Dyadic Reports Q1 2024 Financial Results and Recent Progress

Dyadic International, Inc., a biotechnology firm specializing in large-scale protein production for human and animal vaccines and therapeutics, recently announced its financial results for the first quarter of 2024, alongside significant company advancements.

Human Health Sector

A pivotal milestone for Dyadic was the completion of the Phase 1 clinical trial for DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine candidate. This trial, which started in 1Q 2023, demonstrated the vaccine's safety and ability to elicit an antibody response in humans. Conducted in South Africa, the trial's final results confirmed that both low and high doses were well tolerated and effective in generating an immune response. The Clinical Study Report has been finalized, affirming the vaccine's safety and potential efficacy.

Dyadic also reported progress in other vaccine projects. They have successfully produced an H1N1 influenza antigen in collaboration with Massachusetts General Hospital’s Vaccine and Immunotherapy Center. Additionally, a manuscript on preclinical studies of a C1-produced monoclonal antibody was published in Nature Communications, highlighting its efficacy against various COVID-19 variants in non-human primates and hamsters.

Collaborations have been a significant part of Dyadic's strategy. For instance, they partnered with the Israel Institute for Biological Research to target emerging diseases and bio-threats. Another strategic partnership with Rabian BV focuses on developing rabies vaccines using Dyadic’s C1 production platform, supported by Eurostars and Horizon Europe funding.

Animal Health Sector

In the animal health sector, Dyadic expanded its collaboration with Phibro Animal Health to develop vaccines for companion and livestock animals. Notably, their ferritin nanoparticle H5N1 bird flu vaccine candidate demonstrated a robust immune response in animal studies, indicating potential use across various animal species, including poultry and cattle.

Alternative Proteins Sector

Dyadic's Dapibus™ platform has seen advancements in developing non-pharmaceutical products. They executed a term sheet with a major albumin manufacturer to produce recombinant serum albumin and are progressing with several product candidates. Their efforts in non-animal dairy products have resulted in the development and sampling of recombinant alpha-lactalbumin and other whey proteins. They also entered a co-promotion agreement with Biftek Co. for cell culture growth media supplements.

Corporate Developments

On the corporate front, Dyadic solidified its financial position by issuing $6.0 million in convertible notes. The company also announced leadership changes, with Mr. Patrick Lucy appointed as Board Chairman and Mr. Joe Hazelton promoted to Chief Operating Officer. Financially, as of March 31, 2024, the company held cash and investment-grade securities worth $12.1 million, up from $7.3 million at the end of 2023.

Revenue for the first quarter of 2024 was approximately $335,000, a decrease from $934,000 the previous year due to the winding down of several research collaborations. However, the company reported a reduction in R&D expenses, reflecting the completion of the DYAI-100 clinical trial and fewer ongoing internal projects. General and administrative expenses rose by 20.9%, attributed to increased business development and investor relations efforts.

Despite a net loss of $2,010,000 for the quarter, Dyadic remains optimistic about its future. The company continues to focus on leveraging its microbial platforms for both pharmaceutical and non-pharmaceutical applications, aiming to bring efficient, large-scale protein production solutions to market.

Overall, Dyadic's progress in vaccine development, strategic partnerships, and financial management highlights its commitment to advancing health solutions and sustainable food production. The company is poised to continue its growth and innovation in the biotechnology sector, addressing critical needs across human and animal health.

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