic and diluted loss per share.
Third Quarter 2023 and Recent Business Updates
- In September 2023, Nektar
announced a clinical study collaboration with Cellular Biomedicine
Group Inc. (CBMG) to evaluate NKTR-255 in combination with C-TIL051
in advanced non-small cell lung cancer (NSCLC) patients that are
relapsed or refractory to anti-PD-1 therapy. Under the
collaboration, CBMG will add NKTR-255 to its ongoing Phase 1
clinical trial being conducted at Duke Cancer Institute. Enrollment
for this trial is ongoing.
- In October 2023, Nektar presented
final data from the Phase 1b study of
rezpegaldesleukin in patients with atopic dermatitis at the
2023 European Academy of Dermatology and Venereology (EADV)
Congress.
- Patients with moderate-to-severe AD that were treated with
rezpegaldesleukin showed dose-dependent improvements in Eczema Area
and Severity Index (EASI), Validated Investigator Global Assessment
(vIGA), Body Surface Area (BSA), and Itch Numeric Rating Scale
(NRS) over 12 weeks of treatment compared to placebo, which were
sustained post-treatment over an additional 36 weeks.
- At the highest studied dose, the proportion of Daily Life
Quality Index (DLQI) responders was 75% and the proportion of
Patient Oriented Eczema Measure (POEM) responders was 65% at week
12.
- rezpegaldesleukin was well tolerated with no patients in the
rezpegaldesleukin groups experiencing severe, serious, or fatal
adverse events, and no anti-rezpegaldesleukin antibodies were
detected.
- In October 2023, Nektar initiated
a Phase 2b study of rezpegaldesleukin
in patients with atopic dermatitis.
Conference Call to Discuss Third Quarter 2023 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,
November 7, 2023.
This press release and 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: http://ir.nektar.com/.
The web broadcast of the conference call will be available for
replay through December 8, 2023.
To access the conference call, please pre-register at Nektar
Earnings Call Registration. All registrants will receive dial-in
information and a PIN allowing them to access the live call.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in immunology and oncology as well as a portfolio of approved
partnered medicines. Nektar is headquartered in San Francisco, California, with additional
manufacturing operations in Huntsville,
Alabama. 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: "will," "could," "develop,"
"potential," "advance" and similar references to future periods.
Examples of forward-looking statements include, among others,
statements regarding the therapeutic potential of, and future
development plans for, rezpegaldesleukin and NKTR-255.
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 rezpegaldesleukin and NKTR-255 are based on
preclinical and clinical findings and observations and are subject
to change as research and development continue; (ii)
rezpegaldesleukin and NKTR-255 are investigational agents and
continued research and development for these drug candidates is
subject to substantial risks, including negative safety and
efficacy findings in future clinical studies (notwithstanding
positive findings in earlier preclinical and clinical studies);
(iii) rezpegaldesleukin and NKTR-255 are in various stages of
clinical development and the risk of failure is high and 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
challenges caused by the COVID-19 pandemic, 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) we may not achieve
the expected cost savings we expect from our 2022 corporate
restructuring and reorganization plan or our 2023 cost
restructuring plan and we may undertake additional restructuring
and cost-saving activities in the future, (vi) 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 (vii)
certain other important risks and uncertainties set forth in our
Annual Report on Form 10-Q filed with the Securities and Exchange
