Core Insights - The company is focused on the development of transcript-related projects, indicating a commitment to enhancing its offerings in this area [1] Group 1 - The company publishes thousands of quarterly earnings calls each quarter, showcasing its extensive coverage and growth in the transcript publishing sector [1] - There is an ongoing effort to expand coverage, suggesting a strategic initiative to capture more market share and improve service offerings [1]

Financial Data and Key Metrics Changes - The company ended 2025 with $25.7 million in cash equivalents and short-term investments, managing its operating plan to extend its runway through Q4 2026 [29][30] Business Line Data and Key Metrics Changes - The CBeyond program has shown a clinically meaningful 3% improvement in weight loss over semaglutide alone at 26 weeks, with a 22.3% mean weight loss in the combination arm over 52 weeks [6][17] - Participants on semaglutide alone regained 38.7% of weight over 13 weeks after stopping therapy, while those on the combination of nimacimab plus semaglutide only regained 17.8% [17] Market Data and Key Metrics Changes - The company aims to position nimacimab as a complementary therapy to GLP-1s, targeting second-line add-on settings for patients who have not achieved their weight loss goals with first-line therapies [19][20] Company Strategy and Development Direction - The company is expanding the CBeyond study to include new intravenous cohorts to rapidly generate safety and pharmacokinetic data at higher exposures [13][14] - A collaboration with Halozyme is underway to develop a co-formulation of nimacimab using their ENHANZE technology, aiming for high-volume subcutaneous injections [15][16] - The company is focused on refining the Phase 2b clinical trial design based on FDA feedback, particularly for combination therapy development with GLP-1s [16][30] Management's Comments on Operating Environment and Future Outlook - Management believes nimacimab can fill an important void in the anti-obesity medicine landscape, emphasizing the need for clinical data to support its potential [13][19] - The company is not attempting to compete directly with first-line incretin therapies but rather to address unmet needs in patients who require additional support [21][30] Other Important Information - The company has identified four distinct mechanistic pillars through which nimacimab modulates metabolic pathways, providing confidence in its differentiated profile [23] - Early data from the antibody peptide conjugate program shows promising results, indicating potential for combination-like efficacy with simplified dosing [26][28] Q&A Session Summary Question: Plans to share data from higher dose cohorts - The company is expanding into the Part C expansion study to generate data on higher exposure and expects updates by Q4 2026 [36][38] Question: Concerns about dose levels in the expansion study - Management believes the selected doses are sufficient for achieving the desired peripheral exposure and is open to evaluating higher doses in the future [46][47] Question: Profile and goals for the new program - The new program is seen as long-term optionality, with nimacimab remaining the core value driver while the antibody peptide conjugate data supports broader combination platforms [51][52] Question: Importance of peripheral tissues for nimacimab's effect - Adipose tissue and liver are critical for nimacimab's clinical effect, with different profiles expected for monotherapy versus combination therapy [58][60] Question: Use of IV in the Part C study - IV is being used for the fastest generation of high exposure PK and safety data, with plans to transition to subcutaneous delivery in Phase IIb [64][65]

