CNTB

– Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD continuing as planned based on independent DMC review of pre-specified interim analysis – – Expect to report topline data from both Phase 2 Seabreeze STAT studies mid-2026 – – $20.2 million private placement financing closed on March 31, 2026 – SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today reported financial results for the three months ended March 31, 2026, and provided a business update. “We have had a strong start to the year as we continue to build upon the body of preclinical and clinical evidence supporting the potential of rademikibart to treat acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD), each a significant commercial opportunity where no biologics are currently approved or being developed,” said Barry Quart, Chief Executive Officer of Connect Biopharma. “The recent data from our Phase 1 intravenous (IV) clinical pharmacology study for rademikibart are encouraging, demonstrating faster onset, lower dosing, and the potential for differentiated pricing in the hospital setting if approved. In addition, the recent independent data monitoring committee (DMC) review of the interim analysis of our Phase 2 Seabreeze STAT program gives us confidence that the studies are adequately powered. We currently remain on track to report topline results from both Seabreeze STAT studies mid-year.” Recent Highlights Development Highlights Recruitment of participants into the Phase 2 Seabreeze STAT asthma and COPD studies evaluating the safety and efficacy of rademikibart as an adjunct treatment for acute exacerbations is ongoing with topline data from both studies expected mid-2026. Following topline data, the Company plans to move quickly to meet with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program. In April 2026, the Company announced that the independent DMC overseeing its Phase 2 Seabreeze STAT asthma and COPD studies reviewed the pre-specified interim analysis of efficacy data with no recommendation for change in the sample size and confirmed that it has no safety concerns based on a regular review of safety data...

– Released positive topline data from Phase 1 study of IV rademikibart in patients with asthma or COPD – – Results from Phase 3 study of rademikibart in moderate-to-severe AD presented in late-breaking research session at AAD – – Recruitment ongoing for Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies mid-2026 – – Entered into a securities purchase agreement for $20.2 million equity financing extending our cash runway into second half of 2027 – SAN DIEGO, March 31, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today reported financial results for the three and twelve months ended December 31, 2025, and provided a business update. “2025 was an eventful year for our lead drug candidate, rademikibart, with the initiation of our Phase 2 Seabreeze STAT studies in acute asthma and chronic obstructive pulmonary disease (COPD),” said Barry Quart, Pharm.D., Chief Executive Officer and Director of Connect Biopharma. “We started 2026 with new mechanism of action data, reinforcing rademikibart’s potentially differentiated pharmacologic profile, positive topline results from our Phase 1 intravenous (IV) clinical pharmacology study of rademikibart, and execution of a securities purchase agreement for a $20.2 million equity financing to expand our U.S. institutional investor base and further extend our cash runway. We expect the momentum to continue with topline data from our Phase 2 Seabreeze STAT asthma and COPD studies available midyear.” Recent Highlights Development Highlights In March 2026, the Company announced positive topline data from its Phase 1 clinical pharmacology study of IV rademikibart in patients with stable asthma or COPD. Rademikibart administered as a single 300 mg 2-minute IV push to asthma and COPD patients produced rapid improvement in forced expiratory volume in one second (FEV1) with many patients experiencing improvements in airway function of ≥200 mL as early as 15 minutes post-dosing. The rapid improvement in FEV1 demonstrated with IV rademikibart in this study provides clinical confirmation of preclinical observations that rademikibart has a unique beneficial effect on bronchodilation...

