五星体育直播

五星体育直播 Reports Third Quarter 2024 Financial Results

Quarter Highlights Include Key Additions to Management Team and Extension of Cash Runway into 2027 with $31M Raise via ATM Facility

Company Reiterates Full-year Financial Guidance; On Track to Achieve Product Revenue Growth of at Least 10% vs. FY2023 Excluding Enzyme Sales Related to PAXLOVID鈩�

REDWOOD CITY, Calif., Oct. 31, 2024 (GLOBE NEWSWIRE) -- 五星体育直播 (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced financial results for the third quarter ended September 30, 2024, and provided a business update.

鈥溛逍翘逵�直播 had a strong third quarter, in which we surpassed product revenue goals, welcomed two new, highly experienced executives to our management team, and brought in $31 million via our existing ATM facility, extending our cash runway into 2027, past the point of profitability. By out-licensing our genomics enzymes portfolio to Alphazyme, we also reinforced our ability to focus on our key strategic priorities: the growth of our Pharmaceutical Manufacturing business and our ECO Synthesis鈩� manufacturing platform,鈥� said Stephen Dilly, MBBS, PhD, Chairman and Chief Executive Officer of 五星体育直播. 鈥淲e are in a great position to close the fiscal year on a high note with three data presentations at the upcoming TIDES Europe congress, where we will showcase the real-world application of our ECO Synthesis鈩� platform and highlight concrete commercial interest. We also expect to announce our first technical collaboration with a major pharmaceutical partner by the end of this year. Combined with the increasing volume of inbound inquiries for our ECO Synthesis鈩� technology, we are well on our way to being the first company to capture significant value from the enzymatic synthesis of oligonucleotide therapeutics.鈥�

Third Quarter and Recent Business Highlights

• In October 2024, 五星体育直播 announced an increase in its cash reserves through capital raises totaling $31 million via the Company鈥檚 existing at-the-market (ATM) facility. The expanded reserves allow the Company to self-fund into 2027, providing a clear path to positive cash flow, anticipated around the end of 2026. The continuous interest from existing shareholders serves as validation of the Company鈥檚 accelerated technical progress and will enable 五星体育直播 to invest in the right talent, technology and capabilities to continue executing on its strategy.
• In October 2024, 五星体育直播 announced the appointment of Georgia Erbez to Chief Financial Officer. Ms. Erbez is a seasoned financial executive who most recently served as Chief Operating Officer at Walking Fish Therapeutics.听Prior to that, she served as the Chief Financial Officer of Harpoon Therapeutics. Ms. Erbez also held the role of Chief Business Officer and Chief Financial Officer at Zosano Pharma Corp., and has served as Chief Financial Officer for Revolution Medicines, Asterias Biotherapeutics and Raptor Pharmaceuticals.听
• 五星体育直播 announced the appointment of Alison Moore, PhD, to the newly created role of Chief Technical Officer in October 2024. Dr. Moore is the former Chief Technical Officer of Allogene Therapeutics and joins the 五星体育直播 Management Team after serving for four years on the Company鈥檚 Board of Directors. Prior to Allogene, she spent a total of 20 years at Amgen, most recently as Senior Vice President, Process Development, and held roles in Supply Chain and Manufacturing. Dr. Moore also has experience at Genentech as a Director in Chemistry, Manufacturing and Controls, and in Regulatory Affairs.听
• In October 2024, 五星体育直播 announced the Company licensed its genomics life science enzyme portfolio to Alphazyme, LLC, part of Maravai LifeSciences. The agreement includes licenses for the HiFi DNA Polymerase, HiTemp Reverse Transcriptase, HiRev Isothermal Polymerase and other enzymes that were in development directed towards genomics and diagnostics applications prior to the Company鈥檚 strategic shift announced in July 2023. Under the terms of the agreement, 五星体育直播 is eligible to receive sales-based royalties.
• In September 2024, 五星体育直播 participated in a presentation and panel discussion at the RNA Leaders USA Congress. The Company鈥檚 presentations focused on the use of its Enzyme Catalyzed Oligonucleotide (ECO) Synthesis鈩� manufacturing platform to leverage enzymes in driving the scalable and cost-effective manufacture of short inhibitory ribonucleic acid (siRNA) duplexes.
• In August 2024, 五星体育直播 announced the publication of its inaugural sustainability disclosures detailing the Company鈥檚 environmental, social and governance (ESG) performance for the fiscal year ended December 31, 2023. To learn more about 五星体育直播鈥� sustainability program or obtain a copy of the Company鈥檚 inaugural Sustainability Accounting Standards Board (SASB) index, please visit the .
• 五星体育直播 announced in July 2024 that the Company had finalized a purchase agreement with Crosswalk Therapeutics for two gene therapy assets. Under the terms of the agreement, Crosswalk acquired the Company鈥檚 investigational Fabry and Pompe disease compounds, and 五星体育直播 is eligible to receive future development and commercial milestone payments in addition to a net sales-based royalty.

