Research and Development
YOUR PATIENCE IS APPRECIATED WHILE WE REDESIGN OUR WEBSITE
On December 31, 2015 we sold substantially all the assets of our Industrial Technology business to DuPont’s (NYSE:DD) Industrial Biosciences business. Going forward, Dyadic intends to focus exclusively on its biopharmaceutical business. Accordingly, we are in the process of updating our company website to better reflect our ongoing operations. While our website redesign is in progress, we will be periodically updating all of our historical investor information and news and events (see ABOUT US, INVESTOR INFO and NEWS AND EVENTS tabs) on a current basis.
We have developed an industrially proven expression system based on the fungus Myceliopthora thermophila, nicknamed C1. The C1 technology was previously used commercially by us, and is now being used by renowned industry leaders such as BASF, DuPont and others to develop and produce industrial products from DNA such as enzymes for a wide variety of applications and industries.
As recently reported in our press releases and annual financial statements for the year ended December 31, 2015, the Company is now debt free and we have a strong cash position with sufficient cash reserves to fund our previously announced $15 million share repurchase program. In addition, we believe we are uniquely positioned to build shareholder value by leveraging our C1 technology in the pharmaceutical sector. The combination of a portion of the proceeds from the DuPont Transaction and possible additional industry and government funding that will be sought are expected to provide Dyadic with the opportunity to accelerate the further development and optimization of the C1 technology in the area of biopharmaceuticals. In addition, 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 everything is nothing without a good expression system.” 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. We believe 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.
WHY ARE WE NOW FOCUSED IN THIS AREA?
The Global market for vaccines is projected to rise to $ 100B by 2025. The Therapeutic Biologic Drug Market is expected to increase at 10.1% CAGR until 2020 or approximately $287 billion and the biosimilar market is expected to reach $25.53 Billion in 2020 in the U.S., growing at a CAGR of 54.4%.
We believe there is a growing global need to find a better way to bring biologic drugs such as vaccines and antibodies to market faster, in greater volumes and at lower cost. Biologic drugs are some of the most expensive treatments, and therefore are placing an enormous burden on both patients and the healthcare systems globally.
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 to drug developers and manufacturers. This can potentially improve access and reduce costs to patients and the healthcare system.
OUR CURRENT ACTIVITIES:
Dyadic is currently carrying out research projects in conjunction with Sanofi Pasteur and continuing our involvement within the € 22 million EU-funded ZAPI program.
If the Company is successful in delivering sufficient quantities of the remaining vaccine variants to Sanofi by the middle of the second quarter, the Company anticipates a decision on this research project by the end of 2016.
We anticipate obtaining preliminary results from the ongoing gene expression research we are conducting in the ZAPI program sometime in the second half of this year.
We expect to enter into and conduct additional research & development projects with third parties. The company has started an initial exploratory research program to evaluate the use of the current C1 technology to develop imperative non-glycosylated therapeutic products such as Insulin and ranibizumab, a biosimilar version of Lucentis.
The Global human insulin market has been estimated to reach $42 billion by 2019, at a compound annual growth rate of 12.5% from 2014-2019.
We anticipate reengineering the C1 microorganism (i.e. Glycoengineering the C1 microorganism). The Company’s longer term objective, which will require substantially more time and money to achieve, is to leverage the C1 expression host system for the even larger therapeutic glycoprotein market. The C1 system has the potential to become a significant platform for the development and production of therapeutic glycoproteins with human-compatible or even superior glycan structures. We believe that with the rapid advances already available today, and those being made at an accelerated pace in genomics and synthetic biology, the hyper productive and novel C1 fungal cell line is a superior option to further engineer glycosylation pathways: (i) to create improved immunogenicity in the case of vaccines, or (ii) to eliminate immunogenicity in the case of glycoproteins as therapeutic drugs.
The company is currently evaluating the best strategies to carry out these critical research and development tasks. We are in discussions with various leading experts and laboratories in the field of glycoengineering to identify the best path forward to glycoengineer C1 cell lines.