Skye & Halozyme Target Obesity with Novel Drug Delivery Combination

SAN DIEGO, CA – January 05, 2026 – In a strategic move aimed at the burgeoning multi-billion-dollar obesity market, Skye Bioscience and Halozyme Therapeutics have announced a global collaboration to advance a novel weight-loss drug, nimacimab. The partnership, centered on Halozyme’s renowned ENHANZE® drug delivery technology, seeks to solve a critical dosing challenge and potentially carve out a unique space in a field currently dominated by GLP-1 agonists like Wegovy® and Zepbound®.

The agreement gives Skye Bioscience access to ENHANZE® to develop a new subcutaneous formulation of nimacimab, an investigational antibody designed to treat obesity. This collaboration is pivotal for Skye, as it enables the company to test higher, potentially more effective doses of its drug in a convenient injection format, a hurdle identified in its recent clinical trials. For Halozyme, the deal marks a significant entry into the high-growth obesity therapeutic area, expanding the reach of its blockbuster drug delivery platform.

“Our collaboration with Skye Bioscience expands the reach of our ENHANZE technology into the growing obesity market, a therapeutic area with significant long-term potential,” said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. “This agreement reinforces the scalability of ENHANZE across diverse indications and supports our strategy to drive sustainable royalty growth with new partnerships and innovations.”

A Second Chance for a Controversial Pathway

Skye Bioscience’s nimacimab represents a modern attempt to harness the therapeutic potential of the cannabinoid 1 (CB1) receptor, a target with a fraught history in obesity treatment. More than a decade ago, the small-molecule CB1 inhibitor Rimonabant showed promise for weight loss but was ultimately pulled from the market due to severe psychiatric side effects, including depression and anxiety. The drug readily crossed the blood-brain barrier, affecting CB1 receptors in the central nervous system.

Nimacimab is engineered specifically to avoid this pitfall. As a large-molecule monoclonal antibody, it is designed to be “peripherally restricted,” meaning it acts on CB1 receptors in metabolic tissues like fat, muscle, and the liver, without significantly penetrating the brain. The goal is to achieve the metabolic benefits of CB1 inhibition—such as improved energy expenditure and appetite modulation—without the dangerous neuropsychiatric consequences.

Recent data from Skye’s Phase 2a CBeyond™ clinical trial provided crucial validation for this approach. The study reported that nimacimab had a favorable safety profile with placebo-like tolerability, and importantly, showed no increase in psychiatric adverse events. This clean safety profile is a critical differentiator that re-opens the door for a class of drugs once considered too risky for development.

The Power of Combination and Delivery

While the Phase 2a trial successfully demonstrated nimacimab's peripheral safety, it also revealed a key challenge: the 200 mg monotherapy dose was suboptimal and did not meet its primary weight loss endpoint. Pharmacokinetic analysis suggested that higher drug exposure was needed to unlock its full potential. However, delivering larger doses of an antibody subcutaneously can be difficult, often requiring large, painful injection volumes.

This is where Halozyme’s ENHANZE® technology becomes the linchpin of the strategy. ENHANZE® utilizes an enzyme, rHuPH20, that temporarily breaks down hyaluronan, a gel-like substance in the tissue under the skin. This action allows for the rapid dispersion and absorption of much larger volumes of a co-injected drug than would otherwise be possible with a standard subcutaneous shot. It effectively transforms a delivery method, enabling what might have required a lengthy intravenous infusion to be given as a quick, simple injection.

“To fully evaluate nimacimab’s potential, we need to test higher doses and we need a practical way to deliver them subcutaneously,” said Punit Dhillon, President and Chief Executive Officer of Skye. “Partnering with Halozyme to co-formulate nimacimab with ENHANZE gives us a validated approach to evaluate multiple dose-ranging strategies, including in combination with GLP-1 receptor agonists.”

The most compelling data from the CBeyond™ trial came from a cohort where nimacimab was given alongside the popular GLP-1 drug semaglutide (Wegovy®). Patients in this group showed a clinically meaningful additional weight loss compared to those on semaglutide alone. Critically, this added efficacy came without an increase in the gastrointestinal side effects commonly associated with GLP-1 therapies. This suggests a complementary mechanism of action and positions nimacimab as a potential best-in-class combination agent rather than a direct competitor to the market leaders.

Navigating a Crowded and Evolving Market

The collaboration comes as the anti-obesity drug market is experiencing explosive growth, with some analysts projecting it could exceed $100 billion by 2030. While Eli Lilly and Novo Nordisk currently dominate with their highly effective incretin-based therapies, the field is rapidly evolving. Companies are racing to develop drugs with improved tolerability, alternative mechanisms of action, and the ability to preserve lean muscle mass during weight loss.

Skye and Halozyme are betting that nimacimab can address several of these unmet needs. Its non-incretin mechanism offers an alternative for patients who do not respond to or cannot tolerate GLP-1s, while its favorable side effect profile in combination studies makes it an attractive add-on therapy. The ability to deliver a higher, more effective dose conveniently via ENHANZE® will be crucial to its competitiveness.

Under the terms of the agreement, Skye will make milestone payments to Halozyme upon achieving certain development and commercial goals. Halozyme will also receive mid-single-digit royalties on net sales of the ENHANZE®-enabled product for at least a decade, reinforcing its highly successful business model of licensing its platform technology to pharmaceutical innovators. With a portfolio of ten commercialized products licensed to giants like Roche, Pfizer, and Janssen, Halozyme has established ENHANZE® as a key enabler of modern drug development.

Looking ahead, Skye plans to initiate a pivotal Phase 2b clinical trial in mid-2026. This study will be the first to test nimacimab co-formulated with ENHANZE®, allowing for the evaluation of higher doses both as a monotherapy and in combination with a GLP-1 agonist. The results of this trial will be a critical inflection point, determining if this novel combination of targeted biology and advanced drug delivery can create the next wave of effective and patient-friendly obesity treatments.