What changed in this filing

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Item 1A. Risk Factors

2025-11-06 compared with 2025-08-13 · 34 added, 27 removed, 728 unchanged (8% of the section changed)

10 unchanged sentences

• 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.

• Some of our product supply agreements with customers, if in place, have 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.

• The demand for our products 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.

Our business, financial condition, and results of operations may be harmed if our customers spend less on, or are less successful in, these activities.

In addition, customer spending may be affected by, among other things, general market and economic conditions beyond our control.

• If we are unable to develop and commercialize new products for the pharmaceutical, biotherapeutics, diagnostics and life science tools 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.

3 unchanged sentences

• 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 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.

• 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 and achieving or sustaining profitability.

• 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.

Failure to validate performance at scale, demonstrate regulatory acceptance, or overcome other challenges with the new technologies could impede customer adoption and our revenues.

• As a result of our strategic shift and our refined focus on certain programs and business lines, 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.

1 unchanged sentence

• We use hazardous materials in our business, and we must comply with environmental laws and regulations.

Any claims relating to improper handling, storage or disposal of these materials or noncompliance of applicable laws and regulations could be time-consuming and costly and could adversely affect our business and results of operations.

• 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.

• Even if our customers, future 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.

2 unchanged sentences

• 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.

• If our biocatalysts, or the genes that code for our biocatalysts, are stolen, misappropriated or reverse engineered, others could use these biocatalysts or genes 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, even if the acquisition would be beneficial to our stockholders.

• Market and economic conditions may negatively impact our business, financial condition, and share price.

• International trade policies, including tariffs, sanctions and trade barriers, may adversely affect our business.

• 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.

• Business interruptions resulting from disasters or other disturbances could delay us in the process of developing our products and could disrupt our sales.

Our business continuity and disaster recovery plans may not adequately protect us from a serious disaster or other disturbance.

Risks Related to Our Business and Strategy

We have a history of net losses and we may not achieve or maintain profitability.

We have incurred net losses since our inception, including losses of $65.3 million, $76.2 million, and $33.6 million for the years ended December 31, 2024, 2023, and 2022, respectively, and $34.0 million and $34.3 million for the six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of $596.8 million and $562.8 million, respectively.

We have incurred net losses since our inception, including losses of $65.3 million, $76.2 million, and $33.6 million for the years ended December 31, 2024, 2023, and 2022, respectively, and $53.6 million and $54.9 million for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $616.4 million and $562.8 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.

10 unchanged sentences

These regulations result in our customers imposing quality requirements on us for the manufacture of our enzyme products through supplier qualification processes and customer contracts and specifications.

In order to 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, all performed in accordance with the FDA's Good Laboratory Practice requirements;

• submission to the FDA of an IND, which must become effective before human clinical studies may begin in the United States;

• approval by an independent institutional review board (“IRB”) 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 GCP 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 an NDA or BLA after completion of all clinical studies;

In order to market a biologic or drug product in the United States, our customers, future customers or collaborators generally must undergo the following process required by the FDA:

• completion of extensive preclinical laboratory tests and preclinical animal studies, certain of which must performed in accordance with the FDA's Good Laboratory Practice requirements;

• submission to the FDA of an 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 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 Good 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 an New Drug Application (“NDA”) or Biologics License Application (“BLA”) after completion of all clinical studies;

• potential review of the product candidate by an FDA advisory committee;

6 unchanged sentences

We believe that our products are exempt from FDCA requirements, but FDA or other regulators may disagree and find that our products are subject to such requirements.

We believe our enzyme products are exempt from compliance with the FDCA and the implementing GMP regulations of the FDA, as our products are further processed and incorporated into final drug or biologic products by our customers and we do not make claims related to their safety or effectiveness.

We believe our enzyme products are exempt from compliance with the FDCA and the implementing GMP regulations of the FDA, as our products are further processed and incorporated into final drug or biologic products by our customers and as we do not make claims related to our products’ safety or effectiveness.

Our products are currently manufactured following the voluntary quality standards of ISO 9001:2015, and we anticipate signing and announcing a partnership with a CDMO to provide enzymatically synthesized, GMP-grade siRNA to customers in the near term.

2 unchanged sentences

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 GMP regulations.

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 cGMP 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.

1 unchanged sentence

Although we continue to expand our customer base, our current revenues are derived from a limited number of key customers.