SAN DIEGO, March 10, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect, or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced that the results of a Phase 3 study of rademikibart in moderate-to-severe atopic dermatitis (AD) conducted by the Company’s partner in China, Simcere Pharmaceutical Co., Ltd. (Simcere), will be presented in the Late-Breaking Research session at the 2026 AAD Annual Meeting, which takes place March 27-31, 2026, in Denver, Colorado. “We are very encouraged by the acceptance of our partner’s Phase 3 atopic dermatitis study for an oral presentation in the coveted Late-Breaking Research session at AAD this month,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “We believe the results obtained in this Phase 3 study provide a strong basis for the ultimate approval of Simcere’s pending New Drug Application (NDA) for rademikibart in China. While Connect’s near‑term priorities remain focused on asthma and chronic obstructive pulmonary disease (COPD), the results Simcere has generated in AD underscore rademikibart’s potentially differentiated safety and efficacy and support the opportunity for Connect to target AD as a future indication outside of China. We look forward to the presentation of these findings at AAD later this month.” Presentation details are as follows: Title: 79594 - Rademikibart monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD): A 1-year, phase III, randomized, double-blinded, placebo-controlled trial (RADIANT-AD) Date / Time: Saturday, March 28, 2026, from 9:48 – 10:00 a.m. MDT Location: Bellco Theatre 3 About Rademikibart Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2-related inflammatory diseases such as atopic dermatitis, asthma and COPD. About Simcere Simcere, founded in 1995, is an innovation and R&D-driven pharmaceutical company. The Company focuses on the therapeutic areas of n...

– Recruitment ongoing for Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies in 1H26 – – New Drug Application for rademikibart for the treatment of atopic dermatitis submitted by Simcere, the Company’s exclusive licensee in Greater China, was accepted by China’s NMPA – – Completed termination of American Depositary Receipt program and directly listed our ordinary shares on Nasdaq – – Presented positive data at ERS 2025 supporting the potential of rademikibart to deliver differentiated efficacy and safety in patients across a broad range of baseline type 2 inflammatory markers – SAN DIEGO, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today reported financial results for the three and nine months ended September 30, 2025, and provided a business update. “Throughout 2025, we have worked diligently to position Connect for success by activating our Phase 2 Seabreeze STAT studies of rademikibart in participants experiencing acute asthma and chronic obstructive pulmonary disease (COPD) exacerbations and to further solidify our U.S. presence,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “As we look to the remainder of the year, we are focused on patient recruitment and clinical execution in both studies and expect to deliver topline data in the first half of 2026. We continue to work closely with Simcere in advancing rademikibart in China, making strong progress as Simcere submitted its New Drug Application (NDA) for the treatment of atopic dermatitis (AD) to China’s National Medical Products Administration (NMPA) in July 2025 and continues to progress its Phase 3 asthma maintenance study.” Recent Highlights Development Highlights Recruitment of participants into the Phase 2 Seabreeze STAT asthma and Seabreeze STAT COPD studies evaluating the safety and efficacy of rademikibart as an adjunct treatment for acute exacerbations is ongoing with topline data from both studies expected in the first half of 2026. Presented additional analyses from the Company’s previously completed global Phase 2 trial of rademikibart in patients with moderate-to-severe uncontrolled asthma at the Eur...

– Initiated Phase 2 Seabreeze STAT asthma and COPD studies evaluating rademikibart as an adjunct treatment for acute exacerbations – – Presented positive data at ATS 2025 and EAACI 2025 supporting the potential of rademikibart to deliver differentiated efficacy and safety in patients with eosinophilic-driven type 2 asthma and COPD – – New drug application for rademikibart for the treatment of AD submitted to China’s NMPA by Simcere, the Company’s exclusive licensee in Greater China – – Announced plans to terminate ADR program and directly list ordinary shares on Nasdaq to better facilitate institutional visibility, eliminate ADR depositary fees, and strengthen ability to expand investor base – – Appointed industry veteran Jim Schoeneck to Board of Directors, bringing deep expertise in development and commercialization of breakthrough products and guiding companies through significant transformation and growth – SAN DIEGO, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today reported financial results for the three and six months ended June 30, 2025, and provided a business update. “In the second quarter, we made significant progress across our clinical and corporate goals,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “Our Phase 2 Seabreeze STAT studies are recruiting patients with asthma and chronic obstructive pulmonary disease (COPD), and we were pleased to report strong supporting data at two major medical meetings, further validating rademikibart’s potential to deliver differentiated efficacy and safety. Concurrently, we continued evolving toward becoming a U.S.-centric company with the planned termination of our American Depositary Receipt (ADR) program, and we laid the groundwork for future growth by appointing industry veteran Jim Schoeneck to our Board of Directors. Taken together, we believe we are well positioned to deliver topline clinical data in the first half of 2026 and to ultimately change how patients experiencing acute asthma and COPD exacerbations are treated.” Recent Highlights Development Highlights Recruitment of participants into the Phase 2 Seabreeze STAT asthma and Seabreeze STAT COPD studies evaluating the safety an...

