CDXS 10-K & 10-Q changes, risk factors and insider trading
Codexis, Inc. · Nasdaq · Industrial Organic Chemicals · CIK 1200375 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “International trade policies, including tariffs, sanctions and trade barriers, may adversely affect our business.”
New heading “Our business may be affected by the evolving regulatory framework for AI Technologies”
Removed heading “RISK FACTORS SUMMARY”
Removed heading “We have investments in non-marketable securities, which may subject us to significant impairment charges.”
Largest changes
“The regulatory framework for AI Technologies is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations. Additionally, existing laws and regulations may be interpreted in ways that would affect the operation of our AI Technologies. …”see in full comparison
“International trade policies, including tariffs, sanctions and trade barriers, may adversely affect our business.”see in full comparison
“It is possible that new laws and regulations will be adopted in the United States and in other non-U.S. jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI Technologies for our business, or require us to change the way we use AI Technologies in a manner that negatively affects the performance of our products, services, and business and the way in which we use AI Technologies. …”see in full comparison
In the United States, Health Insurance Portability and Accountability Act (“HIPAA”) imposes, among other things, certain standards relating to the privacy, security, transmission and breach reporting of certain individually identifiable health information. We may obtain health information from third parties, such as research institutions with which we collaborate, that are subject to privacy and security requirements under HIPAA. Although we do not believe that we are directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we could be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information maintained by a HIPAA covered entity in a manner that is not authorized or permitted by HIPAA. Certain states have also adopted and continue to adopt new privacy and security laws and regulations, which govern the privacy, processing and protection of health-related and other personal information. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. For example, the California Consumer Privacy Act (“CCPA”)see in full comparisonwentrequires in-scope businesses to, among other things: provide certain disclosures to California residents regarding the business’s collection, use, and disclosure of their personal information; receive and respond to requests from California residents to access, delete, and correct their personal information, or to opt-out of certain disclosures of their personal information; and enter intoeffectspecific contractual provisions with service providers that process California resident personal information onJanuary 1, 2020. The CCPA creates individual privacy rights for California consumers and increasestheprivacybusiness’sand security obligations of entities handling certain personal information.behalf. The CCPA also provides for civil penalties for violations, as well as a private right of action for certain data breaches (which has increased the likelihood of, and risks associated with, data breach litigation).Further, the California Privacy Rights Act (“CPRA”) significantly amended the CCPA, which went into effect in January 2023. It imposes additional data privacy obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data and opt outs for certain uses of sensitive data. It also created a new California privacy protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement. Additional compliance investment and potential business process changes may also be required as these laws continue to evolve.Similar laws regulating personal information generally or health information in particular have passed inmore than a dozenother states and have been proposed inotheradditional states and at the federal level, reflecting a trend toward more stringent privacy legislation in the United States. The same is true for emerging laws and regulations related to AI. These developments increase our compliance burden and our risk, including risks of regulatory fines, litigation and associated reputational harm. Any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.
“Current or future tariffs will also result in increased research and development expenses, including with respect to increased costs associated with raw materials, laboratory equipment and research materials and components, for our customers, or collaborators and us. In addition, such tariffs may increase our supply chain complexity and could also potentially disrupt our existing supply chain. …”see in full comparison
“We have investments in non-marketable securities, which may subject us to significant impairment charges.”see in full comparison
Full comparison: every changed paragraph (101)
You should carefully consider the risks described below together with the other information set forth in this Annual Report on Form 10-K, which could materially affect our business, financial condition or future results. The risks described below are not the only risks facing our company. Risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. Additional discussion of the material risks and uncertainties summarized in this risk factor summary, as well as certain other risks and uncertainties that we face, can be found in this section.
RISK FACTORS SUMMARY
The following is a summary of the principal factors that cause an investment in the Company to be speculative or risky:
•We have a history of net losses and we may not achieve or maintain profitability.
•Therapeutics development prorams are highly regulated and expensive, and our enzyme products are complex and subject to quality control requirements. The ability of our customers, future customers or collaborators, including any company developing RNAi and other RNA-based therapeutics, to advance product candidates utilizing our products to clinical trials and to ultimately receive regulatory approvals is highly uncertain.
•We believe that our products are exempt from Food, Drug, and Cosmetic Act (“FDCA”) requirements, but FDA or other regulators may disagree and find that our products are subject to such requirements.
•We are dependent on a limited number of customers.
•Some of our product supply agreements with customers have finite duration and may not be extended or renewed.
•The demand for our product depends in part on our customers' research and development and the clinical and market success of their products.
•If we are unable to develop and commercialize new products for our target markets, our business and prospects will be harmed.
•A reduction or delay in government funding of research and development for our customers may adversely affect our business.
•With respect to customers purchasing our products for the manufacture of API for which they have exclusivity due to patent protection, the termination or expiration of such patent protection and any resulting generic competition may materially and adversely affect our revenues, financial condition or results of operations.
•The services and offerings we provide are highly complex, and if we encounter problems providing the services or support required, our business could suffer.
•Any productivity issues or higher-than-expected costs at our facilities could result in material and adverse impacts on our financial condition and results of operations.
•We are dependent on a limited number of third-party contract manufacturers for large scale production of substantially all of our enzymes.
•We are dependent on our collaborators, and our failure to successfully manage these relationships could prevent us from developing and commercializing many of our products.
•We have invested significant resources to enable enzymatic nucleic acid synthesis, which is based on novel ideas and technologies that are largely unproven.
•As a result of our strategic shift and our refined focus on the revenue-generating pharma biocatalysis business and the ECO Synthesis platform, we may fail to capitalize on other opportunities that may be more profitable or for which there is a greater likelihood of success.
•Given our change in strategic direction, we may receive limited revenue or no future value from certain of our existing license agreements.
•The timing of customer orders and related product revenue recognition is unpredictable and may cause our operating results to vary significantly from quarter to quarter, which could adversely affect our stock price.
•We use hazardous materials in our business, and we must comply with environmental laws and regulations.
•We may need additional capital in the future in order to expand our business.
•We may not be able to comply with the terms of our five-year term loan and security agreement (our “Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”), an affiliate of Innovatus Capital Partners, LLC.
•Even if our customers or collaborators obtain regulatory approval for any products utilizing our enzymes, such products will remain subject to ongoing regulatory requirements, which may result in significant additional expense.
•If we or our customers fail to comply with certain healthcare laws, including fraud and abuse laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.
•Our efforts to prosecute, maintain, protect and/or defend our intellectual property rights may not be successful.
•Third parties may claim that we are infringing, violating or misappropriating their intellectual property rights, which may subject us to costly and time-consuming litigation and prevent us from developing or commercializing our technology, products or services.
•We may be involved in lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful.
•If our biocatalysts are stolen, misappropriated or reverse engineered, others could use these biocatalysts to produce competing products.
•We are subject to anti-takeover provisions in our certificate of incorporation and bylaws and under Delaware law that could delay or prevent an acquisition of our company.
•Market and economic conditions may negatively impact our business, financial condition, and share price.
•Business interruptions resulting from political events, disasters or other disturbances could delay us in the process of developing our products and could disrupt our sales.
We have incurred net losses since our inception, including losses of $65.3$44.0 million, $76.2$65.3 million, and $33.6$76.2 million for the years ended December 31, 2025, 2024, 2023, and 2022,2023, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $562.8$606.8 million. If we are unable to continue to successfully develop and commercialize products in our pharma biocatalysis business, increase sales of existing products and services, develop and commercialize our ECO Synthesis manufacturing platform, and or develop new products or services, or otherwise expand our business, whether through new or expanded collaborations or other products and services, our net losses may increase and we may never achieve profitability. In addition, some of our agreements, including the agreements with GSK,GlaxoSmithKline Merck,plc Novartis,(“GSK”), Nestlé,Merck Aldevron,Sharp Roche,& Dohme (“Merck”), Novartis Pharma AG (“Novartis”), Nestlé Health Science (“Nestlé”), Aldevron LLC, Roche Sequencing Solutions, Inc., Crosswalk Therapeutics and Alphazyme LLC, provide for milestone payments, usage payments, and/or future royalty or other payments, which we will only receive if we and/or our collaborators develop and commercialize products or achieve technical milestones. We also intend to continue to fund the development of additional proprietary performance enzyme products and advance new technologies like our ECO Synthesis manufacturing platform. There can be no assurance that any of these products or services will become commercially viable or that we will ever achieve profitability on a quarterly or annual basis. If we fail to achieve profitability, or if the time required to achieve profitability is longer than we anticipate, we may not be able to continue our business. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
Although we are no longer developing our own portfolio of biotherapeutics product candidates, we continue toWe develop enzyme products, including our ECO Synthesis manufacturing platform, that are used by our customers, and that may be used by our customers, future customers or collaborators in connection with their biotherapeutic product candidates. The successful development of biotherapeutic candidates involves many risks and uncertainties, requires long timelines and may lead to uncertain results.
In order toTo market a biologic or drug product in the United States, our customers, future customers or collaborators must undergo the following process required by the FDA:
•completion of extensive preclinical laboratory tests and preclinical animal studies, allcertain of which must be performed in accordance with the FDA's Good Laboratory Practice requirements;
•submission to the FDA of an IND,Investigational New Drug Application, which must become effective before human clinical studies may begin in the United States;
•approval by an independent institutional review board (“IRB”)or ethics committee representing each clinical site before the clinical study may be initiated at the site;
•performance of adequate and well-controlled human clinical studies in accordance with GCPGood Clinical Practice requirements to establish the safety, purity and potency (or efficacy) of the product candidate for each proposed indication;
•preparation of and submission to the FDA of ana New Drug Application (“NDA”) or Biologics License Application (“BLA”) after completion of all clinical studies;
We believe our enzyme products are exempt from compliance with the FDCA and the implementingFDA’s GMP regulationsimplementing of the FDA,regulations, as our products are further processed and not incorporated into final drug or biologic products by our customers and as we do not make claims related to theirour products’ safety or effectiveness. Our products are currently manufactured following the voluntary quality standards of ISO 9001:2015, and we have collaborations with a number of CDMOs, and anticipate signing and announcing aadditional partnership with a CDMOpartnerships to provide enzymatically synthesized, GMP-grade siRNA to customers in the near term. Our planned collaboration with a CDMOCDMOs may not come to fruition and, even if it does, may not scale up as anticipated. Even if the scale up plans succeed, we or the CDMO may incur delays in production or have insufficient product for consumers.customers. And, in the event we, or our suppliers, produce products that fail to comply with voluntary quality standards or GMP standards imposed by customers, we may incur delays in fulfilling orders, write-downs or other losses, damages resulting from product liability claims and harm to our reputation.
