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Dyadic Reports First Quarter 2022 Financial Results and Highlights Recent Company Developments
JUPITER, Fla., May 12, 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 the first quarter of 2022, and highlighted recent company developments. Mark Emalfarb, Dyadic’s President, and Chief Executive Officer, said, “I believe 2022 will be an important inflection point in the development of Dyadic’s C1-cell protein production platform for commercial use. As a result of our research and development efforts standardizing C1’s production processes, we have successfully secured development partnerships with major pharma, animal health and other emerging and rapidly expanding industries, such as alternative food production.” Mr. Emalfarb continued, “We have successfully engineered our C1-cells to where they are now being used to develop potential vaccines and treatments for a growing number of diseases, in addition to COVID-19. Our efforts are beginning to pay off, resulting in a number of pre-clinical trials for vaccines and a monoclonal antibody produced from our proprietary C1-cell protein production platform as well as our anticipated Phase 1 human clinical trial with our DYAI-100 vaccine candidate.” “We are motivated by our partners whose goal is to afford every nation the ability to develop scalable and affordable manufacturing capability which minimizes drug production and distribution shortfalls in developing and established nations to dramatically improve health disparities globally. We look forward to providing future updates as we advance our commercial initiatives across the company’s programs," concluded Mr. Emalfarb. Recent Company Developments
First Quarter 2022 Financial Results Cash Position: At March 31, 2022, cash, cash equivalents, and the carrying value of investment grade securities, including accrued interest were approximately $17.5 million compared to $20.4 million at December 31, 2021. Revenue: Research and development revenue for the three months ended March 31, 2022, increased to approximately $534,000 compared to $461,000 for the same period a year ago. The license revenue recorded in the three months ended March 31, 2022 of approximately $115,000 was in connection with the Phibro/Abic and Janssen license agreements. Cost of Revenue: Cost of research and development revenue for the three months ended March 31, 2022, increased to approximately $405,000 compared to $391,000 for the same period a year ago. The increase in research and development revenue and cost of research and development revenue was due to higher revenue and cost of revenue amounts for individual projects compared to the same period a year ago. R&D Expenses: Research and development expenses for the three months ended March 31, 2022, decreased to approximately $1,343,000 compared to $1,808,000 for the same period a year ago. The decrease primarily reflected the winding down of activities of contract research organization and pharmaceutical quality and regulatory consultants to manage and support the pre-clinical and clinical development as well as a decrease in cGMP manufacturing costs as the Company moves towards its anticipated Phase 1 clinical trial of its DYAI-100 COVID-19 vaccine candidate in the amount of approximately $165,000 and our other internal research projects of $300,000. G&A Expenses: General and administrative expenses for the three months ended March 31, 2022, increased by 6.6% to approximately $1,656,000 compared to $1,554,000 for the same period a year ago. The increase principally reflected increases in insurance expenses of $69,000 and business development and investor relations expenses of $53,000, offset by other decreases of $20,000. Interest Income: Interest income for the three months ended March 31, 2022, was approximately $3,000 compared to $26,000 for the same period a year ago. The decrease was primarily due to the lower balance of held-to-maturity securities and less reinvestment due to the decrease in interest rate. Other Income: Other income for the three months ended March 31, 2022, was $250,000 compared to $0 for the same period a year ago. The other income recognized in the first quarter of 2022 was related to a settlement payment we received from the termination of a proposed license and collaboration. Net Loss: Net loss for the three months ended March 31, 2022, was approximately $2,492,000 or $(0.09) per share compared to $3,295,000 or $(0.12) per share for the same period a year ago. Conference Call Information Date: Thursday. May 12, 2022 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 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 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, 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 http://www.dyadic.com. Contact: Dyadic International, Inc. DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
DYADIC INTERNATIONAL, INC. AND SUBSIDIARIES
See Notes to Consolidated Financial Statements in Item 1 of Dyadic’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2022. |