Skye Initiates Enrollment for Cohort 1 of CBeyond Expansion Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 11 2026
0mins
"Since our March update, execution has focused on turning CBeyond into a Phase 2b-ready development program," said Punit Dhillon, President & CEO of Skye. "We have now initiated enrollment of Cohort 1 of the CBeyond Expansion Study, executed the compatibility and in-use study with ENHANZE to support a practical high-volume subcutaneous approach, and engaged external development advisors to help pressure-test our target product profile, dose-selection rationale and Phase 2b trial design. Our objective in 2026 remains focused on defining the dose and exposure that can support a larger Phase 2b study evaluating nimacimab as a complementary add-on approach for GLP-1-experienced patients."
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Analyst Views on SKYE
Wall Street analysts forecast SKYE stock price to rise
5 Analyst Rating
4 Buy
1 Hold
0 Sell
Strong Buy
Current: 0.714
Low
10.00
Averages
14.33
High
20.00
Current: 0.714
Low
10.00
Averages
14.33
High
20.00
About SKYE
Skye Bioscience, Inc. is a clinical-stage biotechnology company. The Company is focused on development of next-generation molecules that modulate G-protein coupled receptors to treat obesity, overweight, and related conditions. The Company’s lead candidate, nimacimab, is a peripherally restricted negative allosteric modulating antibody targeting cannabinoid receptor 1 (CB1). The Company is also focused on its Phase IIa clinical trial, CBeyond, for nimacimab. The CBeyond clinical trial includes approximately 136 patients, 16 clinical trial sites and a combination arm with a GLP-1 receptor agonist to assess differences in weight loss, body composition, and other attributes. The CB1 receptor is one of the receptors in the endocannabinoid system (ECS) and plays a significant role both in the central nervous system (CNS) and peripheral tissues. The Company's Phase II study in obesity for nimacimab, is a negative allosteric modulating antibody that peripherally inhibits CB1.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Skye Bioscience Advances CBeyond Expansion Study with New Cohort Enrollment
- CBeyond Study Progress: Skye Bioscience has initiated the first phase of the CBeyond Expansion Study, aiming to evaluate the efficacy of 400mg nimacimab versus placebo over 16 weeks, which is expected to provide new treatment options for GLP-1 experienced patients and enhance the company's market position in obesity treatment.
- Safety Review Meeting: The Cohort Review Committee is scheduled to meet on May 18, 2026, to review safety data from Cohort 1 to determine if the criteria for proceeding to Cohort 2 are met, a decision that will directly impact the progression of subsequent clinical trials.
- Financial Performance: As of March 31, 2026, Skye's cash and short-term investments totaled $17.1 million, which is expected to fund operations through Q4 2026, ensuring the achievement of key clinical milestones, although excluding additional costs for future clinical trials.
- Increased R&D Spending: Research and development expenses for Q1 2026 were $7.9 million, up from $7.2 million in Q1 2025, primarily due to increased clinical trial and manufacturing contract costs, indicating the company's ongoing investment in advancing its clinical development strategy.
See More
Investigation into Skye Bioscience Shareholder Lawsuit
- Shareholder Lawsuit Investigation: Kuehn Law, PLLC is investigating whether certain officers and directors of Skye Bioscience, Inc. breached their fiduciary duties to shareholders, with allegations that insiders failed to disclose the true effectiveness of nimacimab.
- Product Effectiveness Controversy: The lawsuit claims that nimacimab was less effective than represented, leading to overstated clinical, regulatory, and commercial prospects, which could mislead investors in their decision-making processes.
- False Statement Risks: The lawsuit highlights that public statements made by Skye Bioscience were materially false and misleading at all relevant times, potentially exposing shareholders to financial losses and underscoring the importance of corporate governance.
- Shareholder Rights Protection: Kuehn Law urges shareholders to contact their attorneys promptly to enforce their rights within a limited timeframe, emphasizing the significance of participation in maintaining the integrity of financial markets.
See More
Investigation into Skye Bioscience Shareholder Lawsuit
- Shareholder Lawsuit Investigation: Kuehn Law, PLLC is investigating whether certain officers and directors of Skye Bioscience, Inc. breached their fiduciary duties to shareholders, which could impact the company's governance structure.
