SAN
FRANCISCO, May 9, 2024 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported financial results for
the first quarter ended March 31,
2024.
Cash and investments in marketable securities at
March 31, 2024 were $326.0 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.
"In the first quarter, we made significant
progress with our highly promising immunology and inflammation
pipeline," said Howard W. Robin,
President and CEO of Nektar. "REZPEG is advancing in the clinic in
our Phase 2b study in patients with
atopic dermatitis and in our Phase 2b
study in patients with alopecia areata. Enrollment for both studies
is on-track, and we expect to report topline data from these trials
in the first half of 2025. Building out our Treg pipeline, our
novel bivalent antibody targeting the TNFR2 receptor is progressing
through IND-enabling studies to support entering the clinic next
year."
Summary of Financial Results
Revenue in the first quarter of 2024 was
$21.6 million as compared to the same
$21.6 million in the first quarter of
2023.
Total operating costs and expenses in the first
quarter of 2024 were $57.1 million as
compared to $156.3 million in the
first quarter of 2023. Operating costs and expenses for the first
quarter of 2023 included a one-time $76.5
million non-cash goodwill impairment charge. Operating
costs and expenses for the first quarter of 2024 further decreased
as compared to 2023 due to decreases in restructuring, impairment
and costs of terminated program, as well as decreases in R&D
and G&A expense.
R&D expense in the first quarter of 2024 was
$27.4 million as compared to
$30.5 million for the first quarter
of 2023. R&D expense for the first quarter of 2024 decreased
primarily due to a decrease in employee costs and related
facilities costs, partially offset by an increase in expense for
the development of rezpegaldesleukin and NKTR-0165, our TNFR2
agonist antibody.
G&A expense was $20.1
million in the first quarter of 2024 as compared to
$21.1 million in the first quarter of
2023.
Restructuring, impairment and other costs of the
terminated program were $1.0 million
in the first quarter of 2024 as compared to $21.2 million in the first quarter of 2023.
Restructuring, impairment and other costs of terminated program
decreased primarily due to $13.2
million in non-cash lease and equipment impairment charges
and $5.5 million in severance expense
recognized in the first quarter of 2023.
Net loss for the first quarter of 2024 was
$36.8 million or $0.19 basic and diluted loss per share as
compared to a net loss of $137.0
million or $0.73 basic and
diluted loss per share in the first quarter of 2023.
First Quarter 2024 and Recent Business
Highlights
- In March 2024, Nektar initiated a
Phase 2b study of rezpegaldesleukin
in patients with severe to very severe alopecia areata. The Company
expects topline data from this study in the first half of
2025.
- Enrollment is ongoing in the Phase 2b study of rezpegaldesleukin in patients with
moderate-to-severe atopic dermatitis. The Company expects
topline data from the study in the first half of 2025.
- In March 2024, we entered into a securities purchase
agreement with TCG Crossover Fund, an institutional accredited
investor, to sell securities in a private placement financing for
gross proceeds to the Company of approximately $30 million, before deducting expenses.
Conference Call to Discuss First 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, May 9, 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 June 9,
2024.
