Nektar Therapeutics Reports Third Quarter 2024 Financial Results
NKTR 11.07.2024
Drug:NKTR-358 rezpegaldesleukin
Drug:NKTR-255 NKTR-255
Diseases:atopic dermatitis
Diseases:alopecia areata
Diseases:B-cell acute lymphoblastic leukemia
Date of Upcoming Event:2024-11-18
Name of Upcoming Event:2024 ACR Convergence Meeting
Cash and investments in marketable securities on
"We made excellent progress this quarter advancing our I&I pipeline, including the ongoing Phase 2b studies of rezpegaldesleukin in atopic dermatitis and alopecia areata," said
"Beyond rezpegaldesleukin, we are focused on advancing our earlier stage TNFR2 antibody and bispecific programs, NKTR-0165 and NKTR-0166, with at least one of these slated to enter the clinic next year," continued Robin. "Next week, we are looking forward to presenting highly promising data at the 2024 ACR Convergence Meeting for our preclinical PEG-CSF program, NKTR-422. Finally, we recently published important data for our IL-15 agonist, NKTR-255, highlighting its potential as a validated mechanism in oncology."
Summary of Financial Results
Revenue in the third quarter of 2024 was
Total operating costs and expenses in the third quarter of 2024 were
R&D expense in the third quarter of 2024 was
G&A expense was
Non-cash restructuring and impairment charges were less than
Net loss for the third quarter of 2024 was
Third Quarter 2024 and Recent Business Highlights
- In
September 2024 , Nektar presented several posters for rezpegaldesleukin (REZPEG) at the 2024 European Academy of Dermatology and Venereology (EADV) Congress. In addition to two trial-in-progress posters, new proteomic analyses were also presented, which showed that rezpegaldesleukin increased the protein levels of immune-regulating pathways and reduced specific serum proteins known to be elevated in patients with atopic dermatitis. - In
October 2024 , Nektar and collaborators announced the publication of 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) inBlood, an open-access journal of theAmerican Society of Hematology . The data show that eight out of nine patients (89%) achieved complete remission, all without detectable measurable residual disease (MRD). - In
October 2024 ,Nature Communications published results from Phase 1b studies of rezpegaldesleukin in two inflammatory skin diseases, demonstrating durable dose-dependent improvements in physician-assessed disease activity and patient-reported outcomes for both studies. Rezpegaldesleukin was evaluated in patients with moderate-to-severe atopic dermatitis (AD) (NCT04081350) or chronic plaque psoriasis (PsO) (NCT04119557). AD patients receiving high dose rezpegaldesleukin demonstrate an 83% improvement in EASI score after 12 weeks of treatment. EASI improvement of ≥ 75% (EASI -75) and vIGA-AD responses were maintained for 36 weeks after treatment discontinuation in 71% and 80% of week 12 responders, respectively. Results validate the role of IL-2-induced Treg proliferation and activation in the AD treatment paradigm, and support the advancement of rezpegaldesleukin in the Phase 2b study in AD. - In November, Nektar announced a definitive agreement with
Ampersand Capital Partners to sell its commercial PEGylation manufacturing business inHuntsville, Alabama for$90 million in enterprise value, which is comprised of$70 million in cash and$20 million in equity ownership in the new portfolio company. TheHuntsville -based facility will be spun out as a standalone Ampersand portfolio company and Ampersand has committed to invest additional growth equity capital into the new company. All of Nektar's employees at theHuntsville facility will be offered employment at the new portfolio company, ensuring continuity in the high-quality manufacturing and PEGylation expertise that longstanding customers trust and rely on. Nektar and the new Ampersand portfolio company will also enter into manufacturing supply agreements to meet Nektar's PEG reagent needs for rezpegaldesleukin and certain pipeline programs. The transaction will be subject to customary closing conditions and costs and is expected to close byDecember 2, 2024 . Following the closing, Nektar will retain all rights to current and future royalty streams and milestones related to existing PEGylated product license agreements. Nektar will also be entitled to appoint a representative to the board of the new Ampersand portfolio company. - Enrollment remains on track for the two Phase 2b studies of REZPEG, 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 in the first half and in the second half of 2025, respectively.
Nektar also announced presentations at the following medical meetings:
2024
Late-breaking Abstract (LBA) 1489:"REStoring lymphoCytes Using NKTR-255 after chemoradiothErapy in solid tumors (RESCUE): Preplanned Interim Safety and Efficacy Analysis", Lin, S.Presentation Type: PosterePoster will be on display on the SITC 2024 virtual meeting platform on
2024
Abstract 1866120:"A Novel Therapeutically Active CSF-1R Agonist Promotes Tissue Macrophages Inflammation Resolution and Induces Tissue Repair Pathways", Kivimae, S.Presentation Type: OralSession: Abstracts: Cytokines & Cell TraffickingPresentation Time:
2024
Abstract 203576:"NKTR-255 Vs Placebo to Enhance Complete Responses and Durability Following CD19-Directed CAR-T Therapy in Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL)", Ahmed, S.Presentation Type: PosterSession: Cellular Immunotherapies: Early Phase Clinical Trials and ToxicitiesPresentation Time:
Conference Call to Discuss Third Quarter 2024 Financial Results
Nektar management will host a conference call to review the results beginning at
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
To access the conference call, please pre-register atNektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.
