Dyadic International Inc (NASDAQ:DYAI) posted its financial results for the year ended 2022 with revenue surging 21.9% year-over-year on the back of license agreements as it rapidly advanced its technology.
For the year ended December 31, 2022, the Jupiter, Florida-based biotechnology platform company reported research and development (R&D) revenue of $2.93 million, compared to $2.40 million for the year ended December 31, 2021. Dyadic said that the license revenue during 2022 was related to the Phibro/Abic and Janssen license agreements.
The company’s R&D expenses for 2022 decreased dramatically to $4.50 million, compared to $8,39 million in 2021 with the winding down of activities for contract research organizations and regulatory consultants to support the Phase 1 clinical trial of its DYAI-100 COVID-19 vaccine candidate.
Significantly, Dyadic also succeeded in narrowing its net loss for the year to approximately $9.7 million, or $0.34 per share, compared to a net loss of $13.1 million, or $0.47 per share, for the year ended December 31, 2021.
Dyadic had cash and investment-grade securities of $12.7 million as of December 31, 2022.
In January 2023, Dyadic received $1.27 million in connection with the sale of Alphazyme LLC. Separately, interest income for 2022 also increased to $180,000, compared to $52,000 for the year ended December 31, 2021.
Dyadic pointed out that it expects its existing strong cash position and investment securities to “be sufficient” to enable it to complete its Phase 1 clinical trial of DYAI-100 and “fund its operations into 2024.”
Regulatory approval for Phase 1 trial of DYAI-100
"In 2022, we made significant advances in our technology and saw meaningful progress in each of our three core verticals," said Dyadic founder and CEO Mark Emalfarb.
"Receiving regulatory approval for our First-In-Human Phase 1 trial for our proprietary DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate was a historical event for Dyadic.”
Emalfarb noted that the company has completed dosing of all patients in both the low and high-dose testing groups and thus far, DYAI-100 has been well tolerated with no serious adverse events being reported.
“The Phase 1 trial is expected to accelerate the adoption of Dyadic's C1-cell protein production platform for vaccines and therapeutic candidates, and I'm pleased to share that since we initiated the Phase 1 trial, we are seeing an increased level of interest from academia, industry, and government agencies in our human biopharmaceuticals business, and we are continuing to make progress in our current collaborations with Janssen, Hengrui, NIIMBL and others," said Emalfarb.
Dyadic leverages its proprietary C1 technology — an industrially proven fungal gene expression technology for producing large amounts of low cost biologic products — to help bring biologic vaccines, therapeutic enzymes, proteins, biosimilars, drugs and potentially other types of biologics such as metabolites and viral vectors such as AAV to market faster and at a lower cost.
The company has patented its proprietary filamentous fungus, Myceliophthora thermophila, nicknamed C1 and the associated molecular tools used to engineer the C1 cells to express and manufacture large volumes of low-cost biologic products such as enzymes and proteins.
Animal Health
Dyadic has expanded its collaboration with Phibro/Abic and others to develop vaccines and treatments for companion and livestock animal diseases.
"We’ve made additional advances in animal health by expanding our relationship with Phibro and initiating a fully funded companion animal proof of concept study with a top five animal health company,” said Emalfarb.
“We have also seen increased interest from animal health companies in the C1 protein production platform for pandemic threat response and preparation due to C1's highly efficient and economical approach to the rapid manufacture of large quantities of vaccines,” he added.
Alternative proteins
In addition, Dyadic is making progress with a joint development agreement that was struck in May 2022, with a global food ingredient company, to develop and manufacture several animal-free ingredient products using the company's technology. Dyadic has achieved the first milestone, for which payment is expected in the second quarter of 2023.
“In our rapidly expanding vertical of alternative proteins, we initiated a fully funded research collaboration with a global food ingredient company to develop certain food proteins where we recently reached the first milestone in this challenging project,” said Emalfarb.
Dyadic has developed the Dapibus thermophilic 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.
The initial response from the food and nutrition industry has been positive with a rising level of interest.
“We are continuing to develop the Dapibus platform, a fungal-based microbial platform for use in non-pharmaceutical applications, such as food, nutrition, health, and wellness, with the objective of generating near term revenues," added Emalfarb.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive