-- Initiated higher-dose CBeyond Expansion Study (Part C) to generate
higher-exposure human safety and pharmacokinetic data with 400 mg and 600
mg IV cohorts;
-- Received written FDA Type C meeting minutes; feedback is informing key
Phase 2b combination design elements and the Company's ongoing evaluation
of a potential add-on development path with incretin therapy;
-- Presented new body composition data demonstrating differentiated weight
maintenance profile for patients that have discontinued combination
therapy;
-- Proof-of-concept preclinical data validates Skye's antigen-peptide
conjugate platform, a single unimolecular therapeutic of nimacimab-GLP1RA
that delivers additive weight-loss.
SAN DIEGO, March 10, 2026 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (NASDAQ: SKYE) ("Skye" or the "Company"), a clinical stage biopharmaceutical company pioneering next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the fourth quarter and full year ended December 31, 2025, along with key accomplishments and upcoming milestones.
"All of the data generated and reported in the past year along with the incremental data highlighted in todays release reinforces our strategy to develop nimacimab as a differentiated peripheral CB1 program designed to complement current incretin therapies and next-generation combination regimens. CBeyond confirmed the safety foundation and combination potential of peripheral CB1 inhibition, including a 22.3% mean weight loss at 52 weeks with nimacimab plus semaglutide and no plateau observed, " said Punit Dhillon, President & CEO of Skye. "Just as important, CBeyond has now given us three practical learnings that shape what comes next: a meaningful combination signal, clean safety with no drug-related central nervous system toxicity at the tested dose, and a clear exposure question to solve in monotherapy. Our next step is straightforward: define the peripheral exposure-response at higher doses through the Expansion Study while using the FDA Type C feedback to shape a disciplined Phase 2b evaluation with clear dose-selection logic and success criteria across monotherapy and combination development."
Clinical Highlights
CBeyond Expansion Study (Part C): Higher-Exposure Evaluation
-- Initiated the Expansion Study of CBeyond to assess preliminary safety and
pharmacokinetics of nimacimab administered intravenously (IV) at doses
higher than the subcutaneous (SC) regimen used in the main or extension
portion of the Phase 2a trial.
-- The CBeyond Expansion Study includes two dose cohorts of nimacimab
monotherapy (400 mg IV and 600 mg IV) compared to placebo administered
weekly over 15 weeks, with a 12-week follow-up period.
-- The CBeyond Expansion Study will enroll eight (8) participants per cohort
randomized 3:1 for a total of 16 participants.
-- Skye expects to report topline data from the CBeyond Expansion Study in
Q4 2026.
Phase 2b (CBeyond 2): Regulatory Alignment and Protocol Finalization
-- Completed an FDA Type C meeting and received written minutes. As Skye
continues its review of the written feedback, the Company is using the
minutes to sharpen its ongoing Phase 2b evaluation across key design
elements (including dose, duration, endpoints and inclusion/exclusion
criteria) and to assess the data package needed for potential combination
development with an incretin therapy.
-- Skye is evaluating a Phase 2b protocol that could study multiple doses of
nimacimab as a monotherapy and in combination with an incretin therapy,
using an adaptive design framework. Skye is continuing Phase 2b protocol
development for the study.
CBeyond Phase 2a Obesity Trial: 26-week Outcomes
-- Combination signal with incretin therapy: At 26 weeks, nimacimab plus
semaglutide achieved an approximately 3% incremental weight-loss benefit
versus semaglutide alone, with statistically significant improvements in
lean-to-fat mass ratio and waist circumference; no plateau observed
through week 26.
-- Safety and tolerability: Nimacimab demonstrated placebo-like
tolerability. In combination with semaglutide, there was no increase in
gastrointestinal adverse events and no difference in neuropsychiatric
adverse events compared to placebo or semaglutide alone.
-- Dose/exposure learning: Nimacimab monotherapy at 200 mg weekly did not
achieve the targeted weight-loss effect; Skye believes dose and exposure
are the primary variables to solve and is testing higher peripheral
exposure of nimacimab.
Interim 52-Week Combination Update
-- In February 2026, Skye reported interim 52-week results in participants
receiving nimacimab (200 mg dose) plus semaglutide (2.4 mg) combination,
demonstrating 22.3% weight loss with no plateau observed, suggesting
potential for further efficacy beyond one year and at higher nimacimab
doses.
