DYADIC INTERNATIONAL INC
For the period ended Mar 31, 2025. Filed May 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 14, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001437749-24-034545
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0001437749-25-016866
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 79 previous paragraphs and 70 current paragraphs.
45 unchanged; 18 reworded; 7 added; 15 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 18 previous and 27 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
After the DuPont Transaction, the Company has directed its efforts toward advancing the C1 platform to address the increasing global demand for the development and manufacturing of prophylactic and therapeutic biopharmaceuticals for human and animal health. The Company’s biopharmaceutical development efforts have been centered on enhancing the capability of the C1 platform to produce stable, properly folded, and functional proteins for pharmaceutical applications, including vaccines and monoclonal antibodies. In addition to improving the quality and productivity of the C1 platform, the Company has sought to validate its platform for human use through a series of fully funded biopharmaceutical projects, extensive animal studies utilizing C1-produced proteins, and, in 2024, the successful completion of a Phase 1 first-in-human study for a vaccine antigen produced using C1, which demonstrated its safety for human applications.
Current report
Recognizing the longer development timelines, clinical testing, and regulatory requirements associated with human and animal pharmaceutical products, the Company has refined its core business strategy to expand into functional recombinant (non-animal derived) solutions for non-pharmaceutical applications in research, nutrition, and industrial markets. To address these opportunities, the Company has developed and launched the Dapibus™ Protein Production Platform (“Dapibus™”), which supports various applications within the functional recombinant protein and enzyme field, namely in Life Sciences, Bioactives & Ingredients, and Bioindustrial applications. Given the reduced developmental costs, shorter timelines, and fewer regulatory requirements associated with functional recombinant solutions, Dapibus™ has enabled the Company to generate near- term recurring revenue while continuing to build long-term value through C1 for pharmaceutical applications. The Company anticipates achieving commercialization of certain functional recombinant products in 2025 through a combination of existing collaborations and internal manufacturing efforts.
Current report
Product Commercialization Targets
Current report
C1 Platform Development Vaccines & Antibodies
Current report
Animal and Human Health
Current report
Net loss for the three months ended March 31, 2025, was $2,028,000 compared to $2,010,000 for the same period a year ago. The increase in net loss was largely due to the decrease $141,000 in other income and $154,000 increase in cost of research revenue, offset by decreases in general and administrative expenses of $193,000, and an increase in research revenue of $59,000.
Current report
On May 1, 2025, the Company entered into a second amendment (the “Second Amendment”) to the Convertible Notes with a majority of the current holders. Pursuant to the Second Amendment, the Redemption Date (as defined in the Second Amendment) will now fall on December 1, 2026.
Removed paragraphs (15)
Previous report
The C1-cell protein production platform is a robust and versatile thermophilic filamentous fungal expression system for the development and production of biologic products including enzymes and other proteins for human and animal health. Some examples of human and animal vaccines and drugs which have the potential to be produced from C1-cells are protein antigens, ferritin nanoparticles, virus-like particles (“VLPs”), monoclonal antibodies (“mAbs”), Bi/Tri-specific antibodies, Fab antibody fragments, Fc-fusion proteins, as well as other therapeutic enzymes and proteins. The Company is involved in multiple funded research collaborations with animal and human pharmaceutical companies which are designed to leverage its C1-cell protein production platform to develop innovative vaccines and drugs, biosimilars and/or biobetters.
Previous report
The Company also developed the Dapibus™ thermophilic filamentous fungal based microbial protein production platform to enable the rapid development and large-scale manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.
Previous report
Alternative Proteins
Previous report
Non-Food Applications
Previous report
Food Applications
Previous report
Bio Industrial Products
Previous report
Animal Health
Previous report
Human Health
Previous report
The license revenue for the three and nine months ended September 30, 2024, was related to the licensing fee from the Proliant agreement of $1.0 million, and a success fee payment from the Inzyme agreement of $425,000. The license revenue for the three and nine months ended September 30, 2023, was related to the Janssen license agreement, which was completed in December 2023.