Upcoming Milestones for the Fourth Quarter 2024

• 五星体育直播 expects to announce its first technical collaboration with the ECO Synthesis鈩� manufacturing platform by the end of 2024.
• The Company expects to complete the build-out of its ECO Synthesis鈩� Innovation Lab around the end of 2024.

Third Quarter 2024 Financial Highlights

• Total revenues were $12.8 million for third quarter 2024 compared to $9.3 million in third quarter 2023. Product revenues were $11.2 million for third quarter 2024 compared to $5.4 million in third quarter 2023, driven by timing of customer orders. R&D revenues for third quarter 2024 were $1.7 million compared to $3.9 million in third quarter 2023; the decrease was primarily due to lower non-recurring items, including for Biotherapeutics programs that the Company previously discontinued.

• Product gross margin was 61% for third quarter 2024 compared to 58% in third quarter 2023. The increase in gross margin was largely due to variability in the product mix.
• R&D expenses for third quarter 2024 were $11.5 million compared to $13.7 million in third quarter 2023; the decrease was primarily driven by lower use of outside services related to Chemistry, Manufacturing and Controls and lower regulatory expenses and a decrease in lease and facilities costs due to the assignment of the Company鈥檚 San Carlos facility lease during the fourth quarter of 2023.
• Selling, General & Administrative expenses for third quarter 2024 were $13.6 million compared to $12.3 million in third quarter 2023; the increase was primarily due to an increase in consulting and outside services.

• The net loss for third quarter 2024 was $20.6 million, or $0.29 per share, compared to a net loss of $34.9 million, or $0.50 per share, for third quarter 2023.
• As of September 30, 2024, the Company had $90.3 million in cash, cash equivalents and short-term investments, which is expected to fund planned operations into 2027 and past the point of positive cash flow, anticipated around the end of 2026.

2024 Financial Guidance Reiterated

五星体育直播 reiterated its full-year 2024 financial guidance originally issued on February 28, 2024, as follows:

• Product revenues are expected to be in the range of $38 million to $42 million, excluding revenue related to PAXLOVID鈩�.
• R&D revenues are expected to be in the range of $18 million to $22 million.
• Gross margin on product revenue is expected to be in the range of 58% to 63%, excluding revenue related to PAXLOVID鈩�.

Conference Call and Webcast

五星体育直播 will hold a conference call and webcast today beginning at 4:30 pm ET. A live webcast and slide presentation to accompany the conference call听will be available on the Investors section of the Company website at听. The conference call dial-in numbers are 877-705-2976 for domestic callers and 201-689-8798 for international callers.

A telephone recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing 877-660-6853 for domestic callers or 201-612-7415 for international callers. Please use the passcode 13726635 to access the recording. A webcast replay will be available on the Investors section of听the Company website听for at least 90 days, beginning approximately two hours after the completion of the call.

About 五星体育直播

五星体育直播 is a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, 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 and nucleic acid therapeutics manufacturing. The Company is currently developing its proprietary ECO Synthesis鈩� manufacturing 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听.

Forward-Looking Statements

This press release contains 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 anticipated milestones, including product launches, technical milestones, data releases and public announcements related thereto; whether 五星体育直播 will be able to, and the timing of it entering its first technical collaboration with its ECO Synthesis鈩� manufacturing platform in 2024; whether 五星体育直播 will be able to, and the timing of it substantially completing, the build-out of its planned ECO Synthesis鈩� Innovation Lab around the end of 2024; 五星体育直播鈥� expectations regarding 2024 product revenues, R&D revenues and gross margin on product revenue, as well as its ability to fund planned operations into 2027; 五星体育直播鈥� ability to achieve positive cash flow around the end of 2026; potential receipt by 五星体育直播 of certain milestone and royalty payments pursuant to its recent transactions with Alphazyme and Crosswalk Therapeutics; the potential to grow the pharmaceutical manufacturing business; and the potential of the ECO Synthesis鈩� manufacturing platform, including its ability to be broadly utilized and to enable commercial-scale manufacture of RNAi therapeutics through an enzymatic route. 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� manufacturing platform and dsRNA ligase; 五星体育直播鈥� 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; 五星体育直播鈥� ability to comply with debt covenants under its loan facility; 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 (SEC) on February 28, 2024 and in 五星体育直播鈥� Quarterly Report on Form 10-Q filed with the SEC on or about the date hereof, 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. 五星体育直播鈥� results for the quarter ended September 30, 2024, are not necessarily indicative of our operating results for any future periods.

For More Information
Investor Contact
Carrie McKim
(336) 608-9706

Media Contact
Lauren Musto
(650) 421-8205

Released October 31, 2024