Skye Provides 2026 Corporate Outlook

Rhea-AI Summary

Skye (Nasdaq: SKYE) provided its 2026 corporate outlook focused on advancing nimacimab, a peripherally restricted CB1‑inhibiting antibody for obesity and metabolic disorders. Key near‑term milestones include a CBeyond Phase 2a 26‑week extension interim update expected Q1 2026, topline 52‑week results Q3 2026, and a target to initiate an adaptive Phase 2b study in Q3 2026 after finalizing the plan and a Type C meeting in Q1 2026. 2025 data reportedly showed additive weight loss with semaglutide, favorable safety/tolerability, dose‑response insights, preclinical durability versus incretins, and manufacturing partnerships to enable higher‑dose subcutaneous delivery.

Positive

• Additive weight loss observed when nimacimab was combined with semaglutide
• Nimacimab showed placebo-like safety and no increased neuropsychiatric events versus placebo
• Manufacturing and delivery partnerships with Arecor and Halozyme to enable higher-dose subcutaneous administration

Negative

• Pivotal efficacy readouts remain pending: 26-week extension interim in Q1 2026 and 52-week topline in Q3 2026
• Phase 2b design and regulatory alignment not finalized until Q1 2026, delaying trial start until target Q3 2026

News Market Reaction

-3.97%

3 alerts

-3.97% News Effect

-7.4% Trough Tracked

-$1M Valuation Impact

$33M Market Cap

0.2x Rel. Volume

On the day this news was published, SKYE declined 3.97%, reflecting a moderate negative market reaction. Argus tracked a trough of -7.4% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $1M from the company's valuation, bringing the market cap to $33M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase 2a extension duration: 26 weeks Topline duration: 52 weeks Off-therapy follow-up: 13 weeks +5 more

8 metrics

Phase 2a extension duration 26 weeks CBeyond Phase 2a extension data update expected Q1 2026

Topline duration 52 weeks CBeyond Phase 2a topline including 13-week off-therapy follow-up

Off-therapy follow-up 13 weeks Included in CBeyond Phase 2a 52-week topline readout

DMC meeting date December 14, 2025 Data Monitoring Committee reviewed CBeyond Phase 2a safety

Phase 2a readout timing Q1 2026 26-week extension data update and interim results expected

52-week topline timing Q3 2026 CBeyond Phase 2a 52-week topline results expected

Phase 2b plan timing Q1 2026 CBeyond 2 Phase 2b plan to be finalized and aligned with regulators

Phase 2b launch target Q3 2026 Adaptive design Phase 2b trial initiation targeted

Market Reality Check

Price: $1.02 Vol: Volume 323,817 is below t...

low vol

$1.02 Last Close

Volume Volume 323,817 is below the 20-day average of 623,399, suggesting muted pre-news activity. low

Technical Shares at $0.98 are trading below the 200-day MA of $2.39 and well under the $5.75 52-week high.

Peers on Argus

SKYE fell 6.67% with several biotech peers also down: AVTX -1.28%, CRDF -3.45%, ...

SKYE fell 6.67% with several biotech peers also down: AVTX -1.28%, CRDF -3.45%, FBRX -2.13%, HURA -1.02%, ZURA -3.40%, indicating sector-wide weakness rather than a purely idiosyncratic move.

Common Catalyst Peers show general biotech weakness; one peer (ZURA) also issued a 2026 outlook, suggesting broader positioning around obesity/immunology pipelines.

Historical Context

5 past events · Latest: Jan 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Drug-delivery deal	Positive	-2.3%	Halozyme ENHANZE license to enable higher-dose subcutaneous nimacimab delivery.
Nov 24	Investor conferences	Positive	+11.6%	Participation in multiple December 2025 healthcare investor conferences and webcasts.
Nov 10	Q3 results & update	Positive	-7.2%	Q3 2025 financials plus CBeyond Phase 2a data and cash runway into 2027.
Nov 05	Clinical data presentation	Positive	+6.3%	ObesityWeek 2025 abstract on improved post-treatment weight regain with nimacimab combo.
Nov 05	Earnings call notice	Neutral	+6.3%	Announcement of upcoming Q3 2025 earnings release and business update webcast.

Pattern Detected

News tied to nimacimab and obesity often delivered positive clinical or strategic updates, but price reactions have been mixed, with several positive items followed by negative or muted moves.

