8-K

NEKTAR THERAPEUTICS (NKTR)

8-K 2021-02-25 For: 2021-02-25
View Original
Added on April 04, 2026

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): February 25, 2021


NEKTAR

THERAPEUTICS

(ExactName of Registrant as Specified in Charter)

Delaware 0-24006 94-3134940
(State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.)

455Mission Bay Boulevard South

SanFrancisco, California 94158

(Addressof 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
--- ---
Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
--- ---
Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
--- ---

Securitiesregistered pursuant to Section 12(b) of the Act:


Title of each class Trading symbol(s) Name of each exchange on which registered
Common<br> Stock, $0.0001 par value NKTR NASDAQ<br> 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 2.02Results of Operations and Financial Condition.

On February 25, 2021, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”) announcing its financial results for the quarter and year ended December 31, 2020. A copy of the Press Release is furnished herewith as Exhibit 99.1.

On February 18, 2021, Nektar announced that it would hold a Webcast conference call on February 25, 2021 to review its financial results for the quarter and year ended December 31, 2020. This conference call is accessible through a link that is posted on the home page and Investors section of the Nektar website: http://ir.nektar.com.

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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. 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 Therapeutics, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01Financial Statements and Exhibits.

Exhibit No. Description
99.1 Press release titled “Nektar Therapeutics Reports Fourth Quarter and Year-End 2020 Financial Results” issued by Nektar Therapeutics on February 25, 2021.
1

SIGNATURES

Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

By: /s/<br> Mark A. Wilson
Mark<br> A. Wilson
General Counsel and Secretary
Date: February 25, 2021

2

Exhibit99.1

NektarTherapeutics Reports Fourth Quarter and Year-End 2020 Financial Results

SAN FRANCISCO, Feb. 25, 2021/PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the fourth quarter and full year ended December 31, 2020.

Cash and investments in marketable securities at December 31, 2020 were approximately $1.2 billion as compared to $1.6 billion at December 31, 2019.

“This past year, Nektar made significant progress advancing our clinical pipeline of novel cytokine therapeutics,” said Howard W. Robin, President and CEO of Nektar. “Our broad registrational program evaluating bempegaldesleukin (BEMPEG) plus nivolumab is progressing well with five registrational studies underway in melanoma, renal cell carcinoma and bladder cancer. We also recently added a sixth study to the registrational program to evaluate BEMPEG in combination with pembrolizumab in head and neck cancer and are pleased to be collaborating with Merck on the study. For our PROPEL study, we look forward to reporting the first data for BEMPEG plus pembrolizumab in patients with metastatic non-small cell lung cancer in the second half of 2021.”

“For our second cytokine program, NKTR-255, we were very encouraged by the early signs of clinical activity that we recently reported at the SITC 2020 meeting, and are now advancing two Phase 1 clinical studies in combination with ADCC antibodies, one in hematological malignancies and one in solid tumors,” continued Mr. Robin. “Finally, our partner Eli Lilly is conducting a broad Phase 2 program for NKTR-358, our T regulatory cell IL-2 agent, with Phase 2 studies in both lupus and ulcerative colitis and plans to initiate additional Phase 2 studies in immune-mediated diseases over the next 12-18 months.”

Summaryof Financial Results

Revenue in the fourth quarter of 2020 was $23.5 million as compared to $33.9 million in the fourth quarter of 2019. Revenue for the year ended December 31, 2020 was $152.9 million as compared to $114.6 million in 2019 and was higher primarily 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^®^ (nivolumab) in adjuvant melanoma and muscle-invasive bladder cancer.