- Disclosure Failures: According to a federal securities lawsuit, insiders at Skye Bioscience caused the company to fail to disclose that nimacimab was less effective than represented, potentially leading to investor misjudgment regarding the company's prospects.
- Overstated Prospects: The exaggeration of nimacimab's clinical, regulatory, and commercial prospects has rendered Skye Bioscience's public statements materially false and misleading at all relevant times, which may affect shareholders' investment decisions.
- Shareholder Rights Protection: Kuehn Law urges shareholders to contact the firm promptly to enforce their rights, emphasizing the importance of participation and indicating that shareholder voices are crucial for the integrity and fairness of financial markets.
See More
Skye Bioscience Q4 2025 Earnings Call Insights
- Clinical Progress: Skye Bioscience's nimacimab demonstrated a 3% weight loss improvement at 26 weeks when combined with semaglutide, achieving a 22.3% mean weight loss after 52 weeks, indicating its potential in weight management therapies and opening new market opportunities for the company.
- Expansion Study Plans: The company is initiating the CBeyond expansion study to evaluate higher doses of nimacimab, planning to advance subcutaneous delivery via Halozyme's ENHANZE technology in preparation for the Phase IIb trial, which could enhance the product's competitive edge in the market.
- Financial Position: As of year-end 2025, Skye Bioscience reported $25.7 million in cash and short-term investments, with a managed operating plan extending the runway through Q4 2026, ensuring funding for critical clinical trials and operational needs.
- Future Outlook: Management anticipates several key catalysts in 2026, including interim data from the CBeyond expansion study and FDA meeting minutes, reflecting the company's confidence in its clinical development and regulatory readiness.
See More
Skye Bioscience Q4 Earnings Miss Expectations
- Earnings Performance: Skye Bioscience reported a Q4 GAAP EPS of -$0.36, missing expectations by $0.06, indicating challenges in profitability that may affect investor confidence.
- Cash Reserves: As of December 31, 2025, the company had $25.7 million in cash, cash equivalents, and short-term investments, which, while providing some liquidity, raises concerns about its ongoing operational viability.
- Increased Net Loss: The net loss for Q4 2025 totaled $14.4 million, significantly higher than the $9.7 million reported in the same period of 2024, reflecting pressure on the company's cost control and revenue growth.
- Share-Based Compensation Adjustments: Non-cash share-based compensation expenses were $1.6 million, down from $2.1 million in Q4 2024, suggesting adjustments in the compensation structure to address financial pressures.
See More
Skye Bioscience to Announce Q4 Earnings on March 9
- Earnings Announcement Schedule: Skye Bioscience is set to release its Q4 earnings report on March 9, after market close, drawing significant attention from market participants regarding its performance.
- Earnings Expectations: Analysts have a consensus EPS estimate of -$0.31, representing a 29.2% year-over-year decline, indicating the financial pressures the company is currently facing.
- Revenue Forecast: The consensus revenue estimate for Skye Bioscience stands at $0, suggesting that the company may not achieve sales growth in the current fiscal quarter.
- Historical Financial Data: Investors can refer to Skye Bioscience's historical financial data to assess performance trends and future potential.
See More
Skye Bioscience Advances CBeyond Expansion Study with New Cohort Enrollment
- CBeyond Study Progress: Skye Bioscience has initiated the first phase of the CBeyond Expansion Study, aiming to evaluate the efficacy of 400mg nimacimab versus placebo over 16 weeks, which is expected to provide new treatment options for GLP-1 experienced patients and enhance the company's market position in obesity treatment.
- Safety Review Meeting: The Cohort Review Committee is scheduled to meet on May 18, 2026, to review safety data from Cohort 1 to determine if the criteria for proceeding to Cohort 2 are met, a decision that will directly impact the progression of subsequent clinical trials.
- Financial Performance: As of March 31, 2026, Skye's cash and short-term investments totaled $17.1 million, which is expected to fund operations through Q4 2026, ensuring the achievement of key clinical milestones, although excluding additional costs for future clinical trials.
- Increased R&D Spending: Research and development expenses for Q1 2026 were $7.9 million, up from $7.2 million in Q1 2025, primarily due to increased clinical trial and manufacturing contract costs, indicating the company's ongoing investment in advancing its clinical development strategy.
