TABLE OF CONTENTS FORM 10-Q _______________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _______________________ For the transition period from _______ to ________ Commission File Number: 001-40212 Connect Biopharma Holdings Limited (Exact name of ...

Connect Biopharma Reports Second Quarter 2025 Financial Results and Provides Business Update – 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 ...

Core Viewpoint - Connect Biopharma Holdings Limited is actively participating in the BTIG Virtual Biotechnology Conference, highlighting its focus on transforming care for inflammatory diseases, particularly asthma and COPD [1][3]. Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company headquartered in San Diego, California, dedicated to developing treatments for asthma and COPD [3]. - The company is advancing rademikibart, a next-generation antibody targeting IL-4Rα, currently undergoing global clinical studies for treating acute exacerbations of asthma and COPD [3]. - Connect Biopharma has an exclusive license and collaboration agreement for rademikibart with Simcere in China [3]. Event Details - The management of Connect Biopharma will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on July 29, 2025, at 9:20 a.m. ET [1]. - A live webcast of the event will be available on the company's website, with an archived replay accessible for approximately 90 days post-event [2].

Core Viewpoint - Connect Biopharma has regained compliance with Nasdaq's minimum bid price requirement, allowing its American Depositary Shares to continue trading on the exchange [1][2]. Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on treating inflammatory diseases, particularly asthma and chronic obstructive pulmonary disease (COPD) [3]. - The company is advancing rademikibart, a next-generation antibody targeting IL-4Rα, and is conducting global clinical studies for its treatment of acute exacerbations of asthma and COPD [3]. - Connect Biopharma has an exclusive license and collaboration agreement for rademikibart with Simcere in China [3].

Core Viewpoint - Connect Biopharma's collaborator, Simcere Pharmaceutical, has submitted a New Drug Application for rademikibart to treat atopic dermatitis in China, indicating significant progress in the development of this potential best-in-class therapy for inflammatory diseases [1][2]. Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory diseases, with rademikibart as its lead product candidate targeting IL-4Rα [6]. - Simcere Pharmaceutical is an R&D-driven company focusing on therapeutic areas such as neuroscience, anti-oncology, autoimmune, and anti-infection [5]. Product Development - Rademikibart is a fully human monoclonal antibody that targets IL-4Rα, blocking the Th2 inflammatory pathway, which is relevant for treating atopic dermatitis and asthma [4]. - The AD market in China presents a considerable opportunity, with an estimated 70 million patients suffering from the condition [3]. Collaboration Agreement - In 2023, Connect Biopharma and Simcere entered an exclusive license and collaboration agreement for rademikibart in Greater China, granting Simcere exclusive rights for development, manufacturing, and commercialization [2][3]. - Connect Biopharma is eligible for milestone payments totaling approximately $110 million and tiered royalties on net sales in Greater China [3].

June 2025 Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the "Act"). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial condition, results of operations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, o ...

Core Insights - Rademikibart has shown significant improvements in lung function and asthma control for patients with eosinophilic-driven type 2 asthma [1][2] - The treatment has led to a reduction in annualized exacerbation rates in the same patient group [1][10] - Ongoing Phase 2 studies for acute exacerbations in asthma and COPD are expected to report topline data in the first half of 2026 [1] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on asthma and COPD treatment [6] - The company is advancing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody [6] - Rademikibart targets acute exacerbations, addressing a significant unmet need among asthma and COPD patients [6] Clinical Data Highlights - In a Phase 2b trial, rademikibart improved prebronchodilator forced expiratory volume in one second (FEV1) within one week, sustained through 24 weeks [3] - The treatment showed greater improvement in patients with elevated baseline eosinophil counts compared to the overall population [3] - Rademikibart demonstrated a 63% reduction in annualized asthma exacerbation rates (AAER) in patients with elevated eosinophils, 69% in those with elevated FeNO, and 74% in patients with both markers [10]

