Skye Bioscience (SKYE) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Ladies and gentlemen, thank you for standing by. My name is JL, and I will be your conference operator today. At this time, I would like to welcome everyone to the Sky BioScience First Quarter Fiscal twenty twenty five Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. I would now like to turn the conference over to Bernie He ...

[Skye Bioscience First Quarter 2025 Results and Corporate Highlights](index=1&type=section&id=Skye%20Bioscience%20Reports%20First%20Quarter%202025%20Results) [Clinical and Corporate Highlights](index=1&type=section&id=Clinical%20and%20Corporate%20Highlights) Skye Bioscience advanced its lead candidate nimacimab for obesity, emphasizing its peripherally restricted mechanism, with Phase 2a trial data expected in late Q3 or early Q4 2025 - CEO Punit Dhillon emphasized that nimacimab's peripherally restricted mechanism may differentiate it from GLP-1s and small-molecule CB1 inhibitors, potentially reshaping the obesity treatment landscape[3](index=3&type=chunk) - Top-line data from the CBeyond™ Phase 2a study of nimacimab is expected in late Q3 or early Q4 2025[5](index=5&type=chunk) - The clinical trial is progressing well: the Data Safety Monitoring Committee has completed three reviews with no safety concerns, and the IRB has approved a 52-week open-label study extension[6](index=6&type=chunk) [Research & Development Highlights](index=2&type=section&id=Research%20%26%20Development%20Highlights) Preclinical data demonstrated nimacimab's efficacy in weight loss, both as monotherapy and in combination, highlighting its peripherally restricted mechanism to avoid neuropsychiatric side effects - Nimacimab's highly-peripherally restricted mechanism is sufficient to drive weight loss, avoiding brain exposure and potential neuropsychiatric side effects seen in less-restricted CB1 inhibitors like monlunabant[12](index=12&type=chunk) - In a preclinical study, nimacimab combined with the dual GLP-1/GIP agonist tirzepatide achieved over **30% weight loss**[12](index=12&type=chunk) - As a monotherapy, nimacimab produced **23.5% weight loss**, which was comparable to both monlunabant and tirzepatide alone in the same study[12](index=12&type=chunk) - In vitro data highlighted nimacimab's superior potency compared to the small molecule CB1 inhibitor monlunabant, especially under elevated concentrations of CB1 agonist associated with obesity[5](index=5&type=chunk)[12](index=12&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Skye Bioscience reported a net loss of **$11.1 million** for Q1 2025, with **$59.2 million** in cash expected to fund operations through Q1 2027, driven by increased operating expenses for the nimacimab Phase 2a study - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled **$59.2 million** This capital is expected to fund operations through at least Q1 2027, covering the completion of the extended Phase 2a study for nimacimab[8](index=8&type=chunk) Q1 2025 vs. Q1 2024 Operating Results | Financial Metric | Q1 2025 | Q1 2024 | Change Driver | | :--- | :--- | :--- | :--- | | **R&D Expenses** | $7.2 million | $1.9 million | Increased contract manufacturing and clinical trial costs for nimacimab | | **G&A Expenses** | $4.6 million | $4.2 million | Increased investor relations, marketing, and consulting fees | | **Net Loss** | $11.1 million | $5.0 million | Higher operating expenses, particularly in R&D | [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) This section presents the unaudited consolidated financial statements for Skye Bioscience, including Statements of Operations for Q1 2025 and Balance Sheets as of March 31, 2025 [Consolidated Statements of Operations](index=4&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Total operating expenses for Q1 2025 increased to **$11.8 million** from **$6.2 million** year-over-year, resulting in a net loss of **$11.1 million** or **$0.28 per share** Consolidated Statements of Operations (Unaudited, USD) | | Three Months Ended March 31, | | :--- | :---: | :---: | | | **2025** | **2024** | | **Operating expenses** | | | | Research and development | $7,197,257 | $1,946,450 | | General and administrative | $4,562,305 | $4,205,800 | | **Total operating expenses** | **$11,759,562** | **$6,152,250** | | **Operating loss** | **($11,759,562)** | **($6,152,250)** | | **Net loss** | **($11,103,319)** | **($5,019,531)** | | **Loss per common share (Basic & Diluted)** | **($0.28)** | **($0.18)** | | **Weighted average shares outstanding (Basic & Diluted)** | 39,651,888 | 27,999,901 | [Consolidated Balance Sheets](index=5&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2025, total assets were **$64.8 million**, a decrease from **$72.8 million** at year-end 2024, primarily due to cash used in operations, while total liabilities increased to **$5.5 million** Consolidated Balance Sheet Highlights (Unaudited, USD) | | **March 31, 2025** | **December 31, 2024** | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $46,421,299 | $68,415,741 | | Total current assets | $63,027,781 | $70,827,247 | | **Total assets** | **$64,793,240** | **$72,763,773** | | **LIABILITIES & EQUITY** | | | | Total current liabilities | $5,319,460 | $4,338,887 | | **Total liabilities** | **$5,542,926** | **$4,612,049** | | **Total stockholders' equity** | **$59,250,314** | **$68,151,724** | | **Total liabilities and stockholders' equity** | **$64,793,240** | **$72,763,773** |

PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Skye Bioscience, a clinical-stage biotech, reported an increased net loss in Q1 2025 driven by higher R&D, with total assets decreasing due to cash usage - The company is a clinical-stage biotechnology firm focused on developing molecules to treat obesity and related conditions, and has not yet generated revenue from its principal operations[19](index=19&type=chunk)[20](index=20&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$64.8 million** as of March 31, 2025, from **$72.8 million** at year-end 2024, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $46,421 | $68,416 | | Short-term investments | $12,803 | $0 | | Total current assets | $63,028 | $70,827 | | Total assets | $64,793 | $72,764 | | **Liabilities & Equity** | | | | Total current liabilities | $5,319 | $4,339 | | Total liabilities | $5,543 | $4,612 | | Total stockholders' equity | $59,250 | $68,152 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of **$11.1 million** in Q1 2025, up from **$5.0 million** in Q1 2024, primarily due to increased research and development expenses Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $7,197 | $1,946 | | General and administrative | $4,562 | $4,206 | | **Operating loss** | **($11,760)** | **($6,152)** | | Total other (income) expense, net | ($658) | ($1,135) | | **Net loss** | **($11,103)** | **($5,020)** | | **Loss per share (basic & diluted)** | **($0.28)** | **($0.18)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$9.2 million** in Q1 2025, with total cash and equivalents decreasing by **$22.0 million** due to investing activities and no financing Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,185) | $(4,708) | | Net cash (used in) provided by investing activities | $(12,809) | $1,142 | | Net cash provided by financing activities | $0 | $85,653 | | **Net (decrease) increase in cash** | **$(21,994)** | **$82,086** | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key disclosures include the 'Wendy Cunning vs Skye Bioscience, Inc.' lawsuit with a **$1.9 million** contingency, disaggregated R&D expenses highlighting nimacimab, and details on stock incentive plans - The company is party to the 'Wendy Cunning vs Skye Bioscience, Inc.' lawsuit, where a previous judgment was vacated, a new trial is scheduled for September 2025, and the estimated legal contingency is **$1,913,003** as of March 31, 2025[44](index=44&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) Disaggregated Research and Development Expenses (Q1 2025 vs Q1 2024, in thousands) | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | nimacimab | $5,184,865 | $129,120 | | Personnel related and stock-based compensation | $1,337,958 | $811,789 | | Other research and development expenses | $669,026 | $144,847 | | SBI-100 | $5,408 | $860,694 | | **Total R&D Expenses** | **$7,197,257** | **$1,946,450** | - As of March 31, 2025, the company had **1,170,197 shares** available for future grant under its Amended and Restated Omnibus Incentive Plan and **230,500 shares** available under its 2024 Inducement Equity Incentive Plan[34](index=34&type=chunk)[35](index=35&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the nimacimab Phase 2a trial, the **270% increase** in R&D expenses to **$7.2 million**, and confirms **$59.2 million** in liquidity is sufficient for the next 12 months - The company's lead candidate, nimacimab, is in a Phase 2a clinical trial for obesity, with top-line data expected in late Q3 or early Q4 2025, and the trial has been extended to 52 weeks to gather longer-term data[57](index=57&type=chunk)[58](index=58&type=chunk) - The company believes its current cash will be sufficient to fund projected operations for at least 12 months from the issuance date of the financial statements[85](index=85&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) R&D expenses surged by **270%** to **$7.2 million** in Q1 2025 due to nimacimab, while G&A expenses increased by **8%**, and other income decreased due to non-recurring gains Change in Research & Development Expenses (Q1 2025 vs Q1 2024, in thousands) | Expense Category | Change | Reason | | :--- | :--- | :--- | | Clinical trial costs | +$1,266,302 | Increased site and patient costs for Nimacimab Phase 2a study | | Contract manufacturing costs | +$2,532,130 | Drug substance and product costs for nimacimab | | Discovery research and development | +$623,020 | Increased work on nimacimab's mechanism of action | - General and administrative expenses increased by **$356,505 (8%)** YoY, primarily due to a **$373,571** increase in investor relations, marketing, and communications expenses[75](index=75&type=chunk)[79](index=79&type=chunk) - Total other income decreased by **$476,476** YoY, mainly because a **$1,145,141** gain on an asset sale in Q1 2024 did not recur, partially offset by a **$435,484** reduction in interest expense and a **$191,500** increase in interest income in Q1 2025[76](index=76&type=chunk)[77](index=77&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$59.2 million** in cash and equivalents as of March 31, 2025, asserting sufficient liquidity for at least 12 months, bolstered by **$83.6 million** from 2024 PIPE financings - The company had unrestricted cash, cash equivalents, and short-term investments of **$59.2 million** as of March 31, 2025, compared to **$68.4 million** as of December 31, 2024[80](index=80&type=chunk) - In January and March 2024, the company raised combined net proceeds of **$83.6 million** from two private placement (PIPE) financings[81](index=81&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,185) | $(4,708) | | Net cash (used in) provided by investing activities | $(12,809) | $1,142 | | Net cash provided by financing activities | $0 | $85,653 | [Quantitative and Qualitative Disclosures about Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is stated as 'Not applicable,' typical for a smaller reporting company with limited market risk exposure - The report states this item is '**Not applicable**'[96](index=96&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[98](index=98&type=chunk) - **No changes** in internal control over financial reporting occurred during the fiscal quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control[99](index=99&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 7 of the financial statements for details on material legal proceedings, primarily the 'Wendy Cunning vs Skye Bioscience, Inc.' lawsuit - For a description of material legal proceedings, the report refers to Note 7, 'General Litigation and Disputes' in the financial statements[101](index=101&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors from the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, have been reported - There have been **no material changes** to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024[102](index=102&type=chunk) [Other Information](index=23&type=section&id=Item%205.%20Other%20Information) Director Deborah Charych and CEO Punit Dhillon adopted Rule 10b5-1 trading plans in February and March 2025, respectively, for potential future stock sales - On February 12, 2025, Director Deborah Charych adopted a Rule 10b5-1 trading plan for the potential sale of up to **58,917 shares**[106](index=106&type=chunk) - On March 28, 2025, CEO Punit Dhillon adopted a Rule 10b5-1 trading plan covering the potential sale of shares from RSUs and his personal holdings through 2025 and 2026[107](index=107&type=chunk) [Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including CEO and CFO certifications and financial statements in Inline XBRL format - The exhibits filed with the report include certifications from the Principal Executive Officer and Principal Financial Officer (pursuant to Rules 13a-14, 15d-14, and Section 906 of Sarbanes-Oxley) and iXBRL data files[108](index=108&type=chunk)

