Skye Bioscience Provides 2025 Look Ahead and Year in Review
Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company, has provided an outlook for 2025, highlighting key milestones and achievements. The company is focused on the development of nimacimab, a first-in-class CB1 inhibitor antibody aimed at treating obesity. Key milestones in 2025 include the completion of enrollment in the CBeyond™ Phase 2 obesity trial and the release of interim data in Q2, followed by topline weight loss data in Q4.
In 2024, Skye achieved several milestones, including the launch of the CBeyond™ Phase 2 trial, the first to assess a GLP-1/CB1 inhibitor combination, and the enrollment of 50% of patients by November 2024. Preclinical data showed significant dose-dependent weight loss and fat mass reduction with lean mass preservation. The company also raised $90M in equity financings and expanded its leadership team.
Skye plans to participate in major scientific conferences in 2025, including the European Congress on Obesity and the American Diabetes Association's 85th Scientific Sessions. They will also present at the 43rd annual J.P. Morgan Healthcare Conference on January 16, 2025.
Skye Bioscience (Nasdaq: SKYE), una compagnia biofarmaceutica in fase clinica, ha fornito una previsione per il 2025, evidenziando traguardi e successi chiave. L'azienda è focalizzata sullo sviluppo di nimacimab, un anticorpo inibitore CB1 di prima classe volto al trattamento dell'obesità. I traguardi chiave per il 2025 includono il completamento dell'arruolamento nel trial di obesità CBeyond™ di Fase 2 e la pubblicazione dei dati provvisori nel secondo trimestre, seguiti dai dati finali sulla perdita di peso nel quarto trimestre.
Nel 2024, Skye ha raggiunto diversi traguardi, tra cui il lancio del trial CBeyond™ di Fase 2, il primo a valutare una combinazione di inibitore GLP-1/CB1, e l'arruolamento del 50% dei pazienti entro novembre 2024. I dati preclinici hanno mostrato una significativa perdita di peso dipendente dalla dose e una riduzione della massa grassa con preservazione della massa magra. L'azienda ha anche raccolto 90 milioni di dollari in finanziamenti azionari e ha ampliato il proprio team dirigenziale.
Skye prevede di partecipare alle principali conferenze scientifiche nel 2025, inclusi il Congresso Europeo sull'Obesità e la 85ª Sessione Scientifica dell'American Diabetes Association. Presentaranno inoltre alla 43ª Conferenza Annuale sulla Sanità J.P. Morgan il 16 gennaio 2025.
Skye Bioscience (Nasdaq: SKYE), una compañía biofarmacéutica en fase clínica, ha proporcionado una perspectiva para 2025, destacando hitos y logros clave. La empresa se centra en el desarrollo de nimacimab, un anticuerpo inhibidor de CB1 de primera clase dirigido a tratar la obesidad. Los hitos clave en 2025 incluyen la finalización de la inscripción en el ensayo de obesidad CBeyond™ de Fase 2 y la publicación de datos intermedios en el segundo trimestre, seguidos por los datos finales sobre la pérdida de peso en el cuarto trimestre.
En 2024, Skye alcanzó varios hitos, incluido el lanzamiento del ensayo CBeyond™ de Fase 2, el primero en evaluar una combinación de inhibidor GLP-1/CB1, y la inscripción del 50% de los pacientes para noviembre de 2024. Los datos preclínicos mostraron una pérdida de peso significativa dependiente de la dosis y una reducción de la masa grasa con preservación de la masa magra. La empresa también recaudó 90 millones de dólares en financiamientos de capital y amplió su equipo de liderazgo.
Skye planea participar en importantes conferencias científicas en 2025, incluyendo el Congreso Europeo sobre Obesidad y la 85ª Sesión Científica de la Asociación Americana de Diabetes. También presentarán en la 43ª Conferencia Anual sobre Salud de J.P. Morgan el 16 de enero de 2025.