In the future, our products could become subject to more onerous regulation, or the FDA could disagree with our assessment that our enzyme products are exempt from current GMPcGMP regulations. In addition, the FDA could conclude that the products we provide to our customers are actually subject to the pharmaceutical, drug or biologic quality-related regulations for manufacturing, processing, packing or holding of drugs, biologics, or finished pharmaceuticals, and could take enforcement action against us, including requiring us to stop distribution of our products until we are in compliance with applicable regulations, which would reduce our revenue, increase our costs and adversely affect our business, prospects, results of operations and financial condition.
Although we continue to expand our customer base, our current revenues are derived from a limited number of key customers. For the years ended December 31, 20242025 and 2023,2024, customers that each individually contributed 10% or more of our total revenue accounted for 51% and 35% of our total revenues, respectively.revenues. We expect a limited number of customers to continue to account for a significant portion of our revenues for the foreseeable future. This customer concentration increases the risk of quarterly fluctuations in our revenues and operating results. The loss or reduction of business from one or a combination of our significant customers could,could materially adversely affect our revenues, financial condition and results of operations.
If we are unable to develop and commercialize new products for the pharmaceutical, biotherapeutics, diagnosticspharmaceutical and life science tools markets, our business and prospects will be harmed.
We plan to launchcontinue to innovate new productstechnologies for use in the pharmaceutical, biotherapeutics, diagnosticspharmaceutical and other life science tools markets such as our ECO Synthesis manufacturing platform.markets. These efforts are subject to numerous risks, including the following:
A portion of our revenue is derived from customers whose funding is partially dependent on both the level and timing of funding from government sources, which funding can be difficult to forecast. Government funding of research and development is subject to the political process, which is inherently fluid and unpredictable. Our revenue may be adversely affected if our customers delay or limit purchases as a result of uncertainties surrounding the approval of government budget proposals, including reduced allocations to government agencies that fund research and development activities. If government proposals to reduce or eliminate budgetary deficits result in reduced allocations to government agencies that fund research and development activities, orour results of operations may be materially adversely affected.
With respect to customers purchasing our products for theuse manufacturein ofmanufacturing APIs for which they have exclusivity due to patent protection, the termination or expiration of such patent protection and any resulting generic competition may materially and adversely affect our revenues, financial condition or results of operations.
With respect to customers purchasing our products for the manufacture of API, or to lead to the manufacture of API, for which exclusivity due to patent protection has or is about to expire, we can expect that the quantity of our products sold to such customers for such products may decline as generic competition for the API increases. While we anticipate that we may, in some cases, also be able to sell products to these generic competitors for the manufacture of these APIs, or lead to the manufacture of these APIs, the overall effect on our revenues, financial condition and results of operations could be materially adverse.
We are dependent on a limited number of third-party contract manufacturers for large scale production of substantially all of our enzymes. We are working to qualify new contract manufacturers to produce certain of our enzymes, however those efforts may not be successful and therefore we may experience limitations on our ability to supply our enzymes to customers.
ManufacturingWe ofmanufacture our enzymes is conducted primarily in four locations: our in-house facility in Redwood City, California, and at three third-party contract manufacturing organizations (“CMOs”): Lactosan in Kapfenberg, Austria, ACS Dobfar S.p.A. (“ACSD”) (formerly known as DPhar S.p.A.) in Anagni, Italy, and Sekisui Diagnostics in Maidstone, United Kingdom. Generally, we perform smaller scale manufacturing in-house and outsource the larger scale manufacturing to these contract manufacturers. We have limited internal capacity to manufacture enzymes. As a result, we are dependent upon the performance and capacity of third-party manufacturers for the larger scale manufacturing of the enzymes used in our pharmaceutical and life sciences businesses.
Accordingly, we face risks of difficulties with, and interruptions in, performance by third partythird-party manufacturers, the occurrence of which could adversely impact the availability, launch and/or sales of our enzymes in the future. Enzyme manufacturing capacity limitations at our third-party manufacturers and manufacturing delays could negatively affect our business, reputation, results of operations and financial condition. The failure of any contract manufacturer to supply us our required volumes of enzyme on a timely basis, or to manufacture our enzymes in compliance with our specifications or applicable quality requirements or in volumes sufficient to meet demand, would adversely affect our ability to sell pharmaceutical and complex chemicals products, could harm our relationships with our customers or collaborators and could negatively affect our revenues and operating results. We may be forced to secure alternative sources of supply, which may be unavailable on commercially acceptable terms, and could cause interruptions or delays in our ability to deliver products to our customers, increase our costs and decrease our profit margins.
Furthermore, as we currently,and may in the future, rely on foreign CMOs, such foreign CMOs may be subject to U.S. legislation, sanctions, trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies. For example, the U.S. BIOSECURE Act, which was enacted in December 2025, prohibits federal agencies from procuring or using any biotechnology equipment or services from “biotechnology companies of concern”, or entering into, extending, or renewing any contracts with entities that use such biotechnology equipment or services from “biotechnology companies of concern”. Congress has interpreted a “biotechnology company of concern” as an entity that is under the control of a foreign adversary and that poses a risk to national security based on its research or multiomic data collection (e.g., collection of genomic information). While the U.S. BIOSECURE Act has a grandfathering period of five years for existing contracts, and has carveouts for manufacture of drugs for supply under Medicaid and Medicare Part B, subject to the Secretary of Veterans Affairs’ discretion, the impact of the U.S. BIOSECURE Act on the biotechnology industry is uncertain. This and similar laws could have the potential to restrict the ability of biopharmaceutical companies like us to purchase services or products from, or otherwise collaborate with, certain biotechnology companies “of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S. government. It is possible some of our contractual counterparties could be impacted by this or future legislation.
We have invested significant resources to enable enzymatic nucleic acid synthesis, which is based on novel ideas and technologies that are largely unproven. Failure to validate performance at scale, demonstrate regulatory acceptance, or overcome other challenges with the new technologies could impede customer adoption and our revenues.
Other challenges with a new technology such as our ECO Synthesis manufacturing platform include having an unknown and unproven development and regulatory path, uncertainlyuncertainty around the value that we can realize from the technology, uncertainty around the timeline for adoption of the technology by customers, and uncertainlyuncertainty around our ability to secure supply of necessary materials or to manufacture at GMP at scale and partner with customers on manufacturing and utilizing the technology. We may also be unable to achieve the expected benefits of the ECO Synthesis manufacturing platform in a timely manner, or at all.
We face competitive challenges related to our ECO Synthesis manufacturing platform. The current industry standard for manufacturing RNAi therapeutics is a well-established, chemical-based method, solid-phase oligonucleotide synthesis, utilizing phosphoramidite chemistry. Primary competitors in this space include CDMOs, such as Agilent Technologies, which has made significant capital investment to expand their RNA manufacturing capabilities using phosphoramidite chemistry. In addition, CDMOs and large pharmaceutical companies are seeking to make incremental improvements to phosphoramidite chemistry, including the development of ligation-based approaches, liquid-phase synthesis, and solvent recycling. There are also multiple early-stage competitors who are pursuing fully enzymatic approaches to the manufacture of RNA, including EnPlusOne Biosciences, a private startup company, and a UK-based consortium led by CPI and consisting of multiple academic and research organizations, including The University of Manchester and large pharmaceutical companies, including AstraZeneca plc and Novartis.
We are aware that other companies, including Ginkgo Bioworks, BRAIN,BRAIN Biotech AG, and Enzymicals AG, have alternative methods for obtaining and generating genetic diversity or use mutagenesis techniques to produce genetic diversity. Some companies, including Biomatter Designs, Arzeda,Arzeda Corp., and Enzymaster, leverage predictive computational algorithms to guide enzyme engineering efforts. In addition, academic institutions such as the California Institute of Technology, University of Washington, University of Manchester, and the Austrian Centre of Industrial Biotechnology are also working in this field. Technological development by others may result in our technology, products and services, as well as products developed by our customers using our biocatalysts, becoming obsolete.
The market for the manufacture and supply of APIs and intermediates is large with many established companies. These companies include many of our large innovator and generic pharmaceutical customers, such as Merck, GSK, Novartis, Pfizer,Pfizer Bristol-Myers,Inc., Kyorin,Bristol-Myers Urovant,Squibb, Kyorin Pharmaceutical Corporation, and Teva Pharmaceuticals, which have significant internal research and development efforts directed at developing processes to manufacture APIs and intermediates. The processes used by these companies include classical conventional organic chemistry reactions, chemo catalytic reactions, biocatalytic reactions or combinations thereof. Our biocatalytic based manufacturing processes must compete with these internally developed routes. Additionally, we also face competition from companies developing and marketing conventional catalysts such as Solvias Inc., BASF and Takasago International Corporation.
The market for supplying enzymes for use in pharma biocatalysis is fragmented. There is competition from large industrial enzyme companies, such as Novozymes and DuPont, as well as subsidiaries of larger contract research/contract manufacturing organizations,CMOs, such as DSM,DSM-Firmenich AG, Cambrex Corporation, Lonza,Lonza Group, WuXi STA and Almac Group Ltd. Some fermentation pathway design companies, like Ginkgo Bioworks (who recently acquired Zymergen),Bioworks, whose traditional focus has been to design microorganisms that express small molecule chemicals, could extend into designing organisms that express enzymes. There is also competition in the enzyme customization and optimization area from several smaller companies, such as BRAIN Biotech AG, Arzeda Corp., and c-LEcta GmbH and Evocatal GmbH.
