Skye Bioscience Reports First Quarter 2025 Results and Highlights Nimacimab Differentiation in Obesity

   -- Nimacimab in combination with tirzepatide improves weight loss effect 
      over tirzepatide alone, and shows comparable weight loss to monlunabant 
      and tirzepatide alone in preclinical diet-induced obesity model 
 
   -- In vitro data reported from new preclinical study highlights superior 
      potency of peripherally restricted CB1 inhibitor, nimacimab, versus 
      monlunabant when tested under pathological levels of CB1 agonists 
 
   -- Expanded preclinical study data to be presented at ADA in June 2025 
 
   -- Top-line data readout from CBeyond$(TM)$ Phase 2a study of nimacimab 
      expected late Q3/early Q4 2025 

SAN DIEGO, May 08, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. $(SKYE)$ ("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 first quarter ended March 31, 2025, along with key accomplishments and upcoming milestones.

"In Q1, we made decisive progress across clinical operations and R&D," said Punit Dhillon, President & CEO of Skye. "Nimacimab continues to demonstrate a differentiated profile as a potential weight loss therapy, with a peripherally restricted mechanism that may set it apart from both GLP-1s and small-molecule CB1 inhibitors. We're advancing a body of preclinical and clinical evidence that supports its potential in reshaping the treatment landscape in obesity."

Clinical Highlights: CBeyond(TM) Phase 2 Obesity Trial

   -- Clinical engagement remains strong: Patients continue to receive active 
      treatment and are progressing through scheduled follow-ups, supported by 
      ongoing collaboration between the clinical team and study sites. 
 
   -- Safety reviews: Data Safety Monitoring Committee has completed three 
      reviews with no concerns raised. The study continues per protocol. 
 
   -- Institutional Review Board ("IRB") approval: The IRB has approved the 
      open-label study extension to 52 weeks. We are finalizing the study 
      protocol with the FDA in preparation for enrollment. 

Research & Development Highlights

   -- Preclinical data: Preclinical data further demonstrated the potential 
      efficacy and potency of nimacimab. 
 
   -- Enhanced safety: Diet-induced obesity ("DIO") mouse model data 
      highlighted the sufficiency of the highly-peripherally restricted CB1 
      inhibitor nimacimab--without central (brain) exposure--to drive weight 
      loss, with similar efficacy compared to the less-peripherally restricted 
      CB1 inhibitor monlunabant, which may be challenged by brain exposure and 
      the risk of neuropsychiatric side effects. 
 
          -- Nimacimab combined with the dual GLP-1/GIP agonist tirzepatide 
             achieved over 30% weight loss 
 
          -- Nimacimab alone produced 23.5% weight loss, comparable to 
             monlunabant and tirzepatide alone in this study. 
 
   -- Superior potency: In vitro, nimacimab's differentiated and favorable 
      mechanism of CB1 inhibition showed superior potency versus the small 
      molecule CB1 inhibitor monlunabant under the elevated concentrations of 
      CB1 agonist associated with obesity. 

First Quarter 2025 Financial Results:

Balance Sheet Highlights:

   -- Cash and cash equivalents and short-term investments totaled $59.2 
      million as of March 31, 2025. The Company expects its current capital to 
      fund projected operations and key clinical milestones through at least Q1 
      2027, which includes the completion of its extended Phase 2a study for 
      nimacimab and Phase 2b manufacturing but excluding the Phase 2b clinical 
      study and manufacturing activities necessary to supply later stage 
      studies. 

Operating Results:

   -- R&D Expenses:Research and development (R&D) expenses for the three months 
      ended March 31, 2025, were $7.2 million, as compared to $1.9 million for 
      the same period in 2024. The increase was primarily due to contract 
      manufacturing and clinical trial costs associated with our Phase 2a 
      clinical study for nimacimab, salaries and stock based compensation, 
      consulting and depreciation expense. 
   -- G&A Expenses:General and administrative (G&A) expenses for the three 
      months ended March 31, 2025, were $4.6 million, as compared to $4.2 
      million for the same period in 2024. The increase was primarily related 
      to investor relations, marketing and communication costs and consulting 
      and advisory fees. 
   -- Net Loss:Net loss for the three months ended March 31, 2025, totaled 
      $11.1 million, with non-cash share-based compensation expense of $2.2 
      million, compared to $5.0 million for the same period in 2024, with 
      non-cash share-based compensation expense of $2.5 million. 

Conference Call Details

Skye will host a conference call to discuss its Q1 2025 results at 1:30 p.m. PT/4:30 p.m. ET today, May 8, 2025. 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 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. In some cases, forward-looking statements can be identified by terminology including "anticipated," "plans," "goal," "focus," "aims," "intends," "believes," "can," "could," "challenge," "predictable," "will," "would," "may" or the negative of these terms or other comparable terminology. These forward looking statements include, but are not limited to: (i) statements regarding the superior safety and tolerability profile of nimacimab relative to other small molecule CB1 inhibitors, (ii) statements relating to any expectations regarding the efficacy and therapeutic potential of nimacimab as a monotherapy or in combination with a GLP-1 targeted drug, including expectations based on preclinical DIO models, (iii) statements regarding nimacimab's potential to change weight loss standards of care, (iv) statements regarding superior potency of nimacimab to other small molecule CB1 inhibitors, such as monlunabant, based on nimacimab's mechanism of action (v) statements regarding the timing of receipt of topline data from Skye's Phase 2 obesity study of nimacimab and (vi) statements regarding the timing of enrollment for the 52-week enrollment study. 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. 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 and Quarterly Report on Form 10-Q. 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 
                              (Unaudited) 
 
                                              Three Months Ended 
                                                   March 31, 
                                             2025           2024 
                                          -----------    ---------- 
Operating expenses 
  Research and development               $  7,197,257   $ 1,946,450 
  General and administrative                4,562,305     4,205,800 
                                          -----------    ---------- 
    Total operating expenses               11,759,562     6,152,250 
 
Operating loss                            (11,759,562)   (6,152,250) 
                                          -----------    ---------- 
 
Other expense (income) 
  Interest expense                              1,452       436,936 
  Interest income                            (619,054)     (427,554) 
  Gain on sale of asset                            --    (1,145,141) 

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