Previous report
Research and development expenses for thenine months ended September 30, 2024, decreased to $1,499,000 compared to $2,444,000 for the same period a year ago. The decrease reflected the winding down of activities related to the Company’s Phase 1 clinical trial of DYAI-100 COVID-19 vaccine candidate as patient dosing was completed in February 2023 and a decrease in the amount of ongoing internal research projects.
Previous report
General and administrative expenses for thenine months ended September 30, 2024, increased by 12.7% to $4,694,000 compared to $4,165,000 for the same period a year ago. The increase reflected increases in business development and investor relations expenses of $241,000, share-based compensation expenses of $90,000, accounting expenses of $82,000, legal expenses of $63,000, and other increases of $92,000, offset by decrease in insurance expenses of $39,000.
Previous report
Loss from operations for the nine months ended September 30, 2024, decreased to $ 4,371,000, compared to $ 6,061,000 for the same period a year ago. The decrease in loss from operations was largely due to the licensing revenue of $1.0 million from Proliant and success fees of $425,000 from Inzyme.
Previous report
For thenine months ended September 30, 2024, total other income (expenses), net, was $112,000 compared to $1,337,000 for the same period a year ago. The decrease in other income was largely due to the gain on sale of the Company’s equity interest in Alphazyme, LLC of $1,018,000 in 2023, and interest expenses of $302,000 related to the Convertible Notes in 2024.
Previous report
Net loss for the three months ended September 30, 2024, was $203,000 compared to $1,614,000 for the same period a year ago. The decrease in net loss was largely due to the licensing revenue of $1.0 million from Proliant and success fees of $425,000 from Inzyme recognized in the third quarter 2024, in addition to increase in research and development revenue of $180,000, partially offset by interest expense, net of interest income of $107,000.
Previous report
Net loss for thenine months ended September 30, 2024, was $4,258,000 compared to $4,724,000 for the same period a year ago. The decrease in loss from operations was largely due to the licensing revenue of $1.0 million from Proliant and success fees of $425,000 from Inzyme recognized in the third quarter of 2024, offset by the gain on sale of the Company’s equity interest in Alphazyme LLC of $1,018,000 in 2023 and decrease in research and development expenses of $946,000, partially offset by increases in general and administrative expenses of $529,000 and interest expenses of $302,000.
Reworded paragraphs (18)
Previous wording
Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) is a global biotechnology company based in Jupiter, Florida with operations in the United States and a satellite office in the Netherlands, and it utilizes several third-party consultants and research organizations to carry out the Company’s activities. Over the past two plus decades, the Company has developed a gene expression platform for producing commercial quantities of industrial enzymes and other proteins, and has previously licensed this technology to third parties, such as Abengoa Bioenergy, BASF, Codexis and others, for use in industrial (non-pharmaceutical) applications. This technology is based on theThermothelomyces heterothallica(formerly known asMyceliophthora thermophila) fungus, which the Company named C1.
Current wording
Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) is a global biotechnology platform company based in Jupiter, Florida with operations in the United States and a satellite office in the Netherlands, and it utilizes several third-party consultants and contract research organizations to carry out the Company’s activities. Over the past two plus decades, the Company developed a gene expression platform for producing commercial quantities of industrial enzymes and other proteins, and previously licensed this technology to third parties, such as Abengoa Bioenergy SA, BASF SE, Codexis, Inc. and others, for use in industrial (non-pharmaceutical) applications. This technology is based on theThermothelomyces heterothallica (formerly known asMyceliophthora thermophila) fungus, which the Company named C1.
