Latest news with #Nimacimab
Yahoo
08-05-2025
- Business
- Yahoo
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™ Phase 2a study of nimacimab expected late Q3/early Q4 2025 SAN DIEGO, May 08, 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 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 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 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: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.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 ( 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: 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 SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months EndedMarch 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 ) Other (income) expense (40,641 ) 1,040 Total other (income) expense, net (658,243 ) (1,134,719 ) Loss before income taxes (11,101,319 ) (5,017,531 ) Provision for income taxes 2,000 2,000 Net loss $ (11,103,319 ) $ (5,019,531 ) Loss per common share: Basic $ (0.28 ) $ (0.18 ) Diluted $ (0.28 ) $ (0.18 ) Weighted average shares of common stock outstanding used to compute loss per share: Basic 39,651,888 27,999,901 Diluted 39,651,888 27,999,901 SKYE BIOSCIENCE, INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS March 31,2025 December 31,2024 (Unaudited) ASSETS Current assets Cash and cash equivalents $ 46,421,299 $ 68,415,741 Short-term investments 12,802,650 — Prepaid expenses 575,382 201,962 Other current assets 3,228,450 2,209,544 Total current assets 63,027,781 70,827,247 Property and equipment, net 1,304,148 1,432,752 Operating lease right-of-use asset 407,401 449,864 Other assets 53,910 53,910 Total assets $ 64,793,240 $ 72,763,773 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 1,713,832 $ 569,252 Accrued payroll liabilities 656,131 1,114,255 Other current liabilities 847,849 654,201 Estimate for accrued legal contingencies and related expenses 1,913,003 1,818,751 Operating lease liability, current portion 188,645 182,428 Total current liabilities 5,319,460 4,338,887 Non-current liabilities Operating lease liability, net of current portion 223,466 273,162 Total liabilities 5,542,926 4,612,049 Commitments and contingencies Stockholders' equity Preferred stock, $0.001 par value; 200,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued and outstanding at March 31, 2025 and December 31, 2024 — — Common stock, $0.001 par value; 100,000,000 shares authorized at March 31, 2025 and December 31, 2024; 30,974,559 and 30,974,559 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 30,975 30,975 Additional paid-in-capital 201,272,330 199,070,421 Accumulated deficit (142,052,991 ) (130,949,672 ) Total stockholders' equity 59,250,314 68,151,724 Total liabilities and stockholders' equity $ 64,793,240 $ 72,763,773 CONTACTS Investor Relationsir@ 410-0266 LifeSci Advisors, Mike Moyermmoyer@ 308-4306 Media Inquiries LifeSci Communications, Michael Fitzhughmfitzhugh@ 234-3889Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
15-04-2025
- Business
- Yahoo
Skye Bioscience Demonstrates Over 30% Weight Loss with Nimacimab and Tirzepatide Combination in Preclinical Model
Nimacimab shows comparable weight loss to monlunabant and tirzepatide alone, and an additive effect in combination with tirzepatide, in diet-induced obesity model New data demonstrates superior potency of nimacimab's differentiated and favorable mechanism of inhibition versus monlunabant Nimacimab Phase 2a CBeyond™ top-line randomized data expected late Q3/early Q4 2025 SAN DIEGO, April 15, 2025 (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 announced new preclinical data for its novel CB1 antibody, nimacimab. In a murine diet-induced obesity (DIO) model, after 25 days of treatment, results demonstrated: Greater than 30% weight loss when nimacimab was combined with the dual GLP-1/GIP agonist, tirzepatide Nimacimab alone demonstrated 23.5% weight loss, comparable to monlunabant and tirzepatide alone. 'This new preclinical study highlights that a truly peripherally-restricted CB1 inhibitor—nimacimab—effectively drives weight loss in a DIO model. Nimacimab compared favorably to and provided significant additive weight loss when combined with GLP-1-targeted drugs like tirzepatide,' said Punit Dhillon, CEO of Skye. 'Using higher doses, this study builds on our previous preclinical DIO data in human CB1 knock-in mice that showed significant dose-dependent weight loss. Biomarker analyses demonstrated that nimacimab-driven weight loss was associated with beneficial changes in key hormones, glycemic control, and inflammatory markers. 