← Back to NKTR filing summaryOriginal filing text · Part I
Item 2 — Management's Discussion and Analysis
Nektar Therapeutics · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
View complete filing on SEC EDGAR ↗This is the extracted source text from the SEC filing. Formatting may differ from the original document.
The following discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed here. Factors that could cause or contribute to such differences include, but are not limited to those discussed in this section as well as factors described in Part II, Item 1A “Risk Factors.”
Overview
Strategic Direction of Our Business
Nektar Therapeutics is a clinical stage, research-based drug discovery biopharmaceutical company focused on the development of novel immunology therapies. Within this growing field, we direct our efforts toward creating new immunomodulatory agents that selectively induce, amplify, attenuate or prevent immune responses in order to achieve desired therapeutic outcomes. We apply our deep understanding of immunology to identify and create innovative drug candidates and use our drug development expertise to advance these molecules through preclinical and clinical development. Our pipeline of clinical-stage and preclinical-stage immunomodulatory agents, such as rezpegaldesleukin, NKTR-0165, and NKTR-0166, targets the treatment of autoimmune diseases. We continue to make significant investments in advancing and building our pipeline of drug candidates as we believe that this is the best strategy to build long-term shareholder value.
Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person’s body. A failure of the body’s self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. Our drug candidate rezpegaldesleukin is a potential first-in-class disease-modifying therapeutic that may address this underlying immune system imbalance in people with many autoimmune disorders and inflammatory diseases. It is designed to target the interleukin-2 (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells (Treg cells). Describing the critical role of Treg cells in maintaining balance in the immune system earned Drs. Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi, the Nobel Prize in medicine in October 2025. By activating these Treg cells, rezpegaldesleukin may act to bring the immune system back into balance. Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune disorders and inflammatory diseases.
We are evaluating rezpegaldesleukin in moderate-to-severe atopic dermatitis, severe-to-very-severe alopecia areata and, in collaboration with TrialNet, in new-onset stage 3 Type 1 diabetes mellitus.
In July 2026, we announced the initiation of the first two global registrational trials (ZENITH AD-1 and ZENITH AD-2) in the Phase 3 ZENITH AD program for rezpegaldesleukin. The Phase 3 ZENITH AD program is evaluating rezpegaldesleukin in patients who are 12 years of age or older with moderate-to-severe atopic dermatitis. The program includes three global, randomized, double-blind, placebo-controlled trials: ZENITH AD-1 and ZENITH AD-2 will enroll biologic and systemic JAK inhibitor treatment-naive patients and ZENITH AD-3 will enroll patients with prior biologic and/or systemic JAK inhibitor treatment experience. We intend to initiate a global registrational trial (ZENITH-AA-1) in early 2027 to evaluate rezpegaldesleukin in patients who are 12 years of age or older with severe-to-very-severe alopecia areata. Our ZENITH AD and AA programs will also include long-term extension studies in both indications and other supportive trials.
In February 2025, we announced that the FDA had 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 July 2025, we announced that the FDA had granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata in adult and pediatric patients 12 years of age and older who weigh at least 40 kg.
In October 2023, we initiated a Phase 2b clinical study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis (the Phase 2b RESOLVE-AD trial), which is ongoing. In March 2024, we initiated a Phase 2b clinical study in patients with severe-to-very severe alopecia areata (the Phase 2b RESOLVE-AA trial), which is also ongoing.
In June 2025, we announced statistically significant data from the 16-week induction period of the Phase 2b REZOLVE-AD trial being conducted in 393 patients. In the trial, patients were randomized (3:3:3:2) to receive subcutaneous treatment with
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one of three doses of rezpegaldesleukin: a high dose of 24 µg/kg every two weeks (q2w), a middle dose of 18 µg/kg every two weeks (q2w), and a low dose of 24 µg/kg every four weeks (q4w), or placebo q2w. The primary endpoint and secondary endpoints were assessed at week 16. Following the 16-week induction period, rezpegaldesleukin-treated patients who achieved Eczema Area and Severity Score (EASI) percent score reductions of >50 were re-randomized (1:1) to continue at the same dose level on a q4w or q12w regimen through week 52 in a blinded maintenance period. Placebo patients with EASI percent score reductions of >50 percent continued to receive placebo q4w.
