Dyadic & Sorrento Announce Binding Term Sheet to License Dyadic’s Lead COVID-19 Vaccine Candidate & C1 Technology for Protein-Based Coronavirus Vaccines & Therapeutics

Dyadic International, Inc. and Sorrento Therapeutics, Inc. recently 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, said “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. Over the past 6 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, added “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.”

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.”

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 1B 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

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. For more information, visit http://www.dyadic.com.