Recent Company History

Over the past months, Skye announced multiple milestones around nimacimab. A Nov 10, 2025 Q3 update highlighted CBeyond Phase 2a efficacy and a cash position of $35.3M, yet shares fell. Earlier in November, an ObesityWeek 2025 abstract showing reduced rebound weight gain coincided with a +6.34% move. A December 2025 collaboration with Halozyme to support higher-dose subcutaneous delivery saw a modest decline. The current 2026 outlook extends this clinical and operational roadmap toward Phase 2b combination development.

Market Pulse Summary

This announcement outlines Skye’s 2026 plan for nimacimab, with CBeyond Phase 2a extension data in Q...

Analysis

This announcement outlines Skye’s 2026 plan for nimacimab, with CBeyond Phase 2a extension data in Q1 2026, 52‑week topline in Q3 2026, and an adaptive Phase 2b trial targeted for Q3 2026. It builds on earlier signals of additive benefits when combined with incretin therapies and ongoing work on higher‑dose, scalable delivery. Investors may track upcoming readouts, regulatory interactions, and trial initiation to gauge execution against this roadmap.

Key Terms

phase 2a, phase 2b, data monitoring committee, monotherapy, +3 more

7 terms

phase 2a medical

"CBeyondTM Phase 2a 26-week extension data update and interim results expected"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

phase 2b medical

"Phase 2b (CBeyond 2) plan to be finalized in Q1; trial launch targeted"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

data monitoring committee medical

"CBeyond Phase 2a Data Monitoring Committee (DMC) meeting on December 14, 2025"

A data monitoring committee is a group of experts responsible for reviewing and overseeing important information during a project or study to ensure everything is proceeding safely and correctly. For investors, it provides an extra layer of oversight, helping to identify potential issues early and ensuring that decisions are based on accurate, unbiased data. This helps maintain trust and safety throughout the process.

monotherapy medical

"evaluate multiple doses of nimacimab as a monotherapy and in combination"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

subcutaneous medical

"develop and potentially commercialize a subcutaneous formulation of 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 medical

"role nimacimab plays to complement GLP-1/incretin-based mechanisms."

GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.

adaptive design medical

"initiation of the adaptive design Phase 2b clinical trial expected in Q3 2026"

Adaptive design is a way to run clinical trials that lets researchers change aspects of the study—such as dose, sample size, or which patient groups are studied—based on data gathered while the trial is ongoing, without starting over. For investors, it matters because this flexibility can shorten development time, reduce costs, and increase the chance of finding a successful outcome, similar to steering a ship toward calmer waters as conditions change.

AI-generated analysis. Not financial advice.

• CBeyond^TM Phase 2a 26-week extension data update and interim results expected Q1 2026.
• CBeyond Phase 2a Data Monitoring Committee (DMC) meeting on December 14, 2025, continued to demonstrate favorable safety profile.
• CBeyond Phase 2a topline results to 52 weeks including 13-week off-therapy follow-up period expected in Q3 2026.
• Phase 2b (CBeyond 2) plan to be finalized in Q1; trial launch targeted for Q3 2026.
  
  

SAN DIEGO, Jan. 12, 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 provided its 2026 corporate outlook outlining planned clinical, manufacturing, and corporate milestones to advance nimacimab, Skye’s peripherally restricted CB1-inhibiting antibody.

“In 2025 we generated our Phase 2a clinical data, deepened our understanding of nimacimab’s exposure-response dynamics, and built the technical foundation required to test higher doses and prepare the framework for a potential subsequent Phase 2 trial with broader clinical endpoints,” said Punit Dhillon, President & Chief Executive Officer. “In 2026, our focus and goals are straightforward: deliver additional clinical readouts from our CBeyond extension study, assess and select higher doses of nimacimab, and launch a Phase 2b study designed to evaluate multiple doses of nimacimab as a monotherapy and in combination with an incretin therapy.”

“We believe emerging data across the obesity treatment landscape underscore the need for modalities complementary to incretin–based therapies,” added Mr. Dhillon. “We believe peripheral CB1 inhibition offers a distinctive opportunity to help achieve incremental weight loss, improve treatment tolerability and sustainability, enhance post-treatment durability, as well as offer additional metabolic and inflammatory benefits.”

