Core Insights - Connect Biopharma Holdings Limited is a clinical-stage biopharmaceutical company focused on transforming care for asthma and chronic obstructive pulmonary disease (COPD) [1][3] - The company announced two oral presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, highlighting the efficacy of its drug Rademikibart in treating eosinophilic driven, Type 2 asthma [1][2] Company Overview - Connect Biopharma is headquartered in San Diego, California, and is dedicated to advancing Rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody [3] - The company targets acute exacerbations in asthma and COPD, addressing a significant unmet need among approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually [3] Clinical Trial Highlights - Rademikibart demonstrated strong efficacy and safety data in a Phase 2 trial for asthma, showing clinically meaningful reductions in exacerbations [3] - Rapid, statistically significant improvements in forced expiratory volume in one second (FEV1) were observed within one week, and in most cases, within 24 hours via home spirometry [3] Presentation Details - The presentations at the EAACI Congress will cover the reduction in annualized exacerbations and improvement in lung function with Rademikibart in eosinophilic driven, Type 2 asthma [2]

Company Overview - Connect Biopharma Holdings Limited is a clinical-stage biopharmaceutical company focused on transforming care for asthma and chronic obstructive pulmonary disease (COPD) [3] - The company is headquartered in San Diego, California and is advancing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody [3] - Rademikibart targets acute exacerbations in asthma and COPD, addressing significant unmet needs among approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually [3] Clinical Development - In a Phase 2 trial for asthma, rademikibart demonstrated strong efficacy and safety data, showing clinically meaningful reductions in exacerbations and rapid improvements in forced expiratory volume in one second (FEV1) [3] - Improvements in FEV1 were observed within one week, and in most cases, within 24 hours via home spirometry [3] Upcoming Events - Company management will participate in the Noble Capital Markets Virtual Conference on June 4, 2025, at 9:00 a.m. ET [1] - The Jefferies Healthcare Conference will take place on June 5, 2025, at 7:35 a.m. ET, with a live webcast available on the company's website [2]

Core Insights - Connect Biopharma's rademikibart shows significant improvement in airway function (FEV1) within 24 hours and reduces acute exacerbations in asthma and COPD patients, supporting ongoing Phase 2 studies expected to report data in 1H26 [1][2] - Rademikibart demonstrates differentiated structural and molecular dynamics with enhanced IL-4Rα inhibition compared to dupilumab, providing a basis for its superior efficacy and safety profile [1][8] Group 1: Clinical Data - Rademikibart rapidly improves lung function (FEV1) during the first week of treatment, with most improvement observed within 24 hours [3] - Patients with elevated eosinophil counts (≥300 cells/µL) showed the greatest improvements in lung function and significant reduction in acute exacerbations [3] - In a post-hoc analysis, rademikibart significantly improved prebronchodilator FEV1 over 24 weeks, particularly in patients with eosinophilic-driven COPD [3] Group 2: Safety and Efficacy - Rademikibart treatment groups had lower proportions of patients with high post-baseline eosinophil counts compared to dupilumab, indicating a differentiated safety profile [8] - Mean eosinophil counts decreased by approximately 30% at Week 24 for rademikibart, while dupilumab treatment groups experienced increases between 50% and 120% [8] - Structural analysis revealed rademikibart's optimized binding to IL-4Rα, enhancing its efficacy compared to dupilumab [8] Group 3: Company Overview - Connect Biopharma is focused on transforming care for asthma and COPD, with rademikibart positioned as a potentially best-in-class anti-IL-4Rα antibody [5] - The company targets a significant unmet need in acute exacerbations, with approximately 1 million asthma and 1.3 million COPD patients in the U.S. experiencing such events annually [5] - Rademikibart has shown strong efficacy and safety data in Phase 2 trials, with rapid improvements in FEV1 observed within one week [5]

