Skye Bioscience (SKYE) Q2 2025 Earnings Call August 07, 2025 04:30 PM ET Speaker0Ladies and gentlemen, thank you for standing by. My name is Joe, and I will be your conference operator today. At this time, would like to welcome everyone to the Sky Bioscience Second Quarter twenty twenty five Financial Results and Business Update 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 confe ...

Clinical Progress - Top-line data from the CBeyond study is expected in late Q3/early Q4[15] - A KOL event is scheduled for September 2025 to discuss the mechanism, Phase 2a clinical data expectations, and market positioning[15, 49] Nimacimab's Differentiation and Mechanism - Nimacimab exhibits significantly less brain penetration compared to small molecule CB1 inhibitors[18] - Nimacimab retains potency even in the presence of competition, unlike small molecules[20] - Preclinical data suggests nimacimab enhances weight loss when combined with low-dose tirzepatide[26] - Preclinical data suggests nimacimab prevents weight rebound and shows potential as maintenance therapy, with tirzepatide rebound at 29.7% and nimacimab maintenance at 12.8% in Phase B[31, 33] Market Opportunity - Nearly two-thirds (66.67%) of patients discontinue GLP-1 RA therapy after one year, and over 80% discontinue after two years, highlighting a therapeutic gap[36] - The company believes nimacimab represents a potential multi-billion dollar opportunity in monotherapy, maintenance, and combination therapy for obesity[37]

Skye Bioscience Reports Second Quarter 2025 Financial Results and Business Update SAN DIEGO, CA, August 7, 2025 -- Skye Bioscience, Inc. (NASDAQ: SKYE) ("Skye" or the "Company"), a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the second quarter ended June 30, 2025, along with key accomplishments and upcoming milestones. "As we eagerly await the 26- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission File Number: 000-55136 Skye Bioscience, Inc. FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ _____________________________________________________________ (Exact name of regis ...

Core Insights - Skye Bioscience, Inc. is focused on developing nimacimab, an anti-obesity drug that targets peripheral CB1 receptors, aiming to address unmet needs in obesity treatment [1][2][3] - The company has launched a video series titled "Anatomy of Progress" to provide updates on nimacimab's development and its advantages over traditional treatments [1][2] Group 1: Product Development - Nimacimab is a peripherally-restricted CB1 antibody that aims to provide weight loss benefits without the neuropsychiatric side effects associated with small molecule CB1 inhibitors [4][3] - The video series discusses the mechanistic advantages of nimacimab, emphasizing its potential to revolutionize obesity treatment by addressing biological resistance to traditional therapies [3][4] Group 2: Clinical Insights - Skye's management participated in a panel discussing the clinical and preclinical experiences with nimacimab, highlighting its peripheral blockade of the CB1 pathway [5] - Presentations at the American Diabetes Association's 85th Scientific Sessions included data on nimacimab's effectiveness in promoting weight loss and reducing obesity-induced inflammation [6][8] Group 3: Market Positioning - The company is positioning nimacimab as a differentiated therapeutic option in the obesity market, particularly as a non-GLP1 alternative, based on feedback from obesity physicians [7] - The market opportunity for nimacimab is framed by its unique target product profile, which is expected to complement existing incretin-based therapies [7][9] Group 4: Research Findings - Preclinical studies demonstrated that nimacimab promotes metabolic homeostasis and improves hormonal regulation in diet-induced obesity models [8] - New biomarker data presented indicates significant reductions in obesity-related inflammation and liver steatosis, supporting nimacimab's potential as a standalone and combination therapy [6][8]

Core Insights - Skye Bioscience, Inc. is set to present new data on nimacimab at the American Diabetes Association's 85th Scientific Sessions, highlighting its focus on obesity and metabolic health disorders [1][2] Presentation Details - Skye's CEO, CMO, and CSO will participate in an invitation-only panel at the Evercore event during the ADA conference [3] - A symposium presentation titled "Mechanistic Insights into Weight Loss and Metabolic Regulation of Obese Mice Treated with Nimacimab" will be held on June 22, 2025, showcasing the therapeutic potential of nimacimab [4] - A poster presentation will discuss how nimacimab promotes metabolic homeostasis in a diet-induced obesity mouse model, emphasizing weight loss and hormonal regulation [5] Company Overview - Skye Bioscience is dedicated to developing next-generation therapeutics targeting G-protein coupled receptors, with a focus on obesity and metabolic health [6][7] - The company is conducting a Phase 2 clinical trial for nimacimab, assessing its effects both alone and in combination with a GLP-1R agonist [7]

Skye Bioscience (SKYE) 2025 Conference June 05, 2025 09:20 AM ET Speaker0 Morning, and welcome everyone to the Jefferies Global Healthcare Conference. I'm Jordan Carey with the investment banking team, and it's my pleasure to introduce Puneet Dillon, CEO of Sky Biosciences. Speaker1 Okay. Thank you so much. All right. Good morning, everyone. Yes, thank you again for the invitation and being here at Jefferies. It's always a pleasure seeing the entire Jefferies team and talking about what we're working on at ...

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 two upcoming healthcare conferences, including the Jefferies Global Healthcare Conference and the Sachs European BioPharma Obesity Innovation Forum [1] Company Overview - Skye is 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]

Core Insights - Skye Bioscience is collaborating with Arecor Therapeutics to develop a higher concentration formulation of nimacimab, a CB1 inhibitor, utilizing Arecor's Arestat™ technology [1][2][3] - Nimacimab is currently being evaluated in a Phase 2a clinical trial for obesity, with initial data expected in late Q3 or early Q4 2025 [2][5] - The partnership allows Skye to fund Arecor's development activities and potentially license the new formulation and associated intellectual property [2][3] Company Overview - Skye Bioscience focuses on developing next-generation therapeutic pathways for metabolic health, particularly through G-protein coupled receptors [5] - The company is conducting a Phase 2a clinical trial for nimacimab, which is a negative allosteric modulating antibody that inhibits CB1 [5] - Arecor Therapeutics aims to enhance existing therapeutic products and has a proprietary technology platform, Arestat™, supported by a strong patent portfolio [4] Product Development - Nimacimab has a pharmacokinetic profile with a half-life of 18–21 days, which is significantly longer than GLP-1-based therapies, and is being evaluated for once-weekly dosing [3] - The collaboration aims to address issues related to tolerability and adherence seen in approved weight loss drugs, as well as concerns about neuropsychiatric toxicities associated with small molecule CB1 inhibitors [3]

Skye Bioscience (SKYE) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Bernie Hertel - Head IR & CommunicationsPunit Dhillon - President, CEO, Secretary & DirectorChris Twitty - Chief Scientific OfficerKaitlyn Arsenault - Chief Financial OfficerPuneet Arora - Chief Medical Officer Conference Call Participants None - AnalystJay Olson - Managing Director & Senior Analyst - BiotechnologyAlbert Lowe - Senior Research AnalystEdward Tenthoff - Sr. Research AnalystKristen Kluska - AnalystAndy H ...