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Skye Bioscience, Inc. (SKYE)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was a heavy investment quarter ahead of Phase 2a topline, with net loss widening to $17.6M and EPS of $(0.44) vs S&P Global consensus of $(0.30), a miss driven largely by manufacturing and clinical resupply costs for nimacimab and Phase 2b preparations . EPS consensus values marked with an asterisk are from S&P Global.*
  • Cash and short-term investments were $48.6M, and management reiterated runway “through at least Q1 2027,” supporting completion of Phase 2a, initial Phase 2b manufacturing, and preparatory activities .
  • Clinical execution remained on track: DSMC completed its fourth unblinded review with no concerns; the 26-week extension study began enrolling, keeping late Q3/early Q4 2025 Phase 2a topline timing intact .
  • New preclinical data underscored nimacimab’s differentiated CB1 mechanism: additive efficacy with low-dose tirzepatide, superior post-treatment weight durability vs incretin therapy, and reduced rebound when used as maintenance after incretin treatment—bolstering combination and maintenance positioning .
  • Near-term catalysts: Sept 4 KOL event at Nasdaq; Phase 2a 26-week topline in late Q3/early Q4 2025—key potential stock reaction drivers .

What Went Well and What Went Wrong

What Went Well

  • Clinical momentum and safety: “The independent Data Safety Monitoring Committee has completed four unblinded reviews with no concerns raised” and extension enrollment has begun, reinforcing program continuity and patient interest .
  • Differentiated mechanism and optionality: Preclinical updates showed the nimacimab + suboptimal tirzepatide combo achieved 44% vehicle-adjusted weight loss and outperformed an optimal tirzepatide dose; nimacimab also showed superior durability post-treatment and reduced rebound as a maintenance therapy .
  • Capital planning and CMC execution: First resupply batch released for Phase 2a; collaboration initiated with Arecor to develop higher-concentration formulations to support longer dosing intervals and lifecycle management .

What Went Wrong

  • EPS miss vs consensus: Q2 EPS of $(0.44) vs $(0.30)* reflected higher-than-anticipated R&D from contract manufacturing and clinical costs; management cited ~$9.1M H1 contract manufacturing spend tied to Phase 2a extension resupply and Phase 2b supply .*
  • Operating spend ramp: R&D rose to $14.3M (vs $4.1M y/y), widening operating loss to $(18.2)M as the company scaled for clinical and CMC activities .
  • No revenue offset: As a pre-commercial biotech, results remain entirely expense-driven with no product revenue, leaving P&L sensitive to development cadence and manufacturing timing .

Financial Results

Income statement snapshot (oldest → newest)

MetricQ4 2024Q1 2025Q2 2025
Research & Development ($)$7,793,156 $7,197,257 $14,337,753
General & Administrative ($)$4,622,945 $4,562,305 $3,906,172
Total Operating Expenses ($)$10,666,101 $11,759,562 $18,243,925
Operating Loss ($)$(10,666,101) $(11,759,562) $(18,243,925)
Net Loss ($)$(9,746,479) $(11,103,319) $(17,624,872)
Basic EPS ($)$(0.24) $(0.28) $(0.44)
Weighted Avg Shares (Basic)39,968,601 39,651,888 39,659,266

EPS vs S&P Global consensus (oldest → newest)

MetricQ2 2024Q1 2025Q2 2025
EPS Estimate ($)$(0.195)*$(0.29)*$(0.30)*
EPS Actual ($)$(0.20) $(0.28) $(0.44)

Values marked with an asterisk (*) are from S&P Global.

Balance sheet and liquidity (period-end, oldest → newest)

MetricQ4 2024Q1 2025Q2 2025
Cash & Short-term Investments ($M)$68.4 $59.2 $48.6
Runway GuidanceThrough at least Q1 2027 Through at least Q1 2027 Through at least Q1 2027

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 2a topline timing (26-week)2025Late Q3/early Q4 2025 (Q4’24 update) Late Q3/early Q4 2025 reiterated Maintained
Cash runwayMulti-yearThrough at least Q1 2027 Through at least Q1 2027 Maintained
26-week extension study2025–2026IRB approved; planning to enroll (Q1) Enrollment initiated; ~50% of original patients expected eligible Advanced
CMC/formulation (concentration)2025+Targeting longer dosing in roadmap Arecor collaboration to develop higher-concentration nimacimab New/Expanded

