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Dyadic Reports 2021 Year End Results and Recent Company Progress
JUPITER, Fla., March 29, 2022 (GLOBE NEWSWIRE) -- 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 the performance of biologic vaccines and therapeutics today announced its financial results for year end 2021 and highlighted recent Company progress. Mark Emalfarb, Dyadic's President and Chief Executive Officer, said, "The C1-cell protein production platform has the potential to address the ongoing need to affordably and rapidly produce vast amounts of vaccines in response to emerging infectious disease threats. We are very encouraged by the growing industry interest and broad commercial possibilities of leveraging our C1-cell protein production platform and our other technologies for use in manufacturing a growing number of vaccines, antibodies, therapeutic proteins and other biologic products. Dyadic continues to develop both strategically and operationally, enhancing our business development and scientific capabilities enabling us to focus our 2022 operating plan on human and animal health, while leveraging other biomolecule market opportunities. As such, we believe that Dyadic has the potential to reshape the current landscape of biomanufacturing. In the meantime, we are pivoting from successfully demonstrating the safety of C1-cells in the production of antigens that are safe, effective, and protective in animals to demonstrating positive human safety data for C1-cell produced proteins with the anticipated initiation of the DYAI-100 Phase 1 clinical trial.” Recent Company Progress Human Health
Animal Health
Other Markets
Executive Leadership Team Dyadic appointed Joseph Hazelton as the Chief Business Officer in November of 2021. Mr. Hazelton was brought on to lead Dyadic’s transition from research and development activities into commercialization endeavors. With over 20 years in the pharmaceutical industry, Mr. Hazelton brings extensive commercial, operational, and leadership experience to expand Dyadic’s business development opportunities for the C1-cell protein production platform across the company’s core verticals of Human Health, Animal Health, and Industrial Enzymes. Financial Highlights Cash Position: As of December 31, 2021, cash, cash equivalents, and the carrying value of investment grade securities, including accrued interest were approximately $20.4 million compared to $29.2 million at December 31, 2020. Revenue: Research and development revenue for the year ended December 31, 2021, increased to approximately $2,404,000 compared to $1,602,000 for the year ended December 31, 2020. At December 31, 2021, the Company recorded the $500,000 upfront payment received from the collaboration and license agreement with Janssen as deferred license revenue. Cost of Revenue: Cost of research and development revenue for the year ended December 31, 2021, increased to approximately $1,944,000 compared to $1,425,000 for the year ended December 31, 2020. The increase in revenue and cost of research and development revenue for the year ended December 31, 2021, was due to a number of larger research collaborations conducted in 2021. There was no provision for contract losses for the year ended December 31, 2021. R&D Expenses: Research and development expenses for the year ended December 31, 2021, increased to approximately $8,392,000 compared to $3,868,000 for the year ended December 31, 2020. The increase primarily reflected the engagement of a contract research organization and pharmaceutical quality and regulatory consultants to manage and support pre-clinical and clinical development as well as an increase in cGMP manufacturing costs as the Company moves towards its anticipated Phase 1 clinical trial of DYAI-100 COVID-19 vaccine candidate in the amount of approximately $5,145,000 offset by a decrease of $621,000 in other internal research and development costs. G&A Expenses: General and administrative expenses for the year ended December 31, 2021, increased 10.1% to approximately $6,698,000 compared to $6,085,000 for the year ended December 31, 2020. The increase principally reflected increases in legal expenses of $447,000, insurance premiums and other outside services of $220,000, payroll and share based compensation related costs of $40,000, offset by reductions in business development and investor relations costs of $94,000. Foreign Currency Exchange: Foreign currency exchange loss for the year ended December 31, 2021, was approximately $97,000 compared to $62,000 for the year ended December 31, 2020. The increase reflected the currency fluctuation of the Euro in comparison to the U.S. dollar. Interest Income: Interest income for the year ended December 31, 2021, decreased to approximately $52,000 compared to $447,000 for the year ended December 31, 2020. The decrease was primarily due to a decrease in interest rate and yield on the Company’s investment grade securities, which are classified as held-to-maturity. Other Non-Operating Items: For the year ended December 31, 2021, the Company recorded a gain from the sale of its investment in BDI in the amount of approximately $1,606,000. Net Loss: Net loss for the year ended December 31, 2021, was approximately $13.1 million, or $(0.47) per share, compared to a net loss of $9.3 million, or $(0.34) per share, for the year ended December 31, 2020. Conference Call Information Date: Tuesday, March 29, 2022 Webcast Link: https://themediaframe.com/mediaframe/webcast.html?webcastid=NtIEiElb An archive of the webcast will be available within 24 hours after completion of the live event and will be accessible on the Investor Relations section of the Company's website at http://www.dyadic.com. To access the replay of the webcast, please follow the webcast link above. About Dyadic International, Inc. Dyadic International, Inc. is a global biotechnology company which 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-cell protein production platform 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-cell protein production platform 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, including those regarding Dyadic International's expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements because of various important factors, including those described in the Company's most recent filings with the SEC. Dyadic 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 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 at www.dyadic.com. Contact: Dyadic International, Inc. DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
See Notes to Consolidated Financial Statements in Part I of Dyadic's Annual Report on Form 10-K filed with Securities and Exchange Commission on March 29, 2022. DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
See Notes to Consolidated Financial Statements in Part I of Dyadic's Annual Report on Form 10-K filed with Securities and Exchange Commission on March 29, 2022. |