Financial Data and Key Metrics Changes - The company ended 2025 with $25.7 million in cash equivalents and short-term investments, managing its operating plan to extend its runway through Q4 2026 [29][30]. Business Line Data and Key Metrics Changes - The CBeyond program has shown promising results, with a combination of nimacimab and semaglutide achieving a clinically meaningful 3% improvement in weight loss over semaglutide alone at 26 weeks, and a mean weight loss of 22.3% over 52 weeks in the combination arm [6][17]. - Participants on semaglutide alone regained 38.7% of weight over 13 weeks after stopping therapy, while those on the combination of nimacimab plus semaglutide only regained 17.8% [18]. Market Data and Key Metrics Changes - The company positions nimacimab as a complementary therapy to GLP-1s, targeting second-line add-on settings for patients who have not achieved their weight loss goals with first-line therapies [19][20]. Company Strategy and Development Direction - The company is focusing on expanding the CBeyond study to include new intravenous cohorts to rapidly generate safety and pharmacokinetic data at higher exposures [13][16]. - The collaboration with Halozyme aims to develop a co-formulation of nimacimab for high-volume subcutaneous injections, enhancing convenience for patients [15][39]. Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of generating clinical data to support nimacimab's potential in the anti-obesity market, particularly in addressing unmet needs for patients who require additional weight loss solutions [13][18]. - The company is refining its Phase IIb clinical trial design based on FDA feedback, focusing on dose, duration, and endpoints [16][30]. Other Important Information - The company has identified four mechanistic pillars through which nimacimab modulates metabolic pathways, including blunting obesity-related inflammation and enhancing lipid metabolism [23]. - The first-generation antibody peptide conjugate program is seen as a long-term optionality, with potential for broader combination therapies beyond GLP-1s [22][52]. Q&A Session Summary Question: Plans to share data from higher dose cohorts - The company is expanding into the Part C expansion study to generate data on higher exposures and expects to provide updates by Q4 2026 [37][38]. Question: Status of formulation work using Halozyme technology - The co-formulation work with Halozyme is ongoing and expected to be ready for the Phase IIb study, utilizing a mix-and-deliver approach [39][40]. Question: Concerns about dose levels in the expansion study - Management believes the selected doses are sufficient based on current data, but they continue to evaluate the potential for higher dosing [46][47]. Question: Profile and goals for the new program - The new program is treated as long-term optionality, with nimacimab remaining the core value driver for the near term [52][53]. Question: Importance of peripheral tissues for nimacimab's clinical effect - Adipose tissue and liver are critical for nimacimab's efficacy, with different profiles expected for monotherapy versus combination therapy [60][62]. Question: Reason for using IV in the Part C phase - IV is used for the fastest generation of high exposure PK and safety data, with plans to transition to subcutaneous delivery in Phase IIb [64][65]. Question: Clarification on dosing equivalence for IV and subcutaneous - The company based the equivalence on a previous bioavailability study, indicating that subcutaneous dosing has about 56% relative bioavailability compared to IV [70][71]. Question: Bar for success from the expanded study - The focus is on PK and safety data rather than efficacy, with expectations that higher exposure will validate the dosing model [77][78].

Financial Data and Key Metrics Changes - The company ended 2025 with $25.7 million in cash equivalents and short-term investments, managing its operating plan to extend its runway through Q4 2026 [30] Business Line Data and Key Metrics Changes - The CBeyond program has shown a clinically meaningful 3% improvement in weight loss over semaglutide alone at 26 weeks, with a 22.3% mean weight loss in the combination arm over 52 weeks [6][18] - Participants on semaglutide alone regained 38.7% of weight over 13 weeks after stopping therapy, while those on the combination of nimacimab plus semaglutide only regained 17.8% [18] Market Data and Key Metrics Changes - The company is positioning nimacimab as a complementary therapy to GLP-1s, targeting second-line add-on settings for patients who have not achieved their weight loss goals with first-line therapies [20][21] Company Strategy and Development Direction - The company is expanding the CBeyond study to include new intravenous cohorts to rapidly generate safety and pharmacokinetic data at higher exposures [14] - The focus is on developing a co-formulation of nimacimab using Halozyme's ENHANZE technology to facilitate high-volume subcutaneous injections [16] - The company aims to determine the exposure and duration of peripheral CB1 engagement required to produce clinically meaningful efficacy [34] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of generating clinical data to support nimacimab's potential in the anti-obesity medicine landscape, particularly in combination with GLP-1s [14][19] - The feedback from the FDA has helped refine the Phase 2b protocol, particularly regarding combination therapy development [17] Other Important Information - The company is advancing its first antibody peptide conjugate program, which aims to combine nimacimab's mechanism of action with a GLP-1 receptor agonist [25][28] Q&A Session Summary Question: Plans to share data from higher dose cohorts and status of formulation work - The company is expanding into the Part C expansion study to generate data on higher exposures and expects updates by Q4 2026 [38][39] - The formulation work with Halozyme is ongoing and expected to be ready for the Phase 2b study [40][41] Question: Concerns about dose levels in the expansion study - Management believes the selected doses are sufficient for the Phase 2b selection, but they are continuing to evaluate higher dosing [48] Question: Profile and goals for the new program - The new program is seen as long-term optionality, with nimacimab remaining the core value driver [52] Question: Importance of peripheral tissues for nimacimab's clinical effect - Adipose tissue and liver are critical for nimacimab's effects, with different profiles expected for monotherapy versus combination therapy [61] Question: Use of IV in the Part C phase of the study - IV is being used for the fastest generation of high exposure PK and safety information, with plans for subcutaneous delivery in Phase IIb [65]