Total operating costs and expenses in the fourth quarter of 2020 were $134.2 million as compared to $143.5 million in the fourth quarter of 2019. Total operating costs and expenses for 2020 were $578.0 million as compared to $554.7 million in 2019. Total operating costs and expenses for full year 2020 increased as compared to 2019 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 fourth quarter of 2020 was $102.7 million as compared to $110.4 million for the fourth quarter of 2019. R&D expense for the year ended December 31, 2020 was $408.7 million as compared to $434.6 million in 2019. Excluding pre-commercial manufacturing costs for NKTR-181 incurred during 2019, research and development expense increased for the full year 2020 primarily due to the clinical development of bempegaldesleukin in five registrational trials.

G&A expense was $27.1 million in the fourth quarter of 2020 and $27.1 million in the fourth quarter of 2019. G&A expense for 2020 was $104.7 million as compared to $98.7 million in 2019.

Net loss for the fourth quarter of 2020 was $117.2 million or $0.65 basic and diluted loss per share as compared to a net loss of $112.2 million or $0.64 basic and diluted loss per share in the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $444.4 million or $2.49 basic and diluted loss per share as compared to net loss of $440.7 million or $2.52 basic and diluted loss per share in 2019.

2020and Year-to-Date 2021 Business Highlights:

In<br> February 2021, Nektar announced a clinical trial collaboration and supply agreement with<br> Merck for a Phase 2/3 study of bempegaldesleukin, Nektar’s investigational IL-2<br> pathway agent, in combination with Merck’s KEYTRUDA^®^ (pembrolizumab)<br> for first-line treatment of patients with metastatic or unresectable recurrent squamous<br> cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1. The study is<br> planned to start in the second half of 2021.
In<br> February 2021, Nektar announced a financing and co-development collaboration with SFJ<br> Pharmaceuticals^®^ for the development of bempegaldesleukin plus pembrolizumab<br> in SCCHN. SFJ has agreed to fund up to $150 million to support the planned<br> Phase 2/3 study and manage clinical trial operations for the study. In return, Nektar<br> agrees to pay SFJ success-based annual milestone payments over a period of seven to eight<br> years which are contingent upon receipt of certain U.S. regulatory approvals for specified<br> indications for bempegaldesleukin, and will begin following completion of the SCCHN study,<br> which is projected to be completed in 2024.
--- ---
In<br> December 2020, Nektar sold its royalties on future sales of<br> ADYNOVATE^®^ and MOVANTIK^®^ to Healthcare Royalty Management,<br> LLC in exchange for $150 million.
--- ---
In<br> December 2020, Nektar announced dosing of the first patient in its Phase 1/2 study of<br> its IL-15 agonist, NKTR-255, in combination with cetuximab in patients with relapsed<br> or refractory head and neck squamous cell carcinoma or colorectal cancer. The study may<br> enroll up to 80 patients at approximately 15 investigator sites in the United States<br> and European Union.
--- ---
In<br> December 2020, Nektar presented preclinical data for NKTR-255 at the American Society<br> of Hematology (ASH) 2020 Annual Meeting, underscoring the potential for NKTR-255 as an<br> innovative immunotherapeutic agent in the treatment of multiple myeloma.
--- ---
In<br> November 2020, Nektar presented new data from its immuno-oncology pipeline at the virtual<br> 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Updated clinical data<br> from the PIVOT-02 study metastatic melanoma cohort showed that bempegaldesleukin with<br> nivolumab resulted in a durable clinical benefit with median progression-free survival<br> of 30.9 months. NKTR-255 showed biological activity in the first patients treated in<br> the monotherapy dose-escalation phase of the ongoing Phase 1 study in multiple myeloma<br> and non-Hodgkin’s lymphoma. In addition, new data showed that the combination of<br> TLR agonist candidate, NKTR-262, plus bempegaldesleukin alters the tumor micro-environment<br> through activation of both the innate and adaptive arms of the immune system.
--- ---
2
In November<br> 2020, Nektar presented new data from its NKTR-358 program at the American College<br> of Rheumatology (ACR) virtual meeting. Data from the Phase 1b study in patients<br> with mild to moderate systemic lupus erythematosus (SLE) showed that NKTR-358 produced<br> a dose-dependent increase in expression of regulatory T cell (Treg) activation markers,<br> providing a rationale for continued development in SLE and other inflammatory indications.
In October<br> 2020, Nektar initiated a Phase 1b clinical study of bempegaldesleukin in adult patients<br> with mild COVID-19 infection. The randomized, double-blind, placebo-controlled trial<br> is designed to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic<br> profile of bempegaldesleukin in adult patients with mild COVD-19.
--- ---
In August<br> 2020, Vaccibody AS and Nektar announced that the first patient had been dosed in the<br> Phase 1/2a study evaluating bempegaldesleukin with VB10.NEO, Vaccibody’s personalized<br> neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head<br> and neck.
