Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company,
hosted a virtual Key Opinion Leader (KOL) event on Friday, December
8, 2023, to discuss the growth of RNA interference (RNAi)
therapeutics as a modality, the manufacturing landscape and the
potential role for the Company’s Enzyme-Catalyzed Oligonucleotide
(ECO) Synthesis™ platform to enable commercial-scale production of
RNAi therapeutics. KOL participants included John Maraganore, PhD,
Founder and Former Chief Executive Officer of Alnylam
Pharmaceuticals, and member of Codexis’ Strategic Advisory Board,
and David Butler, PhD, Chief Technology Officer at Hongene Biotech
Corporation.
“As part of the pioneering team that established
RNAi therapeutics as a whole new class of medicines, I am thrilled
to see the field advance with six approved medicines and a large
and rapidly growing number of investigational programs in clinical
development,” said Dr. Maraganore. “As the RNAi therapeutics field
matures, many programs are targeting prevalent disease indications,
such as cardiovascular and Alzheimer’s disease. While I am
confident in the potential for RNAi therapeutics to transform the
treatment paradigms for millions of impacted patients, today’s
manufacturing practices rely on traditional chemical synthesis
methods that may not accommodate a sharp increase in demand.
Accordingly, I have long felt that an enzymatic route of synthesis
is a critical innovation to reduce required infrastructure
investments, mitigate high volumes of hazardous waste and ensure
that drug developers can effectively address the coming demand of
these medicines for patients.”
Dr. Butler added, “It’s incredible to see the
progress that has been made in advancing siRNA therapeutics, and
traditional chemical synthesis has enabled the development and
initial commercialization of this modality. However, decades of
process improvements are now achieving diminishing returns, and
traditional chemical synthesis remains limited by scale per batch,
expensive equipment, significant purification and waste disposal
costs and a negative environmental impact. A fully enzymatic
approach has the potential to improve efficiencies across each of
these areas while reducing the significant capital expenditure
required of chemical synthesis, all of which would be compelling to
the many manufacturers who are ramping up investment in their
oligonucleotide production capabilities.”
In addition to the KOL presentations, Codexis
management, including Chief Executive Officer Stephen Dilly, MBBS,
PhD; Chief Operating Officer Kevin Norrett, MBA; and Senior Vice
President of Research Stefan Lutz, PhD, provided a technical
overview of the ECO Synthesis™ platform and reviewed the program’s
associated commercial opportunity and upcoming milestones.
“We were honored to have Dr. Maraganore and Dr.
Butler share their insights on the RNAi manufacturing landscape
during last week’s event. Their comments further reinforce the
critical need for us to bring our ECO Synthesis™ platform to
market, and we are pleased with our recent progress on both the
technical and commercial fronts,” said Dr. Dilly. “We are fast
approaching our key milestone of achieving gram-scale synthesis by
the end of this year, which, if met, will provide additional
validation of the potential for an enzymatic route of
manufacturing, and also enable us to enter pre-commercial testing
with select customers in 2024.”
A replay of the virtual event is accessible on
the Investor Relations section of the Company’s website,
https://ir.codexis.com.
About the ECO Synthesis™
Platform Ribonucleic acid (RNA) as a therapeutic modality
has gained tremendous traction in recent years with the growing
number of messenger RNA (mRNA) vaccines and small interfering RNA
(siRNA) candidates advancing in clinical studies. However,
large-scale production of RNA interference (RNAi) therapeutics
using traditional chemical synthesis faces complex challenges in
nucleic acid quality and quantity, as well as overall economics.
With over 450 RNAi therapies currently in clinical development,
including more than 40 assets in Phase 2 and Phase 3 clinical
trials targeting disease indications impacting millions of
patients, RNAi therapeutic demand is projected to outpace current
production capabilities by the end of the decade. Codexis’
proprietary ECO Synthesis™ technology platform is being designed to
address these scalability and cost limitations by potentially
enabling the commercial-scale manufacture of RNAi therapeutics
through an enzymatic route. The Company is on track to demonstrate
gram-scale synthesis by the end of 2023, where it will demonstrate
the preparative-scale manufacture of an oligonucleotide, composed
of the modified nucleotide building blocks typically used in RNAi
therapeutics, under process-like conditions.
About Codexis
Codexis is a leading enzyme engineering company
leveraging its proprietary CodeEvolver® technology platform to
discover, develop and enhance novel, high-performance enzymes and
other classes of proteins. Codexis enzymes solve for real-world
challenges associated with small molecule pharmaceuticals
manufacturing and nucleic acid synthesis. The Company is currently
developing its proprietary ECO Synthesis™ platform to enable the
scaled manufacture of RNAi therapeutics through an enzymatic route.
Codexis’ unique enzymes can drive improvements such as higher
yields, reduced energy usage and waste generation, improved
efficiency in manufacturing and greater sensitivity in genomic and
diagnostic applications. For more information, visit
https://www.codexis.com.
Forward-Looking Statements
This press release may contain 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. In some cases, you can identify
forward-looking statements by terminology such as “aim,”
“anticipate,” “assume,” “believe,” “contemplate,” “continue,”
“could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,”
“may,” “objective,” “plan,” “positioned,” “potential,” “predict,”
“seek,” “should,” “suggest,” “target,” “on track,” “will,” “would”
and other similar expressions that are predictions of or indicate
future events and future trends, or the negative of these terms or
other comparable terminology. To the extent that statements
contained in this press release are not descriptions of historical
facts, they are forward-looking statements reflecting the current
beliefs and expectations of management, including but not limited
to statements regarding whether Codexis will be able to, and the
timing of it demonstrating gram-scale synthesis with its ECO
Synthesis™ technology by the end of 2023 and initiating
pre-commercial testing in 2024; the potential of the ECO Synthesis™
platform, including its ability to be broadly utilized and to
enable commercial-scale manufacture of RNAi therapeutics through an
enzymatic route, and it providing an opportunity for Codexis to
efficiently capture meaningful market share; the potential of an
enzymatic route of synthesis to improve efficiencies in scale,
environmental impacts, and costs related to, among other things,
infrastructure, purification, waste disposal; and expectations
regarding future demand for, and benefits to impacted patients of,
RNAi technologies. 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, among others: Codexis’ dependence on its licensees and
collaborators; if any of its collaborators terminate their
development programs under their respective license agreements with
Codexis; Codexis may need additional capital in the future in order
to expand its business; if Codexis is unable to successfully
develop new technology such as its ECO Synthesis™ platform and
dsRNA; Codexis' dependence on a limited number of products and
customers, and potential adverse effects to Codexis’ business if
its customers’ products are not received well in the markets; if
Codexis is unable to develop and commercialize new products for its
target markets; if competitors and potential competitors who have
greater resources and experience than Codexis develop products and
technologies that make Codexis’ products and technologies obsolete;
if Codexis is unable to accurately forecast financial and
operational performance; and market and economic conditions may
negatively impact Codexis' business, financial condition and share
price. Additional information about 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 (“SEC”)
on February 27, 2023 and in Codexis’ Quarterly Report on Form 10-Q
filed with the SEC on November 3, 2023, including under the caption
“Risk Factors,” and in Codexis’ other periodic reports filed with
the SEC. Codexis expressly disclaims any intent or obligation to
update these forward-looking statements, except as required by
law.
For More Information
Investor ContactCarrie McKim(336)
608-9706ir@codexis.com
Media ContactLauren Musto(781)
572-1147media@codexis.com
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