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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

- **Breakthrough AD Data**: REZPEG achieved statistical significance in EASI-50/75 with fast onset, positioning for Phase III in 2026.
- **Market Expansion**: Targeting $30B AD and $2B AA markets, addressing 50% IL-13 failure rate with differentiated Treg mechanism.
- **Financial Strength**: $180-185M cash by year-end, runway to Q1 2027, supporting Phase III and pipeline growth.
- **Strategic Moves**: Exploring partnerships for non-dilutive funding, with auto-injector to mitigate ISRs.

**【CEO Summary Section】**
- Highlighted the transformative Q2 2025 with REZPEG's Phase IIb data in atopic dermatitis (AD) and alopecia areata (AA), showing statistical significance in EASI-50/75 and safety profiles.
- Announced Fast Track Designations for AD and AA, positioning REZPEG for Phase III in 2026.
- Emphasized market potential with AD at $15B (projected $30B by 2033) and AA at $2B by 2033, targeting both biologic-naive and experienced patients.
- Financial update: $115M equity financing extending cash runway to Q1 2027.

**【CFO Financial Commentary】**
- Q2 2025 cash: $175.9M; net loss $41.6M ($2.95 EPS), with non-GAAP loss $39.2M ($2.78 EPS).
- R&D expenses: $29.9M (Q2), full-year guidance $125-130M; G&A: $17.1M (Q2), full-year $70-75M.
- Extended cash runway to Q1 2027, supporting Phase III readiness and pipeline expansion.

**【Q&A Highlights】**
- **Regulatory & Trial Design**: Planning Phase III with biologic-naive and experienced cohorts, aiming for broad label. End-of-Phase II meeting with FDA scheduled for late 2025.
- **Partnership Strategy**: Exploring collaborations for non-dilutive capital, including potential monetization of dapimab equity stake.
- **Alopecia Data Catalysts**: Phase IIb AA results expected in Dec 2025, focusing on SALT score improvements and durability.
- **Injection Site Reactions (ISRs)**: Mild/moderate, self-resolving; auto-injector to mitigate variability in administration.
- **Litigation Update**: Committed to pursuing Lilly lawsuit, with REZPEG data reinforcing program value.

Nektar Therapeutics (NKTR) Q2 2025 Earnings Call Transcript

- **REZPEG Clinical Momentum:** AD Phase 2b data in June 2025 could validate 16-week induction efficacy (83% EASI reduction in Phase 1b) and set up Phase 3 dosing. AA Phase 2b data in Dec 2025 may show durability vs JAK inhibitors. T1D trial starts in 2025 to test beta-cell preservation.
- **Financial Strength:** $220M cash runway to Q4 2026. 2025 R&D spend ~$115M, supporting multi-asset pipeline. Equity method loss (~$10M annual) non-cash.
- **Strategic Priorities:** Seek Phase 3 partner for REZPEG AD; advance TNFR2 bispecifics; defend IP against Lilly litigation.


**【CEO & JZ Clinical Update】**
- **REZPEG in Atopic Dermatitis (AD):** Phase 2b REZOLVE-AD study of 400 biologic-naïve patients to report 16-week induction data in June 2025. Key endpoints: EASI score change, EASI-75/90, and safety. Maintenance phase (36 weeks) to evaluate dosing intervals (Q4 vs Q12). Historical Phase 1b data showed 83% EASI reduction vs 47% placebo at 12 weeks, with remission signal at 36 weeks post-treatment.
- **Alopecia Areata (AA):** 90-patient Phase 2b REZPEG-AA study to report 36-week data in December 2025. Evaluates 24mcg/kg and 18mcg/kg Q2W vs placebo. Primary endpoint: SALT score improvement. JAK inhibitors (e.g., baricitinib) show rapid hair loss upon discontinuation, unlike REZPEG's Treg-modulating mechanism.
- **Type 1 Diabetes (T1D):** TrialNet-sponsored Phase 2 study to start in 2025, evaluating REZPEG in 66 new-onset T1D patients. Focus on beta-cell preservation via Treg modulation.
- **Pipeline Expansion:** NKTR-0165 (TNFR2 agonist) IND-enabling studies complete in 2025; NKTR-0166 bispecific program advancing preclinically. NKTR-255 (IL-15) data from Fred Hutchinson study to be presented at EHA 2025.

**【CFO Financial Update】**
- **Cash Position:** $220.7M as of Q1 2025, with no debt. Expect $100M cash runway into Q4 2026.
- **Revenue:** Q1 2025: $10.5M (royalty). Full-year guidance: ~$40M.
- **Expenses:**
  - R&D: $30.5M (Q1); full-year $110-120M (includes $5-10M non-cash).
  - G&A: $24.3M (Q1); full-year $60-65M (includes $5-10M non-cash).
  - Non-cash interest: ~$20M annualized.
- **Equity Method Loss:** Q1 2025: $4.5M (HLBV accounting for Gannett Biochem stake). Full-year ~$10M non-cash loss.