We face competitive challenges related to our ECO Synthesis manufacturing platform. The current industry standard for manufacturing RNAi therapeutics is a well-established, chemical-based method, SPOS, utilizing phosphoramidite chemistry. Primary competitors in this space include CDMOs, such as Agilent Technologies, which has made significant capital investment to expand their RNA manufacturing capabilities using phosphoramidite chemistry. In addition, CDMOs and large pharmaceutical companies are seeking to make incremental improvements to phosphoramidite chemistry, including the development of ligation-based approaches, liquid-phase synthesis, and solvent recycling. There are also multiple early-stage competitors who are pursuing fully enzymatic approaches to the manufacture of RNA, including EnPlusOne Biosciences, a private startup company, and a UK-based consortium led by CPI and consisting of multiple academic and research organizations, including The University of Manchester and large pharmaceutical companies, including AstraZeneca plc and Novartis.
Our ability to compete successfully in any of these markets will depend on our ability to develop proprietary products that reach the market in a timely manner and are technologically superior to and/or are less expensive than other products on the market. Many of our competitors have substantially greater production, financial, research and development, personnel and marketing resources than we do. They also started developing products earlier than we did, which may allow them to establish blocking intellectual property positions or bring products to market before we can. In addition, certain of our competitors may also benefit from local government subsidies and other incentives that are not available to us. As a result, our competitors may be able to develop competing and/or superior technologies and processes andprocesses, compete more aggressively and sustain that competition over a longer period of time than we could. Our technologies and products may be rendered obsolete or uneconomical by technological advances or entirely different approaches developed by one or more of our competitors. We cannot be certain that any products we develop in the future will compare favorably to products offered by our competitors or that our existing or future products will compare favorably to any new products that are developed by our competitors. As more companies develop new intellectual property in our markets, the possibility of a competitor acquiring patent or other rights that may limit our products or potential products increases, and could additionally lead to litigation.
Management's Discussion & Analysis (MD&A)
New heading “ECO Synthesis manufacturing platform”
New heading “Small molecule pharma biocatalysis”
New heading “2025 compared to 2024”
New heading “2024 compared to 2023”
Removed heading “Recent Developments”
Removed heading “Finalized Acquisition and License Agreement for certain non-core Life Sciences assets”
Removed heading “Strengthened Board of Directors with new appointments”
Removed heading “Investment in Non-Marketable Securities”
Removed heading “Investment in Non-Marketable Equity Securities”
Largest changes
“Net loss for 2023 was $76.2 million, or a net loss per basic and diluted share of $1.12. This compared to a net loss of $33.6 million, or $0.51 per basic and diluted share, for 2022. The increase in net loss was primarily related to lower product revenues from CDX-616 and one-time charges recognized during 2023 related to asset impairment, including impairment in our investments in non-marketable equity securities, and restructuring charges, which was partially offset by lower operating expenses in 2023.”see in full comparison
“Finalized Acquisition and License Agreement for certain non-core Life Sciences assets”see in full comparison
Full comparison: every changed paragraph (74)
The following management's discussion and analysis of our financial condition and results of operations should be read in conjunction with our audited consolidated financial statements and the related notes thereto included elsewhere in this Annual Report on Form 10-K. This Annual Report on Form 10-K 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 (the “Exchange Act”). These statements include, but are not limited to, expectations regarding our strategy, business plans, financial performance and developments relating to our industry. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “estimate,” or “continue,” and similar expressions or variations. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part I, Item IA1A: "Risk Factors," of this Annual Report on Form 10-K and elsewhere in this report. The forward-looking statements in this Annual Report on Form 10-K represent our views as of the date of this Annual Report on Form 10-K. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Annual Report on Form 10-K.
We are a leading provider of enzymatictechnology solutions forto efficient and scalableimprove therapeutics manufacturing,manufacturing. andWe wefocus leverageon impacting the manufacturing process by using our proprietary CodeEvolver directed evolution technology platform to discover, develop, enhance, and commercialize novel, high-performance enzymes and other classes of proteins. Enzymes are naturally occurring biological molecules critical to almost all biochemical reactions that sustain life.reactions. They can be precisely engineered and optimized for specific functions, and to have particular characteristics, such as an ability to survive environments in which natural enzymes cannot, or to perform (bio)chemical transformations that are different than those for which they naturally evolved. We focus on leveragingemploy our technology and capacityexpertise to enhance the properties and performance of enzymes to drive pivotal improvements in manufacturing of complex therapeutics across two key focus areas: our foundational, revenue-generating pharma biocatalysis business and our Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis (“ECO Synthesis”) manufacturing platform, which is comprised of enzymatic tools and processes, designed to enable large-scale manufacture of RNA interference (“RNAi”) therapeutics. In July 2023, we announced that we discontinued investment in certain development programs, primarily in our novel biotherapeutics business segment. As part of this strategic prioritization, during 2024, we completed the divestiture and monetization of certain biotherapeutics assets as well as certain non-core life science assets, including in genomics and next generation sequencing applications.
ECO Synthesis manufacturing platform
In our revenue-generating pharma biocatalysis business (formerly our pharmaceuticals manufacturing business), we utilize our CodeEvolver technology platform to develop optimized enzymes that are used by some of the world’s largest pharmaceutical companies to improve the efficiency and productivity of their manufacturing processes for small molecule therapeutics. Our unique enzymes drive improvements such as higher yields, increased purity, reduced energy usage and waste generation, all of which lead to improved efficiency and reduced costs in small-molecule manufacturing.
Our ECO Synthesis® manufacturing platform is comprised of enzymatic tools and processes that are designed to enable large-scale manufacture of RNA interference (“RNAi”) therapeutics. We also use the CodeEvolver platform technology to develop enzymes for the synthesis of RNAi therapeutics throughin ourproduction ECOprocesses Synthesis manufacturing platform, where our enzymes are poised tothat deliver manyimprovements, of the same benefits we offer in pharma biocatalysis acrossincluding purity, yield, and improved manufacturing efficiency. In November 2024, we presented data at the TIDES EUEurope conference demonstrating the successful end-to-end enzymatic synthesis of an entire commercially approved small interfering ribonucleic acid (“siRNA”) therapeutic asset with the ECO Synthesis manufacturing platform. In addition to using full enzymatic sequential synthesis, adding one nucleotide at a time to synthesize the two strands from beginning to end, we demonstrated synthesis of the same siRNA asset using three other routes utilizing enzymatic ligation with our double-stranded RNA (“dsRNA”) ligase, which can stitch together fragments of chemically and/or enzymatically synthesized RNA to form the full siRNA drug structure. For the three other routes, our data highlighted that full-length oligosoligonucleotides of equal quality and yields were obtained whether the fragments were made with enzymes or by traditional phosphoramiditesolid chemistry.phase oligonucleotide synthesis (“SPOS”) (current standard production route for oligonucleotide manufacturing). At the end of 2024, we completed the build-outbuild out of our ECO Synthesis Innovation Lab, a facility that useswhere our ECO Synthesis manufacturing platform is deployed to synthesize gram-scale quantities of a customer’s desired siRNA construct suitable for pre-clinical testing. In addition, the infrastructure allows us to provide process development, analytical method development and other manufacturing process optimization which is required to enable the siRNA to proceed to clinical-stage manufacturing and testing. In 2025, we expectsuccessfully tomanufactured manufacturenon-good good laboratorymanufacturing practice (“GLPGMP”)-grade siRNA drug substance for customers in our Innovation Lab under development services contractscontracts. model,We andalso weentered anticipateinto entering a partnershippartnerships with athree large-scale contract development and manufacturing organizationorganizations (“CDMOCDMOs”) to useevaluate our ECO Synthesis platform of enzymatic tools and processes to ultimately synthesize good manufacturing practices (“GMP”)-gradeGMP-grade siRNA drug substance for our customers. In each of these agreements, we are currently in the feasibility testing stage and expect to advance at least one of these partnerships, including initiating a technology transfer to that organization, in 2026. We believe these relationships to be a vital extension of our strategy to be a technology solutions provider for our customers. Through these arrangements, our customers will have access to proven, large-scale commercial manufacturers who are familiar with our process, who can then offer a seamless manufacturing scale-up of our customers’ products. We expect to expand our enzymatic tools and process offeringofferings as we further enhance the ECO Synthesis manufacturing platform to address the overall market needs for scalable and sustainable RNAi manufacturing.
Small molecule pharma biocatalysis
In our small molecule pharma biocatalysis business, we utilize our CodeEvolver technology platform to develop optimized enzymes that are used by some of the world’s largest pharmaceutical companies to improve the efficiency and productivity of their manufacturing processes for small molecule therapeutics. Our unique enzymes drive improvements such as higher yields, increased purity, reduced energy usage and waste generation, all of which lead to improved efficiency and reduced costs in small-molecule manufacturing.
Recent Developments
Finalized Acquisition and License Agreement for certain non-core Life Sciences assets
In line with our strategy relating to non-core Life Sciences assets, in January 2025 we sold assets that were developed under the seqWell Agreement to seqWell in exchange for the right to receive a cash payment upon future events and a warrant to purchase seqWell’s common stock exercisable upon future events, and terminated the seqWell Agreement.
Strengthened Board of Directors with new appointments
We announced the appointment of Raymond De Vré, PhD, to our Board of Directors on November 12, 2024, followed by the appointment of Christos Richards on January 16, 2025.
In May 2021, we filed a Registration Statement on Form S-3 with the SEC, that automatically became effective upon its filing, under which we may sell common stock, preferred stock, debt securities, warrants, purchase contracts, and units from time to time in one or more offerings. On February 27, 2023, we filed a post-effective amendment to that Registration Statement on Form S-3. Pursuant to that post-effective amendment, we registered an aggregate $200.0 million of securities. In May 2021, we entered into an Equity Distribution Agreement (“EDA”) with Piper Sandler & CoCo. (“PSC”), under which PSC, as our exclusive agent, at our discretion and at such times that we determined from time to time, may have sold over a three-year period from the execution of the EDA up to a maximum of $50.0 million of shares of our common stock. Under the terms of the EDA, PSC was permitted to sell the shares at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”). We were not required to sell any shares at any time during the term of the EDA. On April 24, 2024, we terminated the EDA. No shares of our common stock were issued and sold pursuant to the EDA during the year ended December 31, 2024. During the year ended December 31, 2023, 3,079,421 shares of our common stock were issued and sold pursuant to the EDA for gross proceeds of $8.7 million, or $7.9 million in net proceeds after PSC's commissions and direct offering expenses of $0.7 million.
