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Connect Biopharma (NasdaqGM:CNTB) FY Conference Transcript
2026-02-26 20:42
Summary of Conference Call on Connect's Rademikibart Company Overview - **Company**: Connect - **Industry**: Biopharmaceuticals - **Focus**: Development of rademikibart, a next-generation monoclonal antibody targeting IL-4 RA for asthma and COPD treatment [1][2] Core Insights and Arguments - **Product Development**: Rademikibart has completed studies in atopic dermatitis and chronic asthma, with ongoing Phase III studies in China for both indications [2][3] - **Market Opportunity**: There is a significant global market for asthma and COPD, with approximately 40% of patients experiencing exacerbations annually, leading to millions of emergency visits [3][4] - **Unique Mechanism**: Rademikibart binds differently to IL-4 RA compared to existing treatments, resulting in a distinct clinical profile, including a decrease in eosinophil levels, which is beneficial for asthma patients [5][6][8] - **Rapid Onset of Action**: Clinical data indicates that rademikibart shows significant improvement in airway function within 24 hours, making it suitable for acute exacerbations [12][19] - **Comparison with Competitors**: Unlike Dupixent, which may increase eosinophil levels, rademikibart demonstrates a decrease, potentially reducing serious adverse events associated with eosinophilia [9][10][11] Additional Important Points - **Acute Treatment Studies**: Two studies are currently enrolling patients with acute exacerbations of asthma and COPD, with results expected mid-year [15][22] - **Market Research Findings**: There is a strong interest in rademikibart for acute treatment, with a projected peak sales opportunity of up to $5 billion for both acute and chronic indications [21][27] - **Regulatory Pathway**: The company is in discussions with the FDA regarding the Phase III program for acute treatment, which is expected to be shorter and less costly than traditional studies [28][29] - **Financial Position**: Connect has sufficient cash reserves to support operations until 2027, with significant milestones and royalties anticipated from partnerships [23][24] Conclusion Connect is positioned to capitalize on a substantial market opportunity with rademikibart, leveraging its unique mechanism of action and rapid onset of effect to address unmet needs in asthma and COPD treatment. The company is actively pursuing regulatory approvals and has a solid financial foundation to support its development efforts [22][23]
Connect Biopharma to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference
Globenewswire· 2026-02-19 14:00
SAN DIEGO, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma”, “Connect”, or the “Company”), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced that Company management will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on Thursday, February 26th, 2026 at 2:40 p.m. ET. The live webcast of the presentation may be accessed via the Investors section ...
Plus Therapeutics Spurs After-Hours Biotech Rally; Connect Biopharma And Elutia Also Advance
RTTNews· 2026-01-15 03:41
Group 1: Market Movements - Biotech and healthcare companies experienced notable movements in after-hours trading, with several small-cap firms showing strong gains due to corporate updates and investor momentum [1] Group 2: Company Updates - Plus Therapeutics, Inc. (PSTV) surged 8.40% to close at $0.31 after announcing a public offering priced at $0.38 per unit, aiming to raise approximately $15 million to support its precision diagnostics and radiopharmaceutical programs targeting central nervous system cancers [2] - Connect Biopharma Holdings Limited (CNTB) gained 5.96% to $2.31, recently highlighting new mechanism of action data for its lead candidate and outlining strategic priorities for 2026 [3] - ABVC BioPharma, Inc. (ABVC) added 3.37% to finish at $2.15, with the increase attributed to broader sector momentum rather than new corporate updates [3] - Modular Medical, Inc. (MODD) advanced 5.23% to $0.49, experiencing renewed buying interest despite no new news [4] - Traws Pharma, Inc. (TRAW) rose 2.82% to $1.82 after announcing the filing of a U.S. IND application for its potential oral therapy for influenza, supporting investor optimism around its pipeline [4] - Tiziana Life Sciences Ltd (TLSA) posted a 2.72% gain to $1.51 with no new developments reported [5] - Elutia Inc. (ELUT) climbed 6.64% to $0.90, following a corporate update outlining upcoming milestones for its next-generation antibiotic-eluting biomatrix program [5]
Connect Biopharma Highlights New Mechanism of Action Data for Rademikibart and Outlines Priorities for 2026
Globenewswire· 2026-01-12 13:00
Core Insights - Connect Biopharma is advancing rademikibart, a monoclonal antibody targeting IL-4Rα, with promising data supporting its best-in-class potential for treating asthma and COPD [1][6][7] Development Highlights - New data demonstrates a unique mechanism of action for rademikibart, indicating its ability to rapidly improve airway function by reversing the negative effects of IL-4 and IL-13 [2][5] - Recruitment is ongoing for a Phase 1b study of intravenously-administered rademikibart, with topline results expected in the first quarter of 2026 [1][5] - The Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD are also ongoing, with topline data anticipated in mid-2026 [1][5] Financial Guidance - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling $54.8 million, which are expected to fund operations into 2027 [4] Mechanism of Action - Rademikibart shows enhanced binding affinity to IL-4R, creating a more stable complex compared to dupilumab, leading to greater efficacy and safety [5] - In vitro studies indicate that rademikibart significantly improves responsiveness to β-agonist treatment in the presence of IL-4/IL-13, unlike dupilumab [5] Company Overview - Connect Biopharma is focused on transforming care for asthma and COPD, with rademikibart positioned as a next-generation treatment option [7] - The company has an exclusive licensing agreement with Simcere Pharmaceutical Co., Ltd. for rademikibart in Greater China, with potential milestone payments up to approximately $110 million [7]
Connect Biopharma (NasdaqGM:CNTB) Earnings Call Presentation
2026-01-12 12:00
Corporate Presentation for JPM January 2026 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 achiev ...
Connect Biopharma to Present at the 8th Annual Evercore Healthcare Conference
Globenewswire· 2025-11-24 14:00
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].
Connect Biopharma Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-12 14:00
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 / Briefing Transcript
2025-11-03 22:15
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]
Connect Biopharma Presents Data Supporting Rademikibart at the European Respiratory Society Congress 2025
Globenewswire· 2025-09-29 13:00
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]
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].