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Nektar Therapeutics: Cautiously Positive Moving Into Phase 2b Readout
Seeking Alpha· 2025-11-12 05:39
Core Viewpoint - The article emphasizes a focus on non-consensus long-short investment ideas within the biotechnology sector, particularly targeting small to mid-cap companies in the US and EU markets, with an interest in clinical catalysts and new drug launches [1]. Group 1: Investment Focus - The investment strategy centers on small to mid-cap biotechnology companies that are publicly traded [1]. - There is a specific interest in clinical catalysts and the potential impact of new drug launches on stock performance [1]. Group 2: Content Purpose - All content provided is for informational and educational purposes and should not be interpreted as financial or investment advice [3]. - The article aims to present personal views and opinions without affiliation to any employer or financial institution [3][4]. Group 3: Analyst's Position - The analyst has no current stock or derivative positions in the companies mentioned and does not plan to initiate any within the next 72 hours [2]. - There is no compensation received for the article other than from the platform it is published on [2].
New Data from REZOLVE-AD Study of Rezpegaldesleukin Presented in Late-Breaking Oral Abstract Presentation at ACAAI 2025 Annual Scientific Meeting
Prnewswire· 2025-11-08 22:45
Core Insights - Nektar Therapeutics presented new data on rezpegaldesleukin, a first-in-class IL-2 pathway agonist, showing statistically significant improvements in asthma control and atopic dermatitis symptoms in patients with comorbid conditions [1][2][3] Group 1: Clinical Trial Results - The Phase 2b REZOLVE-AD trial enrolled 393 patients with moderate-to-severe atopic dermatitis, with 99 patients having a history of asthma [3][9] - Statistically significant reductions in mean ACQ-5 scores were observed at week 16 for patients with asthma, particularly in those with uncontrolled asthma, where all active doses achieved significance compared to placebo [5][6] - Rezpegaldesleukin demonstrated improvements in primary and secondary endpoints for atopic dermatitis, including EASI-75 and EASI-90, with p-values indicating strong efficacy [6][7] Group 2: Treatment Mechanism and Implications - Rezpegaldesleukin promotes regulatory T-cell (Treg) activity, which may benefit both atopic dermatitis and asthma, suggesting a broader therapeutic potential across T-cell mediated inflammatory diseases [4][3] - The treatment's unique mechanism has not been observed with other biologics currently in development, positioning rezpegaldesleukin as a differentiated option in the market [4] Group 3: Future Developments - Long-term maintenance data from the REZOLVE-AD study is expected in Q1 2026, with plans for Phase 3 studies based on the positive results from the current trial [1][9] - The FDA granted Fast Track designation for rezpegaldesleukin for both atopic dermatitis and severe alopecia areata, indicating potential for expedited development and approval [14]
Nektar Therapeutics Q3 Loss Narrower Than Expected, Revenues Rise Y/Y
ZACKS· 2025-11-07 16:16
Core Insights - Nektar Therapeutics reported a narrower loss of $1.87 per share for Q3 2025, compared to the expected loss of $2.85, and a loss of $2.66 per share in the same quarter last year [1][5] - Total revenues for the quarter were $11.8 million, more than halving year over year, but slightly exceeding the Zacks Consensus Estimate of $11 million [2][5] - The company's stock rose 4.3% in after-market trading following the earnings report, with a year-to-date increase of 295.4%, significantly outperforming the industry growth of 3.7% [3] Financial Performance - The adjusted loss, excluding non-cash losses from equity investments, was $1.85 per share [1] - Research and development expenses decreased by 22% year over year to $27.3 million, primarily due to reduced expenses for NKTR-255 development [6] - General and administrative expenses fell 15% year over year to $16.1 million, attributed to lower facility and stock-based compensation costs [6] - As of September 30, 2025, the company had cash and cash equivalents totaling $270.2 million, up from $175.9 million as of June 30, 2025, with expectations to support operations into Q2 2027 [7] Pipeline Developments - Nektar's