-- Completed enrollment in Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD --
-- Expect to report topline results from both Phase 2 Seabreeze STAT studies in September 2026 --
-- Cash runway expected for a period of at least one year from the date of this release --
SAN DIEGO, Aug. 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 and six months ended June 30, 2026, and provided a business update.
"During the second quarter, we achieved important milestones with the completion of enrollment in both our Phase 2 Seabreeze STAT asthma and chronic obstructive pulmonary disease (COPD) studies. With topline results on track for September 2026, we are approaching a key inflection point with randomized, controlled data of rademikibart in patients experiencing an acute exacerbation," said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. "These studies are powered to evaluate the rate of treatment failure over 28 days and will also assess improvement in lung function, providing important insight into rademikibart's potential to benefit patients in this critical period after an exacerbation. Improved lung function and reduced treatment failure would support rademikibart's potential to address this significant unmet need for patients. Following these topline readouts, we plan to engage with the U.S. Food and Drug Administration (FDA) on a potential Phase 3 program. Supported by a cash runway expected to extend at least one year from the date of this release, we believe that we are well positioned to begin executing the next phase of development."
Recent Highlights
Development Highlights
-- Completed enrollment of the Phase 2 Seabreeze STAT asthma and COPD
studies evaluating the safety and efficacy of rademikibart as an adjunct
treatment for acute exacerbations. Topline data from both studies are
expected in September 2026, which should help determine a potential Phase
3 endpoint and sample size requirements.
-- Following topline results, the Company plans to meet with the FDA
to gain alignment on a Phase 3 program.
-- In August 2026, the Company initiated the Phase 2 Seabreeze STAT IV study,
an open-label, single-arm trial to evaluate intravenous (IV) rademikibart
as an add-on treatment for an acute exacerbation in 40 participants with
asthma or COPD with type 2 inflammation who require an urgent healthcare
visit, similar to the Phase 2 Seabreeze STAT asthma and COPD studies. The
Seabreeze STAT IV study is being conducted at a number of the same
clinical sites that completed the Seabreeze STAT asthma and COPD studies
and is designed to bridge 600 mg subcutaneous to 300 mg IV push
administration for treating acute exacerbations.
Financial Results for the Three and Six Months Ended June 30, 2026
-- Cash, cash equivalents and short-term investments were $31.5 million as
of June 30, 2026. Based on the Company's current operating plan and
projections, the Company believes that its cash, cash equivalents and
short-term investments will be sufficient to meet its anticipated cash
requirements for a period of at least one year from the date of this
release.
-- License and collaboration revenues related to the license agreement with
Simcere, under which Simcere has been granted exclusive rights to develop,
manufacture, and commercialize rademikibart for all indications in
Greater China, including mainland China, Hong Kong, Macau, and
Taiwan. License and collaboration revenues for the three and six months
ended June 30, 2026 were $2.8 million and $2.9 million, respectively, and
were primarily related to the achievement of a regulatory-based milestone,
net of development cost sharing. License and collaboration revenues for
both the three and six months ended June 30, 2025 were $48,000 for cost
reimbursements for clinical materials. As a part of the Simcere license
agreement, Connect is eligible to receive remaining milestone payments up
to an aggregate amount of approximately $99 million upon the achievement
of certain development, regulatory and commercial milestones.
-- Research and development expense for the three and six months ended June
30, 2026 was $16.3 million and $31.3 million, respectively, compared with
$8.8 million and $15.4 million, respectively, for the same periods 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 and six months ended
June 30, 2026 was $4.1 million and $8.8 million, respectively, compared
with $4.7 million and $9.5 million, respectively, for the same periods in
2025. The decrease in general and administrative expense was primarily
due to a decrease in professional fees, as the prior year periods
included one-time professional fees to support our efforts to become more
U.S.-centric, partially offset by an increase in non-cash, share-based
compensation expense.
-- Net loss for the three and six months ended June 30, 2026 was $17.3
million, or ($0.27) per share, and $36.7 million, or ($0.61) per share,
respectively, compared with $12.9 million, or ($0.23) per share, and
$23.2 million, or ($0.42) per share, respectively, for the same periods
in 2025.
About the Seabreeze STAT Asthma Study
Seabreeze STAT Asthma is a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in adult and adolescent participants with asthma and type 2 inflammation. The study has enrolled 160 participants globally with an eosinophil count of >=300 cells/<MU>L who have experienced an acute asthma exacerbation. Participants received either a single dose of rademikibart or placebo, administered subcutaneously. The primary endpoint is treatment failure rate over 28 days following an acute exacerbation. The key secondary endpoint is post-bronchodilator (post-BD) forced expiratory volume in one second (FEV(1) ) at Week 1. Other secondary endpoints include rate and time to new asthma exacerbations, change-from-baseline in asthma symptom score and nocturnal awakenings, post-BD FEV(1) at other timepoints, and incidence of adverse events for 8 weeks after dosing. For more information, please visit clinicaltrials.gov (identifier NCT06940141).
About the Seabreeze STAT COPD Study
Seabreeze STAT COPD is a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in participants with COPD and type 2 inflammation. The study has enrolled 159 participants globally with an eosinophil count of >=300 cells/<MU>L who have experienced an acute COPD exacerbation. Participants received either a single dose of rademikibart or placebo, administered subcutaneously. The primary endpoint is treatment failure rate over 28 days following an acute exacerbation. The key secondary endpoint is post-BD FEV(1) at Week 1. Other secondary endpoints include rate and time to new moderate and severe COPD exacerbations, change-from-baseline in clinical respiratory symptoms of COPD, post-BD FEV(1) , at other timepoints, and incidence of adverse events for 8 weeks after dosing. For more information, please visit clinicaltrials.gov (identifier NCT06940154).
About Rademikibart
Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4R<ALPHA>), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4R<ALPHA>, 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-4R<ALPHA>. 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 $99 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.
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