SAN
FRANCISCO, Aug. 8, 2024 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported financial results for
the second quarter ended June 30,
2024.
Cash and investments in marketable securities at June 30, 2024 were $290.6
million as compared to $329.4
million at December 31, 2023.
Nektar's cash and marketable securities are expected to support
strategic development activities and operations into the third
quarter of 2026.
"We continue to make excellent progress advancing
rezpegaldesleukin in Phase 2 studies in patients with atopic
dermatitis and alopecia areata," said Howard W. Robin, President and CEO of Nektar.
"We are particularly pleased that enrollment is on track
for topline data in the first half of 2025 for atopic
dermatitis and topline data in mid-2025 for alopecia areata. For
our TNFR2 agonist antibody, NKTR-0165, we are conducting
IND-enabling studies with the goal of preparing for an IND
submission in the middle of 2025. Recent data at the 2024 EULAR
Congress highlighted the potential of this unique AI-generated
antibody in inflammatory disorders. Finally, we remain in a strong
financial position with a cash runway extending into the third
quarter of 2026."
Summary of Financial Results
Revenue in the second quarter of 2024 was $23.5 million as compared to $20.5 million in the second quarter of 2023.
Revenue for the first half of 2024 was $45.1
million as compared to $42.1
million in the first half of 2023.
Total operating costs and expenses in the second quarter of 2024
were $73.3 million as compared to
$71.1 million in the second quarter
of 2023. Total operating costs and expenses in the first half of
2024 were $130.3 million as compared
to $227.4 million in the first half
of 2023. Operating costs and expenses for the first half of 2024
decreased due to a decrease in restructuring, impairment and costs
of terminated program and a one-time $76.5
million non-cash goodwill impairment recognized in the first
quarter of 2023.
R&D expense was $29.7 million
in the second quarter of both 2024 and 2023. R&D expense in the
first half of 2024 was $57.1 million
as compared to $60.2 million for the
first half of 2023. R&D expense decreased for the first half of
2024 primarily due to decreases in employee costs and related
facilities costs as well as development expense for NKTR-255 offset
by increases in development expenses for rezpegaldesleukin and
NKTR-0165.
G&A expense was $20.5 million
in the second quarter of 2024 as compared to $17.9 million in the second quarter of 2023.
G&A expense was $40.7 million in
the first half of 2024 as compared to $39.0
million in the first half of 2023. G&A expense increased
for both the second quarter and first half of 2024 primarily due to
a reduction of facilities costs allocated to research and
development expenses partially offset by a decrease in employee
costs.
Non-cash restructuring and impairment charges in the
second quarter of 2024 were $13.3
million and $14.3 million in
the first half of 2024. These non-cash charges are related to the
declining San Francisco commercial
real estate market and real estate lease obligations held by
Nektar.
Net loss for the second quarter of 2024 was $52.4 million or $0.25 basic and diluted loss per share as
compared to a net loss of $51.1
million or $0.27 basic and
diluted loss per share in the second quarter of 2023. Net loss in
the first half of 2024 was $89.2
million or $0.44 basic and
diluted loss per share as compared to a net loss of $188.1 million or $0.99 basic and diluted loss per share in the
first half of 2023. Excluding the $13.3
million and $14.3 million in
non-cash restructuring and real estate impairment charges, net
loss, on a non-GAAP basis, for the second quarter and first half of
2024 were $39.1 million and
$74.9 million, respectively, or
$0.19 and $0.37 basic and diluted loss per share,
respectively.
Second Quarter 2024 and Recent Business Highlights
- In July 2024, our collaborators
at Stanford published data from a Phase
1 trial evaluating NKTR-255 in combination with CD19/22 CAR-T cell
therapy in patients with relapsed or refractory B-cell acute
lymphoblastic leukemia (B-ALL) in Blood, an open-access
journal of the American Society of Hematology. These data showed
that, at 12 months, remission-free survival for NKTR-255 was double
that of historical controls (67% vs 38%). The data also showed that
eight out of nine patients (89%) achieved complete remission with
or without hematologic recovery, all without detectable measurable
residual disease (MRD).
