Nektar Therapeutics Q2 FY2025 earnings call

Key Points

• Howard Robin highlighted the second quarter 2025 was transformative for Nektar, with REZPEG showing compelling initial data in atopic dermatitis. In October 2023, a 400-patient Phase IIb study for REZPEG in moderate to severe atopic dermatitis was initiated. REZOLVE-AD study results validated Nektar's novel approach to accessing Tregs. FDA Fast Track designation for atopic dermatitis and alopecia was granted. Plans to present patient-reported outcome data from REZOLVE-AD in 2025 and report alopecia areata Phase IIb study data in December 2025.
• Jonathan Zalevsky discussed REZOLVE-AD study details, including 393-patient enrollment, primary endpoint achievement, and plans for data presentation in 2026. Mentioned alopecia areata Phase IIb trial completion of enrollment and expected top line results in December 2025. Also, spoke about type 1 diabetes Phase II trial and TNFR2 agonist antibody programs (NKTR-0165, NKTR-0166).

No detailed product segment financial performance with revenue contribution % provided in the transcript.

Financial Guidance

• End of 2025 cash and investments expected to be $180 million to $185 million.
• Full year 2025 noncash royalty revenue expected to be approximately $40 million.
• R&D expense for full year 2025 expected to range between $125 million and $130 million.
• G&A expense for full year 2025 expected to be between $70 million and $75 million.
• Noncash interest expense for 2025 expected to total approximately $20 million.
• Noncash loss from equity method investment for full year 2025 expected to be approximately $10 million.
• Cash runway extended into Q1 2027.

No detailed discussion of specific risks beyond the standard forward-looking statement disclaimer noting uncertainties and risks subject to change, with important risks in Form 10-Q filed on May 9, 2025.

Q: Have you started to engage with regulators with the 16-week data and thoughts on trial design and partnership opportunity for REZPEG in AD?

A: Ongoing engagement with regulators, end of Phase II meeting planned before end of 2025. Trial design includes 2 monotherapy studies and long-term extension study, with plan to include biologic experienced patients. Actively talking to partners about REZPEG collaboration, including strategics and financial partners.

Q: Walk us through thought process around competitor product profile for alopecia areata and upcoming AA readout?

A: Alopecia areata has no approved biologics with sustained treatment effect. JAK inhibitors have liabilities. REZPEG's Phase IIb trial in alopecia areata expects top line results in December 2025, using SALT score as primary endpoint and SALT 20/10 as registrational endpoints, benchmarking against JAK inhibitors' performance.

Q: What underpins confidence REZPEG will be active in biologic experienced atopic derm?

A: REZPEG's mechanism is a cellular agonist, not an antagonist, with breadth to block multiple polarized T cell inflammation, no overlap or contra to post-IL-13 biology, giving confidence in activity in biologic experienced patients.

Q: Thoughts on pivotal study for REZPEG in AD including biologic experienced patient cohort and induction efficacy primary endpoint duration?

A: Phase III program plans 52-week studies, with end of Phase II meeting to clarify induction duration and maintenance regimen. Phase IIb study design allows assessment of deepening responses beyond 16 weeks, with potential for longer induction endpoints and remittive potential assessment through treatment withdrawal components.

Q: Updates on studies to understand ISRs and strategies for mitigating them?

A: Using primary skin organoid cultures to study ISRs related to IL-2 pathways. Launching with prefilled syringe and auto-injector to standardize administration, which should mitigate ISRs. Injection site reactions observed were mild to moderate and self-resolving, not a major marketing barrier.