Codexis, Inc.

known and unknown risks, uncertainties, and other factors that are, in some cases, beyond Codexys' control and that could materially affect actual results. Additional information about factors that could materially affect actual results can be found in Codexys' annual report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2022, and on Form 10-Q filed with the SEC on August 5, 2022, including under the caption risk factors. and in Codexys' other periodic reports filed with the SEC. Codexys expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. I'll now turn the call over to Stephen.

Thank you, Brendan, and thanks, everyone, for joining. Since our second quarter earnings call, we've been working to refine Codexys' strategy by assessing the markets where Codexys and our proprietary CodeEvolver platform have a clear competitive advantage. This review of Codex's ongoing programs enables us to make intentional choices about where we are best equipped to drive long-term success and increased market penetration, and ultimately, where we should focus our resources. Although this is an ongoing process, we have the building blocks of a refreshed vision for the company. I look forward to providing an initial high-level view of this strategy during today's call, and anticipate drilling further into the details in the first quarter of 2023. We've recently made several exciting appointments to our leadership. Kevin Norritt, who's with us on today's call, recently joined Codexys as Chief Operating Officer. We're also delighted to welcome Meg Fitzgerald as our new Chief Legal Officer and General Counsel. with Rahul Singhvi rounding out the recent additions as a new member of our board of directors. Each of these individuals brings valuable expertise to our team and will prove critical to executing on our vision. Right now, we're very focused on prioritizing the most attractive market opportunities for our business segments and heightening our commercial discipline across the company. Our enzyme engineering platform has many potential uses, and Cadexis has undertaken many exploratory projects rooted in interesting science in both our performance enzymes and biotherapeutics business segments. In fact, we increased our R&D investment significantly during the last two years. We initiated many of these efforts when capital was easier to access and relatively inexpensive. Now, today's market reality is significantly different, so we need to react accordingly and narrow our focus. We've learned a great deal from each program in our pipeline, and we're able to apply those insights to make informed decisions about how and where we choose to invest moving forward, and whether we make these investments on our own or in partnership with others. Kevin will share additional insight on where we see opportunities for cadets to focus in the near term. One of our critical guiding factors is to ensure we maintain cash runway through the end of 2024, providing us with time and flexibility to leverage the extensive scientific capabilities and intellectual property that we have at Cadexus. Our comments today will focus on the opportunities in which we see the strongest potential for near-term economic success. Specifically, When discussing our performance enzyme segment, we will focus on our pharmaceutical manufacturing and life science businesses, which represent roughly 95% of the revenue that we generate in this segment today. Within the life sciences market, as with the rest of our business, we aim to identify and invest in programs to drive deeper value from a more concentrated set of assets. Similarly, in our biotherapeutics business, we will highlight which of our assets, based on analysis of the market opportunity and competitive environment, we view as having the greatest potential to create significant value within the next few years. We at Codexys know how to create and build a profitable business. Even when we exclude profit contribution from PaxLovid, we project our pharmaceutical manufacturing business when looked on as a standalone entity will generate a very healthy operating margin in 2022. Furthermore, we can continue to grow pharmaceutical manufacturing with modest investment. As a reminder, today we're selling enzymes for biocatalysis to pharma manufacturers for 14 therapeutic drugs that are currently approved for commercial sales. Another 20 drug candidates currently in phase two and phase three clinical trials use our enzymes in their chemistry manufacturing control process. This pipeline of potential approvals reinforces our confidence in our ability to continue to grow this sector over time. Although this is a healthy and growing business, we have work to do. Many of the larger companies have already developed or will soon develop their own biocatalytic capability. To continue to compete effectively, we must increase our commercial efforts to reach new customers and work tirelessly to improve our responsiveness and value-add proposition. Shifting now to our life science business, we believe this is an area with significant growth potential for Codexys in 2023 and beyond. We believe our Codevolver technology can make important contributions across a broad range of life sciences applications. Inevitably, This means we need to carefully choose where to invest ourselves and where to leverage others. Specifically, we view genomic sequencing and DNA and RNA synthesis as attractive markets in which CATEX's technology and products can deliver strong competitive advantage. To date, this has been publicly demonstrated by our licensing to Roche of an improved DNA ligase for NGS library prep. which continues to progress towards commercialization in new kits, as well as our development of what we believe to be a best-in-class terminal transferase enzyme for enzymatic DNA synthesis in collaboration with molecular assemblies. We will continue to leverage our core strength of developing unique engineered enzymes, or indeed suites thereof, that either enable or improve our genomics customers' product offerings, or our biopharma customers' manufacturing processes. Our goal is to focus on identifying opportunities for cadets to act as a long-term partner, ultimately providing end-to-end solutions for customer needs, as opposed to being limited to our standalone enzyme product offerings. We also remain optimistic about the value that our innovative partners, Molecular Assemblies and Sequel, bring to the equation. and we're confident they will play a key role in our path to success in the life sciences arena. Now, rounding out the performance enzyme segment, there are clearly applications for our technology in other areas such as food, nutrition, and industrial enzymes. However, these end markets represent a very small component of our current revenue, and there is considerable lift needed both in terms of investment and expertise to turn this into a profitable business. Given the market reality I outlined earlier, we'll be very thoughtful about how we spend resources here moving forward. Shifting to our biotherapeutics business. Our most advanced asset is CDX7108, a drug candidate for the treatment of exocrine pancreatic insufficiency, or EPI. This asset is being co-developed with our partners at Nestle Health Science. EPI occurs when a patient cannot produce sufficient pancreatic enzymes, specifically lipase to digest fat, protease to digest protein, and amylase to digest sugars, and leads to weight loss, metabolic disturbances, and fat malabsorption. EPI is currently treated with preparations of porcine-derived pancreatic enzymes that are enteric coated to survive the acidity of the stomach. Although the existing therapies are reasonably effective at delivering amylase and protease activity, achieving adequate levels of lipase activity is challenging, and patients often experience continuing symptoms of fat malabsorption. Despite their current limitations, the two leading therapeutics on the market today have combined annual sales of roughly $1.5 billion. CDX7108 is a potent lipase that has been specifically engineered to remain highly stable in stomach acid and overcome the limitations of existing therapies by delivering improved lipase activity with a less burdensome dosing schedule. Our partners at Nestle Health Science are currently dosing our first patients in a Phase 1b multi-dose trial, having successfully completed the volunteer portion of the study. We anticipate that in the first quarter of 2023, we'll have sufficient data to support moving forward with a phase two clinical trial. And assuming positive data, we'd expect to start the phase two trial in late 2023. PDX7108 is an attractive first entry into the biotherapeutic space. We're using our technology to improve upon a proven approach in a multibillion-dollar existing market with a partner that has already achieved commercial success. Our second clinical stage asset, CDX6114, fully outlicensed in Nestle Health Science, is an oral enzyme candidate to treat patients with phenylketonuria, one of the most common inborn errors of metabolism, or IEMs. Nestle Health Science is currently optimizing the formulation of CDX6114 to improve performance, and we expect them to initiate a phase one clinical trial in 2023. If this collaboration can successfully demonstrate benefit in PKU patients with CDX6114, this will inform our decisions around the oral enzyme approach to other IEMs. Switching now to gene therapy. While our CoDevolver technology undoubtedly has many potential applications in gene therapy, we're very well aware that this is a complex and competitive arena. Specifically, we can use CoDevolver to engineer proteins that may improve targeting and expression within the body when administered as transgenes and gene therapies, offering potentially improved therapeutic benefit as compared to the current options for treatment for conditions like Fabry disease, Pompe disease, and haemophilia A. On this front, we have a fruitful partnership with Takeda. As with our collaborations with Nestle, our partnership with Takeda is structured to help us learn, de-risk, cover costs, and ultimately leverage the power of our transgene engineering capabilities to introduce new therapeutic options for rare diseases and in markets where the unmet need remains high. We are hopeful that one of our transgene therapy assets for gene therapy partnered with Takeda should enter phase one clinical trials in late 2023 or 2024, and we look forward to providing further updates. In summary, as a relatively small company, we have an abundance of opportunities to build value, both on our own and in carefully chosen partnerships, but we need to be disciplined about how much we can successfully take on given our finite resources. Now I'd like to turn the call over to Kevin to discuss in greater detail our go-forward commercial strategy.