Financial Performance - For the three months ended March 31, 2025, research and development expense was $6.6 million, a decrease of 23.4% from $8.7 million in the same period in 2024[103]. - General and administrative expense increased to $4.8 million for the three months ended March 31, 2025, compared to $4.0 million for the same period in 2024, primarily due to increased professional fees and personnel costs[104]. - The net loss for the three months ended March 31, 2025, was $10.3 million, or $0.19 per share, compared to a net loss of $8.7 million, or $0.16 per share, for the same period in 2024[108]. - Cash, cash equivalents, and short-term investments totaled $84.0 million as of March 31, 2025, sufficient to meet anticipated cash requirements for at least one year[107]. - Net cash used in operating activities for the three months ended March 31, 2025, was $10.0 million, significantly higher than $0.6 million for the same period in 2024[109]. - Net cash used in investing activities for the three months ended March 31, 2025, was $20.6 million, compared to net cash provided by investing activities of $9.3 million for the same period in 2024[110]. Clinical Trials and Product Development - The company announced positive data from a Phase 2 trial of rademikibart, indicating its potential as a treatment for asthma with rapid onset of action and significant reductions in exacerbation rates[96]. - The first patient was enrolled in the Phase 2 clinical trial for rademikibart in patients experiencing acute exacerbations of asthma or COPD, with primary endpoints focused on treatment failure over 28 days[98][99]. Corporate Changes and Challenges - The company relocated its corporate headquarters to a new location in San Diego, California, with an operating lease that increases from $0.3 million to $0.4 million over the lease term[113]. - The company faces potential challenges from high inflation rates and economic uncertainty, which may impact operating costs and access to financing[119]. - The company faces challenges in raising capital due to unfavorable global economic and political conditions, which may impact research and development programs[120]. - The company is experiencing stress on working capital resources due to worsening global macroeconomic conditions and wage increases[121]. - Future commercialization efforts may be delayed or reduced if capital cannot be raised on attractive terms[121]. Costs and Strategic Considerations - Costs associated with drug discovery, preclinical development, and clinical trials for product candidates are significant and ongoing[120]. - Regulatory review costs and the expenses related to marketing approvals for successful clinical trials are critical factors for future product launches[120]. - The costs of maintaining and enforcing intellectual property rights are a significant consideration for the company[120]. - The company is focused on the costs of future activities related to product sales, medical affairs, and distribution for approved product candidates[120]. - The company is evaluating third-party manufacturers and suppliers, which adds to the overall manufacturing process development costs[120]. - Ongoing collaborations and the ability to establish new partnerships on favorable terms are essential for the company's growth strategy[120]. - The terms of current and future license agreements and collaborations will impact the company's strategic direction[120].

Financial Performance - For the three months ended March 31, 2025, Connect Biopharma reported a net loss of $10.3 million, or $0.19 per share, compared to a net loss of $8.7 million, or $0.16 per share, for the same period in 2024[7]. - Total operating expenses for the three months ended March 31, 2025, were $11.4 million, compared to $12.6 million for the same period in 2024[14]. Cash and Investments - Cash, cash equivalents, and short-term investments were $84.0 million as of March 31, 2025, expected to fund operations into 2027[7]. - Total assets as of March 31, 2025, were $92.7 million, down from $101.3 million as of December 31, 2024[16]. Research and Development - Research and Development expense decreased to $6.6 million for the three months ended March 31, 2025, from $8.7 million in the same period in 2024, a reduction of $2.1 million[7]. - Connect Biopharma initiated Phase 2 Seabreeze STAT studies for rademikibart as an adjunct treatment for acute exacerbations in asthma and COPD, with topline data expected in 1H 2026[5]. - Rademikibart demonstrated a mean difference from placebo in forced expiratory volume of +420 mL in patients with eosinophilic-driven asthma after 24 weeks, one of the largest increases reported for a biologic[7]. - The company completed a positive Type C meeting with the FDA, aligning on the Phase 2 Seabreeze study protocols[7]. - Four posters were accepted for presentation at the ATS 2025 International Conference, supporting the development of rademikibart for patients with moderate-to-severe asthma or COPD[7]. General and Administrative Expenses - General and Administrative expense increased to $4.8 million for the three months ended March 31, 2025, compared to $4.0 million for the same period in 2024, an increase of $0.8 million[7].