Net loss: US$10.3m (down by 369% from US$3.82m profit in 1Q 2024). US$0.19 loss per share (down from US$0.069 profit in 1Q 2024). We've discovered 4 warning signs about Connect Biopharma Holdings. View them for free. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 7.3% from a week ago. It is worth noting though that we have found 4 warning signs for Connect Biopharma Holdings (1 shouldn't be ignored!) that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Initiated Phase 2 Seabreeze STAT Asthma and Seabreeze STAT COPD studies evaluating rademikibart as an adjunct treatment for acute exacerbations in Asthma and COPD in May 2025; topline data expected in 1H 2026 Published positive data from its global Phase 2 study supporting potential of rademikibart as a novel biologic treatment for patients with asthma and Type 2 inflammation Strong balance sheet with cash runway into 2027 through key clinical catalysts SAN DIEGO, May 15, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today reported financial results for the three months ended March 31, 2025, and provided a business update. “The first quarter of 2025 was very productive, including a positive Type C meeting with the U.S. Food and Drug Administration (FDA), publication of our previously completed global Phase 2 trial results in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), and acceptance of four posters to be presented at the American Thoracic Society (ATS) 2025 International Conference,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “We are focused on execution as we advance our clinical development plan for rademikibart, and we were pleased to initiate the Seabreeze STAT studies evaluating rademikibart as an adjunct treatment for acute exacerbations in both asthma and COPD. Based on our recently published data in the AJRCCM and our upcoming presentations at ATS 2025 International Conference, we are excited by rademikibart’s potential to be the first biologic to rapidly deliver significant improvements in lung function for patients being treated for an acute exacerbation. We are working diligently to enroll patients and we remain well capitalized to deliver topline data in both studies in the first half of 2026.” Recent Highlights Executing on rapid clinical development program for rademikibart as an adjunct treatment for acute exacerbations in both asthma and COPD: Initiated Phase 2 Seabreeze STAT asthma study evaluating the safety and efficacy of rademikibart for acute exacerbations in adolescents and adults with asthma and type 2 inflammation. Initiated Phase 2 Seabreeze STAT COPD study eva...

Strengthened leadership team with key appointments, including Barry Quart, Pharm.D. as CEO, and David Szekeres as President, bringing deep clinical, regulatory, operational and strategic expertise Unveiled rapid clinical development program for rademikibart initially targeting acute care in asthma and COPD; expect to initiate parallel Phase 2 trials in 2Q 2025 with data expected in 2H 2026 Strong balance sheet with cash runway into 2027 and through key clinical catalysts SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma”, “Connect” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care in asthma and chronic obstructive pulmonary disease (COPD), today reported financial results for the year ended December 31, 2024, and provided a business update. “2024 was a transformative year for Connect as we strengthened our leadership team, made significant progress in becoming more U.S.-centric, and unveiled a rapid clinical development strategy for rademikibart initially focused on the treatment of acute asthma and COPD exacerbations, an area where no biologic therapies have been approved. To date, rademikibart has demonstrated a differentiated clinical profile in Phase 2 clinical trials achieving rapid improvement in pulmonary function in less than 24 hours, which was sustained through 24 weeks, highlighting its potential in both acute and chronic care,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “We are on track to initiate parallel Phase 2 trials of rademikibart as an adjunct to standard of care for the treatment of acute asthma and COPD exacerbations in the second quarter of 2025, with data expected in the second half of 2026. We believe rademikibart has the potential to fundamentally alter the treatment paradigm for millions of asthma and COPD patients who experience acute exacerbations every year.” Recent Highlights Clinical Program Highlights Parallel acute exacerbation trials of rademikibart as an adjunct to standard of care in asthma and COPD are on track to be initiated in the second quarter of 2025, with data expected in the second half of 2026. Corporate Highlights The Company continued making progress in becoming more U.S.-centric, including by: assembling an experienced U.S. management team with deep expertise in...