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Dyadic International Inc (DYAI) Q1 2024 Earnings Call Transcript Highlights: A Detailed Review ...

  • Research and Development Revenue: Decreased to approximately $335,000 from $934,000 year-over-year.

  • License Revenue: Details not separately provided, included in total revenue figures.

  • Cost of Research and Development Revenue: Decreased to approximately $144,000 from $727,000 year-over-year.

  • R&D Expenses: Decreased by 35.5% to approximately $523,000 from $811,000 year-over-year.

  • G&A Expenses: Increased to approximately $1,789,000 from $1.48 million year-over-year.

  • Loss from Operations: Slightly increased to $2,126,000 from $2.05 million year-over-year.

  • Net Loss: Approximately $2 million or $0.07 per share, compared to $956,000 or $0.03 per share year-over-year.

  • Cash and Investment Grade Securities: $12.1 million as of March 31, 2024, up from $7.3 million as of December 31, 2023.

Release Date: May 14, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Dyadic International Inc (NASDAQ:DYAI) has successfully closed a $6 million convertible note financing, enhancing its financial resources without issuing any warrants.

  • The company's C1 technology continues to receive global recognition for its speed, productivity, and cost-efficiency, particularly in the alternative protein and bio-industrial sectors.

  • Dyadic International Inc (NASDAQ:DYAI) has announced positive outcomes from its Phase 1 human study of the DY-100 vaccine, demonstrating safety and strong immune response, which has attracted interest from top pharmaceutical companies.

  • The company is expanding its presence in the animal health sector, with promising developments in vaccines and therapeutic proteins for infectious diseases with spillover potential.

  • Dyadic International Inc (NASDAQ:DYAI) is making significant strides in the alternative protein sector, with its platforms facilitating rapid production and large-scale manufacturing of high-value biological products.

Negative Points

  • Research and development revenue for Q1 2024 decreased significantly compared to the same period last year, primarily due to the winding down of several large research collaborations.

  • The company reported an increased net loss for Q1 2024 compared to the previous year, attributed to the sale of equity interest in a previous year and increased general and administrative expenses.

  • Despite advancements, there are ongoing challenges in scaling up production to meet market demands, particularly for new products like recombinant serum albumin.

  • Dyadic International Inc (NASDAQ:DYAI) faces regulatory hurdles and needs to meet various compliance and approval requirements to advance its products to market, especially in new sectors like pharmaceutical-grade materials.

  • The company's dependency on successful partnerships and collaborations for commercialization and market access poses risks if these partnerships do not materialize or yield expected results.

Q & A Highlights

Q: What are the main obstacles and steps needed to achieve sales for the serum human and bovine albumin projects? A: Joseph Hazelton, Chief Operating Officer, explained that the main obstacle is scale-up. The initial analytical testing has shown equivalence to the reference compound for research and diagnostics segments. For pharmaceutical grade segments, the timeline is longer. The focus in the first 12 months is on scaling up production and fill-finish processes. Collaboration partners are expected to significantly accelerate these opportunities.

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Q: Can you describe the financial structure of the albumin projects, including milestones and royalties? A: Mark Emalfarb, President and CEO, mentioned that the term sheet includes an upfront payment, potential milestones, and royalties. The partnership aims to exploit high-volume, low-cost production capabilities of both Dyadic and their partner, which should enhance market access and commercialization.

Q: What are the next regulatory steps for the DYAI-100 booster vaccine, and are there plans to pursue other vaccine opportunities? A: Mark Emalfarb clarified that they do not plan to move forward with DYAI-100 for COVID-19 as the market for booster vaccines is limited. Instead, Dyadic might focus on more effective vaccines developed since then. Regulatory efforts will likely pivot towards advancing their bird flu vaccine in collaboration with Verivox, which has shown effectiveness in various animal models and has potential for rapid, low-cost production.

Q: How is Dyadic addressing the financial aspects of new product opportunities and partnerships? A: Joseph Hazelton and Mark Emalfarb discussed that financial arrangements typically include milestone payments for access to technology and production strains, followed by revenue sharing to capitalize on market entry across different segments. They aim to establish partnerships that leverage Dyadics production capabilities and the partners market access.

Q: What impact has the completion of the Phase 1 trial of DYAI-100 had on regulatory strategies and partner interest? A: Mark Emalfarb noted that while DYAI-100 will not advance, the successful trial outcomes have enhanced Dyadics credibility and attracted interest from top pharmaceutical companies. This has opened opportunities for other vaccine and antibody projects, potentially leading to regulatory advancements and collaborations focused on infectious diseases.

Q: What are Dyadics strategic focuses for driving near-term revenue and growth? A: Mark Emalfarb emphasized the companys commitment to innovation and commercialization in its core sectors: human health, animal health, and alternative proteins. Dyadic aims to expand the use of its C1 and other platforms to accelerate product development and market entry, leveraging both existing and new partnerships.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.