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Connect Biopharma Holdings (CNTB) Earnings Call Presentation
2025-06-19 11:38
June 2025 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 achieve a differentiated, competitive, o ...
Connect Biopharma Presents Data Supporting Rademikibart at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress
Globenewswire· 2025-06-13 13:00
– Rademikibart significantly improved lung function and asthma control in patients with eosinophilic-driven type 2 asthma – – Rademikibart reduced annualized exacerbations in patients with eosinophilic-driven type 2 asthma – – Data supports ongoing Phase 2 acute exacerbation studies in asthma and COPD; expect to report topline data from both studies in 1H26 – SAN DIEGO, June 13, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a clinical-stag ...
Connect Biopharma Holdings (CNTB) 2025 Conference Transcript
2025-06-05 13:10
Summary of Connect Biopharma Holdings (CNTB) Conference Call Company Overview - Connect Biopharma Holdings (CNTB) is undergoing a transformation referred to as "Connect 2.0" with a new management team focused on drug development and regulatory activities [3][4] - The lead program is retimicobart, a next-generation IL-4 receptor alpha monoclonal antibody, positioned as a second-generation alternative to Dupixent [3][4] Core Product Insights - Retimicobart shows a significant improvement in FEV1, a key measure of airway function, with one of the largest improvements seen in biologics for asthma trials [4][5] - The onset of effect occurs within 24 hours, allowing for evaluation in acute settings rather than traditional chronic studies [5][6] - There are over 1 million asthma and 1.3 million COPD patients visiting ERs annually due to acute exacerbations, indicating a substantial market opportunity [5][9] Market Opportunity - Current biologics do not have indications for acute exacerbations, creating a "white space" for retimicobart [6][22] - Market research indicates that the novel acute indication could drive significant chronic use, with a preference share of 40%-45% for acute use and 75% for chronic treatment following acute administration [10][22] - The product is expected to have a multi-billion dollar commercial potential with both acute and chronic indications [23][30] Clinical Development - Two parallel trials (cbreeze stat) for asthma and COPD are underway, with data expected in the first half of the following year [15][16] - The acute studies are designed to assess improvements in FEV1 and reduce hospitalization rates, with a focus on cost savings for hospitals [16][30] - The company has received FDA clearance to move into phase three for atopic dermatitis, pending completion of a partner study in China [21][24] Financial Considerations - Development costs for acute indications are estimated at around $50 million, while combined acute and chronic programs could reach $200 million [29] - The company has sufficient cash reserves to execute its plans into 2027, allowing for strategic development without immediate dilution [24][30] Regulatory Landscape - There is no precedent for acute indications in the biologics market, presenting both challenges and opportunities for Connect Biopharma [33] - Extensive discussions with the FDA have provided insights into potential pathways for approval [33] Conclusion - Connect Biopharma is positioned to leverage its innovative product retimicobart in a largely untapped market for acute asthma and COPD treatment, with a strong focus on rapid clinical development and strategic partnerships to enhance its market presence [22][30]
Connect Biopharma Holdings (CNTB) Conference Transcript
2025-06-04 14:00
