Wuxi Biologics (Cayman), Inc.

iStock, ffikretow As the Chinese contract manufacturer awaits the U.S. Senate’s consideration of the BIOSECURE Act, it has added 800 new customers in the first nine months of 2024, while being hit with a 2% revenue decline in the third quarter. With the BIOSECURE Act looming, WuXi AppTec released a business report on Monday, touting revenue and profit growth in the first three quarters of 2024 amid “external challenges” from the proposed legislation seeking to restrict American companies from working with Chinese firms. In addition to its new clients, the China-based CDMO said it was able to retain its existing active customer base of more than 6,000 companies. Most of its new contracts were early- or mid-stage projects, with only 20 commercial or Phase III assets secured so far this year, according to a company presentation . In total, WuXi AppTec added 915 molecules in the first three quarters of 2024. In Q3, WuXi AppTec recorded around $1.46 billion in total revenue, a 2% year-over-year decline. Almost all its business segments took a sales hit, most notably the company’s domestic drug discovery division which suffered a 78.2% decline in revenue. Meanwhile, its biggest division—WuXi Chemistry—grew 1.4% to bring in $1.1 billion in the quarter. Still, chairman and CEO Ge Li in a statement called the company’s Q3 performance “steady,” choosing to focus on its results excluding COVID-19 and touting 14.6% year-over-year growth in Q3. For the full year 2024, WuXi AppTec expects to generate $5.36 billion to $5.67 billion in revenue, with free cash flow of $840 million to $980 million. “Although the recently proposed U.S. legislation may create short-term uncertainty for the global pharmaceutical and life sciences industry, WuXi AppTec remains steadfast in ‘doing the right thing and doing it right,’” Li said, noting that the company will continue to “enhance our capabilities and capacity” to better support its customers in developing treatments for patients worldwide. WuXi AppTec’s financial results on Monday suggest for now that the CDMO is remaining resilient in the face of the BIOSECURE Act threat in the U.S.—its biggest market. The BIOSECURE Act, introduced in January 2024 , is aimed at keeping U.S. taxpayer dollars from biotech companies of national concern, particularly those aligned with the Chinese government. WuXi AppTec is explicitly named by the proposed legislation, alongside WuXi Biologics, Beijing Genomics Institute, MGI and Complete Genomics. Last month, the U.S. House of Representatives overwhelmingly passed the BIOSECURE Act, which moves on to the Senate for consideration and where strong bipartisan support is expected. Several industry players are strongly in favor of the bill—including the Biotechnology Innovation Organization and manufacturing service providers —but other analysts point to supply chain vulnerabilities that the legislation would potentially aggravate. A June 2024 report from GlobalData noted that nearly 50 U.S.-based companies currently have contracts with Chinese firms, and that the BIOSECURE Act could disrupt the supply of many drugs—both commercially available or in clinical trials.

SHANGHAI, Oct. 28, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the launch of WuXia™ RidGS, a high-yield glutamine synthetase (GS)-knockout Chinese hamster ovary (CHO) expression system platform. The platform, specialized in non-antibiotic cell line development, employs zinc finger nucleases (ZFN) technology for targeted knockout of the endogenous GS gene in CHO cells. Based on the WuXia™ platform, WuXia™ RidGS not only retains the robust cell growth, metabolism, and expression profile characteristic of WuXia™, but also boasts an average clonal expression level exceeding 6 g/L for monoclonal antibodies(mAbs). WuXia™ RidGS ensures cell line stability for mAbs, as well as for various other therapeutic modalities, including bispecific antibodies, Fc-fusion proteins, and recombinant proteins. The quality of protein products expressed by the platform showcases favorable glycosylation patterns while maintaining an exceptional purity profile. In addition, without the need for antibiotics, WuXia™ RidGS host and production cells consistently maintain stable productivity and uniform product quality throughout extensive, long-term cell line stability studies. Dr. Chris Chen, CEO of WuXi Biologics, commented, "With the launch of WuXia™ RidGS, we are pleased to offer a more efficient alternative for the development of advanced therapeutic proteins. WuXi Biologics continues its commitment to developing tailored technology platforms that cater to the evolving needs of our global clients, accelerating the speed to market for life-saving therapies and advancing the accessibility of high-quality biologics for patients worldwide." About the WuXia ™ Cell Line Development Platform Family WuXia™ is a proven, high-yielding (up to about 11 g/L) mammalian cell line platform developed by WuXi Biologics. Accepted by regulatory agencies worldwide, the WuXia™ platform has generated over 900 cell lines expressing monoclonal and bispecific antibodies, fusion proteins, enzymes and other recombinant proteins for clinical and commercial manufacturing. WuXiaADCC Plus™ and WuXia™ RidGS mirror the impressive attributes of WuXia™, while catering to the diverse needs of global customers. About WuXi Biologics WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2024, WuXi Biologics is supporting 742 integrated client projects, including 16 in commercial manufacturing (excluding COVID CMO and non-COVID dormant CMO projects). WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability. For more information about WuXi Biologics, please visit: SOURCE WuXi Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Planegg/Martinsried, October 24, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, today reported financial results and provided a business update for the third quarter ended September 30, 2024. The Quarterly Statement Q3 2024 can be found on the website: https://medigene.com/investors-media/reports-presentations/. "During the third quarter of 2024, our focus remained on executing our strategic plan and creating additional value for both patients and our shareholders, beyond T cell receptor engineered T cell (TCR-T) therapies, by expanding our ability to apply our sensitive, specific and potentially