Connect Biopharma Holdings Limited

Item 7.01 Regulation FD Disclosure. Press Release. On September 30, 2026, Connect Biopharma Holdings Limited (the “Company”) issued a press release announcing topline results from its global phase 2 study evaluating rademikibart, the Company’s next-generation, potentially best-in-class anti-interleukin-4-receptor alpha antibody as an add-on treatment for acute exacerbations in adult participants with chronic obstructive pulmonary disease (“COPD”) and type 2 inflammation (the “COPD Study”). A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference. Corporate Presentation. A copy of presentation materials related to the COPD Study, all or a part of which may be used by the Company in investor or scientific presentations from time to time, is furnished herewith as Exhibit 99.2 (the “Corporate Presentation”). The Company does not undertake any obligation to update the Corporate Presentation. The information in this Item 7.01, including in Exhibit 99.1 and Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events. On September 30, 2026, the Company announced topline results for the COPD Study. The COPD Study is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in participants with COPD and type 2 inflammation. The study enrolled 159 participants globally with an eosinophil count of ≥300 cells/μL who have experienced an acute COPD exacerbation. Participants were randomized 1:1 to receive either a single dose of rademikibart or placebo, administered subcutaneously in addition to standard of care. The primary endpoint was treatment failure, defined as death due to any cause, (re)admission to a hospital for COPD, emergency department (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment within 28 days after randomization. Secondary endpoints included post-bronchodilator (“post-BD”) forced expiratory volume in one second (“FEV1”) at Week 1 (key secondary), rate and time to new moderate and severe COPD exacerbations, change-from-baseline in clinical respiratory symptoms of COPD, post-BD FEV1 at other timepoints, and incidence of adverse events for 8 weeks after dosing. Key topline results include: • Rademikibart significantly reduced the rate of treatment failure by 81% through Week 4 compared to placebo (p=0.0122) • Rademikibart significantly reduced the rate of new moderate to severe COPD exacerbations by 85% through Week 4 compared to placebo (p=0.030) • Rademikibart significantly reduced new visits to emergency departments and hospital admissions for new exacerbations by 100% through Week 4 compared to placebo (p=0.0137) • Rademikibart significantly reduced the use of rescue inhalers from Week 2 through Week 7 and significantly improved COPD symptoms at Week 2 compared to placebo (Total Score, p=0.0197) • Clinically meaningful 70 mL greater improvement in FEV1 at Week 4 with rademikibart compared to placebo (p=0.1607) • Rademikibart was well tolerated and no new safety signals were observed through the end of the study. The safety profile was comparable to placebo, with a lower incidence of adverse events and serious adverse events reported in the rademikibart arm compared to the placebo arm.