'Skye believes nimacimab shows potential both as a monotherapy and in combination with a GLP-1 targeted drug to address unmet needs in obesity with the potential to change weight loss standards of care. Initial data from Skye's Phase 2a study in obesity is expected in late Q3/early Q4 2025.' Mr. Dhillon added, 'The second key finding of this animal study is that Skye's highly-peripherally restricted nimacimab drives efficacy similar to a less-peripherally restricted CB1 inhibitor, monlunabant, in a DIO model. These in vivo data continue to support our belief that our differentiated antibody approach can potentially provide meaningful efficacy without the challenge current small molecule CB1 inhibitors face—brain exposure that can cause unwanted neuropsychiatric side effects.' Figure 1 - DIO model to interrogate combination of nimacimab and tirzepatideNew In Vitro Data Characterizes Differentiated Potency Characteristics Skye also shared new in vitro potency data demonstrating that nimacimab's non-competitive allosteric binding to CB1 provides for a differentiated and potentially advantageous mechanism of inhibition versus small molecules like monlunabant, which must compete with CB1 agonists. In this study, potency of nimacimab and monlunabant were assessed against two concentrations of the CB1 agonist CP55940. The first condition evaluated potency of each drug with a lower concentration of CP55940 (50nM or EC80), while the second condition evaluated potency against an elevated concentration of CP55940 (2000nM or 40X EC80). These two conditions serve as a model of a physiological versus a pathological state where conditions such as obesity can promote an increase in the CB1 ligands, anandamide (AEA) and 2-arachidonoylglycerol (2-AG), and thus competition for the CB1 receptor. These data demonstrated that while nimacimab's potency remained relatively stable, the activity of monlunabant when challenged with a higher concentration of a CB1 agonist was significantly impacted. Dr. Chris Twitty, Chief Scientific Officer of Skye, said, 'These data demonstrate for the first time how nimacimab's allosteric binding to the CB1 receptor is differentiated from the small molecules which bind to the receptor's active orthosteric site. We know that in a disease state such as obesity, the CB1 receptor as well as its natural ligands, AEA and 2-AG, are upregulated. In this diseased state, there may be significant competition for the active binding site. In our in vitro experiment we aimed to recreate this potential situation. The biological impact of these data suggests that when there is significant competition for CB1 binding, the activity of small molecules like monlunabant can be significantly impacted. Clinically this could result in impacting the relationship between pharmacodynamics and pharmacokinetics of the drug, ultimately requiring more of the small molecule to overcome the competition. Alternatively, nimacimab does not compete for the same site as the natural ligands, and our data show that as a result of this allosteric binding, the potency is minimally impacted regardless of the concentration of competing molecules.' 'In the context of CB1 inhibition, we aim to realize the weight loss and metabolic benefits of this mechanism without the neuropsychiatric side effects seen with small molecule drugs. In our estimation, the potential of superior potency of nimacimab in this disease state may offer the widest possible therapeutic window among CB1 inhibitors.' Figure 2 - Comparison of potency between monlunabant* and nimacimab*** Monlunabant's potency dropped significantly at high agonist levels due to direct competition for the receptor's orthosteric site.** Nimacimab's potency was preserved due to its allosteric binding mechanism that avoids direct competition. 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 2 clinical trial ( 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: Connect with us on X and LinkedIn. CONTACTSInvestor Relationsir@ 410-0266 LifeSci Advisors, Mike Moyermmoyer@ 308-4306 Media InquiriesLifeSci Communications, Michael Fitzhughmfitzhugh@ 234-3889 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 based on nimacimab's mechanism of action and (v) statements regarding the timing of receipt of final data from Skye's Phase 2 obesity study of nimacimab. 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. Photos accompanying this announcement are available at
