NEW YORK, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Skye Bioscience, Inc. (“Skye” or “the Company”) (NASDAQ: SKYE) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired Skye secu ...

Core Points - A shareholder class action lawsuit has been filed against Skye Bioscience, Inc. alleging that the company made materially false and misleading statements regarding the effectiveness of nimacimab [1] - The lawsuit claims that the clinical, regulatory, and commercial prospects of nimacimab were overstated, leading to misleading public statements by the defendants [1] - The lawsuit covers shareholders who purchased shares between November 4, 2024, and October 3, 2025, and experienced significant losses [2] Legal Information - The deadline for shareholders to ask the court to be appointed lead plaintiff in the case is January 16, 2026 [3] - Holzer & Holzer, LLC is the law firm representing the shareholders, known for its vigorous representation in securities litigation [3]

NEW YORK, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of all persons or entities who purchased or otherwise acquired Skye Bioscience, Inc. (“Syke” or the “Company”) (NASDAQ: SKYE) securities between November 4, 2024 and October 3, 2025, inclusive (the “Class Period”). The Complaint alleges that throughout the Class Period, Defendants made mater ...

Core Viewpoint - A class action lawsuit has been filed against Skye Bioscience, Inc. for allegedly misleading investors about the effectiveness and prospects of its lead drug candidate, nimacimab [1][2]. 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 [1]. Allegations - The lawsuit claims that during the class period, Skye failed to disclose that nimacimab was less effective than previously stated, leading to overstated clinical, regulatory, and commercial prospects [2]. - On October 6, 2025, Skye announced that nimacimab did not achieve its primary endpoint of weight loss compared to placebo in a Phase 2a study, resulting in a significant stock price drop of $2.85 per share, or 60%, closing at $1.90 per share [3]. Legal Proceedings - Shareholders may be eligible to participate in the class action and can contact Robbins LLP if they wish to serve as lead plaintiff [4]. - The representation in the lawsuit is on a contingency fee basis, meaning shareholders will not incur fees or expenses [5].

Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash and cash equivalents and short-term investments totaling $35.3 million, which is expected to fund operations and key clinical milestones into 2027 [3] - R&D expenses for Q3 2025 were $9.4 million, an increase from $4.9 million in Q3 2024, primarily due to contract manufacturing and clinical trial costs [4] - General and administrative expenses decreased to $3.9 million in Q3 2025 from $4.6 million in Q3 2024 [4] - The net loss for Q3 2025 was $12.8 million, compared to $3.9 million for the same period in 2024 [5] Business Line Data and Key Metrics Changes - The focus remains on the clinical development of Nemesimab, with insights from the CBON study shaping future studies [6][7] - The combination of Nemesimab and semaglutide showed a 3% additional weight loss at 26 weeks compared to semaglutide alone, indicating a nearly 30% improvement [9] - The combination therapy also improved the lean-to-fat mass ratio significantly, with a p-value of 0.0126 [9] Market Data and Key Metrics Changes - The company is addressing the competitive landscape by focusing on the scalability and long-term market penetration of Nemesimab [8][13] - The safety profile of Nemesimab has been positive, with no neuropsychiatric signals observed, which is crucial for market acceptance [17] Company Strategy and Development Direction - The company is committed to refining the dose of Nemesimab to unlock its true efficacy and capture its therapeutic potential [10][12] - There is a strong emphasis on manufacturing and cost management to ensure competitiveness in the obesity market [14] - The company plans to present new preclinical and clinical data at major scientific conferences in 2026, indicating a proactive approach to investor relations and market engagement [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data and the potential for Nemesimab, highlighting the importance of translating insights into actionable strategies [19] - The focus for the next 90 days includes generating a more complete picture of Nemesimab's potential and refining the dosing strategy [17] Other Important Information - The company completed enrollment for a 26-week extension study with 43 patients, which is expected to provide insights into the long-term efficacy of Nemesimab [11] - The company is exploring both induction and maintenance therapy opportunities for Nemesimab, recognizing the commercial potential in both areas [52][59] Q&A Session Summary Question: Insights on weight loss and exposure from the trial - Management indicated that the observed concentrations at the 200 mg dose did not achieve expected efficacy due to underdosing, and further analysis is ongoing [21][23] Question: Concerns about the 26-week extension data with 43 patients - Management acknowledged the smaller patient number but expressed confidence in the ability to see clear separation in results, especially given the strong initial data [26][28] Question: Regulatory considerations for monotherapy approval - It was confirmed that monotherapy approval would be necessary for maintenance therapy, and discussions with regulatory agencies are ongoing [32][34] Question: Feedback from KOLs following the CB1 phase 2A data - Positive feedback was received regarding the combination data and the potential for a differentiated mechanism of action without neuropsychiatric adverse events [60][64]

