Connect Biopharma Reports Increased Net Loss and Advances Rademikibart Trials

Connect Biopharma Holdings Limited, a clinical-stage biopharmaceutical company, has voluntarily elected to file annual reports on Form 10-K with the U.S. Securities and Exchange Commission (SEC). The company focuses on transforming care for asthma and chronic obstructive pulmonary disease (COPD) and is advancing rademikibart, an antibody targeting interleukin-4-receptor alpha (IL-4Rα). As of December 31, 2025, the company held $44.3 million in cash, cash equivalents, and short-term investments. In March 2026, Connect Biopharma entered into a private placement agreement expected to yield net proceeds of $18.6 million.

For the year ended December 31, 2025, Connect Biopharma reported license and collaboration revenues of $64,000, primarily from cost reimbursements related to the Simcere License Agreement. This is a significant decrease compared to the $26.0 million reported for the year ended December 31, 2024, which included an upfront license fee and milestone payments. Research and development expenses increased to $37.8 million in 2025 from $29.3 million in 2024, driven by the initiation of Phase 2 clinical trials for rademikibart in acute exacerbations of asthma and COPD. General and administrative expenses also saw a slight increase, rising to $20.3 million in 2025 from $19.2 million in the previous year, mainly due to professional fees associated with becoming more U.S.-centric.

The company's net loss for 2025 was $55.5 million, a substantial increase from the $15.6 million loss reported in 2024. This increase was primarily due to the decrease in license and collaboration revenues and the increase in research and development expenses. Other income, net, decreased from $7.0 million in 2024 to $2.8 million in 2025, mainly due to lower government subsidies and interest income. As of December 31, 2025, the company's accumulated deficit was $400.8 million.

Key operational developments include the initiation of Phase 2 trials for rademikibart in acute asthma and COPD exacerbations, and positive topline data from a Phase 1 clinical pharmacology study of IV rademikibart. In March 2026, the company announced positive topline data from its Phase 1 clinical pharmacology study of IV rademikibart in patients with stable asthma or COPD. Rademikibart administered as a single 300 mg 2-minute IV push to asthma and COPD patients produced rapid improvement in FEV1 with many patients experiencing improvements in airway function of ≥200 mL as early as 15 minutes post-dosing. The rapid improvement in FEV1 demonstrated with IV rademikibart in this study provides clinical confirmation of preclinical observations that rademikibart has a unique beneficial effect on bronchodilation. Mean FEV1 improvements of ~200 - 400 mL were maintained through Day 29 in asthma and COPD patients. Rademikibart was generally well-tolerated in asthma and COPD patients.

Looking ahead, Connect Biopharma anticipates that its existing cash, cash equivalents, and short-term investments, along with the net proceeds from the March 2026 private placement, will be sufficient to fund operations for at least one year. The company expects research and development expenses to increase in 2026 as it continues to advance its clinical programs, particularly the Phase 2 trials for rademikibart. Topline data from these Phase 2 studies are expected in mid-2026. The company's long-term success is contingent upon the successful development, regulatory approval, and commercialization of rademikibart.