Core Viewpoint - Connect Biopharma is advancing its clinical development of rademikibart, a novel biologic treatment for asthma and COPD, with positive Phase 2 trial results and a strong financial position to support ongoing studies and operations [1][2][3]. Clinical Development - The company initiated Phase 2 Seabreeze STAT studies for rademikibart as an adjunct treatment for acute exacerbations in asthma and COPD, with topline data expected in the first half of 2026 [1][3]. - A positive Type C meeting with the FDA was completed, aligning on the Phase 2 study protocols [3]. - Rademikibart showed significant improvements in lung function, with a mean difference from placebo in forced expiratory volume of +420 mL in patients with eosinophilic-driven asthma after 24 weeks [3]. Financial Performance - For the three months ended March 31, 2025, the company reported a net loss of $10.3 million, or $0.19 per share, compared to a net loss of $8.7 million, or $0.16 per share, for the same period in 2024 [8][13]. - Research and Development expenses decreased to $6.6 million from $8.7 million year-over-year, while General and Administrative expenses increased to $4.8 million from $4.0 million [8][13]. - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled $84.0 million, expected to fund operations into 2027 [8][15]. Upcoming Events - The company has four posters accepted for presentation at the American Thoracic Society (ATS) 2025 International Conference, supporting the development of rademikibart for patients with moderate-to-severe asthma or COPD experiencing acute exacerbations [2][3][8].

Core Viewpoint - Connect Biopharma is advancing the development of rademikibart, a potential treatment for acute exacerbations in patients with COPD and asthma, with the initiation of the Phase 2 Seabreeze STAT COPD study expected to report topline data in the first half of 2026 [1][2] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and COPD, headquartered in San Diego, California [4] - The company is developing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody, targeting the significant unmet need in acute exacerbations among asthma and COPD patients [4] Study Details - The Seabreeze STAT COPD study is a Phase 2, randomized, double-blind, placebo-controlled trial evaluating rademikibart as an adjunct to standard care for acute exacerbations in COPD patients with type 2 inflammation [3] - Approximately 160 participants will be enrolled globally, characterized by an eosinophil count of ≥300 cells/μL, receiving either rademikibart or placebo [3] - The primary endpoint is the safety and efficacy of rademikibart, measured by the treatment failure rate over 28 days following an acute exacerbation [3] Market Need - There is a major unmet need for fast and effective treatments for acute exacerbations in COPD and asthma, with 1.3 million patients visiting emergency departments annually for COPD flare-ups [3] - Approximately 50% of these patients experience treatment failure within four weeks of an exacerbation, highlighting the necessity for new therapeutic options [3] Clinical Data - Previous Phase 2 data indicated that rademikibart has the potential to improve outcomes for COPD patients, particularly those with elevated eosinophil counts [2] - In prior trials, rademikibart demonstrated strong efficacy and safety, with significant reductions in exacerbations and rapid improvements in forced expiratory volume (FEV1) observed within one week [4]

SAN DIEGO, May 13, 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 announced the initiation of its Phase 2 Seabreeze STAT Asthma study (NCT06940141) following written agreement on the final study protocol from the U.S. Food and Drug Administration. The study will evaluate the safety ...

– Data to be presented supports development of rademikibart for patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation – Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the company is advancing rademikibart, a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. With an initial focus on acute exacerbations—an area with significant ...

Core Insights - Connect Biopharma is set to initiate parallel Phase 2 trials for rademikibart in patients with moderate-to-severe asthma or COPD experiencing acute exacerbations, with trials expected to start in Q2 2025 [1][2] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and COPD, headquartered in San Diego, California [5] - The company is advancing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody, targeting acute exacerbations in asthma and COPD [5] Clinical Trials - The two Phase 2 trials will each enroll approximately 160 patients with uncontrolled, moderate-to-severe asthma or COPD, specifically those with eosinophils ≥300 cells/µL [3] - The trials aim to evaluate the effects of a single 600 mg subcutaneous dose of rademikibart over a 28-day period following an acute exacerbation [3] - Previous studies indicated that about 45% of patients receiving standard care experienced treatment failure within 28 days post-exacerbation, highlighting the need for improved treatments [3] Expected Outcomes - Data from the Phase 2 trials is anticipated to be reported in the first half of 2026, with the company having a cash runway into 2027 [3] - Rademikibart has shown promising results in prior studies, demonstrating rapid improvements in pulmonary function within 24 hours [2][5]