Cash and investments in marketable securities at
"We continue to make excellent progress advancing rezpegaldesleukin in Phase 2 studies in patients with atopic dermatitis and alopecia areata," said
Summary of Financial Results
Revenue in the second quarter of 2024 was
Total operating costs and expenses in the second quarter of 2024 were
R&D expense was
G&A expense was
Non-cash restructuring and impairment charges in the second quarter of 2024 were
Net loss for the second quarter of 2024 was
Second Quarter 2024 and Recent Business Highlights
- In
July 2024 , our collaborators atStanford published 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) in Blood, an open-access journal of theAmerican Society of Hematology . These data showed that, at 12 months, remission-free survival for NKTR-255 was double that of historical controls (67% vs 38%). The data also showed that eight out of nine patients (89%) achieved complete remission with or without hematologic recovery, all without detectable measurable residual disease (MRD). - In
June 2024 , Nektar presented the first preclinical data on NKTR-0165 at theEuropean Alliance of Associations for Rheumatology (EULAR) 2024Congress . The data presented show that NKTR-0165 is a unique antibody that selectively binds to TNFR2 on Tregs to enhance its immunosuppressive activities, and could potentially become a first-in-class treatment for various autoimmune diseases, including ulcerative colitis and vitiligo. Nektar plans to initiate first-in-human studies in the first half of 2025.
- Enrollment remains on track for the two Phase 2b studies of rezpegaldesleukin, 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, respectively, in the first half and in the middle of 2025.
Nektar also announced upcoming presentations at the following scientific congress:
2024
- ePoster P0662: "Serum proteomic biomarker analysis of the interleukin-2 receptor pathway agonist rezpegaldesleukin in patients with atopic dermatitis", Yu, D.
- ePoster P0600 (Trial in Progress): "A Phase 2b, Randomized, Double-Blinded,
Parallel-Group , Placebo-Controlled, International, Multicenter, Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in Adults with Moderate-to-Severe Atopic Dermatitis", Gkalpakiotis, S.
- ePoster P2080 (Trial in Progress): "A Phase 2b Study Evaluating the Efficacy and Safety of Single Agent Rezpegaldesleukin, an Interleukin-2 Receptor (IL-2R) Pathway Agonist, in the Treatment of Severe to Very Severe Alopecia Areata", Reich, A.
Conference Call to Discuss Second 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 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 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 (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, NKTR-0165, 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, NKTR-0165, 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, 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 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 health epidemics, including 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 Quarterly Report on Form 10-Q filed with the
Contact:
For Investors:
628-895-0661
For Media:
(212) 600-1902
david.rosen@argotpartners.com
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
(In thousands) | |||||||||||
(Unaudited) | |||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ 27,940 | $ 35,277 | |||||||||
Short-term investments | 243,295 | 268,339 | |||||||||
Accounts receivable | 1,196 | 1,205 | |||||||||
Inventory, net | 14,465 | 16,101 | |||||||||
Other current assets | 8,292 | 9,779 | |||||||||
Total current assets | 295,188 | 330,701 | |||||||||
Long-term investments | 19,405 | 25,825 | |||||||||
Property, plant and equipment, net | 15,187 | 18,856 | |||||||||
Operating lease right-of-use assets | 9,240 | 18,007 | |||||||||
Other assets | 4,314 | 4,644 | |||||||||
Total assets | $ 343,334 | $ 398,033 | |||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | 6,475 | 9,848 | |||||||||
Accrued expenses | 29,514 | 22,162 | |||||||||
Operating lease liabilities, current portion | 21,337 | 19,259 | |||||||||
Total current liabilities | 57,326 | 51,269 | |||||||||
Operating lease liabilities, less current portion | 90,763 | 98,517 | |||||||||
Liabilities related to the sales of future royalties, net | 107,506 | 112,625 | |||||||||
Other long-term liabilities | 8,051 | 4,635 | |||||||||
Total liabilities | 263,646 | 267,046 | |||||||||
Commitments and contingencies | |||||||||||
Stockholders' equity: | |||||||||||
Preferred stock | - | - | |||||||||
Common stock | 19 | 19 | |||||||||
Capital in excess of par value | 3,649,577 | 3,608,137 | |||||||||
(3,000) | - | ||||||||||
Accumulated other comprehensive income (loss) | (494) | 80 | |||||||||
Accumulated deficit | (3,566,414) | (3,477,249) | |||||||||
Total stockholders' equity | 79,688 | 130,987 | |||||||||
Total liabilities and stockholders' equity | $ 343,334 | $ 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 | Six months ended | |||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||
Revenue: | ||||||||||||||
Product sales | $ 6,640 | $ 4,658 | $ 12,674 | $ 9,376 | ||||||||||
Non-cash royalty revenue related to the sales of future royalties | 16,790 | 15,832 | 32,298 | 32,693 | ||||||||||
License, collaboration and other revenue | 59 | 9 | 156 | 24 | ||||||||||
Total revenue | 23,489 | 20,499 | 45,128 | 42,093 | ||||||||||
Operating costs and expenses: | ||||||||||||||
Cost of goods sold | 9,740 | 6,994 | 18,274 | 14,054 | ||||||||||
Research and development | 29,724 | 29,681 | 57,132 | 60,150 | ||||||||||
General and administrative | 20,510 | 17,869 | 40,659 | 38,950 | ||||||||||
Restructuring, impairment and costs of terminated program | 13,289 | 16,554 | 14,264 | 37,747 | ||||||||||
Impairment of goodwill | - | - | - | 76,501 | ||||||||||
Total operating costs and expenses | 73,263 | 71,098 | 130,329 | 227,402 | ||||||||||
Loss from operations | (49,774) | (50,599) | (85,201) | (185,309) | ||||||||||
Non-operating income (expense): | ||||||||||||||
Non-cash interest expense on liabilities related to the sales of future royalties | (6,408) | (6,152) | (11,939) | (12,557) | ||||||||||
Interest income | 3,901 | 4,846 | 8,121 | 9,181 | ||||||||||
Other income (expense), net | (36) | 736 | (135) | 435 | ||||||||||
Total non-operating income (expense), net | (2,543) | (570) | (3,953) | (2,941) | ||||||||||
Loss before provision for income taxes | (52,317) | (51,169) | (89,154) | (188,250) | ||||||||||
Provision (benefit) for income taxes | 46 | (47) | 11 | (110) | ||||||||||
Net loss | $ (52,363) | $ (51,122) | $ (89,165) | $ (188,140) | ||||||||||
Basic and diluted net loss per share | $ (0.25) | $ (0.27) | $ (0.44) | $ (0.99) | ||||||||||
Weighted average shares outstanding used in computing basic and diluted net loss per share | 208,828 | 189,656 | 201,787 | 189,268 | ||||||||||
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