Skye Bioscience, Inc. (SKYE)·Q4 2024 Earnings Summary

Executive Summary

• Enrollment in the CBeyond Phase 2a obesity study for nimacimab was completed at 136 patients, enabling removal of the interim analysis and accelerating full 26-week top-line data to late Q3/early Q4 2025; dosing has been extended to 52 weeks to strengthen long-term safety/efficacy .
• Q4 operating cadence intensified: R&D expenses rose to $7.793M and G&A to $4.623M, driving Q4 net loss to $9.746M ($0.24 per share) versus $3.898M ($0.10) in Q3, with cash/equivalents at $68.416M at year-end .
• Cash runway updated to “through at least Q1 2027,” a shift from Q3’s “through Q3 2027,” reflecting increased near-term investment in the Phase 2 program and manufacturing preparations; CFO flagged Q4 burn at ~$8.1M .
• Management reiterated differentiation versus small-molecule CB1 inhibitors (neuropsychiatric profile) and highlighted growing strategic appetite for non-incretin mechanisms, positioning nimacimab for potential monotherapy and GLP-1 combo utility .
• Stock reaction catalysts: the accelerated timing for 26-week top-line efficacy, June 2025 ADA event with expanded preclinical package, and the 52-week extension data path into 1H 2026 .

What Went Well and What Went Wrong

What Went Well

• Enrollment exceeded plan (136 vs 120), enabling removal of the interim analysis and earlier full 26-week top-line readout; management: “we now expect final top line data… late Q3 or early Q4… allowing us to forgo the originally planned interim analysis” .
• Two DSMB reviews completed with continuation recommended, reinforcing safety monitoring cadence; management emphasized no neuropsychiatric signal in prior Phase I (4 weeks, >60 patients) and ongoing DSMB oversight .
• Manufacturing transfer/GMP runs underway, with optimization for potential monthly dosing; COO noted weekly is acceptable but monthly would aid adherence and COGS .

Quote: “We are enthusiastic about our updated clinical development plan, which will dramatically speed up our path to important 52-week treatment data… Robust data in 2025 and 2026 will be valuable…” — Punit Dhillon, CEO .

What Went Wrong

• Operating intensity drove higher quarterly loss: Q4 net loss was $9.746M vs $3.898M in Q3 (R&D $7.793M; G&A $4.623M), reflecting Phase 2 costs and stock-based comp/professional fees .
• Cash runway messaging shifted from Q3’s “through Q3 2027” to “through at least Q1 2027,” with CFO reiterating 2025 spending at least at Q4 levels as CBeyond progresses and CMC scales .
• Estimates context limited: S&P Global Wall Street consensus was unavailable at time of retrieval, constraining explicit “vs. estimates” benchmarking this quarter (see Estimates Context).

Financial Results

P&L, EPS, Cash

Notes:

• CFO disclosed operating cash burn averaged ~$6.3M per quarter in 2024, rising to ~$8.1M in Q4 .

Estimates vs Actual (Q4 2024)

KPIs (Clinical/Operational)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We now expect final top line data from all patients in late Q3 or early Q4… allowing us to forgo the originally planned interim analysis” — Punit Dhillon, CEO .
• “Our capital will fund our operations through at least the first quarter of 2027… runway currently excludes the Phase IIb and Phase III clinical study costs” — Kaitlyn Arsenault, CFO .
• “We are working to optimize nimacimab’s formulation and delivery to transition from weekly to monthly dosing” — Company statement .
• “Adding the open-label extension will allow us to reach deeper weight loss” — Christopher Twitty, CSO .

Q&A Highlights

• 52-week extension implications: management expects deeper weight loss trajectory; extension includes additional DEXA assessments at mid and end, preserving power with interim removal .
• DSMB oversight and safety: independent DSMB reviews quarterly with go/no-go; neuropsychiatric concerns linked to CNS exposure in small molecules (modeling shows CNS-driven AE risk) .
• Enrollment drivers: strong patient/investigator interest in alternative mechanisms; inclusion of combo arm; academic centers participation .
• Dosing cadence: weekly acceptable per KOLs; monthly dosing targeted for convenience and COGS benefits .
• Diabetes opportunity: mechanism suggests insulin sensitivity and metabolic pathway modulation; future diabetic studies anticipated .

Estimates Context

• S&P Global Wall Street consensus for Q4 2024 EPS and revenue was unavailable at time of retrieval due to access limits; therefore, “vs. estimates” comparisons are not provided this quarter. We will update when consensus is accessible.

Key Takeaways for Investors

• Nimacimab’s Phase 2a execution is ahead of schedule with a clean safety monitoring backdrop, elevating near-term data catalysts and reducing clinical timeline risk .
• The 52-week extension strengthens durability/safety read-through and supports regulatory engagement for Phase 2b in 1H 2026, potentially enhancing asset value ahead of partnering discussions .
• Operational intensity is rising (R&D/G&A), widening Q4 loss vs Q3; watch cash utilization into 2025 as manufacturing scales and the ADA event approaches .
• Runway messaging narrowed to at least Q1 2027; monitor burn trajectory and potential business development to extend cash horizon through Phase 2b/3 needs .
• Differentiation vs small-molecule CB1 remains core to the thesis (peripheral restriction, neuropsych profile), with non-incretin deal flow/macro favorably framing alternative mechanisms .
• Near-term trading setup hinges on: June ADA preclinical package, clarity on monthly dosing feasibility, and confirmation of accelerated 26-week data window late Q3/early Q4 2025 .
• Absence of consensus estimates limits beat/miss framing; focus on operational milestones and safety updates as primary stock drivers this quarter.

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