As announced in June 2025, the Phase 2b REZOLVE-AD trial met its primary endpoint of the mean improvement in EASI from baseline at week 16 for all three dose arms of rezpegaldesleukin versus placebo (p<0.001). All three dose arms also achieved statistical significance at week 16 for the key secondary endpoints of EASI-75 (percent of patients who achieve ≥75% reduction in EASI from baseline), EASI-50 (percent of patients who achieve ≥50% reduction in EASI from baseline) and BSA (mean percent improvement in Body Surface Area score from baseline). The q2w arms of rezpegaldesleukin (high and middle doses) achieved statistical significance at week 16 for the key secondary endpoints of vIGA-AD 0/1 (percent of patients achieving a score of 0 or 1 on the validated Investigator’s Global Assessment for Atopic Dermatitis with ≥ 2-point reduction from baseline) and Itch NRS (percent of patients with baseline ≥ 4 who experienced a ≥ 4-point reduction in the Itch Numerical Rating Score from baseline). In addition, at week 16, the high dose of 24 µg/kg q2w achieved statistical significance on EASI-90 (percent of patients who achieve ≥ 90% reduction in EASI from baseline). When evaluating EASI-75 and EASI-90 by disease severity using baseline vIGA-AD score, similar responses were observed in severe patients (baseline vIGA-AD of 4) as in moderate patients (baseline vIGA-AD of 3).
In addition, the safety profile for the 16-week induction period for rezpegaldesleukin in the Phase 2b REZOLVE-AD trial was consistent with previously reported results. The most common treatment-emergent adverse events (TEAEs) were local injection site reactions (ISRs), observed in 69.7% of all rezpegaldesleukin-treated patients, with the largest proportion of these being mild or moderate (99.6%). ISRs were self-resolving and <1% of patients discontinued because of an ISR. Across all rezpegaldesleukin doses administered in the study over the 16-week induction period, 55.9% had no reports of ISRs, 30.1% had mild reports, 13.8% had moderate reports, and only 0.2% were severe. Other TEAEs more commonly observed (>5%) in the study treatment arms (n=320) versus placebo (n=73) include eosinophilia (7.8% vs. 2.7%), pyrexia (6.3% vs 2.7%), headache (6.3% vs. 4.1%) and arthralgia (5.0% vs 1.4%). In the pooled rezpegaldesleukin arms, TEAEs, excluding ISRs, were reported in 60.3% of patients and in 57.5% of placebo-treated patients. There was no increased risk of conjunctivitis, oral ulcers, or infections, including oral herpes, in the rezpegaldesleukin arms.
In September 2025, we presented new data from the Phase 2b REZOLVE-AD trial at the European Academy of Dermatology and Venereology (EADV) 2025 Congress. Building on previously presented data, these data demonstrated that high dose rezpegaldesleukin achieved statistical significance on multiple patient-reported outcome assessments at completion of the 16-week induction period. Additionally, as observed interim data for patients who previously received placebo during the induction period and crossed over to receive 24 weeks of treatment with high dose rezpegaldesleukin had increased EASI-75 and vIGA-AD efficacy with extended dosing beyond week 16.
In February 2026, we announced data from the blinded 36-week maintenance period of the Phase 2b REZOLVE-AD trial. Rezpegaldesleukin demonstrated long-term durability and continued atopic dermatitis disease symptom improvement during the maintenance period. Q4w and q12w dosing regimens resulted in sustained disease control for EASI-75, EASI-90, vIGA-AD response, and Itch NRS response, with the 24 µg/kg q4w and q12w regimens showing the highest maintenance of response at week 52. 71% and 83% of patients maintained EASI-75 responses and 85% and 63% maintained vIGA-AD 0/1 responses with 24 µg/kg q4w and q12w dosing, respectively, at week 52. A meaningful proportion of patients achieved new EASI-75, EASI-90, Itch NRS and vIGA-AD 0/1 responses at week 52 of the study. A two to five fold increase in percentage of patients who achieved EASI-100 was observed in the 24 µg/kg q4w and q12w dosing regimens. Among all re-randomized patients from week 16 to week 52, q4w maintenance dosing increased EASI-100 response from 4% to 22% and q12w dosing increased EASI-100 response from 9% to 18%. Among re-randomized patients who had an EASI-75 or vIGA-AD response at maintenance baseline, q4w dosing increased EASI-100 response from 6% to 30% and q12w dosing increased EASI-100 response from 14% to 27%.
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The safety profile of rezpegaldesleukin in maintenance was consistent with observations from the induction part of the study. Rezpegaldesleukin was well-tolerated with no new safety concerns identified during the maintenance and escape periods. The discontinuation rate due to adverse events was 3.5% for all aggregated patients. Overall rates of TEAEs were 72% for rezpegaldesleukin treated patients, 65% for placebo patients in maintenance, and 83% for all escape patients. The most frequent TEAE was ISRs, nearly all of which were mild (77%), and which occurred at a lower rate and frequency than observed in the initial induction part of the study (discontinuation rate due to injection site reactions was 0.7%). The Phase 2b REZOLVE-AD trial remains ongoing for a 52-week posttreatment follow-up period.