Previous wording
On December 31, 2015, the Company sold its industrial technology business to Danisco USA (“Danisco”), the industrial biosciences business of DuPont (NYSE: DD) (the “DuPont Transaction”). As part of the DuPont Transaction, Dyadic retained co-exclusive rights to the C1-cell protein production platform for use in all human and animal pharmaceutical applications, and currently the Company has the exclusive ability to enter into sub-license agreements (subject to the terms of the license and to certain exceptions) for use in all human and animal pharmaceutical applications. Danisco retained certain rights to utilize the C1-cell protein production platform in pharmaceutical applications, including the development and production of pharmaceutical products, for which it will be required to make royalty payments to Dyadic upon commercialization. After December 31, 2029, Danisco will have certain rights to sublicense C1 technology to third parties for which the Company will be entitled to receive royalties on such pharmaceutical products for a certain period of time. In certain circumstances, Dyadic may owe a royalty to either Danisco or certain licensors of Danisco, depending upon whether Dyadic elects to utilize certain patents either owned by Danisco or licensed in by Danisco.
Current wording
For the past nine years since the Company sold its industrial technology business to Danisco USA (“Danisco”), the industrial biosciences business of DuPont (NYSE: DD) (the “DuPont Transaction”), the Company has been focused on building innovative microbial protein production platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable, and accessible biopharmaceutical products for human and animal health and for other biologic products for use in non-pharmaceutical applications. As part of the DuPont Transaction, Dyadic retained co-exclusive rights to its proprietary and patented C1 protein production platform (the “C1 platform”) for use in all human and animal pharmaceutical applications, and currently, the Company has the exclusive ability to enter into sub-license agreements (subject to the terms of the license and to certain exceptions) for use in all human and animal pharmaceutical applications. Danisco retained certain rights to utilize the C1 platform in pharmaceutical applications, including the development and production of pharmaceutical products, for which it will be required to make royalty payments to Dyadic upon commercialization. In certain circumstances, Dyadic may owe a royalty to either Danisco or certain licensors of Danisco, depending upon whether Dyadic elects to utilize certain patents either owned by Danisco or in licensed by Danisco.
Previous wording
*Revenue related to grants:*The Company may receive grants from governments, agencies, and other private and not-for-profit organizations. These grants are intended to be used to fund the Company’s research collaborations partially or fully, including opportunities arising in connection with COVID-19 that the Company is pursuing with certain collaborators. However, most, if not all, of such potential grant revenues, if received, is expected to be earmarked for third parties to advance the research required, including preclinical and clinical trials for SARS-CoV-2 vaccines and/or antibodies candidates.
Current wording
*Revenue related to grants:*The Company receives grants from governments, agencies, and other private and not-for-profit organizations. These grants are intended to be used to fund the Company’s research collaborations partially or fully, including opportunities and projects that the Company is pursuing with certain collaborators. However, most, if not all, of such potential grant revenues, is expected to be earmarked for third parties to advance the research required, including preclinical and clinical trials for vaccines and/or antibodies candidates. Revenue related to grants are presented on a gross basis on the Consolidated Statements of Operations.
Previous wording
Three and Nine Months Ended September 30, 2024 Compared to the Same Periods in 2023
Current wording
Three Months Ended March 31, 2025 Compared to the Same Periods in 2024
Previous wording
Revenue and Cost of Research and Development Revenue
Current wording
Revenue and Cost of Revenue
Previous wording
The following table summarizes the Company’s revenue and cost of research and development revenue for the three and nine months ended September 30, 2024 and 2023:
Current wording
The following table summarizes the Company’s revenue and cost of revenue for the three months ended March 31, 2025 and 2024:
Previous wording
For the three months ended September 30, 2024, the increase in research and development revenue and cost of research and development revenue was due to the increasing numbers of collaborations conducted in 2024. The Company’s revenue was generated from eleven collaborations compared to seven collaborations for the same period a year ago. For thenine months ended September 30, 2024, the decrease in research and development revenue and cost of research and development revenue was due to the winding down of several large research collaborations conducted in 2023. For thenine months ended September 30, 2024, the Company’s revenue was generated from nineteen collaborations compared to twenty collaborations for the same period a year ago.
Current wording
For the three months ended March 31, 2025, the decrease in research and development revenue and cost of research and development revenue was due to the decreasing numbers of collaborations conducted in 2025. The Company’s research and development revenue was generated from four collaborations compared to nine collaborations for the same period a year ago. The grant revenue and cost of grant revenue for the three months ended March 31, 2025, was related to the Gates Foundation Grant and CEPI grants. There was no grant revenue for the three months ended March 31, 2024.