스카이 바이오사이언스(Nasdaq: SKYE)는 임상 단계의 생물의약품 회사로서 2025년에 대한 전망을 제공하며 주요 이정표와 성과를 강조했습니다. 이 회사는 비만 치료를 목표로 하는 1세대 CB1 억제제 항체인 니마시맙(nimacimab)의 개발에 집중하고 있습니다. 2025년의 주요 이정표로는 CBeyond™ 2상 비만 시험의 등록 완료와 2분기에 interim data 발표, 4분기에는 체중 감소의 topline data 발표가 포함됩니다.
2024년 동안 스카이는 여러 이정표를 달성했으며, 여기에는 GLP-1/CB1 억제제 조합을 평가하는 첫 번째 2상 시험인 CBeyond™ 시험 시작과 2024년 11월까지 환자의 50% 등록이 포함됩니다. 전임상 데이터는 용량 의존적인 체중 감소 및 지방량 감소와 함께 근육량을 보존하는 중요한 결과를 보여주었습니다. 이 회사는 또한 9천만 달러의 자본금 조달을 하고, 경영진 팀을 확장했습니다.
스카이는 2025년에 유럽 비만 학회와 미국 당뇨병 학회의 85회 학술 세션 등 주요 과학 회의에 참가할 계획입니다. 그들은 또한 2025년 1월 16일에 열리는 제43회 J.P. 모건 헬스케어 컨퍼런스에서 발표할 것입니다.
Skye Bioscience (Nasdaq: SKYE), une entreprise biopharmaceutique en phase clinique, a fourni des perspectives pour 2025, soulignant les principales étapes et réalisations. L'entreprise se concentre sur le développement de nimacimab, un anticorps inhibiteur de CB1 de première classe destiné à traiter l'obésité. Les principales étapes de 2025 incluent l'achèvement du recrutement dans l'essai de phase 2 sur l'obésité CBeyond™ et la publication de données intermédiaires au 2e trimestre, suivies des données finales sur la perte de poids au 4e trimestre.
En 2024, Skye a atteint plusieurs jalons, notamment le lancement de l'essai de phase 2 CBeyond™, le premier à évaluer une combinaison d'inhibiteur GLP-1/CB1, et l'inscription de 50 % des patients d'ici novembre 2024. Les données précliniques ont montré une perte de poids significative dépendante de la dose et une réduction de la masse grasse tout en préservant la masse maigre. L'entreprise a également levé 90 millions de dollars lors de financements par actions et a élargi son équipe de direction.
Skye prévoit de participer à d'importantes conférences scientifiques en 2025, y compris le Congrès Européen sur l'Obésité et les 85èmes Sessions Scientifiques de l'American Diabetes Association. Ils présenteront également lors de la 43ème Conférence Annuelle sur les Soins de Santé de J.P. Morgan, le 16 janvier 2025.
Skye Bioscience (Nasdaq: SKYE), ein biopharmazeutisches Unternehmen in der klinischen Phase, hat einen Ausblick für 2025 gegeben und dabei wichtige Meilensteine und Erfolge hervorgehoben. Das Unternehmen konzentriert sich auf die Entwicklung von Nimacimab, einem ersten CB1-Inhibitor-Antikörper, der zur Behandlung von Fettleibigkeit eingesetzt werden soll. Zu den wichtigsten Meilensteinen in 2025 gehören der Abschluss der Rekrutierung in der CBeyond™ Phase-2-Studie zur Fettleibigkeit und die Veröffentlichung von Zwischenberichten im 2. Quartal, gefolgt von den endgültigen Daten zur Gewichtsreduktion im 4. Quartal.
Im Jahr 2024 erreichte Skye mehrere Meilensteine, darunter den Start der CBeyond™ Phase-2-Studie, die erste, die eine Kombination von GLP-1/CB1-Inhibitoren bewertet, und die Rekrutierung von 50% der Patienten bis November 2024. Vorläufige Daten zeigten eine signifikante dosisabhängige Gewichtsreduktion und eine Verringerung der Fettmasse bei gleichzeitiger Erhaltung der fettfreien Masse. Das Unternehmen hat zudem 90 Millionen USD durch Eigenkapitalfinanzierungen gesammelt und sein Führungsteam erweitert.