To access the conference call, follow these instructions:
Dial: (800) 715-9871 (U.S & Canada)
Conference ID: 4855448
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 (REZPEG, or 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 and NKTR-0165. 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-0165 are based
on preclinical and clinical findings and observations and are
subject to change as research and development continue; (ii)
rezpegaldesleukin and NKTR-0165 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 is in clinical development and NTKR-0165 is
in preclinical 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 recent
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-K filed with the
Securities and Exchange Commission on March
5, 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
|
|
March 31,
2024
|
|
December 31,
2023 (1)
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
48,642
|
|
$
35,277
|
|
Short-term
investments
|
|
|
|
|
|
240,596
|
|
268,339
|
|
Accounts
receivable
|
|
|
|
|
|
3,617
|
|
1,205
|
|
Inventory,
net
|
|
|
|
|
|
16,238
|
|
16,101
|
|
Other current
assets
|
|
|
|
|
|
10,743
|
|
9,779
|
|
|
Total current
assets
|
|
|
|
|
|
319,836
|
|
330,701
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
investments
|
|
|
|
|
|
36,778
|
|
25,825
|
|
Property, plant and
equipment, net
|
|
|
|
|
|
17,475
|
|
18,856
|
|
Operating lease
right-of-use assets
|
|
|
|
|
|
17,267
|
|
18,007
|
|
Other assets
|
|
|
|
|
|
4,656
|
|
4,644
|
|
|
Total assets
|
|
|
|
|
|
$
396,012
|
|
$
398,033
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
|
|
8,757
|
|
9,848
|
|
Accrued
expenses
|
|
|
|
|
|
24,281
|
|
22,162
|
|
Operating lease
liabilities, current portion
|
|
|
|
|
|
19,368
|
|
19,259
|
|
|
Total current
liabilities
|
|
|
|
|
|
52,406
|
|
51,269
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
liabilities, less current portion
|
|
|
|
|
94,710
|
|
98,517
|
|
Liabilities related to
the sales of future royalties, net
|
|
|
|
|
117,857
|
|
112,625
|
|
Other long-term
liabilities
|
|
|
|
|
|
4,334
|
|
4,635
|
|
|
Total
liabilities
|
|
|
|
|
|
269,307
|
|
267,046
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
|
|
|
-
|
|
-
|
|
Common stock
|
|
|
|
|
|
19
|
|
19
|
|
Capital in excess of
par value
|
|
|
|
|
|
3,644,140
|
|
3,608,137
|
|
Treasury
stock
|
|
|
|
|
|
(3,000)
|
|
-
|
|
Accumulated other
comprehensive income (loss)
|
|
|
|
|
(403)
|
|
80
|
|
Accumulated
deficit
|
|
|
|
|
|
(3,514,051)
|
|
(3,477,249)
|
|
|
Total stockholders'
equity
|
|
|
|
|
|
126,705
|
|
130,987
|
|
Total liabilities and
stockholders' equity
|
|
|
|
|
|
$
396,012
|
|
$
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
March 31,
|
|
|
|
|
|
|
|
|
2024
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
|
|
|
|
$
6,034
|
|
$
4,718
|
|
Non-cash royalty
revenue related to the sales of future royalties
|
|
|
|
15,508
|
|
16,861
|
|
License, collaboration
and other revenue
|
|
|
|
|
|
97
|
|
15
|
|
Total
revenue
|
|
|
|
|
|
21,639
|
|
21,594
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
|
|
8,534
|
|
7,060
|
|
Research and
development
|
|
|
|
|
|
27,408
|
|
30,469
|
|
General and
administrative
|
|
|
|
|
|
20,149
|
|
21,081
|
|
Restructuring,
impairment and costs of terminated program
|
|
|
|
975
|
|
21,193
|
|
Impairment of
goodwill
|
|
|
|
|
|
-
|
|
76,501
|
|
Total operating costs
and expenses
|
|
|
|
|
|
57,066
|
|
156,304
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
|
|
(35,427)
|
|
(134,710)
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
|
Non-cash interest
expense on liabilities related to the sales of future
royalties
|
|
|
(5,531)
|
|
(6,405)
|
|
Interest
income
|
|
|
|
|
|
4,220
|
|
4,335
|
|
Other income (expense),
net
|
|
|
|
|
|
(99)
|
|
(301)
|
|
Total non-operating
income (expense), net
|
|
|
|
|
|
(1,410)
|
|
(2,371)
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
|
|
|
|
(36,837)
|
|
(137,081)
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for
income taxes
|
|
|
|
|
|
(35)
|
|
(63)
|
|
Net loss
|
|
|
|
|
|
$
(36,802)
|
|
$
(137,018)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
|
|
|
$
(0.19)
|
|
$
(0.73)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing basic and diluted net loss per
share
|
|
194,746
|
|
188,875
|
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SOURCE Nektar Therapeutics