UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1044 North U.S. Highway One, Suite 201 Jupiter, Florida 33477 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ ...

Core Insights - Dyadic International, Inc. reported significant progress in commercializing its proprietary Dapibus™ and C1 microbial protein production platforms, driving long-term growth opportunities in both pharmaceutical and non-pharmaceutical applications [1][4]. Financial Performance - Total revenue for the year ended December 31, 2024, increased to approximately $3.5 million, up from $2.9 million in 2023, driven by license revenue of $1 million from Proliant and approximately $890,000 from Inzymes ApS [14]. - The company recognized approximately $1.9 million in milestone and license revenue in 2024 [6]. - Cash and investment-grade securities amounted to $9.3 million as of December 31, 2024, compared to $7.3 million in 2023 [13]. Research and Development - Research and development expenses decreased to approximately $2.0 million in 2024 from $3.3 million in 2023, attributed to the completion of the Phase 1 clinical trial of the DYAI-100 COVID-19 vaccine candidate [16]. - The company is advancing the development of several products, including Human Serum Albumin and DNASe1, with multiple products nearing market launch [6][7]. Grants and Collaborations - Dyadic received up to $7.5 million in grants from CEPI and the Gates Foundation to accelerate the C1 platform development timeline for faster and lower-cost vaccine and antibody manufacturing [6]. - The company is collaborating with organizations such as the Coalition for Epidemic Preparedness Innovations and the Bill & Melinda Gates Foundation to enhance its biopharmaceutical capabilities [3]. Product Development - Dyadic is progressing towards the commercial launch of Human Serum Albumin in Q2 2025, in partnership with Proliant Health and Biologicals [7]. - The company is also developing recombinant proteins for non-animal dairy applications, including alpha-lactalbumin and human lactoferrin, with expected sampling efforts in 2H 2025 [11]. Market Opportunities - Dyadic aims to expand its reach in alternative proteins and human and animal health markets, leveraging its growing network of partnerships and funding support [4]. - The C1 platform is under evaluation for diagnostics and vaccines across various species, including poultry and cattle, indicating potential for broad market applications [20].

Core Viewpoint - Dyadic International, Inc. has received a funding award from CEPI to utilize its C1 platform for accelerating the development of protein-based vaccines, aiming to significantly reduce production time and costs [1][5][6] Group 1: Funding and Collaboration - CEPI is providing US$4.5 million to Fondazione Biotecnopolo di Siena (FBS) for proof-of-concept research on producing antigens using Dyadic's C1 filamentous fungus technology [2] - The partnership supports the 100 Days Mission, which aims to reduce vaccine development timelines to just over three months in response to pandemic threats [5][12] Group 2: Technology and Production Efficiency - Traditional mammalian cell methods for producing protein antigens can take four to six months due to the need for stable cell line creation, while the C1 fungus technology could reduce this to just 35 days [3] - The C1 fungus technology is expected to produce large quantities of proteins that can be easily scaled, requiring less complex and expensive biopharmaceutical facilities compared to mammalian cell cultures [4] Group 3: Strategic Goals and Future Directions - CEPI's funding will focus on producing a SARS-CoV-2 spike protein to compare the efficacy of antigens produced by C1 fungus versus traditional mammalian cells [6][7] - Successful outcomes from this project could lead to selecting antigens from other pathogens of interest to CEPI, further demonstrating reduced timelines for vaccine development [7]

Core Insights - Dyadic International, Inc. is set to report its financial results for the year ended 2024 and will host a corporate update conference call on March 26, 2025 [1] Company Overview - Dyadic International, Inc. is a biotechnology company focused on the large-scale manufacture of proteins for human and animal vaccines, therapeutics, and non-pharmaceutical applications such as food and industrial uses [4][6] - The company utilizes microbial gene expression and protein production platforms based on the fungus Thermothelomyces heterothallica, with its lead platform being the C1-cell protein production platform [5] Conference Call Details - The conference call is scheduled for March 26, 2025, at 5:00 p.m. Eastern Time, with dial-in numbers provided for both toll-free and international participants [2] - A webcast link for the conference call is available, and an archive will be accessible within 24 hours post-event [2] Contact Information - For inquiries, the Chief Financial Officer, Ping W. Rawson, can be contacted via phone or email [8]