-- Strong safety and tolerability profile maintained with no added
gastrointestinal adverse events, and importantly, no drug-related
neuropsychiatric adverse events.
Follow-up Period 13-Week Weight Regain Update
-- Weight regain during off-treatment follow-up was lower by over 50% --
nimacimab plus semaglutide cohort regained only 17.8% of lost weight vs.
37.3% for semaglutide alone during 13-week off-therapy follow-up.
-- Semaglutide weight regain profile similar to what has been reported in
STEP-1 extension trial.
-- Body composition data from 13-week follow-up period shows differentiated
weight regain profile:
-- Combination cohort maintained fat mass loss and gained lean mass
over 13-week off-treatment follow-up period.
-- Semaglutide cohort gained fat mass over 13-week off-treatment
period.
-- Overall, combination cohort improved lean-to-fat mass ratio during
13-week off-treatment period.
Research & Development Highlights
-- Dosing Rationale & CBeyond Trial
-- The 200 mg weekly CBeyond dose was selected based on availability
of drug and comparable Phase 1 PK modeling and IC90-normalized
comparisons to monlunabant's P2 mid-dose level -- however,
clinical outcomes diverged, with monlunabant achieving --6.3%
weight loss versus nimacimab's --1.5%.
-- Translational biodistribution studies across mice, NHP, and
published human data revealed that peripheral tissue exposure --
not serum levels -- is the key determinant of efficacy. Increased
dosing achieves the tissue target engagement required for robust
metabolic benefit, while maintaining minimal central nervous
system exposure and a strong safety margin.
-- APC Pipeline
-- Skye has developed an antibody-peptide conjugate $(APC)$ program
that unites nimacimab's unique CB1 inhibitory mechanism and
extended half-life with the power of a GLP-1 receptor agonist in a
single, unimolecular therapeutic, with a broader pipeline of novel
bioconjugated molecules in development. In a preclinical
proof-of-concept study, the APC dosed every three days matched the
efficacy of a daily combination regimen and meaningfully exceeded
either agent alone.
Manufacturing Readiness and CMC Development Highlights
-- Higher Volume Dose Delivery: Licensed ENHANZE$(R)$ (recombinant human hyaluronidase) drug delivery technology from Halozyme to enable patient-friendly, high volume subcutaneous administration. -- Phase 2b Readiness: Manufacturing of nimacimab drug substance in anticipation of the proposed Phase 2b trial supply continued in Q4 2025, and will continue in 2026, along with manufacturing of nimacimab drug product. -- Optimizing Manufacturing Process for Supply & Competitive Cost of Goods (COGs): Continued evaluating manufacturing process development options aimed at increasing batch output via improvements in upstream process productivity (titer) and downstream process yield. -- Expanding and Strengthening the Supply Chain: Advanced diligence and discussions with commercial contract manufacturing organizations to support development and manufacturing of commercial-scale processes to enable cost-efficient supply of nimacimab for late-stage clinical trials and eventual commercial supply for the treatment of obesity, overweight, and related metabolic disorders. -- Drug Formulation Optimization: Continued progress in the development of a higher-concentration nimacimab formulation aimed at reducing SC injection volume in support of patient-friendly subcutaneous administration across a range of potential dose levels. -- Advancing Toward Monthly Dosing: Working to further evaluate and optimize nimacimab's formulation, administration and dosing paradigm to potentially enable the transition from weekly to monthly dosing with the intent to improve the patient experience, patient and physician adoption, and overall commercial attractiveness for improved positioning of nimacimab in obesity and overweight market entry dynamics.
Upcoming Anticipated Milestones
-- Q2 2026: Present nimacimab preclinical data at scientific/medical
conferences.
-- Q2 2026: Analyst event in conjunction with the Scientific Sessions of the
American Diabetes Association (ADA) in June to introduce additional
clinical and preclinical data, market research insights, and other
aspects of the Company's development program.
-- Q4 2026: CBeyond Phase 2a Expansion Study topline results to 16-weeks.
-- Q4 2026: Finalize Phase 2b (CBeyond 2) study design.
