On February 28, 2022 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Nektar Therapeutics, FEB 28, 2022, View Source [SID1234609137]).

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Cash and investments in marketable securities at December 31, 2021 were approximately $0.8 billion as compared to $1.2 billion at December 31, 2020.

"We are pleased with the significant progress that Nektar has made advancing our clinical pipeline in 2021 in the areas of solid tumors, liquid tumors and auto-immune disorders," said Howard W. Robin, President and CEO of Nektar. "In the first half of 2022, we expect topline results from three of our six registrational trials evaluating bempegaldesleukin in combination with a checkpoint inhibitor in melanoma, renal cell carcinoma and bladder cancer. We look forward to collaborating with our partner Bristol Myers to support timely potential regulatory filings for the first three studies and to complete preparations to support a potential commercial launch."

Mr. Robin continued, "Our second oncology cytokine program, NKTR-255, a full IL-15 agonist, is being combined with multiple mechanisms in both solid tumors and hematological malignancies and we are excited that Merck KGaA and Pfizer will evaluate the combination of NKTR-255 with avelumab in the JAVELIN Bladder Medley, which is expected to start in the first half of 2022. Eli Lilly and Nektar also made significant progress in 2021 and we now have NKTR-358 in a broad set of clinical trials, including Phase 2 studies in lupus and ulcerative colitis with another planned in atopic dermatitis and a fourth planned in another auto-immune indication. In December of 2021, Lilly presented the first proof-of-concept data for NKTR-358 in atopic dermatitis which showed sustained disease control for at least 6 months after last treatment dose and highlighted the potential for this T regulatory cell stimulating agent to differentiate from standard of care."

Summary of Financial Results

Revenue in the fourth quarter of 2021 was $25.0 million as compared to $23.5 million in the fourth quarter of 2020. Revenue for the year ended December 31, 2021 was $101.9 million as compared to $152.9 million in 2020 and was lower due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb for the initiation of registrational trials of bempegaldesleukin plus Opdivo in adjuvant melanoma and muscle invasive bladder cancer in 2020.

Total operating costs and expenses in the fourth quarter of 2021 were $137.9 million as compared to $134.2 million in the fourth quarter of 2020. The increase was due to an increase in G&A expense. Total operating costs and expenses for the full year 2021 were $548.0 million as compared to $578.0 million in 2020. Operating costs and expenses for the full year 2021 decreased as compared to 2020 primarily due to the recording of $45.2 million impairment charge in 2020 resulting from the discontinuation of the NKTR-181 program.

R&D expense in the fourth quarter of 2021 was $99.6 million as compared to $102.7 million for the fourth quarter of 2020. R&D expense for the year ended December 31, 2021 was $400.3 million as compared to $408.7 million in 2020.

G&A expense was $32.1 million in the fourth quarter of 2021 and $27.1 million in the fourth quarter of 2020. G&A expense for the full year 2021 was $122.8 million compared to $104.7 million in 2020. G&A expense increased primarily due to an increase in pre-commercial costs for bempegaldesleukin.

Net loss for the fourth quarter of 2021 was $145.6 million or $0.79 basic and diluted loss per share as compared to a net loss of $117.2 million or $0.65 basic and diluted loss per share in the fourth quarter of 2020. Net loss for the year ended December 31, 2021 was $523.8 million or $2.86 basic and diluted loss per share as compared to a net loss of $444.4 million or $2.49 basic and diluted loss per share in 2020.

2021 Business Highlights:

In December 2021, Nektar announced Phase 1b proof-of-concept data for NKTR-358, a novel T regulatory cell stimulator, in patients with moderate-to-severe atopic dermatitis. The data demonstrate the potential for NKTR-358 to differentiate from standard of care and supports Eli Lilly’s planned Phase 2 study in this indication.
In December 2021, Nektar presented data from the dose-escalation portion of its ongoing Phase 1 study of NKTR-255 in patients with relapsed/refractory hematologic malignancies at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data supports the development of NKTR-255 in combination with anticancer agents that induce antibody dependent cellular toxicity as well as CAR-T therapies.
In November 2021, Nektar presented clinical data from the ongoing PROPEL study evaluating bempegaldesleukin plus KEYTRUDA (pembrolizumab) in patients with non-small cell lung cancer at the 2021 European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress.
In November 2021, Nektar presented initial clinical results from the Phase 1/2 study of NKTR-255 in combination with cetuximab in solid tumors in a late-breaking abstract at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The data showed early evidence of clinical benefit in the first patients treated in the dose-escalation portion of the study.
In October 2021, Bristol-Myers Squibb and Nektar completed enrollment in the Phase 3 first-line metastatic melanoma study evaluating bempegaldesleukin combined with Opdivo versus Opdivo in 760 patients with previously untreated, unresectable or metastatic melanoma.
In September 2021, Nektar entered into a new oncology clinical collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the maintenance regimen of NKTR-255 in combination with avelumab, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma (UC) in the Phase II JAVELIN Bladder Medley study. The study is expected to begin enrolling patients in the second quarter of 2022.
In July 2021, data from the Phase 2 study of bempegaldesleukin combined with Opdivo was published in the Journal of Clinical Oncology, highlighting the encouraging safety and efficacy data in patients with first-line metastatic melanoma.
In May 2021, Nektar announced the publication of preclinical data in the Journal of Translational Autoimmunity describing NKTR-358 as a first-in-class, composition of stable PEG conjugates of native IL-2 designed to selectively stimulate T regulatory cell function.
In May 2021, Nektar announced its first publication of preclinical data highlighting anti-tumor properties of IL-15 agonist, NKTR-255, in the Journal for ImmunoTherapy of Cancer.
In February 2021, Nektar announced a clinical trial collaboration and supply agreement with Merck for a Phase 2/3 study of bempegaldesleukin in combination with KEYTRUDA (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1.
In February 2021, Nektar announced a financing and co-development collaboration with SFJ Pharmaceuticals for the development of bempegaldesleukin plus KEYTRUDA (pembrolizumab) in SCCHN. SFJ agreed to fund up to $150 million to support the planned Phase 2/3 study and to manage clinical trial operations for the study. In return, Nektar agreed to pay SFJ success-based annual milestone payments over a period of seven to eight years, which are contingent upon receipt of certain U.S. regulatory approvals for specified indications for bempegaldesleukin, and will begin following completion of the SCCHN study.
Conference Call to Discuss Fourth Quarter and Year-End 2021 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, Monday, February 28, 2022.

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: View Source The web broadcast of the conference call will be available for replay through March 28, 2022.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (International)
Conference ID: 8890486 (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 this press release, or explained on the conference call, related information will be made available on the Investors section of the Nektar website as soon as practical after the conclusion of the conference call.