Core Viewpoint - Dyadic International, Inc. is actively participating in several prominent industry events to showcase its biotechnology capabilities in large-scale protein manufacturing for various applications, including vaccines and therapeutics [1][2]. Company Overview - Dyadic International, Inc. focuses on the efficient large-scale manufacture of proteins for human and animal vaccines, therapeutics, and non-pharmaceutical applications such as food, nutrition, and wellness [3][5]. - The company utilizes microbial gene expression and protein production platforms based on the fungus Thermothelomyces heterothallica, with its lead platform being the C1-cell protein production platform [4]. Technology and Applications - Dyadic's C1-cell protein production platform is designed to enhance the development, reduce production costs, and improve the performance of biologic vaccines and drugs for both human and animal health markets [4]. - The Dapibus™ protein production platform has been developed for the rapid and large-scale manufacture of low-cost proteins and other biologic products for non-pharmaceutical uses [4]. Industry Events - Dyadic will participate in the World AGRI-Tech Innovation Summit on March 11-12, 2025, and the Future Food-Tech event on March 13-14, 2025, both in San Francisco, CA [2]. - The company will also be involved in the Microbial Engineering III event from March 30 to April 3, 2025, in Porto, Portugal [2].

Core Insights - Dyadic International, Inc. is focusing on the production and monetization of alternative proteins, which is expected to provide significant near-term revenue opportunities as partners prepare for multiple product launches in this sector [2] - The company has received renewed interest in leveraging its C1 platform for human and animal health vaccines and diagnostics, highlighted by a $3 million grant from the Bill & Melinda Gates Foundation [2] - Dyadic will attend the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13 to 16, 2025, to engage with global partners [1][9] Alternative Proteins Business - The company is advancing its Human Serum Albumin product, expected to launch in the first half of 2025, and anticipates achieving a productivity milestone worth $500,000 during the same period [6] - Dyadic is in discussions for its recombinant transferrin products, which offer a consistent, animal-free alternative to serum-derived transferrin [6] - A recombinant dairy enzyme for cheese production is in the final stages of launch preparation, with additional dairy enzymes under development [6] Diagnostic and Vaccine Development - Collaborations with ViroVax are focused on developing a self-assembling ferritin nanoparticle H5-2.3.4.4b A/Astrakhan bird flu antigen for diagnostic testing and vaccine applications [7][14] - The C1-produced ferritin nanoparticle Mpox vaccine is also in early development stages [7] - Initial studies using the C1-produced H5 antigen have shown promising results in generating neutralizing antibodies in poultry and cattle sera, indicating potential for diagnostics and disease prevention [14] Company Overview - Dyadic International, Inc. specializes in the large-scale manufacture of proteins for human and animal vaccines, therapeutics, and non-pharmaceutical applications [10][12] - The company utilizes the C1-cell protein production platform, which is based on the fungus Thermothelomyces heterothallica, to enhance the development and reduce production costs of biologic vaccines and drugs [11]

Core Insights - Dyadic International, Inc. has received a $3 million grant from the Gates Foundation to develop monoclonal antibodies targeting respiratory syncytial virus (RSV) and malaria using its proprietary C1 protein production platform [1][4]. Group 1: Company Overview - Dyadic International, Inc. is a biotechnology company focused on the efficient large-scale manufacture of proteins for human and animal vaccines and therapeutics, as well as non-pharmaceutical applications [6]. - The C1 protein production platform is based on an industrially proven microorganism designed to accelerate development, reduce production costs, and improve scalability and performance of biologic vaccines and therapeutics [5][7]. Group 2: Health Impact - RSV is a significant cause of lower respiratory tract infections in children, leading to 3.2–36 million hospitalizations and over 100,000 deaths annually, predominantly in low-income and middle-income countries [2]. - In 2022, there were approximately 249 million malaria cases and 608,000 deaths globally, with the WHO African Region accounting for 94% of cases and 95% of deaths [2]. Group 3: Grant Utilization - The grant will enhance the C1 platform to enable rapid and cost-effective production of high-quality monoclonal antibodies, aiming to improve global access to critical treatments for RSV and malaria [4]. - The initiative seeks to deliver affordable therapeutic solutions to address urgent global health challenges, particularly in underserved populations [4][3]. Group 4: Future Plans - Dyadic plans to commercialize successful research efforts through licensure, expanding access to affordable treatment options and reducing the global burden of infectious diseases [5].

