Latest news with #SkyeBioscience
Yahoo
22-05-2025
- Business
- Yahoo
Skye Bioscience to Participate in Upcoming Investment Conferences
SAN DIEGO, May 22, 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 that it will participate in the following upcoming healthcare conferences: Investment Conferences Jefferies Global Healthcare Conference (New York) Presentation Thursday, June 5, 9:20 AM ET + 1x1 meetings Sachs European BioPharma Obesity Innovation Forum Next Gen Therapeutics Panel + presentation + 1x1 meetings, Wednesday, June 11 Available webcasts will be accessible on Skye's 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 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. CONTACTS Investor Relations ir@ (858) 410-0266 LifeSci Advisors, Mike Moyer mmoyer@ (617) 308-4306 Media Inquiries LifeSci Communications, Michael Fitzhugh mfitzhugh@ (628) 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
19-05-2025
- Business
- Yahoo
Skye Bioscience Establishes Partnership with Arecor Therapeutics to Develop Enhanced Formulation of Obesity Candidate Nimacimab
Proprietary formulation technology being applied to potentially enhance properties of nimacimab SAN DIEGO, May 19, 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 a formulation development collaboration with Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical company advancing today's therapies to enable healthier lives. The partnership aims to develop a higher concentration formulation of Skye's CB1 inhibitor, nimacimab, using Arecor's proprietary formulation technology platform, Arestat™. Skye is evaluating nimacimab, a first-in-class CB1-inhibiting monoclonal antibody, in its Phase 2a CBeyond™ clinical trial in patients with obesity and overweight. Data from the initial 26-week treatment period is anticipated in late Q3 or early Q4 2025. Under the terms of the agreement, Skye will fund Arecor's development activities with the option to license rights to the new proprietary formulation of nimacimab and associated intellectual property to further develop and commercialize the product. Sarah Howell, Chief Executive Officer of Arecor, said: 'We are pleased to partner with Skye to support the development of a novel, enhanced formulation of nimacimab, a promising first-in-class candidate with the potential to address significant unmet needs in metabolic disease. This collaboration highlights the strength of our proprietary Arestat™ technology in enabling the development of enhanced therapeutic products that can improve patient outcomes and supports our strategy of bringing innovative medicines to market that address significant unmet patient needs in high-value markets.' Tu Diep, Chief Operating Officer of Skye, said: 'Approved weight loss drugs have issues with tolerability and adherence, while the small molecule CB1 inhibitors raise concerns about cumulative exposure-related neuropsychiatric toxicities. Nimacimab already has an advantageous pharmacokinetic profile and to date it does not pose these issues. It has a potentially best-in-class half-life of 18–21 days--substantially longer than GLP-1-based therapies--and is being evaluated in a Phase 2a study with once-weekly dosing. Serving our goal of continuous innovation, we are pleased to work with Arecor on the goal of further enhancing nimacimab to improve patient compliance and treatment outcomes.' About Arecor Arecor Therapeutics plc is a globally focused biopharmaceutical company transforming patient care by bringing innovative medicines to market through the enhancement of existing therapeutic products. By applying our innovative proprietary technology platform, Arestat™, we are developing an internal portfolio of proprietary products in diabetes and other indications, as well as working with leading pharmaceutical and biotechnology companies to deliver therapeutic products. The Arestat™ platform is supported by an extensive patent portfolio. For further details please see our website, About Skye BioscienceSkye 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 therapeutic candidates 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. SKYE CONTACTS Investor Relationsir@ 410-0266 LifeSci Advisors, Mike Moyermmoyer@ 308-4306 Media InquiriesLifeSci Communications, Michael Fitzhughmfitzhugh@ 234-3889 ARECOR CONTACTS Arecor Therapeutics plc Dr Sarah Howell, Chief Executive Officer Tel: +44 (0) 1223 426060Email: info@ David Ellam, Interim Chief Financial Officer Tel: +44 (0) 1223 426060Email: info@ Singer Capital Markets Advisory LLP (NOMAD and Joint Broker) Phil Davies, Sam Butcher Tel: +44 (0) 20 7496 3000 WG Partners LLP (Joint Broker) Nigel Barnes, Satheesh NadarajahDavid Wilson, Claes Spang Tel: +44 (0) 20 3705 9321 ICR Healthcare Chris Gardner, David Daley, Lindsey Neville Tel: +44 (0) 20 3709 5700Email: arecor@ FORWARD LOOKING STATEMENTSThis 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 statements regarding the pharmacokinetic and pharmacodynamic profile of nimacimab and 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 in to access your portfolio