On May 2, 2024, we entered into a Controlled Equity Offering℠ Sales℠ Agreement (the “Cantor Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), under which Cantor, at our discretion and at such times that we may determine from time to time, may sell up to a maximum of $75.0 million of shares of our common stock. Under the terms of the Cantor Sales Agreement, Cantor may sell the shares at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act. On May 2, 2024, we filed a registration statement on Form S-3 registering the offer and sale of these shares under the Securities Act which became effective on May 14, 2024. We will pay a commission of up to 3.0% of gross sales proceeds of any common stock sold under the Cantor Sales Agreement. During the year ended December 31,In 2024, 10,440,000 shares of our common stock were issued and sold pursuant to the Cantor Sales Agreement and we received grossnet proceeds of $31.3 million, or $29.7 million in net proceeds after Cantor’s commissions and direct offering expensesexpenses. During the year ended December 31, 2025, 7,244,966 shares of $1.6our million.common stock were issued and sold pursuant to the Cantor Sales Agreement, all during the second quarter of 2025, and we received net proceeds of $16.4 million after Cantor’s commissions and direct offering expenses. As of December 31, 2024,2025, $43.7$26.4 million remained available for sale under the Cantor Sales Agreement.
On February 13, 2024, we entered into a five-year term loan and security agreement (the “Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”), an affiliate of Innovatus Capital Partners, LLC, as Lender, consisting of up to two tranches, of which the first tranche of $30.0 million was disbursed upon execution of the Loan Agreement.Agreement We will be eligible to draw onand the second tranche of $10.0 million was funded on June 27, 2025 upon achievement of certain milestonesfinancial including certain pre-specified revenue thresholds and subject to payment of a facility fee equal to 1.00% of the amount of such term loan.milestones. The Term Loan carries an interest-only period of 36 months (with the possibility to extend up to 48 months upon achievement of certain pre-specified financial milestones) and will bear interest at a floating rate of the sum of (a) the greater of (i) prime rate and (ii) 7.50%, plus (b) 3.25%.
•Product revenue consistconsists of sales of biocatalysts,biocatalysts used in the manufacture of small molecule active pharmaceutical intermediates, enzymes such as dsRNA ligase used in the manufacture of siRNA molecules, enzymes for the molecular biology and diagnostic markets, and Codex™ biocatalyst panels and kits.
•Research and development revenue includeincludes license, technology access and exclusivity fees, research services fees, milestone payments, royalties, optimization and screening fees.
Revenues typically fluctuate on a quarterly basis due to the variability in our customers'customers’ manufacturing schedules and the timing of our customers'customers’ clinical trials. In addition, we have limited internal capacity to manufacture enzymes. As a result, we are dependent upon the performance and capacity of third partythird-party manufacturers for the commercial scale manufacturing of the enzymes used in our pharmaceuticalpharma biocatalysis, ECO and finemolecular chemicalsbiology business.and diagnostics enzymes businesses.
2025 compared to 2024
Total revenues decreasedincreased by $10.8$11.0 million in 20242025 to $59.3$70.4 million, as compared to 2023.2024. The decreaseincrease was primarily driven by lower product revenue and lowerhigher research and development revenue as compared to the prior year.
Product revenue was $26.0 million in 2025, a decrease of 29% compared with $36.8 million in 2024. The decrease in product revenue was primarily due to variability in manufacturing schedules and timing in clinical trial progression of our customers, which impacted order volumes for our enzyme products.
Product revenue was $36.8 million in 2024, a decrease of 14% compared with $42.9 million in 2023. The decrease in product revenue was primarily due to one-time revenue recognition of $8.2 million in 2023 related to Pfizer's fee previously received under the Enzyme Supply Agreement with Pfizer Ireland Pharmaceuticals, a subsidiary of Pfizer, Inc., a $2.9 million decrease due to the early termination of an enzyme supply agreement with a customer in 2023, and the one-time recognition of a $1.3 million settlement fee in 2023 under the same enzyme supply agreement. This decrease was partially offset with higher sales of branded pharmaceutical products in 2024.
Research and development revenue decreasedincreased by $4.7$21.8 million in 20242025 to $22.6$44.4 million, or 17%97% compared with $27.2$22.6 million in 2023.2024. The decreaseincrease was primarily due to $9.1$34.0 million lower research and development fees from Nestlé Health Science (“Nestlé”), the one-time recognition of $5.0 million revenue related to a license agreement in 2023 and $2.0 million lowerhigher revenue from our master servicelicensing agreements with PfizerMerck Inc.entered (“Pfizer”),into $1.2during the second and fourth quarters of 2025, and $3.3 million lowerhigher revenue from Takeda Pharmaceutical Co. Ltd. under a Strategic Collaborationexisting and License Agreement, and $4.3 million lower revenue from other legacy collaboration agreements. This decreaseincrease was partially offset by the non-recurrence of $6.0 million higher revenue from our licensing agreement with Roche Sequencing Solutions, Inc. (“Roche”) entered into in February 2024, recognition ofand $9.5 million of revenue related to a license agreement with Pfizer Inc. (“Pfizer”) entered into in December 2024, and $1.9 million higher revenue from existing collaboration agreements.2024.
2024 compared to 2023
For a discussion of our results of operations pertaining to 2024 as compared to 2023 see Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024 (filed with the Securities and Exchange Commission on February 27, 2025).
Total revenues decreased by $68.4 million in 2023 to $70.1 million, as compared to 2022. The decrease was driven by lower product revenue as compared to the prior year.
Product revenue was $42.9 million in 2023, a decrease of 63% compared with $116.7 million in 2022. The decrease in product revenue was primarily due to decreased sales of CDX-616 to Pfizer. This decrease was partially offset by $8.2 million release of prior year's deferrals related to Pfizer's fee, $3.2 million release of prior periods' product revenue deferrals due to early termination of the enzyme supply obligations to a customer and $1.3 million of product revenue recognized as settlement fee pursuant to the enzyme supply agreement with the same customer.
Research and development revenue increased by $5.3 million in 2023 to $27.2 million, or 24% compared with $21.9 million in 2022, primarily due to higher revenue from a 2023 Pfizer license agreement and from Nestlé Health Science under a Strategic Collaboration Agreement with Nestlé (the “Nestlé SCA”) and development agreement and an acquisition agreement with Nestlé (the “Acquisition Agreement”), which was partially offset by lower research and development fees from existing collaboration agreements being recognized in 2023 as compared to the prior year.
Cost of product revenue decreased by $7.0 million in 2025 to $9.3 million, as compared to 2024. Product gross margins increased to 64% in 2025 as compared to 56% in 2024. The changes in cost of product revenue and product gross margin are primarily due to shift in sales toward more profitable products, and declines in less profitable legacy products.
Cost of product revenue increased by $3.5 million in 2024 to $16.3 million, as compared to 2023. The increase was primarily due to the combination of increased sales of certain enzyme product and higher costs. Product gross margins decreased to 56% in 2024 as compared to 70% in 2023, primarily due to variability in the product mix and with 2023 benefiting from product revenue recognized with no related cost in 2023 related to the utilization of Pfizer’s fee and to the early termination of an enzyme supply agreement with a customer.
Cost of product revenue decreased by $25.2 million in 2023 to $12.8 million, as compared to 2022. The decrease was primarily due to lower volume of product sales as compared to the prior year. Product gross margins increased to 70% in 2023 as compared to 67% in 2022, primarily due to product revenue recognized with no related costs in 2023 related to the utilization of Pfizer's fee and early termination of an enzyme supply agreement with a customer, and was partially offset by variability in the product mix.
Research and development expenses were $52.3 million in 2025 compared to $46.3 million in 2024, an increase of $6.0 million, or 13%. This increase was primarily due to a $2.3 million increase in employee-related costs, $1.4 million in higher lab supplies, $3.7 million in higher allocable costs and $0.2 million in higher depreciation expenses. These were partially offset by a $1.3 million decrease from lower use of outside services related to Chemistry, Manufacturing and Controls procedures (“CMC”) and $0.7 million in lower stock-based compensation expense.
Research and development expenses were $46.3 million in 2024 compared to $58.9 million in 2023, a decrease of $12.6 million, or 21%. This decrease was primarily due to a $4.4 million decrease from lower use of outside services related to Chemistry, Manufacturing and Controls procedures (“CMC”) and lower regulatory expense, $4.3 million decrease in costs associated with lower headcount, $3.8 million decrease from lower lease and facilities costs due to the assignment of our San Carlos facility lease during the fourth quarter of 2023, and $0.3 million in lower depreciation expenses. These were partially offset by $0.4 million in higher allocable costs.
Research and development expenses were $58.9 million in 2023 compared to $80.1 million in 2022, a decrease of $21.2 million, or 26%. This decrease was primarily due to a $10.0 million decrease in costs associated with lower headcount, $6.4 million decrease in outside services and CMC and regulatory expense, $4.1 million in lower lab supplies expense, $1.3 million in lower stock comp expense, and a $1.0 million decrease in lease costs due to the assignment of our San Carlos facility lease. These were partially offset by $1.7 million in higher allocable costs.
Selling, general and administrative expenses consist of employee-related costs, which include salaries and other personnel-related expenses (including stock-based compensation), hiring and training costs, consulting and outside services expenses (including audit and legal counsel relatedcounsel-related costs), marketing costs, buildingvarious leaseallocable expenses, which include occupancy-related costs, and depreciation expenses and amortization expenses.
Selling, general and administrative expenses were $47.1 million in 2025 compared to $55.1 million in 20242024, compareda to $53.3 million in 2023, an increasedecrease of $1.9$8.1 million, or 4%.15%. This increasedecrease was primarily due to $2.9$2.7 million in higherlower stock-based compensation expense, $0.9$1.8 million in higherlower consulting and outside services, and $0.7$2.6 million in higherlower legal fees.fees, $1.5 million in lower allocable expenses and $0.6 million decrease in employee-related costs. This was partially offset by a $1.9$1.1 million increase in lower payroll-based expenseslease and $0.7facilities millionassociated in lower allocable expenses.costs.
Selling, general and administrative expenses were $53.3 million in 2023 compared to $52.2 million in 2022, an increase of $1.1 million, or 2%. This increase was primarily due to $3.6 million in higher payroll-based expenses, $0.6 million in higher legal expense, $0.4 million in higher repairs and maintenance expense, and $0.3 million in higher consulting and outside services. This was partially offset by $3.2 million in lower stock-based compensation expense and $0.4 million in lower allocable expenses.
