New Risk • Jul 01
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 7.9% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$133m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Announcement • Jun 29
Zura Bio Limited Exceeds Enrollment Target in Both Hidradenitis Suppurativa and Systemic Sclerosis Phase 2 Studies and Expands Tibulizumab Program Zura Bio Limited has completed enrollment of the Phase 2 TibuSHIELD trial of tibulizumab in adults with hidradenitis suppurativa. The TibuSHIELD trial exceeded the target enrollment, with 247 participants enrolled. Zura Bio Limited remains on track to complete enrollment of the Phase 2 TibuSURE trial of tibulizumab in adults with early diffuse cutaneous systemic sclerosis in early July. The TibuSURE trial has already exceeded the target enrollment of 80 participants. Topline data from TibuSHIELD are expected in the fourth quarter of 2026. Topline data from TibuSURE are expected in the first half of 2027. Building on tibulizumab's bispecific mechanism targeting both interleukin-17 and B cell activating factor, Zura Bio Limited plans to initiate a Phase 2 study in a third immune-mediated indication by year end 2026. Cash and cash equivalents were $225.6 million as of March 31, 2026. Consistent with prior guidance and inclusive of the planned third-indication study, Zura Bio Limited continues to expect its existing cash to fund planned operations through at least the end of 2028. TibuSHIELD is a global, Phase 2, randomized, double-blind, placebo-controlled clinical study evaluating the safety, tolerability, and efficacy of tibulizumab in adults with moderate to severe hidradenitis suppurativa. Participants were randomized 1:1:1 to receive two different doses of tibulizumab or placebo. The study includes a 16-week efficacy assessment period followed by a 12-week safety follow-up and an optional open-label extension. The primary endpoint of the study is the percent change from baseline in total abscess and nodule count at Week 16. Secondary endpoints include the proportion of participants achieving HiSCR50 or HiSCR75, defined as at least a 50% or 75% reduction in abscess and nodule count without an increase in abscesses or draining fistulas at Week 16. TibuSURE is a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating tibulizumab in adults with early diffuse cutaneous systemic sclerosis. The study includes a 24-week double blind efficacy assessment period followed by an optional open-label period following completion. The primary endpoint is change from baseline in modified Rodnan Skin Score at Week 24. Secondary endpoints assessing interstitial lung disease include forced vital capacity and quantitative high-resolution computed tomography. TibuSURE is the first clinical trial designed to evaluate the dual inhibition of interleukin-17 and B cell activating factor in diffuse cutaneous systemic sclerosis. Zura Bio Limited’s lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two Phase 2 clinical studies in adults: TibuSHIELD, a study in hidradenitis suppurativa, and TibuSURE, a study in systemic sclerosis. Zura Bio Limited plans to initiate a Phase 2 study for tibulizumab in a third immune-mediated indication by year end 2026. Additional product candidates, torudokimab (ZB-880) and crebankitug (ZB-168), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. 
