Core Viewpoint - Connect Biopharma Holdings Limited is participating in the 8th Annual Evercore Healthcare 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 rademikibart, an antibody targeting IL-4Rα for asthma and COPD treatment [3]. - The company is conducting global clinical studies for rademikibart, addressing significant unmet needs in acute exacerbations of asthma and COPD [3]. - Connect Biopharma has granted an exclusive license for rademikibart to Simcere Pharmaceutical Co., Ltd. in Greater China, with potential milestone payments up to approximately $110 million and tiered royalties on net sales [3]. Event Participation - Company management will engage in a fireside chat at the conference on December 2, 2025, at 10:50 a.m. ET, with a live webcast available on the company's investor website [1][2].

Core Insights - Connect Biopharma is actively recruiting participants for Phase 2 Seabreeze STAT studies targeting acute exacerbations in asthma and COPD, with topline data expected in the first half of 2026 [1][5] - The New Drug Application (NDA) for rademikibart, aimed at treating atopic dermatitis, has been accepted by China's National Medical Products Administration (NMPA) [1][2] - The company has terminated its American Depositary Receipt (ADR) program and directly listed its ordinary shares on Nasdaq to enhance institutional visibility [1][5] - Positive data presented at the European Respiratory Society (ERS) Congress 2025 indicates rademikibart's potential for differentiated efficacy and safety across various type 2 inflammatory markers [1][5] Development Highlights - Recruitment for the Phase 2 Seabreeze STAT studies for asthma and COPD is ongoing, with topline data anticipated in 1H26 [1][5] - Significant improvements in lung function and asthma control were observed in a global Phase 2 trial of rademikibart, particularly in patients with elevated eosinophil counts and fractional exhaled nitric oxide levels [5] - Simcere Pharmaceutical, Connect's exclusive licensee in Greater China, submitted its NDA for rademikibart for atopic dermatitis in July 2025 [5] - The atopic dermatitis market in China presents a significant opportunity, with an estimated 70 million patients affected [5] Corporate Highlights - Connect Biopharma has completed the termination of its ADR program and directly listed its shares on Nasdaq to eliminate depositary fees and expand its investor base [1][5] - The company is eligible for up to $110 million in milestone payments from Simcere upon achieving specific development and regulatory milestones [5][8] - Connect Biopharma is collaborating with the Jovante Woods Foundation to raise awareness about acute asthma attacks [5] Financial Results - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments of $54.8 million, expected to fund operations into 2027 [11] - License and collaboration revenues for Q3 2025 were $16,000, a decrease from $1.2 million in Q3 2024, primarily due to the nature of the agreement with Simcere [11][16] - Research and development expenses increased to $11.1 million for Q3 2025, compared to $9.0 million in Q3 2024, driven by costs related to rademikibart development [11][16] - The net loss for Q3 2025 was $17.2 million, or $0.31 per share, compared to a net loss of $12.9 million, or $0.23 per share, in Q3 2024 [11][16]

Connect Biopharma Holdings (NasdaqGM:CNTB) Update Summary Company Overview - Connect Biopharma is a China-based biotech company that has transitioned to a U.S.-centric focus, now headquartered in San Diego [3][4] - The company specializes in monoclonal antibody technology, with its lead program being rademikibart, a next-generation treatment targeting IL-4 receptor alpha, similar to Dupixent [3][4] Core Points and Arguments Strategic Shift - The company has moved its headquarters to San Diego and converted from trading ADRs to ordinary shares, marking a significant step in its U.S. focus [4] - The board's mandate was to determine the best approach for the development of rademikibart and to enhance the company's U.S. presence [3] Market Opportunity - Rademikibart targets both asthma and COPD, with a market forecast of approximately $5 billion for these conditions [5] - The drug aims to address acute treatment needs, particularly for patients experiencing active exacerbations, where current biologics, including Dupixent, are not indicated [5][19] Clinical Data and Efficacy - Rademikibart has shown significant improvement in FEV1 (forced expiratory volume in one second) in clinical studies, with a notable improvement of nearly 250 mL observed within one week [10] - Over 70% of the benefit was achieved within hours of administration, indicating a rapid onset of action [10][19] - The drug has demonstrated a different safety profile compared to Dupixent, with a reduction in eosinophil levels rather than an increase, which is a common side effect of Dupixent [12][24] Competitive Landscape - Currently, there are no approved biologics for the acute treatment of asthma or COPD, creating a unique market position for rademikibart [27][28] - The company believes it can maintain a competitive edge due to the lack of competitors targeting acute exacerbations [27][28] Financial Position and Milestones - Connect Biopharma reported a strong cash position of $72 million as of the end of Q2 2025, providing financial stability to fund ongoing studies [22] - The company anticipates approximately $110 million in milestone payments remaining in its agreement with Simcere, with potential approvals for atopic dermatitis and asthma expected in 2026 [22][26] Additional Important Information - The company is conducting two acute studies, one for asthma and one for COPD, with results expected in the first half of next year [17][26] - There is a potential for non-dilutive funding through regional partnerships, which the company is actively pursuing [26] - The manufacturing process has been transferred to a U.S. contract manufacturer, ensuring the ability to produce commercial material for future phases [20] Conclusion Connect Biopharma is positioning itself as a key player in the treatment of asthma and COPD, particularly in the acute treatment space, with promising clinical data and a strong financial foundation to support its development efforts. The lack of competition in the acute treatment market presents a significant opportunity for the company to capture market share and drive revenue growth in the coming years [27][28]