Yahoo
19-05-2025
- Business
- Yahoo
Skye Bioscience Establishes Partnership with Arecor Therapeutics to Develop Enhanced Formulation of Obesity Candidate Nimacimab
Proprietary formulation technology being applied to potentially enhance properties of nimacimab SAN DIEGO, May 19, 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 a formulation development collaboration with Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical company advancing today's therapies to enable healthier lives. The partnership aims to develop a higher concentration formulation of Skye's CB1 inhibitor, nimacimab, using Arecor's proprietary formulation technology platform, Arestat™. Skye is evaluating nimacimab, a first-in-class CB1-inhibiting monoclonal antibody, in its Phase 2a CBeyond™ clinical trial in patients with obesity and overweight. Data from the initial 26-week treatment period is anticipated in late Q3 or early Q4 2025. Under the terms of the agreement, Skye will fund Arecor's development activities with the option to license rights to the new proprietary formulation of nimacimab and associated intellectual property to further develop and commercialize the product. Sarah Howell, Chief Executive Officer of Arecor, said: 'We are pleased to partner with Skye to support the development of a novel, enhanced formulation of nimacimab, a promising first-in-class candidate with the potential to address significant unmet needs in metabolic disease. This collaboration highlights the strength of our proprietary Arestat™ technology in enabling the development of enhanced therapeutic products that can improve patient outcomes and supports our strategy of bringing innovative medicines to market that address significant unmet patient needs in high-value markets.' Tu Diep, Chief Operating Officer of Skye, said: 'Approved weight loss drugs have issues with tolerability and adherence, while the small molecule CB1 inhibitors raise concerns about cumulative exposure-related neuropsychiatric toxicities. Nimacimab already has an advantageous pharmacokinetic profile and to date it does not pose these issues. It has a potentially best-in-class half-life of 18–21 days--substantially longer than GLP-1-based therapies--and is being evaluated in a Phase 2a study with once-weekly dosing. Serving our goal of continuous innovation, we are pleased to work with Arecor on the goal of further enhancing nimacimab to improve patient compliance and treatment outcomes.' About Arecor Arecor Therapeutics plc is a globally focused biopharmaceutical company transforming patient care by bringing innovative medicines to market through the enhancement of existing therapeutic products. By applying our innovative proprietary technology platform, Arestat™, we are developing an internal portfolio of proprietary products in diabetes and other indications, as well as working with leading pharmaceutical and biotechnology companies to deliver therapeutic products. The Arestat™ platform is supported by an extensive patent portfolio. For further details please see our website, About Skye BioscienceSkye 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 therapeutic candidates 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. SKYE CONTACTS Investor Relationsir@ 410-0266 LifeSci Advisors, Mike Moyermmoyer@ 308-4306 Media InquiriesLifeSci Communications, Michael Fitzhughmfitzhugh@ 234-3889 ARECOR CONTACTS Arecor Therapeutics plc Dr Sarah Howell, Chief Executive Officer Tel: +44 (0) 1223 426060Email: info@ David Ellam, Interim Chief Financial Officer Tel: +44 (0) 1223 426060Email: info@ Singer Capital Markets Advisory LLP (NOMAD and Joint Broker) Phil Davies, Sam Butcher Tel: +44 (0) 20 7496 3000 WG Partners LLP (Joint Broker) Nigel Barnes, Satheesh NadarajahDavid Wilson, Claes Spang Tel: +44 (0) 20 3705 9321 ICR Healthcare Chris Gardner, David Daley, Lindsey Neville Tel: +44 (0) 20 3709 5700Email: arecor@ FORWARD LOOKING STATEMENTSThis 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 statements regarding the pharmacokinetic and pharmacodynamic profile of nimacimab and 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.