Skye plant die Teilnahme an wichtigen wissenschaftlichen Konferenzen im Jahr 2025, darunter der Europäische Kongress zur Adipositas und die 85. Wissenschaftliche Sitzung der American Diabetes Association. Sie werden außerdem am 16. Januar 2025 auf der 43. jährlichen J.P. Morgan Healthcare Conference präsentieren.
- Expected Phase 2 obesity data in Q2 and Q4 2025.
- Completion of enrollment in the CBeyond™ Phase 2 obesity trial.
- Interim data release in Q2 2025.
- Topline weight loss data release in Q4 2025.
- Launch of CBeyond™ Phase 2 trial in 2024.
- 50% patient enrollment achieved by November 2024.
- Significant dose-dependent weight loss in preclinical data.
- Raised $90M in equity financings.
- Expanded leadership team and board of directors.
- None.
Insights
The CBeyond™ Phase 2 trial represents a groundbreaking clinical milestone as the first human study evaluating a monoclonal antibody-based CB1 inhibitor. The trial's design, targeting an 8% difference in mean weight loss versus placebo, positions nimacimab as a potential disruptor in the
The preclinical data showing
The study's inclusion of a nimacimab-semaglutide combination arm is particularly noteworthy, as positive synergistic outcomes could position SKYE to capture market share in the rapidly growing obesity combination therapy space.
SKYE's strong financial positioning with a
The obesity therapeutic market represents a massive commercial opportunity, with leading GLP-1 drugs generating multi-billion dollar revenues. Nimacimab's differentiated profile addressing current GLP-1 limitations (GI side effects, lean mass loss) could capture significant market share if Phase 2 data proves successful.
The strengthened leadership team, including new board appointments with deep industry expertise, positions SKYE well for potential partnership discussions or M&A interest following Phase 2 readouts.
Expected Phase 2 obesity data in Q2 2025 and Q4 2025 will shape clinical potential and development path of distinctive CB1 inhibitor
SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company developing new therapeutic pathways for metabolic health, enters 2025 positioned to announce Phase 2 data for nimacimab, a non-incretin mechanism and first-in-class, peripherally-restricted CB1 inhibitor antibody with the potential to enhance important facets of obesity treatment while achieving significant weight loss. Skye’s goal in 2025 is to achieve clinical milestones and new scientific insights related to the unique effects and metabolic mechanisms of peripheral CB1 inhibition.
“The understanding of mechanisms and opportunities to best treat obesity and overweight is still early in its evolution. There is potential to offer clinicians and patients more choices to address the unmet needs of incretin therapeutics, which include unresponsiveness to these drugs, gastrointestinal adverse events, amplified lean mass loss, and the inability to adhere to a longer-term drug regimen. There is a need for alternative approaches that can more sustainably support long-term weight management and metabolic health goals,” said Punit Dhillon, President and Chief Executive Officer of Skye.
“In 2024, Skye took important steps to advance peripheral CB1 inhibition as a potential addition to the obesity drug “toolbox.” We established a clear clinical development plan for nimacimab, including accelerating nimacimab’s development plans for Phase 2b. We generated data that showed the importance of highly-peripherally-restricted CB1 inhibition and nimacimab’s potential differentiation in the obesity landscape within the class of CB1 inhibition. Corporately, we enhanced the leadership expertise within our management team, board, and obesity KOLs to drive value for stakeholders, and we established a strong balance sheet to support our strategic plan.”
2025 Major Anticipated Clinical Milestones and Planned Scientific Conference Participation
Anticipated Clinical Milestones
- CBeyond™ Phase 2 obesity trial: completion of enrollment
- CBeyond™ Phase 2 obesity trial: interim data targeted for Q2 2025:
50% enrollment of planned 120 patients after 26 weeks of treatment. - CBeyond™ Phase 2 obesity trial: topline weight loss data targeted for Q4 2025 after full enrollment of 120 patients completing 26 weeks of treatment.