**【Key Q&A Highlights】**
- **REZOLVE-AD Phase 2b Design:**
  - 3 dose arms (24mcg/kg Q2W, 18mcg/kg Q2W, 24mcg/kg Q1M) vs placebo (3:3:3:2). 67% enrollment outside U.S. to mitigate high placebo rates (47% in Phase 1b).
  - Maintenance phase: 36 weeks at original dose (Q4 or Q12). Escape arm for non-responders (24mcg/kg Q2W).
  - Long-term follow-up (12 months post-treatment) to assess remission.
- **Partnership Strategy:** Likely seek collaboration for Phase 3 given current cash runway. Aim to retain significant equity stake while minimizing dilution.
- **Litigation Update:** Ongoing litigation with Lilly over IL-13 patents. Nektar believes Lilly caused material harm and pursuing aggressive legal strategy. TrialNet sponsorship of T1D study unrelated to litigation outcome.


Nektar Therapeutics (NKTR)-8 May 25-2025 Q1 Earnings call transcript

- **REZPEG Clinical Momentum:** Phase 2b trials in atopic dermatitis (Q2 2025 data) and alopecia areata (Q4 2025 data) on track, with enrollment completed ahead of schedule.
- **New Indication Expansion:** TrialNet collaboration to evaluate REZPEG in type 1 diabetes, targeting beta cell preservation.
- **Financial Strength:** $269 million cash as of Q4 2024; 2025 cash runway extends into Q4 2026.
- **Efficacy Focus:** Targeting EASI-50+ response rates in AD, leveraging Treg mechanism for durability vs. IL-13/JAK inhibitors.
- **Market Opportunity:** ~15 million US AD patients with <10% treated; REZPEG's novel mechanism addresses unmet need.

**【CEO Opening Remarks】**
- Nektar achieved significant clinical milestones in 2024, completing enrollment for the Phase 2b REZOLVE-AD (atopic dermatitis) and REZOLVE-AA (alopecia areata) trials ahead of schedule.
- REZPEG, the company's lead IL-2 Treg agonist, is expected to report topline data from the 16-week induction phase of REZOLVE-AD in Q2 2025 and REZOLVE-AA in Q4 2025.
- The company maintains a strong financial position with $269 million in cash as of Q4 2024 and a cash runway extending into Q4 2026.

**【Brian Kotzin (Interim CMO) on Type 1 Diabetes】**
- Announced collaboration with TrialNet to evaluate REZPEG in a Phase 2 trial for new onset type 1 diabetes (n=66).
- TrialNet will fund and conduct the study, targeting patients with preserved beta cell function.
- REZPEG's mechanism of boosting regulatory T cells (Tregs) is hypothesized to slow disease progression by preserving insulin-producing beta cells.

**【Jonathan Zalevsky (R&D Lead) on Clinical Trials】**
- **REZOLVE-AD (Atopic Dermatitis):**
  - 400-patient trial completed enrollment in 14 months, with 17% US recruitment to mitigate rising placebo effects.
  - Patients stratified by geography (67% Europe, 17% US) and disease severity.
  - Primary endpoint: EASI-50 at 16 weeks; maintenance phase (36 weeks) evaluates durability.
  - Fast Track designation granted by FDA for moderate-to-severe atopic dermatitis.
- **REZOLVE-AA (Alopecia Areata):**
  - 90-patient trial completed enrollment in 12 months, with 62% recruited in Poland.
  - Primary endpoint: SALT score improvement at 36 weeks.
  - Targeting severe-to-very-severe patients (SALT 50-100) with at least 6 months of disease duration.

**【Sandra Gardiner (CFO) Financial Update】**
- **Q4 2024 Financials:**
  - Revenue: $29.2 million (Q4) / $98.4 million (FY24)
  - R&D Expenses: $28.7 million (Q4) / $120.9 million (FY24)
  - Net Income: $7.3 million (Q4) / Net Loss: $119 million (FY24)
- **2025 Guidance:**
  - Cash runway to extend into Q4 2026; ending FY2025 with ~$100 million in cash.
  - Revenue: $40-50 million (non-cash royalties)
  - R&D Expense: $110-120 million
  - G&A Expense: $60-65 million

**【Q&A Highlights】**
- **Efficacy Bar for Pivotal Development:**
  - Targeting EASI-50+ response rates comparable to Dupixent, with potential for higher durability due to Treg mechanism.
  - Phase 1b data showed 83% EASI improvement vs. 38% placebo.
- **Placebo Control Strategy:**
  - Limited US recruitment (17%) and strict eligibility criteria (stable disease, board-certified dermatologists) to minimize placebo response.
- **Biomarker Correlation:**
  - Translational markers (Treg expansion, IL-2 signaling) will be analyzed for correlation with clinical outcomes in Phase 2b trials.
- **Market Share Potential:**
  - Novel mechanism (IL-2 Treg agonism) differentiates REZPEG from IL-13 and JAK inhibitors; ~90% of moderate-to-severe AD patients remain untreated.


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