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Connect Biopharma Presents Data Supporting Rademikibart at the European Respiratory Society Congress 2025
Globenewswire· 2025-09-29 13:00
– Rademikibart demonstrated rapid and significant improvement in lung function and asthma control in patients, with greatest improvements observed in those with elevated baseline levels of key type 2 inflammatory markers – – Significant reduction in annualized exacerbations observed in patients with one or more elevated type 2 inflammatory markers at baseline – – Data supports ongoing Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies i ...
Connect Biopharma Holdings (NasdaqGM:CNTB) FY Conference Transcript
2025-09-08 14:32
Summary of Connect Biopharma Holdings FY Conference Call Company Overview - Connect Biopharma is a China-based biotech company that has transitioned to a U.S.-centric model, focusing on monoclonal antibody discovery and development, particularly rademikibart, a second-generation Dupixent targeting IL-4 receptor alpha [2][3] Clinical Development Focus - Rademikibart is being developed for acute exacerbations of asthma, differentiating from traditional chronic-only strategies [4] - The drug shows a rapid onset of effect, with over 70% of FEV1 benefit achieved within 24 hours, which is significantly faster than existing biologics [6][7] - There is a substantial unmet need for improved treatments for acute exacerbations, with millions of patients affected annually [5] Competitive Landscape - Current biologics for asthma do not have indications for acute exacerbations, presenting a unique market opportunity for rademikibart [8] - Rademikibart has a differentiated safety profile, showing no increase in eosinophils, unlike Dupixent, which can lead to serious adverse events [9][10] Commercial Strategy - The acute indication is seen as a gateway to chronic use, with market research indicating a strong preference among clinicians to continue using rademikibart if patients respond well acutely [12][13] - The company plans to leverage the acute indication to penetrate the crowded chronic asthma market, where ongoing treatment is required [13] Clinical Trials and Regulatory Strategy - Two phase 2 studies are currently underway, with top-line results expected in the first half of 2026 [15] - The primary endpoint for these studies is treatment failure, defined as patients returning for medical care within four weeks, with an expected failure rate of about 45% based on similar studies [17][18] - The company aims to use data from these trials to support regulatory discussions for an acute indication with the FDA [18] Financial Position - Connect Biopharma reported $72 million in cash at the end of Q2 2025, which, along with expected milestones from its partnership in China, is projected to sustain operations into 2027 [21] Key Takeaways - Rademikibart's rapid onset of action and unique safety profile position it favorably against existing treatments - The acute indication strategy is critical for market entry and potential chronic use - Strong financial backing and a clear regulatory pathway support the company's development plans [12][21]
Connect Biopharma Announces Two Presentations at the European Respiratory Society (ERS) Congress 2025
Globenewswire· 2025-09-04 12:00
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].
Connect Biopharma Holdings (CNTB) 2025 Conference Transcript
2025-09-03 20:20
Summary of Connect Biopharma Holdings (CNTB) Conference Call Company Overview - Connect Biopharma Holdings is a biotech company that transitioned from a Chinese-based organization to a US-centric one, with a focus on monoclonal antibody technology and the development of its lead product, Radimigabart [5][4]. Product Development - Radimigabart is positioned as a second-generation DUPIXENT, targeting IL-4 receptor alpha, with initial focus on atopic dermatitis and asthma, now shifted to respiratory diseases like asthma and COPD [6][10]. - The drug has shown rapid onset of effect in previous studies, particularly in treating acute exacerbations of asthma and COPD [7][13]. - Radimigabart is expected to have a longer half-life and a differentiated safety profile compared to DUPIXENT, which has adverse effects like increased eosinophils [8][10]. Market Opportunity - Approximately 4 million patients annually experience acute exacerbations of asthma and COPD, with no new drug approvals for this condition in over 30 years [15][16]. - Current standard treatments include prednisone and bronchodilators, indicating a significant unmet need for effective acute treatment options [16]. Clinical Trials - Two parallel Phase II trials are underway, targeting patients with acute exacerbations of asthma and COPD, with the goal of reducing treatment failures by at least 50% [19][20]. - The studies are designed to evaluate the efficacy of Radimigabart in improving airway function and reducing the incidence of subsequent exacerbations [27][20]. Financial Position - As of the end of Q2, the company reported approximately $72 million, sufficient to complete current trials [49]. - The company anticipates key catalysts in the upcoming year, including data from a Phase I IV study and the Phase II trials [49]. Future Plans - The company plans to develop Radimigabart for both acute and chronic settings, responding to clinician interest in maintaining patients on the same drug post-acute treatment [39][40]. - The anticipated costs for Phase III studies are estimated to be around $12 million for acute studies and $5-7 million for chronic studies [42][43]. Key Takeaways - Connect Biopharma is strategically shifting its focus to the US market and developing Radimigabart as a novel treatment for acute respiratory conditions. - The company is addressing a significant market gap with its innovative approach to treating acute exacerbations, which has not seen new drug development in decades. - Financially, the company is positioned to support its ongoing clinical trials and is optimistic about upcoming data releases that could drive investor interest [49].
