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 Report