Scientific Conferences
- European Congress on Obesity, May 11-14, 2025
- 85th Scientific Sessions ADA (American Diabetes Association), June 20–23, 2025
- EASD (European Association for the Study of Diabetes), September 16-19, 2025
- Obesity Week, November 4-7, 2025
2024 Milestones Achieved
Clinical Development
- Launch of CBeyond™ Phase 2 trial: the first clinical trial assessing the efficacy of a monoclonal antibody-based CB1 inhibitor in humans and the first to assess a GLP-1/CB1 inhibitor combination.
- Skye started enrolling patients in its Phase 2 study of nimacimab in August 2024. Nimacimab, a first-in-class CB1-inhibiting monoclonal antibody, is a negative allosteric modulator that acts as both an inverse agonist and antagonist.
- Study design:
- Randomized, doubled-blind, placebo-controlled
- Primary endpoint: designed to demonstrate an
8% difference in mean weight loss of nimacimab versus placebo at 26 weeks, with 13 weeks of follow-up - Secondary and exploratory endpoints will evaluate safety, tolerability, neuropsychiatric and cognitive outcomes, and change in body composition by DEXA, and is also assessing synergistic outcomes when nimacimab is combined with semaglutide, a GLP-1 receptor agonist.
- Announced
50% enrollment achieved in November 2024 - IND clearance received for Phase 2 clinical trial of nimacimab in obesity
- Established leading clinical advisory board for obesity program comprised of leading obesity KOLs.
Preclinical
- Presented results of a diet-induced obesity (DIO) mouse model and provided insights into mechanism of CB1 inhibition and nimacimab and the unique elements of its differentiated CB1 inhibitor. Key initial findings included:
- Dose-dependent weight loss with nimacimab of
4.5% ,11.4% and16.0% compared to vehicle - Significant fat mass loss with lean mass preservation
- Dose-dependent improvement in glucose tolerance
- Dose-dependent weight loss with nimacimab of
- Preliminary results provide the first direct evidence supporting the hypothesis that peripheral CB1 inhibition is the primary driver of weight loss whereas central CB1 inhibition contributes minimally to efficacy yet promotes neuropsychiatric adverse events. We expect additional preclinical data to be forthcoming. A recording of this presentation, conducted as a satellite event at ObesityWeek 2024.
Corporate
- Paul Grayson was appointed as our new Chairman of the Board of Directors and Dr. Karen Smith and Dr. Annalisa Jenkins were appointed to the Board of Directors
- Dr. Puneet Arora, an endocrinologist with extensive metabolic experience, was appointed as Chief Medical Officer
- Uplisted to Nasdaq Global Market
- Notably expanded sell-side analyst coverage
- Raised
$90M in private placement equity financings led by top tier life science investors.
Upcoming Investor Conference
Skye Bioscience will be a corporate presenter at the 43rd annual J.P. Morgan Healthcare Conference Thursday, January 16, 2025, at 10:30 AM - 11:10 AM and is available for 1x1 meetings.
A live and archived webcast 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 (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.
CONTACTS
Investor Relations
ir@skyebioscience.com
(858) 410-0266
LifeSci Advisors, Mike Moyer
mmoyer@lifesciadvisors.com
(617) 308-4306
Media Inquiries
LifeSci Communications, Michael Fitzhugh
mfitzhugh@lifescicomms.com
(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: statements regarding our product development for nimacimab, statements relating to any expectations regarding the safety, efficacy, tolerability or dosing of nimacimab, including based on Skye’s DIO mouse model, statements regarding nimacimab’s therapeutic potential to treat obesity and other metabolic conditions, statements regarding the timing of receipt of interim and final data from Skye’s Phase 2 obesity study of nimacimab, and statements regarding the therapeutic potential of antibody-based peripherally-restricted CB1 inhibitors, including that peripheral CB1 inhibition is the primary driver of weight loss. 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.
FAQ
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