MARKET WIRE NEWS

Results from Phase 3 Study of Rademikibart in Moderate-to-Severe Atopic Dermatitis to be Presented in the Late-Breaking Research Session at the 2026 American Academy of Dermatology (AAD) Annual Meeting

MWN-AI** Summary

Connect Biopharma Holdings Limited (Nasdaq: CNTB) has announced the upcoming presentation of pivotal results from a Phase 3 study of rademikibart, targeting moderate-to-severe atopic dermatitis (AD), at the Late-Breaking Research session during the American Academy of Dermatology (AAD) Annual Meeting taking place from March 27-31, 2026, in Denver, Colorado. This study, conducted in partnership with Simcere Pharmaceutical Co., Ltd., highlights the potential of rademikibart as a significant contender in treating AD.

The CEO of Connect Biopharma, Barry Quart, expressed optimism about the acceptance of the Phase 3 study results for oral presentation. He emphasized that these findings may bolster the pending New Drug Application (NDA) for rademikibart in China, suggesting a strong foundation for future approvals. While Connect primarily concentrates on asthma and chronic obstructive pulmonary disease (COPD) in the near term, the results could pave the way for expanded opportunities in atopic dermatitis globally.

Rademikibart functions as a human monoclonal antibody designed to target interleukin-4 receptor alpha (IL-4R?), blocking inflammatory pathways involved in AD and other Th2-related inflammatory diseases. The study under review, titled “Rademikibart monotherapy in adult and adolescent patients with moderate-to-severe AD: A 1-year, Phase 3, randomized, double-blinded, placebo-controlled trial (RADIANT-AD),” is set to take place on March 28, 2026, from 9:48 – 10:00 a.m. MDT at the Bellco Theatre 3.

Connect Biopharma, headquartered in San Diego, California, remains dedicated to addressing unmet needs in asthma and COPD while exploring the future potential of rademikibart in treating atopic dermatitis outside of China. Overall, the study's results could further enhance the company's strategic positioning in the biopharmaceutical landscape.

MWN-AI** Analysis

Connect Biopharma Holdings Limited (Nasdaq: CNTB) is poised for a notable market presence as it prepares to present the results of a Phase 3 study for rademikibart, a treatment for moderate-to-severe atopic dermatitis (AD), at the upcoming 2026 AAD Annual Meeting. The anticipation around this study, particularly due to its acceptance for a Late-Breaking Research session, signifies that positive findings could bolster investor confidence and enhance the company’s valuation.

Rademikibart targets the interleukin-4 receptor alpha, a pivotal player in various allergic and inflammatory conditions. This specificity may differentiate it from existing therapies on the market, offering a competitive edge if the study results demonstrate robust efficacy and safety profiles. Investors should keenly monitor the presentation scheduled for March 28, where critical outcomes regarding patient response rates, safety, and tolerability will be shared. Positive data could catalyze momentum for Connect Biopharma, particularly as Simcere, its partner in China, progresses with a New Drug Application (NDA) for rademikibart in that region.

Given the significant unmet need in AD—an area increasingly prioritized by healthcare providers—successful results could open avenues for further indications beyond China, such as asthma and COPD, areas currently targeted by Connect. The potential for expanded use significantly elevates the valuation of Connect Biopharma, especially if robust and positive clinical data is presented.

As of now, the company holds a compelling position with remaining milestone payments from Simcere worth up to $110 million and potential royalties. Investors should consider taking positions ahead of the presentation, but be aware of inherent risks in biopharma developments—regulatory approvals can be unpredictable. Hence, market watchers should assess both the potential upside and the volatility risks associated with biopharma investment before March's presentation.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

SAN DIEGO, March 10, 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 announced that the results of 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), will be presented in the Late-Breaking Research session at the 2026 AAD Annual Meeting, which takes place March 27-31, 2026, in Denver, Colorado.

“We are very encouraged by the acceptance of our partner’s Phase 3 atopic dermatitis study for an oral presentation in the coveted Late-Breaking Research session at AAD this month,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “We believe the results obtained in this Phase 3 study provide a strong basis for the ultimate approval of Simcere’s pending New Drug Application (NDA) for rademikibart in China. While Connect’s near?term priorities remain focused on asthma and chronic obstructive pulmonary disease (COPD), the results Simcere has generated in AD underscore rademikibart’s potentially differentiated safety and efficacy and support the opportunity for Connect to target AD as a future indication outside of China. We look forward to the presentation of these findings at AAD later this month.”

Presentation details are as follows:

Title: 79594 - Rademikibart monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD): A 1-year, phase III, randomized, double-blinded, placebo-controlled trial (RADIANT-AD)
Date / Time: Saturday, March 28, 2026, from 9:48 – 10:00 a.m. MDT
Location: Bellco Theatre 3

About Rademikibart

Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4R?), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4R?, 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 Simcere

Simcere, founded in 1995, is an innovation and R&D-driven pharmaceutical company. The Company focuses on the therapeutic areas of ??neuroscience, oncology, autoimmune and anti-infection, with forward-looking layout of disease areas that may have significant clinical needs in the future, fulfilling the mission of “for patients, for life”. Driven by a dual-strategy of in-house R&D and synergistic innovation, Simcere has established strategic cooperation partnerships with multiple innovative biotechs and research institutes.

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?. 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 future financial condition, results of operations, 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), planned or expected product approval applications or approvals, anticipated milestones and royalties, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, anticipated patient populations or market opportunities for our prospective products, if approved, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we or our current or future partners will need expanded or additional trials in order to obtain regulatory approval for our product candidates; whether Simcere’s pending NDA for rademikibart in China will receive approval by the National Medical Products Administration (NMPA), and the timing of any such approval; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the People’s Republic of China, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community.

Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the SEC. Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date of this presentation. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements.

This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the NMPA, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.

Investor Relations Contact:

Alex Lobo
Precision AQ
Alex.Lobo@precisionaq.com
(212) 698-8802

Media Contact:

Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604


FAQ**

How does the acceptance of Connect Biopharma Holdings Limited CNTB's partner Simcere's Phase 3 study impact investor confidence in the potential approval of rademikibart for atopic dermatitis in China?

The acceptance of Simcere's Phase 3 study for rademikibart significantly boosts investor confidence in Connect Biopharma's potential approval for atopic dermatitis in China, as it validates the drug's efficacy and safety in a pivotal trial phase.

What are the implications for Connect Biopharma Holdings Limited CNTB if rademikibart receives regulatory approval in China, particularly in terms of milestone payments and future market opportunities?

If rademikibart receives regulatory approval in China, Connect Biopharma Holdings Limited CNTB could benefit from milestone payments, enhancing its financial stability, while also opening up significant market opportunities in the growing immunology sector.

Can you elaborate on how Connect Biopharma Holdings Limited CNTB plans to utilize the findings from the Phase 3 study of rademikibart in potential future treatments for asthma and COPD?

Connect Biopharma Holdings Limited (CNTB) plans to leverage the Phase 3 study findings of rademikibart to optimize its development strategies for innovative asthma and COPD therapies, aiming for improved patient outcomes and expanded treatment options.

What strategies is Connect Biopharma Holdings Limited CNTB implementing to manage the risks associated with the clinical trials and regulatory approvals of rademikibart?

Connect Biopharma is implementing comprehensive risk management strategies, including robust clinical trial design, adaptive trial protocols, extensive regulatory engagement, and proactive stakeholder communication to navigate the challenges of rademikibart's clinical trials and regulatory approvals.

**MWN-AI FAQ is based on asking OpenAI questions about Connect Biopharma Holdings Limited (NASDAQ: CNTB).

Connect Biopharma Holdings Limited

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