March 10, 2026 2025 Q4 Financial Results & Business Update Nasdaq: SKYE © 2026 Skye Bioscience, Inc. Disclaimer and Important Information for Investors This presentation ("Presentation") has been prepared solely for general information purposes by or on behalf of Skye Bioscience, Inc. (together with its subsidiaries and affiliates, "Skye"). Any discussion of the potential use or expected success of our product candidates is subject to our product candidates being approved by regulatory authorities. Cautiona ...

Financial Performance - The company has incurred cumulative net losses of $186,874,486 as of December 31, 2025, with a net loss of $55,924,814 for the year ended December 31, 2025[141]. - The company reported negative cash flow from operating activities of $43,062,529 for the year ended December 31, 2025[142]. - The company has $25,737,221 in cash, cash equivalents, and short-term investments as of December 31, 2025, raising substantial doubt about its ability to continue as a going concern[142]. - The company expects to continue incurring significant losses for the foreseeable future as it develops nimacimab, its only product candidate in clinical development[141]. - The company anticipates that its expenses will increase significantly as it conducts ongoing clinical trials and research activities[151]. Capital and Funding - The company has entered into an Equity Distribution Agreement to sell up to $100 million of shares of common stock, but has not sold any shares to date[153]. - The company may need to seek additional funds sooner than planned due to uncertainties surrounding its capital requirements and operational demands[152]. - The company’s ability to raise additional capital may be adversely impacted by global economic conditions and market volatility[153]. - The company has an effective shelf registration on Form S-3 for offering up to $300,000,000 of its securities, but may face limitations if its public float is below $75,000,000[154]. - NASDAQ requires stockholder approval for transactions involving the issuance of common stock at a price less than the greater of book or market value, which could limit future capital raising efforts[155]. Regulatory and Compliance Risks - The regulatory approval process for nimacimab is expected to be lengthy and costly, potentially taking many years and requiring substantial evidence from clinical trials[174]. - The FDA or comparable foreign regulatory authorities may impose additional requirements for clinical trials or deny approval based on safety and efficacy concerns[178]. - The company must navigate complex regulatory environments that could impact commercialization and profitability, including potential changes in government regulations[210]. - Compliance with healthcare laws may involve substantial costs and could lead to significant penalties, including exclusion from government-funded healthcare programs[244]. - Non-compliance with data protection laws, such as HIPAA and GDPR, could materially adversely affect the company's financial condition and operations[246][249]. Clinical Development Challenges - Clinical drug development is lengthy and expensive, with a high historical failure rate for product candidates in the industry[159]. - Delays in clinical trial commencement or completion can increase costs and limit revenue generation, adversely affecting commercial prospects[163]. - Patient enrollment and retention issues in clinical trials could negatively impact product development efforts and trial outcomes[165]. - The company may face challenges with third-party contractors affecting the timely and accurate performance of clinical trials[169]. - The company has not conducted any later-stage clinical trials or submitted an NDA or BLA for nimacimab, which may hinder its ability to seek regulatory approval[173]. Market and Competitive Landscape - The company faces significant competition from other biotechnology and pharmaceutical companies, which could adversely affect its operating results[139]. - The company faces significant competition in the obesity treatment market, particularly from established therapies like GLP-1 receptor agonists, which may hinder market penetration for nimacimab[213]. - Market acceptance of nimacimab will depend on factors such as clinical efficacy, competitive pricing, and the strength of relationships with healthcare providers and payors[221]. - Third-party payors may challenge prices and refuse coverage for drugs if cheaper alternatives are available, impacting revenue potential[226]. - The total addressable market for nimacimab may be smaller than estimated, adversely affecting future revenue[232]. Intellectual Property Risks - The company's success is heavily reliant on its ability to protect its intellectual property and proprietary technologies, with potential adverse effects on financial condition if protection fails[273]. - Patent positions in the pharmaceutical and biotechnology sectors are uncertain, with no consistent policy emerging regarding patent claims in the United States[274]. - Legal challenges to patents can result in invalidation or narrowing of patent rights, impacting the ability to compete effectively[281]. - The risk of patent infringement claims increases as the biopharmaceutical industry expands and more patents are issued[287]. - Intellectual property litigation could lead to significant liability and may require the company to enter into licensing agreements that may not be commercially reasonable[294]. Operational and Environmental Risks - Business disruptions, including natural disasters and pandemics, could significantly harm future revenue and financial condition, increasing costs and expenses[331]. - Unfavorable global economic conditions, such as fluctuating interest rates and inflation, may adversely affect business, financial condition, and stock price[332]. - Compliance with U.S. and foreign export and import controls, sanctions, and anti-corruption laws may impair competitive ability and lead to severe penalties[334]. - Changes in tariff and import/export regulations could negatively affect global economic conditions and the company's financial results[337]. - The company may face significant costs related to compliance with environmental laws and regulations, which could adversely affect its business and financial condition[330]. Stock and Shareholder Issues - The stock price of the company has experienced significant volatility, ranging from $0.68 to $5.75 during the fiscal year ended December 31, 2025[310]. - As of the date of the Annual Report, the company's common stock has had a closing bid price of less than $1.00 per share for 39 consecutive trading days, risking delisting from NASDAQ[313]. - The company has issued pre-funded warrants for a total of 9,978,739 shares, with 3,677,879 already exercised, potentially diluting existing shareholders[320]. - The company has outstanding warrants to purchase up to 9,390,042 shares at exercise prices ranging from $0.001 to $288 per share, which may cause immediate and substantial dilution to existing stockholders[323]. - The company has never declared or paid any cash dividends on its common stock and does not anticipate doing so in the foreseeable future[317].