Fourth Quarter and Full Year 2025 Financial Results
Balance Sheet Highlights:
-- Cash, cash equivalents, and short-term investments totaled $25.7 million
as of December 31, 2025. The Company expects its current capital to fund
projected operations and key clinical milestones through the fourth
quarter of 2026, including completion of its Phase 2a extension study for
nimacimab and initial manufacturing to enable the anticipated Phase 2b
clinical study, but excluding the anticipated clinical cost of a proposed
Phase 2b clinical study and additional anticipated drug manufacturing
costs to supply any such Phase 2b study.
Operating Results:
-- R&D Expenses:Research and development (R&D) expenses for the three months
ended December 31, 2025, were $11.5 million, as compared to $7.8 million
for the same period in 2024. The increase was primarily due to contracted
manufacturing costs associated with our anticipated Phase 2b clinical
trial for nimacimab in obesity and overweight, and employee related
benefits. Increases were offset by a decrease in clinical costs, for the
three months ended December 31, 2025 vs. 2024.R&D expenses for the year
ended December 31, 2025, were $42.4 million, as compared to $18.7 million
for the same period in 2024. The increase was primarily due to contracted
clinical study and manufacturing costs associated with our anticipated
Phase 2b clinical trial for nimacimab in obesity and overweight. The
remainder of the increase resulted from increases in discovery research
efforts, salaries and stock based compensation expense, and consulting
fees offset by a decrease in clinical study costs.
-- G&A Expenses:General and administrative (G&A) expenses for the three
months ended December 31, 2025, were $3.4 million, as compared to $4.6
million for the same period in 2024. The decrease was primarily related
to non-cash incentive stock-based compensation, payroll, benefits and
other employee costs, professional services including fees for tax, audit,
financial advisory services, and other general business expenses.G&A
expenses for the year ended December 31, 2025, were $15.8 million, as
compared to $17.7 million for the same period in 2024. The decrease was
primarily related to non-cash incentive stock-based compensation,
professional services including fees for tax, audit, legal services,
financial advisory services, patent prosecution for nimacimab
intellectual property, other general business expenses.
-- Net Loss:Net loss for the three months ended December 31, 2025, totaled
$14.4 million, with non-cash share-based compensation expense of $1.6
million, compared to $9.7 million for the same period in ended 2024, with
non-cash share-based compensation expense of $2.1 million.Net loss for
the year ended December 31, 2025, totaled $55.9 million, with non-cash
share-based compensation expense of $7.8 million, compared to $26.6
million for the year ended 2024, with non-cash share-based compensation
expense of $8.3 million. The primary reason for the significant increase
in net loss is related to a $20.7 million increase in contract
manufacturing costs primarily related to the Phase 2a study extension and
Phase 2b drug supply. In addition, during 2024 we recognized a $4.2
million gain from the partial derecognition of contingent liabilities and
a $2.0 million gain from insurance recoveries related to legal
proceedings, $3.0 million in interest income and a gain of $1.4 million
from the sale of real estate.
Conference Call Details
Skye will host a conference call to discuss its FY 2025 and Q4 2025 results at 1:30 p.m. PT/4:30 p.m. ET today, March 10th. The live streaming of the call can be accessed at the Skye Investor Relations website, along with the Company's earnings press release, financial tables, and investor presentation. Following the call, a replay and transcript will be available at the same website.
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 and overweight 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(R)). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, regarding: Skye's expectations for nimacimab, including our clinical trial plans, enrollment in clinical trials, the potential applications of nimacimab; nimacimab's potential as a combination or maintenance therapy by supplementing GLP-1 therapies, the timing of initiating clinical trials and data read-outs, including the expected timing for reporting topline data from the Phase 2a extension study; the potential for Skye to develop a leading orthogonal platform to intensify incretin outcomes and help patients achieve more durable metabolic benefit; Skye's product development plan for nimacimab; and the Company's cash runway. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including "anticipated," "plans," "goal," "focus," "aims," "intends," "believes," "expects," "can," "could," "challenge," "predictable," "will, " "would," "may" or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Company's periodic filings with the Securities and Exchange Commission, including in the "Risk Factors" section of Skye's most recent Annual Report on Form 10-K. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.
