Core Insights - Codexis, Inc. will present three data presentations at the TIDES Europe annual meeting, showcasing the application of its ECO Synthesis™ platform for siRNA manufacturing [1][2] Group 1: Company Overview - Codexis is a leading provider of enzymatic solutions aimed at efficient and scalable therapeutics manufacturing, utilizing its proprietary CodeEvolver® technology platform [4] - The company is developing the ECO Synthesis™ manufacturing platform to enable commercial-scale production of RNAi therapeutics through enzymatic methods [4] Group 2: Industry Context - RNA as a therapeutic modality has gained significant traction, particularly with the rise of mRNA vaccines and siRNA candidates in clinical studies [2] - There are currently over 450 RNAi therapies in clinical development, with more than 40 in Phase 2 and Phase 3 trials, indicating a growing demand that is expected to exceed current production capabilities by the end of the decade [2] Group 3: ECO Synthesis Manufacturing Platform - The ECO Synthesis™ platform aims to address scalability and cost limitations in RNAi therapeutics manufacturing, potentially allowing for commercial-scale production through enzymatic routes [3] - Codexis has demonstrated high coupling efficiency greater than 98% in enzymatic synthesis, comparable to traditional phosphoramidite chemistry, while also achieving lower impurity levels [3]

REDWOOD CITY, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced that it will report its financial results for the third quarter of 2024 on Thursday, October 31, 2024, following the close of market. Codexis management will host a conference call and webcast at 4:30 pm Eastern Time to discuss the Company's financial results and provide a business update. Participants may acces ...

Company raises $31 million through ATM, bringing cash runway into 2027 New additions to leadership in technical operations, finance and intellectual property prepare Codexis for the next phase of growth REDWOOD CITY, Calif., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced an increase in its cash reserves through capital raises totaling $31 million via the Company's existing at-the ...

Core Insights - Codexis, Inc. has entered into a non-exclusive commercial and manufacturing license agreement with Alphazyme LLC for multiple enzymes in its life science enzyme portfolio, including HiFi DNA Polymerase and HiTemp Reverse Transcriptase [1][3] - The agreement allows Codexis to receive sales-based royalties and is part of its strategy to divest non-core assets while focusing on its Pharmaceutical Manufacturing business and ECO Synthesis™ platform [3][4] Company Strategy - The partnership with Alphazyme is expected to enhance Codexis' commercial reach in the genomics segment, leveraging Alphazyme's existing sales force and experience [2][3] - Codexis aims to maintain focus on maximizing near-term commercial opportunities, including the growth of its Pharmaceutical Manufacturing business and the build-out of its ECO Synthesis™ Innovation Lab [2][3] Product Development - Codexis is developing its proprietary ECO Synthesis™ manufacturing platform to enable the commercial-scale manufacture of RNAi therapeutics through an enzymatic route, addressing scalability and cost limitations of traditional methods [5] - Recent data presented at TIDES USA 2024 demonstrated that Codexis achieved coupling efficiency greater than 98% in enzymatic synthesis, comparable to traditional phosphoramidite chemistry [5] Industry Context - Alphazyme is recognized as a premier partner for industrial-scale molecular biology enzymes, collaborating with manufacturers in the nucleic acid synthesis and detection markets [2][6] - Maravai LifeSciences, the parent company of Alphazyme, provides critical products for drug therapies, diagnostics, and vaccines, positioning itself as a leader in the life sciences sector [7]

REDWOOD CITY, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced that management will participate in two upcoming investor conferences. The Cantor Global Healthcare Conference (New York, NY) Tuesday, September 17, 2024, at 11:30 am ET, management will participate in a fireside chat The Craig-Hallum Bioprocessing Conference (Virtual) Thursday, September 19, 2024, at 2:00 pm ET, management will participate in a fireside chat A live we ...

Core Insights - Codexis, Inc. will participate in the RNA Leaders annual meeting on September 4-5, 2024, focusing on enzyme-driven manufacturing of siRNA duplexes [1][2] - The biopharmaceutical industry is advancing RNA manufacturing solutions to enhance production capacities and streamline clinical trials [2] - Codexis' presentations will highlight the cost-effective manufacturing of siRNA duplexes using engineered double-stranded RNA ligases [3] Company Developments - Codexis has launched double-stranded RNA ligase screening and optimization services, which improve siRNA manufacturing by enhancing yield and purity [3] - The ECO Synthesis™ manufacturing platform aims to address scalability and cost limitations in RNAi therapeutics production [6][8] - Recent data presented at TIDES USA 2024 showed over 98% coupling efficiency in enzymatic synthesis of siRNA, comparable to traditional methods [6][7] Industry Context - The demand for RNAi therapeutics is expected to exceed current production capabilities by the end of the decade, with over 450 RNAi therapies in clinical development [5] - Traditional chemical synthesis of RNAi therapeutics faces challenges in quality and economics, highlighting the need for innovative manufacturing solutions [5] - The growth of mRNA vaccines and siRNA candidates in clinical studies underscores the increasing relevance of RNA as a therapeutic modality [5]

