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- **REZPEG Clinical Momentum**: Phase IIb data in atopic dermatitis and alopecia areata set for December 2025 readouts, with potential Phase III starts in 2026.
- **Treg Innovation**: Unique IL-2 signaling mechanism addresses unmet needs in autoimmune diseases, highlighted by Nobel Prize recognition.
- **Financial Strength**: $240 million cash balance extends runway to Q2 2027, supporting dual-track development of REZPEG and pipeline assets.
- **Strategic Differentiation**: REZPEG's safety profile and remittive potential position it as a first-in-class biologic in multiple indications.

**【CEO Summary Section】**
- Reintroduced Mary Tagliaferri as Chief Medical Officer, emphasizing her role in advancing the Phase III program for REZPEG in atopic dermatitis.
- Highlighted the scientific breakthrough of REZPEG, which mimics natural IL-2 signaling to stimulate regulatory T cells (Tregs), achieving statistical significance in the Phase IIb RESOLVE-AD study.
- Announced the presentation of preplanned asthma comorbidity data at ACAAI 2025 and the 52-week maintenance data in Q1 2026.
- Discussed the potential for REZPEG to address unmet needs in alopecia areata, with Phase IIb results expected in December 2025.

**【CFO Financial Commentary】**
- Ended Q3 2025 with $270.2 million in cash, extending the cash runway to Q2 2027.
- R&D expenses for the year projected at $125-130 million, driven by clinical trials for REZPEG and early-stage pipeline programs.
- Noncash royalty revenue expected to total $40 million for the year, supporting the company's financial flexibility.

**【CRO Pipeline Update】**
- RESOLVE-AD Phase IIb: 393 patients showed statistically significant EASI-50 response at week 16, with 36-week maintenance data expected to demonstrate durability.
- RESOLVE-AA Phase IIb: 94 patients enrolled to evaluate REZPEG's efficacy in severe alopecia areata, with SALT 20 as the primary endpoint.
- TNFR2 agonist pipeline: Advanced a bispecific antibody program targeting Tregs and Bregs, with clinical trials planned for 2026.

**【Q&A Highlights】**
- **Asthma Comorbidity Data**: REZPEG improved asthma control in 25% of atopic dermatitis patients with asthma, outperforming IL-13 and OX40 inhibitors.
- **Alopecia Areata Strategy**: If Phase IIb meets low-dose Olumiant benchmarks, Phase III will leverage Fast Track designation for accelerated approval.
- **Safety Profile**: REZPEG's PEGylated IL-2 mechanism avoids JAK inhibitor black box warnings, positioning it as a safer long-term therapy.
- **Manufacturing**: Secured supply chain through Gannet BioChem and multiple CMOs, with auto-injector development for commercial launch.

Nektar Therapeutics (NKTR) Q3 2025 Earnings Call Transcript

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