Previous wording
Research and development expenses for thethree months ended September 30, 2024, decreased to $460,000 compared to $716,000 for the same period a year ago. The decrease reflected the winding down of activities related to the Company’s Phase 1 clinical trial of DYAI-100 COVID-19 vaccine candidate as patient dosing was completed in February 2023, and a decrease in the amount of ongoing internal research projects.
Current wording
Research and development expenses for the three months ended March 31, 2025, decreased to $495,000 compared to $523,000 for the same period a year ago. The decrease was due to a decrease in the number of ongoing internal research projects.
Previous wording
General and administrative expenses for the three months ended September 30, 2024, increased by 1.2% to $1,298,000 compared to $1,282,000 for the same period a year ago. The increase reflected increases in business development and investor relations expenses of $52,000, and other increases of $24,000, offset by decreases in management incentives of $38,000, and accounting and legal expenses of $22,000.
Current wording
General and administrative expenses for the three months ended March 31, 2025, decreased by 10.8% to $1,596,000 compared to $1,789,000 for the same period a year ago. The decrease reflected decreases in business development and investor relations expenses of $97,000, in management incentives of $78,000, and accounting and legal expenses of $41,000 and insurance expense of $10,000 offset by other increases of $34,000.
Previous wording
Loss from operations for the three months ended September 30, 2024, decreased to $ 203,000 compared to $ 1,720,000 for the same period a year ago. The decrease in loss from operations was largely due to the licensing revenue of $1.0 million from Proliant and success fees of $425,000 from Inzyme.
Current wording
Loss from operations for the three months ended March 31, 2025, decreased to $ 2,002,000 compared to $ 2,126,000 for the same period a year ago. The decrease in loss from operations was largely due to decreases in general and administrative expenses of $193,000, and an increase in research revenue of $59,000, offset by an increase of $154,000 in cost of research revenue.
Previous wording
For the three months ended September 30, 2024, total other income (expenses), net, was an expense of $1,000 compared to an income of $106,000 for the same period a year ago. The decrease in other income was due to interest expenses related to the Convertible Notes in 2024.
Current wording
For the three months ended March 31, 2025, total other income (expenses), net, was an expense of $25,000 compared to an income of $116,000 for the same period a year ago. The decrease in other income was largely due to a $81,000 increase in interest expenses related to the Convertible Notes and the $61,000 Gain on sale of Alphazyme in 2024.
Previous wording
As of September 30, 2024, $600,000 of the Convertible Notes were converted into 335,195 shares of Common Stock. For more information regarding the Convertible Notes, including the covenants related thereto see Note 4 to the Consolidated Financial Statements.
Current wording
During the year ended December 31, 2024, $910,000 of the Convertible Notes were converted into 556,623 shares of Common Stock. For more information regarding the Convertible Notes, including the covenants related thereto, see Note 4 to the Consolidated Financial Statements.
Previous wording
The Company expects its existing cash and cash equivalents and cash raised from the Convertible Notes, investments in debt securities, and operating cash flows from its existing and future license agreement(s) will be sufficient to meet its operational, business, and other liquidity requirements for at least the next twelve (12) months from the date of issuance of the financial statements contained in this Quarterly Report. However, the Company has based this estimate on assumptions that may prove to be wrong, and its operating plan may change as a result of many factors currently unknown to it. In the event our financing needs are not able to be met by our existing cash, cash equivalents and investments, we would seek to raise additional capital through strategic financial opportunities that could include, but are not limited to, future public or private equity offerings, collaboration agreements, and/or other means. Any amounts raised may be used for the further development and commercialization of product candidates, and for other working capital purposes. There is no guarantee that any of these strategic or financing opportunities will be executed or realized on favorable terms, if at all, and some could be dilutive to existing shareholders.