lead candidate, rezpegaldesleukin (rezpeg), is in Phase IIb studies for atopic dermatitis and alopecia areata, showing promising progress [8][9] - The Phase IIb REZOLVE-AD study for atopic dermatitis met its primary and key secondary endpoints [9] - Rezpeg has received Fast Track designation from the FDA for both severe-to-very severe alopecia areata and moderate-to-severe atopic dermatitis [10] - The company regained full rights to rezpeg from Eli Lilly in April 2023, eliminating royalty obligations [11] Market Position - Nektar Therapeutics currently holds a Zacks Rank of 2 (Buy) [12] - Other biotech stocks with a similar ranking include ANI Pharmaceuticals and Acadia Pharmaceuticals [12]
Nektar Therapeutics (NKTR) Reports Q3 Loss, Beats Revenue Estimates
ZACKS· 2025-11-06 23:56
Core Insights - Nektar Therapeutics reported a quarterly loss of $1.85 per share, which was better than the Zacks Consensus Estimate of a loss of $2.85, representing an earnings surprise of +35.09% [1] - The company generated revenues of $11.79 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 11.42%, although this is a decline from $24.12 million in the same quarter last year [2] - Nektar's stock has increased by approximately 289.2% year-to-date, significantly outperforming the S&P 500's gain of 15.6% [3] Earnings Outlook - The future performance of Nektar's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$2.98 on revenues of $10.36 million, and for the current fiscal year, it is -$12.26 on revenues of $42.63 million [7] Industry Context - The Medical - Drugs industry, to which Nektar belongs, is currently ranked in the top 39% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - The correlation between near-term stock movements and earnings estimate revisions suggests that tracking these revisions can provide insights into stock performance [5]
Nektar(NKTR) - 2025 Q3 - Earnings Call Transcript
2025-11-06 23:00
Financial Data and Key Metrics Changes - The company ended Q3 2025 with $270.2 million in cash and investments, with no debt on the balance sheet [23] - The net loss for Q3 was $35.5 million, or $1.87 basic and diluted net loss per share [25] - The company expects to end the year with approximately $240 million in cash and investments, an increase from prior guidance of $100-$185 million [24] Business Line Data and Key Metrics Changes - Non-cash royalty revenue for Q3 was $11.5 million, with an expectation of approximately $40 million for the full year [24] - R&D expenses for Q3 were $27.3 million, with full-year expectations ranging between $125-$130 million [24] - G&A expenses for Q3 were $16.1 million, with full-year expectations between $70-$75 million [24] Market Data and Key Metrics Changes - In the U.S., over 15 million people suffer from moderate to severe atopic dermatitis, with fewer than 10% receiving biologic treatments [9] - Nearly 7 million people in the U.S. have or will develop alopecia areata, with over 1 million having severe to very severe disease [10] Company Strategy and Development Direction - The company is focused on advancing its lead program, REZPEG, into phase 3 development, targeting atopic dermatitis and alopecia areata [4][11] - REZPEG aims to provide a novel treatment option for patients with chronic dermatological diseases, differentiating itself from existing therapies [11][19] - The company plans to hold an end-of-phase 2 meeting with the FDA to review phase 3 plans for REZPEG in atopic dermatitis [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of REZPEG to address unmet needs in atopic dermatitis and alopecia areata, especially given the limitations of current treatments [10][19] - The recognition of REZPEG in the context of recent scientific discoveries highlights its potential therapeutic impact [5] - Management emphasized the importance of addressing comorbid conditions, such as asthma, in patients with atopic dermatitis [16] Other Important Information - The company plans to present top-line results from the phase 2b resolved AA study in December 2025 [11] - The company has extended its cash runway guidance into the second quarter of 2027 [24] Q&A Session Summary Question: Upcoming ACAAI data presentation - The company is presenting results from a pre-planned exploratory analysis on asthma control in patients with atopic dermatitis, highlighting the potential impact on