Nektar Therapeutics Reports First Quarter 2025 Financial Results
- FDA granted Fast Track designation for rezpegaldesleukin in atopic dermatitis
- Cash runway extended into Q4 2026
- Completed enrollment in two Phase 2b trials for rezpegaldesleukin
- Operating costs decreased to $55.0M from $57.1M year-over-year
- Revenue declined 51.4% to $10.5M from $21.6M year-over-year
- Net loss increased to $50.9M from $36.8M year-over-year
- R&D expenses increased to $30.5M from $27.4M
- G&A expenses rose to $24.3M from $20.1M
- $4.5M non-cash loss from equity investment in Gannet BioChem
Insights
Nektar reports widening Q1 losses and accelerated cash burn while approaching critical mid-year clinical readouts for its lead autoimmune candidate.
Nektar's Q1 2025 results reveal concerning financial trends with revenue dropping to
Cash position declined to
On the operational front, R&D expenses increased to
The company's near-term prospects hinge on upcoming data readouts from two Phase 2 trials: rezpegaldesleukin in atopic dermatitis (June 2025) and alopecia areata (December 2025). The FDA's Fast Track designation for rezpegaldesleukin in atopic dermatitis represents regulatory validation, potentially expediting future review processes if the data proves positive.
For their secondary pipeline asset NKTR-0165, targeting the TNFR2 receptor for multiple sclerosis, ulcerative colitis, and vitiligo, management expects to file an IND application by year-end. The enrollment completion in both rezpegaldesleukin Phase 2 trials indicates adherence to development timelines, an operational positive amid financial challenges.
Overall, Nektar faces a critical inflection point with approaching clinical readouts that will determine whether their strategic pivot toward autoimmune disorders can reverse their financial trajectory. Without near-term partnership opportunities mentioned, the company appears dependent on clinical success to attract future funding or partners.
Cash and investments in marketable securities on March 31, 2025 were
"We are on track to report topline data in June from the Phase 2 study of rezpegaldesleukin in atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "These data will be followed by the topline data from the Phase 2 study of rezpegaldesleukin in patients with alopecia areata in December of this year. The results of both randomized studies will demonstrate the potential of rezpegaldesleukin to provide a new treatment paradigm for patients with these serious dermatological diseases. As a first-in-class T regulatory cell biologic, rezpegaldesleukin is poised to emerge as an important novel mechanism to treat millions of patients with chronic autoimmune disorders."
"We are also on track to complete our IND-enabling work for NKTR-0165, our unique antibody targeting the TNFR2 receptor, that has the potential to be developed as a treatment for multiple sclerosis, ulcerative colitis and vitiligo," continued Robin. "We are targeting the submission of the IND for NKTR-0165 at the end of this year. Additionally, we are making significant progress on our new bispecific antibody, NKTR-0166. This antibody incorporates a TNFR2 epitope with a validated antibody target and is advancing into preclinical studies."
Summary of Financial Results
Revenue in the first quarter of 2025 was
Total operating costs and expenses in the first quarter of 2025 were
R&D expense in the first quarter of 2025 was
G&A expense was
In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem's equity each quarter. This resulted in a
Net loss for the first quarter of 2025 was
Recent Business Highlights
- In April 2025, the European Hematological Association (EHA) selected the abstract submitted by Nektar collaborators at the Fred Hutchinson Cancer Center entitled "Enhanced CAR T-cell Expansion and Durable Complete Responses with NKTR-255 Plus Lisocabtagene Maraleucel in Relapsed/Refractory Large B-cell Lymphoma," for oral presentation at the 30th annual EHA Congress, being held in
Milan, Italy from June 12-15, 2025. - In February 2025, Nektar announced completion of target enrollment in the REZOLVE-AA 84-patient Phase 2b clinical trial of rezpegaldesleukin in severe-to-very severe alopecia areata.
- In February 2025, Nektar announced a new clinical trial agreement with TrialNet, an international clinical trial network at the forefront of diabetes research, to evaluate rezpegaldesleukin in a Phase 2 study of approximately 70 patients with new onset type 1 diabetes mellitus.
- In February 2025, the FDA granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
- In January 2025, Nektar announced completion of target enrollment in the REZOLVE-AD 396-patient Phase 2b clinical trial of rezpegaldesleukin in moderate-to-severe atopic dermatitis.
