Weight loss drug companies have come off of their peak hype from about a year ago. Novo Nordisk A/S ( NVO ), manufacturer of Ozempic and Wegovy, has seen its stock price cut by more than halfI am a private investor based out of Toronto, Canada and I have been investing since 2003. After 8 years in Corporate Finance with a Canadian Telecom company I have decided to dedicate myself full-time to the capital markets. I write on Seeking Alpha to demonstrate my financial analysis and writing skills across a varie ...

Core Viewpoint - Skye Bioscience, Inc. announced promising preclinical data for its CB1 antibody, nimacimab, indicating significant weight loss in a murine diet-induced obesity model, suggesting potential as a treatment for obesity and metabolic disorders [1][2][5] Group 1: Preclinical Data and Efficacy - Nimacimab demonstrated effective weight loss in a diet-induced obesity model after 25 days of treatment, showing a 23.5% weight loss when used alone, comparable to monlunabant and tirzepatide [5] - When combined with tirzepatide, nimacimab achieved greater than 30% weight loss, indicating an additive effect [5] - The study highlighted that nimacimab's weight loss was associated with beneficial changes in key hormones, glycemic control, and inflammatory markers [1][5] Group 2: Mechanism of Action - Nimacimab employs a non-competitive allosteric binding mechanism to the CB1 receptor, which may provide advantages over small molecules like monlunabant that compete for the receptor's active site [3][7] - In vitro data showed that nimacimab's potency remained stable even at higher concentrations of CB1 agonists, while monlunabant's potency significantly decreased under similar conditions [6][9] - The differentiated mechanism of nimacimab aims to achieve weight loss benefits without the neuropsychiatric side effects associated with current small molecule CB1 inhibitors [7][10] Group 3: Future Developments - Skye anticipates initial data from its Phase 2a study in obesity to be available in late Q3 or early Q4 2025, which will further assess nimacimab's efficacy [2][5] - The company is conducting a Phase 2 clinical trial to evaluate nimacimab's effects both as a monotherapy and in combination with GLP-1 receptor agonists [10]

Company Overview - Skye Bioscience, Inc. is a clinical-stage biopharmaceutical company focused on developing new therapeutic pathways for obesity and metabolic health disorders [2] - The company aims to create first-in-class therapeutics by leveraging biologic targets with substantial human proof of mechanism [2] Clinical Development - Skye is conducting a Phase 2 clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, specifically targeting obesity [2] - The trial is also assessing the combination of nimacimab with a GLP-1R agonist, Wegovy® [2] Upcoming Events - The executive team of Skye will be available for one-on-one meetings at the Piper Sandler Spring Biopharma Symposium on April 17th in Boston, MA [1]

Financial Data and Key Metrics Changes - Research and development expenses for Q4 2024 were $7.8 million, up from $1.6 million in Q4 2023, primarily due to clinical and manufacturing costs associated with the Phase IIa CBeyond study for nimacimab [30] - For the year ended December 31, 2024, research and development expenses totaled $18.7 million, compared to $5.8 million in 2023, driven by increased clinical costs and employee-related benefits [31] - General and administrative expenses for Q4 2024 were $4.6 million, up from $2.5 million in Q4 2023, mainly due to stock-based compensation and professional services [32] - The net loss for the year ended December 31, 2024, was $26.6 million, a decrease from $37.6 million in 2023, attributed to the expensing of acquisition costs in 2023 [33] Business Line Data and Key Metrics Changes - The company has shifted focus from the development of SBI-100 to nimacimab, reallocating resources to achieve clinical milestones [11] - The CBeyond clinical trial for nimacimab saw over-enrollment, completing enrollment with 136 patients, exceeding the planned 120 patients [9] Market Data and Key Metrics Changes - The company views nimacimab as a differentiated alternative in the obesity treatment market, especially as the GLP-1 receptor agonist space becomes crowded [24] - Recent industry deals highlight the growing interest in non-incretin mechanisms for obesity treatment, validating the potential of CB1 inhibitors like nimacimab [81] Company Strategy and Development Direction - The company plans to engage with regulators for a Phase IIb dose-escalation study anticipated to start in Q2 2026, while also enhancing manufacturing capabilities [22] - The strategic decision to extend the CBeyond trial to 52 weeks aims to gather more comprehensive safety and efficacy data, which will support regulatory discussions [19] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in nimacimab's safety profile, noting no neuropsychiatric side effects in the Phase I study and ongoing positive reviews from the Data Safety Monitoring Board [16][50] - The company anticipates that the additional data from the extended trial will enhance understanding of nimacimab's capabilities and support its regulatory package [19] Other Important Information - The company reported cash and cash equivalents of $68.4 million as of December 31, 2024, with an operating cash burn averaging $6.3 million per quarter [34][36] - The company has eliminated related party balances and remediated litigation matters during 2024, improving its financial position [35] Q&A Session Summary Question: What can be expected from the 26 and 52-week readouts? - Management indicated that the extension study was strategic to gather longer-term efficacy and safety data, which is crucial for regulatory discussions [42][43] Question: How does the removal of the interim analysis affect the study's power? - The removal of the interim analysis preserves the study's power, allowing for a more robust efficacy and safety analysis with a larger patient dataset [60][100] Question: What feedback has been received from investigators regarding the study? - Investigators have shown strong enthusiasm for the obesity trials, contributing to the rapid enrollment pace [96] Question: Will there be additional DEXA scans during the extended study? - Yes, there will be a DEXA scan at the midpoint of the extension and another at the end of the treatment period to assess body composition changes [99] Question: How does the company view the potential for nimacimab in diabetic patients? - The company is excited about testing nimacimab in diabetic populations, as its mechanism may improve insulin sensitivity and address inflammation [132]