See More
Investigation into Skye Bioscience Shareholder Lawsuit
- Shareholder Lawsuit Investigation: Kuehn Law, PLLC is investigating whether certain officers and directors of Skye Bioscience, Inc. breached their fiduciary duties to shareholders, with allegations that insiders failed to disclose the true effectiveness of nimacimab.
- Product Effectiveness Controversy: The lawsuit claims that nimacimab was less effective than represented, leading to overstated clinical, regulatory, and commercial prospects, which could mislead investors in their decision-making processes.
- False Statement Risks: The lawsuit highlights that public statements made by Skye Bioscience were materially false and misleading at all relevant times, potentially exposing shareholders to financial losses and underscoring the importance of corporate governance.
- Shareholder Rights Protection: Kuehn Law urges shareholders to contact their attorneys promptly to enforce their rights within a limited timeframe, emphasizing the significance of participation in maintaining the integrity of financial markets.
See More
Investigation into Skye Bioscience Shareholder Lawsuit
- Shareholder Lawsuit Investigation: Kuehn Law, PLLC is investigating whether certain officers and directors of Skye Bioscience, Inc. breached their fiduciary duties to shareholders, which could impact the company's governance structure.
- Disclosure Failures: According to a federal securities lawsuit, insiders at Skye Bioscience caused the company to fail to disclose that nimacimab was less effective than represented, potentially leading to investor misjudgment regarding the company's prospects.
- Overstated Prospects: The exaggeration of nimacimab's clinical, regulatory, and commercial prospects has rendered Skye Bioscience's public statements materially false and misleading at all relevant times, which may affect shareholders' investment decisions.
- Shareholder Rights Protection: Kuehn Law urges shareholders to contact the firm promptly to enforce their rights, emphasizing the importance of participation and indicating that shareholder voices are crucial for the integrity and fairness of financial markets.
See More
Skye Bioscience Q4 2025 Earnings Call Insights
- Clinical Progress: Skye Bioscience's nimacimab demonstrated a 3% weight loss improvement at 26 weeks when combined with semaglutide, achieving a 22.3% mean weight loss after 52 weeks, indicating its potential in weight management therapies and opening new market opportunities for the company.
- Expansion Study Plans: The company is initiating the CBeyond expansion study to evaluate higher doses of nimacimab, planning to advance subcutaneous delivery via Halozyme's ENHANZE technology in preparation for the Phase IIb trial, which could enhance the product's competitive edge in the market.
- Financial Position: As of year-end 2025, Skye Bioscience reported $25.7 million in cash and short-term investments, with a managed operating plan extending the runway through Q4 2026, ensuring funding for critical clinical trials and operational needs.
- Future Outlook: Management anticipates several key catalysts in 2026, including interim data from the CBeyond expansion study and FDA meeting minutes, reflecting the company's confidence in its clinical development and regulatory readiness.
See More
Skye Bioscience Q4 Earnings Miss Expectations
- Earnings Performance: Skye Bioscience reported a Q4 GAAP EPS of -$0.36, missing expectations by $0.06, indicating challenges in profitability that may affect investor confidence.
- Cash Reserves: As of December 31, 2025, the company had $25.7 million in cash, cash equivalents, and short-term investments, which, while providing some liquidity, raises concerns about its ongoing operational viability.
- Increased Net Loss: The net loss for Q4 2025 totaled $14.4 million, significantly higher than the $9.7 million reported in the same period of 2024, reflecting pressure on the company's cost control and revenue growth.
- Share-Based Compensation Adjustments: Non-cash share-based compensation expenses were $1.6 million, down from $2.1 million in Q4 2024, suggesting adjustments in the compensation structure to address financial pressures.
See More
Skye Bioscience to Announce Q4 Earnings on March 9
- Earnings Announcement Schedule: Skye Bioscience is set to release its Q4 earnings report on March 9, after market close, drawing significant attention from market participants regarding its performance.
- Earnings Expectations: Analysts have a consensus EPS estimate of -$0.31, representing a 29.2% year-over-year decline, indicating the financial pressures the company is currently facing.
- Revenue Forecast: The consensus revenue estimate for Skye Bioscience stands at $0, suggesting that the company may not achieve sales growth in the current fiscal quarter.
- Historical Financial Data: Investors can refer to Skye Bioscience's historical financial data to assess performance trends and future potential.
See More