Conference Call to Discuss First Quarter 2025 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 on May 8, 2025.
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 June 8, 2025.
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 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 (REZPEG, or 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. Nektar's pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. 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
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," "plan," "target," 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. 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) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in
For Investors:
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NEKTAR THERAPEUTICS | ||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
(In thousands) | ||||||||||
(Unaudited) | ||||||||||
ASSETS | March 31, 2025 | December 31, 2024 (1) | ||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 38,894 | $ 44,252 | ||||||||
Short-term investments | 179,738 | 210,974 | ||||||||
Other current assets | 11,281 | 6,066 | ||||||||
Total current assets | 229,913 | 261,292 | ||||||||
Long-term investments | 2,019 | 13,869 | ||||||||
Property and equipment, net | 3,162 | 3,411 | ||||||||
Operating lease right-of-use assets | 7,999 | 8,413 | ||||||||
Equity method investment in Gannet BioChem | 7,757 | 12,218 | ||||||||
Other assets | 5,391 | 4,647 | ||||||||
Total assets | $ 256,241 | $ 303,850 | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | 17,834 | 11,560 | ||||||||
Accrued expenses | 31,254 | 29,972 | ||||||||
Operating lease liabilities, current portion | 21,842 | 19,868 | ||||||||
Total current liabilities | 70,930 | 61,400 | ||||||||
Operating lease liabilities, less current portion | 78,495 | 82,696 | ||||||||
Liabilities related to the sales of future royalties, net | 86,322 | 91,776 | ||||||||
Other long-term liabilities | 6,756 | 7,241 | ||||||||
Total liabilities | 242,503 | 243,113 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders' equity: | ||||||||||
Preferred stock | - | - | ||||||||
Common stock | 19 | 19 | ||||||||
Capital in excess of par value | 3,663,772 | 3,659,867 | ||||||||
Treasury stock | (3,000) | (3,000) | ||||||||
Accumulated other comprehensive income (loss) | 39 | 61 | ||||||||
Accumulated deficit | (3,647,092) | (3,596,210) | ||||||||
Total stockholders' equity | 13,738 | 60,737 | ||||||||
Total liabilities and stockholders' equity | $ 256,241 | $ 303,850 | ||||||||
(1) The consolidated balance sheet at December 31, 2024 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 | ||||||||||
NEKTAR THERAPEUTICS | ||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
(In thousands, except per share information) | ||||||||||
(Unaudited) | ||||||||||
Three months ended March 31, | ||||||||||
2025 | 2024 | |||||||||
Revenue: | ||||||||||
Product sales | $ - | $ 6,034 | ||||||||
Non-cash royalty revenue related to the sales of future royalties | 10,460 | 15,508 | ||||||||
License, collaboration and other revenue | - | 97 | ||||||||
Total revenue | 10,460 | 21,639 | ||||||||
Operating costs and expenses: | ||||||||||
Cost of goods sold | - | 8,534 | ||||||||
Research and development | 30,480 | 27,408 | ||||||||
General and administrative | 24,346 | 20,149 | ||||||||
Restructuring and impairment | 169 | 975 | ||||||||
Total operating costs and expenses | 54,995 | 57,066 | ||||||||
Loss from operations | (44,535) | (35,427) | ||||||||
Non-operating income (expense): | ||||||||||
Non-cash interest expense on liabilities related to the sales of future royalties | (4,974) | (5,531) | ||||||||
Interest income | 2,874 | 4,220 | ||||||||
Other income (expense), net | 266 | (99) | ||||||||
Total non-operating income (expense), net | (1,834) | (1,410) | ||||||||
Loss before provision (benefit) for income taxes and equity method investment | (46,369) | (36,837) | ||||||||
Provision (benefit) for income taxes | 52 | (35) | ||||||||
Loss before equity method investment | (46,421) | (36,802) | ||||||||
Gain (loss) from equity method investment | (4,461) | - | ||||||||
Net loss | $ (50,882) | $ (36,802) | ||||||||
Basic and diluted net loss per share | $ (0.24) | $ (0.19) | ||||||||
Weighted average shares outstanding used in computing basic and diluted net loss | 210,924 | 194,746 | ||||||||
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SOURCE Nektar Therapeutics
FAQ
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