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Skye Bioscience Reports Third Quarter 2025 Financial Results and Business Update

Key Takeaway: Skye Bioscience reported its third-quarter financial results for 2025, highlighting progress in its CBeyond Phase 2a obesity trial. The company is optimistic about nimacimab's potential as a treatment for obesity, particularly in combination with GLP-1R agonists. Upcoming biomarker data is expected to provide further insights into the drug's efficacy. However, the company faces challenges related to funding and the uncertainties of clinical trial outcomes.
Price reaction · baseline $1.42 (2025-11-10 close) · hit after-hours · 1 other SKYE headline(s) in the window, move may be shared
day 0 close · peak
+2.8%

Market Sentiment Analysis

POSITIVE FACTORS

  • Skye's nimacimab shows potential in obesity treatment.
  • Positive data from combination therapy with GLP-1R agonist.
  • Upcoming biomarker data may enhance understanding of nimacimab.

CONCERNS & RISKS

  • Future clinical trials depend on capital resources.
  • No guarantee of increased efficacy with higher dosing.
  • Potential risks associated with third-party manufacturing.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+84%
120-day peak, hindsight
Typical move
24.3%
average across 4 past catalysts
Cash runway
~4 mo
High dilution risk
Lead asset
Nimacimab
Phase 2 · Obesity

Full Press Release Details

SAN DIEGO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye” or the “Company”), a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the third quarter ended September 30, 2025, along with key accomplishments and upcoming milestones.
“As we obtain additional data from our CBeyond Phase 2a study, a holistic review provides us with additional confidence that nimacimab’s biology is active and has the potential to fill notable gaps in the obesity and overweight landscape in order to support a healthier weight loss journey for patients,” said Punit Dhillon, President & CEO of Skye. “With the positive combination data, we are shifting our focus to a combination development pathway while simultaneously planning to further understand nimacimab’s potential benefit in a monotherapy setting. We anticipate that forthcoming biomarker data and the readout from the 26-week extension will continue to build upon this story and provide further insights into nimacimab’s full potential as a metabolic therapy.”

Clinical Highlights: CBeyond™Phase 2a Obesity Trial

Third Quarter 2025 Financial Results:

Balance Sheet and Cash Flow Highlights:

Operating Results:

Conference Call Details

Skye will host a conference call to discuss its Q3 2025 results at 1:30 p.m. PT/4:30 p.m. ET today, November 10, 2025. The live streaming of the call can be accessed at the Skye investor relations website, along with the Company's earnings press release and financial tables. 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 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 onXandLinkedIn.

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: nimacimab’s potential to fill notable gaps in the obesity and overweight landscape; nimacimab’s potential as a combination or maintenance therapy by supplement GLP-1 therapies; 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 Company’s cash runway. 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, program considerations and potentially other factors outside the Company’s control; the potential for additional weight loss after 26 weeks may not ultimately be observed; there is no guarantee that higher dosing of nimacimab will achieve increased efficacy, and likewise it is possible that higher dosing will produce adversely different safety and tolerability results than those observed to date; 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.
SKYE BIOSCIENCE, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)
For the Three Months EndedSeptember 30, For the Nine Months EndedSeptember 30,
2025 2024 2025 2024
Operating expenses
Research and development $ 9,357,444 $ 4,883,337 $ 30,892,454 $ 10,908,538
General and administrative 3,907,090 4,638,927 12,375,567 13,171,547
Change in estimate for legal contingency (4,553,468 ) (4,553,468 )
Total operating expenses 13,264,534 4,968,796 43,268,021 19,526,617
Operating loss (13,264,534 ) (4,968,796 ) (43,268,021 ) (19,526,617 )
Other (income) expense
Interest (income) expense (90,766 ) 796,222
Interest and other income, net (418,474 ) (907,697 ) (1,609,807 ) (2,296,488 )
Gains from asset sales (91,400 ) (72,837 ) (180,763 ) (1,217,978 )
Other expense 801 2,200
Total other (income) expense, net (509,874 ) (1,070,499 ) (1,790,570 ) (2,716,044 )
Loss before income taxes (12,754,660 ) (3,898,297 ) (41,477,451 ) (16,810,573 )
Provision for income taxes 5,400 10,071
Net loss $ (12,754,660 ) $ (3,898,297 ) $ (41,482,851 ) $ (16,820,644 )
Loss per common share:
Basic $ (0.32 ) $ (0.10 ) $ (1.05 ) $ (0.48 )
Diluted $ (0.32 ) $ (0.10 ) $ (1.05 ) $ (0.48 )
Weighted average shares of common stock outstanding used to compute loss per share:
Basic 39,665,927 38,819,387 39,654,512 35,317,352
Diluted 39,665,927 38,819,387 39,654,512 35,317,352
SKYE BIOSCIENCE, INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS
September 30,2025 December 31,2024
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents $ 18,441,079 $ 68,415,741
Short-term investments 16,871,229
Prepaid expenses 3,712,311 201,962
Other current assets 900,175 2,209,544
Total current assets 39,924,794 70,827,247
Property and equipment, net 1,033,965 1,432,752
Operating lease right-of-use asset 311,620 449,864
Other assets 53,910 53,910
Total assets $ 41,324,289 $ 72,763,773
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable $ 2,825,005 $ 569,252
Accrued payroll liabilities 920,774 1,114,255
Other current liabilities 2,366,123 654,201
Estimate for accrued legal contingencies and related expenses 2,054,357 1,818,751
Operating lease liability, current portion 201,638 182,428
Total current liabilities 8,367,897 4,338,887
Non-current liabilities
Operating lease liability, net of current portion 120,207 273,162
Total liabilities 8,488,104 4,612,049
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.001 par value; 200,000 shares authorized at September 30, 2025 and December 31, 2024; no shares issued and outstanding at September 30, 2025 and December 31, 2024
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2025 and December 31, 2024; 30,989,046 and 30,974,559 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 30,989 30,975
Additional paid-in-capital 205,237,719 199,070,421
Accumulated deficit (172,432,523 ) (130,949,672 )
Total stockholders’ equity 32,836,185 68,151,724
Total liabilities and stockholders’ equity $ 41,324,289 $ 72,763,773

Investor Relationsir@skyebioscience.com(858) 410-0266

LifeSci Advisors, Mike Moyermmoyer@lifesciadvisors.com(617) 308-4306

Media InquiriesLifeSci Communications, Michael Fitzhughmfitzhugh@lifescicomms.com(628) 234-3889

Frequently Asked Questions

What are the key highlights from Skye's Q3 2025 report?

Skye reported progress in its CBeyond Phase 2a obesity trial and positive data on nimacimab's combination therapy.

What is nimacimab's role in obesity treatment?

Nimacimab is being developed to modulate G-protein-coupled receptors for obesity management.

When will Skye host a conference call regarding Q3 results?

Skye will host a conference call on November 10, 2025, at 1:30 p.m. PT.

What challenges does Skye face in its clinical trials?

Skye's trials depend on capital resources and face uncertainties regarding trial outcomes.

What is the significance of the upcoming biomarker data?

The biomarker data is expected to provide further insights into nimacimab's efficacy as a metabolic therapy.

Last updated: Nov 10, 2025