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Skye Bioscience Highlights Attributes of its Peripherally-restricted CB1 Inhibitor Antibody at Keystone Obesity Conference

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Skye Bioscience (Nasdaq: SKYE) presented preclinical data on nimacimab, a peripherally-restricted CB1-inhibitor antibody, at the Keystone Obesity conference on January 29, 2026. Key DIO mouse-model findings: nimacimab added to tirzepatide produced 39% and 46% weight loss, effects were durable after discontinuation, rebound was blunted by ~80%, and weight loss was not driven primarily by caloric restriction. Nimacimab also enhanced semaglutide-induced weight loss, suggesting potential as a maintenance or combination therapy to support efficacy with lower incretin doses.

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Positive

  • Additive weight loss of 39% with nimacimab plus suboptimal tirzepatide dose
  • Additive weight loss of 46% with nimacimab plus clinically active tirzepatide dose
  • Weight-loss effect was durable after treatment discontinuation
  • Weight rebound after tirzepatide was blunted by ~80% when followed by nimacimab
  • Nimacimab enhanced weight loss induced by semaglutide

Negative

  • None.

News Market Reaction

-4.95%
4 alerts
-4.95% News Effect
-$2M Valuation Impact
$32M Market Cap
0.2x Rel. Volume

On the day this news was published, SKYE declined 4.95%, reflecting a moderate negative market reaction. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $32M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Weight loss with tirzepatide combo (suboptimal dose): 39% weight loss Weight loss with tirzepatide combo (active dose): 46% weight loss Weight rebound blunting: 80% regain blunted
3 metrics
Weight loss with tirzepatide combo (suboptimal dose) 39% weight loss Diet-induced obesity mouse model with nimacimab plus suboptimal tirzepatide
Weight loss with tirzepatide combo (active dose) 46% weight loss Diet-induced obesity mouse model with nimacimab plus clinically active tirzepatide
Weight rebound blunting 80% regain blunted Nimacimab maintenance after tirzepatide discontinuation in DIO mouse model

Market Reality Check

Price: $1.01 Vol: Volume 95,971 is well bel...
low vol
$1.01 Last Close
Volume Volume 95,971 is well below 20-day average of 407,908 (relative volume 0.24). low
Technical Price at $1.01 is trading below the 200-day MA of $2.35 and 82.43% below the 52-week high.

Peers on Argus

SKYE fell 5.61% while momentum data show only CRDF appearing, up 4.94%. Broader ...
1 Up

SKYE fell 5.61% while momentum data show only CRDF appearing, up 4.94%. Broader biotech peers listed are generally down, but scanner activity does not indicate a coordinated sector move.

Historical Context

5 past events · Latest: Jan 21 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Jan 21 Conference poster notice Positive +0.8% Announcement of upcoming Keystone obesity poster on nimacimab DIO models.
Jan 12 Corporate outlook Positive -4.0% 2026 outlook with Phase 2a/2b plans and multiple nimacimab milestones.
Jan 05 Collaboration deal Positive -2.3% Global collaboration with Halozyme to co-formulate nimacimab using ENHANZE.
Nov 24 Investor conferences Neutral +11.6% December 2025 investor conferences and fireside chats to engage shareholders.
Nov 10 Earnings and trial data Positive -7.2% Q3 2025 results plus positive nimacimab+semaglutide Phase 2a combo data.
Pattern Detected

Nimacimab- and obesity-focused updates have often been followed by mixed or negative price reactions, with several positive or neutral announcements seeing declines.

Recent Company History

Over the last few months, SKYE issued multiple updates centered on nimacimab and obesity. A Nov 10, 2025 Q3 release highlighted favorable Phase 2a combo data and funding into 2027, yet the stock fell. A Dec 2025 collaboration with Halozyme and a Jan 12, 2026 corporate outlook outlining key 2026 milestones also saw negative reactions. By Jan 21, 2026, news of this Keystone obesity poster was met with only a modest gain, framing today’s detailed preclinical data against a backdrop of cautious trading.

Market Pulse Summary

This announcement details preclinical obesity data for nimacimab, showing substantial weight-loss ef...
Analysis

This announcement details preclinical obesity data for nimacimab, showing substantial weight-loss effects of 39% and 46% when combined with tirzepatide and improved weight rebound control. These findings build on prior nimacimab-focused communications emphasizing combination strategies with incretin-based therapies. Investors may watch how these mouse data connect to ongoing and planned clinical studies, as well as future updates on durability, maintenance use after discontinuation, and safety at more tolerable incretin doses.