In December 2025, we announced topline results from the 36-week induction treatment period of the Phase 2b REZOLVE-AA study being conducted in 92 patients with severe-to-very-severe alopecia areata. Patients were randomized (3:3:2) to receive one of two rezpegaldesleukin doses (24 µg/kg or 18 µg/kg) or placebo, administered as a subcutaneous injection twice monthly. The primary endpoint was the mean percentage reduction from baseline in the Severity of Alopecia Tool (SALT) score at week 36. Primary and secondary endpoints were assessed at the end of the 36-week induction treatment period.
Both rezpegaldesleukin dose arms more than doubled the SALT score reduction treatment effect observed with placebo, with the majority of patients experiencing hair growth at week 16 or later. A mean percent SALT reduction at week 36 of 28.2% for the 24 µg/kg rezpegaldesleukin arm, 30.3% for the 18 µg/kg rezpegaldesleukin arm, and 11.2% for placebo (p=0.186 and p=0.121, respectively) was observed. At all timepoints, the rezpegaldesleukin treatment arms separated from placebo in the study. Both rezpegaldesleukin treatment arms showed a dose dependent clinical treatment effect as compared to placebo on the key secondary endpoints of SALT ≤30, SALT≤20 and SALT≤10 and SALT30.
Four of 92 patients included in the modified intent-to-treat (mITT) analysis were found to have study eligibility violations that should have disqualified them for randomization into the trial. Both rezpegaldesleukin treatment arms met statistical significance on the primary endpoint when excluding the four patients with major study eligibility violations. At week 36, the mean percent SALT reduction was 29.6% for 24 µg/kg, 30.4% for 18 µg/kg, and 5.7% for placebo (p=0.049 and p=0.042, respectively). Importantly, the absolute treatment effect for the rezpegaldesleukin arms was similar with or without the exclusion of eligibility violations. One patient in the placebo arm with an eligibility violation accounted for the 5.5% difference in the performance of the placebo arm.
Consistent with prior studies, a favorable safety and tolerability profile was observed, with nearly all TEAEs mild-to-moderate in severity and self-resolving, even in patients receiving 52 weeks of treatment. The discontinuation rate due to adverse events was 1.4% in the combined rezpegaldesleukin treatment arms. No patients discontinued treatment due to an ISR. The placebo adjusted-ISR rate was consistent with prior studies, with 87.0% of ISRs reported as mild. There was no increased risk of major adverse cardiovascular events, thrombosis, infection, acne or oral herpes for REZPEG-exposed patients, compared to placebo.
In April 2026, we announced 52-week topline results from the 16-week blinded treatment extension period of the REZOLVE-AA trial. Following completion of the induction phase, patients with a SALT Score greater than 20 at week 36 who also demonstrated hair growth were eligible to continue on rezpegaldesleukin at their induction dose level in a blinded 16-week exploratory treatment extension through week 52. From week 36 to week 52, 29% of patients at 18 µg/kg dose and 31% of patients at 24 µg/kg dose achieved new SALT Score ≤20 responses as compared to none in the placebo arm. Increasing proportions of patients achieved clinically meaningful hair growth thresholds across numerous SALT measurements with 94% of patients completing treatment extension. The Phase 2b REZOLVE-AA trial remains ongoing for a 24-week posttreatment follow-up period.
In February 2025, we announced that we had entered into a collaboration agreement with TrialNet to evaluate rezpegaldesleukin in patients with new-onset stage 3 Type 1 diabetes mellitus in a Phase 2 study, which was initiated in May 2026. TrialNet will conduct the study with funding from the National Institutes of Health, primarily through the Special Statutory Funding Program for Type 1 Diabetes through the National Institute of Diabetes and Digestive and Kidney Diseases. Nektar will supply rezpegaldesleukin for the study and will retain all rights to the rezpegaldesleukin program under the collaboration.
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We continue to advance our most promising research drug candidates into preclinical development with the objective of advancing these early-stage research programs to human clinical studies over the next several years. Our lead research program is based on tumor necrosis factor (TNF) receptor type II (TNFR2) agonism, without modulation of the TNFR1 signaling, after we exercised an option in December 2023 to gain an exclusive license to specified agonistic antibodies and other materials that were developed pursuant to a research collaboration and license option agreement we entered into with Biolojic Design, Ltd. in 2021. TNFR2 signaling drives immunoregulatory function and can provide a direct protective effect for tissue cells. TNFR2 is highly expressed on Tregs, neuronal cells and endothelial cells and has been shown to potentiate the suppressive effects and overall functional properties of Tregs. NKTR-0165 is being developed for potential treatment of autoimmune diseases, such as ulcerative colitis, multiple sclerosis and vitiligo. NKTR-0165 is currently in the Investigational New Drug (IND) enabling phase. We have also designed a unique bispecific antibody, NKTR-0166, that incorporates the TNFR2 agonist epitope and an antagonist epitope validated in the treatment of rheumatology diseases. As a dual agonist:antagonist of known pathways associated with key pathways linked to disease pathogenesis, this investigational antibody is being developed to address a number of rheumatic disorders.