--- ---
In June<br> 2020, Nektar announced the presentation of results from the Phase 1b study evaluating<br> multiple ascending doses of NKTR-358 at the Annual European Congress of Rheumatology (EULAR 2020)<br> virtual meeting. The data showed that treatment with NKTR-358 was safe and well tolerated<br> in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent<br> expansion of regulatory T cells (Tregs) that was maintained over multiple administrations.
--- ---
In May<br> 2020, Nektar announced the publication of clinical data from its PIVOT-02 study evaluating<br> bempegaldesleukin in combination with nivolumab in immunotherapy-naïve patients<br> with advanced solid tumors, including melanoma, renal cell carcinoma (RCC) and non-small<br> cell lung cancer. The data, published in *Cancer Discovery,*a journal<br> of the American Association for Cancer Research, showed that bempegaldesleukin plus<br> nivolumab resulted in encouraging overall response rates across multiple tumor types,<br> independent of baseline PD-L1 expression, with responses continuing to deepen over time.
--- ---
In<br>April 2020, Nektar repaid the principal and accrued interest of its senior notes totaling $254.8 million.
--- ---
In February<br> 2020, Nektar announced the publication of preclinical bempegaldesleukin data in two manuscripts<br> in Nature Communications showing how bempegaldesleukin works synergistically<br> with multiple immune-based therapies to enhance T-cell-mediated tumor control.
--- ---
In January<br> 2020, Nektar and Bristol-Myers Squibb announced a new joint development plan that expanded<br> the ongoing registrational program for bempegaldesleukin plus Opdivo^®^  from three ongoing registrational trials in first-line metastatic melanoma, first-line<br> cisplatin-ineligible metastatic urothelial cancer and first-line metastatic RCC to include<br> two additional registrational trials in adjuvant melanoma and muscle-invasive bladder<br> cancer. In addition, the expanded development plan includes a Phase 1/2 study to evaluate bempegaldesleukin<br> plus nivolumab in combination with a tyrosine-kinase inhibitor in first-line RCC in order<br> to support a future registrational trial.
--- ---
In January<br> 2020, Nektar made the strategic business decision to withdraw its New Drug Application<br> (NDA) for NKTR-181, an investigational medicine in development for chronic pain and make<br> no further investment into the program.
--- ---
3

ConferenceCall to Discuss Fourth Quarter and Year-End 2020 Financial ResultsNektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, February 25, 2021.

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 March 25, 2021.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)

Conference ID: 3857247 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

AboutNektar

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.

CautionaryNote Regarding Forward-Looking StatementsThis press release contains forward-looking statements which can be identified by words such as: “may,”“design,” “potential,” “advance,” “plan” and similar references to future periods.Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and futuredevelopment plans for, bempegaldesleukin, NKTR-358 and NKTR-255, and the timing of the initiation of clinical studies and theavailability of clinical data for our drug candidates. Forward-looking statements are neither historical facts nor assurancesof future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the futureof our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Becauseforward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstancesthat are difficult to predict and many of which are outside of our control. Our actual results may differ materially from thoseindicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Importantfactors 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, NKTR-358 and NKTR-255 are basedon preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) bempegaldesleukin,NKTR-358 and NKTR-255 are investigational agents and continued research and development for these drug candidates is subject tosubstantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findingsin earlier preclinical and clinical studies); (iii) bempegaldesleukin, NKTR-358 and NKTR-255 are in various stages of clinicaldevelopment and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timingof the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challengescaused by the COVID-19 pandemic, regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changingstandards of care, evolving regulatory requirements, clinical trial design, clinical outcomes and competitive factors; (v) patentsmay not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additionalintellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties setforth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2020. Any forward-lookingstatement made by us in this press release is based only on information currently available to us and speaks only as of the dateon which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may bemade 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:

