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Skye Bioscience, Inc. (SKYE)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally solid: enrollment in the CBeyond Phase 2a obesity trial was completed ahead of schedule; IRB approved a 52-week open-label extension; and three DSMB safety reviews raised no concerns .
  • Financially, R&D rose materially on trial execution; net loss widened to $11.1M; diluted EPS of $(0.28) modestly beat consensus of $(0.29); revenue remains non-existent for this development-stage program .
  • Guidance/timing: topline 26-week weight-loss data is expected late Q3/early Q4 2025; 52-week extension aims to bolster safety and durability; cash runway reiterated through at least Q1 2027 .
  • Strategic narrative: management emphasized nimacimab’s peripherally restricted CB1 mechanism, additive combo potential with GLP-1/GIP agonists, and tariff/manufacturing agility; formulation collaboration with Arecor seeks higher concentration to improve dosing convenience .

What Went Well and What Went Wrong

What Went Well

  • “We completed enrollment in our Phase 2a CBeyond Trial ahead of schedule,” positioning for a full topline read in late Q3/early Q4 and enabling a 52-week extension to strengthen safety/efficacy evidence .
  • Compelling preclinical data: nimacimab monotherapy showed ~23.5% weight loss; the nimacimab+tirezepatide combo reached >30% in DIO models; in vitro potency remained stable under elevated endocannabinoids vs. small-molecule CB1 inhibitors .
  • Safety oversight: DSMB has completed three reviews with no concerns; quarterly reviews continue, supporting risk management around neuropsychiatric AEs .

What Went Wrong

  • Higher OpEx: R&D expenses increased to fund Phase 2a trial and manufacturing; G&A ticked up on IR/marketing/consulting, widening net loss vs. prior-year period .
  • Macro/policy uncertainty: management flagged evolving U.S. drug pricing/regulatory leadership; CFO discussed potential tariff impacts and mitigation, introducing planning complexity despite limited near-term exposure .
  • External read-through risk: prior Novo monlunabant updates created negative stock read-through; management continues emphasis on mechanistic differentiation to reduce future misinterpretation risk .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
R&D Expenses ($USD Millions)$4.883 $7.793 $7.197
G&A Expenses ($USD Millions)$4.639 $4.623 $4.562
Net Loss ($USD Millions)$(3.898) $(9.746) $(11.103)
Diluted EPS ($USD)$(0.10) $(0.24) $(0.28)
Weighted Avg Shares - Diluted38,819,387 39,968,601 39,651,888
Cash and Cash Equivalents ($USD Millions)$67.413 $68.416 $46.421
Short-term Investments ($USD Millions)— — $12.803
Total Stockholders’ Equity ($USD Millions)$75.803 $68.152 $59.250

Notes:

  • The Q1 2025 consolidated statement shows operating loss equal to total operating expenses, with no revenue line reported (consistent with development-stage status) .

Estimates vs Actual (Q1 2025)

MetricEstimate*Actual
EPS ($USD)$(0.29)*$(0.28)
Revenue ($USD Millions)$0.0*N/A (no revenue line reported)

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Topline 26-week weight-loss data timing2025Q4 2025 targeted Late Q3/early Q4 2025 Accelerated (in Q4’24), Maintained in Q1’25
Interim analysis2025Interim data targeted Q2 2025 Removed due to faster enrollment Removed
52-week extension2025–2026Planned extension announced IRB approved; protocol finalized with FDA; enrollment prep ongoing Confirmed/Executing
Cash runwayThrough Q1 2027Through at least Q1 2027 Through at least Q1 2027 Maintained
DSMB safety reviewsOngoingTwo completed Three completed; no concerns Updated (positive)
Formulation/dosing2025+Advancing toward monthly dosing Arecor collaboration to develop higher concentration formulation Progress update

