五星体育直播

五星体育直播 Announces Achievement of Gram-scale Synthesis with its ECO Synthesis鈩� Platform

Milestone enables 五星体育直播 engineers to model the manufacturing process for RNAi therapeutics

Company remains on track to initiate pre-commercial customer testing in 2024

REDWOOD CITY, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- 五星体育直播 (NASDAQ: CDXS), a leading enzyme engineering company, today announced it has achieved gram-scale synthesis with its Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis鈩� technology. This critical technical milestone demonstrates the preparative-scale manufacture of an oligonucleotide, composed of the modified nucleotide building blocks typically used in ribonucleic acid (RNA) therapeutics, under process-like conditions.

Successful completion of this milestone enables 五星体育直播 engineers to initiate a comprehensive assessment of the purity profile for small interference RNA (siRNA) developed with ECO Synthesis鈩� technology. Separately, data collected on process-related parameters provides foundational information for early models of the siRNA manufacturing process and allows the Company to open conversations with early access customers on their RNA interference (RNAi) therapeutics manufacturing processes. Early access customer testing is on track to initiate in 2024 ahead of an anticipated full commercial launch in 2026.

鈥淥ur scientists have done outstanding work to bring us to this critical milestone for the development of our ECO Synthesis鈩� technology so rapidly. We have increased production scale by four orders of magnitude since August to move into preparative scale of the oligonucleotide. This is significant because it allows our engineers to begin modeling and testing manufacturing methods with confidence, which will enable us to start sharing data-driven insights with potential customers on key metrics like purity profile,鈥� said Stephen Dilly, MBBS, PhD, Chief Executive Officer of 五星体育直播. 鈥淔urthermore, we have demonstrated the ability of our enzymes to include modified building blocks reliably and with high conversion efficiency in a timely fashion. This, together with our steady progress in the enzymatic synthesis of the nucleotide building blocks and starter oligonucleotide, gives us real excitement for the potential of the ECO Synthesis鈩� platform and we look forward to initiating pre-commercial testing next year.鈥�

The need for an enzymatic route of synthesis for RNAi therapeutics was recently reinforced at the Company鈥檚 virtual KOL investor event featuring John Maraganore, PhD, Founder and Former Chief Executive Officer of Alnylam Pharmaceuticals and 五星体育直播 Strategic Advisory Board member, and David Butler, PhD, Chief Technology Officer of Hongene Biotech Company. These distinguished experts were joined by 五星体育直播 leadership and discussed the growth of RNAi therapeutics as a modality, the manufacturing landscape and the potential role for 五星体育直播鈥� ECO Synthesis鈩� platform to enable commercial-scale production of RNAi therapeutics. A replay of the virtual event is accessible on the Investor Relations section of the Company鈥檚 website, .

About the ECO Synthesis鈩� Platform

Ribonucleic acid (RNA) as a therapeutic modality has gained tremendous traction in recent years with the growing number of messenger RNA (mRNA) vaccines and small interfering RNA (siRNA) candidates advancing in clinical studies. However, large-scale production of RNA interference (RNAi) therapeutics using traditional chemical synthesis faces complex challenges in nucleic acid quality and quantity, as well as overall economics. With over 450 RNAi therapies currently in clinical development, including more than 40 assets in Phase 2 and Phase 3 clinical trials targeting disease indications impacting millions of patients, RNAi therapeutic demand is projected to outpace current production capabilities by the end of the decade. 五星体育直播鈥� proprietary ECO Synthesis鈩� technology platform is being designed to address these scalability and cost limitations by potentially enabling the commercial-scale manufacture of RNAi therapeutics through an enzymatic route. The Company achieved gram-scale synthesis in December 2023, where it demonstrated the preparative-scale manufacture of an oligonucleotide, composed of the modified nucleotide building blocks typically used in RNAi therapeutics, under process-like conditions. 五星体育直播 remains on track to initiate early access customer testing in 2024.

About 五星体育直播

五星体育直播 is a leading enzyme engineering company leveraging its proprietary CodeEvolver^庐 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 .

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 whether 五星体育直播 will be able to initiate, and the timing of it initiating, pre-commercial customer testing of its ECO Synthesis鈩� technology in听2024 and a full commercial launch in 2026; the potential of the ECO Synthesis鈩� platform, including its ability to be broadly utilized and to enable commercial-scale manufacture of RNAi therapeutics through an enzymatic route; the potential of an enzymatic route of synthesis to drive improvements relative to traditional chemical synthesis related to, among other things, nucleic acid quantity and quality and overall economics; and expectations regarding future demand for RNAi technologies. 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 and dsRNA; 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.

For More Information

五星体育直播 Contacts
Investor Contact
Carrie McKim
(336) 608-9706

Media Contact
Lauren Musto
(781) 572-1147

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Released December 13, 2023