safer (3S) TCRs into new modalities,” said Selwyn Ho, CEO at Medigene. “We are excited to have announced a three-year strategic partnership with WuXi Biologics to co-research TCR-guided T Cell Engagers (TCR-TCEs) for solid tumors, extending our pipeline. Our MDG3010 program will be a joint development with WuXi Biologics, aiming to create bispecific therapeutics that target cancer cells with precision while minimizing off-target effects. The target for this bispecific will be revealed later. As for our lead program MDG1015, we received FDA clearance for our investigational new drug application and are on track for the clinical trial application submission filing with the European Medicines Agency (EMA) in Q4 2024. In line with our guidance since 2023, and subject to additional financing, we anticipate initiating and generating an early data read-out for the EPITOME-1015-I trial by the end of 2025.” Financial and corporate development The financial performance in Q3 2024 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 1.4 million during the third quarter of 2024, derived primarily from the partnership with BioNTech. R&D expenses for the quarter amounted to EUR 2.7 million, reflecting our ongoing commitment to advancing our pipeline. As of September 30, 2024, the Company holds cash and cash equivalents in the amount of EUR 9.5 million. During the quarter, a 2:1 share capital reduction and consolidation of the shares was executed, as resolved by the AGM on June 24, 2024. This reduced the number of shares following the previous withdrawal of one share, from 29,475,188 to 14,737,594, with the newly converted shares trading under WKN A40ESG (ISIN: DE000A40ESG2) since August 29, 2024. The measure did not affect the company’s value or individual shareholders' ownership percentages and resulted in a reclassification from “subscribed capital” to “capital reserves” on Medigene AG’s balance sheet, aimed at raising the market value per share above the notional par value of one euro. Subsequent to the quarter, Medigene announced that the Company has secured a financing option through an equity commitment of up to EUR 15 million through a Standby Equity Purchase Agreement (SEPA) with a fund managed by Yorkville Advisors Global L.P. The SEPA enables Medigene to proceed the further development of the Company’s programs. This financing facility is designed to complement potential other sources of financing from both the capital markets and from non-dilutive sources from current and potential future partners and offers significant flexibility to deploy capital. As such, and unchanged from previous guidance, the Management Board therefore maintains its guidance and retains cash runway into July 2025 based on current plans. From a partnering perspective, Medigene entered a three-year, multi-target strategic partnership with WuXi Biologics to design and co-research TCR-guided T Cell Engagers (TCEs) for the treatment of solid tumors. The MDG3010 program aims to co-develop TCR-TCE constructs, jointly owned with WuXi Biologics, with Medigene retaining the option to further advance their development. These constructs will integrate Medigene’s highly specific 3S TCRs for precise target recognition with WuXi Biologics' anti-CD3 mAb, TCE platform, and proprietary bispecific antibody platform, WuXiBody™. Scientific and clinical development The company’s lead program, MDG1015, a first-in-class, third-generation NY-ESO-1 / LAGE-1a targeted TCR-T therapy combining a 3S TCR with the PD1-41BB costimulatory switch protein (CSP), has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application to initiate a phase 1 clinical trial (EPITOME1015-I) for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma. The submission of the clinical trial application (CTA) to the European Medicines Agency (EMA) remains on schedule for Q4 2024. During the quarter, Medigene presented at various scientific conferences. Latest pre-clinical data for MDG2021, the second TCR-T therapy within the KRAS library targeting KRAS G12D mutation with HLA-A*11, were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in September. In addition, the latest expansion of Company’s End-to-End Platform, UniTope & TraCR, an innovative combination of universal TCR tagging and tracking, was presented at the ESMO Congress 2024 in September as well as the American Society of Gene & Cell Therapy Annual Meeting in October. In Q3 2024, Medigene further advanced its intellectual property portfolio, which as of September 30, 2024, comprised 29 patent families with 104 issued patents and 124 pending applications. In July 2024, a patent was granted protecting TCR targeting NY-ESO-1 / LAGE 1a, which is the main component of the Company´s lead program MDG1015. In August 2024, the Company announced the receipt of a patent by the European Patent Office protecting the JOVI technology, a method allowing the enrichment of T cells using a specific anti-Cβ antibody. Also in August 2024, the Company announced a patent grant from the Hong Kong Patent Office for its inducible Medigene T cell receptor (iM-TCR) technology, enhancing control and safety of TCR-T therapies. This adds to previously granted patents by the Europe and Japan Patent Offices. --- end of press release --- About Medigene AG Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that are utilized in multiple therapeutic modalities, such as T cell receptor engineered T cell (TCR-T) therapies, TCR-guided T cell engager therapies and TCR-natural killer cell therapies for both its in-house product pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is a potential best-in-class, TCR-T therapy to treat multiple solid tumor indications. The End-to-End Platform technologies enable armoring and enhancing of these T cells to overcome the immunosuppressive tumor microenvironment (TME) and ensure the T cell drug product composition maximizes safety, efficacy and durability of response. Medigene’s MDG1015 received IND approval in Q3 2024 and is filing for CTA in Q4 2024. For more information, please visit https://medigene.com/ This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only. Medigene AG Pamela Keck Phone: +49 89 2000 3333 01 E-mail: investor@medigene.com In case you no longer wish to receive any information about Medigene, please inform us by e-mail (investor@medigene.com). We will then delete your address from our distribution list.