五星体育直播 Announces Purchase Agreement with Nestl茅 Health Science for CDX-7108

Company to retain economic interest in biotherapeutic asset while removing cash burn from development and commercialization costs

REDWOOD CITY, Calif., Dec. 27, 2023 (GLOBE NEWSWIRE) -- 五星体育直播 (NASDAQ: CDXS), a leading enzyme engineering company, today announced it has entered into a purchase agreement with Nestl茅 Health Science, a globally recognized leader in the field of nutritional science, for CDX-7108, an investigational therapy for the potential treatment of exocrine pancreatic insufficiency (EPI). Under the terms of the agreement, 五星体育直播 will receive up to $45M in potential milestone payments, including a $5M upfront payment, as well as single-digit net-sales-based royalties. 五星体育直播 will receive up to an additional $5M if Nestl茅 Health Science exercises an option to purchase two additional early-stage enzymes being developed for EPI. Nestl茅 Health Science will be solely responsible for the continued development and commercialization of CDX-7108, including all associated costs.

鈥淭his agreement solidifies the future development of CDX-7108鈥攁 potential new therapy that could be added to the treatment armamentarium for patients with exocrine pancreatic insufficiency鈥攁nd enables 五星体育直播 to focus resources on the advancement of our ECO Synthesis鈩 platform and the return to growth of our Pharmaceutical Manufacturing business,鈥 said Stephen Dilly, MBBS, PhD, Chief Executive Officer of 五星体育直播. 鈥淧reliminary data from the CDX-7108 Phase I study announced earlier this year support continued investigation into Phase II clinical studies. We believe that CDX-7108 could represent a meaningful advance in the standard of care for patients, and we are pleased to retain an economic interest in the program as Nestl茅 continues development.鈥

五星体育直播 and Nestl茅 Health Science completed pre-clinical work for CDX-7108 and a Phase I clinical trial under the terms of a previous agreement. With this asset purchase agreement, Nestl茅 Health Science may continue advancing the compound through the development process.

About CDX-7108
CDX-7108 is a lipase variant specifically engineered to overcome the limitations of traditional pancreatic enzyme replacement therapy (PERT) deficiencies. PERT is the main treatment for exocrine pancreatic insufficiency (EPI), a debilitating condition of the gastrointestinal tract that is caused by conditions that impair pancreatic function, such as pancreatitis, pancreatic cancer, Cronh鈥檚 disease, celiac disease and cystic fibrosis. CDX-7108 was engineered to be highly stable to the acidic conditions of the stomach and resistant to proteases in the upper intestines. Preliminary data from an interim analysis of the Phase I study proof-of-concept arm supported continued investigation into Phase II clinical studies.

About Nestl茅 Health Science
Nestl茅 Health Science, a leader in the science of nutrition and gastrointestinal health, is a globally managed business unit of Nestl茅.聽The company is committed to redefining the management of health, offering an extensive portfolio of science-based nutritional products for patients and consumers. Nestl茅 Health Science鈥檚 trusted relationship with the healthcare professional community and significant commercial capabilities provide the foundation for continued growth of its marketed portfolio of pharmaceutical products including the successful launch in 2023 of a microbiome-based therapeutic.

About 五星体育直播
五星体育直播 is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. 五星体育直播 enzymes solve for real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis鈩 platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. 五星体育直播鈥 unique enzymes can drive improvements such as higher yields, reduced energy usage and waste generation, improved efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications. For more information, visit .

五星体育直播 Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as 鈥渁im,鈥 鈥渁nticipate,鈥 鈥渁ssume,鈥 鈥渂elieve,鈥 鈥渃ontemplate,鈥 鈥渃ontinue,鈥 鈥渃ould,鈥 鈥渄esign,鈥 鈥渄ue,鈥 鈥渆stimate,鈥 鈥渆xpect,鈥 鈥済oal,鈥 鈥渋ntend,鈥 鈥渕ay,鈥 鈥渙bjective,鈥 鈥減lan,鈥 鈥減ositioned,鈥 鈥減otential,鈥 鈥減redict,鈥 鈥渟eek,鈥 鈥渟hould,鈥 鈥渟uggest,鈥 鈥渢arget,鈥 鈥渙n track,鈥 鈥渨ill,鈥 鈥渨ould鈥 and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. To the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management, including but not limited to statements regarding the anticipated potential benefits of the purchase agreement, such as the anticipated development and commercial milestone payments, which are dependent, in part, on the efforts of Nestl茅 Health Science to continue the development and commercialization of CDX-7108. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond 五星体育直播鈥 control and that could materially affect actual results. Factors that could materially affect actual results include, among others: 五星体育直播鈥 dependence on its licensees and collaborators; if any of its collaborators terminate their development programs under their respective license agreements with 五星体育直播; 五星体育直播 may need additional capital in the future in order to expand its business; if 五星体育直播 is unable to successfully develop new technology such as its ECO Synthesis鈩 platform; 五星体育直播' dependence on a limited number of products and customers, and potential adverse effects to 五星体育直播鈥 business if its customers鈥 products are not received well in the markets; if 五星体育直播 is unable to develop and commercialize new products for its target markets; if competitors and potential competitors who have greater resources and experience than 五星体育直播 develop products and technologies that make 五星体育直播鈥 products and technologies obsolete; if 五星体育直播 is unable to accurately forecast financial and operational performance; and market and economic conditions may negatively impact 五星体育直播' business, financial condition and share price. Additional information about factors that could materially affect actual results can be found in 五星体育直播鈥 Annual Report on Form 10-K filed with the Securities and Exchange Commission (鈥淪EC鈥) on February 27, 2023, and in 五星体育直播鈥 Quarterly Report on Form 10-Q filed with the SEC on November 3, 2023, including under the caption 鈥淩isk Factors,鈥 and in 五星体育直播鈥 other periodic reports filed with the SEC. 五星体育直播 expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

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