Latest news with #SkyeBioscience
Business Insider
14 hours ago
- Business
- Business Insider
Analysts Predict Up to ~590% Spike for These 2 ‘Strong Buy' Penny Stocks
Big names may rule the headlines, but many of the market's future stars begin as under-the-radar underdogs. While Wall Street focuses on the trillion-dollar club – think the 'Magnificent 7' – some of the most compelling opportunities are tucked away in the bargain bin, trading for $5 or less. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter These low-priced stocks – known as penny stocks – often operate in high-growth corners of the market, and when the right catalyst hits, whether a breakthrough innovation or a disruptive product, they can deliver explosive gains. That said, not every penny stock is a diamond in the rough. Some linger at the bottom for good reason, dragged down by shaky fundamentals or challenges that may be too big to overcome. So, how do you spot the ones ready to take off? That's where Wall Street's analysts come into play. Using TipRanks' database, we've zeroed in on two standout penny stocks earning high marks from analysts. Both boast a 'Strong Buy' consensus rating and substantial upside potential – with one eyeing a nearly 590% surge. Let's take a closer look and find out what the optimism is all about. Skye Bioscience (SKYE) We'll start with Skye Bioscience, a biopharmaceutical researcher developing new treatments for metabolic disorders, with a particular focus on obesity. This is a fertile area for an innovative biotech firm – the global anti-obesity drug market is projected to grow from $12.8 billion in 2025 to $104.9 billion by 2035, reflecting a 21.1% CAGR over the forecast period. Beyond its prevalence, obesity contributes to a host of physical and mental health complications, creating a need for effective therapies. To meet this need, Skye is taking a novel approach to weight loss by targeting the CB1 pathway through selective inhibition. Its lead candidate, nimacimab, is a peripherally restricted CB1 inhibitor, specifically designed to sidestep the central nervous system side effects that limited earlier CB1-targeting drugs. Now in a Phase 2a clinical trial, CBeyond, nimacimab is approaching a key catalyst: the release of topline data expected in late Q3 or early Q4 2025. In earlier testing at the preclinical and Phase 1 stages, nimacimab demonstrated encouraging results. In an April update, Skye reported that in a mouse model, combining nimacimab with tirzepatide (a dual GLP-1/GIP agonist) resulted in over 30% weight loss after 25 days. Nimacimab alone produced a 23.5% reduction, comparable to monotherapies with tirzepatide or monpelabant. Supporting its safety profile, multiple reviews by the Data Safety Monitoring Committee have been completed with no concerns raised to date. Looking ahead to future clinical development and potential commercialization, Skye has partnered with Arecor Therapeutics to explore a new formulation of nimacimab. Under the agreement, Skye will fund the development using Arecor's proprietary formulation platform and holds an option to license the resulting formulation, including associated intellectual property and commercialization rights. With SKYE trading at $2.16, JMP analyst Jonathan Wolleben sees a big opportunity brewing – especially with a topline data readout just around the corner. 'We continue to like nimacimab's position in the CB1 inhibitor pipeline as a truly peripherally restricted inhibitor, and we view the rapid and over-enrollment of CBeyond as reflective of the high patient enthusiasm for the differentiated mechanism in the obesity pipeline. We think CBeyond is well-designed to answer key safety and efficacy questions, and we like that the DSMC reviews have not raised any concerns to date. Given the history of mechanism, safety will be top of mind for investors. Recall that SKYE saw no neuropsychiatric side effects in its prior Phase 1 and no accumulation in the CNS or brain in non-human primates… We'll see 26-week weight loss data from SKYE's Phase 2a trial in late 3Q/early 4Q where the study is powered to detect an 8% pbo-adj. difference which we would view as a win and should drive shares higher,' Wolleben opined. Backing his bullish case, Wolleben rates SKYE a Buy with a $16 price target, implying a massive one-year upside potential of 594%. (To watch Wolleben's track record, click here) The overall view of SKYE is even more bullish than that. The stock's Strong Buy consensus rating is unanimous, based on 6 positive analyst reviews, and the $17.20 average price target suggests a whopping 696% premium over the next 12 months. (See SKYE stock update) PolyPid (PYPD) Surgery is difficult for patients, even under the best conditions, with infection, inflammation, and pain among the potential post-operative complications. PolyPid, a clinical-stage biopharmaceutical company, is working to address these issues through improved medication delivery. The company has developed a proprietary drug delivery platform called PLEX (polymer-lipid encapsulation matrix), designed to provide targeted, localized, and sustained release of post-operative medications. This layered system – built from alternating polymers and lipids – can deliver a wide range of therapeutic agents, including small molecules, proteins, peptides, and nucleic acids. PLEX is engineered to maintain drug potency and minimize toxicity, enabling controlled release over extended periods, potentially lasting several months. Leveraging this platform, PolyPid developed its lead product candidate, D-PLEX100, which has been evaluated in two Phase 3 clinical trials – SHIELD I and SHIELD II – focused on preventing surgical site infections following abdominal colorectal procedures. While the SHIELD I study did not meet its primary endpoint, PolyPid announced positive topline results from SHIELD II earlier this month. The trial achieved both its primary and key secondary endpoints, demonstrating statistically significant benefits in 798 patients undergoing large abdominal surgeries. With these results, the company is preparing for a potential New Drug Application (NDA) submission in early 2026 and views the data as a catalyst for advancing global partnership discussions. To support its next steps, the company also secured up to $26.7 million in funding through the exercise of outstanding warrants, extending its cash runway beyond the expected FDA approval window for D-PLEX100. Roth Capital analyst Boobalan Pachaiyappan views the SHIELD II results as a turning point – not only confirming clinical efficacy but also laying out a compelling path toward regulatory approval and a sizable market opportunity for D-PLEX100. 'D-PLEX100 delivered efficacy across the board on all secondary endpoints… Although a comprehensive safety data analysis was not presented, given that only top-line data are available, the lack of safety signals suggests that D-PLEX100 is safe and tolerable, exhibiting a profile consistent with previous studies, and is suitable for treating SSI patients… We expect D-PLEX100 FDA approval in 2H26, with the initial launch in 2027 focusing on colorectal surgeries (partner: TBD) and the EU/U.K. launch in 2028 (partner: ADVANZ Pharma; private), with subsequent launches within the broader abdominal procedures category (~4.5M surgeries) in the following years… Our models suggest >$800M in peak sales in 2035, with PYPD revenue >$200M (net royalty rate: 25%),' Pachaiyappan wrote. Pachaiyappan quantifies his positive stance with a Buy rating on PYPD and a $9 price target that points toward a one-year gain of 174%. (To watch Pachaiyappan's track record, click here) Overall, there are 5 recent analyst reviews on record for PYPD shares, and the 4-to-1 split, favoring Buy over Hold, gives the stock its Strong Buy consensus rating. The shares are priced at $3.28, and their $11.50 average target price suggests an upside of 250% on the one-year horizon. (See PYPD stock forecast) To find good ideas for penny stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights.
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.
