Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the
“Company”) (NASDAQ: DYAI), a global biotechnology company focused
on further improving, applying and deploying its proprietary
C1-cell protein production platform to accelerate development,
lower production costs and improve access to biologic vaccines and
drugs at flexible commercial scales, and Sorrento Therapeutics,
Inc. ("Sorrento") (NASDAQ: SRNE), a clinical stage
biopharmaceutical company developing new therapies to treat cancer,
pain and COVID-19, today announced the signing of a binding term
sheet to enter into a License Agreement to develop and
commercialize vaccines, therapeutics, and diagnostics for
coronaviruses, including Dyadic’s lead COVID-19 vaccine candidate,
DYAI-100, produced using Dyadic's proprietary and patented C1-cell
protein production platform. The final terms of the license will be
set forth in a definitive agreement to be entered into between the
parties.
Sorrento’s Chairman and CEO, Dr. Henry Ji,
commented, “We look forward to continuing our collaboration with
Dyadic, which began last year, initially with a goal of developing
and commercializing a protein-based COVID-19 vaccine that can be
rapidly manufactured in large quantities in our existing cGMP
facilities, and stored and transported at room temperature, in
order to increase access and affordability to underserved
populations globally.” Dr Ji. continued, “Over the past six months
we have carried out several promising preclinical animal trials
using the C1 produced RBD antigen in Dyadic’s lead COVID-19 vaccine
candidate, DYAI-100. Our goal is to manufacture a COVID-19 vaccine
that will provide protection across the variants of concern,
including Delta, and in addition, apply the C1 protein production
platform broadly across our current and future coronavirus
programs.”
Mark Emalfarb, Dyadic’s President and Chief
Executive Officer noted, “We are delighted to have executed a
binding term-sheet with Sorrento Therapeutics to license the C1
technology for the development and commercialization of coronavirus
vaccines, therapeutics, and diagnostics, including COVID-19. This
marks a significant milestone in our corporate development efforts
as we expect the license agreement we will enter into to enable us
to monetize our internal COVID-19 development efforts with a
partner that has the resources and expertise to advance vaccines,
therapeutics, and diagnostics both clinically and
commercially.”
“The license agreement, when executed,
contemplates an up-front payment of $10 million in cash and stock,
up to $4 million in reimbursements for preclinical and clinical
development costs incurred by Dyadic for the development and
advancement of our proprietary DYAI-100 vaccine, up to $33 million
in milestone payments and ongoing royalties following
commercialization. All future development costs related to this
license will be incurred by Sorrento,” concluded Mr. Emalfarb.
Mr. Michael Tarnok, Dyadic’s Board Chairman
noted, “This is a significant event for Dyadic and humankind
globally, having achieved our goal of creating a pathway that
potentially addresses the COVID-19 vaccine production gap for mass
scale immunizations and treatments across the globe, quickly and
efficiently. The Sorrento license will cover all other territories
not already covered by Dyadic’s existing COVID-19 agreements with
Medytox, Syngene and the Rubic Consortium.”
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat cancers
and COVID-19. Sorrento's multimodal, multipronged approach to
fighting cancer is made possible by its extensive immuno-oncology
platforms, including key assets such as fully human antibodies
(“G-MAB™ library”), clinical stage immuno-cellular therapies
(“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and
clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™,
Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions,
including COVITRACK™, COVI-STIX™ and COVITRACE™.
Sorrento's commitment to life-enhancing
therapies for patients is also demonstrated by its effort to
advance a first-in-class (TRPV1 agonist) non-opioid pain management
small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg,
dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel,
viscous gel formulation of a widely used corticosteroid for
epidural injections to treat lumbosacral radicular pain, or
sciatica, and to commercialize ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. RTX has
completed a Phase IB trial for intractable pain associated with
cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is
in a pivotal Phase 3 trial for the treatment of lumbosacral
radicular pain, or sciatica. ZTlido® was approved by the FDA on
February 28, 2018.
For more information visit
www.sorrentotherapeutics.com
About Dyadic International, Inc.