- In June 2024, Nektar presented
the first preclinical data on NKTR-0165 at the European Alliance of
Associations for Rheumatology (EULAR) 2024 Congress. The data
presented show that NKTR-0165 is a unique antibody that selectively
binds to TNFR2 on Tregs to enhance its immunosuppressive
activities, and could potentially become a first-in-class treatment
for various autoimmune diseases, including ulcerative colitis and
vitiligo. Nektar plans to initiate first-in-human studies in the
first half of 2025.
- Enrollment remains on track for the two Phase 2b studies of rezpegaldesleukin, one in patients
with moderate-to-severe atopic dermatitis and one in patients with
severe to very severe alopecia areata. Nektar expects topline data
from these studies, respectively, in the first half and in the
middle of 2025.
Nektar also announced upcoming presentations at the following
scientific congress:
2024 European Academy of Dermatology and Venereology (EADV)
Congress
- ePoster P0662: "Serum proteomic biomarker
analysis of the interleukin-2 receptor pathway agonist
rezpegaldesleukin in patients with atopic dermatitis", Yu,
D.
- ePoster P0600 (Trial in Progress): "A Phase
2b, Randomized, Double-Blinded,
Parallel-Group, Placebo-Controlled, International, Multicenter,
Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in
Adults with Moderate-to-Severe Atopic Dermatitis",
Gkalpakiotis, S.
- ePoster P2080 (Trial in Progress): "A Phase
2b Study Evaluating the Efficacy and
Safety of Single Agent Rezpegaldesleukin, an Interleukin-2 Receptor
(IL-2R) Pathway Agonist, in the Treatment of Severe to Very Severe
Alopecia Areata", Reich, A.
Conference Call to Discuss Second Quarter 2024 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,
August 8, 2024.
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 September 8, 2024.
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 clinical-stage biotechnology
company focused on developing treatments that address the
underlying immunological dysfunction in autoimmune and chronic
inflammatory diseases. Nektar's lead product candidate,
rezpegaldesleukin (NKTR-358), is a novel, first-in-class regulatory
T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and
one in alopecia areata. Our pipeline also includes a preclinical
candidate NKTR-0165, which is a bivalent tumor necrosis factor
receptor type II agonist antibody. Nektar, together with various
partners, is also evaluating NKTR-255, an investigational IL-15
receptor agonist designed to boost the immune system's natural
ability to fight cancer, in several ongoing clinical trials. Nektar
is headquartered in San Francisco, California. For
further information, visit www.nektar.com and follow us
on LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which can
be identified by words such as: "will," "expect," "develop,"
"potential," "advance," "anticipate," 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, NKTR-0165, 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, NKTR-0165, and NKTR-255 are based
on preclinical and clinical findings and observations and are
subject to change as research and development continue; (ii)
rezpegaldesleukin, NKTR-0165, 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
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 health epidemics, including 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 Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on May
10, 2024. 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
|
|
June 30,
2024
|
|
December 31, 2023
(1)
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
27,940
|
|
$
35,277
|
|
|
Short-term
investments
|
|
|
|
|
|
243,295
|
|
268,339
|
|
|
Accounts
receivable
|
|
|
|
|
|
1,196
|
|
1,205
|
|
|
Inventory,
net
|
|
|
|
|
|
14,465
|
|
16,101
|
|
|
Other current