Dan Budwick of 1AB

973-271-6085

dan@1abmedia.com

4

NEKTAR THERAPEUTICS

CONDENSEDCONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

December 31,<br><br> <br>2020 December 31,<br><br> <br>2019^(1)^
ASSETS
Current<br> assets:
Cash<br> and cash equivalents $ 198,955 $ 96,363
Short-term<br> investments 862,941 1,228,499
Accounts<br> receivable 38,889 36,802
Inventory 15,292 12,665
Advance<br> payments to contract manufacturers 3,908 31,834
Other<br> current assets 18,020 15,387
Total<br> current assets 1,138,005 1,421,550
Long-term<br> investments 136,662 279,119
Property,<br> plant and equipment, net 59,662 65,665
Operating<br> lease right-of-use assets 126,476 134,177
Goodwill 76,501 76,501
Other<br> assets 1,461 344
Total<br> assets $ 1,538,767 $ 1,977,356
LIABILITIES<br> AND STOCKHOLDERS’ EQUITY
Current<br> liabilities:
Senior<br> secured notes, net and interest payable $ - $ 252,891
Accounts<br> payable 22,139 19,234
Accrued<br> compensation 14,532 11,467
Accrued<br> clinical trial expenses 44,207 32,626
Accrued<br> contract manufacturing expenses 11,310 7,304
Other<br> accrued expenses 9,585 12,338
Operating lease<br> liability, current portion 13,915 12,516
Deferred<br> revenue, current portion 91 5,517
Total<br> current liabilities 115,779 353,893
Operating lease<br>liability, less current portion 136,373 142,730
Liabilities<br> related to the sale of future royalties, net 200,340 72,020
Deferred<br> revenue, less current portion 2,464 2,554
Other<br> long-term liabilities 6,516 768
Total<br> liabilities 461,472 571,965
Commitments<br> and contingencies
Stockholders’<br> equity:
Preferred<br> stock - -
Common<br> stock 18 17
Capital<br> in excess of par value 3,388,730 3,271,097
Accumulated<br> other comprehensive loss (2,295 ) (1,005 )
Accumulated<br> deficit (2,309,158 ) (1,864,718 )
Total<br> stockholders’ equity 1,077,295 1,405,391
Total<br> liabilities and stockholders’ equity $ 1,538,767 $ 1,977,356
(1) The<br> consolidated balance sheet at December 31, 2019 has been derived from the audited financial<br> statements at that date but does not include all of the information and notes required<br> by generally accepted accounting principles in the United States for complete financial<br> statements.
--- ---
5

NEKTARTHERAPEUTICS

CONDENSEDCONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share information)

(Unaudited)