Financial Performance - Skye Bioscience reported a net loss of $12.8 million for Q3 2025, compared to a net loss of $3.9 million for the same period in 2024, reflecting a significant increase in losses [11]. - General and administrative (G&A) expenses decreased to $3.9 million in Q3 2025 from $4.6 million in Q3 2024, mainly due to lower consulting and professional fees [10]. - The total operating expenses for Q3 2025 were $13.3 million, compared to $5.0 million for the same period in 2024 [17]. Research and Development - Research and development (R&D) expenses for Q3 2025 were $9.4 million, up from $4.9 million in Q3 2024, primarily due to increased clinical trial costs and contract manufacturing [9]. - The Phase 2a study of nimacimab showed a 29% relative increase in weight loss when combined with semaglutide compared to semaglutide alone after 26 weeks [6]. - Patients treated with the nimacimab and semaglutide combination experienced a weight regain of 18.1% over 12 weeks post-treatment, compared to 49.8% for those on semaglutide alone [6]. - The combination therapy also resulted in an additional waist circumference reduction of 3.2 cm compared to semaglutide alone [5]. - The 26-week extension study for nimacimab was fully enrolled with 43 patients, and data is expected in Q1 2026 [12]. - The company anticipates further insights into nimacimab's potential as a metabolic therapy from upcoming biomarker data and the 26-week extension study readout [3]. Financial Position - Cash, cash equivalents, and short-term investments totaled $35.3 million as of September 30, 2025, expected to fund operations into 2027 [8]. - Total current assets decreased from $70,827,247 on December 31, 2024, to $39,924,794 on September 30, 2025, representing a decline of approximately 43.7% [19]. - Cash and cash equivalents significantly decreased from $68,415,741 to $18,441,079, a reduction of about 73.0% [19]. - Total liabilities increased from $4,612,049 on December 31, 2024, to $8,488,104 on September 30, 2025, marking an increase of approximately 83.5% [19]. - Stockholders' equity dropped from $68,151,724 to $32,836,185, reflecting a decrease of about 51.8% [19]. - The accumulated deficit increased from $(130,949,672) to $(172,432,523), indicating a worsening of approximately 31.7% [19]. - Total assets decreased from $72,763,773 to $41,324,289, a decline of about 43.0% [19]. - The number of common shares issued and outstanding slightly increased from 30,974,559 to 30,989,046 [19]. - Short-term investments were reported at $16,871,229 as of September 30, 2025, with no short-term investments reported on December 31, 2024 [19]. - Current liabilities rose from $4,338,887 to $8,367,897, an increase of approximately 93.5% [19]. - Operating lease liability, net of current portion, decreased from $273,162 to $120,207, a reduction of about 56.0% [19].

Financial Performance - The company has not generated any revenue to date and does not expect to until regulatory approval and commercialization of nimacimab or future drug candidates[75]. - Operating losses for the nine months ended September 30, 2025, amounted to $43,268,021, compared to $19,526,617 for the same period in 2024[101]. - Net cash used in operating activities was $(33,296,042) for the nine months ended September 30, 2025, reflecting a net loss of $41,482,851[110]. - The company has incurred an accumulated deficit of $172,432,523 as of September 30, 2025[101]. - Total other income decreased by $560,625, a 52% decline, totaling $(509,874) for the three months ended September 30, 2025[91]. Research and Development - Skye Bioscience reported research and development expenses of $9,357,444 for Q3 2025, a 92% increase from $4,883,337 in Q3 2024[76][86]. - The company incurred $30,892,454 in research and development expenses for the nine months ended September 30, 2025, compared to $10,908,538 for the same period in 2024[76]. - Research and development expenses increased by $19,983,916, representing a 183% increase, totaling $30,892,454 for the nine months ended September 30, 2025[92]. - Clinical trial costs increased by $578,014 due to higher site and patient costs related to the Phase 2a study for nimacimab[86]. - Clinical trial costs increased by $4,203,355 due to higher site and patient costs related to the Phase 2a clinical study of nimacimab[94]. - Contract manufacturing costs rose by $2,704,671 due to drug substance and product costs for the extended Phase 2a clinical study[86]. - Contract manufacturing costs rose by $11,854,544, driven by expenses related to the Phase 2a clinical study of nimacimab[94]. - The Phase 2a clinical trial of nimacimab showed a weight loss of -13.2% in the combination arm with semaglutide, compared to -10.25% with semaglutide alone, with a p-value of 0.0372[71]. - In the combination arm, 100% of patients achieved over 5% weight loss, while 67% achieved over 10% weight loss, compared to 85% and 50% respectively with semaglutide alone[71]. - Skye expects to report data from the 26-week extension study of nimacimab in Q1 2026[72]. Expenses - General and administrative expenses decreased by $731,837 to $3,907,090 in Q3 2025, a 16% decline from $4,638,927 in Q3 2024[87]. - General and administrative expenses decreased by $795,980, a 6% decline, totaling $12,375,567 for the nine months ended September 30, 2025[95]. - The estimated legal contingency as of September 30, 2025, including accrued legal expenses, is $2,054,357[82]. - The company faces expenses related to attracting and retaining skilled personnel, public company costs, and potential litigation costs[116]. Financing Activities - The company raised $83,556,563 from private placement equity transactions in January and March 2024[102]. - During the nine months ended September 30, 2024, cash provided by financing activities included $83,556,563 from PIPE financings, net of issuance costs[115]. - There are no off-balance sheet arrangements that materially affect the company's financial condition or results of operations[117].

