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].

"I am delighted to join Connect and have been impressed by the potential of rademikibart to transform the treatment paradigm for acute and chronic asthma and COPD patients. I look forward to working closely with the team to guide the Company's development efforts and chart a course for long-term commercial success," said Mr. Schoeneck. Mr. Schoeneck is an accomplished biotech leader with more than 40 years of experience developing and commercializing breakthrough medicines and guiding companies through sign ...

"The termination of our ADR program is a meaningful step in our evolution to becoming a U.S.-centric company. The conversion from ADRs to directly listing our ordinary shares on Nasdaq will better facilitate institutional visibility, eliminate ADR depositary fees, and strengthen our ability to expand our investor base," said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. "These changes, in conjunction with the progress we have made in our rapid Phase 2 clinical development program for rademik ...

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].