Restructuring charges consist of employee severance and other termination benefits due to workforce reduction plans that were initiated in the priorfourth years.quarter of 2025 and in the third quarter of 2023. There were no restructuring charges recognized for the year ended December 31, 2024. Restructuring charges were $3.4 million in 2025 and $3.3 million andin $3.2 million for the years ended December 31, 2023, and 2022, respectively.2023.
No asset impairment charges were recognized for the year ended December 31, 2025. Asset impairment and other charges for the year ended December 31, 2024 were $0.2 million related to a long-lived asset impairment charge in the second quarter of 2024. Asset impairment and other charges for the year ended December 31, 2023 were $10.0 million, consisting of a $9.2 million long-lived asset impairment charge and a $0.8 million goodwill impairment charge, all of which arewere non-cash charges. No asset impairment charges were recorded for the year ended December 31, 2022.
Interest income decreased by $0.5$1.0 million in 20242025 compared to 2023,2024, primarily due to lower average cash balances. Interest income increased by $2.7 million in 2023 compared to 2022, primarily due to higher average interest rates oncash, cash equivalents and short-term investments balances.
Interest and other expense, net, decreased by $1.9$5.6 million in 20242025 compared to 2023,2024, primarily due to the higher$6.9 million impairment charges recognized in 2023 related toof our investments in Molecular Assemblies, Inc. (“MAI”), and seqWell Inc. (“seqWell”) during the third and Arzedafourth Corp.quarter (“Arzeda”),of 2024 that did not reoccur in the current year. This decrease was partially offset by $3.5 million inhigher interest related to the long-term debt indue to the currentfunding year.of the second tranche of the Innovatus Loan in June 2025.
Interest and other expense, net, increased by $12.4 million in 2023 compared to 2022, primarily due to impairment of our investments in MAI, seqWell and Arzeda.
The provision for income taxes in 2024 was primarily due to the accrual of interest and penalties on historic uncertain tax positions.
The provision for income taxes in 2025 and 2024 was primarily due to the accrual of interest and penalties on historic uncertain tax positions. The provision for income taxes in 2023 was primarily for fiscal year 2023 state income taxes and the accrual of interest and penalties on historic uncertain tax positions.
The provision for income taxes in 2022 was primarily due to the income tax withholding imposed by foreign taxing authorities on income earned in certain countries outside of the Unites Stated and remitted to the United States and the accrual of interest and penalties on historic uncertain tax positions, as well as current year state income taxes.
Net loss for 20242025 was $65.3$44.0 million, or a net loss per basic and diluted share of $0.89.$0.50. This compared to a net loss of $76.2$65.3 million, or $1.12$0.89 per basic and diluted share, for 2023.2024. The decrease in net loss was primarily related to higher revenues and lower costs and operating expenses in 2024.2025.
Net loss for 2023 was $76.2 million, or a net loss per basic and diluted share of $1.12. This compared to a net loss of $33.6 million, or $0.51 per basic and diluted share, for 2022. The increase in net loss was primarily related to lower product revenues from CDX-616 and one-time charges recognized during 2023 related to asset impairment, including impairment in our investments in non-marketable equity securities, and restructuring charges, which was partially offset by lower operating expenses in 2023.
Liquidity is the measurement of our ability to meet working capital needs and to fund capital expenditures. We have historically funded our operations primarily through cash generated from operations, stock option exercises and public and private offerings of our common stock. In addition, pursuant to our Loan Agreement with Innovatus, an affiliate of Innovatus Capital Partners, LLC, we borrowed $30.0 million from Innovatus, as Lender, on February 13, 2024 and may become eligible to borrow up toborrowed an additional $10.0 million on June 27, 2025 upon the achievement of certain financial milestones. The Loan AgreementAgreement, provideswhich provided for an aggregate principal amount of up to $40.0 millionmillion, and withhas a maturity date of February 13, 2029 (the “Innovatus Loan”). We actively manage our cash usage and investment of liquid cash to ensure the maintenance of sufficient funds to meet our working capital needs. Our cash and cash equivalents are held in U.S. banks.
On February 13, 2024, we entered into the Loan Agreement with Innovatus consisting of up to two tranches, of which the first tranche of $30.0 million was disbursed upon execution of the Loan Agreement.Agreement We will be eligible to draw onand the second tranche of $10.0 million was funded in June 2025 upon achievement of certain milestones including certain pre-specified revenue thresholdsthresholds. andBoth tranches were subject to payment of a facility fee equal to 1.00% of the amount of such term loan. The Term Loan carries an interest-only period of 36 months (with the possibility to extend up to 48 months upon achievement of certain pre-specified financial milestones) and will bear interest at a floating rate of the sum of (a) the greater of (i) the prime rate and (ii) 7.50%, plus (b) 3.25%. As of December 31, 2025, we were in compliance with all covenants of the Loan Agreement.
In May 2021, we entered into an Equity Distribution Agreement (“EDA”) with Piper Sandler & Co (“PSC”), under which PSC, as our exclusive agent, at our discretion and at such times that we may determine from time to time, may sell over a three-year period from the execution of the EDA up to a maximum of $50.0 million of shares of our common stock. In 2023, 3,079,421 shares of our common stock were issued and sold pursuant to the EDA, all during the first half of 2023, and we received net proceeds of $7.9 million. On April 24, 2024, we terminated the EDA.
On May 2, 2024, we entered into the Cantor Sales Agreement with Cantor, under which Cantor, at our discretion and at such times that we may determine from time to time, may sell up to a maximum of $75.0 million of shares of our common stock. Under the terms of the Cantor Sales Agreement, Cantor may sell the shares at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act. On May 2, 2024, we filed a registration statement on Form S-3 registering the offer and sale of these shares under the Securities Act which became effective on May 14, 2024. We will pay a commission of up to 3.0% of gross sales proceeds of any common stock sold under the Cantor Sales Agreement. During the year ended December 31,In 2024, 10,440,000 shares of our common stock were issued and sold pursuant to the Cantor Sales AgreementAgreement, all during the third quarter of 2024, and we received net proceeds of $29.7 million after Cantor’s commissions and direct offering expenses. During the year ended December 31, 2025, 7,244,966 shares of our common stock were issued and sold pursuant to the Cantor Sales Agreement, all during the second quarter of 2025, and we received gross proceeds of $31.3$17.3 million, or $29.7$16.4 million in net proceeds after Cantor’s commissions and direct offering expenses of $1.6$0.8 million. As of December 31, 2024,2025, $43.7$26.4 million of shares remained available for sale under the Cantor Sales Agreement.
We believe that our existing cash and cash equivalents, combined with our future expectations for product revenues, research and development revenue, and expense management will provide adequate funds for planned ongoing operations, planned capital expenditures and working capital requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our capital resources sooner than we expect.
The $3.2$30.0 million decrease in net cash used in operating activities in 20242025 as compared to 20232024 was primarily due to the net effectreceipt of decreasesa in$37.8 cashmillion paidfee from operating expenses, primarily driven by the restructuring of our business in 2023 which included the assignment of our previous San Carlos facility leaseMerck in the fourth quarter of 2023,2025, which was partially offset by increased payments associated with higher operating costs and changesreduction in operating assets and liabilities.force.
The $63.9 million decrease in net cash provided by operating activities in 2023 as compared to 2022 was primarily due to the net effect of decreases in cash received from our customers due to lower revenue in 2023 and with 2022 benefiting from the receipt of a $25.9 million fee from Pfizer that is creditable against future orders, partially offset by decreases in cash paid for cost of revenues and operating expenses.
The $52.1$80.5 million increasedecrease in net cash used in investing activities in 20242025 as compared to 20232024 was primarily due to the net effect of higher proceeds from the maturity of short-term investments and lower cash utilized for purchasespurchase of short-term investments, partially offset by lower purchases of property and equipment in the current year.investments.
The $8.7 million decrease in net cash used in investing activities in 2023 as compared to 2022 was primarily due to higher cash utilized for additional investments in equity securities and purchases of property and equipment in the prior year.
The $52.4$32.6 million increasedecrease in net cash provided by financing activities in 20242025 as compared to 20232024, was primarily due to the $29.5 million proceeds from the first tranche of the Innovatus Loan in February 2024 and higher proceeds from issuance of common stock under the Cantor Sales Agreement in the third quarter of 2024, partially offset by the proceeds from issuancethe funding of commonthe stocksecond undertranche of the EDAInnovatus duringLoan thein firstJune half of 2023.2025.
The $8.7 million increase in net cash provided by financing activities in 2023 as compared to 2022 was primarily due to proceeds from issuance of common stock under the EDA and lower cash paid on taxes related to net share settlement of equity awards.
Our contracts frequently provide customers with rights to use or access our products or technology, along with other promises or performance obligations. IfWe weevaluate determinewhether thatthe license is distinct from other performance obligations based on whether the customer cannot benefit from the license withouton ourits services,own or together with readily available resources. When the license willdoes benot accountedhave forstandalone functionality and is interdependent with other promises, such as the receipt of essential enzyme starting materials, the rights to use the license and receipt of materials are treated as combined withperformance obligations. These combined performance obligations are considered interdependent and are recognized upon the otherlater performanceof obligations.the commencement of the license right or the transfer of control of the materials to the customer. If we determine that a license is distinct, we would recognize an allocable portion of the transaction price when the license is transferred to the customer, and the customer can use and benefit from it. We estimate the SSP for license rights by using historical information if licenses have been previously sold to customers.
At the inception of each arrangement that includes variable consideration such as development milestone payments, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our control or the control of the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received.