assets
|
|
|
|
|
|
8,292
|
|
9,779
|
|
|
|
Total current
assets
|
|
|
|
|
|
295,188
|
|
330,701
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
investments
|
|
|
|
|
|
19,405
|
|
25,825
|
|
|
Property, plant and
equipment, net
|
|
|
|
|
|
15,187
|
|
18,856
|
|
|
Operating lease
right-of-use assets
|
|
|
|
|
|
9,240
|
|
18,007
|
|
|
Other assets
|
|
|
|
|
|
4,314
|
|
4,644
|
|
|
|
Total assets
|
|
|
|
|
|
$
343,334
|
|
$
398,033
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
|
|
6,475
|
|
9,848
|
|
|
Accrued
expenses
|
|
|
|
|
|
29,514
|
|
22,162
|
|
|
Operating lease
liabilities, current portion
|
|
|
|
|
21,337
|
|
19,259
|
|
|
|
Total current
liabilities
|
|
|
|
|
|
57,326
|
|
51,269
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
liabilities, less current portion
|
|
|
|
90,763
|
|
98,517
|
|
|
Liabilities related to
the sales of future royalties, net
|
|
|
|
107,506
|
|
112,625
|
|
|
Other long-term
liabilities
|
|
|
|
|
|
8,051
|
|
4,635
|
|
|
|
Total
liabilities
|
|
|
|
|
|
263,646
|
|
267,046
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
|
|
|
-
|
|
-
|
|
|
Common stock
|
|
|
|
|
|
19
|
|
19
|
|
|
Capital in excess of
par value
|
|
|
|
|
|
3,649,577
|
|
3,608,137
|
|
|
Treasury
stock
|
|
|
|
|
|
(3,000)
|
|
-
|
|
|
Accumulated other
comprehensive income (loss)
|
|
|
|
(494)
|
|
80
|
|
|
Accumulated
deficit
|
|
|
|
|
|
(3,566,414)
|
|
(3,477,249)
|
|
|
|
Total stockholders'
equity
|
|
|
|
|
|
79,688
|
|
130,987
|
|
|
Total liabilities and
stockholders' equity
|
|
|
|
|
$
343,334
|
|
$
398,033
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The consolidated
balance sheet at December 31, 2023 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 June
30,
|
|
Six months ended June
30,
|
|
|
|
|
|
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
|
|
|
|
$
6,640
|
|
$
4,658
|
|
$
12,674
|
|
$
9,376
|
|
Non-cash royalty
revenue related to the sales of future royalties
|
|
|
16,790
|
|
15,832
|
|
32,298
|
|
32,693
|
|
License, collaboration
and other revenue
|
|
|
|
|
59
|
|
9
|
|
156
|
|
24
|
|
Total
revenue
|
|
|
|
|
|
23,489
|
|
20,499
|
|
45,128
|
|
42,093
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
|
|
9,740
|
|
6,994
|
|
18,274
|
|
14,054
|
|
Research and
development
|
|
|
|
|
|
29,724
|
|
29,681
|
|
57,132
|
|
60,150
|
|
General and
administrative
|
|
|
|
|
|
20,510
|
|
17,869
|
|
40,659
|
|
38,950
|
|
Restructuring,
impairment and costs of terminated program
|
|
|
13,289
|
|
16,554
|
|
14,264
|
|
37,747
|
|
Impairment of
goodwill
|
|
|
|
|
|
-
|
|
-
|
|
-
|
|
76,501
|
|
Total operating costs
and expenses
|
|
|
|
|
|
73,263
|
|
71,098
|
|
130,329
|
|
227,402
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
|
|
(49,774)
|
|
(50,599)
|
|
(85,201)
|
|
(185,309)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash interest
expense on liabilities related to the sales of future
royalties
|
|
(6,408)
|
|
(6,152)
|
|
(11,939)
|
|
(12,557)
|
|
Interest
income
|
|
|
|
|
|
3,901
|
|
4,846
|
|
8,121
|
|
9,181
|
|
Other income (expense),
net
|
|
|
|
|
|
(36)
|
|
736
|
|
(135)
|
|
435
|
|
Total non-operating
income (expense), net
|
|
|
|
|
(2,543)
|
|
(570)
|
|
(3,953)
|
|
(2,941)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
|
|
|
(52,317)
|
|
(51,169)
|
|
(89,154)
|
|
(188,250)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for
income taxes
|
|
|
|
|
|
46
|
|
(47)
|
|
11
|
|
(110)
|
|
Net loss
|
|
|
|
|
|
$
(52,363)
|
|
$
(51,122)
|
|
$
(89,165)
|
|
$
(188,140)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
|
|
$
(0.25)
|
|
$
(0.27)
|
|
$
(0.44)
|
|
$
(0.99)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing basic and diluted net loss per
share
|
|
208,828
|
|
189,656
|
|
201,787
|
|
189,268
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Nektar Therapeutics