Key Terms

cb1-inhibitor antibody, diet-induced obesity (dio) mouse model, incretin agonists, tirzepatide, +2 more
6 terms
cb1-inhibitor antibody medical
"its peripherally-restricted CB1-inhibitor antibody: Can nimacimab enhance optimal"
A CB1-inhibitor antibody is a lab-made protein designed to block the CB1 receptor, a molecule on cells that responds to natural or drug-related cannabinoids and influences appetite, mood and metabolism. For investors, it represents a biologic drug approach that could treat conditions like obesity, addiction or certain neurological disorders; its commercial value depends on efficacy, safety (psychiatric and metabolic effects) and regulatory approval, much like a targeted lock-and-key therapy.
diet-induced obesity (dio) mouse model medical
"discontinuation in a Diet-Induced Obesity (DIO) Mouse Model" at Keystone’s conference"
A diet-induced obesity (DIO) mouse model is a laboratory mouse fed a high-calorie diet to reliably develop obesity and related metabolic changes, used to test how treatments affect weight, blood sugar, cholesterol and related biology. For investors, results from DIO studies provide early evidence about whether a drug or therapy can work in conditions linked to human obesity—think of it as a small-scale rehearsal that helps judge potential efficacy and risks before costly human trials.
incretin agonists medical
"Can nimacimab enhance optimal and suboptimal doses of incretin agonists?How durable"
Incretin agonists are drugs that copy natural gut hormones released after a meal to boost insulin release and help lower blood sugar. They matter to investors because they can significantly change treatment patterns and company revenues—think of a hit product that reshapes an industry—by driving sales growth, altering prescription trends, and affecting healthcare costs and competition in the diabetes and weight-management markets.
tirzepatide medical
"Nimacimab Alone or in Combination with Tirzepatide, and as a Maintenance Therapy"
Tirzepatide is a prescription medicine that helps lower blood sugar and reduce appetite by activating two hormones that regulate insulin and hunger; think of it as a two-in-one switch that calms the body’s sugar spikes and decreases cravings. Investors watch it because regulatory approvals, clinical results, pricing and patient demand determine sales potential and competitive impact on companies in diabetes and obesity treatment markets.
semaglutide medical
"Nimacimab enhanced weight loss induced by semaglutide. Chris Twitty, PhD, Chief"
Semaglutide is a medication originally developed to help manage blood sugar levels in people with diabetes, but it also promotes weight loss. It works by mimicking a natural hormone that helps control appetite and insulin release. For investors, its potential to influence healthcare and weight management markets makes it a significant product in the pharmaceutical industry.
caloric restriction medical
"Is caloric-restriction the primary mechanism of nimacimab-driven weight loss?"
Caloric restriction is a long-term reduction in daily calorie intake while still getting essential nutrients, aimed at slowing metabolic stress and improving health markers without causing malnutrition. Investors care because evidence from animal and human studies links it to slower aging and reduced disease risk, which can drive demand for therapies, supplements, clinical trials, and dietary products; think of it as a maintenance plan for the body that can create markets for companies selling related treatments and services.

AI-generated analysis. Not financial advice.

SAN DIEGO, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”) a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today presented a poster titled "Investigating the Efficacy of Nimacimab Alone or in Combination with Tirzepatide, and as a Maintenance Therapy Post Tirzepatide Discontinuation in a Diet-Induced Obesity (DIO) Mouse Model" at Keystone’s conference, Obesity Therapeutics: Unlocking Benefits and Minimizing Side Effects.

Skye’s presentation addressed the following questions regarding the ability of its peripherally-restricted CB1-inhibitor antibody:

  • Can nimacimab enhance optimal and suboptimal doses of incretin agonists?
  • How durable is nimacimab’s effect on weight loss after treatment discontinuation?
  • Can nimacimab be used as a maintenance therapy after tirzepatide discontinuation?
  • Is caloric-restriction the primary mechanism of nimacimab-driven weight loss?