We have historically derived substantially all of our revenue and significant amounts of research and development operating capital from our collaboration agreements. We have received upfront and milestone payments and cost-sharing reimbursements under a number of previous collaboration agreements, and certain of our collaboration partners have borne substantial costs of developing our drug candidates. We may continue our approach of entering into revenue-generating collaboration agreements to pay in whole or in part the development costs of our drug candidates, or we may finance the development of our drug candidates with our own capital.
Our pipeline also includes NKTR-255, an investigational biologic in oncology that is designed to target the IL-15 pathway in order to activate the body’s innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response. We are seeking potential partnerships for this asset.
Several of our historical collaboration agreements have resulted in approved drugs, for which we may be entitled to royalties for net sales of these approved drugs. However, we have sold our rights to receive royalties under these arrangements, including:
•2012 Purchase and Sale Agreement: In 2012, we sold all of our rights to receive royalties from CIMZIA® (for the treatment of Crohn’s disease and other autoimmune indications) and MIRCERA® (for the treatment of anemia associated with chronic kidney disease) under our collaborations with UCB Pharma (UCB) and F. Hoffmann-La Roche Ltd, respectively, to RPI Finance Trust (RPI), an affiliate of Royalty Pharma for $124.0 million.
•2020 Purchase and Sale Agreement: In December 2020, we sold our rights, subject to a cap, to receive royalties from MOVANTIK® / MOVENTIG® (for the treatment of opioid-induced constipation), ADYNOVATE® / ADYNOVI® (a half-life extension product of Factor VIII) and other hemophilia products, under our arrangements with AstraZeneca AB, Baxalta, Inc. (a wholly owned-subsidiary of Takeda Pharmaceutical Company Ltd.), and Novo Nordisk A/S, respectively, for $150.0 million to entities managed by Healthcare Royalty Management, LLC (HCR). In March 2024, Nektar and HCR amended the 2020 Purchase and Sale Agreement to remove the cap on the royalties in exchange for $15.0 million. See Note 3 to our Condensed Consolidated Financial Statements for additional information.
We continued to manufacture the polymer reagents used in the production of some of the drug products until the sale of our manufacturing facility in Huntsville, Alabama (the Facility) in December 2024. See Note 4 to our Condensed Consolidated Financial Statements for additional information. The sale of the Facility does not alter the royalties or other milestones payable under these agreements or our collaboration agreement with UCB for dapirolizumab pegol as further disclosed in Note 7 to our Condensed Consolidated Financial Statements.
Our business is subject to significant risks, including the risks inherent in our development efforts, the results of our clinical trials, our dependence on marketing efforts by our collaboration partners, uncertainties associated with obtaining and enforcing patents, the lengthy and expensive regulatory approval process and competition from other products. Drug research and
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development is an inherently uncertain process with a high risk of failure at every stage prior to approval. The timing and outcome of clinical trial results are extremely difficult to predict. Clinical development successes and failures can have a disproportionately positive or negative impact on our scientific and medical prospects, financial condition and prospects, results of operations and market opportunities. For a discussion of these and some of the other key risks and uncertainties affecting our business, see Item 1A “Risk Factors” below.
With respect to financing our near-term business needs, as set forth below in “Liquidity and Capital Resources”, we estimate we have working capital to fund our current business plans through at least the next twelve months. At June 30, 2026, we had approximately $1,023.4 million in cash and investments in marketable securities.
From July 2025 to April 2026, we completed a number of equity-based financing transactions, under which we have sold 19,400,822 shares of our common stock and 293,103 pre-funded warrants, resulting in net proceeds of $1,068.6 million. See Note 6 to our Condensed Consolidated Financial Statements for additional information.
Results of Operations
The following sets forth our Condensed Consolidated Statements of Operations data for each of the periods indicated (in thousands, except percentages).