What changed in the latest 10-Q
Risk Factors
Largest changes
We have incurred net losses since our inception, including net losses of $44.0 million, $65.3 million, and $76.2see in full comparisonmillion,million for the years ended December 31, 2025, 2024, and 2023, respectively, and$8.7$20.7 million and$20.7$34.0 million for thethreesix months endedMarchJune31,30, 2026 and 2025, respectively. As ofMarchJune31,30, 2026 and December 31, 2025, we had an accumulated deficit of$615.5$627.5 million and $606.8 million, respectively. If we are unable to continue to successfully develop and commercialize products in our pharma biocatalysis business, increase sales of existing products and services, develop and commercialize our ECO Synthesis manufacturing platform, develop new products or services, or otherwise expand our business,whether through new or expanded collaborations or other products and services,our net losses may increase and we may never achieve profitability. This includes our ability to expand our business through new or expanded collaborations or other products and services. In addition, some of our agreements, including the agreements with GlaxoSmithKline plc (“GSK”), Merck Sharp & Dohme (“Merck”), Novartis Pharma AG (“Novartis”), Nestlé Health Science (“Nestlé”), Aldevron LLC, Roche Sequencing Solutions, Inc., Crosswalk Therapeutics and Alphazyme LLC, provide for milestone payments, usage payments, and/or future royalty or other payments, which we will only receive if we and/or our collaborators develop and commercialize products or achieve technical milestones. We also intend to continue to fund the development of additional proprietary performance enzyme products and advance new technologieslikesuch as our ECO Synthesis manufacturing platform. There can be no assurance that any of these products or services will become commercially viable or that we will ever achieve profitability on a quarterly or annual basis. If we fail to achieve profitability, or if the time required to achieve profitability is longer than we anticipate, we may not be able to continue our business. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
“We expect to continue to incur significant operating expenses and net losses for the foreseeable future as we develop and commercialize our ECO Synthesis manufacturing platform and expand our commercial activities. Our results have fluctuated significantly from period to period and we expect that they will continue to do so, and results in any single quarter, including any quarter in which we report net income, are not necessarily indicative of results for any future period or for a full year. …”see in full comparison
Our success depends in part on our ability to obtain patents and maintain adequate protection of our intellectual property rights directed to our technology, products and services in the United States and other countries. We have adopted a strategy of seeking patent protection in the United States and in foreign countries with respect to certain of the technology used in or relating to our products, services, and processes. As such, as ofsee in full comparisonMarchJune31,30, 2026, we owned or controlled approximately1,4001,300 active issued patents and pending patent applications in the United States and in various foreign jurisdictions. As ofMarchJune31,30, 2026, our patents and patent applications, if issued, have terms that expire between 2026 and approximately 2046. We also have license rights to a number of issued patents and pending patent applications in the United States and in various foreign jurisdictions. Our owned and licensed patents and patent applications include those directed to our enabling technology and to the methods and products that support our business in the pharmaceutical manufacturing, life sciences, oligonucleotide synthesis, and other markets. We intend to continue to apply for patents relating to our technology, methods, services and products as we deem appropriate.
Full comparison: every changed paragraph (7)
We have incurred net losses since our inception, including net losses of $44.0 million, $65.3 million, and $76.2 million,million for the years ended December 31, 2025, 2024, and 2023, respectively, and $8.7$20.7 million and $20.7$34.0 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026 and December 31, 2025, we had an accumulated deficit of $615.5$627.5 million and $606.8 million, respectively. If we are unable to continue to successfully develop and commercialize products in our pharma biocatalysis business, increase sales of existing products and services, develop and commercialize our ECO Synthesis manufacturing platform, develop new products or services, or otherwise expand our business, whether through new or expanded collaborations or other products and services, our net losses may increase and we may never achieve profitability. This includes our ability to expand our business through new or expanded collaborations or other products and services. In addition, some of our agreements, including the agreements with GlaxoSmithKline plc (“GSK”), Merck Sharp & Dohme (“Merck”), Novartis Pharma AG (“Novartis”), Nestlé Health Science (“Nestlé”), Aldevron LLC, Roche Sequencing Solutions, Inc., Crosswalk Therapeutics and Alphazyme LLC, provide for milestone payments, usage payments, and/or future royalty or other payments, which we will only receive if we and/or our collaborators develop and commercialize products or achieve technical milestones. We also intend to continue to fund the development of additional proprietary performance enzyme products and advance new technologies likesuch as our ECO Synthesis manufacturing platform. There can be no assurance that any of these products or services will become commercially viable or that we will ever achieve profitability on a quarterly or annual basis. If we fail to achieve profitability, or if the time required to achieve profitability is longer than we anticipate, we may not be able to continue our business. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
We expect to continue to incur significant operating expenses and net losses for the foreseeable future as we develop and commercialize our ECO Synthesis manufacturing platform and expand our commercial activities. Our results have fluctuated significantly from period to period and we expect that they will continue to do so, and results in any single quarter, including any quarter in which we report net income, are not necessarily indicative of results for any future period or for a full year. While we believe that our existing cash and cash equivalents, combined with our future expectations for product revenues, research and development revenue, and expense management, will provide adequate funds for planned ongoing operations, capital expenditures and working capital requirements for at least the next 12 months, we have based this estimate on assumptions that may prove to be wrong, and we could utilize our capital resources sooner than we expect. We may need additional capital if our current plans and assumptions change, and we may not be able to raise sufficient additional funds on terms that are favorable to us, if at all. If future financings involve the issuance of equity securities, our existing stockholders would be diluted.
Although we continue to expand our customer base, our current revenues are derived from a limited number of key customers. For the threesix months ended MarchJune 31,30, 2026 and 2025, customers that each individually contributed 10% or more of our total revenue accounted for 64%60% and 66%43% of our total revenues, respectively. We expect a limited number of customers to continue to account for a significant portion of our revenues for the foreseeable future. This customer concentration increases the risk of quarterly fluctuations in our revenues and operating results. The loss or reduction of business from one or a combination of our significant customers could materially adversely affect our revenues, financial condition and results of operations.
Our product supply agreements with customers generally have a finite duration, may not be extended or renewed and generally do not require the customer to purchase any particular quantity or quantities of our products. Additionally, some customers order our products on a quote and purchase order basis under standard terms and conditions, with no guarantee of future orders. While our products are not considered commodities and may not be easily substituted for by our customers, particularly when our products are used in the manufacture of active pharmaceutical ingredients, our customers may nevertheless terminate or fail to renew their product supply agreements with us or significantly curtail their purchases thereunder under certain circumstances. We are working to develop new relationships with existing or new customers, but despite these efforts we may not, at the time that any of our existing product supply agreements expire or are terminated, or purchases thereunder curtailed, have other contracts in place generating similar or material revenue. Any such expiration, termination or reduction could materially adversely affect our revenues, financial condition and results of operations. For the three and six months ended MarchJune 31,30, 2026, we derived a majority of our product revenue from these product supply agreements.
As we continue to scale up our manufacturing processes towith providethe objective of providing enzymatically synthesized, GMP-grade siRNA to customers, either directly or through a third-party CDMO partner, we may face manufacturing capacity constraints or higher-than-expected costs at our facilities. We currently do not manufacture GMP-grade products at any of our own facilities and are reliant on third-party CDMOs. Any delays in bringing our own facility online and meeting customer expectations may have an adverse impact on our relationship with such customer. Any failure of our third-party CDMO to meet expected delivery timelines would adversely affect our relationships with our customers, and potentially our financial condition and results of operations. There can be no assurance that revenue lost due to productivity issues or capacity constraints will be recovered on expected timeframes or at all. If we are unsuccessful in remedying any productivity issues at our facilities or those of our CDMO, if we are unable to recover revenue from unproduced batches when expected or at all, or if costs at our facilities are higher than expected, we may experience material and adverse impacts on our financial condition and results of operations.
Our success depends in part on our ability to obtain patents and maintain adequate protection of our intellectual property rights directed to our technology, products and services in the United States and other countries. We have adopted a strategy of seeking patent protection in the United States and in foreign countries with respect to certain of the technology used in or relating to our products, services, and processes. As such, as of MarchJune 31,30, 2026, we owned or controlled approximately 1,4001,300 active issued patents and pending patent applications in the United States and in various foreign jurisdictions. As of MarchJune 31,30, 2026, our patents and patent applications, if issued, have terms that expire between 2026 and approximately 2046. We also have license rights to a number of issued patents and pending patent applications in the United States and in various foreign jurisdictions. Our owned and licensed patents and patent applications include those directed to our enabling technology and to the methods and products that support our business in the pharmaceutical manufacturing, life sciences, oligonucleotide synthesis, and other markets. We intend to continue to apply for patents relating to our technology, methods, services and products as we deem appropriate.
Concerns about inflation, energy costs, geopolitical issues, the United States mortgage market and a declining real estate market, unstable global credit markets and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished liquidity and credit availability, declines in consumersconsumers’ confidence and discretionary spending, diminished expectations for the global economy and expectations of slower global economic growth going forward, increased unemployment rates, and increased credit defaults in recent years. Our general business strategy may be adversely affected by any such economic downturns, volatile business environments and continued unstable or unpredictable economic and market conditions.
Management's Discussion & Analysis (MD&A)
New heading “Public Offering”
Largest changes
“Research and development revenue decreased by $6.3 million to $1.7 million in the three months ended June 30, 2026 compared to the same period in 2025, primarily due to the recognition of $4.7 million of milestone revenue from legacy collaboration agreements and $2.5 million of revenue from a licensing agreement in the second quarter of 2025 that did not reoccur in the current period. The decrease was partially offset by $0.9 million in higher revenue from existing and legacy agreements in the current period. …”see in full comparison
Research and development expenses decreased bysee in full comparison$1.5$2.1 million in the three months endedMarchJune31,30, 2026 compared to the same period in 2025 primarily due to$2.3$1.6 million decrease in employee-related costs due to lowerallocable costs, partially offset byheadcount, $0.3 millionincrease in employee-related costs, $0.2 million increasedecrease fromhigherlower use of outside services, $0.3 million in lower lab supplies, $0.1 millionincreasedecrease inleasedepreciationand facilities costs,expense, and $0.1 millionincreasedecrease indepreciationstock-basedexpensecompensation expense, partially offset by $0.2 million in higher allocable costs. The decrease in research and development expenses offacilities$3.6 million in the six months ended June 30, 2026, compared to the same period in 2025, was primarily due to $3.0 million decrease in employee-related costs, $0.3 million in lower consulting andlaboratoryoutsideequipment.services, $0.3 million decrease in stock-based compensation expense, and $0.2 million in lower lab supplies, partially offset by $0.2 million in higher allocable costs.
The provision for income taxes for the three and six months endedsee in full comparisonMarchJune31,30, 2026 was primarily due to income taxes imposed by foreign taxing authorities related to the ongoing liquidation of our Indiansubsidiary.subsidiary and accrual of interest and penalties on historic uncertain tax positions. The provision for income taxes for the three and six months endedMarchJune31,30, 2025 was primarily due to the accrual of interest and penalties on historic uncertain tax positions.
“At the end of 2024, we completed the build out of our ECO Synthesis Innovation Lab, a facility where our ECO Synthesis manufacturing platform is deployed to synthesize gram-scale quantities of a customer’s desired siRNA construct suitable for pre-clinical testing. In addition, the infrastructure allows us to provide process development, analytical method development and other manufacturing process optimization which is required to enable the siRNA to proceed to clinical-stage manufacturing and testing. …”see in full comparison
Our ECO Synthesis® manufacturing platform is comprised of enzymatic tools and processes that are designed to enable large-scale manufacture of RNA interference (“RNAi”) therapeutics. We use the CodeEvolver platform technology to develop enzymes for the synthesis of RNAi therapeutics in production processes that deliver improvements, including purity, yield, and manufacturing efficiency. In November 2024, we presented data at the TIDES Europe conference demonstrating the successful end-to-end enzymatic synthesis of an entire commercially approved small interfering ribonucleic acid (“siRNA”) therapeutic asset with the ECO Synthesis manufacturing platform. In addition to using full enzymatic sequential synthesis, adding one nucleotide at a time to synthesize the two strands from beginning to end, we demonstrated synthesis of the same siRNA asset using three other routes utilizing enzymatic ligation with our double-stranded RNA (“dsRNA”) ligase, which can stitch together fragments of chemically and/or enzymatically synthesized RNA to form the full siRNA drug structure. For the three other routes, our data highlighted that full-length oligonucleotides of equal quality and yields were obtained whether the fragments were made with enzymes or by traditional solid phase oligonucleotide synthesis (“SPOS”) (current standard production route for oligonucleotide manufacturing).see in full comparisonAt the end of 2024, we completed the build out of our ECO Synthesis Innovation Lab, a facility where our ECO Synthesis manufacturing platform is deployed to synthesize gram-scale quantities of a customer’s desired siRNA construct suitable for pre-clinical testing. In addition, the infrastructure allows us to provide process development, analytical method development and other manufacturing process optimization which is required to enable the siRNA to proceed to clinical-stage manufacturing and testing. In 2025, we successfully manufactured non-good manufacturing practice (“GMP”)-grade siRNA drug substance for customers in our Innovation Lab under development services contracts. We also entered into partnerships with three large-scale contract development and manufacturing organizations (“CDMOs”) to evaluate our ECO platform of enzymatic tools and processes to ultimately synthesize GMP-grade siRNA drug substance for our customers. In each of these agreements, we are currently in the feasibility testing stage and expect to advance at least one of these partnerships, including initiating a technology transfer to that organization, in 2026. We believe these relationships to be a vital extension of our strategy to be a technology solutions provider for our customers. Through these arrangements, our customers will have access to proven, large-scale commercial manufacturers who are familiar with our process, who can then offer a seamless manufacturing scale-up of our customers’ products. We expect to expand our enzymatic tools and process offerings as we further enhance the ECO Synthesis platform to address the overall market needs for scalable and sustainable RNAi manufacturing.
Full comparison: every changed paragraph (31)
The following management's discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto and management's discussion and analysis of financial condition and results of operations for the year ended December 31, 2025 included in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 11, 2026 (the “Annual Report”). This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements include, but are not limited to, expectations regarding our strategy, business plans, financial performance and developments relating to our industry. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “estimate,” or “continue,” and similar expressions or variations. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part II, Item 1A: “Risk Factors” of this Quarterly Report on Form 10-Q and Part I, Item 1A: “Risk Factors” of our Annual Report, and elsewhere in this report. The forward-looking statements in this Quarterly Report on Form 10-Q represent our views as of the date of this Quarterly Report on Form 10-Q. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q.
Our ECO Synthesis® manufacturing platform is comprised of enzymatic tools and processes that are designed to enable large-scale manufacture of RNA interference (“RNAi”) therapeutics. We use the CodeEvolver platform technology to develop enzymes for the synthesis of RNAi therapeutics in production processes that deliver improvements, including purity, yield, and manufacturing efficiency. In November 2024, we presented data at the TIDES Europe conference demonstrating the successful end-to-end enzymatic synthesis of an entire commercially approved small interfering ribonucleic acid (“siRNA”) therapeutic asset with the ECO Synthesis manufacturing platform. In addition to using full enzymatic sequential synthesis, adding one nucleotide at a time to synthesize the two strands from beginning to end, we demonstrated synthesis of the same siRNA asset using three other routes utilizing enzymatic ligation with our double-stranded RNA (“dsRNA”) ligase, which can stitch together fragments of chemically and/or enzymatically synthesized RNA to form the full siRNA drug structure. For the three other routes, our data highlighted that full-length oligonucleotides of equal quality and yields were obtained whether the fragments were made with enzymes or by traditional solid phase oligonucleotide synthesis (“SPOS”) (current standard production route for oligonucleotide manufacturing). At the end of 2024, we completed the build out of our ECO Synthesis Innovation Lab, a facility where our ECO Synthesis manufacturing platform is deployed to synthesize gram-scale quantities of a customer’s desired siRNA construct suitable for pre-clinical testing. In addition, the infrastructure allows us to provide process development, analytical method development and other manufacturing process optimization which is required to enable the siRNA to proceed to clinical-stage manufacturing and testing. In 2025, we successfully manufactured non-good manufacturing practice (“GMP”)-grade siRNA drug substance for customers in our Innovation Lab under development services contracts. We also entered into partnerships with three large-scale contract development and manufacturing organizations (“CDMOs”) to evaluate our ECO platform of enzymatic tools and processes to ultimately synthesize GMP-grade siRNA drug substance for our customers. In each of these agreements, we are currently in the feasibility testing stage and expect to advance at least one of these partnerships, including initiating a technology transfer to that organization, in 2026. We believe these relationships to be a vital extension of our strategy to be a technology solutions provider for our customers. Through these arrangements, our customers will have access to proven, large-scale commercial manufacturers who are familiar with our process, who can then offer a seamless manufacturing scale-up of our customers’ products. We expect to expand our enzymatic tools and process offerings as we further enhance the ECO Synthesis platform to address the overall market needs for scalable and sustainable RNAi manufacturing.
At the end of 2024, we completed the build out of our ECO Synthesis Innovation Lab, a facility where our ECO Synthesis manufacturing platform is deployed to synthesize gram-scale quantities of a customer’s desired siRNA construct suitable for pre-clinical testing. In addition, the infrastructure allows us to provide process development, analytical method development and other manufacturing process optimization which is required to enable the siRNA to proceed to clinical-stage manufacturing and testing. In 2025, we successfully manufactured non-good manufacturing practice (“GMP”)-grade siRNA drug substance for customers in our Innovation Lab under development services contracts. We also entered into partnerships with three large-scale contract development and manufacturing organizations (“CDMOs”) to evaluate our ECO platform of enzymatic tools and processes to ultimately synthesize GMP-grade siRNA drug substance for our customers. Under each of these agreements, we have conducted technology transfer to several partners in 2026 for further evaluation of the technology. We believe these relationships to be a vital extension of our strategy to be a technology solutions provider for our customers. Through these arrangements, our customers will have access to proven, large-scale commercial manufacturers who are familiar with our process, who can then offer a seamless manufacturing scale-up of our customers’products. We expect to expand our enzymatic tools and process offerings as we further enhance the ECO Synthesis platform to address the overall market needs for scalable and sustainable RNAi manufacturing.
In November 2025, we signed a lease for a 34,000-square-foot GMP manufacturing facility in Hayward, California, which we refer to as our ECO GMP Manufacturing Center. The multi-purpose facility is designed to expand our internal capabilities into GMP manufacturing of siRNA and other oligonucleotides using our ECO Synthesis manufacturing platform, and its flexible design is also intended to support production of purified enzymes used in the ECO Synthesis process. We applied for a building permit during the second quarter of 2026 and expect to commence retrofit construction during the second half of 2026. We expect the facility to support customers’ early clinical trial supply requirements. Our CDMO partnerships and the ECO GMP Manufacturing Center are complementary elements of our strategy: the ECO GMP Manufacturing Center is intended to serve early clinical-stage supply, while our CDMO partners are intended to provide large-scale commercial manufacturing capacity.
Total revenues decreased by $0.4 million to $14.9 million in the three months ended June 30, 2026 compared to the same period in 2025, primarily due to lower research and development revenue partially offset by higher product revenue in the current period. Total revenues increased by $7.3 million to $30.2 million in the six months ended June 30, 2026 compared to the same period in 2025, primarily due to higher product revenue.
Product revenue increased by $5.8 million to $13.2 million in the three months ended June 30, 2026 compared to the same period in 2025, primarily due to $1.7 million higher sales of enzymes used in commercial pharmaceutical manufacturing and $4.1 million higher sales of enzymes for use in clinical-stage manufacturing and process development activities. Product revenue increased by $7.0 million to $20.4 million in the six months ended June 30, 2026 compared to the same period in 2025, primarily due to $1.8 million higher sales of enzymes used in commercial pharmaceutical manufacturing and $5.2 million higher sales of enzymes for use in clinical-stage manufacturing and process development activities. Our product revenue fluctuates from period to period due to variability in our customers’ manufacturing schedules and the timing of their clinical trial progression and receipt of their product approvals, which affects order volumes for our enzyme products.
Research and development revenue decreased by $6.3 million to $1.7 million in the three months ended June 30, 2026 compared to the same period in 2025, primarily due to the recognition of $4.7 million of milestone revenue from legacy collaboration agreements and $2.5 million of revenue from a licensing agreement in the second quarter of 2025 that did not reoccur in the current period. The decrease was partially offset by $0.9 million in higher revenue from existing and legacy agreements in the current period. Research and development revenue increased by $0.3 million to $9.8 million in the six months ended June 30, 2026 compared to the same period in 2025, primarily due to the recognition of $6.3 million of license revenue previously recorded as deferred revenue as of December 31, 2025, $0.7 million of revenue recognized related to ECO Synthesis evaluation services, and $1.0 million of higher revenue from existing and legacy agreements. The increase was partially offset by the non-recurrence of $4.7 million of milestone revenue and $3.0 million of licensing revenue recognized in 2025.