Core Insights - Connect Biopharma presented data on rademikibart, showing significant improvements in lung function and asthma control, particularly in patients with elevated type 2 inflammatory markers [1][2][3] - The company anticipates reporting topline data from ongoing Phase 2 Seabreeze STAT studies for asthma and COPD in the first half of 2026 [1][2] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on treating inflammatory diseases, headquartered in San Diego, California [6] - The company is advancing rademikibart, a next-generation anti-IL-4Rα antibody, through global clinical studies targeting acute exacerbations of asthma and COPD [6] Clinical Trial Results - Rademikibart demonstrated rapid and sustained improvements in lung function, with a 507 mL increase in prebronchodilator FEV1 for patients with high eosinophil counts and high FeNO levels at Week 24 [3] - A significant reduction in asthma exacerbations was noted, with a 63% reduction in patients with high eosinophils and a 69% reduction in those with high FeNO [3] - The Phase 2b trial results indicated that rademikibart's efficacy varied based on regional differences, with greater benefits observed in the overall trial population compared to the Polish subgroup [3][4] Future Development Plans - The data from the Phase 2b study will inform the clinical development plans and site strategies for ongoing studies [2][4] - Connect Biopharma is collaborating with Simcere in China for the development of rademikibart [6]

Core Viewpoint - Connect Biopharma Holdings Limited is advancing its clinical-stage product candidate, rademikibart, which targets inflammatory diseases, particularly asthma, and will present new trial data at the European Respiratory Society Congress 2025 [1][3]. Group 1: Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company headquartered in San Diego, California, focused on transforming care for asthma and chronic obstructive pulmonary disease (COPD) [3]. - The company is conducting global clinical studies of rademikibart, which is designed to target interleukin-4 receptor alpha (IL-4Rα) [2][3]. - Connect Biopharma has an exclusive license and collaboration agreement for rademikibart with Simcere in China [3]. Group 2: Product Information - Rademikibart is a fully human monoclonal antibody that blocks the functions of IL-4 and IL-13, aiming to treat Th2 related inflammatory diseases such as atopic dermatitis and asthma [2]. - The product is currently under clinical investigation and has not yet received marketing approval from regulatory agencies [8]. Group 3: Upcoming Presentations - Connect Biopharma will present two posters at the ERS Congress 2025, detailing the impact of eosinophils and regional differences on the response to rademikibart in moderate-to-severe asthma [1]. - The presentations are scheduled for September 29, 2025, during the session on biologics for asthma and allergic rhinitis [1].

Core Viewpoint - Connect Biopharma has transitioned to a direct listing of its ordinary shares on Nasdaq, marking a strategic shift towards becoming a U.S.-centric company focused on treating inflammatory diseases [1][2][3]. Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company headquartered in San Diego, California, dedicated to transforming care for asthma and COPD [5]. - The company is advancing rademikibart, a next-generation monoclonal antibody targeting IL-4Rα, which is currently undergoing global clinical studies for treating acute exacerbations of asthma and COPD [5]. Recent Developments - The ADR program and Deposit Agreement were terminated on September 2, 2025, with ADRs being mandatorily cancelled and exchanged for ordinary shares at a one-for-one ratio [2]. - Ordinary shares began trading directly on Nasdaq under the existing symbol "CNTB" [2]. Future Focus - The company aims to execute its Phase 2 Seabreeze STAT studies for rademikibart, which is expected to enhance institutional access with U.S. investors and build long-term shareholder value [3].