Dyadic International, Inc. is a global
biotechnology company that is developing what it believes will be a
potentially significant biopharmaceutical gene expression platform
based on the fungus Thermothelomyces heterothallica (formerly
Myceliophthora thermophila), named C1. The C1 microorganism, which
enables the development and large-scale manufacture of low-cost
proteins, has the potential to be further developed into a safe and
efficient expression system that may help speed up the development,
lower production costs and improve the performance of biologic
vaccines and drugs at flexible commercial scales. Dyadic is using
the C1 technology and other technologies to conduct research,
development and commercial activities for the development and
manufacturing of human and animal vaccines and drugs, such as virus
like particles (VLPs) and antigens, monoclonal antibodies, Fab
antibody fragments, Fc-Fusion proteins, biosimilars and/or
biobetters, and other therapeutic proteins. Certain other research
activities are ongoing, which include the exploration of using C1
to develop and produce certain metabolites and other biologic
products. Dyadic pursues research and development collaborations,
licensing arrangements and other commercial opportunities with its
partners and collaborators to leverage the value and benefits of
these technologies in development and manufacture of
biopharmaceuticals. As the aging population grows in developed and
undeveloped countries, Dyadic believes the C1 technology may help
bring biologic vaccines, drugs, and other biologic products to
market faster, in greater volumes, at lower cost, and with new
properties to drug developers and manufacturers, and improve access
and cost to patients and the healthcare system, but most
importantly save lives.
Please visit Dyadic's website
at http://www.dyadic.com for additional information,
including details regarding Dyadic's plans for its
biopharmaceutical business.
Safe Harbor Regarding Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934. All
statements other than statements of historical fact are
forward-looking. Examples of forward-looking statements include,
but are not limited to, statements regarding Dyadic's expectations,
intentions, strategies, and beliefs pertaining to future events or
future financial performance. Forward-looking statements generally
can be identified by use of the words “expect,” “should,” “intend,”
“aim,” “anticipate,” “believe,” “will,” “project,” “may,” “might,”
“potential,” “pursue,” or “continue” and other similar terms or
variations of them or similar terminology. However, not all
forward-looking statements contain these words. Actual events or
results may differ materially from those in the forward-looking
statements because of various important factors, including (1) the
expected entry into a definitive license agreement with Sorrento,
(2) the development and commercialization of COVID-19 vaccines,
including DYAI-100, and therapeutic antibodies, protein
therapeutics and diagnostics for coronaviruses; (3) the properties
of DYAI-100, including its induction of high-titer neutralization
activity against SARS-CoV-2 and its variants of concern, (4) the
capability to manufacture protein-based vaccines in large
quantities; (5) the resources and expertise of Dyadic and its
partners in developing and commercializing vaccines, therapeutics
and diagnostics; (6) the expectation that such vaccines would be
effective against SARS-CoV-2 and its variants of concern; (7)
general economic, political and market conditions; (8) our ability
to generate the required productivity, stability, purity,
performance, cost, safety and other data necessary to carry out and
implement our biopharmaceutical research and business plans and
strategic initiatives; (9) our ability to implement and
successfully carry out Dyadic’s and third parties’ research and
development efforts; (10) the pharmaceutical and biotech
industry, governmental regulatory and other agencies’ willingness
to adopt, utilize and approve the use of the C1 gene expression
platform; and (11) other factors described in the Company's
most recent filings with the SEC. Given these risks and
uncertainties, you should not place undue reliance on any
forward-looking statements. The forward-looking statements
contained in this press release are made only as of the date
hereof, and Dyadic does not intend, and except as required by law
assumes no obligation to update publicly any such forward-looking
statements, whether because of new information, future events or
otherwise. For a more complete description of the risks that could
cause our actual results to differ from our current expectations,
please see the section entitled "Risk Factors" in Dyadic's annual
reports on Form 10-K and quarterly reports on Form 10-Q filed with
the Securities and Exchange Commission (the “SEC”), as such factors
may be updated from time to time in Dyadic's periodic filings with
the SEC, which are accessible on the SEC's website and
www.dyadic.com.
Contacts:
Sorrento Therapeutics Inc. Alexis Nahama,
DVMSVP, Corporate DevelopmentEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™, COVISHIELD™,
Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and
COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by Scilex
Pharmaceuticals Inc.
All other trademarks are the property of their respective
owners.
Dyadic International, Inc.Ping W. RawsonChief
Financial OfficerPhone: (561) 743-8333Email: prawson@dyadic.com
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