– Expect to report topline data from both Phase 2 Seabreeze STAT studies mid-2026,
– $20.2 million private placement financing closed on March 31, 2026,
SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today reported financial results for the three months ended March 31, 2026, and provided a business update.
"We have had a strong start to the year as we continue to build upon the body of preclinical and clinical evidence supporting the potential of rademikibart to treat acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD), each a significant commercial opportunity where no biologics are currently approved or being developed," said Barry Quart, Chief Executive Officer of Connect Biopharma. "The recent data from our Phase 1 intravenous (IV) clinical pharmacology study for rademikibart are encouraging, demonstrating faster onset, lower dosing, and the potential for differentiated pricing in the hospital setting if approved. In addition, the recent independent data monitoring committee (DMC) review of the interim analysis of our Phase 2 Seabreeze STAT program gives us confidence that the studies are adequately powered. We currently remain on track to report topline results from both Seabreeze STAT studies mid-year."
Recent Highlights
Development Highlights
Recruitment of participants into the Phase 2 Seabreeze STAT asthma and COPD studies evaluating the safety and efficacy of rademikibart as an adjunct treatment for acute exacerbations is ongoing with topline data from both studies expected mid-2026. Following topline data, the Company plans to move quickly to meet with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program.
In April 2026, the Company announced that the independent DMC overseeing its Phase 2 Seabreeze STAT asthma and COPD studies reviewed the pre-specified interim analysis of efficacy data with no recommendation for change in the sample size and confirmed that it has no safety concerns based on a regular review of safety data.
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.
These data demonstrated that a single IV administration of rademikibart rapidly improved lung function as early as 15 minutes post-dosing, with clinically meaningful improvements in forced expiratory volume in one second (FEV1) generally maintained for up to four weeks. The rapid improvements in FEV1 demonstrated with IV rademikibart provide clinical evidence supporting the preclinical observations that rademikibart has a unique beneficial effect on bronchodilation.
In March 2026, results from a Phase 3 study of rademikibart in moderate-to-severe atopic dermatitis (AD) conducted by the Company's partner in China, Simcere Pharmaceutical Co., Ltd. (Simcere), were presented during a Late-Breaking Research session at the 2026 American Academy of Dermatology Annual Meeting. In this study, rademikibart achieved rapid, durable efficacy results across all key endpoints through 52 weeks, with near‑maximal responses achieved in ~90% of patients.
Corporate Highlights
On March 31, 2026, the Company completed its previously announced private placement with gross proceeds of $20.2 million and estimated net proceeds of $18.6 million. The private placement was led by the Company's largest current investor, Panacea Venture, with participation by other existing and new U.S.-based healthcare focused investors.
Financial Results for the Three Months Ended March 31, 2026
Cash and cash equivalents were $46.0 million as of March 31, 2026. Based on its current operating plan and projections, the Company expects that its cash and investments will be sufficient to fund operations into the second half of 2027.
License and collaboration revenues for the three months ended March 31, 2026 were $0.2 million related to the upfront license fee under the license agreement with Simcere. There were no license and collaboration revenues for the three months ended March 31, 2025. As a part of the license agreement, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones.
Research and development expense for the three months ended March 31, 2026 was $15.0 million, compared with $6.6 million for the same period in 2025. The increase in research and development expense was primarily due to an increase in rademikibart-related development costs, as a result of the initiation of the Phase 2 Seabreeze STAT asthma and COPD studies in May 2025.
General and administrative expense for the three months ended March 31, 2026 and 2025 was comparable at $4.7 million and $4.8 million, respectively.
Net loss for the three months ended March 31, 2026 was $19.4 million, or ($0.34) per share, compared with $10.3 million, or ($0.19) per share, for the same period in 2025.
About Rademikibart
Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis, asthma and COPD.
About Connect Biopharma
Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect has granted an exclusive license to Simcere Pharmaceutical Co., Ltd., for rademikibart in Greater China. Under the exclusive license and collaboration agreement, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China.
For more information visit www.connectbiopharma.com.
Forward-Looking Statements
This press release 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 cash balance and cash runway, financial guidance, future financial and operating results and related expectations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), statements regarding the timing or results of any interim analysis or interim, topline or preliminary data and whether such analysis or data is indicative of safety, efficacy, final trial results or likelihood of regulatory approval for our product candidates, planned or ...