Core Insights - Skye Bioscience, Inc. reported financial results for Q4 and full year 2025, highlighting advancements in its clinical programs targeting obesity and related conditions [1][14]. Financial Performance - As of December 31, 2025, cash, cash equivalents, and short-term investments totaled $25.7 million, expected to fund operations through Q4 2026 [14]. - R&D expenses for Q4 2025 were $11.5 million, up from $7.8 million in Q4 2024, primarily due to manufacturing costs for the anticipated Phase 2b trial [15]. - For the full year 2025, R&D expenses reached $42.4 million, compared to $18.7 million in 2024, driven by clinical study and manufacturing costs [16]. - G&A expenses for Q4 2025 were $3.4 million, down from $4.6 million in Q4 2024, mainly due to reduced stock-based compensation and professional services [17]. - The net loss for Q4 2025 was $14.4 million, compared to $9.7 million in Q4 2024, with a full-year net loss of $55.9 million, significantly higher than the $26.6 million loss in 2024 [20][21]. Clinical Developments - The CBeyond Expansion Study initiated higher-dose evaluations of nimacimab, with cohorts receiving 400 mg and 600 mg IV doses, aiming to generate safety and pharmacokinetic data [6][7]. - Interim results from the Phase 2a trial showed a 22.3% mean weight loss at 52 weeks for the nimacimab plus semaglutide combination, with no plateau observed [12]. - The combination therapy demonstrated a statistically significant improvement in lean-to-fat mass ratio and waist circumference, with a lower weight regain during the follow-up period compared to semaglutide alone [12]. Upcoming Milestones - Skye plans to present preclinical data in Q2 2026 and finalize the Phase 2b study design by Q4 2026, with topline results from the CBeyond Expansion Study expected in the same quarter [13][18]. Research and Development Highlights - Skye is advancing its antibody-peptide conjugate (APC) program, which combines nimacimab's mechanism with a GLP-1 receptor agonist for enhanced therapeutic effects [12]. - The company is also working on optimizing manufacturing processes to support the anticipated Phase 2b trial and improve cost efficiency [11]. Company Overview - Skye Bioscience focuses on developing next-generation molecules targeting G-protein-coupled receptors for metabolic health, with nimacimab being a key candidate in its pipeline [23].

