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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of report (Date of earliest event reported):
November 7, 2023
NEKTAR THERAPEUTICS
(Exact Name of Registrant as Specified in Charter)
Delaware |
|
0-24006 |
|
94-3134940 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
455 Mission Bay Boulevard South
San Francisco, California 94158
(Address of Principal Executive Offices and
Zip Code)
Registrant’s telephone number, including
area code: (415) 482-5300
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading symbol(s) |
|
Name of each exchange on which registered |
Common Stock, $0.0001 par value |
|
NKTR |
|
NASDAQ Global Select Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial
Condition.
On
November 7, 2023, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”)
announcing its financial results for the quarter ended September 30, 2023. A copy of the Press Release is furnished herewith
as Exhibit 99.1.
The
information in this report, including the exhibit hereto, is being furnished and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information
contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange
Commission made by Nektar, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
NEKTAR THERAPEUTICS |
|
|
|
Date: November 7, 2023 |
By: |
/s/ Mark A. Wilson |
|
|
Mark A. Wilson |
|
|
Chief Legal Officer and Secretary |
2
Exhibit
99.1
Nektar
Therapeutics Reports Third Quarter 2023 Financial Results
SAN
FRANCISCO, November 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. |
| o | 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. |
| o | 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. |
| o | 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)
(Unaudited)
| |
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 | |
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