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]

Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Skye Bioscience, Inc. regarding potential securities fraud or unlawful business practices by the company and its officers or directors [1] - On October 6, 2025, Skye announced that its Phase 2a study of nimacimab did not meet its primary endpoint of weight loss compared to placebo, leading to a significant drop in stock price [1] Company Overview - Skye Bioscience, Inc. is a publicly traded company on NASDAQ under the ticker SKYE [1] - The company is involved in the development of nimacimab, a peripherally-restricted CB1 inhibitor antibody [1] Financial Impact - Following the announcement of the study results, Skye's stock price fell by $2.85 per share, representing a 60% decrease, closing at $1.90 per share on October 6, 2025 [1]

Core Insights - Skye Bioscience (SKYE) shares plummeted 60% after failing to meet the primary weight loss goal in a mid-stage proof-of-concept study for its only pipeline candidate, nimacimab, aimed at treating obesity [1][5] - The phase IIa CBeyond study involved 136 adults and assessed the efficacy, safety, and pharmacokinetics of nimacimab [1][3] Study Details - Patients were randomized into four groups: nimacimab 200 mg, placebo, nimacimab with Novo Nordisk's Wegovy, and placebo with Wegovy, treated weekly for 26 weeks [2] - The nimacimab 200 mg monotherapy showed a body weight reduction of 1.52% compared to 0.26% with placebo at week 26, failing to achieve the primary weight loss goal [3] - The combination of nimacimab 200 mg and Wegovy resulted in a clinically meaningful weight loss of 13.2%, compared to 10.25% with Wegovy alone, with 100% of patients in the combination group achieving over 5% weight loss [7][8] Safety and Pharmacokinetics - Preliminary pharmacokinetic analysis indicated lower than expected exposure to nimacimab, suggesting the 200 mg dose may be suboptimal [4] - The safety profile of nimacimab was favorable, with no increase in gastrointestinal adverse events or treatment-related neuropsychiatric adverse events reported [9] Future Plans - Skye Bioscience is continuing the phase IIa CBeyond study for an additional 26-week extension, with results expected in early 2026 [10][11] - The company plans to test higher doses of nimacimab based on favorable preclinical data and observed dose-dependent weight loss [12] Market Context - Novo Nordisk's Wegovy is a leading GLP-1 therapy for obesity, generating $5.41 billion in sales during the first half of 2025, a 78% increase year-over-year [13] - Wegovy has received FDA accelerated approval for treating noncirrhotic metabolic dysfunction-associated steatohepatitis, with an oral formulation under review [14]

Company Overview - Skye Bioscience, trading under the symbol SKYE on NASDAQ, is focused on developing pharmaceutical products [1] - The company's market capitalization is approximately $58.88 million, indicating a moderate level of investor interest [4] Recent Developments - On October 6, 2025, Craig-Hallum downgraded SKYE from a Buy to a Hold rating, with the stock priced at $1.91, reflecting a cautious stance on its future performance [1][5] - Despite the Nasdaq Composite gaining over 150 points, SKYE shares experienced a sharp decline, currently priced at $1.90, which represents a significant decrease of 60% from previous levels [2] Stock Performance - The stock has fluctuated between a low of $1.77 and a high of $2.30 during the day, with a yearly high of $5.96 and a low of $1.14, indicating volatility and uncertainty in performance [3] - The trading volume for SKYE is 13.21 million shares, suggesting that investor caution may be influenced by recent performance and market conditions [4]

Company Performance Summary - Horizon Space Acquisition I Corp. (HSPOR) experienced a price drop to $0.12, a decline of around 41.77%, indicating challenges in achieving its business objectives [2][7] - Lixiang Education Holding Co., Ltd. (LXEH) saw its price fall to $0.94, a dramatic decrease of 66.71%, although it has regained compliance with Nasdaq's market value requirements [3][7] - Skye Bioscience, Inc. (SKYE) experienced a decrease in its stock price to $1.89, a drop of 60.20%, following disappointing topline data from its Phase 2a clinical trial [4] - Stellar V Capital Corp. Warrant (SVCCW) saw its warrant price adjust to $0.34, reflecting a decrease of 35.85%, indicating uncertainty about its future acquisition prospects [5] Market Trends and Reactions - The companies mentioned span various industries, including healthcare, education, and financial services, and have experienced significant market adjustments [6] - The reasons behind these price movements could include broader market trends, industry-specific challenges, or company-related developments, with investors closely monitoring for signs of recovery [6]

Core Insights - Skye Biosciences is conducting a conference call to discuss the Phase IIa top line clinical trial results [1] Group 1 - The conference call is led by Bernie Hertel, Head of Investor Relations [1]