2025 Foundation Supporting 2026 Execution

CBeyond Phase 2a delivered clinically relevant signals and and new insight to further guide development

• Additive weight loss in combination with semaglutide. Clinically meaningful additional weight loss of nimacimab and semaglutide versus semaglutide alone, with no plateau observed at 26 weeks, highlighted for the first time the complementary positive effect of a peripheral CB1 inhibitor with an incretin therapeutic.
• Additive reduction in waist circumference and superior lean to fat mass ratio was also observed with the addition of nimacimab to semaglutide.
• CBeyond provided insight into dose-response, informing the next stage of dose selection and study design.
• Positive safety and tolerability. Nimacimab alone demonstrated a favorable safety profile with placebo-like tolerability. In combination with semaglutide, there was no increase in gastrointestinal adverse events. Importantly, there was no difference in neuropsychiatric adverse events reported resulting from treatment with nimacimab compared to placebo or from the combination of nimacimab and semaglutide compared to semaglutide alone.
• See Phase 2a 26-week data news release for full details along with investor presentation and Spotlight page for detailed charts and explanations.
  
  

Preclinical research validates broad potential utility of nimacimab

• Significant weight loss in DIO mouse models as a monotherapy as well as in combination with both an active or suboptimal dose of tirzepatide.
• Significantly less weight rebound post-treatment compared to incretin drugs and in cohorts administered nimacimab following treatment with incretin drugs.
• Productive modulation of gut and adipose hormones integral to metabolic and anti-inflammatory processes.
• Foundational evidence for efficacy of antibody-based peripherally-restricted CB1 inhibition and the role nimacimab plays to complement GLP-1/incretin-based mechanisms.
• Results can be reviewed in Skye’s investor presentation and are explained in “primer” videos on Skye’s Spotlight page.
  
  

Operational groundwork for higher-dose delivery and scalability

• CMC and clinical supply readiness. Advanced manufacturing scale-up and CMC execution, producing nimacimab drug supply for planned follow-on studies and de-risking near-term clinical execution.
• Higher dosing with enhanced concentration and injection volume. Planning for optimal high-dose drug administration, through 2025 Skye initiated collaborations focused on this goal:
  • May: agreement with Arecor Therapeutics plc (AIM: AREC) to develop a higher concentration formulation of nimacimab using Arecor’s proprietary formulation technology platform, Arestat™.
  • December: licensed Halozyme Therapeutics’ ENHANZE^® drug delivery technology to develop and potentially commercialize a subcutaneous formulation of nimacimab that may facilitate larger injection volumes.
    
    

Looking Ahead to 2026: Key Objectives and Expected Clinical Milestones

Clinical development: generate longer-duration data and establish the right dose

Skye’s 2026 clinical program goals are designed to (i) evaluate multiple higher doses of nimacimab, and (ii) initiate a Phase 2b study that supports combination development.

Planned clinical milestones include:

• CBeyond^TM Phase 2a 26-week extension data update and interim results expected in Q1 2026.
• CBeyond Phase 2a topline results to 52 weeks including 13-week off-therapy follow-up period expected in Q3 2026.
• Phase 2b (CBeyond 2) plan will be finalized and aligned with regulators, including completion of a Type C meeting in Q1 2026, with initiation of the adaptive design Phase 2b clinical trial expected in Q3 2026.
  
  

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.

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 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, planned clinical milestones; plans to advance nimacimab into the next stage of development to optimize dosing; future clinical development of nimacimab, including the initiation and design of any future clinical trials; the expected timing for reporting data from the Phase 2a extension study; the potential market opportunities; any expectations regarding the efficacy and therapeutic potential of nimacimab; the potential for nimacimab to be a first-in-class drug. 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

When will Skye (SKYE) report the CBeyond Phase 2a 26‑week extension interim results?

Skye expects a CBeyond Phase 2a 26‑week extension data update and interim results in Q1 2026.

When are CBeyond Phase 2a topline 52‑week results for SKYE expected?

Topline results to 52 weeks, including a 13‑week off‑therapy follow‑up, are expected in Q3 2026.

What is Skye’s timeline to start the Phase 2b (CBeyond 2) trial for SKYE?

Skye plans to finalize the Phase 2b plan and complete a Type C meeting in Q1 2026, with initiation targeted in Q3 2026.

What clinical benefits did nimacimab show in the 2025 Phase 2a data for SKYE?

Reported 2025 signals include additive weight loss with semaglutide, reduced waist circumference, and improved lean‑to‑fat mass ratio.

What steps has Skye taken to enable higher‑dose nimacimab dosing for SKYE?

Skye entered agreements with Arecor for higher‑concentration formulation work and licensed Halozyme ENHANZE to support larger subcutaneous injection volumes.