Dyadic Reports Second Quarter 2022 Financial Results and Highlights Recent Company Developments
JUPITER, Fla., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial platforms to address the growing demand for global protein production and unmet clinical needs for effective and affordable biopharmaceutical products for human and animal health, today announced its financial results for the second quarter of 2022, and highlighted recent company developments.
“The recent submission of our first-in-human clinical trial application with the South African Health Products Regulatory Authority (SAHPRA) is a significant milestone for Dyadic and our C1-cell protein production platform,” said Mark Emalfarb, President and Chief Executive Officer of Dyadic. “We have leveraged our industrially-proven C1 platform to bring a rapid, highly productive, and affordable approach for emerging and developed countries to fight against COVID-19, and we believe that our novel C1 protein production platform could be instrumental in the control and prevention of infectious and other diseases. It is important to note that in addition to assessing the DYAI-100 vaccine candidate for safety and preliminary efficacy against the SARS-CoV-2 virus, this will be the first time that a protein produced by Dyadic’s proprietary and patented C1 protein production platform will be used in a human clinical trial. The anticipated first in human safety data is expected to provide the regulatory support for and accelerate the adoption of the C1 platform to develop and produce vaccines and therapeutics in addition to our DYAI-100 vaccine candidate. This is an important step toward establishing C1 as a transformative option as a protein production platform for biopharmaceuticals. C1 has been our core platform for speeding the development and manufacture of human and animal pharmaceutical products and will continue to serve as our foundation in the life sciences arena.”
Mr. Emalfarb continued, “The Company now has commercial agreements in each of its three core verticals: Human Health, Animal Health, and Alternative Proteins. With the anticipated first-in-human data for a C1-produced product expected later this year, we look forward to adding new commercial and research agreements in human health. Led by our Chief Business Officer, Joe Hazelton, we plan to increase our business development focus on opportunities in Animal Health and Alternative Proteins. In Animal Health, our portfolio of vaccines and therapeutic proteins, as well as external licensing agreements and collaborations, is expected to allow the Company to further penetrate the growing global $15 billion animal health vaccine market and enter the billion-dollar therapeutic protein companion animal market.”
“Our recently developed DapibusTM microbial cell line is gaining interest across multiple applications and industries for the development and manufacture of alternative proteins for world health. We are currently evaluating several opportunities within the global cultured meat industry, which is already a $3 billion market that is still in demonstration scale with over $1.3 billion in industry investments in 2021 alone. Dyadic is dedicating resources and support for existing projects within this rapidly growing market, driven by our fully funded joint development agreement with our Global Food Ingredients collaborator,” Mr. Emalfarb concluded.
Recent Company Developments
Second Quarter and First Half 2022 Financial Results
Cash Position: As of June 30, 2022, cash, cash equivalents, and the carrying value of investment grade securities, including accrued interest were approximately $15.7 million compared to $20.4 million as of December 31, 2021. Based on current plans, the Company expects that its existing cash, cash equivalents, and investment securities will be sufficient to enable it to fund phase 1 clinical trials of DYAI-100 and its operating expenses into 2024.
Revenue: Research and development revenue and license revenue for the quarter ended June 30, 2022, decreased to approximately $659,000 compared to $937,000 for the same period a year ago. Research and development revenue and license revenue for the six months ended June 30, 2022, decreased to approximately $1,306,000 compared to $1,397,000 for the same period a year ago.
Cost of Revenue: Cost of research and development revenue for the quarter ended June 30, 2022, decreased to approximately $411,000 compared to $830,000 for the same period a year ago. Cost of research and development revenue for the six months ended June 30, 2022, decreased to approximately $816,000 compared to $1,220,000 for the same period a year ago.
The decrease in research and development revenue and cost of research and development revenue was due to the decrease in the number of on-going research collaborations compared to the same period a year ago.
R&D Expenses: Research and development expenses for the quarter ended June 30, 2022, decreased to approximately $1,831,000 compared to $2,209,000 for the same period a year ago. Research and development expenses for the six months ended June 30, 2022, decreased to approximately $3,174,000 compared to $4,017,000 for the same period a year ago.
The decrease primarily due to 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.
G&A Expenses: General and administrative expenses for the quarter ended June 30, 2022, decreased to approximately $1,714,000 compared to $1,748,000 for the same period a year ago. General and administrative expenses for the six months ended June 30, 2022, increased to approximately $3,370,000 compared to $3,302,000 for the same period a year ago.
Net Loss: Net loss for the quarter ended June 30, 2022, was approximately $3,288,000 or $(0.12) per share compared to $3,846,000 or $(0.14) per share for the same period a year ago. Net loss for the six months ended June 30, 2022, was approximately $5,780,000 or $(0.20) per share compared to $7,141,000 or $(0.26) per share for the same period a year ago.
Conference Call Information
Date: Wednesday. August 10, 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.
DYAI-100, also known as C1-SARS-CoV-2 RBD vaccine, is a novel receptor-binding domain (RBD) recombinant vaccine, highly expressed in Dyadic’s proprietary C1-cell protein production platform in prevention of COVID-19. The C1-SARS-CoV-2 RBD vaccine drug product consists of the SARS-CoV-2 RBD-C-tag adjuvanted with alum Alhydrogel. DYAI-100 is expected to start a phase 1 clinical trial in South Africa in late 2022 to assess the safety, reactogenicity, and immunogenicity of C1-SARS-CoV-2 RBD vaccine, administered as a booster, in healthy volunteers.
About C1-cell Protein Production Platform
C1-cell protein production platform is Dyadic’s lead technology, which is based on an industrially proven microorganism (named C1). The C1-cell protein production platform is a robust and versatile thermophilic filamentous fungal expression system for the development and production of biologic products, including enzymes. This platform is currently used to speed development, lower production costs, and improve performance of biologic vaccines and drugs at flexible commercial scales for the human and animal health markets.
About DapibusTM Protein Production Platform
DapibusTM is Dyadic’s newly developed filamentous fungal based microbial gene expression and protein production platform, which is also based on Thermothelomyces heterothallica, but further designed and customized to enable the rapid development and large-scale manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.
About Dyadic International, Inc.
Dyadic International, Inc. is a global biotechnology company committed to building disruptive microbial platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable, and accessible biopharmaceutical products for human and animal health.
Dyadic’s gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). Our lead technology, C1-cell protein production platform, is based on an industrially proven microorganism (named C1), which is currently used to speed development, lower production costs, and improve performance of biologic vaccines and drugs at flexible commercial scales for the human and animal health markets. Dyadic has also developed the DapibusTM filamentous fungal based microbial protein production platform to enable the rapid development and large-scale manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.
With a passion to enable our partners and collaborators to develop effective preventative and therapeutic treatments in both developed and emerging countries, Dyadic is building an active pipeline by advancing its proprietary microbial platform technologies, including our lead asset DYAI-100 COVID-19 vaccine candidate, as well as other biologic vaccines, antibodies, and other biological products.
To learn more about Dyadic and our commitment to helping bring vaccines and other biologic products to market faster, in greater volumes and at lower cost, please visit http://www.dyadic.com.
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, such as the success of our clinical trial application and our ability to secure commercial agreements and take advantage of other business opportunities. 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.
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 August 10, 2022.
Continental Breakfast Served - For Diamond, Enterprise, Platinum, Super Pass, Exhibitor/Conference, Speaker, Press Pass Holders
5G and Private Networking
Building Secure and Responsible Applications with Generative AI