Core Insights - Skye Bioscience, Inc. is making significant progress in its clinical operations and R&D, particularly with its lead candidate nimacimab for obesity treatment [2][3] - The company reported a net loss of $11.1 million for Q1 2025, an increase from $5.0 million in Q1 2024, primarily due to higher R&D expenses [10][8] - Skye's cash and cash equivalents totaled $59.2 million as of March 31, 2025, which is expected to fund operations through at least Q1 2027 [5] Clinical Highlights - The CBeyond™ Phase 2a trial for nimacimab is ongoing, with top-line data expected in late Q3 or early Q4 2025 [6][7] - Nimacimab has shown promising results in preclinical studies, demonstrating over 30% weight loss when combined with tirzepatide and 23.5% weight loss as a monotherapy [7] - The Data Safety Monitoring Committee has completed three safety reviews with no concerns, and the study protocol is being finalized with the FDA for a 52-week open-label study extension [7] Financial Results - R&D expenses for Q1 2025 were $7.2 million, up from $1.9 million in Q1 2024, driven by costs related to the Phase 2a clinical study [8] - General and administrative expenses increased to $4.6 million in Q1 2025 from $4.2 million in Q1 2024, mainly due to investor relations and marketing costs [9] - The total operating expenses for Q1 2025 were $11.8 million, compared to $6.2 million in the same period last year [16] Balance Sheet Highlights - As of March 31, 2025, total assets were $64.8 million, down from $72.8 million at the end of 2024 [19] - Current liabilities increased to $5.3 million from $4.3 million at the end of 2024, reflecting higher accounts payable and accrued liabilities [19] - Stockholders' equity decreased to $59.3 million from $68.2 million at the end of 2024, primarily due to the net loss incurred [19]

