C1 Uses

BIOLOGIC DRUGS FOR TODAY AND TOMORROWS AGING AND GROWING PATIENT POPULATION

As the aging population grows in developed and undeveloped countries, Dyadic believes its patented and proprietary C1 technology can potentially help bring biologic drugs to market faster, in greater volumes and at lower cost to drug developers and manufacturers. This can potentially improve access and reduce costs to patients and the healthcare system.

Biopharmaceutical Markets

(1)  World Health Organization.

(2)  Human Insulin Market – Drugs Type, Brands, Delivery Devices, Applications Forecasts to 2020.

(3)  Global Market Study on Biological Drugs: North America to Witness Highest Growth By 2020.

(4)  World Biosimilars Market (follow-on-biologics) Opportunities, and Forecast, 2014-2020.

Dyadic’s global presence

History: We have developed an industrially proven expression system based on the fungus Myceliophthora thermophila, nicknamed C1.   Based on our academic and commercial collaborations, we believe experts in academia and industry regard Dyadic’s C1 expression system as among the foremost expression systems in the world.  Prior to the DuPont Transaction, the C1 technology was previously used commercially by us, and we had successfully licensed our C1 expression system, on a non-exclusive basis, to some of the world’s largest and most renowned industrial biotechnology companies such as Abengoa, BASF, Codexis, among to develop and produce industrial products from DNA such as enzymes for a wide variety of applications and industries.

On December 31, 2015 we sold substantially all the assets of our Industrial Technology business to DuPont’s Industrial Biosciences business for $75 million in cash.   DuPont has granted back to Dyadic co-exclusive rights to the C1 technology for use in human and animal pharmaceutical applications, with exclusive ability to enter into sub-license agreements in that field.  This transaction is an exceptional opportunity to unlock value and provide Dyadic operational flexibility to further develop our pharmaceutical business. We will now focus our C1 technology exclusively on the human and animal pharmaceutical markets where we believe C1 has the potential to help develop and manufacture drugs and vaccines faster and more efficiently than existing production systems.

We are optimistic about the impact that the C1 expression system may have on the development and manufacturing of biologic vaccines and drugs and that utilizing the C1 expression system may be the critical differentiator in allowing Dyadic, our collaborators and licensees to compete in these technology-driven markets. Further, we believe biologics developed without the most productive expression system will face reimbursement challenges.

Why:  The Company has long believed that the pharmaceutical field is one of the most attractive opportunities in which the C1 technology may be applied.  We believe the C1 technology platform has potential to be a safe and efficient expression system that may help speed up the development and production of biologics at flexible commercial scales. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes C1 can potentially help bring biologic drugs to market faster, in greater volumes and at lower cost, and with new properties to drug developers and manufacturers and hopefully, improve access and cost to patients and the healthcare system, but most importantly saving lives. . This can potentially improve access and reduce costs to patients and the healthcare system.

Dyadic’s C1 Technology PLATFORM

In addition, we believe the unique attributes of C1 may create attractive research, licensing, collaboration and other opportunities if C1 demonstrates operational efficiencies and reduced capital requirements for biologic drug manufacturers.

We believe in the saying that the expression system is not everything, but we believe biologics developed without the most productive expression system will face reimbursement challenges. Based on our academic and commercial collaborations, we believe experts in academia and industry regard Dyadic’s C1 Expression System as among the foremost expression systems in the world.

Proprietary & Patented Myceliophthora thermophila, commercially known as our C1 Technology: Dyadic has developed a highly productive recombinant production host that uses modern genetic recombination techniques to develop and manufacture novel enzyme and other protein products.  The C1 technology platform enables the targeted discovery, development and industrial scale manufacturing of innovative enzyme and other protein products, thereby providing customers with value-added solutions for their pressing business needs.

The use of the C1 technology platform has the potential to remove a critical bottleneck in protein development and manufacturing processes

  • Allows for rapid scaling
  • Significantly lower CapEx and OpEx
  • Potential to improve therapeutic vaccine and drug performance

Dyadic is seeking partnerships to sub-license, or partner its C1 platform technology in the vaccine, antibody and biosimilar industries.