Three Months Ended<br><br> <br>December 31, Year Ended<br><br> <br>December 31,
2020 2019 2020 2019
Revenue:
Product<br> sales $ 2,884 $ 5,815 $ 17,504 $ 20,117
Royalty<br> revenue (412 ) 12,214 30,999 41,222
Non-cash<br> royalty revenue related to sale of future royalties 20,562 8,718 48,563 36,303
License,<br> collaboration and other revenue 428 7,115 55,849 16,975
Total<br> revenue 23,462 33,862 152,915 114,617
Operating<br> costs and expenses:
Cost<br> of goods sold 4,323 5,989 19,477 21,374
Research<br> and development 102,724 110,369 408,678 434,566
General<br> and administrative 27,136 27,142 104,682 98,712
Impairment<br> of assets and other costs for terminated program - - 45,189 -
Total<br> operating costs and expenses 134,183 143,500 578,026 554,652
Loss from operations (110,721 ) (109,638 ) (425,111 ) (440,035 )
Non-operating<br> income (expense):
Interest<br> expense - (5,428 ) (6,851 ) (21,310 )
Non-cash<br> interest expense on liability related to sale of future royalties (8,183 ) (7,191 ) (30,267 ) (25,044 )
Interest<br> income and other income (expense), net 1,829 10,371 18,282 46,335
Total<br> non-operating expense, net (6,354 ) (2,248 ) (18,836 ) (19 )
Loss before provision for income taxes (117,075 ) (111,886 ) (443,947 ) (440,054 )
Provision<br> for income taxes 128 278 493 613
Net loss $ (117,203 ) $ (112,164 ) $ (444,440 ) $ (440,667 )
Net loss per share:
Basic $ (0.65 ) $ (0.64 ) $ (2.49 ) $ (2.52 )
Diluted $ (0.65 ) $ (0.64 ) $ (2.49 ) $ (2.52 )
Weighted<br> average shares outstanding used in computing net loss per share:
Basic 179,684 176,130 178,581 174,993
Diluted 179,684 176,130 178,581 174,993
6

NEKTARTHERAPEUTICS

CONDENSEDCONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

2019
Cash<br> flows from operating activities:
Net loss (444,440 ) $ (440,667 )
Adjustments<br> to reconcile net loss to net cash used in operating activities:
Non-cash<br> royalty revenue related to sale of future royalties (48,563 ) (36,303 )
Non-cash<br> interest expense on liability related to sale of future royalties 30,267 25,044
Stock-based<br> compensation 94,261 99,795
Depreciation<br> and amortization 14,182 13,156
Impairment<br> of advance payments to contract manufacturers and equipment for terminated program 20,351 -
Accretion<br> of premiums (discounts), net and other non-cash transactions 3,943 (11,394 )
Changes<br> in operating assets and liabilities:
Accounts<br> receivable 1,913 6,411
Inventory (2,627 ) (1,284 )
Operating<br>leases, net 2,743 13,090
Other<br> assets 4,476 1,190
Accounts<br> payable 2,382 12,967
Accrued<br> compensation 4,697 1,530
Other<br> accrued expenses 8,644 4,349
Deferred<br> revenue (5,516 ) (16,565 )
Net<br> cash used in operating activities (313,287 ) (328,681 )
Cash<br> flows from investing activities:
Purchases<br> of investments (987,533 ) (1,380,865 )
Maturities<br> of investments 1,449,304 1,614,036
Sales<br> of investments 41,700 -
Purchases<br> of property, plant and equipment (7,258 ) (26,285 )
Net<br> cash provided by investing activities 496,213 206,886
Cash<br> flows from financing activities:
Proceeds<br> from sale of future royalties, net of 3.8 million of transaction costs 146,250 -
Repayment<br> of senior notes (250,000 ) -
Proceeds<br> from shares issued under equity compensation plans 23,396 23,355
Net<br> cash provided by financing activities (80,354 ) 23,355
Effect<br> of exchange rates on cash and cash equivalents 20 (102 )
Net<br> increase (decrease) in cash and cash equivalents 102,592 (98,542 )
Cash<br> and cash equivalents at beginning of year 96,363 194,905
Cash<br> and cash equivalents at end of year 198,955 $ 96,363
Supplemental<br> disclosure of cash flow information:
Cash<br> paid for interest 9,742 $ 19,199
Cash<br> paid for income taxes 539 $ 555
Right-of-use<br> assets recognized in exchange for operating lease liabilities 2,133 $ 57,691

All values are in US Dollars.

7