Skye Bioscience (SKYE) 2025 Conference May 08, 2025 11:00 AM ET Speaker0 two of the Citizens Life Science Conference. My name is John Walden, senior analyst here. We're pleased to have Sky Bioscience and Puneet Dillon, CEO joining us to tell us a little bit about the story. Sky, we initiated coverage on just a little while ago, but, this is a name that I think is underappreciated in the obesity space going after, you know, a relatively novel well, not novel mechanism, but way less crowded space with some di ...

Core Viewpoint - Skye Bioscience, Inc. is set to discuss its Q1 2025 financial results in a conference call on May 8, 2025, highlighting its focus on therapeutic pathways for obesity and metabolic health disorders [1][2]. Company Overview - Skye Bioscience is a clinical-stage biotechnology company dedicated to developing next-generation molecules that target G-protein coupled receptors for metabolic health [3]. - The company is conducting a Phase 2 clinical trial for nimacimab, an antibody that inhibits CB1, and is also evaluating its combination with a GLP-1R agonist (Wegovy®) [3]. Upcoming Events - A conference call will take place on May 8, 2025, at 1:30 p.m. PT/4:30 p.m. ET to discuss the company's financial results, with an earnings press release to be issued after market close on the same day [1][2].

Core Insights - Skye Bioscience, Inc. is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][2] - The company will participate in several upcoming healthcare conferences, including the European Congress on Obesity and the Citizens Life Sciences Conference [1][4] Company Overview - Skye is dedicated to developing next-generation molecules that modulate G-protein coupled receptors, aiming for first-in-class therapeutics with clinical and commercial differentiation [2] - The company is conducting a Phase 2 clinical trial for nimacimab, a negative allosteric modulating antibody that inhibits CB1, and is also assessing its combination with a GLP-1R agonist (Wegovy®) [2] Upcoming Events - Skye will present a poster at the European Congress on Obesity in Malaga, Spain on May 13 [1] - The company will also have a presentation at the Citizens Life Sciences Conference in New York on May 8 and will hold one-on-one meetings at the Craig-Hallum Institutional Investor Conference in Minneapolis on May 28 [4]

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]