Earnings Call Themes & Trends

TopicQ3 2024 (Previous-2)Q4 2024 (Previous-1)Q1 2025 (Current)Trend
Peripheral CB1 mechanismDIO model showed dose-dependent weight loss; peripheral sufficiency emphasized Reiterated translational thesis; safety vs small molecules Mechanistic potency stable at high endocannabinoids; additive combo effect Reinforced differentiation
Enrollment/TimelinePhase 2 started; interim Q2’25; topline Q4’25 targeted Enrollment completed; interim removed; topline late Q3/early Q4’25 Reiterated topline timing; extension to 52 weeks Acceleration maintained
Safety/DSMBN/ATwo DSMB reviews; continue study Three DSMB reviews; no concerns Positive continuity
Combo with GLP-1Assess synergy with semaglutide in study Combo arm extended to 52 weeks Preclinical combo with tirzepatide >30% weight loss; clinical combo ongoing Strengthening evidence
Manufacturing/DosingScale-up; monthly dosing goal GMP runs, optimization underway Arecor collaboration for higher concentration formulation Execution progress
Regulatory/MacroN/AEngage on Phase 2b by 2026 Monitoring tariffs; supply chain flexibility; FDA protocol amendment clarified Active risk management

Management Commentary

  • “Nimacimab continues to demonstrate a differentiated profile as a potential weight loss therapy, with a peripherally restricted mechanism that may set it apart from both GLP-1s and small-molecule CB1 inhibitors.” — Punit Dhillon (CEO) .
  • “The combination with nimacimab produced 31.5% weight loss...nimacimab may offer the widest possible therapeutic window among CB1 inhibitors.” — Christopher Twitty (CSO) .
  • “Our current capital will fund operations and key clinical milestones through at least Q1 2027...” — Kaitlyn Arsenault (CFO) .
  • “We’re operating in a period of regulatory uncertainty...we have preserved flexibility in our supply chain and capital deployment planning.” — Punit Dhillon (CEO) .

Q&A Highlights

  • Upcoming data disclosures: ECO focus on PK/PD modeling supporting peripheral necessity; ADA to feature expanded biomarker and combination data packages .
  • Safety oversight: DSMB quarterly unblinded reviews include AEs of special interest (neuropsychiatric); next review scheduled mid-July; no concerns to date .
  • Efficacy expectations: Primary endpoint designed for 8% separation at 26 weeks; management targets >5% placebo-adjusted separation, aligning with new external data context .
  • Trial design/extension: 52-week open-label extension to strengthen safety/PK/PD modeling; combo arm continues blinded; DEXA scans longitudinally across extension .
  • Commercial framing: Monotherapy and combo opportunities viewed as relatively equal, billion-dollar markets; co-formulation potential acknowledged as future path post-proof-of-concept .

Estimates Context

  • Q1 2025 EPS was a modest beat: Actual $(0.28) vs consensus $(0.29); the company remains pre-revenue with no revenue line reported, while consensus revenue was $0.0, effectively in line .
  • R&D-driven OpEx trajectory likely pushes street to reaffirm cash runway confidence rather than near-term P&L leverage; focus remains on clinical outcomes and safety profile.
    Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Proof-of-concept catalyst: topline 26-week weight-loss data late Q3/early Q4 2025 is the pivotal stock driver; 52-week extension adds durability/safety evidence into 2026 .
  • Mechanism differentiation matters: peripherally restricted CB1 inhibition with strong in vitro potency under pathological endocannabinoid levels, plus additive combo effects, supports a differentiated risk/benefit vs small molecules .
  • Safety monitoring remains favorable: three DSMB reviews without concerns mitigate class risk perceptions into the topline read .
  • Operational readiness: GMP scale-up and Arecor collaboration to enhance formulation concentration support pathway to Phase 2b and potential dosing convenience .
  • Macro hedging: CFO’s tariff/supply chain commentary suggests planning agility; near-term exposure appears limited, reducing execution risk .
  • Financial runway: cash, equivalents, and short-term investments of $59.2M fund operations through at least Q1 2027, covering key readouts and Phase 2b manufacturing preparatory work .
  • Narrative evolution: continued emphasis on combo potential with incretin therapies and peripheral mechanism should help distinguish nimacimab as non-incretin adjunct/alternative in an increasingly crowded obesity market .