Connect Biopharma Completes Termination of its American Depositary Receipt Program and Directly Lists its Ordinary Shares on Nasdaq
Globenewswire· 2025-09-03 12:00
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].
Connect Biopharma to Present at Two Upcoming Investor Conferences in September
GlobeNewswire News Room· 2025-08-27 13:00
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]
康乃德生物上涨5.06%,报1.818美元/股,总市值1.01亿美元
Jin Rong Jie· 2025-08-22 14:33
8月22日,康乃德生物(CNTB)盘中上涨5.06%,截至22:16,报1.818美元/股,成交4.34万美元,总市值 1.01亿美元。 本文源自:金融界 作者:行情君 财务数据显示,截至2025年06月30日,康乃德生物收入总额4.8万美元,同比减少99.8%;归母净利 润-2317.1万美元,同比减少476.52%。 资料显示,康乃德生物医药控股有限公司是一家拥有临床阶段产品、全球化布局的生物医药公司,通过 自主研发的T细胞功能调节平台开发创新疗法,从而改善炎症性免疫疾病患者的生活品质。 ...
康乃德生物上涨2.31%,报1.77美元/股,总市值9862.73万美元
Jin Rong Jie· 2025-08-22 13:52
Core Viewpoint - Conformative Biopharma (CNTB) has experienced a significant decline in revenue and net profit, indicating potential challenges in its financial performance and market position [1] Financial Performance - As of June 30, 2025, Conformative Biopharma reported total revenue of $48,000, representing a year-over-year decrease of 99.8% [1] - The company recorded a net loss attributable to shareholders of $23.171 million, which is a staggering year-over-year decline of 476.52% [1] Market Activity - On August 22, CNTB opened with a 2.31% increase, trading at $1.77 per share, with a total trading volume of $352.0 [1] - The company's total market capitalization stands at approximately $98.6273 million [1] Company Overview - Conformative Biopharma is a biopharmaceutical company in the clinical stage, focusing on developing innovative therapies through its proprietary T-cell functional modulation platform to improve the quality of life for patients with inflammatory immune diseases [1]
康乃德生物上涨3.22%,报1.724美元/股,总市值9605.30万美元
Jin Rong Jie· 2025-08-21 14:08
8月21日,康乃德生物(CNTB)盘中上涨3.22%,截至21:59,报1.724美元/股,成交2.37万美元,总市值 9605.30万美元。 财务数据显示,截至2025年06月30日,康乃德生物收入总额4.8万美元,同比减少99.8%;归母净利 润-2317.1万美元,同比减少476.52%。 本文源自:金融界 大事提醒: 作者:行情君 8月13日,康乃德生物2025财年中报归属股东应占溢利-2317万美元,同比下降476.52%,基本每股收 益-0.42美元。 资料显示,康乃德生物医药控股有限公司是一家拥有临床阶段产品、全球化布局的生物医药公司,通过 自主研发的T细胞功能调节平台开发创新疗法,从而改善炎症性免疫疾病患者的生活品质。 ...
Connect Biopharma Teams with Ickey Woods and the Jovante Woods Foundation to Expand Asthma Education Program Nationwide
Globenewswire· 2025-08-14 12:00
"Asthma has been in our family for as long as I can remember," said Ickey, who is the Foundation's chairman. "But the day I will never forget is August 14, 2010, when I learned that asthma, particularly acute attacks and their complications, can kill. Jovante was a shining, always positive family member who excelled at school and at sports. When Chandra and I began to process what happened, we knew that more needed to be done to help other families understand the severity of asthma and prevent another trage ...