Summary of Connect Biopharma Holdings (CNTB) Conference Call - June 04, 2025 Company Overview - Connect Biopharma is undergoing a transformation referred to as "Connect 2.0" with a new management team experienced in drug development and public biotech operations [2][22] - The company is focusing on retimicobart, a second-generation IL-4 receptor alpha monoclonal antibody, targeting asthma and COPD [2][3] Key Developments - Two parallel Phase II studies have been initiated for retimicobart, specifically addressing acute exacerbations in asthma and COPD [2][3] - The company has sufficient cash to fund these studies, with a runway extending into 2027 [3][22] - The headquarters has been relocated to San Diego, reducing the company's footprint in China to become more U.S.-centric [3] Market Opportunity - Market research indicates that having an acute indication for retimicobart could create a market opportunity exceeding $5 billion globally [4] - There are over 2 million emergency department visits annually in the U.S. for asthma and COPD exacerbations, highlighting a significant patient population [5][8] - Current treatments for acute exacerbations are largely unchanged from two decades ago, primarily involving steroids and bronchodilators, which take hours to stabilize patients [24][25] Product Differentiation - Retimicobart is positioned uniquely as no other biologic currently has an acute indication for asthma or COPD [4][6] - The product has shown rapid onset of action, with over 70% of the benefit observed within 24 hours of administration [5][13] - The company aims to reduce emergency room visits and hospitalizations, potentially shortening hospital stays and providing cost savings for healthcare systems [28][29] Clinical Data - Previous Phase II studies indicated significant improvements in respiratory function (FEV1) with retimicobart, showing an average improvement of 420 ml at 24 weeks [4][12] - The product demonstrated a rapid improvement in airway function, with 73% of the benefit observed within 24 hours [13][16] - The company has a differentiated safety profile compared to Dupixent, particularly in patients with high eosinophil counts [17][20] Financial Position - As of March, the company reported a cash position of nearly $84 million, sufficient to fund ongoing Phase II programs [22] - The exclusivity for retimicobart extends well into 2040, providing a long-term competitive advantage [20] Future Catalysts - Results from the two Phase II trials are expected in the first half of next year, with ongoing preclinical data supporting the product's differentiation [33][32] - The company is also developing a separate product for hospital use to enhance economic viability and fit within existing reimbursement structures [30] Conclusion - Connect Biopharma is strategically positioned to address significant unmet needs in the treatment of acute asthma and COPD exacerbations, with a strong focus on rapid onset of action and cost-effectiveness for healthcare providers [28][29][30]
Connect Biopharma Announces Two Oral Presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress
Globenewswire· 2025-06-03 13:00
SAN DIEGO, June 03, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced two oral presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually. The presentation details a ...
Connect Biopharma to Present at Two Upcoming Investor Conferences in June
Globenewswire· 2025-05-28 13:00
SAN DIEGO, May 28, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) ("Connect Biopharma" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced that company management will participate in the following upcoming conferences: Noble Capital Markets Virtual Conference Format: Corporate Presentation Date: Wednesday, June 4, 2025 Time: 9:00 a.m. ET Jefferies H ...
Connect Biopharma Presents Data Supporting Development of Rademikibart at the American Thoracic Society (ATS) 2025 International Conference
Globenewswire· 2025-05-20 13:00
– Rademikibart significantly improved airway function, as measured by FEV1 , within a day and significantly reduced acute exacerbations in patients with inflammation-mediated chronic asthma strongly supporting ongoing Phase 2 acute exacerbation studies in asthma and COPD which are expected to report topline data in 1H26 – – New preclinical data highlights differentiated structural and molecular dynamics of rademikibart with enhanced interleukin-4 receptor alpha (IL-4Rα) inhibition compared to dupilumab prov ...
