Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Nektar Therapeutics (NKTR, Financial) made significant progress in advancing its pipeline focused on immunology and inflammation, particularly with its lead asset REZPEG.
- Enrollment for the Phase 2 study of REZPEG in Atopic Dermatitis is on track, with a top-line data readout expected in the first half of 2025.
- The company announced a strategic divestiture of its manufacturing facility, which will streamline operations and bolster its financial position, extending its cash runway into the fourth quarter of 2026.
- Nektar 255, an IL-15 program in oncology, showed promising results in enhancing CAR T cell therapies and demonstrated potential in recovering radiation-induced lymphopenia.
- The company has a strong financial position with $249 million in cash and investments, and no debt, further strengthened by the sale of its manufacturing facility for $90 million.
Negative Points
- The ongoing litigation against Eli Lilly remains unresolved, with no specific timeline for when damages might be publicly specified.
- The Phase 2b study for REZPEG in Alopecia Areata has experienced a timing shift, with data now expected in the second half of 2025.
- The company faces challenges in predicting efficacy in biologically experienced patients, as current trials are focused on biologic-naive patients.
- There is uncertainty regarding the long-term effects of REZPEG, as proteomic results beyond the induction period are not yet available.
- The company reported a net loss of $37 million for the third quarter of 2024, highlighting ongoing financial challenges despite a strong cash position.
Q & A Highlights
Q: Can you provide more color on the enrollment progress for the atopic dermatitis and alopecia areata studies?
A: Mary Tagliaferri, Chief Medical Officer: We started the atopic dermatitis trial in October 2023 and expect top-line data in the first half of 2025. We will update the status on clinicaltrials.gov once enrollment is complete. The Phase 1 study was in biologic-naive patients, and we have continued this approach in the Phase 2b study. It's too early to predict efficacy in biologically experienced patients.
Q: When could damages be publicly specified in the ongoing litigation against Eli Lilly?
A: Howard Robin, President and CEO: We can't comment on ongoing litigation specifics. We are in mediation and believe we have a strong case. However, I can't provide a timeline for when damages will be specified.
Q: Can you remind us of the protocol for topical steroid use in the Phase 2b atopic dermatitis trial?
A: Mary Tagliaferri, Chief Medical Officer: This is not a combination trial. Patients must wash out of topical corticosteroids before enrolling and cannot use them during the study. Use of rescue medication after the first two weeks leads to discontinuation from the study.
Q: Can you provide some color on the patient baseline characteristics in the atopic dermatitis trial?
A: Mary Tagliaferri, Chief Medical Officer: The study is fully blinded, and we are not reviewing aggregated data at this time. We will provide clear baseline characteristics and top-line data for the different doses compared to placebo once available.
Q: Regarding the alopecia areata study, why has the timing shifted to the second half of 2025?
A: Mary Tagliaferri, Chief Medical Officer: The trial began about five months after the atopic dermatitis study. We are enrolling in the US, Canada, and Europe. The timing shift is due to the longer process of bringing European sites online, but we are on track to have data in the second half of 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
