Halozyme and Skye Bioscience Announce Global Collaboration and License Agreement to Evaluate Nimacimab Co-Formulated with ENHANZE® for Obesity

Rhea-AI Summary

Skye Bioscience (NASDAQ: SKYE) licensed Halozyme's ENHANZE drug‑delivery technology in December 2025 to co‑formulate nimacimab for subcutaneous, higher‑dose delivery in obesity.

The non‑exclusive global collaboration supports evaluation of larger injection volumes and planned Phase 2b testing in obesity starting in mid‑2026, including assessment of nimacimab combined with a GLP‑1 receptor agonist. Financial terms include milestone payments from Skye and mid‑single‑digit royalties to Halozyme on net sales of nimacimab developed with ENHANZE for at least 10 years.

Positive

• Non‑exclusive global license of ENHANZE for nimacimab co‑formulation
• Planned Phase 2b obesity trial initiation in mid‑2026
• Mid‑single‑digit royalties to Halozyme provide long‑term revenue linkage

Negative

• Skye obliged to milestone payments tied to development and commercialization
• Royalties to Halozyme reduce Skye's potential net sales from ENHANZE‑formulated nimacimab

Key Figures

Royalty term At least 10 years Royalties to Halozyme on net sales of nimacimab with ENHANZE

Planned trial phase Phase 2b Upcoming obesity clinical trial of nimacimab with ENHANZE

Trial timing Mid-2026 Planned initiation of Phase 2b obesity trial

Market Reality Check

$1.11 Last Close

Volume Volume 401,385 vs 20-day average 504,933 (relative volume 0.79x), not heavy for a 17.14% move. normal

Technical Price $0.8782 is trading below the $2.42 200-day moving average, reflecting a longer-term downtrend.

Peers on Argus 1 Up

SKYE gained 17.14% while key biotech peers were mostly down (e.g., FBRX -13.26%, AVTX -6.43%, CRDF -5%), with only ZURA up 5.92%. Momentum scanner shows just one peer (IOBT) moving up modestly. This points to a stock-specific reaction to the Halozyme collaboration rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 24	Investor conferences	Neutral	+11.6%	Announcement of December 2025 healthcare conference participation and investor meetings.
Nov 10	Earnings & update	Positive	-7.2%	Q3 2025 results plus encouraging nimacimab combo data and funding into 2027.
Nov 05	Clinical data	Positive	+6.3%	ObesityWeek 2025 late-breaking abstract with favorable weight-loss and rebound data.
Nov 05	Earnings date notice	Neutral	+6.3%	Scheduling announcement for upcoming Q3 2025 earnings release and conference appearance.
Oct 06	Phase 2a topline	Negative	-60.0%	CBeyond™ Phase 2a topline showing monotherapy miss but combo benefit versus semaglutide.

Pattern Detected

News tied directly to nimacimab’s clinical data and business progress has produced volatile, sometimes divergent reactions, including a sharp selloff on mixed Phase 2a topline results and a decline following seemingly positive Q3 data and cash runway commentary.

Recent Company History

Over the last few months, Skye’s trajectory has centered on nimacimab for obesity. On Oct 6, 2025, CBeyond™ Phase 2a topline data showed monotherapy missing its primary endpoint but a positive semaglutide combination signal, triggering a -60% move. Subsequent ObesityWeek 2025 data and conference participation in early November delivered additional combination efficacy details and modestly positive price reactions. Q3 2025 results on Nov 10, 2025 highlighted a $35.3M cash position and funding into 2027, yet the stock fell -7.19%. Today’s Halozyme collaboration extends this obesity-focused strategy by enabling higher-dose subcutaneous nimacimab development.

Market Pulse Summary

This announcement establishes a non-exclusive collaboration with Halozyme to co-formulate nimacimab with ENHANZE for higher-dose subcutaneous delivery in obesity, with plans for a Phase 2b trial starting in 2026. It builds on prior Phase 2a data where nimacimab showed benefits in combination with semaglutide. Investors may track upcoming clinical milestones, the design and execution of the Phase 2b obesity study, and subsequent development or commercialization milestones tied to this licensing agreement.

Key Terms

subcutaneous medical

"higher-dose, subcutaneous administration strategies for nimacimab"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

glp-1 receptor agonists medical

"including in combination with GLP-1 receptor agonists."

GLP-1 receptor agonists are medicines that mimic a natural gut hormone to lower blood sugar and reduce appetite, often used to treat diabetes and obesity. Investors care because these drugs can drive large prescription sales, face strict regulatory approval and patent timelines, and their safety, pricing, or label changes can meaningfully affect a drug maker’s revenue much like a bestselling product or a recalled item would impact any company’s financial outlook.

glp-1r agonist medical

"This study will also assess the combination of nimacimab and a GLP-1R agonist."

