Skye Bioscience Reports 52-Week Efficacy Data for Nimacimab
Skye Bioscience announced interim 52-week data from the combination therapy arms in the extension phase of the Phase 2a CBeyond proof-of-concept study of nimacimab, its peripherally-restricted CB1 inhibitor antibody. The blinded extension of the CBeyond study for combination cohorts was opened in May 2025 for participants assigned to either nimacimab plus semaglutide or placebo plus semaglutide arms. Of the 9 participants in the placebo plus semaglutide arm that joined the extension study, mean weight loss at 26 weeks was 13.9%. Seven participants completed treatment of the additional 26 weeks and lost an additional 5.8% of weight during the extension period, resulting in a mean weight loss of 19.7% after 52 weeks of treatment. In October 2025, Skye reported top-line 26-week data from CBeyond showing that the nimacimab and semaglutide combination cohort achieved clinically meaningful weight loss compared with semaglutide alone, with no plateau observed.
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- Clinical Trial Progress: Skye Bioscience's Phase 2a CBeyond study for obesity shows significant results with nimacimab combined with GLP-1R agonist (Wegovy), achieving an average weight loss of 14.4% at 26 weeks and 22.3% at 52 weeks, indicating the therapy's potential in weight management.
- Safety Assessment: The extension study reported no serious adverse events for the nimacimab and semaglutide combination, demonstrating good tolerability and safety, which bolsters confidence for future clinical applications.
- Comparative Analysis: The combination therapy group lost 13.2% of weight at 26 weeks compared to 10.25% in the semaglutide-only control group, suggesting that the combination may offer more durable weight loss effects.
- Future Outlook: Topline data from the CBeyond Phase 2a extension is expected in Q3 2026, with analyst William Blair noting that supportive data could attract investor interest, despite a current stock price decline of 5.53%.
- Clinical Trial Results: Skye Bioscience's CBeyond Phase 2a study shows that the combination of nimacimab and semaglutide achieved a significant 22.3% weight loss over 52 weeks, highlighting the therapy's efficacy and potential market competitiveness.
- Durability Advantage: During the 13-week off-therapy follow-up, the nimacimab plus semaglutide cohort regained only 17.8% of lost weight compared to 37.3% for semaglutide alone, indicating a superior durability advantage of the combination therapy.
- Safety Assessment: The combination therapy demonstrated good tolerability at tested doses during the extension study, with no serious adverse events reported, further enhancing the therapy's market appeal.
- Future Outlook: Skye anticipates that optimized dosing of nimacimab in future clinical trials could lead to even deeper weight loss, showcasing the company's long-term growth potential in the obesity treatment sector.
- Clinical Research Presentation: Skye Bioscience will present its study on the obesity-targeting antibody nimacimab at the Keystone conference on January 28, 2026, exploring its effects on weight loss at various doses, aiming to provide new insights for obesity treatment.
- Mechanism Exploration: The research will assess whether nimacimab can serve as a maintenance therapy after discontinuation of tirzepatide and whether its weight loss effects primarily rely on caloric restriction, thus providing crucial data support for clinical applications.
- Innovative Drug Characteristics: Nimacimab, as a peripherally-restricted monoclonal antibody, is designed to avoid central nervous system penetration, potentially reducing the neuropsychiatric side effects commonly associated with small-molecule antagonists, showcasing its unique advantages in obesity treatment.
- Clinical Trial Progress: Skye is currently conducting a Phase 2a clinical trial for nimacimab in combination with the GLP-1R agonist Wegovy®, which will provide empirical support for its market potential in the obesity sector.

- Lawsuit Reminder: The Schall Law Firm alerts investors of a class action lawsuit against Skye Bioscience for violations of securities laws, concerning securities purchases from November 4, 2024, to October 3, 2025, with a deadline to contact by January 16, 2026, to participate in claims.
- False Statements: The complaint alleges that Skye's drug candidate nimacimab was less effective than claimed, with the company overstating its commercial and clinical prospects, resulting in investor losses when the truth emerged.
- Legal Process: The class action has not yet been certified, meaning investors are not represented by an attorney until certification occurs, and those who choose not to act will remain absent class members, potentially forfeiting their claims.
- Investor Rights: The Schall Law Firm specializes in securities class actions and encourages affected investors to reach out for free consultations to discuss their rights, aiming to assist in recovering losses and protecting their legal interests.

- Lawsuit Reminder: The DJS Law Group alerts investors of a class action lawsuit against Skye Bioscience, Inc. (NASDAQ:SKYE) for violations of securities laws during the trading period from November 4, 2024, to October 3, 2025, encouraging affected investors to contact the firm for potential claims.
- False Statements: The complaint alleges that Skye made false and misleading statements regarding its drug nimacimab, which failed to demonstrate the efficacy previously claimed, resulting in significant losses for investors during the class period.
- Claim Deadline: Investors should note that the deadline to participate in the claims is January 16, 2026, and appointment as lead plaintiff is not required to seek recovery of losses.
- Legal Service Advantage: DJS Law Group specializes in securities class actions and corporate governance litigation, focusing on enhancing investor returns through balanced counseling and aggressive advocacy, serving some of the largest hedge funds and alternative asset managers globally.

- Class Action Notice: Rosen Law Firm reminds investors who purchased Skye Bioscience securities between November 4, 2024, and October 3, 2025, that they must apply to be lead plaintiff by January 16, 2026, to participate in the class action and potentially receive compensation.
- Fee Arrangement: Investors participating in the lawsuit will not incur any upfront costs, as the law firm operates on a contingency fee basis, which reduces financial risk for investors and encourages broader participation.
- Case Background: The lawsuit alleges that Skye Bioscience made materially false and misleading statements during the class period, particularly regarding the effectiveness and commercial prospects of nimacimab, resulting in investor losses when the truth emerged.
- Law Firm's Strength: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, demonstrating its strength and experience in handling such cases.