Core Points - Codexis, Inc. has approved equity grants for three new employees, which include options to purchase 137,950 shares and 27,000 restricted stock units (RSUs) under the 2024 Inducement Plan [1][2] Group 1: Equity Grants - The stock options have an exercise price equal to the closing price per share on the grant date and vest over four years, with 25% vesting on the first anniversary and the remainder vesting monthly thereafter [2] - The RSUs will vest in equal annual installments until the third anniversary of the grant date, contingent on the employees' continued service [2] Group 2: Company Overview - Codexis is a leading enzyme engineering company utilizing its proprietary CodeEvolver® technology platform to develop high-performance enzymes and proteins [4] - The company addresses challenges in small molecule pharmaceuticals manufacturing and nucleic acid synthesis, and is developing the ECO Synthesis™ platform for RNAi therapeutics [4] - Codexis' enzymes aim to improve yields, reduce energy usage and waste, enhance manufacturing efficiency, and increase sensitivity in genomic and diagnostic applications [4]

Core Insights - Codexis, Inc. has published its first sustainability disclosures, detailing its environmental, social, and governance (ESG) performance for the fiscal year ending December 31, 2023, aligning with IFRS SASB guidance [1] - The company aims to enhance its sustainability performance and reporting as it continues to grow as a partner in sustainable drug manufacturing [2] Company Overview - Codexis is a leading enzyme engineering company utilizing its proprietary CodeEvolver® technology platform to develop high-performance enzymes and proteins [3] - The company is focused on addressing challenges in small molecule pharmaceuticals manufacturing and nucleic acid synthesis, and is developing the ECO Synthesis™ platform for RNAi therapeutics [3] - Codexis' enzymes contribute to higher yields, reduced energy usage, lower waste generation, and improved efficiency in manufacturing and diagnostic applications [3]

Financial Data and Key Metrics - Q2 2024 total revenues were $8 million, including $6.3 million in product revenues and $1.7 million in R&D revenues, down compared to Q2 2023 [23] - Product gross margin was 45% in Q2 2024, down from Q2 2023 due to product mix [23] - R&D expenses decreased by 34% year-over-year to $11.4 million in Q2 2024, reflecting cost-saving measures [24] - SG&A expenses were $15.7 million in Q2 2024, including a one-time $2 million stock-based compensation charge [24] - The company ended Q2 with $73.2 million in cash, cash equivalents, and investments, sufficient to fund operations through positive cash flow expected by the end of 2026 [28] Business Line Performance - The pharma manufacturing business is expected to drive strong product revenue growth in the second half of 2024, supported by existing and expected orders [6][26] - The ECO Synthesis platform has accelerated commercial momentum, with the company now engaging with major players in the siRNA manufacturing space [7] - The double-stranded RNA ligase program is gaining traction, with a large pharma customer testing the technology for a Phase 2 asset moving into Phase 3 [13] Market and Strategic Focus - The company is focused on growing its pharmaceutical manufacturing business and enabling siRNA therapeutics through the ECO Synthesis platform [4] - The ECO Synthesis platform has demonstrated the ability to synthesize full-length oligonucleotides and achieve coupling efficiency of over 98%, comparable to traditional chemical methods [8][10] - The company is targeting a stepwise approach to becoming a direct producer of GMP-grade siRNA, with plans to produce GLP-grade material in 2025 [7][18] Management Commentary on Outlook - Management reiterated full-year 2024 guidance, expecting double-digit product revenue growth and a strong second half of the year [4][22] - The company is confident in its path to positive cash flow by the end of 2026, driven by growth in the pharma manufacturing pipeline and double-stranded RNA ligase orders [28][29] - The ECO Innovation Lab and potential GMP facility are seen as key drivers of future growth and value creation [19][21] Q&A Session Summary Question: How can the ECO Synthesis platform be leveraged for drugs in clinical testing? - The platform is applicable to drugs in development or on the market, with companies showing interest in the margin improvements it offers [31][32] - The double-stranded RNA ligase provides immediate cost savings for products in clinical trials, while the full ECO Synthesis platform can be applied for sequential synthesis and ligation [33] Question: What technical milestones remain for the ECO Synthesis platform? - Key priorities include reducing cycle time for iterative additions and developing an enzymatic route for critical reagents [36] - The company is ahead of schedule, with progress in delivering constructs for proof-of-concept comparisons with traditional chemical methods [37] Question: What is the demand for the ligase optimization service? - Customers are increasingly opting for in-house optimization services, which are faster and more efficient [38] - The service has expanded the pipeline of potential candidates, with confidence in securing additional ligase orders and attracting new customers [39] Question: What is the rationale for hiring Britton Jimenez as SVP of Commercial Operations? - Britton brings 20+ years of CDMO experience, addressing a skills gap as the company enters its next growth phase [41] Question: How is the funding environment impacting customer behavior? - The funding environment has improved, with no significant pushback on innovation budgets, and customers are eager to fund projects in the siRNA space [45][46]

| --- | --- | --- | |---------------------------------|-------|----------------------| | | | | | | | | | | | | | August 8, 2024 Q2 2024 Results | | | | | | We engineer enzymes | Forward Looking Statements 1 These slides contain forward-looking statements that involve risks and uncertainties. These statements relate to future events or our future financial or operational performance and involve known and unknown risks, uncertainties and other factors that could cause our actual results or levels of activity, ...