Core Viewpoint - Skye Bioscience, Inc. is set to discuss its 2025 fourth quarter and full-year financial results and business updates during a conference call on March 10, 2026 [1] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [3] - The company is working on next-generation molecules that modulate G-protein coupled receptors, aiming to create first-in-class therapeutics with clinical and commercial differentiation [3] Clinical Trials - Skye is conducting a Phase 2a clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, in the context of obesity [3] - The trial is also evaluating the combination of nimacimab with a GLP-1R agonist (Wegovy®) [3]

Core Insights - Skye Bioscience, Inc. has shared interim data from the Phase 2a CBeyond study of nimacimab, a negative allosteric modulating antibody targeting obesity, in combination with a GLP-1R agonist, semaglutide [1][2] Interim Data Summary - The extension phase of the CBeyond study for combination cohorts began in May 2025, with participants receiving either nimacimab plus semaglutide or placebo plus semaglutide [2] - In the nimacimab plus semaglutide arm, participants experienced a mean weight loss of 14.4% at 26 weeks [2] - Seven participants in the nimacimab plus semaglutide arm completed an additional 26 weeks, achieving a total mean weight loss of 22.3% after 52 weeks, with no weight loss plateau observed [3] Safety and Tolerability - The combination therapy of nimacimab and semaglutide demonstrated safety and was well-tolerated, with no serious adverse events reported during the extension period [3] Placebo Group Results - In the placebo plus semaglutide arm, participants had a mean weight loss of 13.9% at 26 weeks, and those who completed the additional 26 weeks lost an additional 5.8%, resulting in a total mean weight loss of 19.7% after 52 weeks [4] Comparison of Treatment Efficacy - Top-line data indicated that the combination of nimacimab and semaglutide achieved a clinically meaningful weight loss of -13.2% compared to -10.25% for semaglutide alone, with no plateau observed [5] - The nimacimab monotherapy did not meet the primary endpoint, showing a weight loss of -1.52% compared to -0.26% for placebo [5] Weight Regain Analysis - Participants treated with nimacimab + semaglutide regained only 17.8% of their weight loss at 26 weeks during a 13-week off-therapy follow-up, indicating a potential durable response [6] - In contrast, those on semaglutide alone experienced a weight regain of 37.3% from the weight lost at 26 weeks [6] Future Expectations - Topline data from the CBeyond Phase 2a extension, including monotherapy data and follow-up results, is anticipated in the third quarter of 2026 [7] Analyst Perspective - Analysts from William Blair noted that with a cash runway extending into the fourth quarter of 2026, further analysis of the Phase 2a study could attract investor interest, contingent on supportive data regarding the exposure/weight loss relationship [8] - At the time of publication, Skye Bioscience shares were down 5.53% to $0.95 [8]

Core Insights - Skye Bioscience announced interim 52-week data from the Phase 2a CBeyond study of nimacimab, a peripherally-restricted CB1 inhibitor antibody, showing promising weight loss results in combination with semaglutide [1][9] Study Design and Participant Details - The CBeyond extension study began in May 2025, involving participants who completed 26 weeks of treatment with either nimacimab plus semaglutide or placebo plus semaglutide [2] - A total of 19 participants from the combination cohorts entered the extension study, with 10 in the nimacimab plus semaglutide arm and 9 in the placebo plus semaglutide arm [2] Weight Loss Results - Participants in the nimacimab plus semaglutide arm experienced a mean weight loss of 14.4% at 26 weeks, with an additional 7.9% lost during the extension, totaling 22.3% after 52 weeks [3][8] - In the placebo plus semaglutide arm, mean weight loss was 13.9% at 26 weeks, with an additional 5.8% lost during the extension, resulting in a total of 19.7% after 52 weeks [4] Comparison with Previous Data - The combination of nimacimab and semaglutide achieved a clinically meaningful weight loss of -13.2% compared to semaglutide alone at 26 weeks [5] - The overall weight loss for all participants in the nimacimab plus semaglutide group was -13.6% at 26 weeks, with a follow-up weight regain of only 17.8% during a 13-week off-therapy period [6][10] Safety and Tolerability - The combination therapy demonstrated a strong safety profile, with no serious adverse events reported during the extension period [3][8] - The treatment was well tolerated at the tested doses, reinforcing the potential for nimacimab as a safe option in obesity treatment [9][11] Future Outlook - The company anticipates that further optimization of nimacimab dosing could lead to even greater weight loss and improved outcomes in future clinical trials [9][11] - Full topline reporting of the CBeyond Phase 2a extension data, including monotherapy data, is expected in Q3 2026 [11]