Skye Bioscience (SKYE) Q4 2025 earnings summary

Executive summary

• Advanced CBeyond program for nimacimab, a first-in-class peripheral CB1 antibody, demonstrated additive and durable weight loss with favorable tolerability in combination with GLP-1 therapies over 52 weeks, including a 22.3% mean weight loss and no plateau observed.

• Initiated higher-dose CBeyond Expansion Study (400 mg and 600 mg IV) to optimize peripheral tissue exposure and efficacy, with subcutaneous delivery planned for Phase IIb using Halozyme's ENHANZE technology.

• Received FDA feedback on Phase IIb trial design, refining dose, duration, endpoints, and inclusion criteria, and aligning with regulatory expectations for combination therapies.

• Demonstrated durable weight loss and improved body composition in off-therapy analysis, with combination therapy showing less weight regain and maintenance of fat mass loss.

• Unveiled early data on a novel antibody-peptide conjugate (APC) platform, achieving combination-like efficacy in a single molecule and expanding the R&D pipeline.

Financial highlights

• Ended 2025 with $25.7 million in cash equivalents and short-term investments, expected to fund operations through Q4 2026, excluding full Phase IIb costs.

• R&D expenses for Q4 2025 were $11.5 million, up from $7.8 million in Q4 2024; full-year R&D expenses rose to $42.4 million from $18.7 million year-over-year, mainly due to manufacturing and clinical trial costs.

• G&A expenses for Q4 2025 were $3.4 million, down from $4.6 million in Q4 2024; full-year G&A expenses decreased to $15.8 million from $17.7 million.

• Net loss for Q4 2025 was $14.4 million, compared to $9.7 million in Q4 2024; full-year net loss increased to $55.9 million from $26.6 million, primarily due to higher contract manufacturing costs.

Outlook and guidance

• Topline data from the CBeyond Expansion Study and final Phase IIb study design expected in Q4 2026.

• Anticipate completion of ENHANZE compatibility and high-concentration formulation feasibility in 2026.

• Advancing Phase IIb study to demonstrate additional weight loss in GLP-1 experienced adults, with ongoing manufacturing and supply chain readiness.

• Current capital expected to fund operations and key milestones through Q4 2026, excluding full Phase IIb clinical costs.