Current wording
As of March 31, 2025, the Company had $5,064,941 cash and $2,307,685 short-term investment securities (including accrued interest) totaling $7,349,413. The Company expects its existing cash, cash equivalents and its investment securities will be sufficient to meet its operational, business, and other liquidity requirements for at least the next twelve (12) months from the date of issuance of the financial statements contained in this Quarterly Report. However, the Company has based this estimate on assumptions that may prove to be wrong, and its operating plan may change as a result of many factors currently unknown to it. In the event our financing needs are not able to be met by our existing cash, cash equivalents and investments, we would seek to raise additional capital through strategic financial opportunities that could include, but are not limited to, future public or private equity offerings, collaboration agreements, convertible notes or other debt instruments, and/or other means. Any amounts raised may be used for the further development and commercialization of product candidates, and for other working capital purposes. There is no guarantee that any of these strategic or financing opportunities will be executed or realized on favorable terms, if at all, and some could be dilutive to existing shareholders
Previous wording
As of September 30, 2024, cash and cash equivalents were$5.9 million compared to$6.5 million as of December 31, 2023. The carrying value of investment grade securities, including accrued interest as of September 30, 2024, was$4.0 million compared to$0.8 million as of December 31, 2023.
Current wording
As of March 31, 2025, cash and cash equivalents were$5.1 million compared to$6.5 million as of December 31, 2024. The carrying value of investment grade securities, including accrued interest as of March 31, 2025, was$2.3 million compared to$2.8 million as of December 31, 2024.
Previous wording
Net cash used in operating activities for thenine months ended September 30, 2024 was $3.3 million, which was principally attributable to a net loss of $4.3 million, partially offset by changes in operating assets and liabilities of $0.2 million and share-based compensation expenses of $0.9 million.
Current wording
Net cash used in operating activities for thethree months ended March 31, 2025 was $2.0 million, which was principally attributable to a net loss of $2.0 million, partially offset by changes in operating assets and liabilities of $0.2 million and share-based compensation expenses of $0.2 million.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2023, of approximately $5.8 million was principally attributable to a net loss of approximately $4.7 million, gain from the sale of investment in Alphazyme, LLC of approximately $1.0 million, and changes in operating assets and liabilities of approximately $1.0 million, partially offset by share-based compensation expenses of approximately $0.9 million.
Current wording
Net cash used in operating activities for the three months ended March 31, 2024 was $1.1 million, which was principally attributable to a net loss of $2.0 million, partially offset by changes in operating assets and liabilities of $0.7 million and share-based compensation expenses of $0.3 million.
Previous wording
Net cash used in investing activities for thenine months ended September 30, 2024 was $3.1 million, compared to a net cash provided by investing activities of $7.4 million for the nine months ended September 30, 2023. The decrease in net cash used in investing activities was attributable to additional purchases of investment securities of $3.7 million, decreases in proceeds received from maturities of investment securities of $5.6 million, and proceeds from the sale of investment in Alphazyme of $1.3 million.
Current wording
Net cash provided by investing activities for thethree months ended March 31, 2025 was $0.5 million, compared to a net cash used in investing activities of $0.7 million for thethree months ended March 31, 2024. The change in investing activities was attributable to a reduction in purchases of investment securities of $0.2 million, increases in proceeds received from maturities of investment securities of $1.0 million, and proceeds from the sale of investment in Alphazyme in 2024 of $0.1 million.
Previous wording
Net cash provided by financing activitiesfor thenine months ended September 30, 2024 was $5.8 million, which was related to net proceeds from issuance of convertible notes. For thenine months ended September 30, 2023, there were no cash flows from financing activities.
Current wording
Net cash provided by financing activitiesfor thethree months ended March 31, 2025 was $24,000, which was related to net proceeds from exercise of stock, compared to the net cash provided by financing activity of $5,824,000 for thethree months ended March 31, 2024, which was related to net proceeds from the issuance of convertible notes.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
After the DuPont Transaction, the Company has been building innovative microbial platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable, and accessible biopharmaceutical products for human and animal health and for other biologic products for use in non-pharmaceutical applications.