Three Months Ended June 30, $ Change 2026 vs. 2025 % Change 2026 vs. 2025
2026 2025
Revenue:
Non-cash royalty revenue related to the sales of future royalties $ 10,131 $ 11,175 $ (1,044 ) (9 )%
Total revenue 10,131 11,175 (1,044 ) (9 )%
Operating costs and expenses:
Research and development 39,129 29,886 9,243 31 %
General and administrative 12,765 17,072 (4,307 ) (25 )%
Restructuring and impairment 578 447 131 29 %
Total operating costs and expenses 52,472 47,405 5,067 11 %
Loss from operations (42,341 ) (36,230 ) (6,111 ) 17 %
Non-operating income (expense):
Non-cash interest expense on liability related to sale of future royalties (7,206 ) (5,394 ) (1,812 ) 34 %
Interest income 9,346 1,969 7,377 375 %
Other income (expense), net (100 ) 260 (360 ) (138 )%
Total non-operating income (expense), net 2,040 (3,165 ) 5,205 (164 )%
Loss before provision (benefit) for income taxes and equity method investment (40,301 ) (39,395 ) (906 ) 2 %
Provision (benefit) for income taxes 2 (188 ) 190 (101 )%
Loss before equity method investment (40,303 ) (39,207 ) (1,096 ) 3 %
Loss from equity method investment (319 ) (2,386 ) 2,067 (87 )%
Net loss $ (40,622 ) $ (41,593 ) $ 971 (2 )%
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Six Months Ended June 30, $ Change 2026 vs. 2025 % Change 2026 vs. 2025
2026 2025
Revenue:
Non-cash royalty revenue related to the sales of future royalties $ 20,992 $ 21,635 $ (643 ) (3 )%
Total revenue 20,992 21,635 (643 ) (3 )%
Operating costs and expenses:
Research and development 74,809 60,366 14,443 24 %
General and administrative 26,204 41,418 (15,214 ) (37 )%
Restructuring and impairment 1,374 616 758 123 %
Total operating costs and expenses 102,387 102,400 (13 ) (0 )%
Loss from operations (81,395 ) (80,765 ) (630 ) 1 %
Non-operating income (expense):
Non-cash interest expense on liability related to sale of future royalties (15,148 ) (10,368 ) (4,780 ) 46 %
Interest income 13,588 4,843 8,745 181 %
Other income (expense), net (436 ) 526 (962 ) (183 )%
Total non-operating income (expense), net (1,996 ) (4,999 ) 3,003 (60 )%
Loss before provision (benefit) for income taxes and equity method investment (83,391 ) (85,764 ) 2,373 (3 )%
Provision (benefit) for income taxes 66 (136 ) 202 (149 )%
Loss before loss from equity method investment (83,457 ) (85,628 ) 2,171 (3 )%
Loss from equity method investment (2,069 ) (6,847 ) 4,778 (70 )%
Net loss $ (85,526 ) $ (92,475 ) $ 6,949 (8 )%
Revenue
Our revenue has historically been derived from our collaboration agreements, under which we may receive product sales revenue, royalties, and license fees, as well as development and sales milestones and other contingent payments. We recognize revenue when we transfer promised goods or services to our collaboration partners.
•Non-cash royalty revenue and Non-cash interest expense: We recognize non-cash royalty revenue and non-cash interest expense resulting from royalties on several products for which we had previously sold our rights to receive royalties under the 2012 and 2020 Purchase and Sale Agreements. See Note 3 to our Condensed Consolidated Financial Statements for additional information regarding these agreements. These non-cash revenues and expenses have no effect on our cash flows, and we do not consider them material to our operations. We expect non-cash royalty revenue to decrease for 2026 as compared to 2025 due to the end of the royalty terms for several products, and we expect non-cash interest expense to increase slightly as a result of a higher effective interest rate.
•License, collaboration and other revenue: License, collaboration and other revenue includes the recognition of upfront payments, milestone and other contingent payments received in connection with our license and collaboration agreements. The amount of revenue depends in part upon the estimated recognition period of the upfront payments allocated to continuing performance obligations, the achievement of milestones and other contingent events, the continuation of existing collaborations, the amount of research and development work, and entering into new collaboration agreements, if any. License, collaboration and other revenue was not material for the periods presented or for the full year 2025, and unless we enter into a new collaboration agreement with upfront payments, we do not expect to recognize significant revenue in 2026.
Research and Development Expense
Research and development expense consists primarily of clinical study costs, contract manufacturing costs, direct costs of outside research, materials, supplies, licenses and fees as well as personnel costs (including salaries, benefits, contractor and
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temporary workers, and non-cash stock-based compensation). Research and development expense also includes certain overhead allocations of support costs.