treatment decisions [28][30] Question: Interest in REZPEG's remissive effect - Management noted significant interest in REZPEG's potential remissive effect in atopic dermatitis, differentiating it from other treatments [35][36] Question: Phase 3 program for alopecia areata - The company plans to start the phase 3 study for alopecia areata next year, depending on December data outcomes [43][44] Question: Benchmarking against other therapies - Management discussed the competitive landscape, noting that REZPEG's safety profile could provide a significant advantage over JAK inhibitors [66][68] Question: Manufacturing capabilities - The company is confident in its manufacturing capabilities and is exploring options for securing national priority vouchers [74][75] Question: Placebo effect minimization strategies - The company plans to implement strategies to minimize placebo effects in the phase 3 study, similar to those used in the phase 2b study [76][77]
Nektar(NKTR) - 2025 Q3 - Quarterly Report
2025-11-06 22:58
Drug Development and Clinical Trials - Nektar Therapeutics is focused on developing innovative immunomodulatory agents for autoimmune diseases and cancer, with significant investments in its drug pipeline[134] - The Phase 2b REZOLVE-AD trial for rezpegaldesleukin showed statistically significant improvement in Eczema Area and Severity Score (EASI) at week 16, with p<0.001 for all dose arms compared to placebo[139] - In the REZOLVE-AD trial, 73% of patients treated with NKTR-255 achieved a complete response rate at six months, compared to 50% for the placebo group[146] - Rezpegaldesleukin has received Fast Track designation from the FDA for treating moderate-to-severe atopic dermatitis and severe-to-very severe alopecia areata[136] - Nektar Therapeutics has entered into a collaboration agreement with TrialNet to evaluate rezpegaldesleukin in patients with new onset stage 3 type 1 diabetes mellitus[136] - The company is advancing its lead research program on TNFR2 agonism, with the first drug candidate NKTR-0165 entering IND enabling studies in 2024[143] - Nektar Therapeutics is on track for topline data readout from the Phase 2b RESOLVE-AA study in December 2025[142] Financial Performance - Total revenue for the three months ended September 30, 2025, was $11.79 million, a decrease of 51% compared to $24.12 million in the same period of 2024[156] - Product sales were $0 for the three months ended September 30, 2025, down from $8.02 million in 2024, representing a 100% decline[156] - Research and development expenses for the three months ended September 30, 2025, were $27.25 million, a decrease of 22% from $35.03 million in 2024[156] - The net loss for the three months ended September 30, 2025, was $35.52 million, compared to a net loss of $37.06 million in 2024, reflecting a 4% improvement[156] - Non-cash royalty revenue for the three months ended September 30, 2025, was $11.49 million, down 27% from $15.73 million in 2024[156] - Total operating costs and expenses for the three months ended September 30, 2025, were $43.46 million, a decrease of 26% from $58.47 million in 2024[156] - Research and development expenses for the nine months ended September 30, 2025, were $87.62 million, a decrease of 5% from $92.16 million in 2024[158] - Research and development expense for NKTR-0165 is expected to increase slightly for the full year 2025 compared to 2024 due to IND enabling activities[165] - Research and development expense for NKTR-255 decreased for the three and nine months ended September 30, 2025, and is expected to decrease for the full year 2025 compared to 2024 as the Phase 2 study has been completed[166][167] - Total research and development expense is expected to increase slightly for the full year 2025 compared to 2024, driven by activities for a Phase 3 trial for rezpegaldesleukin and continued development of NKTR-0165[169] Cash and Investments - Cash and investments in marketable securities as of September 30, 2025, totaled approximately $270.2 million[151] - The company completed a public offering on July 2, 2025, raising approximately $107.2 million from the sale of 4,893,618 shares at $23.50 per share[152] - The company issued 600,198 shares under the ATM Sales Agreement at a weighted average price of $59.24 per share, generating net proceeds of $34.3 million[153] - In September and October 