Summary of Connect Biopharma Holdings (CNTB) Conference Call Company Overview - Connect Biopharma Holdings (CNTB) is undergoing a transformation referred to as "Connect 2.0" with a new management team focused on drug development and regulatory activities [3][4] - The lead program is retimicobart, a next-generation IL-4 receptor alpha monoclonal antibody, positioned as a second-generation alternative to Dupixent [3][4] Core Product Insights - Retimicobart shows a significant improvement in FEV1, a key measure of airway function, with one of the largest improvements seen in biologics for asthma trials [4][5] - The onset of effect occurs within 24 hours, allowing for evaluation in acute settings rather than traditional chronic studies [5][6] - There are over 1 million asthma and 1.3 million COPD patients visiting ERs annually due to acute exacerbations, indicating a substantial market opportunity [5][9] Market Opportunity - Current biologics do not have indications for acute exacerbations, creating a "white space" for retimicobart [6][22] - Market research indicates that the novel acute indication could drive significant chronic use, with a preference share of 40%-45% for acute use and 75% for chronic treatment following acute administration [10][22] - The product is expected to have a multi-billion dollar commercial potential with both acute and chronic indications [23][30] Clinical Development - Two parallel trials (cbreeze stat) for asthma and COPD are underway, with data expected in the first half of the following year [15][16] - The acute studies are designed to assess improvements in FEV1 and reduce hospitalization rates, with a focus on cost savings for hospitals [16][30] - The company has received FDA clearance to move into phase three for atopic dermatitis, pending completion of a partner study in China [21][24] Financial Considerations - Development costs for acute indications are estimated at around $50 million, while combined acute and chronic programs could reach $200 million [29] - The company has sufficient cash reserves to execute its plans into 2027, allowing for strategic development without immediate dilution [24][30] Regulatory Landscape - There is no precedent for acute indications in the biologics market, presenting both challenges and opportunities for Connect Biopharma [33] - Extensive discussions with the FDA have provided insights into potential pathways for approval [33] Conclusion - Connect Biopharma is positioned to leverage its innovative product retimicobart in a largely untapped market for acute asthma and COPD treatment, with a strong focus on rapid clinical development and strategic partnerships to enhance its market presence [22][30]

Summary of Connect Biopharma Holdings (CNTB) Conference Call - June 04, 2025 Company Overview - Connect Biopharma is undergoing a transformation referred to as "Connect 2.0" with a new management team experienced in drug development and public biotech operations [2][22] - The company is focusing on retimicobart, a second-generation IL-4 receptor alpha monoclonal antibody, targeting asthma and COPD [2][3] Key Developments - Two parallel Phase II studies have been initiated for retimicobart, specifically addressing acute exacerbations in asthma and COPD [2][3] - The company has sufficient cash to fund these studies, with a runway extending into 2027 [3][22] - The headquarters has been relocated to San Diego, reducing the company's footprint in China to become more U.S.-centric [3] Market Opportunity - Market research indicates that having an acute indication for retimicobart could create a market opportunity exceeding $5 billion globally [4] - There are over 2 million emergency department visits annually in the U.S. for asthma and COPD exacerbations, highlighting a significant patient population [5][8] - Current treatments for acute exacerbations are largely unchanged from two decades ago, primarily involving steroids and bronchodilators, which take hours to stabilize patients [24][25] Product Differentiation - Retimicobart is positioned uniquely as no other biologic currently has an acute indication for asthma or COPD [4][6] - The product has shown rapid onset of action, with over 70% of the benefit observed within 24 hours of administration [5][13] - The company aims to reduce emergency room visits and hospitalizations, potentially shortening hospital stays and providing cost savings for healthcare systems [28][29] Clinical Data - Previous Phase II studies indicated significant improvements in respiratory function (FEV1) with retimicobart, showing an average improvement of 420 ml at 24 weeks [4][12] - The product demonstrated a rapid improvement in airway function, with 73% of the benefit observed within 24 hours [13][16] - The company has a differentiated safety profile compared to Dupixent, particularly in patients with high eosinophil counts [17][20] Financial Position - As of March, the company reported a cash position of nearly $84 million, sufficient to fund ongoing Phase II programs [22] - The exclusivity for retimicobart extends well into 2040, providing a long-term competitive advantage [20] Future Catalysts - Results from the two Phase II trials are expected in the first half of next year, with ongoing preclinical data supporting the product's differentiation [33][32] - The company is also developing a separate product for hospital use to enhance economic viability and fit within existing reimbursement structures [30] Conclusion - Connect Biopharma is strategically positioned to address significant unmet needs in the treatment of acute asthma and COPD exacerbations, with a strong focus on rapid onset of action and cost-effectiveness for healthcare providers [28][29][30]

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]