五星体育直播

五星体育直播 Reports Third Quarter 2023 Financial Results

Company Remains on Track to Demonstrate Gram-Scale Synthesis with ECO Synthesis鈩� Platform for RNAi Therapeutics Production by End of Year

Strong Financial Position Enables Projected Runway to Expected Positive Cash Flow Around End of 2026

Company to Host Virtual ECO Synthesis鈩� Platform-Focused KOL Event on December 8, 2023, featuring John Maraganore

REDWOOD CITY, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- 五星体育直播 (NASDAQ: CDXS), a leading enzyme engineering company, today announced financial results for the third quarter ended September听30, 2023, and provided a business update.

鈥淥ver the past quarter, we have continued to deliver on our plan to reduce our cash burn and put ourselves in an enviable position of financial strength. Our core Pharmaceutical Manufacturing business generates cash, we have a potentially game-changing technology in the ECO Synthesis鈩� platform, and, importantly, we have the financial resources to execute on our plans,鈥� said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of 五星体育直播. 鈥淲ith our current balance sheet, we now expect to fund our planned operations to positive cash flow, which is anticipated around the end of 2026. We look forward to continuing to execute on our key milestones, including the demonstration of gram-scale synthesis with our ECO Synthesis鈩� platform by the end of this year.鈥�

Third Quarter and Recent Business Highlights

• In July 2023, 五星体育直播 announced an update to its strategy to focus resources on programs with the strongest probability of creating significant value in the near-term and beyond. Accordingly, the Company is prioritizing the advancement and commercialization of its Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis鈩� technology platform, designed to enable the commercial-scale manufacture of RNA interference (RNAi) therapeutics, and its highly complementary Pharmaceutical Manufacturing business. The Company also discontinued investment in certain development programs across Biotherapeutics and Life Sciences, consolidated operations to its headquarters in Redwood City, California and reduced headcount by approximately 25%. These actions enable a potential path to positive cash flow around the end of 2026 based on the Company鈥檚 current planned operations.
  
  
• In September 2023, the Company announced it had executed an Assignment and Assumption of Lease for its San Carlos, California location. As a result of consolidating operations, 五星体育直播 estimates it will realize cumulative cash savings of more than $30 million through 2031.
  
  
• In September 2023, Dr. Dilly was named winner of the prestigious 2023 Bloom Burton Award, which honors an individual who made the greatest contribution to Canada鈥檚 innovative healthcare industry the previous year.听Dr. Dilly was recognized for his leadership of Vancouver-headquartered Sierra Oncology, where he led the company through Phase 3 clinical development of momelotinib and its drive toward commercialization up until the company鈥檚 $1.9 billion acquisition by GSK.
  
  
• In November 2023, 五星体育直播 presented a technical update for its ECO Synthesis鈩� platform at the TIDES Europe annual meeting. The presentation focused on the Company鈥檚 broader enzyme evolution and process development efforts for both the iterative nucleotide addition and the supply of critical nucleotide reagents. Driving for high volumetric productivity, data highlighted multiple, consecutive additions of 2鈥�-modified RNA nucleotides to a growing oligonucleotide sequence, achieving significant coupling efficiencies with immobilized enzymes. Additionally, proof-of-concept was presented for an enzymatic 鈥渙ne-pot, two-step鈥� phosphorylation cascade to manufacture nucleotide reagents for supply with the ECO Synthesis鈩� platform.
  

Formation of Strategic Advisory Board (SAB) and Key Opinion Leader (KOL) Event on December 8, 2023

• The Company announced the formation of its SAB, chaired by 五星体育直播 Board Member Rahul Singhvi, ScD. This group will play a pivotal role in guiding the Company鈥檚 strategic direction and offer valuable insights to inform the continued development of the ECO Synthesis鈩� platform. John Maraganore, PhD, founder and former Chief Executive Officer of Alnylam Pharmaceuticals, has joined the SAB as the inaugural external member. Dr. Maraganore is a pioneer in the RNAi therapeutics space, having built and led Alnylam from an early research platform through the global approval and commercialization of the first five RNAi therapeutic medicines.
  
  
• 五星体育直播 plans to host an ECO Synthesis鈩� platform-focused KOL event at 10:00 am ET on December 8, 2023. In addition to updates from 五星体育直播 leadership, the agenda will feature a presentation from John Maraganore. Dr. Maraganore will share his perspective on the role an enzymatic solution like the ECO Synthesis鈩� platform would play in the existing RNAi therapeutics manufacturing landscape.
  

Key Upcoming Milestones

• The Company expects to achieve gram-scale synthesis with its ECO Synthesis鈩� technology platform by the end of 2023, where it will demonstrate the preparative-scale manufacture of an oligoribonucleotide, composed of modified nucleotide building blocks typically used in RNAi therapeutics, under process-like conditions. This critical milestone provides a key point of technical validation to enable pre-commercial customer testing of the platform.
  
  
• 五星体育直播 anticipates that the ECO Synthesis鈩� platform will enter pre-commercial testing with select customers in 2024. Feedback from this early access program will provide valuable insights and could lead to initial commercial licensing opportunities with those customers in 2025. The full ECO Synthesis鈩� platform is expected to be widely available to customers in 2026.
  
