Qyuns Therapeutics Co., Ltd. (“Qyuns” or the “Company”, stock code: 2509.HK) is pleased to announce that its partner, Caldera Therapeutics, Inc. (“Caldera”), has successfully dosed the first healthy volunteers in a Phase I clinical trial of QX030N/CLD-423 (Caldera’s R&D code).

QX030N注射液（样图）

Sample Image of QX030N injection

QX030N/CLD-423 is a clinical stage bispecific antibody targeting the clinically validated IL-23p19 and TL1A pathways. Single targeted inflammatory bowel disease (“IBD”) therapies have hit an efficacy ceiling. Bispecifics are the next horizon of IBD treatment. QX030N/CLD-423 is rationally designed to achieve a best-in-disease profile with optimized efficacy, safety, pharmacokinetics and developability, expecting to be the next frontier in IBD treatment.

On April 23, 2025, the Company and Caldera Therapeutics entered into an out-license agreement (the “License Agreement”). The License Agreement has granted Caldera an exclusive right to develop and commercialize QX030N/CLD-423 globally. Qyuns has received an aggregate of US$15 million from Caldera in upfront and milestone payments, along with an equity stake in Caldera. Furthermore, upon the achievement of specific clinical, regulatory, and commercial milestones, the Company is eligible to receive additional payments of up to US$540 million, as well as tiered royalties based on the net sales of QX030N/CLD-423. The Group may also receive additional payments of up to USD$545 million, subject to the achievement of certain clinical development, regulatory and commercial milestones. The Group will also be entitled to receive tiered royalties on net sales from Caldera Therapeutics during a specified time period after the first commercial sales of QX030N.

To date, Caldera has a total of US$112.5 million capital raised, including US$75 million Series A round from Atlas Venture, LAV and venBio, and a US$37.5 million Series A-1 round led by Omega Funds, with participation from new investors Wellington Management and Janus Henderson Investors. Caldera's management team previously led Morphic Therapeutics, which was acquired by Eli Lilly for US$3.2 billion in July 2024.

About Caldera

Caldera Therapeutics is a clinical stage company developing QX030N/CLD-423, a first-in-class bispecific antibody targeting the clinically validated IL-23p19 and TL1A pathways for the treatment of IBD and other immunologic and inflammatory diseases. Supported by leading biotech investors Atlas Venture, LAV, venBio, Omega Funds, Wellington Management and Janus Henderson Investors, Caldera Therapeutics has assembled a senior leadership team with deep experience in the discovery and development of IBD therapeutics and a proven track record of building companies through to successful exits.

DISCLAIMER

*This news release is intended to share the latest progress updates on the R&D efforts of the Company (or its partners) and is not for advertising purposes. It does not constitute a recommendation for any drugs and/or indications. For any related diseases or medication needs, please consult a qualified healthcare professional.

*This news release may contain certain forward-looking statements, which are inherently subject to significant risks and uncertainties. When words such as "anticipate," "believe," "predict," "expect," "plan," "intend" and other similar expressions are used, insofar as they relate to the Company, they shall be deemed to be forward-looking statements. The Company has no obligation to continuously update these predictive statements. These forward-looking statements are based on the current views, assumptions, expectations, estimates, projections and understandings of the Company’s management regarding future events at the time of making such statements. They do not constitute guarantees of future developments nor reliable indicators of future performance. We hereby explicitly caution you that you should not rely on any forward-looking statements. Forward-looking statements are subject to various risks, uncertainties and other factors (including but not limited to general market conditions, regulatory changes, geopolitical tensions, or data limitations and changes), some of which are beyond the Company’s control and difficult to predict. Therefore, due to future changes and developments in our business, competitive environment, political, economic, legal and social conditions, actual results may differ materially from the information contained in the forward-looking statements. The Company, its directors and employee agents shall not be liable for any obligation to update, revise or supplement such forward-looking statements, nor for any liability arising from the failure or inaccuracy of any forward-looking statements.