Skye Bioscience (NASDAQ:SKYE) and privately held Redx announced a definitive transaction agreement that would combine the companies into a Nasdaq-listed fibrosis-focused biotechnology company named Fibrx Therapeutics.
The transaction, unanimously approved by both companies’ boards, is expected to close in the fourth quarter of 2026, subject to shareholder approvals, customary closing conditions, approval of the Redx scheme of arrangement by the High Court of Justice of England and Wales, and Nasdaq listing approval.
At closing, pre-transaction Redx equity holders are expected to own approximately 59.75% of the combined company, while financing investors are expected to own about 34.87%. Pre-transaction Skye equity holders are expected to own approximately 5.38%, subject to adjustment based on Skye’s actual net cash immediately before closing.
Skye shareholders to receive CVR tied to nimacimab
Dhillon said Skye evaluated its internal pipeline, financing alternatives and strategic options over recent months. The company had previously paused development of its nimacimab obesity program and discontinued its CBeyond Phase II trial during the second quarter of 2026.
According to Dhillon, nimacimab was well tolerated in CBeyond, with a safety profile in line with placebo and no increase in gastrointestinal or neuropsychiatric adverse events. In combination with semaglutide, the drug produced what he described as a clinically meaningful additional amount of weight loss versus semaglutide alone.
However, Dhillon said the obesity-treatment landscape has advanced rapidly, citing oral GLP-1 therapies and highly efficacious combination and triple agonists. He said an add-on therapy such as nimacimab would need to show clear additional weight loss atop an optimized incretin therapy while also offering convenient administration.
Skye concluded that the profile indicated by its data—a dose of at least 600 milligrams and roughly 6 milliliters of weekly injection volume—fell outside that convenience range and would require a substantial, multiyear Phase III investment without assurance of a differentiated label, Dhillon said.
Under the proposed transaction, Skye shareholders will receive a contingent value right entitling them to 90% of net cash proceeds, if any, from a monetization of nimacimab and its intellectual property during the 12 months following the transaction’s closing.
Fibrx to focus on fibrosis pipeline
Redx CEO Lisa Anson, who is expected to lead Fibrx after the transaction closes, said the combined company will operate as a pure-play fibrosis company centered on Redx’s pipeline of small-molecule therapies.
Its lead program will be RXC008, a gastrointestinal-restricted pan-ROCK inhibitor that Redx plans to advance into a Phase II trial in fibrostenotic Crohn’s disease in the fourth quarter of 2026. Anson said RXC008 has an open investigational new drug application and FDA Fast Track designation.
Redx expects top-line Phase II data in the second half of 2028, followed by a full data set in the first half of 2029. The company has selected a contract research organization and begun site setup, according to Anson.
Anson said fibrostenotic Crohn’s disease affects roughly half of the 1.7 million Crohn’s disease patients and has no approved therapies targeting the underlying fibrotic component of the disease. Current anti-inflammatory treatments do not prevent fibrotic progression, she said, leaving some patients to undergo surgery.
RXC008 was designed to block both ROCK1 and ROCK2 in the gastrointestinal tract while limiting systemic exposure, which Redx said is intended to avoid the blood-pressure effects historically associated with systemic pan-ROCK inhibition. In a Phase I healthy-volunteer study, Anson said RXC008 was well tolerated, with no serious adverse events or evidence of hypotension. Tissue exposure in the ileum and colon was within the predicted efficacious range based on the company’s preclinical models, she said.
- RXC008: GI-restricted pan-ROCK inhibitor preparing for Phase II in fibrostenotic Crohn’s disease.
- Zelasudil (RXC007): Selective ROCK2 inhibitor that completed a signal-seeking Phase II study in idiopathic pulmonary fibrosis.
- DDR program: Preclinical discoidin domain receptor inhibitor program, including selective DDR1 and DDR1/2 inhibitors.
Anson said Redx is evaluating the most appropriate development path for zelasudil, including a potential partnership. She also highlighted Redx’s discovery history, including pirtobrutinib, which was sold to Loxo Oncology and is now marketed by Lilly.
Skye said it intends to file a proxy statement with the Securities and Exchange Commission for a special meeting of stockholders related to the proposed transaction.
About Skye Bioscience (NASDAQ:SKYE)
Skye Bioscience, Inc is a clinical-stage biotechnology company focused on the development of novel, selective cannabinoid type 1 (CB1) receptor modulators for the treatment of ocular diseases. Headquartered in Sunnyvale, California, Skye Bioscience leverages proprietary chemistry and formulation expertise to design and optimize compounds with high potency, tissue selectivity and favorable drug-like properties. The company’s lead product candidate is being evaluated for the treatment of glaucoma and other ophthalmic conditions characterized by elevated intraocular pressure.
Skye Bioscience’s pipeline centers on synthetic cannabinoids engineered to avoid central nervous system side effects commonly associated with traditional cannabinoid therapies.