nect Biopharma (CNTB) - 2025 Q1 - Quarterly Report
2025-05-15 13:08
Financial Performance - For the three months ended March 31, 2025, research and development expense was $6.6 million, a decrease of 23.4% from $8.7 million in the same period in 2024[103]. - General and administrative expense increased to $4.8 million for the three months ended March 31, 2025, compared to $4.0 million for the same period in 2024, primarily due to increased professional fees and personnel costs[104]. - The net loss for the three months ended March 31, 2025, was $10.3 million, or $0.19 per share, compared to a net loss of $8.7 million, or $0.16 per share, for the same period in 2024[108]. - Cash, cash equivalents, and short-term investments totaled $84.0 million as of March 31, 2025, sufficient to meet anticipated cash requirements for at least one year[107]. - Net cash used in operating activities for the three months ended March 31, 2025, was $10.0 million, significantly higher than $0.6 million for the same period in 2024[109]. - Net cash used in investing activities for the three months ended March 31, 2025, was $20.6 million, compared to net cash provided by investing activities of $9.3 million for the same period in 2024[110]. Clinical Trials and Product Development - The company announced positive data from a Phase 2 trial of rademikibart, indicating its potential as a treatment for asthma with rapid onset of action and significant reductions in exacerbation rates[96]. - The first patient was enrolled in the Phase 2 clinical trial for rademikibart in patients experiencing acute exacerbations of asthma or COPD, with primary endpoints focused on treatment failure over 28 days[98][99]. Corporate Changes and Challenges - The company relocated its corporate headquarters to a new location in San Diego, California, with an operating lease that increases from $0.3 million to $0.4 million over the lease term[113]. - The company faces potential challenges from high inflation rates and economic uncertainty, which may impact operating costs and access to financing[119]. - The company faces challenges in raising capital due to unfavorable global economic and political conditions, which may impact research and development programs[120]. - The company is experiencing stress on working capital resources due to worsening global macroeconomic conditions and wage increases[121]. - Future commercialization efforts may be delayed or reduced if capital cannot be raised on attractive terms[121]. Costs and Strategic Considerations - Costs associated with drug discovery, preclinical development, and clinical trials for product candidates are significant and ongoing[120]. - Regulatory review costs and the expenses related to marketing approvals for successful clinical trials are critical factors for future product launches[120]. - The costs of maintaining and enforcing intellectual property rights are a significant consideration for the company[120]. - The company is focused on the costs of future activities related to product sales, medical affairs, and distribution for approved product candidates[120]. - The company is evaluating third-party manufacturers and suppliers, which adds to the overall manufacturing process development costs[120]. - Ongoing collaborations and the ability to establish new partnerships on favorable terms are essential for the company's growth strategy[120]. - The terms of current and future license agreements and collaborations will impact the company's strategic direction[120].
nect Biopharma (CNTB) - 2025 Q1 - Quarterly Results
2025-05-15 13:03
Financial Performance - For the three months ended March 31, 2025, Connect Biopharma reported a net loss of $10.3 million, or $0.19 per share, compared to a net loss of $8.7 million, or $0.16 per share, for the same period in 2024[7]. - Total operating expenses for the three months ended March 31, 2025, were $11.4 million, compared to $12.6 million for the same period in 2024[14]. Cash and Investments - Cash, cash equivalents, and short-term investments were $84.0 million as of March 31, 2025, expected to fund operations into 2027[7]. - Total assets as of March 31, 2025, were $92.7 million, down from $101.3 million as of December 31, 2024[16]. Research and Development - Research and Development expense decreased to $6.6 million for the three months ended March 31, 2025, from $8.7 million in the same period in 2024, a reduction of $2.1 million[7]. - Connect Biopharma initiated Phase 2 Seabreeze STAT studies for rademikibart as an adjunct treatment for acute exacerbations in asthma and COPD, with topline data expected in 1H 2026[5]. - Rademikibart demonstrated a mean difference from placebo in forced expiratory volume of +420 mL in patients with eosinophilic-driven asthma after 24 weeks, one of the largest increases reported for a biologic[7]. - The company completed a positive Type C meeting with the FDA, aligning on the Phase 2 Seabreeze study protocols[7]. - Four posters were accepted for presentation at the ATS 2025 International Conference, supporting the development of rademikibart for patients with moderate-to-severe asthma or COPD[7]. General and Administrative Expenses - General and Administrative expense increased to $4.8 million for the three months ended March 31, 2025, compared to $4.0 million for the same period in 2024, an increase of $0.8 million[7].
Connect Biopharma Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-15 13:00
Initiated Phase 2 Seabreeze STAT Asthma and Seabreeze STAT COPD studies evaluating rademikibart as an adjunct treatment for acute exacerbations in Asthma and COPD in May 2025; topline data expected in 1H 2026 Published positive data from its global Phase 2 study supporting potential of rademikibart as a novel biologic treatment for patients with asthma and Type 2 inflammation Strong balance sheet with cash runway into 2027 through key clinical catalysts SAN DIEGO, May 15, 2025 (GLOBE NEWSWIRE) -- Connect Bi ...