About
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, NKTR-0166, NKTR-422, and NKTR-255, and whether all the closing conditions of the announced definitive agreement will be met. 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, NKTR-0166, NKTR-422 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, NKTR-0166, NKTR-422 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, NKTR-0165, NKTR-0166, NKTR-422 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 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) 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 (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 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.
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CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
(In thousands) | ||||||||||
(Unaudited) | ||||||||||
ASSETS | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 30,109 | $ 35,277 | ||||||||
Short-term investments | 214,386 | 268,339 | ||||||||
Accounts receivable | - | 1,205 | ||||||||
Inventory, net | - | 16,101 | ||||||||
Other current assets | 8,933 | 9,779 | ||||||||
Assets held for sales | 33,053 | - | ||||||||
Total current assets | 286,481 | 330,701 | ||||||||
Long-term investments | 4,537 | 25,825 | ||||||||
Property, plant and equipment, net | 3,603 | 18,856 | ||||||||
Operating lease right-of-use assets | 8,826 | 18,007 | ||||||||
Other assets | 4,519 | 4,644 | ||||||||
Total assets | $ 307,966 | $ 398,033 | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | 8,577 | 9,848 | ||||||||
Accrued expenses | 32,377 | 22,162 | ||||||||
Operating lease liabilities, current portion | 21,504 | 19,259 | ||||||||
Liabilities related to assets held for sale | 5,125 | - | ||||||||
Total current liabilities | 67,583 | 51,269 | ||||||||
Operating lease liabilities, less current portion | 86,758 | 98,517 | ||||||||
Liabilities related to the sales of future royalties, net | 97,829 | 112,625 | ||||||||
Other long-term liabilities | 6,912 | 4,635 | ||||||||
Total liabilities | 259,082 | 267,046 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders' equity: | ||||||||||
Preferred stock | - | - | ||||||||
Common stock | 19 | 19 | ||||||||
Capital in excess of par value | 3,654,981 | 3,608,137 | ||||||||
(3,000) | - | |||||||||
Accumulated other comprehensive income (loss) | 355 | 80 | ||||||||
Accumulated deficit | (3,603,471) | (3,477,249) | ||||||||
Total stockholders' equity | 48,884 | 130,987 | ||||||||
Total liabilities and stockholders' equity | $ 307,966 | $ 398,033 | ||||||||
(1) The consolidated balance sheet at | ||||||||||
of the information and notes required by generally accepted accounting principles in | ||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||
(In thousands, except per share information) | ||||||||||||||
(Unaudited) | ||||||||||||||
Three months ended | Nine months ended | |||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||
Revenue: | ||||||||||||||
Product sales | $ 8,015 | $ 5,822 | $ 20,689 | $ 15,198 | ||||||||||
Non-cash royalty revenue related to the sales of future royalties | 15,731 | 18,167 | 48,029 | 50,860 | ||||||||||
License, collaboration and other revenue | 378 | 155 | 534 | 179 | ||||||||||
Total revenue | 24,124 | 24,144 | 69,252 | 66,237 | ||||||||||
Operating costs and expenses: | ||||||||||||||
Cost of goods sold | 4,435 | 12,431 | 22,709 | 26,485 | ||||||||||
Research and development | 35,031 | 24,070 | 92,163 | 84,220 | ||||||||||
General and administrative | 18,957 | 21,147 | 59,616 | 60,097 | ||||||||||
Restructuring, impairment and costs of terminated program | 46 | 11,360 | 14,310 | 49,107 | ||||||||||
Impairment of goodwill | - | - | - | 76,501 | ||||||||||
Total operating costs and expenses | 58,469 | 69,008 | 188,798 | 296,410 | ||||||||||
Loss from operations | (34,345) | (44,864) | (119,546) | (230,173) | ||||||||||
Non-operating income (expense): | ||||||||||||||
Non-cash interest expense on liabilities related to the sales of future royalties | (6,020) | (5,910) | (17,959) | (18,467) | ||||||||||
Interest income | 3,437 | 5,211 | 11,558 | 14,392 | ||||||||||
Other income (expense), net | (120) | (335) | (255) | 100 | ||||||||||
Total non-operating income (expense), net | (2,703) | (1,034) | (6,656) | (3,975) | ||||||||||
Loss before provision for income taxes | (37,048) | (45,898) | (126,202) | (234,148) | ||||||||||
Provision (benefit) for income taxes | 9 | (61) | 20 | (171) | ||||||||||
Net loss | $ (37,057) | $ (45,837) | $ (126,222) | $ (233,977) | ||||||||||
Basic and diluted net loss per share | $ (0.18) | $ (0.24) | $ (0.62) | $ (1.23) | ||||||||||
Weighted average shares outstanding used in computing basic and diluted net loss pershare | 209,249 | 190,406 | 204,292 | 189,651 | ||||||||||
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