Core Insights - Connect Biopharma Holdings Limited is a clinical-stage biopharmaceutical company focused on treating inflammatory diseases, particularly asthma and COPD [3] - The company is advancing rademikibart, a next-generation antibody targeting IL-4Rα, currently undergoing global clinical studies [3] - Connect Biopharma has an exclusive collaboration with Simcere for rademikibart in China [3] Upcoming Conferences - Company management will participate in the Cantor Global Healthcare Conference on September 3rd, 2025, at 3:20 p.m. ET [1] - The H.C. Wainwright 27th Annual Global Investment Conference is scheduled for September 8th, 2025, at 9:30 a.m. ET [2] - Live webcasts of both events will be available on the company's investor website, with archived replays accessible for approximately 90 days [2]

Core Points - Connect Biopharma Holdings Limited collaborates with the Jovante Woods Foundation to enhance asthma education and awareness, particularly focusing on acute asthma attacks [1][3] - The partnership aims to expand educational programming across the U.S. and includes a video package sharing Jovante Woods' story to highlight the dangers of acute asthma [3][4] - The initiative is driven by the need for improved treatments for acute asthma exacerbations, with Connect Biopharma advancing its Phase 2 Seabreeze STAT studies [4][8] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and COPD, headquartered in San Diego, California [8] - The company is developing rademikibart, a monoclonal antibody targeting IL-4Rα, aimed at treating acute exacerbations of asthma and COPD [7][8] - Connect Biopharma has an exclusive collaboration agreement for rademikibart with Simcere in China [8] Foundation Activities - The Jovante Woods Foundation, established by Ickey and Chandra Woods, aims to raise awareness about asthma and educate families on treatment management [2] - The Foundation has organized educational events and fundraisers in various states, including Ohio, California, and Nevada [2] - The collaboration with Connect Biopharma will enhance the Foundation's reach and frequency of educational programming [5]

Core Viewpoint - Connect Biopharma Holdings Limited is making significant strides in its clinical and corporate objectives, particularly with its Phase 2 Seabreeze STAT studies for asthma and COPD, and is transitioning to a more U.S.-centric operational model [2][4]. Development Highlights - The Phase 2 Seabreeze STAT studies for asthma and COPD are currently recruiting patients, with topline data expected in the first half of 2026 [5]. - Positive data supporting rademikibart's efficacy and safety were presented at ATS 2025 and EAACI 2025, indicating its potential as a treatment for eosinophilic-driven type 2 asthma and COPD [4][5]. - A new drug application for rademikibart for atopic dermatitis has been submitted to China's NMPA by Simcere, the exclusive licensee in Greater China [4][6]. - The company plans to terminate its ADR program and directly list ordinary shares on Nasdaq to enhance institutional visibility and reduce costs [4][8]. - Jim Schoeneck, an industry veteran, has been appointed to the Board of Directors, bringing expertise in product development and commercialization [4][8]. Financial Results - As of June 30, 2025, the company reported cash, cash equivalents, and short-term investments of $71.8 million, sufficient to fund operations into 2027 [6][18]. - License and collaboration revenues for the three and six months ended June 30, 2025, were $48,000, a significant decrease from $24.1 million in the same periods of 2024 [6][16]. - Research and development expenses increased to $8.8 million for the three months ended June 30, 2025, compared to $5.3 million in 2024, primarily due to costs associated with rademikibart's development [6][16]. - The net loss for the three months ended June 30, 2025, was $12.9 million, or $0.23 per share, compared to a net income of $14.8 million, or $0.27 per share, in the same period of 2024 [6][16].

Core Insights - Connect Biopharma has expanded its Board of Directors from six to seven members with the appointment of Jim Schoeneck, who brings over 40 years of experience in drug development and commercialization [1][2][3] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and chronic obstructive pulmonary disease (COPD) [4] - 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 [4] Leadership and Expertise - Jim Schoeneck's appointment is expected to enhance the company's strategic and commercial capabilities, particularly in advancing the development and commercialization of rademikibart [2][3] - Schoeneck has held leadership positions in various biotech firms and has a strong background in guiding companies through significant transformations [3] Product Development - Rademikibart is positioned to address the needs of millions of patients with asthma or COPD who experience acute exacerbations annually [2] - The company anticipates clinical data from its Phase 2 Seabreeze STAT studies in the first half of 2026 [2]