Research and development expense increased for the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025, respectively, as reported in the following table, which presents expenses incurred for direct third-party costs, including clinical and regulatory services, contract manufacturing, clinical supplies, and preclinical study support for each of our drug candidates. The table also presents personnel, overhead and other indirect costs as we utilize our employee, contractor and infrastructure resources across multiple research and development programs (in thousands):
Three Months Ended June 30, $ Change 2026 vs. 2025 Six Months Ended June 30, $ Change 2026 vs. 2025
2026 2025 2026 2025
Rezpegaldesleukin (IL-2 receptor agonist/regulatory T cell agent) $ 22,389 $ 12,930 $ 9,459 $ 43,125 $ 26,733 $ 16,392
Tumor necrosis factor receptor type II (TNFR2) program 735 3,775 (3,040 ) 1,533 6,244 (4,711 )
Discovery research and other programs 436 2,374 (1,938 ) 332 4,044 (3,712 )
Total clinical development, contract manufacturing and other third party costs 23,560 19,079 4,481 44,990 37,021 7,969
Personnel, overhead and other costs 13,765 9,572 4,193 26,202 20,499 5,703
Stock-based compensation and depreciation 1,804 1,235 569 3,617 2,846 771
Research and development expense $ 39,129 $ 29,886 $ 9,243 $ 74,809 $ 60,366 $ 14,443
Research and development expense for rezpegaldesleukin increased for the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025, as we commenced activities to support the Phase 3 ZENITH AD program in atopic dermatitis, including clinical trial start-up activities with our contract research organizations, and manufacturing activities associated with rezpegaldesleukin. This increase was partially offset by lower costs from our Phase 2b studies in atopic dermatitis and alopecia areata, as patients have completed the induction phase and moved into the maintenance or off-treatment follow up phases of these studies. We expect the costs of development of rezpegaldesleukin for full year 2026 to significantly increase as we continue the development of rezpegaldesleukin, including the Phase 3 ZENITH AD program in atopic dermatitis, the Phase 3 ZENITH AA program in alopecia areata, and manufacturing activities associated with rezpegaldesleukin. We expect research and development expense to increase significantly in future periods as patients are enrolled in our Phase 3 ZENITH AD and ZENITH AA programs and our contract manufacturing organizations produce clinical drug supply to support these studies and complete other development activities.
Research and development expense for our TNFR2 program decreased for the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025, as we have completed a significant portion of our IND enabling activities for NKTR-0165. We expect the costs of development of TNFR2 program to decrease for full year 2026 as compared to 2025 for the same reason. We may owe additional milestone payments to Biolojic, as further disclosed in Note 5 to our Condensed Consolidated Financial Statements.
Personnel, overhead and other costs increased for the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025, due to increased personnel to support our Phase 3 rezpegaldesleukin program. We expect personnel, overhead and other costs for full year 2026 to increase compared to full year 2025 to support our development of rezpegaldesleukin.
We expect total research and development expense to increase significantly for full year 2026 compared to 2025 to support our development of rezpegaldesleukin, including the Phase 3 ZENITH AD program in atopic dermatitis, the Phase 3 ZENITH AA program in alopecia areata, and manufacturing activities associated with rezpegaldesleukin.
The timing and amount of our future clinical trial expenses will vary significantly based upon our evaluation of ongoing clinical results and the structure, timing, and scope of additional clinical development programs and potential clinical collaboration partnerships (if any) for these programs.
In addition to our drug candidates that we plan to evaluate in clinical development during 2026 and beyond, we believe it is vitally important to continue our investment in a pipeline of new drug candidates to continue to build the value of our drug candidate pipeline and our business. We continue our interest in identifying new drug candidates across a wide range of molecule
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classes, including small molecules and large proteins, peptides and antibodies, across multiple therapeutic areas. We also plan from time to time to evaluate opportunities to in-license potential drug candidates from third parties to add to our drug discovery and development pipeline. We plan to continue to advance our most promising early research drug candidates into preclinical development with the objective to advance these early-stage research programs to human clinical studies over the next several years.
Our expenditures on current and future preclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. In order to advance our drug candidates through clinical development, each drug candidate must be tested in numerous preclinical safety, toxicology and efficacy studies. We then conduct clinical studies for our drug candidates that take several years to complete. The cost and time required to complete clinical trials may vary significantly over the life of a clinical development program as a result of a variety of factors, including but not limited to:
•the number of patients required for a given clinical study design;
•the length of time required to enroll clinical study participants;
•the number and location of sites included in the clinical studies;
•the clinical study designs required by the health authorities (i.e. primary and secondary endpoints as well as the size of the study population needed to demonstrate efficacy and safety outcomes);
•the potential for changing standards of care for the target patient population;
•the competition for patient recruitment from competitive drug candidates being studied in the same clinical setting;
•the costs and timing of producing supplies of the drug candidates needed for clinical trials and regulatory submissions;
•the safety and efficacy profile of the drug candidate;
•the use of clinical research organizations to assist with the management of the trials; and
•the costs and timing of, and the ability to secure, approvals from government health authorities.
Furthermore, our strategy includes the potential of entering into collaborations with third parties to participate in the development and commercialization of some of our drug candidates, or clinical collaborations where we would share costs and operational responsibility with a partner. In certain situations, the clinical development program and process for a drug candidate and the estimated completion date will largely be under the control of that third party and not under our control. We cannot forecast with any degree of certainty which of our drug candidates will be subject to future collaborations or how such arrangements would affect our development plans or capital requirements.