Financial Performance - Skye Bioscience reported a net loss of $9.7 million for Q4 2024, compared to a net loss of $4.4 million for the same period in 2023[20]. - The net loss for Q4 2024 was $9,746,479, compared to a net loss of $4,419,930 in Q4 2023, indicating an increase in losses of 120%[27]. - Basic loss per share for Q4 2024 was $(0.24), an improvement from $(0.36) in Q4 2023, reflecting a reduction in loss per share of 33%[27]. - Total operating expenses for the year ended December 31, 2024, were $30,192,718, down from $34,735,173 in 2023, representing a decrease of 13%[27]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $7.8 million, a significant increase from $1.6 million in Q4 2023, primarily due to clinical trial costs for nimacimab[15]. - Skye's R&D expenses for the full year 2024 were $18.7 million, compared to $5.8 million in 2023, reflecting increased clinical trial activities[16]. - Research and development expenses for Q4 2024 were $7,793,156, a significant increase from $1,591,494 in Q4 2023, reflecting a growth of 388%[27]. - The Phase 2a trial's dosing has been extended to 52 weeks to enhance long-term safety and efficacy data[8]. - Enrollment in the Phase 2a CBeyond trial of nimacimab exceeded the target, completing at 136 patients, with top-line data expected in late Q3/early Q4 2025[6]. - The company is advancing toward monthly dosing of nimacimab to improve patient experience and adherence[10]. Financial Position - Cash and cash equivalents totaled $68.4 million as of December 31, 2024, expected to fund operations through at least Q1 2027[19]. - Cash and cash equivalents increased to $68,415,741 as of December 31, 2024, up from $1,256,453 in 2023, showing a growth of 5,444%[29]. - Total assets rose to $72,763,773 in 2024, compared to $11,940,411 in 2023, marking an increase of 509%[29]. - Stockholders' equity improved to $68,151,724 in 2024, compared to a deficit of $(2,131,818) in 2023, indicating a turnaround in equity position[29]. - The company reported a total current liabilities of $4,338,887 in 2024, down from $13,900,999 in 2023, a decrease of 69%[29]. Other Financial Metrics - General and administrative (G&A) expenses for Q4 2024 were $4.6 million, up from $2.5 million in Q4 2023, mainly due to non-cash stock-based compensation and professional services[17]. - Skye achieved a $4.2 million gain from the partial derecognition of contingent liabilities and a $2.0 million gain from insurance recoveries in 2024[21]. - The weighted average shares of common stock outstanding increased to 39,968,601 in Q4 2024 from 12,343,269 in Q4 2023, an increase of 224%[27]. - The company did not incur any costs to acquire IPR&D assets in 2024, compared to $21,215,214 in 2023, indicating a strategic shift in asset acquisition[27]. - The company plans to present preclinical data at scientific conferences in Q2 2025, alongside an analyst event during the American Diabetes Association sessions[19].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 000-55136 Skye Bioscience, Inc. (Exact name of registrant as specified in its charter) Nevada 45-0692882 (Stat ...

SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (NASDAQ: SKYE) ("Skye" or the "Company"), a clinical stage biopharmaceutical company pioneering next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the fourth quarter and full year ended December 31, 2024, along with key accomplishments and upcoming milestones. "Skye's prime accomplishment in 2024 was the initiation and rapid advanceme ...

SAN DIEGO, March 14, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (NASDAQ:SKYE) ("Skye"), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, will host a conference call on Thursday, March 20th at 1:30 p.m. PT/4:30 p.m. ET to discuss its 2024 fourth quarter and full-year financial results. An earnings press release will be issued after the market closes on March 20th. The live webcast of the call can be accessed at the Skye ...

SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, is pleased to announce the participation of Punit Dhillon, Chief Executive Officer, in a South by Southwest panel session exploring the future of obesity management beyond GLP-1 drugs. SXSW Conference Panel Session: "Weighing in on Weight Loss Medicine" Focus: TheDate: Monday, Mar ...

Company Overview - Skye Bioscience, Inc. is a clinical-stage biopharmaceutical company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][3] - The company is leveraging biologic targets with substantial human proof of mechanism to create first-in-class therapeutics with clinical and commercial differentiation [3] Clinical Development - Skye is conducting a Phase 2 clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, specifically targeting obesity [3] - The trial is also assessing the combination of nimacimab with a GLP-1R agonist (Wegovy®) [3] Upcoming Events - Punit Dhillon, the CEO of Skye, will present a corporate overview at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, from 11:10 AM to 11:40 AM ET in Boston, MA [1][5] - A live and archived webcast of the presentation will be available on Skye's website [2]