A GLP-1R agonist is a type of medicine that mimics a natural gut hormone (GLP-1) to help control blood sugar and often reduce appetite and body weight; think of it as pressing a reset button on the body’s signals for hunger and insulin release. Investors care because these drugs target large markets for diabetes and obesity, can drive significant sales if adopted widely, and often spark regulatory, competitive and pricing debates that affect company value.

phase 2b clinical trial medical

"Skye is planning to initiate a Phase 2b clinical trial in obesity"

A phase 2b clinical trial is a mid-stage medical study that tests whether a new treatment works and which dose is best by enrolling a larger group of patients than earlier phase 2 studies. For investors, its results are a key signal of a drug’s real-world effectiveness and safety, and can strongly influence the chances of later regulatory approval, future funding needs, and a company’s stock outlook—like a larger pilot test before full rollout.

AI-generated analysis. Not financial advice.

Agreement supports development and commercialization of higher-dose, subcutaneous administration strategies for nimacimab

SAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Skye Bioscience, Inc. (Nasdaq: SKYE) today announced the companies entered into a non-exclusive global collaboration and license agreement in December 2025. Under the collaboration, Skye has licensed Halozyme's ENHANZE^® drug delivery technology for the development and potential commercialization of a subcutaneous formulation of nimacimab for the treatment of obesity. The collaboration is intended to support Skye’s evaluation of higher nimacimab subcutaneous doses through delivery of larger injection volumes.

“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.”

“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.”

Skye will make milestone payments tied to the achievement of certain development and commercialization events. Halozyme will also be entitled to mid-single digit royalties on net sales of nimacimab developed with ENHANZE^® for at least 10 years.

Skye is planning to initiate a Phase 2b clinical trial in obesity for nimacimab with ENHANZE in the middle of 2026. This study will also assess the combination of nimacimab and a GLP-1R agonist.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies.

As the innovators of ENHANZE^® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme’s commercially validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE^® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V.

Halozyme is also developing Hypercon™ to expand the breadth of its drug delivery technology portfolio. Hypercon™ is an innovative microparticle technology that is expected to set a new standard in hyper concentration of drugs and biologics that can reduce the injection volume for the same dosage and expands opportunities for at-home and health care provider administration. The addition of Hypercon™ enhances our ability to transform the patient treatment experience by enabling the creation and delivery of highly concentrated biologics, substantially broadening the scope of therapeutics that can be delivered subcutaneously. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson, Eli Lilly, and argenx.

Halozyme also develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability, and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex^® and XYOSTED^®, partnered commercial products, and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.

Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.

For more information, visit www.halozyme.com and connect with us on LinkedIn and Twitter.

About Skye Bioscience

Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of potential first-in-class therapeutics with potential clinical and commercial differentiation. Skye is conducting a Phase 2a clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy^®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.

Forward-Looking Statements

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning royalty revenue growth, potential new partnerships and innovations, the possible activity, benefits and attributes of ENHANZE^®, the possible method of action of ENHANZE^®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and statements concerning certain other potential benefits of ENHANZE^® including facilitating more rapid delivery and administration of larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden and improving the treatment experience for patients. These forward-looking statements also include statements regarding the product development and commercialization efforts of Skye (including the potential regulatory approval and launch of nimacimab as a result of such efforts and the potential future market opportunity for such products) and Halozyme's potential receipt of payments associated with achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue" and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including risks and uncertainties concerning whether development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized and the potential future market for such products, unexpected levels of revenue growth, expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme and Skye’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme and Skye undertake no duty to update forward-looking statements to reflect events after the date of this release.

Contacts   

Halozyme
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com   

Skye Investor & Media Relations
ir@skyebioscience.com
(858) 410-0266

LifeSci Advisors
Mike Moyer
mmoyer@lifesciadvisors.com
(617) 308-4306

FAQ

What did Skye (SKYE) announce about nimacimab and ENHANZE on January 5, 2026?

Skye announced a non‑exclusive global license with Halozyme to co‑formulate nimacimab with ENHANZE for subcutaneous, higher‑dose delivery in obesity.

When will Skye start the nimacimab Phase 2b obesity trial with ENHANZE?

Skye plans to initiate the Phase 2b clinical trial in obesity in mid‑2026.

Will the Phase 2b study test nimacimab with GLP‑1 receptor agonists?

Yes, the planned Phase 2b will also assess the combination of nimacimab and a GLP‑1R agonist.

What are the key commercial terms between Skye and Halozyme for nimacimab with ENHANZE?

Skye will make milestone payments tied to development/commercial events and Halozyme will receive mid‑single‑digit royalties on net sales for at least 10 years.

Is the ENHANZE license exclusive for nimacimab?

No, the agreement is described as a non‑exclusive global collaboration and license.