Summary of Skye Bioscience FY Conference Call Company Overview - **Company**: Skye Bioscience (NasdaqGM:SKYE) - **Focus**: Metabolic therapeutics, specifically developing a peripherally restricted CB1 antibody named Nemesumab - **Current Development Stage**: Phase 2 development with initial data reported from a 26-week trial Key Points and Arguments Clinical Data and Efficacy - The initial 26-week data from the phase 2 trial indicated that a 200-milligram dose of Nemesumab showed limited efficacy, establishing a floor for weight loss response [3][4] - A combination therapy with Semaglutide resulted in a 30% increase in weight loss compared to Semaglutide alone, with patients losing approximately 13% of their body weight over 26 weeks [3][11] - The company aims to achieve a weight loss trajectory of around 20% at the 52-week mark, positioning Nemesumab competitively against other therapies like CagriSema and tirzepatide [4][26] Mechanism of Action - The large molecule approach of Nemesumab is designed to avoid crossing the blood-brain barrier, reducing neuropsychiatric side effects associated with small molecules [5][6] - The combination of GLP-1 mechanism (caloric restriction) and CB1 inhibition (fat storage modulation) is believed to create a synergistic effect, enhancing weight loss [11][12] Safety and Dosing Strategy - The safety profile of Nemesumab is considered favorable, allowing for higher dosing without significant adverse effects [6][10] - Future dosing strategies may involve increasing the dose significantly beyond the current 200-milligram level, with estimates suggesting a range of 600 to 1,000 milligrams may be optimal based on preclinical data [21][23] Future Development Plans - The company is prioritizing the combination therapy while keeping options open for monotherapy, especially if it can achieve a weight loss target of 5%-8% [25][30] - An extension study is set to report data in Q1, which will inform the design of a potential phase 2B trial [30] Additional Important Insights - The company is exploring formulation and delivery technologies to facilitate at-home administration of higher volume injections [24] - There is a nuanced approach to interpreting data from patients who may have treatment gaps, particularly in the monotherapy group [28][29] - The competitive landscape is acknowledged, with a focus on demonstrating superior efficacy and safety profiles compared to existing therapies [26][30]

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Skye Biosciences, Inc. due to allegations of misleading statements regarding the effectiveness of its drug nimacimab, which led to significant stock price declines [4][6][7]. Group 1: Legal Investigation - Faruqi & Faruqi is encouraging investors who suffered losses in Skye to contact them to discuss legal options [1]. - A federal securities class action has been filed against Skye, with a deadline of January 16, 2026, for investors to seek the role of lead plaintiff [4]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [5]. Group 2: Allegations Against Skye - The complaint alleges that Skye and its executives violated federal securities laws by making false and misleading statements about nimacimab's effectiveness and overstating its clinical and commercial prospects [6]. - On October 6, 2025, Skye announced that nimacimab did not achieve its primary endpoint in a clinical study, leading to a 60% drop in stock price, closing at $1.90 per share [7]. Group 3: Class Action Participation - The lead plaintiff in a class action is the investor with the largest financial interest who directs the litigation on behalf of the class [8]. - Any member of the class can move the court to serve as lead plaintiff or choose to remain an absent class member without affecting their ability to share in any recovery [8].

Core Viewpoint - Rosen Law Firm is encouraging investors of Skye Bioscience, Inc. to secure legal counsel before the January 16, 2026 deadline for a class action lawsuit related to securities purchased between November 4, 2024, and October 3, 2025 [2][3]. Group 1: Class Action Details - Investors who purchased Skye securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [3]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by January 16, 2026 [4]. - The lawsuit alleges that defendants made materially false and misleading statements regarding Skye's business and the effectiveness of its product, nimacimab, which led to investor damages when the truth was revealed [6]. Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions, highlighting its own achievements, including the largest securities class action settlement against a Chinese company [5]. - The firm has been consistently ranked among the top firms for securities class action settlements, recovering hundreds of millions of dollars for investors, including over $438 million in 2019 alone [5].

Company Overview - Skye Bioscience, Inc. is a clinical stage biopharmaceutical company focused on developing molecules that modulate G protein-coupled receptors (GPCRs) to treat obesity, overweight, and metabolic diseases. The lead product candidate is nimacimab [1]. Class Action Details - A class action was filed on behalf of investors who purchased or acquired Skye securities during the class period from November 4, 2024, to October 3, 2025, due to alleged misleading information regarding the viability of nimacimab [1]. - The allegations include that Skye failed to disclose that nimacimab was less effective than represented and that its clinical, regulatory, and commercial prospects were overstated [2]. Recent Developments - On October 6, 2025, Skye announced topline data from its 26-week Phase 2a CBeyond proof-of-concept study of nimacimab, revealing that the monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo. Additionally, preliminary pharmacokinetic analysis indicated lower than expected drug exposure, suggesting a potential need for higher dosing [3]. - Following this announcement, Skye's stock price fell by $2.85 per share, or 60%, closing at $1.90 per share on the same day [3].

