DYAI: CEPI Grants Recognize C1

Zacks Small Cap Research
03-27

By John Vandermosten, CFA

NASDAQ:DYAI

READ THE FULL DYAI RESEARCH REPORT

Dyadic International Inc. (NASDAQ:DYAI) announced 2024 results and listed a number of accomplishments that will bring both product and grant revenue in the next months. We are most excited about the partnership with Proliant Health. Dyadic signed a deal in June with Proliant which has so far generated multiple milestone payments while preparing for commercialization of animal-free recombinant albumin products manufactured using C1. We anticipate albumin product sales in 2Q:25. Later this year, product sales from non-animal dairy enzymes with partner Inzymes are forecast to flow through the door. Several grant awards have also been announced, including a Gates Foundation award and two Coalition for Epidemic Preparedness Innovation (CEPI) awards, which are also backed by the Gates Foundation.

2024 Operational & Financial Results

Dyadic released 2024 operational and financial results in a press release on March 26th, 2025, filed its Form 10-K with the SEC and held a conference call with investors. Since the last quarterly update, Dyadic participated in several industry events around the globe where it updated stakeholders on the progress achieved for the C1 and Dapibus microbial platforms and identified several recombinant proteins of interest.

2024 financial results for the period ending December 31st, 2024, compared to the prior year period:

  • Revenues were $3.5 million, up 21% from $2.9 million. The increase is due to milestones from the Proliant and Inzymes relationships and contributions from 19 vs. 16 collaborations respectively;
  • Research and development expenses totaled $3.2 million, down 39% from $5.3 million. The decrease was attributable to the absence of expenses related to the DYAI-100 clinical trial;
  • General and administrative expenses were $6.1 million vs. $5.8 million, rising 5%. The change was attributable to higher professional services, share based compensation, business development and investor relations expenses offset by decreases in management incentives, legal expenses and insurance;
  • Other expenses were $0.1 million vs. $1.4 million as increases in interest income were more than offset by expenses related to the convertible notes and the contributions in the prior year from the sale of Dyadic’s interest in Alphazyme;
  • Net loss amounted to ($5.8) million compared to ($6.8) million. On a per share basis, net loss was ($0.20) vs. ($0.24).

As of December 31st, 2024, cash, equivalents and short-term securities totaled $9.3 million compared to $7.3 million at the end of 2023. Cash burn for 2024 was ($4.0) million compared with ($6.7) million for 2023. Financing cash flows were $5.8 million reflecting the net proceeds from the $6.0 million convertible note issuance in the first quarter.

CEPI Awards

Fondazione Biotecnopolo di Siena

On March 20th, Dyadic announced that CEPI[1] granted $4.5 million to the non-profit Fondazione Biotecnopolo di Siena (FBS) to conduct proof of concept research that will examine the efficiency of producing antigens using C1 vs. mammalian cells. In the release, Dyadic highlights the potential efficiencies of C1 comparing the four-to-six-month duration of producing protein antigens using mammalian cells compared with a potential 35 days for C1. The goals of the program are to develop a system that can rapidly produce large quantities of therapeutic proteins in standard biomanufacturing facilities with an output that does not require extreme cold for transport and storage.

Specifically, the CEPI grant will support the production of a SARS-CoV-2 spike protein comparing output from C1 mammalian cell expression systems. Researchers will then compare the two to see if the antigen produced by the C1 fungus is comparable in structure and immunogenicity to those produced in mammalian cells. If successful, the next phase of the project will focus on selecting an antigen from a pathogen of interest to CEPI for development of a vaccine that can be rapidly deployed.

Uvax Bio

On March 23rd, CEPI announced a $2.6 million investment to advance Uvax Bio’s Middle East Respiratory Syndrome (MERS). CEPI’s funding will also support research to assess manufacturing the vaccine using C1. If successful, this could increase the speed of vaccine production and lower manufacturing costs to improve access to vaccine doses in the future.

$3 Million Gates Foundation Grant

Dyadic’s other work, especially that related to the $3 million grant from the Bill and Melinda Gates Foundation, provides other pathways to revenue. The Gates Foundation funding will allow Dyadic to validate its expression platform to manufacture monoclonal antibodies to address malaria and respiratory syncytial virus (RSV). The grant, announced last November, is seeking a way to make traditionally expensive biologics more cost effective so that they can be produced in developing countries such as Africa. If Dyadic successfully completes early-stage clinical trials, it may partner with South Africa’s Rubic One Health or Fondazione Biotecnopolo di Siena to advance it towards commercialization in developing regions where cost constraints demand novel solutions.

Milestones

  • $3 million grant from Gates Foundation – November 2024
  • Proliant customer outreach for bovine/human albumin – 4Q:24 & 1Q:25
  • Proliant conducting scale up activities – 1Q:25
  • Proliant takes orders for C-1 produced product – 1Q:25
  • Proliant ships albumin orders – 2Q:25
  • Fibroblast growth factors sampling – 2Q:25
  • Proliant productivity milestone – 3Q:25
  • Human lactoferrin research & pharmaceutical applications sampling – 2H:25
  • Expanded enzymes (RNAse inhibitors/T7 RNA polymerase) development & optimization results – late 2025
  • Launch of recombinant dairy enzyme – late 2025

Summary

Dyadic reports 2024 results on the cusp of product revenues from recombinant albumin sales. Dairy enzyme product revenues are expected before year end. Funding from grants is another important contributor to the business with three recent awards tied to the productivity and efficiency of the C1 expression system. The company has other initiatives that can also generate product revenues such as DNAse1, which is the subject of ongoing discussions and could be the third product to generate sales. Options abound for many of these proteins. Dyadic could either partner with a CDMO to sell the product itself or find a partner that would pay a royalty. We hope to see Dyadic continue this methodical approach to pick the low hanging fruit so it can evolve into a self-funding entity and pursue other recombinant markets in the animal health, food, and vaccine markets. In the meantime, Dyadic maintains a strong balance sheet, with minimal cash burn. Our main focus remains on Proliant, dairy enzymes and DNAse1.

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[1] The Coalition for Epidemic Preparedness Innovations (CEPI) is a global partnership established to accelerate the development of vaccines against emerging infectious diseases that could potentially cause epidemics or pandemics. CEPI was launched in January 2017 at the World Economic Forum in Davos, Switzerland, with initial funding from the Bill and Melinda Gates Foundation, the Wellcome Trust, and governments including Norway and India.

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