Connect Biopharma Holdings Limited

Item 7.01 Regulation FD Disclosure. Press Release. On September 15, 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 and adolescent participants with asthma and type 2 inflammation (the “Asthma 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 Asthma 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 15, 2026, the Company announced topline results for the Asthma Study. The Asthma Study is a randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in adult and adolescent participants with asthma and type 2 inflammation. The study enrolled 160 patients who were randomized 1:1 to receive either a 600mg dose of rademikibart (n=79) or placebo (n=81), 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 asthma, emergency department (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment within 28 days after randomization. The key secondary endpoint was absolute change from baseline in post-bronchodilator forced expiratory volume in one second (“FEV1”) at Week 1, which is also the proposed primary endpoint for Phase 3. Key topline results include: • Rademikibart demonstrated a statistically significant increase from baseline in post-bronchodilator FEV1 on Day 7 of 250 mL compared to 120 mL with placebo (130mL greater improvement compared to placebo; p=0.023). • Rademikibart reduced the treatment failure rate by approximately 66% over 28 days compared to placebo (p=0.153). • The endpoint missed statistical significance due to an overall lower treatment failure rate than projected. • 50% reduction in emergency department visits or unscheduled medical visits for worsening asthma symptoms compared to placebo. • 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 low incidence of adverse events (“AEs”) in both arms, no individual AE occurring in more than two participants, no AEs leading to study discontinuation in either arm, and one serious adverse event (“SAE”) reported in the rademikibart arm compared to three SAEs in the placebo arm. The Company expects to report topline data from the ongoing Phase 2 Seabreeze STAT chronic obstructive pulmonary disease (“COPD”) study (CBP-201-207) of rademikibart for the treatment of acute exacerbations in COPD patients with type 2 inflammation later this month and plans to move quickly to meet with the U.S. Food and Drug Administration (“FDA”) to gain alignment on a Phase 3 program.