-- Released positive topline data from Phase 1 study of IV rademikibart in patients with asthma or COPD --
-- Results from Phase 3 study of rademikibart in moderate-to-severe AD presented in late-breaking research session at AAD --
-- Recruitment ongoing for Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies mid-2026 --
-- Entered into a securities purchase agreement for $20.2 million equity financing extending our cash runway into second half of 2027 --
SAN DIEGO, March 31, 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 twelve months ended December 31, 2025, and provided a business update.
"2025 was an eventful year for our lead drug candidate, rademikibart, with the initiation of our Phase 2 Seabreeze STAT studies in acute asthma and chronic obstructive pulmonary disease (COPD)," said Barry Quart, Pharm.D., Chief Executive Officer and Director of Connect Biopharma. "We started 2026 with new mechanism of action data, reinforcing rademikibart's potentially differentiated pharmacologic profile, positive topline results from our Phase 1 intravenous (IV) clinical pharmacology study of rademikibart, and execution of a securities purchase agreement for a $20.2 million equity financing to expand our U.S. institutional investor base and further extend our cash runway. We expect the momentum to continue with topline data from our Phase 2 Seabreeze STAT asthma and COPD studies available midyear."
Recent Highlights
Development Highlights
-- 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 forced
expiratory volume in one second (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.
-- In March 2026, the Company announced the results of a Phase 3 study of
rademikibart in moderate-to-severe atopic dermatitis $(AD)$ conducted by
Simcere:
-- Rademikibart achieved rapid, durable efficacy results across all
key endpoints through 52 weeks, with near-maximal responses
achieved in 90% of patients.
-- Rademikibart was well tolerated with safety similar to placebo at
16 weeks and lower conjunctivitis than other agents in the class.
-- Data were presented in the Late-Breaking Research session at the
2026 American Academy of Dermatology Annual Meeting (AAD).
-- In January 2026, the Company announced new in vitro and preclinical
mechanism of action data providing mechanistic support for rademikibart's
potentially differentiated efficacy and safety profile, compared to what
has been observed for dupilumab, and providing a potential basis for the
large and rapid improvement in FEV1 observed in the Company's previously
completed Phase 2b global chronic asthma study.
-- 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.
Corporate Highlights
-- In March 2026, the Company entered into a securities purchase agreement
with a select group of institutional accredited investors to sell
6,130,000 shares of its ordinary shares in a private placement at a price
of $3.25 per share with respect to any purchaser that is not owned or
controlled by an individual who is an officer, director, employee or
consultant of the Company (Private Placement). The aggregate gross
proceeds for the Private Placement are $20.2 million, before deducting
placement agent fees and other offering expenses. The Company estimates
the placement agent fees and other offering expenses will be $1.6
million. The Private Placement is scheduled to close on or about March
31, 2026.
Financial Results for the Three and Twelve Months Ended December 31, 2025
-- Cash, cash equivalents and short-term investments were $44.3 million as
of December 31, 2025. Based on its current operating plans, the Company
expects that its cash, cash equivalents and short-term investments,
including the net proceeds from the Private Placement, will be sufficient
to fund operations into the second half of 2027.
-- License and collaboration revenues relate 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.
There were no license and collaboration revenues for the three months
ended December 31, 2025. License and collaboration revenues for the
twelve months ended December 31, 2025 were $64,000 for cost
reimbursements. License and collaboration revenues for the three and
twelve months ended December 31, 2024 were $0.7 million and $26.0 million,
respectively, for the upfront license fee, achievement of certain
development milestones and cost reimbursements. As a part of the license
agreement, we are 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 and twelve months ended
December 31, 2025, was $11.3 million and $37.8 million, respectively,
compared with $6.2 million and $29.3 million, respectively, for the same
periods in 2024. 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 twelve months ended
December 31, 2025, was $4.2 million and $20.3 million, respectively,
compared with $4.1 million and $19.2 million, respectively, for the same
periods in 2024. The increase in general and administrative expense was
primarily due to costs incurred to support our efforts to become a more
U.S.-centric company.
-- Net loss for the three and twelve months ended December 31, 2025, was
$15.1 million, or ($0.27) per share, and $55.5 million, or ($1.00) per
share, respectively, compared with $8.9 million, or ($0.16) per share,
and $15.6 million, or ($0.28) per share, respectively, for the same
periods in 2024.
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 $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
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