rezpegaldesleukin (rezpeg)

Search documents
Nektar Q2 Loss Narrower Than Expected, Revenues Fall Y/Y
ZACKS· 2025-08-08 16:46
Core Insights - Nektar Therapeutics reported a narrower loss of $2.95 per share for Q2 2025, compared to a loss of $3.76 per share in the same quarter last year, and better than the Zacks Consensus Estimate of a loss of $3.13 [1][6] - Total revenues for Q2 2025 decreased by 52.4% year over year to $11.2 million, slightly exceeding the Zacks Consensus Estimate of $11 million, primarily due to the sale of the Huntsville manufacturing facility [2][6] - The company’s shares have increased by 56% year to date, outperforming the industry’s rise of 5.5% [2] Financial Performance - Research and development (R&D) expenses were $29.9 million, reflecting a year-over-year increase of approximately 0.7% [3] - General and administrative (G&A) expenses decreased by around 16.6% year over year to $17.1 million [3] - As of June 30, 2025, Nektar had cash and cash equivalents and marketable securities totaling $175.9 million, down from $220.7 million as of March 31, 2025 [3] Pipeline Developments - Nektar's lead pipeline candidate, rezpegaldesleukin (rezpeg), is being developed for various autoimmune and inflammatory diseases, with ongoing Phase IIb trials for atopic dermatitis and alopecia areata [7][8] - The Phase IIb REZOLVE-AD study for moderate-to-severe atopic dermatitis met its primary and key secondary endpoints in June 2025 [7] - The FDA granted Fast Track designation to rezpeg for treating severe-to-very severe alopecia areata, in addition to its previous designation for moderate-to-severe atopic dermatitis [8] Strategic Developments - Nektar regained full rights to rezpeg from Eli Lilly in April 2023, allowing the company to take charge of its clinical development without owing any royalty payments [9]
NKTR Stock Soars as Lead Drug Meets Goal in Atopic Dermatitis Study
ZACKS· 2025-06-25 16:31
Core Insights - Nektar Therapeutics announced that its phase IIb REZOLVE-AD study for rezpegaldesleukin (rezpeg) in treating moderate-to-severe atopic dermatitis met its primary and key secondary endpoints [1][7][8] Group 1: Study Results - The study achieved its primary endpoint of mean improvement in Eczema Area and Severity Score (EASI) from baseline for all three doses of rezpeg compared to placebo at week 16 [2][5] - All doses of rezpeg showed significant improvements in key secondary endpoints, including EASI-75, EASI-50, and mean improvement in Body Surface Area score at week 16 [5][6] - The highest dose of rezpeg also demonstrated statistical significance on EASI-90, indicating a 90% reduction in EASI scores for some patients [6] Group 2: Market Reaction - Following the announcement, Nektar's shares surged by 156.3% and gained an additional 6.8% in after-market trading [2][7] - Year-to-date, Nektar's shares have increased by 75.3%, contrasting with a slight decline of 0.1% in the industry [4] Group 3: Future Plans and Potential - The company plans to present the 16-week induction phase data from the REZOLVE-AD study at a medical conference in 2025 [8] - Management highlighted the potential of rezpeg to become a first and best-in-class immune-modulator for inflammatory skin disorders and other autoimmune conditions [8][9] - Rezpeg is also being studied for alopecia areata, with top-line data expected in the fourth quarter of 2025 [10][11] Group 4: Ownership and Development - Nektar regained full rights to rezpeg from Eli Lilly in April 2023, allowing the company to take charge of its clinical development without royalty payments [11][12]
Nektar Q1 Loss Wider Than Expected, Revenues Fall Y/Y, Stock Down
ZACKS· 2025-05-09 14:10
Core Viewpoint - Nektar Therapeutics reported a wider-than-expected adjusted loss in Q1 2025, with significant revenue decline attributed to the sale of its manufacturing facility, leading to a reliance on non-cash royalty revenues [1][2]. Financial Performance - The adjusted loss per share for Q1 2025 was 22 cents, compared to the Zacks Consensus Estimate of an 18-cent loss and a loss of 18 cents in the same quarter last year [1]. - Total revenues for Q1 2025 decreased by 51.4% year-over-year to $10.5 million, missing the Zacks Consensus Estimate of $18 million [1]. - Research and development (R&D) expenses rose to $30.5 million, an increase of approximately 11.3% year-over-year [4]. - General and administrative (G&A) expenses increased by around 20.9% year-over-year to $24.3 million [4]. - As of March 31, 2025, the company had cash and cash equivalents and marketable securities totaling $220.7 million, down from $269.1 million as of December 31, 2024 [4]. Guidance - Nektar anticipates revenues for the remaining three quarters of 2025 to be similar to Q1 levels, projecting total revenues of around $40 million for the full year [5]. - R&D costs for 2025 are expected to range between $110 million and $120 million, while G&A expenses are anticipated to be in the $60-$65 million range [5]. - The company expects to end 2025 with approximately $100 million in cash and investments, which is projected to fund operations into the fourth quarter of 2026 [6]. Pipeline Developments - Nektar's lead pipeline candidate, rezpegaldesleukin (rezpeg), is being developed for various autoimmune and inflammatory diseases, with the company regaining full rights from Eli Lilly in April 2023 [7][8]. - Two phase IIb studies are currently evaluating rezpeg for atopic dermatitis and alopecia areata, with top-line data expected in the coming months [9]. - A new clinical trial agreement was established in February 2025 to evaluate rezpeg in a phase II study for new-onset type 1 diabetes mellitus, expected to start later this year [10]. - Nektar also has two pre-clinical programs, NKTR-0165 and NKTR-0166, with plans to submit an investigational new drug application for NKTR-0165 by the end of 2025 [11].