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Topline timingRemoved interim; accelerated to late Q3/early Q4’25 “Remain on track to deliver top line results by late Q3, early Q4” Stable/on track
Safety oversight2 DSMC reviews completed 4th unblinded DSMC review completed; no concerns Strengthening safety track record
Extension studyIRB approved; planning Extension enrolling; ~50% eligible Executing/expanding data set
Mechanism (peripheral CB1)Efficacy without central exposure emphasized Reinforced peripherally-restricted, allosteric mechanism; negligible brain penetration Consistent differentiation
Combination & maintenancePreclinical rationale evolving Combo with low-dose tirzepatide > optimal tirzepatide; reduced rebound; maintenance role More supportive data
CMC/manufacturingScaling and optimization plans First resupply batch released; Arecor collaboration Operational readiness improving

Management Commentary

  • “The Phase 2a CBEYOND trial is advancing as planned, on budget and ahead of schedule… We remain on track to deliver top line results by late Q3, early Q4.”
  • “We ended the second quarter with cash and short term investments totaling $48,600,000… projected to fund operations and key clinical milestones through at least Q1 2027.”
  • On combo/maintenance positioning: “Nimacimab… is not just an alternative. We believe it’s a next generation backbone candidate for durable, combinable, and more accessible obesity care.”
  • On formulation strategy (Arecor): targeting higher concentration than 100 mg/mL to enable longer or less frequent dosing; current clinic uses 100 mg/mL .

Q&A Highlights

  • R&D step-up drivers: ~$9.1M H1 contract manufacturing tied to Phase 2a extension resupply and Phase 2b supply; reflects deliberate scaling to minimize downtime between trials .
  • Efficacy objectives: Phase 2a designed to detect ~8% placebo-adjusted difference with 80% power; a 5–8% range would be a “strong signal of biological activity” for mechanism validation, safety/tolerability, and progression to dose-ranging Phase 2b .
  • Discontinuation and maintenance opportunity: Real-world incretin discontinuation provides a sizable maintenance market where nimacimab’s tolerability and peripheral mechanism may sustain weight loss; extension eligibility ~50% due to timing/logistics and dropouts typical for obesity studies .
  • Durability follow-up: 13-week durability follow-up after extension means durability data are a 2026 event .

Estimates Context

  • Q2 2025 EPS: $(0.44) vs S&P Global consensus $(0.30)* → miss of $(0.14); revenue consensus $0 and no product revenue reported .*
  • Prior comparisons: Q1 2025 EPS $(0.28) vs $(0.29); Q2 2024 EPS $(0.20) vs $(0.195)—both essentially in line historically, making this quarter’s miss notable as CMC costs ramped .*
  • FY 2025 EPS consensus: $(1.38); directionally, sustained R&D/CMC spend trajectory may pressure near-term EPS absent offsets; magnitude will depend on Phase 2a readout and Phase 2b initiation pace.

Values marked with an asterisk (*) are from S&P Global.

KPIs and Operational Milestones

KPIQ4 2024Q1 2025Q2 2025
DSMC reviews completed2 3 4
Extension study statusPlanned IRB approved Enrolling; ~50% eligible
ManufacturingScale-up planning —First resupply batch released
FormulationTarget longer dosing —Arecor collaboration for higher concentration
Headcount——20 employees
Liquidity (Cash+ST Inv)$68.4M $59.2M $48.6M

Key Takeaways for Investors

  • EPS miss was investment-driven: Quarter reflects front-loaded CMC/manufacturing and trial resupply ahead of topline; not an efficacy/safety signal—DSMC again clean .
  • Clinical catalysts are near: Late Q3/early Q4 topline can reframe the narrative; watch placebo-adjusted weight loss and safety/tolerability given design power around ~8% .
  • Differentiation growing: Combo efficacy vs optimal tirzepatide, superior post-treatment durability, and maintenance effect positions nimacimab in a potentially complementary role to incretins, with a cleaner tolerability profile due to peripheral restriction .
  • Runway de-risks near-term execution: Funding through at least Q1 2027 supports Phase 2a completion and Phase 2b preparatory work without immediate financing risk .
  • Trading setup: Stock likely sensitive to KOL event (Sept 4) and Phase 2a topline; any clear signal in the 5–8% placebo-adjusted range with clean GI and neuropsychiatric profile could drive re-rating; downside if efficacy falls below expectations or safety surprises emerge .
  • Medium-term thesis: If Phase 2a supports mechanism and tolerability, Phase 2b dose-ranging plus CMC advances (higher concentration) could expand optionality across monotherapy, combo, and maintenance settings .

Values marked with an asterisk () are from S&P Global.*