Nimacimab

10 biotech companies to watch in 2025: Anavex Life Sciences (blarcamesine for neurodegenerative diseases), Candid Therapeutics (T cell engager antibodies for autoimmune diseases), Enterprise Therapeutics (ETD001 for cystic fibrosis), Jazz Pharmaceuticals (Ziihera for biliary tract cancer), Life Biosciences (ER-100 for optic neuropathies), Ovid Therapeutics (OV888 for cerebral cavernous malformation), Skye Bioscience (nimacimab for obesity), TG Therapeutics (Briumvi for multiple sclerosis), Wave Life Sciences (WVE-006 for alpha-1 antitrypsin deficiency), and Quotient Therapeutics (somatic genomics platform for drug discovery).

Skye Bioscience has enrolled over 50% of targeted patients in its CBeyond phase 2 trial for nimacimab, a peripherally restricted CB1 inhibitor for weight loss. Expected interim data in Q2 2025. Nimacimab shows potential for safer, more sustainable anti-obesity treatments without brain engagement, with favorable gastrointestinal tolerability and lean mass preservation.

Skye Bioscience, Inc. (SKYE) reported Q3 2024 earnings, highlighting progress in R&D, including a Phase 2 trial for nimacimab (obesity treatment) and positive preclinical data for its CB1 inhibitor. The company started patient enrollment for the Phase 2 study, aiming for significant weight loss differences. Preclinical results showed promising weight loss and metabolic benefits. Financially, Skye Bioscience reported a net loss of $3.9 million, improved from the previous year due to reduced legal expenses and interest income. The company is focused on achieving clinical milestones in 2025, including interim Phase 2 data release.

Pharmaceutical companies are racing to develop obesity drugs more potent than Novo Nordisk's Wegovy and Eli Lilly's Zepbound. Key trials in the next six months will reveal contenders like Lilly's Zepbound, Novo's dual-acting cagrisema, Amgen's maritide, and Roche's GLP-1 pill CT-996. Additionally, efforts to preserve muscle mass and explore new drug targets like CB1 inhibition are underway.

New CB1 receptor inhibitors, developed by Novo Nordisk, Corbus Pharmaceuticals, and Skye Bioscience, aim to treat obesity with improved safety profiles. These drugs target peripheral receptors, avoiding neuropsychiatric risks associated with earlier CB1 antagonists like rimonabant. Early trials show promising results, with potential for combination therapies with GLP-1 drugs to enhance weight loss effects.

JMP Securities' Jonathan Wolleben reiterated a Buy rating on Skye Bioscience (SKYE) with a $15.00 price target, optimistic about nimacimab's potential to avoid neuropsychiatric AEs seen in other obesity drugs. Piper Sandler also reiterated a Buy rating with a $20.00 price target. SKYE's stock dropped 75.19% over six months.