NEKTAR THERAPEUTICS Q4 FY2024 earnings call

Clinical Trials - REZPEG

• Completed enrollment in REZOLVE-AD Phase 2b trial in atopic dermatitis in under 14 months, with topline data from 16-week induction period expected in June 2025. REZPEG granted Fast Track designation by FDA for atopic dermatitis. The REZOLVE-AD study randomized ~400 biologic-naive patients with moderate to severe atopic dermatitis across three dosing regimens of REZPEG or placebo. Enrollment was from ~110 sites globally, with 67% in Europe, 17% in US, and others in Canada/Australia.
• Completed enrollment in REZOLVE-AA Phase 2b study in alopecia areata with 90 patients, with topline data from 36-week treatment period expected in Q4 2025. The trial recruited patients across ~30 global sites, with 62% in Poland, 24% in Canada, and rest in US.

Preclinical Programs

• Advanced TNFR2 agonist antibody program NKTR-0165, with IND-enabling studies ongoing and plan to submit IND in second half of 2025. Also designing bispecific molecules pairing TNFR2 agonism with other targets, with first bispecific to be ready for IND-enabling studies next quarter.
• NKTR-255 oncology program showed potential in combination with CAR T-cell therapy and checkpoint inhibitors, with ongoing collaborations to evaluate in various cancer indications.

In the fourth quarter of 2024, Nektar Therapeutics had revenue of $29.2 million. For the full year 2024, revenue was $98.4 million. R&D expenses in Q4 2024 were $28.7 million, and full year R&D expenses were $120.9 million. G&A expenses in Q4 2024 were $17.1 million, with full year G&A expenses at $76.8 million. Net income for Q4 2024 was $7.3 million, while the full year 2024 resulted in a net loss of $119 million. The company sold its Huntsville manufacturing facility on December 02, 2024, for $64.7 million in cash (net of transaction costs) and retained approximately 20% equity ownership in Gannet BioChem.

Financial Guidance for 2025

• Revenue expected to be between $40 million and $50 million, primarily non-cash royalties.
• Cash runway expected to extend into Q4 2026, with plan to end 2025 with approximately $100 million in cash and investments.
• R&D expense预计在$110 million到$120 million之间, including ~$5M-$10M non-cash depreciation and stock-based comp.
• G&A expense预计在$60 million到$65 million之间, including ~$5M-$10M non-cash depreciation and stock-based comp.
• Non-cash interest expense预计在$15 million到$20 million之间.

Q: Yasmeen Rahimi asked about dose response across three-dose arms in REZOLVE-AD and criteria for patients to move from induction to maintenance phase.

A: Jonathan Zalevsky responded that the dose response was addressed with three cohorts considering dose level and regimen, with 24 mcg/kg twice a month, 24 mcg/kg once a month, and 18 mcg/kg twice a month. For moving from induction to maintenance, patients with EASI-50 or better response are eligible.

Q: Julian Harrison asked about efficacy bar for REZPEG to advance to pivotal development and differences in dapirolizumab vs litifilimab.

A: Jonathan Zalevsky said they expect to replicate Phase 1b results, seeing both separation from placebo and efficacy in range of standard of care. Dapirolizumab and litifilimab have different mechanisms of action, with dapirolizumab targeting CD40 ligand and litifilimab BDCA2 inhibitor.

Q: Jay Olson asked about timing of interim PFS results from JAVELIN Bladder Medley study and expectations.

A: Jonathan Zalevsky said results expected in middle of 2025, event-driven, aiming to improve PFS and OS compared to single agent Bavencio.

Q: Roger Song asked about patient baseline in REZOLVE-AD and impact on placebo arm.

A: Jonathan Zalevsky mentioned preference for baseline EASI in range of 25-30 to lower placebo response, and they took steps like limiting US sites, focusing on experienced dermatologists/immunologists, and multiple EASI measurements to protect against high placebo response.

Q: Mayank Mamtani asked about screen failure rate, escape arm structure in REZOLVE-AD, and translational markers in AD and AA studies.

A: Jonathan Zalevsky said screen failure rate details would be shared later, escape arm allows patients not meeting EASI-50 criteria at 16 weeks to enter 24 mcg/kg twice a month dose, and translational markers include biomarkers measured in both studies with plans to incorporate in future trials.

Q: Eric (on for Chris Shibutani) asked about biomarker translatability and plans to incorporate in future trials.

A: Jonathan Zalevsky said Phase 1b study had descriptive biomarker analysis, Phase 2b study is larger and optimized for correlative analysis, with plans to dive deeper into translational molecular phenotype and incorporate biomarkers in future trial designs.