Skye Bioscience Q2 2025 slides: Nimacimab targets obesity treatment gaps

Introduction & Market Context

Skye Bioscience Inc. (NASDAQ:SKYE) presented its Q2 2025 financial results and business update on August 7, 2025, highlighting the company’s progress with its lead candidate Nimacimab, a CB1 inhibitor being developed for obesity treatment. The presentation comes as Skye’s stock closed at $2.55, down 8.74% on the day, reflecting possible market skepticism despite the company’s optimistic outlook on its clinical programs.

The company is positioning Nimacimab to address significant gaps in the rapidly evolving obesity treatment landscape, particularly focusing on the high discontinuation rates of GLP-1 receptor agonists, which have dominated the market in recent years.

As shown in the following slide from the company’s presentation, Skye is progressing through its clinical development timeline with several key milestones achieved:

Quarterly Performance Highlights

While the presentation did not disclose detailed financial metrics for Q2 2025, previous earnings reports indicate that Skye has been significantly increasing its R&D investments. In Q1 2025, the company reported R&D expenses of $7.2 million, up from $1.9 million in the same period of 2024, reflecting the advancement of its clinical programs.

The company highlighted the completion of patient enrollment in its CBeyond trial, with the Last Patient Last Visit (LPLV) expected in August 2025. Topline data from this trial is anticipated in late Q3 or early Q4 2025, representing a crucial catalyst for the company.

Skye’s cash position stood at $59.2 million as of March 31, 2025, which management previously indicated would fund operations through Q1 2027, providing runway through multiple clinical milestones.

Strategic Initiatives

Skye’s presentation emphasized Nimacimab’s differentiated mechanism of action compared to small molecule CB1 inhibitors. The company highlighted two key differentiators: peripheral restriction (limited brain penetration) and its function as a negative allosteric modulator.

As illustrated in the following slide, these properties potentially address safety concerns associated with earlier CB1 inhibitors while maintaining efficacy:

The company further detailed the four mechanistic pillars of Nimacimab’s action, which provide the scientific rationale for its development in obesity:

Particularly promising are the preclinical results showing Nimacimab’s potential to enhance weight loss when combined with low-dose tirzepatide (a GLP-1/GIP dual agonist). The data suggests that adding Nimacimab to suboptimal doses of tirzepatide could achieve weight loss comparable to higher doses of tirzepatide alone:

Perhaps most significantly, Skye presented data suggesting Nimacimab may address one of the key challenges in obesity treatment: weight regain after discontinuation. The following slide demonstrates substantially less weight rebound with Nimacimab compared to tirzepatide in preclinical models:

Competitive Industry Position

Skye is entering a highly competitive obesity treatment market dominated by GLP-1 receptor agonists like semaglutide (Wegovy) and tirzepatide (Zepbound). However, the company identified a significant therapeutic gap based on high discontinuation rates of these therapies.

According to data presented by Skye, nearly two-thirds of patients discontinue GLP-1 therapy after one year, and over 80% discontinue after two years:

This discontinuation pattern creates potential opportunities for Nimacimab as either a monotherapy, maintenance therapy, or combination therapy, as outlined in the company’s target product profile:

Forward-Looking Statements

Skye outlined several upcoming catalysts that could significantly impact the company’s trajectory:

1. CBeyond Last Patient Last Visit in August 2025

2. Topline data expected in late Q3/early Q4 2025

3. Key Opinion Leader event planned for September 2025

4. CBeyond Extension Last Patient Last Visit in November 2025

CEO Puneet Dillon has previously expressed confidence in the company’s approach, stating in the Q1 earnings call: "We’ve demonstrated this robust inhibition of CB1 across multiple assays," highlighting the company’s innovative approach with Nimacimab.

The company faces significant challenges, including intense competition in the obesity market and the inherent risks of clinical development. While preclinical data appears promising, investors will be closely watching the upcoming topline results to validate Nimacimab’s potential in human subjects.

Skye’s positioning of Nimacimab as a potential multi-billion dollar opportunity reflects the massive growth in the obesity treatment market, but the company will need to demonstrate clear differentiation and clinical benefits to capture market share from established players and other emerging therapies in this increasingly crowded space.

Full presentation:

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