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December 3, 2014

Codexis Uses Its CodeEvolver(R) Protein Engineering Platform Technology to Develop an Enzyme Therapeutic Candidate for the Potential Treatment of Phenylketonuria (PKU) via Oral Administration

REDWOOD CITY, Calif., Dec. 3, 2014 (GLOBE NEWSWIRE) — Codexis, Inc. (Nasdaq:CDXS), a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced that it has developed a novel enzyme therapeutic product candidate for the potential treatment of phenylketonuria (PKU) via oral administration. PKU is an inherited metabolic disorder in which the enzyme that converts the essential amino acid phenylalanine into tyrosine is deficient. As a result, phenylalanine accumulates in high levels in the brain causing serious neurological problems, including intellectual disability, seizures and cognitive and behavioral problems. Phenylalanine is found in many foods, including meat, dairy products, fish, poultry and many fruits and vegetables. 

Codexis has conducted studies in a PKU animal model that demonstrate proof of concept for Codexis’ therapeutic enzyme product candidate. In these studies, Codexis’ enzyme therapeutic candidate was introduced into the stomach of the animal resulting in decreased blood phenylalanine levels. Codexis has filed patent applications covering the composition of matter for its therapeutic enzymes and the use of these enzymes as a treatment for PKU. 

Codexis is seeking partners for its PKU program to advance its development. Codexis expects to begin preclinical studies for its enzyme therapeutic candidate in 2015. 

Codexis will briefly discuss its PKU program at 12:30 p.m. on Thursday, December 4, 2014 at the LD Micro Main Event VII Conference, being held at The Luxe Hotel in Los Angeles, California. This presentation will be webcast at

About Phenylketonuria

Phenylketonuria, or PKU, is an autosomal recessive genetic disorder caused by a mutation in the gene that encodes for the hepatic enzyme phenylalanine hydroxylase (PAH), making the enzyme deficient or nonfunctional. PAH is necessary to convert the essential amino acid phenylalanine into the amino acid tyrosine. Phenylalanine is found in many foods, including meat, dairy products, fish, poultry and many fruits and vegetables. Without functional PAH, high levels of phenylalanine accumulate in the body and cause serious neurological complications, including intellectual disability, seizures, mental illness, tremors and cognitive and behavioral problems. To avoid high levels of phenylalanine in their blood, individuals with PKU must follow a strict, life-long diet that is low in phenylalanine and supplement their diet with a synthetic phenylalanine-free formula to provide them with sufficient nutrients. Maintaining a strict, life-long diet can be challenging for individuals with PKU. There are an estimated 50,000 people with PKU in the developed world. PKU is considered a rare disease in the United States and the European Union. The United States and most other developed countries test for PKU as part of newborn screening programs.

About CodeEvolver ® Protein Engineering Platform Technology

CodeEvolver is Codexis’ proprietary protein engineering platform, which enables rapid development of custom-designed enzymes that are highly optimized for efficient manufacturing processes. The CodeEvolver platform is comprised of proprietary methods for the optimization of proteins through the design and generation of diverse genetic libraries, automated screening techniques, algorithms for the interpretation of screening data and predictive modeling. The Codexis CodeEvolver platform technology is covered by more than 180 issued patents and pending patent applications worldwide. 

About Codexis, Inc.

Codexis, Inc. is a leading developer of biocatalysts for pharmaceutical and fine chemical production. Codexis’ proven technology enables scale-up and implementation of biocatalytic solutions to meet customer needs for rapid, cost-effective and sustainable process development – from research to manufacturing. For more information, see

Forward-Looking Statements

This press release contains forward-looking statements relating to Codexis’ enzyme therapeutic product candidates, including Codexis’ expectation that it will begin preclinical studies for its enzyme therapeutic candidate in 2015 and partner its PKU program to advance its development. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Codexis’ control and that could materially affect actual results. Factors that could materially affect actual results include Codexis’ need for substantial additional capital in the future in order to expand its business; Codexis’ dependence on its collaborators; Codexis’ dependence on a limited number of products and customers in its pharmaceutical business; Codexis’ dependence on one contract manufacturer for commercial scale production of substantially all of Codexis’ enzymes; potential adverse effects to Codexis’ business if its customers’ pharmaceutical products are not received well in the markets; Codexis’ ability to develop and commercialize new products for the pharmaceutical markets; the success of Codexis’ cost saving measures; Codexis’ ability to deploy its technology platform in new market spaces; any impairments Codexis may be required to record in the future with respect to its goodwill, intangible assets or other long-lived assets; the variability of Codexis’ pharmaceutical product gross margins which are variable and may decline from quarter to quarter; Codexis’ ability to retain key personnel; Codexis’ reliance on customers to provide information in order for Codexis to report accurately its financial results in a timely manner; Codexis’ ability to compete which may decline if it loses some of its intellectual property rights; third party claims that Codexis infringes third party intellectual property rights; and Codexis could face increased competition if third parties misappropriate Codexis biocatalysts. Additional factors that could materially affect actual results can be found in Codexis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2014, and in subsequent quarterly reports on Form 10-Q, including under the captions titled “Risk Factors.” Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

CONTACT: Investors
         Andrew McDonald, 646-597-6987

         Kate Whelan, +44 72 216 98 49


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