For the six months ended June 30, 2025 and 2024, customers that each individually contributed 10% or more of our total revenue accounted for 43% and 40% of our total revenues, respectively.

For the nine months ended September 30, 2025 and 2024, customers that each individually contributed 10% or more of our total revenue accounted for 55% and 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.

7 unchanged sentences

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 June 30, 2025, we derived a majority of our product revenue from these product supply agreements.

For the three and nine months ended September 30, 2025, we derived a majority of our product revenue from these product supply agreements.

The demand for our products depends in part on our customers’ research and development and the clinical and market success of their products.

51 unchanged sentences

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 delays in our ability to deliver products to our customers, increase our costs and decrease our profit margins.

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.

We currently have supply agreements in place with Lactosan, ACSD and Sekisui.

25 unchanged sentences

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.

Our ECO Synthesis manufacturing platform is designed to enable the commercial-scale manufacture of RNAi and other RNA-based therapeutics through an enzymatic route.

44 unchanged sentences

We have investments in illiquid or non-marketable equity securities acquired in private transactions.

As of June 30, 2025, 2.0% of our consolidated assets consisted of investment securities, which are illiquid investments.

As of September 30, 2025, 2.3% of our consolidated assets consisted of investment securities, which are illiquid investments.

Investments in non-marketable securities are inherently risky and difficult to value.

71 unchanged sentences

Our future capital requirements may be substantial, particularly as we continue to develop our business.

Although we believe that, based on our current level of operations, our existing cash, cash equivalents and equity securities will provide adequate funds for ongoing operations, planned capital expenditures and working capital requirements for at least the next 12 months, we may need additional capital if our current plans and assumptions change.

Although we believe that, based on our current level of operations, our existing cash, cash equivalents and equity securities will provide adequate funds for planned ongoing operations, capital expenditures and working capital requirements for at least the next 12 months, we may need additional capital if our current plans and assumptions change.

Our need for additional capital will depend on many factors, including the financial success of our performance enzyme business, our spending to develop and commercialize new and existing enzyme products and the amount of collaboration funding we may receive to help cover the cost of such expenditures, the effect of any acquisitions of other businesses, technologies or facilities that we may make or develop in the future, our spending on new market opportunities, including the ongoing commercialization of our ECO Synthesis manufacturing platform , scaling the ECO Synthesis manufacturing platform to GMP capability, and the filing, prosecution, enforcement and defense of patent claims.

49 unchanged sentences

Even if our customers, future 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.

We expect that our future revenues will depend, in part, on the ability of our customers to obtain and maintain regulatory approvals for therapeutic products utilizing our biocatalysts and other products.

Any product that receives FDA approval will remain subject to ongoing regulatory requirements for manufacturing, labeling, packaging, distribution, storage, advertising, promotion, sampling, record-keeping and submission of safety and other post-market information, among other things.

81 unchanged sentences

Any such litigation could result in substantial costs and diversion of our resources.

Moreover, any settlement of or adverse judgment resulting from litigation relating to intellectual property rights could require us to obtain a license to continue to make, use, import, sell or offer for sale the technology, products or services that is the subject of the claim, or otherwise restrict or prohibit our use of the technology, products or services.

Moreover, any settlement of or adverse judgment resulting from litigation relating to intellectual property rights could require us to obtain a license, which may be on terms that are not favorable to us, to continue to make, use, import, sell or offer for sale the technology, products or services that is the subject of the claim, or otherwise restrict or prohibit our use of the technology, products or services.

Our ability to compete may decline if we do not adequately prosecute, maintain, protect and/or defend our proprietary technology, products or services or our intellectual property rights.

1 unchanged sentence

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 June 30, 2025 , we owned or controlled approximately 1,650 active issued patents and pending patent applications in the United States and in various foreign jurisdictions.

As of June 30, 2025 , our patents and patent applications, if issued, have terms that expire between 2025 and approximately 2045.

As such, as of September 30, 2025 , we owned or controlled approximately 1,650 active issued patents and pending patent applications in the United States and in various foreign jurisdictions.

As of September 30, 2025 , our patents and patent applications, if issued, have terms that expire between 2025 and approximately 2045.

We also have license rights to a number of issued patents and pending patent applications in the United States and in various foreign jurisdictions.

325 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors