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- **Phase IIa Results Stand Out**: Nimasimab + semaglutide delivered 3% additional weight loss (p=0.0372) with no safety issues.
- **Durability Advantage**: 18% weight regain vs. 50% for semaglutide alone, supporting maintenance potential.
- **Higher Doses Key**: PK/PD modeling shows efficacy improves with exposure; Phase IIb combo study to define optimal dose.
- **CMC Progress**: Scalable manufacturing and cost optimization on track for commercial readiness.
- **Positive KOL Feedback**: Physicians highlight nimasimab's differentiated mechanism and safety profile.

**【CFO Financial Commentary】**
- Cash and cash equivalents: $35.3 million, providing runway into 2027 for Phase IIa extension and manufacturing activities.
- R&D expenses: $9.4 million (Q3 2025) vs. $4.9 million (Q3 2024), driven by clinical trial costs, contract manufacturing, and discovery R&D.
- G&A expenses: $3.9 million (Q3 2025) vs. $4.6 million (Q3 2024), down due to reduced consulting fees and recruitment costs.
- Net loss: $12.8 million (Q3 2025), including $1.9 million in share-based compensation.

**【CEO Clinical Update and Strategy】**
- **Phase IIa CB1 Study Results**: Nimasimab + semaglutide achieved 3% additional weight loss (p=0.0372) vs. semaglutide alone, with no neuropsychiatric or additive GI adverse events.
- **Body Composition Benefits**: Improved lean-to-fat mass ratio (0.26 vs. 0.13, p=0.0126) and reduced waist circumference (3.17 cm, p=0.0492).
- **Durability**: 18% weight regain (2.3 kg) vs. 50% (4.7 kg) for semaglutide alone (p=0.006).
- **Extension Study**: 43 patients enrolled (300 mg monotherapy, 200 mg combo), with data expected Q1-Q2 2026.
- **CMC Progress**: High-concentration formulations on track, cost optimization efforts underway.
- **R&D Validation**: Preclinical data confirms nimasimab's fat-selective mechanism and durability.

**【Q&A Highlights】**
- **Dose-Response Relationship**: Higher doses correlate with greater efficacy; Phase IIb combo study to evaluate optimal dose.
- **Extension Study Sample Size**: 43 patients sufficient for PK/PD modeling, not powered for statistical significance.
- **Regulatory Path**: Potential for monotherapy and maintenance approvals; discussions with agencies ongoing.
- **Rebound Data**: Nimasimab's durability differentiates it from GLP-1s, with 18% regain vs. 50% for semaglutide.
- **Safety Concerns**: No CNS adverse events observed; GI tolerability comparable to placebo.
- **KOL Feedback**: Enthusiasm for nimasimab's safety profile and potential in maintenance therapy.

Skye Bioscience, Inc. (SKYE) Q3 2025 Earnings Call Transcript

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SKYE

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