Skye Pivots From Obesity To Fibrosis As Fibrx Adds 2027 DDR IND Catalyst Behind Crohn’s Disease Program

Skye Bioscience is moving away from its former obesity-development strategy after discontinuing the CBeyond Phase 2a nimacimab trial, and its proposed combination with Redx Pharma will transform the company into Fibrx Therapeutics, a fibrosis-focused biotechnology company whose pipeline includes a planned 2027 IND submission for a Discoidin Domain Receptor inhibitor program.

Nimacimab had been Skye’s lead program and was being evaluated for weight loss in patients with obesity or overweight. During Q2, Skye discontinued CBeyond, paused further nimacimab development and engaged a financial advisor after reviewing changes in the anti-obesity drug landscape and the commercial opportunity associated with the product’s potential target profile.

Under the transaction, Skye will acquire Redx through a U.K. scheme of arrangement, but the resulting company will operate as Fibrx Therapeutics and be led by Redx’s existing management team. Approximately $125 million of financing has been assembled around the combination.

Fibrx’s lead program will be RXC008, an oral, GI-restricted pan-ROCK inhibitor targeting fibrostenotic Crohn’s disease. The program has an open U.S. IND, received FDA Fast Track designation in January 2026 and is ready to begin a Phase 2 study, with topline data expected in the second half of 2028.

The financing is expected to support Fibrx operations into 2029, including through the RXC008 Phase 2 readout.

Behind RXC008, Fibrx will inherit Redx’s preclinical DDR inhibitor program. The portfolio includes five distinct chemical series and patents covering dual DDR1/DDR2 and selective inhibitors. DDRs are collagen receptors whose expression is increased in fibrotic conditions involving organs including the kidney, lung and liver.

An IND submission for a DDR inhibitor is expected in 2027, giving the newly formed company a second development catalyst behind the Crohn’s disease program. The pipeline will also include zelasudil, or RXC007, a selective ROCK2 inhibitor that has completed a signal-searching Phase 2 study in idiopathic pulmonary fibrosis and is being positioned as a potential partnering asset.

The economic structure of the combination also emphasizes how significantly Skye is changing direction. Existing Skye equity holders are expected to own approximately 5.38% of Fibrx, compared with 46.17% for existing Redx holders and 48.45% for financing investors, subject to adjustments tied to Skye’s net cash at closing.

Skye shareholders will nevertheless retain exposure to any near-term value derived from the discontinued obesity asset. Pre-transaction Skye shareholders are expected to receive contingent value rights providing them collectively with 90% of net cash proceeds from a potential nimacimab monetization under the terms described for the transaction.

The transaction is expected to close in Q4 2026, subject to shareholder, regulatory, court and other customary approvals. Once completed, Fibrx is expected to remain listed on Nasdaq and be headquartered at Redx’s existing Alderley Park operation in the U.K.

KEY QUOTES:

“This transaction gives Redx the capital and the platform to progress our pipeline and deliver the Phase 2 program for our lead asset, RXC008, a GI-restricted pan-ROCK inhibitor. We believe this is an exciting opportunity to be a leader in developing a therapeutic option for patients suffering with fibrostenotic Crohn’s disease, considered by many to be one of the largest unmet medical needs in IBD, by directly targeting fibrosis in stricturing disease for which there is currently no treatment option other than surgery. We are delighted to have attracted a number of leading institutional biotech investors, and the Nasdaq listing will facilitate engagement with a deep pool of capital that will be required to support our future growth. We are excited to be launching Fibrx as a clinical-stage fibrosis-focused company with the prospect of creating substantial value for investors while delivering a meaningful positive impact for patients.”

Lisa Anson, Chief Executive Officer of Redx Pharma

“Over the last several months, Skye has evaluated a wide range of options to maximize shareholder value, including an assessment of our internal pipeline, financing opportunities and strategic alternatives. We believe this transaction provides our shareholders a compelling opportunity to realize both short- and long-term value creation through Redx’s novel anti-fibrotic therapies, led by their first-in-class pan-ROCK inhibitor, RXC008. In addition, Skye shareholders will receive a contingent value right entitling them to receive 90% of net cash proceeds that may be realized for the monetization by the combined company of nimacimab and its associated intellectual property.”

Punit Dhillon, President and Chief Executive Officer of Skye Bioscience