Dyadic International, Inc. (Nasdaq: DYAI) (“Dyadic” or the “Company”), d/b/a Dyadic Applied BioSolutions, today announced that, within approximately 15 days of receiving the plasmids, it developed stable pools of C1 cell lines and manufactured and initially purified two Scripps-designed Bundibugyo ebolavirus recombinant protein antigens.

In response to the active Bundibugyo ebolavirus outbreak, both C1-produced antigens have been delivered to FBS and Scripps Research for preclinical evaluation in support of a potential non-mRNA vaccine candidate targeting Bundibugyo ebolavirus.

The speed of this work is particularly important given the severity and rapid progression of the current outbreak. There is currently no specifically approved vaccine or treatment for Ebola disease caused by Bundibugyo virus.

Dyadic believes these conditions highlight the urgent need for protein-production platforms capable of rapidly developing vaccine antigens, monoclonal antibodies and other biologic countermeasures while also supporting the manufacturing capacity, scalability, affordability and geographic accessibility required for effective outbreak response.

“This is not simply about developing a protein quickly. It is about establishing a potentially faster, more productive, scalable and affordable path for developing and manufacturing non-mRNA vaccines, monoclonal antibodies and other biologics in the quantities needed to respond to active outbreaks and other rapidly evolving health emergencies. When infections can spread faster than conventional countermeasures can be developed and produced, every week matters.” said Mark Emalfarb, Chief Executive Officer of Dyadic.

Emalfarb continued, “Scale flexibility with C1 works in both directions. Production may be expanded to larger microbial bioreactors when substantial quantities or doses are required — or higher yields, greater productivity and shorter bioreactor cycle times may allow manufacturers to produce more protein using a smaller biomanufacturing footprint. That can mean more batches, more protein and more doses from the same manufacturing infrastructure — or potentially less of it. Because C1 is a fungal production system, it also does not require the mammalian or insect-cell viral-clearance steps typically associated with CHO and insect-cell manufacturing, potentially eliminating additional purification operations that can add time, complexity and cost.”

This achievement further validates Dyadic's proprietary C1 platform as a rapid protein production technology that has the potential to support future licensing agreements, commercial manufacturing partnerships, and additional product development opportunities across multiple biologics markets.

In addition to the Bundibugyo ebolavirus antigen program, externally funded and supported collaborations involving FBS, the Coalition for Epidemic Preparedness Innovations (“CEPI”), the Gates Foundation, the European Vaccines Hub and other leading global scientific organizations are helping to advance and validate Dyadic’s rapid C1 protein-development and manufacturing capabilities. C1 has been applied to both vaccine antigens and monoclonal antibodies, with demonstrated antibody titers exceeding 12 g/L in seven days. This includes monoclonal antibody programs targeting respiratory syncytial virus and malaria supported by a $3.1 million grant from the Gates Foundation, which Dyadic has now received in full.

The global biologics sector continues to expand, with industry estimates generally forecasting annual growth in the high-single-digit range and even stronger growth for monoclonal antibodies. This growth is creating a significant potential opportunity for platforms that can accelerate development, increase productivity, scale efficiently and lower manufacturing costs. If C1 can deliver these benefits and gain broader adoption, it could help reshape biologics manufacturing, improve the commercial viability of vaccines, monoclonal antibodies and other therapeutic proteins, and expand patient access in markets where cost, capacity and speed can determine whether treatments are broadly available.