2025, the company issued 1,273,923 shares under the ATM Sales Agreement for net proceeds of $72.5 million[187] - The company has received $1.9 billion in total consideration from collaboration agreements, including a $150.0 million upfront payment from Eli Lilly for rezpegaldesleukin[188] Operational Challenges and Risks - The company faces significant uncertainties and risks related to clinical and regulatory outcomes for its drug candidates, including potential higher-than-anticipated expenses[189] - The San Francisco Bay Area office lease market is weak, impacting the company's ability to sublease its laboratory and office spaces, leading to uncertainty regarding economic terms[192] - The company has no credit facility or committed capital sources, and future financing options depend on the success of drug development programs and market conditions[190] - The company expects cash flows used in operating activities to increase for 2025 compared to 2024, excluding any upfront or milestone payments[194] - Cash flows used in operating activities for the nine months ended September 30, 2025, totaled $143.6 million, compared to $129.5 million for the same period in 2024, indicating an increase in cash outflows[194] - The company has not experienced liquidity issues with its investments in marketable securities, which are generally held to maturity of less than two years[193] Accounting and Market Risks - There have been no material changes to the company's critical accounting policies and estimates since the last annual report[199] - Market risks as of September 30, 2025, have not changed materially from those discussed in the previous annual report[201] - The company is evaluating its estimates and assumptions on an ongoing basis, which may differ from actual results under different conditions[198]
Nektar(NKTR) - 2025 Q3 - Quarterly Results
2025-11-06 21:24
Financial Performance - Revenue for Q3 2025 was $11.8 million, a decrease of 51% compared to $24.1 million in Q3 2024[5] - Net loss for Q3 2025 was $35.5 million, or $1.87 per share, compared to a net loss of $37.1 million, or $2.66 per share in Q3 2024[11] - Total revenue for the three months ended September 30, 2025, was $11.79 million, a decrease of 51% compared to $24.12 million in the same period of 2024[24] - The net loss for the three months ended September 30, 2025, was $35.52 million, compared to a net loss of $37.06 million in the same period of 2024[24] - Basic and diluted net loss per share for the three months ended September 30, 2025, was $1.87, an improvement from $2.66 in the same period of 2024[24] - Total revenue for the nine months ended September 30, 2025, was $33.43 million, a decrease of 51.7% compared to $69.25 million in the same period of 2024[24] Operating Costs - Total operating costs and expenses in Q3 2025 were $43.5 million, down 26% from $58.5 million in Q3 2024[6] - Total operating costs and expenses for the three months ended September 30, 2025, were $43.46 million, down from $58.47 million in the same period of 2024, indicating a reduction of 25.6%[24] Research and Development - R&D expenses in Q3 2025 were $27.3 million, a reduction of 22% compared to $35.0 million in Q3 2024[7] - Research and development expenses for the nine months ended September 30, 2025, were $87.62 million, compared to $92.16 million for the same period in 2024, reflecting a decrease of 5.5%[24] Cash and Investments - Cash and investments in marketable securities as of September 30, 2025, were $270.2 million, slightly up from $269.1 million on December 31, 2024[3] - The company expects its cash and investments to support operations into the second quarter of 2027[3] Equity Method Investment - Non-cash losses from the equity method investment in Gannet BioChem were $0.5 million in Q3 2025 and $7.4 million for the first nine months of 2025[10] - Loss from equity method investment for the nine months ended September 30, 2025, was $(7.38) million, with no loss reported in the same period of 2024[24] Liabilities - Total liabilities decreased to $216.3 million as of September 30, 2025, from $243.1 million on December 31, 2024[21] Regulatory and Research Updates - The FDA granted Fast Track designation for rezpegaldesleukin for severe-to-very-severe alopecia areata in July 2025[17] - The company will present new findings from the REZOLVE-AD study at the ACAAI Scientific Meeting on November 8, 2025[12] Non-Operating Income - Non-operating income (expense), net for the three months ended September 30, 2025, was $(3.35) million, compared to $(2.70) million in the same period of 2024[24] Share Information - The weighted average shares outstanding used in computing basic and diluted net loss per share increased to 18,946,559 for the three months ended September 30, 2025, from 13,949,851 in the same period of 2024[24] Royalty Revenue - Non-cash royalty revenue related to future royalties was $11.49 million for the three months ended September 30, 2025, down from $15.73 million in the same period of 2024[24]
