格隆汇11月18日｜中概股收盘涨幅居前的个股为：聪链集团涨32.38%，燃石医学涨30.15%，创智环球 科技涨20.7%，康乃德生物涨17.45%，CTRL Group涨17.02%。(格隆汇) | 代码 | 名称 | 最新价 | 涨跌幅 √ | 涨跌额 | 成交额 | | --- | --- | --- | --- | --- | --- | | ICG | 聪链集团 | 1.390 | 32.38% | +0.340 | 289.59万 | | BNR | 燃石医学 | 15.280 | 30.15% | +3.540 | 249.65万 | | CGTL | 创智环球科技 | 0.8086 | 20.70% | +0.1387 | 1269.6万 | | CNTB | 康乃德生物 | 2.490 | 17.45% | +0.370 | 541.73万 | | MCTR | CTRL Group | 1.1000 | 17.02% | +0.1600 | 14.21万 | ...

Revenue Performance - License and collaboration revenues for Q3 2025 were $16,000, a significant decrease from $1.2 million in Q3 2024, and for the nine months ended September 30, 2025, revenues were $64,000 compared to $25.3 million for the same period in 2024[106]. Expenses - Research and development expenses for Q3 2025 totaled $11.1 million, up from $9.0 million in Q3 2024, and for the nine months ended September 30, 2025, expenses were $26.5 million compared to $23.0 million in 2024, primarily due to increased costs related to rademikibart development[107]. - General and administrative expenses for Q3 2025 were $6.6 million, compared to $6.1 million in Q3 2024, and for the nine months ended September 30, 2025, expenses were $16.1 million versus $15.1 million in 2024, driven by increased professional fees[108]. Net Loss - 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; for the nine months ended September 30, 2025, the net loss was $40.4 million, or $0.73 per share, compared to $6.7 million, or $0.12 per share, in 2024[112]. Cash Position - Cash, cash equivalents, and short-term investments as of September 30, 2025, were $54.8 million, which management believes will be sufficient to meet anticipated cash requirements for at least one year[111]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $40.0 million, an increase from $21.3 million in the same period in 2024, primarily due to a higher net loss[113]. - Net cash used in investing activities for the nine months ended September 30, 2025, was $1.2 million, a decrease from net cash provided of $12.3 million in 2024, mainly due to net purchases of short-term investments[114]. Clinical Trials and Development - The company initiated two Phase 2 clinical trials for rademikibart during Q2 2025, with topline data expected in the first half of 2026[100]. Corporate Developments - The company relocated its corporate headquarters in February 2025, with a lease for 6,942 square feet of office space, with annual rent starting at $0.3 million[117]. - The company plans to fund its short-term purchase obligations with current financial resources, which mainly consist of non-cancellable commitments with third-party manufacturers[119]. Capital and Funding Challenges - The company faces challenges in raising capital due to unfavorable global economic and political conditions[124]. - Research and development costs are impacted by supply chain constraints and geopolitical conflicts, potentially stressing working capital resources[125]. - The company may need to delay, reduce, or eliminate research and development programs if capital cannot be raised on attractive terms[125]. Costs and Future Activities - The costs associated with drug discovery, clinical trials, and regulatory reviews are significant and ongoing[124]. - The company is evaluating third-party manufacturers and suppliers, which adds to manufacturing process development costs[124]. - Future activities related to product sales, marketing, and distribution will incur additional costs once marketing approvals are obtained[124]. Intellectual Property and Collaborations - The company is focused on maintaining and enforcing its intellectual property rights, which involves substantial costs[124]. - The success of ongoing collaborations and the ability to establish new ones on favorable terms is critical for future growth[124]. - The company is assessing the terms of current and future license agreements and collaborations[124]. Operational Challenges - The impact of tariffs and shifting U.S. federal government policies may further complicate the company's operational landscape[125].

Financial Performance - License and collaboration revenues for Q3 2025 were $16,000, a decrease of 98.7% compared to $1.2 million in Q3 2024[10] - 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[14] - Total operating expenses for Q3 2025 were $17.7 million, compared to $15.1 million in Q3 2024, reflecting a 17.4% increase[20] Expenses - Research and development expenses for Q3 2025 were $11.1 million, up 23.3% from $9.0 million in Q3 2024[14] - General and administrative expenses for Q3 2025 were $6.6 million, an increase of 8.7% compared to $6.1 million in Q3 2024[14] Assets and Equity - Total assets as of September 30, 2025, were $67.4 million, down from $101.3 million as of December 31, 2024[22] - Total shareholders' equity decreased to $55.4 million as of September 30, 2025, from $92.2 million at the end of 2024[22] Future Outlook - Cash, cash equivalents, and short-term investments were $54.8 million as of September 30, 2025, expected to fund operations into 2027[10] - The company expects to report topline data from ongoing Phase 2 Seabreeze STAT studies in the first half of 2026[5] - Simcere submitted a New Drug Application for rademikibart for atopic dermatitis, with potential milestone payments of up to $110 million[10]

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]

Core Points - Connect Biopharma is presenting a webinar led by CEO Barry Quart, focusing on the company's operations and future prospects [1] - The company trades on NASDAQ under the ticker symbol CNTB [1] Forward-Looking Statements - The presentation may include forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, which pertain to future financial and operational results [2] - These statements reflect management's expectations, beliefs, goals, plans, or prospects and are subject to risks and uncertainties [3]

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]

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]

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].

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].