• CBeyondTM Phase 2a 26-week extension data update and interim results expected Q1 2026.
• CBeyond Phase 2a Data Monitoring Committee (DMC) meeting on December 14, 2025, continued to demonstrate favorable safety profile.
• CBeyond Phase 2a topline results to 52 weeks including 13-week off-therapy follow-up period expected in Q3 2026.
• Phase 2b (CBeyond 2) plan to be finalized in Q1; trial launch targeted for Q3 2026.
   

SAN DIEGO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (NASDAQ:SKYE) ("Skye") a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today provided its 2026 corporate outlook outlining planned clinical, manufacturing, and corporate milestones to advance nimacimab, Skye's peripherally restricted CB1-inhibiting antibody.

"In 2025 we generated our Phase 2a clinical data, deepened our understanding of nimacimab's exposure-response dynamics, and built the technical foundation required to test higher doses and prepare the framework for a potential subsequent Phase 2 trial with broader clinical endpoints," said Punit Dhillon, President & Chief Executive Officer. "In 2026, our focus and goals are straightforward: deliver additional clinical readouts from our CBeyond extension study, assess and select higher doses of nimacimab, and launch a Phase 2b study designed to evaluate multiple doses of nimacimab as a monotherapy and in combination with an incretin therapy."

"We believe emerging data across the obesity treatment landscape underscore the need for modalities complementary to incretin–based therapies," added Mr. Dhillon. "We believe peripheral CB1 inhibition offers a distinctive opportunity to help achieve incremental weight loss, improve treatment tolerability and sustainability, enhance post-treatment durability, as well as offer additional metabolic and inflammatory benefits."

2025 Foundation Supporting 2026 Execution

CBeyond Phase 2a delivered clinically relevant signals and and new insight to further guide development

• Additive weight loss in combination with semaglutide. Clinically meaningful additional weight loss of nimacimab and semaglutide versus semaglutide alone, with no plateau observed at 26 weeks, highlighted for the first time the complementary positive effect of a peripheral CB1 inhibitor with an incretin therapeutic.
• Additive reduction in waist circumference and superior lean to fat mass ratio was also observed with the addition of nimacimab to semaglutide.
• CBeyond provided insight into dose-response, informing the next stage of dose selection and study design.
• Positive safety and tolerability. Nimacimab alone demonstrated a favorable safety profile with placebo-like tolerability. In combination with semaglutide, there was no increase in gastrointestinal adverse events. Importantly, there was no difference in neuropsychiatric adverse events reported resulting from treatment with nimacimab compared to placebo or from the combination of nimacimab and semaglutide compared to semaglutide alone.
• See Phase 2a 26-week data news release for full details along with investor presentation and Spotlight page for detailed charts and explanations.

Preclinical research validates broad potential utility of nimacimab

• Significant weight loss in DIO mouse models as a monotherapy as well as in combination with both an active or suboptimal dose of tirzepatide.
• Significantly less weight rebound post-treatment compared to incretin drugs and in cohorts administered nimacimab following treatment with incretin drugs.
• Productive modulation of gut and adipose hormones integral to metabolic and anti-inflammatory processes.
• Foundational evidence for efficacy of antibody-based peripherally-restricted CB1 inhibition and the role nimacimab plays to complement GLP-1/incretin-based mechanisms.
• Results can be reviewed in Skye's investor presentation and are explained in "primer" videos on Skye's Spotlight page.
   

Operational groundwork for higher-dose delivery and scalability

• CMC and clinical supply readiness. Advanced manufacturing scale-up and CMC execution, producing nimacimab drug supply for planned follow-on studies and de-risking near-term clinical execution.
• Higher dosing with enhanced concentration and injection volume. Planning for optimal high-dose drug administration, through 2025 Skye initiated collaborations focused on this goal:
  • May: agreement with Arecor Therapeutics plc (AIM: AREC) to develop a higher concentration formulation of nimacimab using Arecor's proprietary formulation technology platform, Arestat™.
  • December: licensed Halozyme Therapeutics' ENHANZE® drug delivery technology to develop and potentially commercialize a subcutaneous formulation of nimacimab that may facilitate larger injection volumes.
     

Looking Ahead to 2026: Key Objectives and Expected Clinical Milestones

Clinical development: generate longer-duration data and establish the right dose

Skye's 2026 clinical program goals are designed to (i) evaluate multiple higher doses of nimacimab, and (ii) initiate a Phase 2b study that supports combination development.

Planned clinical milestones include:

• CBeyondTM Phase 2a 26-week extension data update and interim results expected in Q1 2026.
• CBeyond Phase 2a topline results to 52 weeks including 13-week off-therapy follow-up period expected in Q3 2026.
• Phase 2b (CBeyond 2) plan will be finalized and aligned with regulators, including completion of a Type C meeting in Q1 2026, with initiation of the adaptive design Phase 2b clinical trial expected in Q3 2026.