General and Administrative Expense
General and administrative expense includes the cost of administrative staffing, finance and legal activities, including certain overhead support allocations. Additionally, general and administrative expense includes our lease and other facilities expenses, net of sublease income.
General and administrative expense decreased for the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025, mainly due to a decrease in legal expenses.
We expect general and administrative expenses to increase in the second half of 2026 due to increases in legal expenses and employee costs. However, we expect general and administrative expense for full year 2026 to decrease slightly as compared to full year 2025.
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Restructuring and Impairment
As discussed in Note 8 to our Condensed Consolidated Financial Statements, we have incurred significant contract termination costs as a result of our prior restructuring plans. which we report as restructuring and impairment expense. We recognized $4.9 million in contract termination costs for the full year 2025. We continue to recognize expense until settlement. Because we continue to adjust the liability based on updates to our assumptions at each reporting date, our estimates may continue to change until settlement.
During full year 2025, we recognized $4.4 million in non-cash impairment charges related to our lease spaces.
Interest Income
Interest income increased for the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025, respectively, due to higher investment balances as a result of our equity-based financings as further disclosed in Note 6 to our Condensed Consolidated Financial Statements. We expect interest income to increase for full year 2026 compared to full year 2025 for the same reason.
Loss from Equity Method Investment
As discussed in Note 4 to our Condensed Consolidated Financial Statements, we determine our gain or loss on our equity method investment in Gannet BioChem using the hypothetical liquidation at book value (HLBV) due to Ampersand’s priority liquidation preference and right to receive a cumulative preferred dividend. The HLBV method is a balance sheet approach that calculates the change in the hypothetical amount we and Ampersand would be entitled to receive if Gannet BioChem were liquidated at book value at the end of each period, subject to certain adjustments for any contributions, distributions and basis differences. We report our gain or loss from our equity method investment in Gannet BioChem on a three-month lag. Therefore, our loss recorded for the three months ended June 30, 2026 and 2025 reflects Gannet BioChem’s activities for the three months ended March 31, 2026 and 2025, respectively. Our loss recorded for the six months ended June 30, 2026 and 2025, reflects Gannet BioChem’s activities for six months ended March 31, 2026 and from closing on December 2, 2024 through March 31, 2025, respectively. Our losses for these periods reflect Ampersand’s cumulative preferred dividend earned for such periods and Gannet BioChem’s net losses for such periods. Our loss of $6.8 million for the six months ended June 30, 2025 includes $2.5 million of Ampersand’s closing transaction costs deducted from Ampersand’s cash investment in Gannet BioChem.
We do not expect a significant gain or loss from equity method investment in 2026.
Liquidity and Capital Resources
We have financed our operations primarily through public and private placements of debt and equity securities, royalties and product sales, as well as, revenue from upfront and milestone payments under our strategic collaboration agreements. As of June 30, 2026, we had approximately $1,023.4 million in cash and investments in marketable securities. We estimate that we have working capital to fund our current business plans for at least the next twelve months from the date of filing.
From July 2025 to April 2026, we completed a number of equity-based financing transactions, under which we sold 19,400,822 shares of our common stock and 293,103 pre-funded warrants, resulting in net proceeds of $1,068.6 million. We have an active shelf registration statement that we filed on Form S-3ASR and a related prospectus in November 2025, (the November 2025 Shelf Registration), as a “well-known seasoned issuer,” as defined in Rule 405 under the Securities Act. The November 2025 Shelf Registration became automatically effective upon filing, and permits us to offer, from time to time, an unspecified amount of common stock, preferred stock, debt securities and warrants.
In May 2026, we entered into a new equity distribution agreement (the May 2026 ATM Sales Agreement) with Guggenheim Securities, LLC and H.C. Wainwright & Co., LLC, relating to the sale of our common stock having an aggregate offering price of up to $150.0 million in an “at-the-market” offering under the November 2025 Shelf Registration. We agreed to pay Guggenheim Securities, LLC and H.C. Wainwright & Co. LLC a commission equal to 3.0% of the gross sales price of all
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common stock sold under the May 2026 ATM Sales Agreement. As of June 30, 2026, no shares have been issued under the May 2026 ATM Sales Agreement.
See Note 6 to our Condensed Consolidated Financial Statements for additional information.
We expect the clinical development of our drug candidates, including rezpegaldesleukin and our TNFR2 program, including NKTR-0165 and NKTR-0166 will continue to require significant investment to continue to advance in clinical development with the objective of obtaining regulatory approval or entering into one or more collaboration partnerships. In particular, we will require substantial amounts of capital to complete our Phase 3 ZENITH AD and AA programs and related manufacturing activities and to file for potential regulatory approvals.