Total revenues increased by $7.7 million to $15.2 million in the three months ended March 31, 2026 compared to the same period in 2025.
Product revenue increased by $1.1 million to $7.2 million in the three months ended March 31, 2026 compared to the same period in 2025, primarily due to variability in manufacturing schedules and timing in clinical trial progression of our customers, which impacted order volumes for our enzyme products.
Research and development revenue increased by $6.6 million to $8.1 million in the three months ended March 31, 2026 compared to the same period in 2025 primarily due to the recognition of $6.3 million of deferred revenue related to our licensing agreement with Merck entered into during the fourth quarter of 2025 following the satisfaction of the remaining performance obligations, and $0.3 million revenue related to ECO Synthesis evaluation services.
Cost of product revenue decreasedincreased by $1.4 million and $0.7 million in the three and six months ended MarchJune 31,30, 2026, respectively, compared to the same period in 2025. Product gross margin was 71%73% and 73% in the three and six months ended MarchJune 31,30, 2026, respectively, compared to 55%72% and 64% in the corresponding period in 2025. The changes in cost of product revenue and product gross margins are primarily due to a shift in sales toward more profitable products, and declines in less profitable legacy products.
Research and development expenses decreased by $1.5$2.1 million in the three months ended MarchJune 31,30, 2026 compared to the same period in 2025 primarily due to $2.3$1.6 million decrease in employee-related costs due to lower allocable costs, partially offset byheadcount, $0.3 million increase in employee-related costs, $0.2 million increasedecrease from higherlower use of outside services, $0.3 million in lower lab supplies, $0.1 million increasedecrease in leasedepreciation and facilities costs,expense, and $0.1 million increasedecrease in depreciationstock-based expensecompensation expense, partially offset by $0.2 million in higher allocable costs. The decrease in research and development expenses of facilities$3.6 million in the six months ended June 30, 2026, compared to the same period in 2025, was primarily due to $3.0 million decrease in employee-related costs, $0.3 million in lower consulting and laboratoryoutside equipment.services, $0.3 million decrease in stock-based compensation expense, and $0.2 million in lower lab supplies, partially offset by $0.2 million in higher allocable costs.
Selling, general and administrative expenses decreased by $2.6$1.4 million during the three months ended MarchJune 31,30, 2026, compared to the same period in 2025 primarily due to $3.1$0.8 million in lower stock-based compensation expenses, $0.6 million decrease in employee-related costs due to lower headcount, $0.3$0.2 million decrease in allocable costs and $0.1 million in lower consulting and outside services, partially offset by $0.2 million increase in facilities associated costs. The decrease in selling, general and administrative expenses of $4.0 million during the six months ended June 30, 2026 as compared to the same period in 2025, was primarily due to $2.0 million in lower employee-related costs, $1.6 million decrease in stock-based compensation expense, $0.5 million in lower legal costs, $1.0$0.2 million decrease in consulting and outside services and $0.2 million in lower stock-basedallocable compensation expenses,costs, partially offset by a $2.3$0.4 million increase in higherfacilities allocableassociated costs.
Interest income slightlyremained decreasedrelatively byconsistent $0.1 million induring the three and six months ended MarchJune 31,30, 2026, compared to the same period in 2025, primarilyreflecting duecomparable toaverage lowerbalances of cash, cash equivalents and short-term investments balance.investments.
Interest and other expense, net increased by $0.3 million and $0.7 million in the three and six months ended MarchJune 31,30, 2026, respectively, compared to the same period in 2025, primarily due to higher interest related to long-term debt due to the funding of the second tranche of the Innovatus Loan in June 2025.
The provision for income taxes for the three and six months ended MarchJune 31,30, 2026 was primarily due to income taxes imposed by foreign taxing authorities related to the ongoing liquidation of our Indian subsidiary.subsidiary and accrual of interest and penalties on historic uncertain tax positions. The provision for income taxes for the three and six months ended MarchJune 31,30, 2025 was primarily due to the accrual of interest and penalties on historic uncertain tax positions.
Net loss for the three months ended MarchJune 31,30, 2026 was $8.7$12.0 million, or a net loss per basic and diluted share of $0.10.$0.13. This compared to a net loss of $20.7$13.3 million, or a net loss per basic and diluted share of $0.25,$0.16, for the three months ended MarchJune 31,30, 2025. The decrease in net loss was primarily related to $7.7 million higher revenue and $4.7$2.0 million lower costs and operating expenses.expenses in 2026.
Net loss for the six months ended June 30, 2026 was $20.7 million, or a net loss per basic and diluted share of $0.23. This compared to a net loss of $34.0 million, or a net loss per basic and diluted share of $0.40, for the six months ended June 30, 2025. The decrease in net loss was primarily related to higher revenue and lower costs and operating expenses in 2026.
Our primary uses of capital for the foreseeable future, including the next 12 months, are for compensation and related expenses, research and development expenses including manufacturing costs, laboratory and related supplies, legal and other outside services, and general overhead costs.costs, and capital expenditures associated with our planned facility buildout and related equipment purchases.
The following summarizes our cash and cash equivalents and short-term investments balances and working capital as of MarchJune 31,30, 2026 and December 31, 2025 (in thousands):
We have historically experienced negative cash flows from operations as we continue to invest in key technology development projects and improvements to our CodeEvolver technology platform, develop and commercialize new and existing products including our ECO Synthesis manufacturing platform and expand our business development and collaboration with new customers. Our cash flows from operations will continue to be affected principally by product sales and product gross margins, sales from licensing our technology to major pharmaceutical companies, and collaborative research and development services provided to customers, as well as our headcount costs. Our primary source of cash flows from operating activities is cash receipts from our customers for purchases of products, collaborative research and development services, and licensing our technology to major pharmaceutical companies. Our largest uses of cash from operating activities are for employee-related expenditures, rent payments, inventory purchases to support our product sales and non-payroll research and development costs. In addition, we expect capital expenditures to increase as we continue investments in our new manufacturing facility, including facility improvements and equipment purchases necessary to support future operations.
On February 13, 2024, we entered into the Loan Agreement with Innovatus consisting of up to two tranches, of which the first tranche of $30.0 million was disbursed upon execution of the Loan Agreement and the second tranche of $10.0 million was funded in June 2025 upon achievement of certain milestones including certain pre-specified revenue thresholds. Both tranches were subject to payment of a facility fee equal to 1.00% of the amount of such term loan. The Term Loan carries an interest-only period of 36 months (with the possibility to extend up to 48 months upon achievement of certain pre-specified financial milestones) and will bear interest at a floating rate of the sum of (a) the greater of (i) prime rate and (ii) 7.50%, plus (b) 3.25%. As of MarchJune 31,30, 2026, we were in compliance with all covenants of the Loan Agreement.
On May 2, 2024, we entered into the Cantor Sales Agreement with Cantor, under which Cantor, at our discretion and at such times that we may determine from time to time, may sell up to a maximum of $75.0 million of shares of our common stock. Under the terms of the Cantor Sales Agreement, Cantor may sell the shares at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act. On May 2, 2024, we filed a registration statement on Form S-3 registering the offer and sale of these shares under the Securities Act which became effective on May 14, 2024. We will pay a commission of up to 3.0% of gross sales proceeds of any common stock sold under the Cantor Sales Agreement. In 2024, 10,440,000 shares of our common stock were issued and sold pursuant to the Cantor Sales Agreement, all during the third quarter of 2024, and we received net proceeds of $29.7 million after Cantor’s commissions and direct offering expenses. In 2025, 7,244,966 shares of our common stock were issued and sold pursuant to the Cantor Sales Agreement, all during the second quarter of 2025, and we received $16.4 million in net proceeds after Cantor’s commissions and direct offering expenses. As of MarchJune 31,30, 2026, $26.4 million of shares remained available for sale under the Cantor Sales Agreement.
Public Offering
On July 23, 2026, we entered into an underwriting agreement for an underwritten public offering of 16,666,667 shares of our common stock at a public offering price of $1.50 per share, less underwriting discounts and commissions. The underwriters were granted a 30-day option to purchase up to an additional 2,500,000 shares.
The offering closed on July 27, 2026, and we received net proceeds of approximately $23.1 million after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company. On July 29, 2026, the underwriters partially exercised their option and purchased an additional 1,333,333 shares of common stock at the public offering price of $1.50 per share, less underwriting discounts and commissions.
The following is a summary of cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025 (in thousands):
The $0.6$9.0 million decrease in net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 as compared to the same period in 2025, was primarily due to smaller net operating loss driven by higher revenue and lower operating expenses, including decreased employee-related costs resulting from the reduction in force implemented in the fourth quarter of 2025, as well as lower spending on outside services.
The $12.9$12.3 million decrease in net cash provided by investing activities for the threesix months ended MarchJune 31,30, 2026 as compared to the same period in 2025, was primarily due to higher purchases of short-term investments and lower proceeds from maturities of short-term investments in the current period, partially offset by reduced capital expenditures.
The $1.1$27.8 million decrease in net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 as compared to the same period in 2025, was primarily due to the absence of proceeds from employeeissuance of common stock optionin exercisesconnection with an equity sales agreement and proceeds from long term debt in the current period.
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make judgments, estimates and assumptions in the preparation of our consolidated financial statements and accompanying notes. Actual results could differ from those estimates. There have been no material changes to our critical accounting policies or estimates during the three and six months ended MarchJune 31,30, 2026 from those discussed in our Annual Report.
CDXS insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 1 filing (1 insider, 1 trade date, 2,605 shares, about $6.2K). Net open-market shares: -2,605 (purchases minus sales); net value about -$6.2K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-06-11 | De Vre Raymond |
Open-market sale | 2,605 | $2.37 | $6.2K |
Well-known investors holding CDXS (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 5,549,139 | $12.5M | 0.01% | Added 39% |
| D. E. Shaw & Co. | 2026-06-30 | 1,342,014 | $3.0M | 0.0% | Added 37% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 845,431 | $1.9M | 0.0% | Added 39% |
| Two Sigma Investments | 2026-06-30 | 696,599 | $1.6M | 0.0% | Added 188% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 191,580 | $433.0K | 0.0% | Reduced 33% |
| Renaissance Technologies | 2026-06-30 | 41,500 | $93.8K | 0.0% | Reduced 79% |