  
• The Company anticipates making its newly engineered, double-stranded RNA (dsRNA) ligase widely available for customers in the second half of 2024. As part of 五星体育直播鈥� initial market entry into the RNAi therapeutics space, the dsRNA ligase is designed to augment and improve traditional phosphoramidite chemistry by stitching together small, manufactured strands of RNA.
  

Third Quarter 2023 Financial Highlights

• Total revenues, excluding enzyme sales related to PAXLOVID鈩�, decreased by 57% to $9.3 million for third quarter 2023 compared to $21.5 million in third quarter 2022. Including enzyme sales related to PAXLOVID鈩�, total revenues were $9.3 million in third quarter 2023 compared to $34.5 million in third quarter 2022. On a segment basis, $8.7 million in revenue was from the Performance Enzymes segment and $0.6 million was from Biotherapeutics in third quarter 2023.
  
  
• Product revenues, excluding enzyme sales related to PAXLOVID鈩�, decreased by 64% to $5.4 million for third quarter 2023 compared to $15.1 million in third quarter 2022. Including enzyme sales related to PAXLOVID鈩�, product revenues were $5.4 million in third quarter 2023 compared to $28.0 million in third quarter 2022.
  
  
• R&D revenues for third quarter 2023 were $3.9 million compared to $6.4 million in third quarter 2022; the decrease was primarily due to lower research and development fees from existing collaboration agreements being recognized in 2023 as compared to the same period in the prior year.
  
  
• Product gross margin, excluding enzyme sales related to PAXLOVID鈩�, was 58% for third quarter 2023 compared to 55% in third quarter 2022. Including enzyme sales related to PAXLOVID鈩�, product gross margin for third quarter 2023 was 58% compared to 65% in third quarter 2022; the decrease was largely due to variability in product mix, partially offset by revenue recognized with no related cost in the third quarter of 2023.
  
  
• R&D expenses for third quarter 2023 were $13.7 million compared to $21.8 million in third quarter 2022; the decrease was primarily driven by a decrease in costs associated with lower headcount, lower lab supply costs, lower stock-based compensation costs and a decrease in outside services related to manufacturing and regulatory expenses.
  
  
• Selling, General & Administrative expenses for third quarter 2023 were $12.3 million compared to $13.5 million in third quarter 2022; the decrease was primarily due to lower stock-based compensation costs and fees for outside services.
  
  
• Third quarter 2023 expenses also included one-time restructuring charges of $3.1 million related to the reduction in force announced in July 2023, $9.2 million related to a non-cash impairment charge from the exit of the facility located in San Carlos, California and $0.8 million from a non-cash write-down of goodwill related to the Biotherapeutics segment.
  
  
• Third quarter 2023 other expense included one-time, non-cash impairment charges of $3.9 million related to investments the Company previously made in private life sciences companies.
  
  
• The net loss for third quarter 2023 was $34.9 million, or $0.50 per share, compared to a net loss of $10.0 million, or $0.15 per share, for third quarter 2022. Excluding enzyme sales related to PAXLOVID鈩�, net loss for third quarter 2022 would have been $20.0 million, or $0.31 per share.
  

• Excluding all charges related to the restructuring and impairments, net loss for third quarter 2023 was $17.9 million, or $0.26 per share.
  

• As of September 30, 2023, the Company had $74.6 million in cash and cash equivalents. 五星体育直播 expects its existing cash and cash equivalents will be sufficient to fund its planned operations to positive cash flow, expected around the end of 2026.
  

2023 Financial Guidance

五星体育直播 reiterated its 2023 financial guidance ranges originally issued on July 20, 2023, and reiterated on August 3, 2023, as follows:

• Product revenues are expected to be in the range of $30 million to $35 million, excluding enzyme sales related to PAXLOVID鈩�.
  
  
• R&D revenues are expected to be in the range of $21 million to $24 million.
  
  
• Gross margin on product revenue is expected to be in the range of 55% to 65%, excluding enzyme sales 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 p.m. 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 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 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 whether 五星体育直播 will be able to, and the timing of it demonstrating gram-scale synthesis with its ECO Synthesis鈩� technology by the end of 2023, entering pre-commercial testing with select customers in 2024, entering into initial commercial licensing opportunities in 2025 and the subsequent expected commercial launch in 2026; 五星体育直播鈥� expectations regarding 2023 total revenues, R&D revenues and gross margin on product revenue, as well as its ability to fund planned operations to the end of 2026; 五星体育直播鈥� ability to achieve positive cash flow around the end of 2026; anticipated cumulative cash savings as a result of consolidating operations; the potential of the ECO Synthesis鈩� platform, including its ability to be broadly utilized, and it providing an opportunity for 五星体育直播 to efficiently capture meaningful market share; and expectations regarding future demand for siRNA and dsRNA. 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 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, 2023, are not necessarily indicative of our operating results for any future periods.

For More Information

Investor Contact
Carrie McKim
(336) 608-9706
听

Media Contact
Lauren Musto
(781) 572-1147
听

⁽¹⁾ Research and development expenses and selling, general and administrative expenses exclude depreciation and amortization of finance leases.
⁽²⁾ Impairment charge of $0.8听million is related to the goodwill allocated to the Novel Biotherapeutics segment.
⁽³⁾ Corporate costs include unallocated selling, general and administrative expenses, unallocated asset impairment and restructuring charges, interest income, and other income (expense), net.

Released November 2, 2023