Thank you, Stephen. As many of you know, I've been with Codexys since the beginning of October, and since then I have been spending my time understanding our capabilities and assessing current market opportunities to determine our best bets for future commercial growth. I joined Codexys because of the impressive core science, validating partnerships, existing profitable business, and vast potential for growth across a variety of life science markets. As I have gotten to know the company over the past five weeks, I recognize that there are opportunities to increase our understanding of the commercial opportunity and to refine our customer strategy. My work is focused on driving consistent short-term revenue growth within pharmaceutical manufacturing and life sciences, as well as delivering long-term value creation through our biotherapeutics pipelines. We have a real opportunity to further communicate the Codexys value proposition to downstream customers, and I will be driving an increased commercial focus throughout the organization in the process. Let me provide you with some examples. In pharmaceutical manufacturing, we have strong relationships with many of the top pharmaceutical manufacturers in the world. Building upon this strong foundation, my goal is to improve our targeted identification process with a focus on customers that require support for both pharma manufacturing and DNA and RNA synthesis. By focusing on adjacent customers and markets, we can leverage our expertise to quickly drive commercial engagement. One near-term focus area will be increasing our reach to midsize pharma companies who are looking for cost-effective solutions to manufacture their drugs. To do this, we plan to make some refinements to our selling model and modestly increase our sales footprint. In addition, we have begun a process to take a closer look at how we are organized geographically to ensure efficiency as it relates to increased customer touchpoints. In life sciences, our initial forays have typically focused on specific enzymes for insertion into customer workflows as replacements for a particular step. While this remains a key aspect of our strategy, it is far from the only approach to this market. As we evolve our strategy in this space, we expect to target workflows more holistically, co-optimizing several enzymes for combination by our customers, and longer term, consider developing and selling kits, which could provide our customers with a more complete solution. Our overall strategy here is to move from R&D-focused revenue streams towards recurring product sales. To accomplish this, we need to develop suites of enzymes that work in tandem for our end For example, improved library prep workflows for next-generation sequencing or PCR-based approaches for RNA sequencing. Finally, in our biotherapeutics business, we are in the process of prioritizing our pipeline of assets and clarifying the investment required to reach the next critical value inflection point to support partnering or codexis-driven clinical development. With a focus on the market opportunity, competition, reimbursement, potential pricing, we plan to develop a deep understanding and clear parameters about how much to invest in an asset, when to partner, and when to stop investment. This is an exciting time for Codexys, and the key thing I want to convey today is that as we shape the go-forward plan, we are committed to prioritizing our time and financial resources on areas where we believe we have the strongest commercial opportunity and the greatest probability of success. With that, I will now turn the call over to Ross to discuss our financial results for the quarter.