Dyadic International, Inc. — FY2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021; this is an annual report, not a standalone fourth-quarter filing. Filed March 29, 2022. Dyadic is a biotechnology platform company developing its C1 fungal protein-production system for human and animal biopharmaceutical applications. It had no products approved for sale; reported revenue came from research collaborations and grants.
Financial results and liquidity
| Metric | FY2021 | FY2020 |
|---|---|---|
| Research and development revenue | $2.40 million | $1.60 million |
| Cost of research and development revenue | $1.94 million | $1.42 million |
| Revenue less direct research costs | $0.46 million (about 19% of revenue) | $0.18 million (about 11%) |
| Research and development expense | $8.39 million | $3.87 million |
| General and administrative expense | $6.70 million | $6.08 million |
| Operating loss | $14.73 million | $10.03 million |
| Net loss | $13.07 million ($0.47 per share) | $9.33 million ($0.34 per share) |
| Net cash used in operating activities | $11.28 million | $6.57 million |
- At year-end, cash and cash equivalents were $15.75 million and short-term investment securities were $4.51 million; combined, approximately $20.26 million, down from $29.09 million a year earlier.
- Current assets were $21.01 million and current liabilities $2.56 million, implying working capital of about $18.45 million. The balance sheet reported no debt.
- Total assets were $21.30 million, total liabilities $2.91 million, and stockholders’ equity $18.39 million. Accumulated deficit was $63.75 million.
Changes and notable items
- Revenue increased about 50%, reflecting larger research collaborations. Revenue less direct research costs also improved, but the company remained substantially loss-making.
- R&D expense more than doubled, primarily due to CRO, quality and regulatory support and cGMP manufacturing for the DYAI-100 COVID-19 vaccine program. G&A rose about 10%.
- Interest income fell to $52,000 from $447,000. The company recorded a $1.61 million gain from selling its BDI investments; this was a significant offset to the operating loss, not recurring collaboration revenue.
- Operating cash use increased year over year. Financing cash inflow of $1.23 million primarily reflected stock-option exercises; investing cash inflow included security maturities and BDI sale proceeds.
Outlook, risks, and contingencies
- Management stated existing cash and investment-grade securities were expected to meet operating and liquidity needs for at least the next 12 months. The company was self-funding DYAI-100 preclinical work, cGMP manufacturing and a planned Phase I trial; it expected to advance toward a first-in-human trial in 2022 but gave no assurance it could do so. No numerical revenue or earnings guidance was provided.
- The December 2021 Janssen agreement included a $500,000 upfront payment, recorded as deferred license revenue at year-end, and up to €1.6 million in R&D funding. Further license, milestone and commercial payments are contingent on options, development and production outcomes; Janssen may terminate on 90 days’ notice.
- After year-end, Dyadic signed an exclusive animal-vaccine license with Phibro on February 10, 2022. Potential economics are not stated in the provided filing text. In February 2022, Dyadic indicated its intention to terminate the Novovet sublicense. The Sorrento term sheet was mutually terminated in March 2022 without an early termination penalty.
- BTG, the DYAI-100 manufacturing subcontractor, requested a direct commercial manufacturing agreement in February 2022. If negotiations fail, the project could be delayed. The filing also identifies reliance on a small number of CROs and collaborators, regulatory and clinical-development uncertainty, competition, intellectual-property risks, and potential additional-capital needs.
- Dyadic had $3.32 million of purchase obligations as of year-end, primarily CRO services, including $2.62 million scheduled for 2022. It reported no material pending litigation. The audited financial statements received an unqualified opinion; the auditor reported no critical audit matters. Management assessed disclosure controls and internal control over financial reporting as effective, without auditor attestation because Dyadic is a smaller reporting company.
Investor facts to verify
- Cash burn, committed CRO spending and whether management’s stated 12-month liquidity outlook remains adequate as DYAI-100 costs progress.
- DYAI-100 manufacturing arrangements, trial-readiness, regulatory pathway and timing; distinguish preclinical evidence from human safety or efficacy data.
- Janssen R&D funding recognition, option exercise and milestone conditions, termination rights, and any subsequent commercial progress.
- Revenue concentration and durability of funded collaborations, alongside the company’s continuing operating losses and lack of approved products.
- Potential dilution from outstanding options and the $50 million at-the-market offering facility; the filing reported no sales under that facility as of filing.