In the past, we have received a number of significant payments from collaboration agreements and other significant transactions. Additionally, certain of our collaboration partners have borne substantial costs of developing our drug candidates. We may continue our approach of entering into revenue-generating collaboration agreements to pay in whole or in part the development costs of our drug candidates, or we may finance the development of our drug candidates with our own capital.
Our current business is subject to significant uncertainties and risks as a result of, among other factors, clinical and regulatory outcomes for rezpegaldesleukin, and our TNFR2 program, including NKTR-0165 and NKTR-0166; the sales levels for those products, if and when they are approved; whether, when and on what terms we are able to enter into new collaboration transactions; expenses being higher or timelines being longer than anticipated, unplanned expenses and the need to satisfy contingent liabilities, including litigation matters and indemnification obligations; and cash receipts, including interest and sublease income, being lower than anticipated.
We have no credit facility or any other sources of committed capital. The availability and terms of various financing alternatives, if required in the future, substantially depend on many factors including the success or failure of drug development programs in our pipeline. The availability and terms of financing alternatives and any future significant payments from existing or new collaborations depend on the positive outcome of ongoing or planned clinical studies, whether we or our partners are successful in obtaining regulatory authority approvals in major markets, and if approved, the commercial success of these drugs, as well as general capital market conditions. We may pursue various financing alternatives to fund the expansion of our business as appropriate.
As a result of our prior restructuring plans, we are seeking to sublease all of our leased facilities in San Francisco, California, including our laboratory and office space on Mission Bay Blvd. South (the Mission Bay Facility) and our office space on Third St. (the Third. St. Facility), and we have current subleases for a portion of the Mission Bay Facility. The San Francisco Bay Area office lease market has been negatively impacted by economic uncertainties, particularly impacting the technology industry, and the change in work habits, as employees continue to work remotely. Accordingly, for the Third St. Facility and the unleased portions of the Mission Bay Facility, there is significant uncertainty as to whether or when we will be able to enter into a sublease as well as the economic terms of such subleases, if any. Meanwhile, the San Francisco Bay Area life sciences lease market continues to be weak as a significant amount of leasable space remains available in the San Francisco Bay Area. Accordingly, there is uncertainty as to whether or when we will be able to enter into a sublease as well as the economic terms of such subleases, if any. If we enter into additional sublease arrangements, we will be subject to the credit risks of the sublessees. If a sublessee fails to satisfy its payment obligations, we remain responsible for our obligations under the underlying lease and may incur losses, additional impairment charges, or other expenses.
Due to the potential for adverse developments in the credit markets, we may experience reduced liquidity with respect to some of our investments in marketable securities. These investments are generally held to maturity, which, in accordance with our investment policy, is less than two years. However, if the need arises to liquidate such securities before maturity, we may experience losses on liquidation. To date we have not experienced any liquidity issues with respect to these securities. We believe that, even allowing for potential liquidity issues with respect to these securities and the effect of various conditions on the financial markets, our remaining cash and investments in marketable securities will be sufficient to meet our anticipated cash needs for at least the next twelve months.
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Cash flows from operating activities
Cash flows used in operating activities for the six months ended June 30, 2026 and 2025 totaled $120.1 million and $94.8 million, respectively. The increase in cash flows used in operating activities for the six months ended June 30, 2026, reflects activities to support our Phase 3 ZENITH AD program in atopic dermatitis and manufacturing activities associated with rezpegaldesleukin, as well as increases in employee costs to support our Phase 3 program.
We expect that cash flows used in operating activities, excluding upfront, milestone and other contingent payments received, if any, will increase significantly for 2026 as compared to 2025 to support our development of rezpegaldesleukin primarily focusing on the Phase 3 ZENITH AD program in atopic dermatitis, the Phase 3 ZENITH AA program in alopecia areata and manufacturing activities related to rezpegaldesleukin.
Cash flows from investing activities
During the six months ended June 30, 2026, we purchased $749.8 million investments in marketable securities, net of maturities, as we have invested the proceeds from our equity financings, offset by funding our operations. During the six months ended June 30, 2025, the maturities of our investments in marketable securities, net of purchases, totaled $94.0 million, which we used to fund our operations. Our other investing activities were not significant for the periods presented.
Cash flows from financing activities
Other than the financing activities described above and further disclosed in Note 6 to our Condensed Consolidated Financial Statements, we also received proceeds of $4.9 million from issuance of common stock related to our employee option and stock purchase plans during the six months ended June 30, 2026.
Critical Accounting Policies and Estimates
The preparation and presentation of financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form our basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates on an ongoing basis. Actual results may differ from those estimates under different assumptions or conditions.
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