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Connect Biopharma Holdings Limited reports clinical and corporate developments for a clinical-stage biopharmaceutical company focused on inflammatory diseases. Its principal program is rademikibart, an antibody designed to target interleukin-4-receptor alpha, with company updates centered on asthma, chronic obstructive pulmonary disease and moderate-to-severe atopic dermatitis.
Recurring news includes rademikibart clinical data, Seabreeze STAT asthma and COPD study updates, Data Monitoring Committee and regulatory-related disclosures, partner activity involving Simcere in China, financial results, financing activity, investor conference participation and governance matters.
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 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.
Connect Biopharma (Nasdaq: CNTB), a clinical-stage biopharmaceutical company specializing in Asthma and COPD treatments, has announced its participation in two major investor conferences in March 2025.
The company will present at the Leerink Partners Global Biopharma Conference on March 12, 2025, at 1:40 p.m. ET, and the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025, at 2:30 p.m. ET. Both presentations will be in a fireside chat format.
Live webcasts will be available on Connect's investor relations website, with archived replays accessible for approximately 90 days after the events.
Connect Biopharma Holdings (Nasdaq: CNTB), a global clinical-stage biopharmaceutical company, has announced its participation in the Cantor Fitzgerald Global Healthcare Conference 2024. The event will take place from September 17th to 19th in New York, NY. Connect Biopharma's management team will deliver a company presentation on September 19, 2024, at 9:10am ET at the InterContinental New York Barclay Hotel.
The presentation will be accessible via webcast, and the management team will also host one-on-one meetings during the conference. Investors interested in scheduling meetings should contact their Cantor Fitzgerald representative. Connect Biopharma will provide links to access the company presentation on their website's Investor section under Presentations & Events.
Connect Biopharma (CNTB) reported its first half 2024 financial results and provided a business update. Key highlights include:
1. New U.S.-based leadership appointed: Barry Quart as CEO and David Szekeres as President.
2. Evaluating future clinical development strategy for rademikibart.
3. Significantly reducing presence in China as part of U.S.-centric transformation.
4. Cash and cash equivalents of $110.2 million, expected to support operations into at least H1 2027.
5. Revenue of $24.1 million for H1 2024.
6. Net income of $7.6 million for H1 2024, compared to a net loss of $30.5 million in H1 2023.
7. R&D expenses decreased to $13.3 million from $26.6 million in H1 2023.