Core Viewpoint - A class action lawsuit has been filed against Skye Bioscience, Inc. for allegedly making materially false and misleading statements regarding its business and drug candidate nimacimab, leading to investor losses during the specified Class Period [1][3]. Group 1: Lawsuit Details - The class action lawsuit is on behalf of investors who acquired Skye Bioscience securities between November 4, 2024, and October 3, 2025 [1]. - The lawsuit seeks to recover losses under federal securities laws due to misleading statements about the effectiveness and prospects of the drug candidate nimacimab [3]. Group 2: Investor Information - Investors who purchased Skye Bioscience securities during the Class Period and suffered losses have until January 16, 2026, to seek appointment as lead plaintiff [2]. - Interested investors can contact Johnson Fistel, PLLP for more information regarding their rights and potential recovery options [2]. Group 3: Allegations Against Skye Bioscience - The lawsuit alleges that Skye Bioscience failed to disclose that nimacimab was less effective than represented, leading to overstated clinical, regulatory, and commercial prospects [3]. - The true details regarding the drug's effectiveness were revealed on October 3, 2025, resulting in substantial damages for investors [3]. Group 4: Law Firm Background - Johnson Fistel, PLLP is a recognized shareholder rights law firm with a strong track record, having recovered approximately $90.7 million for investors in 2024 [4].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Skye Bioscience, Inc. regarding a class action lawsuit due to allegations of misleading statements about the effectiveness of its lead product candidate, nimacimab, during the specified class period [1]. Group 1: Allegations and Class Period - The class period for the allegations is from November 4, 2024, to October 3, 2025 [1]. - The complaint claims that the defendants made materially false and misleading statements about nimacimab, asserting it was more effective than it actually was, which overstated its clinical, regulatory, and commercial prospects [1]. Group 2: Next Steps for Shareholders - Shareholders who purchased shares of SKYE during the class period are encouraged to register for the class action by January 16, 2026, to potentially be appointed as lead plaintiff [2]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the status of the case [2]. Group 3: Law Firm's Mission - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud, ensuring companies adhere to responsible business practices [3].

Core Viewpoint - A class action lawsuit has been filed against Skye Bioscience, Inc. for alleged violations of the Securities Exchange Act, specifically related to misleading statements about the efficacy of its drug nimacimab [1][2]. Group 1: Lawsuit Details - The class period for the lawsuit is from November 4, 2024, to October 3, 2025, with a deadline for lead plaintiff appointments set for January 16, 2026 [2]. - The complaint alleges that Skye made false and misleading statements regarding the efficacy of nimacimab, which did not demonstrate the claimed effectiveness [2]. Group 2: Shareholder Participation - Shareholders who purchased shares during the class period are encouraged to contact the DJS Law Group for potential lead plaintiff appointments, although this is not required to participate in any recovery [2][3]. - Once registered, shareholders will be enrolled in a portfolio monitoring system to receive updates on the case's progress at no cost [3]. Group 3: DJS Law Group's Role - DJS Law Group specializes in securities class actions and corporate governance litigation, focusing on enhancing investor returns through advocacy [4]. - The firm represents large hedge funds and alternative asset managers, emphasizing the value of litigation claims as significant assets [4].

Core Viewpoint - Rosen Law Firm is urging investors of Skye Bioscience, Inc. to secure legal counsel before the January 16, 2026 deadline for a securities class action lawsuit related to misleading statements made by the company during the class period from November 4, 2024, to October 3, 2025 [2][6]. Group 1 - Investors who purchased Skye securities during the specified class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [3]. - A class action lawsuit has already been filed, and potential lead plaintiffs must act by January 16, 2026 [4]. - The Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting their own achievements in recovering significant amounts for investors [5]. Group 2 - The lawsuit claims that Skye Bioscience made materially false and misleading statements regarding its product nimacimab, including its effectiveness and commercial prospects, which led to investor damages when the truth was revealed [6]. - The firm has a history of successful settlements, including the largest securities class action settlement against a Chinese company, and has consistently ranked highly in terms of settlements achieved [5].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased securities of Skye Bioscience, Inc. during the specified Class Period of the upcoming lead plaintiff deadline on January 16, 2026, for a class action lawsuit [1][2]. Group 1: Class Action Details - Investors who bought Skye securities between November 4, 2024, and October 3, 2025, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties must act by the lead plaintiff deadline to represent other class members [2]. - The lawsuit alleges that Skye's defendants made materially false and misleading statements regarding the effectiveness and prospects of nimacimab, leading to investor damages when the truth was revealed [4]. Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in achieving significant settlements [3]. - The firm has been recognized for its performance in securities class action settlements, including being ranked No. 1 in 2017 and consistently in the top 4 since 2013, recovering hundreds of millions for investors [3]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in handling such cases [3].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Skye Biosciences, Inc. due to allegations of misleading statements regarding the effectiveness of its drug nimacimab, which led to significant stock price declines following the release of disappointing clinical trial results [1][3][4]. Group 1: Legal Investigation - Faruqi & Faruqi, LLP is encouraging investors who suffered losses in Skye to contact them for discussing legal options, with a deadline of January 16, 2026, to seek the role of lead plaintiff in a federal securities class action [1][5]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [2]. Group 2: Allegations Against Skye - The complaint alleges that Skye and its executives violated federal securities laws by making false and misleading statements about nimacimab's effectiveness and overstating its clinical, regulatory, and commercial prospects [3]. - On October 6, 2025, Skye announced that its nimacimab did not achieve the primary endpoint of weight loss compared to placebo, resulting in a 60% drop in stock price, closing at $1.90 per share [4].