Connect Biopharma Holdings (CNTB) Stock News, Mar-May 2025

Connect Biopharma (NASDAQ: CNTB) presented promising data for rademikibart, their next-generation IL-4Rα antibody, at the ATS 2025 International Conference. The Phase 2b trial results showed significant improvements in lung function (FEV1) within 24 hours and reduced acute exacerbations in asthma patients. The drug demonstrated particular efficacy in patients with elevated eosinophil counts. Notably, rademikibart showed a superior safety profile compared to dupilumab, with approximately 30% decrease in eosinophil counts at Week 24, versus dupilumab's 50-120% increase. Structural analysis revealed rademikibart's optimized binding to IL-4Rα, with ~60° rotation compared to dupilumab, resulting in stronger and more stable interaction. Phase 2 studies in asthma and COPD are ongoing with topline data expected in 1H26.

Connect Biopharma (NASDAQ: CNTB) reported Q1 2025 financial results and significant progress in its clinical development programs. The company initiated two Phase 2 Seabreeze STAT studies evaluating rademikibart for acute exacerbations in both asthma and COPD, with topline data expected in 1H 2026. Published data showed promising results, with rademikibart demonstrating rapid improvements in lung function, particularly in eosinophilic-driven asthma patients showing a +420 mL difference from placebo. The company maintains a strong financial position with $84.0 million in cash and investments, providing runway into 2027. Q1 2025 resulted in a net loss of $10.3 million ($0.19 per share), compared to $8.7 million ($0.16 per share) in Q1 2024.

Connect Biopharma (NASDAQ: CNTB) has initiated its Phase 2 Seabreeze STAT COPD study to evaluate rademikibart as a treatment for acute exacerbations in COPD patients. The study, approved by the FDA, will assess the drug's safety and efficacy as an adjunct to standard care in patients with COPD and type 2 inflammation.

The trial will enroll approximately 160 participants globally with acute COPD exacerbation and eosinophil count ≥300 cells/μL. Participants will receive either a single dose of rademikibart or placebo. The primary endpoint will measure treatment failure rate over 28 days following acute exacerbation. The company expects to report topline data in 1H 2026.

This initiative follows promising post-hoc analysis from their Phase 2b Asthma study, showing potential benefits particularly in patients with elevated baseline eosinophil counts. Currently, about 1.3 million patients visit emergency departments annually for COPD flare-ups, with 50% experiencing treatment failure within four weeks.

Connect Biopharma (NASDAQ: CNTB) has initiated the Phase 2 Seabreeze STAT Asthma study to evaluate rademikibart as an adjunct treatment for acute asthma exacerbations. The study, approved by the FDA, will assess the drug's safety and efficacy in approximately 160 participants with asthma and type 2 inflammation. Previous Phase 2 trial results published in AJRCCM showed rademikibart's ability to improve lung function within 24 hours of administration, with sustained improvements through 24 weeks. The primary endpoint will measure treatment failure rate over 28 days following an acute exacerbation. The company expects to report topline data in 1H 2026 and plans to initiate a similar Phase 2 study in COPD patients. If successful, rademikibart could become the first biologic indicated for acute asthma exacerbations.

Connect Biopharma (NASDAQ: CNTB) has announced it will present four posters at the American Thoracic Society (ATS) 2025 International Conference in San Francisco from May 18-21, 2025. The presentations focus on their drug candidate rademikibart for treating moderate-to-severe asthma and COPD.

The presentations include studies on: rademikibart's efficacy in COPD-like patients, its effect on blood eosinophil counts, structural properties of the drug's IL-4Rα complex, and rapid improvement in lung function for asthma patients. The company plans to initiate parallel Phase 2 trials in Q2 2025.

Key presenters include Dr. Michael Wechsler and Dr. Raúl Collazo, with sessions covering topics such as asthma and COPD clinical studies, biomarkers in lung disease, and treatment modalities in inflammatory lung diseases.

Connect Biopharma (NASDAQ: CNTB) has received positive feedback from the FDA regarding its Type C meeting for rademikibart, advancing plans for two parallel Phase 2 trials in Q2 2025. The trials will evaluate the drug's effectiveness in patients with moderate-to-severe asthma or COPD experiencing acute exacerbations.

Each trial will enroll approximately 160 patients with eosinophils ≥300 cells/µL, testing a single 600 mg subcutaneous dose of rademikibart over 28 days following an acute exacerbation. Previous Phase 2 studies showed the drug was well-tolerated and improved pulmonary function within 24 hours.

The company expects to report trial data in H1 2026 and maintains a cash runway into 2027. Currently, about 45% of patients receiving standard care experience treatment failure within 28 days post-exacerbation, highlighting a significant unmet medical need.

Connect Biopharma (NASDAQ: CNTB) has published positive results from its global Phase 2 trial of rademikibart for moderate-to-severe uncontrolled asthma in the American Journal of Respiratory and Critical Care Medicine. The study involved 322 adult patients randomized to receive either 150mg or 300mg of rademikibart or placebo for 24 weeks.

Key findings include:

• Significant improvement in lung function starting week 1 and sustained through 24 weeks
• In patients with ≥300 eosinophils/µL, the mean difference from placebo in FEV1 was +420 mL at Week 24
• Fewer acute exacerbations in treatment groups (24 events in 214 patients) versus placebo (26 events in 108 patients)
• No serious treatment-related adverse events reported

Based on these results, the FDA has agreed to advance rademikibart into Phase 3 trials for asthma maintenance treatment.

Connect Biopharma (NASDAQ: CNTB) reported its 2024 financial results, marking a transformative year with key leadership appointments and strategic developments. The company unveiled plans for parallel Phase 2 trials of rademikibart for acute asthma and COPD exacerbations, scheduled to begin in Q2 2025 with data expected in 2H 2026.

Financial highlights include:

• Cash position of $93.7 million as of December 31, 2024, with runway into 2027
• Revenue of $26.0 million for 2024
• Research and Development expenses decreased to $29.3 million from $53.0 million in 2023
• Net loss improved to $15.6 million ($0.28 per share) compared to $62.1 million ($1.13 per share) in 2023

The company has strengthened its U.S. presence by relocating headquarters to San Diego and transitioning to U.S.-based manufacturing and accounting operations.

Connect Biopharma (NASDAQ: CNTB) has received a deficiency notice from Nasdaq dated March 24, 2025, regarding non-compliance with the minimum bid price requirement. The company's American Depositary Shares (ADSs) have traded below the required $1.00 per share for 30 consecutive business days.

The company has been granted an initial 180-day period until September 22, 2025, to regain compliance by maintaining a closing bid price of at least $1.00 for a minimum of ten consecutive business days. If unsuccessful, CNTB may be eligible for an additional 180-day compliance period by transferring to the Nasdaq Capital Market and meeting specific listing requirements.

The notice has no immediate impact on CNTB's listing status, and shares continue trading on the Nasdaq Global Market. However, failure to meet compliance requirements could result in delisting, subject to appeal.