SKYE BIOSCIENCE, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended December
31 (Unaudited) Year Ended December 31
2025 2024 2025 2024
----------- ----------- ----------- -----------
Operating
expenses
Research and
development $ 11,469,425 $ 7,793,156 $ 42,361,879 $ 18,701,694
General and
administrative 3,426,119 4,622,945 15,801,686 17,725,741
Change in
estimate for
legal
contingency -- -- -- (4,234,717)
Income from
insurance
recovery -- (1,750,000) -- (2,000,000)
----------- ----------- ----------- -----------
Total
operating
expenses 14,895,544 10,666,101 58,163,565 30,192,718
----------- ----------- ----------- -----------
Operating loss (14,895,544) (10,666,101) (58,163,565) (30,192,718)
----------- ----------- ----------- -----------
Other (income)
expense
Interest expense -- (46,914) -- 749,308
Interest income (274,096) (732,274) (1,883,903) (3,028,762)
Gain from asset
sale (179,987) (140,434) (360,750) (1,358,412)
Other expense 502 -- 502 2,200
----------- ----------- ----------- -----------
Total other
(income)
expense, net (453,581) (919,622) (2,244,151) (3,635,666)
Loss before income
taxes (14,441,963) (9,746,479) (55,919,414) (26,557,052)
Provision for
income taxes -- -- 5,400 10,071
----------- ----------- ----------- -----------
Net loss $(14,441,963) $ (9,746,479) $(55,924,814) $(26,567,123)
=========== =========== =========== ===========
Loss per common
share
Basic $ (0.36) $ (0.24) $ (1.41) $ (0.73)
----------- ----------- ----------- -----------
Diluted $ (0.36) $ (0.24) $ (1.41) $ (0.73)
----------- ----------- ----------- -----------
Weighted average
shares of common
stock outstanding
used to compute
loss per share:
Basic 39,673,303 39,968,601 39,662,664 36,486,519
----------- ----------- ----------- -----------
Diluted 39,673,303 39,968,601 39,662,664 36,486,519
----------- ----------- ----------- -----------
SKYE BIOSCIENCE, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, 2025 December 31, 2024
ASSETS
Current assets
Cash and cash equivalents $ 5,882,498 $ 68,415,741
Short-term investments 19,854,723 --
Prepaid expenses 504,890 201,962
Other current assets 852,036 2,209,544
-------------- --------------
Total current assets 27,094,147 70,827,247
Property and equipment, net 898,930 1,432,752
Operating lease right-of-use
asset 266,646 449,864
Other assets 53,910 53,910
-------------- --------------
Total assets $ 28,313,633 $ 72,763,773
============== ==============
LIABILITIES AND
STOCKHOLDERS' EQUITY
(DEFICIT)
Current liabilities
Accounts payable $ 2,033,431 $ 569,252
Accrued payroll
liabilities 1,269,474 1,114,255
Other current liabilities 2,643,840 654,201
Estimate for accrued legal
contingencies and related
expenses 2,069,067 1,818,751
Operating lease liability,
current portion 189,647 182,428
-------------- --------------
Total current
liabilities 8,205,459 4,338,887
Non-current liabilities
Operating lease liability,
net of current portion 83,999 273,162
-------------- --------------
Total liabilities 8,289,458 4,612,049
-------------- --------------
Commitments and
contingencies
Stockholders' equity
(deficit)
Preferred stock, $0.001
par value; 200,000 shares
authorized at December
31, 2025 and December 31,
2024; no shares issued
and outstanding at
December 31, 2025 and
December 31, 2024 -- --
Common stock, $0.001 par
value; 100,000,000 shares
authorized at December
31, 2025 and December 31,
2024; 33,378,139 and
30,974,559 shares issued
and outstanding at
December 31, 2025 and
December 31, 2024,
respectively 33,379 30,975
Additional paid-in-capital 206,865,282 199,070,421
Accumulated deficit (186,874,486) (130,949,672)
-------------- --------------
Total stockholders'
equity (deficit) 20,024,175 68,151,724
-------------- --------------
Total liabilities and
stockholders' equity
(deficit) $ 28,313,633 $ 72,763,773
============== ==============
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
(END) Dow Jones Newswires
March 10, 2026 16:01 ET (20:01 GMT)
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