Skye Bioscience (SKYE) Q4 2025 earnings summary

Executive summary

• Advanced nimacimab development with new data showing additive, durable weight loss and favorable tolerability in combination with GLP-1 therapies, supporting a differentiated, orthogonal mechanism for obesity treatment.

• Initiated CBeyond Expansion Study to evaluate higher IV doses (400 mg and 600 mg) to optimize peripheral tissue exposure and confirm safety, with parallel work on subcutaneous delivery using Halozyme's ENHANZE technology.

• Received FDA feedback on Phase IIb/2b trial design, informing dose, duration, endpoints, and inclusion criteria, and clarifying the registration path for combination therapy.

• Demonstrated durable weight loss, improved body composition, and less weight regain in off-therapy analysis for combination therapy compared to semaglutide alone.

• Unveiled early proof-of-concept data for the 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, cash equivalents, and short-term investments, expected to fund operations through Q4 2026, excluding full Phase 2b 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.

• 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 expected in Q4 2026, with interim updates on formulation and preclinical work throughout the year.

• Phase IIb/2b study design to be finalized after dose selection and regulatory input, with readiness for operational execution by year-end 2026.

• ENHANZE-enabled subcutaneous formulation to be ready for Phase IIb, with auto-injector targeted for Phase III.