Commission on August 9, 2023. 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:
Vivian Wu of Nektar
Therapeutics
628-895-0661
For Media:
David Rosen of Argot Partners
(212) 600-1902
david.rosen@argotpartners.com
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
(Unaudited)
|
|
ASSETS
|
|
September 30,
2023
|
|
December 31, 2022
(1)
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
64,921
|
|
$
88,227
|
|
Short-term
investments
|
|
307,737
|
|
416,750
|
|
Accounts
receivable
|
|
2,204
|
|
5,981
|
|
Inventory,
net
|
|
15,130
|
|
19,202
|
|
Other current
assets
|
|
9,033
|
|
15,808
|
|
|
Total current
assets
|
|
399,025
|
|
545,968
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
19,949
|
|
32,451
|
Operating lease
right-of-use assets
|
|
18,747
|
|
53,435
|
Goodwill
|
|
-
|
|
76,501
|
Other assets
|
|
4,523
|
|
2,245
|
|
|
Total assets
|
|
$
442,244
|
|
$
710,600
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
3,288
|
|
$
12,980
|
|
Accrued
expenses
|
|
29,729
|
|
36,557
|
|
Operating lease
liabilities, current portion
|
|
19,095
|
|
18,667
|
|
|
Total current
liabilities
|
|
52,112
|
|
68,204
|
|
|
|
|
|
|
|
Operating lease
liabilities, less current portion
|
|
102,193
|
|
112,829
|
Liabilities related to
the sales of future royalties, net
|
|
123,610
|
|
155,378
|
Other long-term
liabilities
|
|
4,961
|
|
7,551
|
|
|
Total
liabilities
|
|
282,876
|
|
343,962
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
Common stock
|
|
19
|
|
19
|
|
Capital in excess of
par value
|
|
3,600,871
|
|
3,574,719
|
|
Accumulated other
comprehensive loss
|
|
(6,352)
|
|
(6,907)
|
|
Accumulated
deficit
|
|
(3,435,170)
|
|
(3,201,193)
|
|
|
Total stockholders'
equity
|
|
159,368
|
|
366,638
|
|
Total liabilities and
stockholders' equity
|
|
$
442,244
|
|
$
710,600
|
|
(1) The consolidated
balance sheet at December 31, 2022 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)
|
|
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
5,822
|
|
$
4,969
|
|
$
15,198
|
|
$
15,969
|
|
Non-cash royalty
revenue related to the sales of future royalties
|
|
18,167
|
|
18,342
|
|
50,860
|
|
52,167
|
|
License, collaboration
and other revenue
|
|
155
|
|
314
|
|
179
|
|
1,896
|
Total
revenue
|
|
24,144
|
|
23,625
|
|
66,237
|
|
70,032
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
12,431
|
|
4,972
|
|
26,485
|
|
15,402
|
|
Research and
development
|
|
24,070
|
|
33,590
|
|
84,220
|
|
183,583
|
|
General and
administrative
|
|
21,147
|
|
22,534
|
|
60,097
|
|
70,394
|
|
Restructuring,
impairment, and costs of terminated program
|
|
11,360
|
|
16,830
|
|
49,107
|
|
124,350
|
|
Impairment of
goodwill
|
|
-
|
|
-
|
|
76,501
|
|
-
|
Total operating costs
and expenses
|
|
69,008
|
|
77,926
|
|
296,410
|
|
393,729
|
|
Loss from
operations
|
|
(44,864)
|
|
(54,301)
|
|
(230,173)
|
|
(323,697)
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
|
Change in fair value of
development derivative liability
|
|
-
|
|
-
|
|
-
|
|
33,427
|
|
Non-cash interest
expense on liabilities related to the sales of future
royalties
|
|
(5,910)
|
|
(6,953)
|
|
(18,467)
|
|
(21,710)
|
|
Interest income and
other income (expense), net
|
|
4,876
|
|
2,050
|
|
14,492
|
|
3,541
|
Total non-operating
income (expense), net
|
|
(1,034)
|
|
(4,903)
|
|
(3,975)
|
|
15,258
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
(45,898)
|
|
(59,204)
|
|
(234,148)
|
|
(308,439)
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for
income taxes
|
|
(61)
|
|
(155)
|
|
(171)
|
|
71
|
Net loss
|
|
$
(45,837)
|
|
$
(59,049)
|
|
$
(233,977)
|
|
$
(308,510)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.24)
|
|
$
(0.31)
|
|
$
(1.23)
|
|
$
(1.65)
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing basic and diluted net loss
per share
|
|
190,406
|
|
187,641
|
|
189,651
|
|
186,767
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/nektar-therapeutics-reports-third-quarter-2023-financial-results-301980712.html
SOURCE Nektar Therapeutics