Nektar Therapeutics to Participate in the Jefferies Global Healthcare Conference in London
Prnewswire· 2025-10-30 22:00
Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases [3] - The company's lead product candidate, rezpegaldesleukin (REZPEG or NKTR-358), is a first-in-class regulatory T cell stimulator currently in two Phase 2b clinical trials for atopic dermatitis and alopecia areata, as well as a Phase 2 trial for Type 1 diabetes mellitus [3] - Nektar's pipeline includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody, bispecific programs NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422 [3] - The company is also evaluating NKTR-255, an investigational IL-15 receptor agonist aimed at enhancing the immune system's ability to combat cancer, in several ongoing clinical trials [3] Upcoming Events - Nektar Therapeutics will participate in the Jefferies Global Healthcare Conference from November 17-20, 2025, in London, with a webcast scheduled for November 20, 2025, at 11:00 a.m. GMT / 3:00 a.m. PT [1] - A replay of the presentation will be available for 30 days following the event [1] Financial Information - The company is set to announce its financial results for the third quarter on November 6, 2025, after the close of U.S.-based financial markets [5]
Nektar to Announce Financial Results for the Third Quarter on Thursday, November 6, 2025, After Close of U.S.-Based Financial Markets
Prnewswire· 2025-10-28 22:00
Core Insights - Nektar Therapeutics will announce its third-quarter financial results on November 6, 2025, after U.S. market close, with a conference call hosted by CEO Howard Robin at 5:00 p.m. Eastern Time [1] - The conference call will be accessible via a link on Nektar's website, with a replay available until December 6, 2025 [2] Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases [3] - The lead product candidate, rezpegaldesleukin (REZPEG or NKTR-358), is a first-in-class regulatory T cell stimulator currently in two Phase 2b clinical trials for atopic dermatitis and alopecia areata, as well as a Phase 2 trial for Type 1 diabetes mellitus [3] - Nektar's pipeline includes a preclinical bivalent TNFR2 antibody, bispecific programs NKTR-0165 and NKTR-0166, and a modified CSF protein NKTR-422 [3] - The company is also evaluating NKTR-255, an investigational IL-15 receptor agonist aimed at enhancing the immune system's ability to combat cancer, in several ongoing clinical trials [3]
San Francisco is making a comeback. So are these stocks from the City by the Bay
CNBC· 2025-10-28 16:36
Core Insights - The search for profitable stocks in San Francisco revealed unexpected results, with a focus on biotech and other sectors rather than solely A.I. related companies [1][2] Company Performance - Nektar Therapeutics (NKTR) is the top performer, with a 150% increase in the past 90 days, focusing on treatments for dermatitis and Alopecia areata, with a bullish price target of $93.60 from analysts [5] - Sunrun (RUN), a solar power company, has doubled in value over three months, experiencing significant volatility, with shares fluctuating from $6 to above $20 [6] - The RealReal (REAL), a resale company for luxury items, is trading slightly above the median price target set by analysts, indicating potential caution for investors [7] - Planet Labs (PL), an 'earth intelligence' company, has seen its stock nearly double in a year, with sales more than doubling over the last four years, though it has experienced volatility [8] - Other notable companies include Fastly (FSLY), Maze Therapeutics (MAZE), Olema Pharmaceuticals (OLMA), Septerna (SEPN), and Cytokinetics (CYTK), all of which have performed well recently, particularly in the biotech sector [9]