Key takeaways from the DIO studies:

  • Nimacimab showed significant additive weight loss effects when combined with suboptimal or clinically active dose levels of tirzepatide (39% and 46% weight loss respectively).
  • Nimacimab weight loss was durable after treatment discontinuation.
  • Nimacimab treatment after tirzepatide discontinuation improved the weight rebound profile (regain blunted by ~80%).
  • Nimacimab weight loss was not primarily driven by caloric restriction.
  • Nimacimab enhanced weight loss induced by semaglutide.

Chris Twitty, PhD, Chief Scientific Officer of Skye, who presented the poster, commented: “These findings suggest that nimacimab, when combined with lower and more tolerable incretin agonist doses, may achieve a favorable safety profile while still driving meaningful efficacy. This approach may help support longer treatment adherence and provide a more sustainable option for long-term weight management.”

Click here to see the poster.

About Nimacimab

Nimacimab is a potential first-in-class, peripherally-restricted monoclonal antibody inhibitor of the CB1 receptor. Unlike previous CB1-targeting drugs, nimacimab is designed to avoid central nervous system penetration, potentially limiting neuropsychiatric side effects seen with small-molecule antagonists. As a non-incretin, non-peptide agent, nimacimab acts independently of the GLP-1 pathway and has also demonstrated additive or complementary effects in combination with incretin-based therapies in preclinical and clinical studies.

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 first-in-class therapeutics with 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.

CONTACTS

Investor Relations
ir@skyebioscience.com
(858) 410-0266
LifeSci Advisors, Mike Moyer
mmoyer@lifesciadvisors.com
(617) 308-4306

Media Inquiries
LifeSci Communications, Michael Fitzhugh
mfitzhugh@lifescicomms.com
(628) 234-3889

FORWARD-LOOKING STATEMENTS

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements relating to: Skye's future plans and prospects, any expectations regarding the efficacy and therapeutic potential of nimacimab, including based on DIO models. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “planning,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important risks and uncertainties, including, without limitation, the initiation and design of any future clinical trials will be impacted by the Company’s capital resources, the Company’s ability to obtain additional sources of capital needed to run an additional Phase 2 clinical trial, program considerations and potentially other factors outside the Company’s control; the Company’s dependence on third parties in connection with product manufacturing; research and preclinical and clinical testing; the Company’s ability to advance, obtain regulatory approval of and ultimately commercialize nimacimab, competitive products or approaches limiting the commercial value of nimacimab; the timing and results of preclinical and clinical trials; the Company’s ability to fund development activities and achieve development goals; the impact of any global pandemics, inflation, supply chain issues, government shutdowns, high interest rates, adverse regulatory changes; the Company’s ability to protect its intellectual property; risks associated with the Company’s common stock and the other important factors discussed under the caption “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2024, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.


FAQ

What did Skye report at the January 29, 2026 Keystone Obesity conference about nimacimab (SKYE)?

Nimacimab showed additive and durable weight-loss benefits in a DIO mouse model. According to the company, nimacimab combined with tirzepatide produced 39% and 46% weight loss and durable effects after treatment stop, with rebound blunted by ~80%.

How did nimacimab perform with suboptimal versus clinically active tirzepatide doses in the SKYE presentation?

Nimacimab added meaningful weight loss to both tirzepatide dose levels. According to the company, combinations delivered 39% (suboptimal) and 46% (clinically active) weight loss in the DIO mouse model.

Can nimacimab be used as a maintenance therapy after tirzepatide discontinuation for SKYE?

Nimacimab improved the post-tirzepatide weight-rebound profile in mice. According to the company, nimacimab after tirzepatide discontinuation blunted weight regain by about 80%, suggesting maintenance potential.

Was nimacimab-driven weight loss primarily due to reduced calorie intake in Skye’s DIO studies?

No, weight loss was not primarily driven by caloric restriction. According to the company, data indicate mechanisms beyond reduced food intake contributed to nimacimab’s weight-loss effects in the DIO model.

Did Skye report nimacimab interactions with other incretin therapies like semaglutide at Keystone 2026?

Yes; nimacimab enhanced semaglutide-induced weight loss in preclinical testing. According to the company, nimacimab increased weight-loss efficacy when combined with semaglutide in the DIO mouse model.
Skye Bioscience

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Biotechnology
Pharmaceutical Preparations
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United States
SAN DIEGO