Yahoo
13-05-2025
- Health
- Yahoo
Skye Bioscience Clinical Model Demonstrating Necessity of Peripheral CB1 Inhibition for Weight Loss Presented at European Congress on Obesity
• This model demonstrates that central inhibition of CB1 is not required for weight loss • Anti-CB1 inhibiting antibody, nimacimab, showed greatest peripheral restriction compared with monlunabant and rimonabant, small molecule-based CB1 inhibitors, which both exhibited increasing dose-dependent brain penetration • This model predicts nimacimab's potentially superior therapeutic index, which is dependent on minimal brain exposure while maintaining sufficient peripheral inhibition SAN DIEGO, May 13, 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, presented a clinical pharmacokinetic ('PK') and pharmacodynamic ('PD') model that underscores the fundamental relationship between biodistribution and efficacy of CB1 inhibitors at the annual European Congress on Obesity meeting. This model demonstrated that achieving strong peripheral CB1 inhibition is sufficient to achieve efficacy, including weight loss. In contrast, blocking CB1 in the brain (central inhibition), which is associated with neuropsychiatric side effects, is not enough on its own to achieve weight loss. Published clinical PK and potency data coupled with Phase 2 ('P2') and Phase 3 efficacy data from Novo Nordisk's monlunabant and Sanofi's rimonabant, respectively, as well as Phase 1 data from nimacimab were used to develop a model to determine whether peripheral CB1 inhibition alone is sufficient for weight loss, or if central inhibition is also required for optimal efficacy. The results showed that central inhibition of CB1 alone was not sufficient for weight loss with P2 data for monlunabant, and demonstrated that increasing drug levels in the brain did not improve efficacy. Relatedly, monlunabant's Ph2 dose range established that all doses achieved significant peripheral inhibition, resulting in significant but similar weight loss. The model also showed that a 5 mg dose of rimonabant that had significant levels in the brain but not peripherally was not effective, leading to only minimal weight loss. 'This model meaningfully advances our understanding of how CB1 inhibitors work, demonstrating that peripheral and not central target engagement is foundational to achieving efficacy including weight loss. Moreover, it clarifies how the therapeutic index of CB1 inhibitors is tied to the relationship between receptor inhibition in the brain, or centrally, versus peripherally--and the widest therapeutic index is associated with the greatest peripheral restriction,' said Punit Dhillon, CEO. 'Our clinical model, together with Skye's recent mouse diet-induced obesity studies, highlights that nimacimab can potentially achieve significant weight loss with a molecule uniquely restricted to tissues outside the brain. We believe nimacimab's highly favorable therapeutic index sets our antibody-based drug apart from small-molecule CB1 inhibitors.' Beyond the relationship with weight loss, using reported safety data from the same clinical trials allowed the model to provide further insight into the therapeutic index of different CB1 inhibitors. Unlike weight loss, neuropsychiatric adverse events such as anxiety and mood changes became present and escalated as CB1 inhibition in the brain increased. While nimacimab has been shown to be virtually undetectable in the brain, penetration into the brain is a challenge small molecule CB1 inhibitors such as rimonabant and monulunabant continue to face. Dr. Chris Twitty, Chief Scientific Officer added, 'While the sufficiency of peripheral CB1 inhibition, as it relates to metabolic gains including weight loss, has been demonstrated preclinically in tissue-specific knock-out systems, our modeling provides a clinical lens that demonstrates parallel findings. Our data show that nimacimab's Phase 2 dose achieves peripheral CB1 engagement at more than seven times the inhibition threshold, while remaining over 600 times below this threshold in the brain. We remain confident in our belief that the Phase 2 dose of nimacimab will be safe and effective, with potent inhibition and a favorable PK profile in the periphery with very little presence in the brain.' The poster can be accessed on Skye's Spotlight page. 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. CONTACTS Investor 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 clinical models of rimonabant and monlunabant and nimacimab , (iii) statements regarding nimacimab's potential to achieve significant weight loss, and (iv) statements regarding superior potency of nimacimab to other small molecule CB1 inhibitors based on nimacimab's mechanism of action. 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.
Yahoo
07-05-2025
- Business
- Yahoo
Skye Bioscience to Announce 2025 First Quarter Financial Results on May 8th, 2025
Skye Bioscience, Inc. SAN DIEGO, May 07, 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, will host a conference call on Thursday, May 8th at 1:30 p.m. PT/4:30 p.m. ET to discuss its 2025 first quarter financial results. An earnings press release will be issued after the market close on May 8th. The live webcast 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. Please join the call 5-10 minutes prior to the scheduled start time. 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 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 . CONTACTS Investor Relations ir@ (858) 410-0266 LifeSci Advisors, Mike Moyer mmoyer@ (617) 308-4306 Media Inquiries LifeSci Communications, Michael Fitzhugh mfitzhugh@ (628) 234-3889