Core Insights - Skye Bioscience, Inc. is focused on developing nimacimab, a molecule aimed at treating obesity and related conditions, with promising results from its Phase 2a clinical trial [1][2][12] Financial Results - For Q3 2025, Skye reported a net loss of $12.8 million, with R&D expenses increasing to $9.4 million from $4.9 million in Q3 2024, primarily due to clinical trial costs and contract manufacturing [10][8] - General and administrative expenses decreased to $3.9 million from $4.6 million in the same period last year [9] - Cash and cash equivalents totaled $35.3 million as of September 30, 2025, expected to fund operations into 2027 [7] Clinical Trial Highlights - The topline data from the CBeyond Phase 2a study showed a 29% relative increase in weight loss for the nimacimab/semaglutide combination compared to semaglutide alone after 26 weeks [6] - The combination therapy also resulted in a significant reduction in waist circumference by 3.2 cm compared to semaglutide alone [6] - Rebound weight gain was lower in the combination group, with 18.1% weight regained compared to 49.8% in the semaglutide-only group over 12 weeks post-treatment [6] Upcoming Milestones - Skye has completed enrollment for a 26-week extension study with 43 patients, and data is expected in Q1 2026 [6] - The company is shifting focus to a combination development pathway while also exploring nimacimab's potential as a monotherapy [2]

Core Insights - Skye Bioscience, Inc. announced positive topline data from its Phase 2 study of nimacimab, showing that it effectively reduces weight regain when combined with semaglutide compared to semaglutide alone [1][2] Study Results - In a 12-week post-treatment analysis, participants receiving nimacimab 200 mg weekly plus semaglutide experienced only 18.1% weight regain, significantly lower than the 49.8% regain observed in the semaglutide-only group [2] - The combination group maintained significant weight loss compared to the placebo group (p=0.006), while the semaglutide-only group lost significance (p=0.12) [2] - The combination therapy resulted in a weight loss of -13.2% compared to -10.25% for semaglutide alone (p=0.0372) [2] Waist Circumference Changes - The combination of nimacimab and semaglutide led to a reduction in waist circumference of -11.26 cm compared to -8.09 cm for semaglutide alone, with a statistically significant difference of -3.17 cm (p=0.0492) [3] Future Development Plans - The company plans to conduct a dose-ranging study to determine the optimal dosing of nimacimab in both monotherapy and combination settings, despite initial monotherapy results not showing significant weight loss [3][4] - Skye aims to position nimacimab as a versatile treatment option in the obesity treatment paradigm, potentially addressing multiple needs beyond just being a non-incretin add-on [3] Company Overview - Skye Bioscience focuses on developing next-generation therapeutics for metabolic health, particularly through the modulation of G-protein coupled receptors [4] - The company is currently conducting a Phase 2a clinical trial for nimacimab, which is designed to assess its efficacy in combination with GLP-1R agonists [4][5]

Core Viewpoint - Skye Bioscience, Inc. is set to discuss its Q3 2025 financial results and business updates in a conference call on November 10, 2025, following the release of its financial results after market close [1][2] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders through next-generation molecules that modulate G-protein coupled receptors [3] - The company is conducting a Phase 2 clinical trial for nimacimab, an antibody that inhibits CB1, and is also assessing its combination with a GLP-1R agonist (Wegovy®) [3] Upcoming Events - A live webcast of the conference call will be available on the Skye Investor Relations website, along with the earnings press release and financial tables [2] - Skye will present at the Stifel 2025 Healthcare Conference in New York on November 13, 2025, and will be available for one-on-one meetings [2]