Financial Data and Key Metrics Changes - Revenue for Q3 2024 increased to approximately $1,958,000 compared to $397,000 for the same period a year ago, driven by licensing revenue of $1 million from Proliant and a success fee of $425,000 from Inzyme [38] - Cost of revenue for Q3 2024 increased to approximately $396,000 compared to $106,000 for the same period a year ago, attributed to the increasing number of collaborations [39] - Research and development expenses decreased to approximately $460,000 compared to $716,000 for the same period a year ago, reflecting the winding down of activities related to the Phase I clinical trial of DYAI-100 [40] - General and administrative expenses increased by 1.2% to $1,298,000 compared to $1,282,000 for the same period a year ago [41] - Loss from operations decreased to $203,000 compared to $1,720,000 for the same period a year ago, largely due to licensing revenue [42] - Net loss for Q3 2024 was $203,000 or $0.01 per share compared to $1,614,000 or $0.06 per share for the same period a year ago [43] Business Line Data and Key Metrics Changes - The focus on high-value alternative protein products is yielding tangible results, with significant progress in the commercialization of recombinant proteins like human serum albumin and alpha-lactalbumin [15][16] - The partnership with Proliant Health & Biologics is expected to generate significant revenue, with $1 million received in access and milestone fees [18] - The company is preparing to launch its own research-grade products, including RNase-free DNASE-1, with preorders expected to begin in early 2025 [20][21] Market Data and Key Metrics Changes - The global cell culture media market is valued at over $4.7 billion in 2023, expected to grow at a CAGR of 12.5% through 2030 [24] - The animal-free dairy products market is valued at over $26 billion in 2022, with ongoing revenue generation from precision microbial fermentation [26] - The DNA/RNA enzymes market is estimated at $900 million, with plans to expand product offerings in this segment [22] Company Strategy and Development Direction - The company is pursuing a dual-track strategy focusing on near-term revenue from alternative proteins while building long-term value in human and animal health markets [31] - The strategic direction emphasizes the commercialization of alternative proteins and biopharmaceuticals, leveraging proprietary Dapibus and C1 platforms [13][14] - The company aims to capitalize on emerging opportunities in the health, wellness, and nutrition sectors, positioning itself as a leader in global protein production [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to meet current challenges and shape future solutions in health and nutrition [13] - The company is actively seeking non-dilutive pathways to advance development in avian influenza and Mpox vaccine candidates [88] - Management highlighted the importance of generating near-term revenue while building sustainable value through innovative solutions [88] Other Important Information - The company has cash and investment-grade securities of $10 million as of September 30, 2024, compared to $7.3 million as of December 31, 2023 [43] - Total cash burn for 2024 is expected to decrease significantly to approximately $4.7 million [43] Q&A Session Summary Question: Understanding regulatory requirements for research-grade recombinant proteins - Management clarified that manufacturing must be done at an ISO-certified facility, and there are no regulatory reviews needed for product launch, focusing on QA and QC specifications [45] Question: Number of certificates of analysis held - The company confirmed it has three certificates of analysis for DNASE-1, bovine transferrin, and bovine alpha-lactalbumin, all comparable to existing products [46] Question: Difficulty in manufacturing high-dollar research products - Management explained that production varies by market, with some products requiring high volumes while others are produced in smaller quantities, affecting profitability [50][51] Question: Market preference for recombinant versus animal-derived products - Management indicated that preferences depend on the application, with recombinant products generally preferred for their lower contamination risk [60][61] Question: Addressable market size and royalty rates - Management provided insights into the addressable market, estimating significant opportunities in cell culture media and DNA/RNA enzymes, with royalty rates varying by segment and application [66][70]

Revenue Performance - Revenue for Q3 2024 increased to approximately $1,958,000, up from $397,000 in the same period last year, driven by $1 million in license revenue and $425,000 in success fees[12] - Total revenue for the three months ended September 30, 2024, was $1,957,500, a significant increase of 394% compared to $397,060 for the same period in 2023[24] - License revenue for the three months ended September 30, 2024, was $1,425,000, compared to only $44,118 in the prior year, marking a growth of 3130%[24] Financial Position - The company has a strong cash position of approximately $10 million as of September 30, 2024, compared to $7.3 million at the end of 2023[11] - Total current assets increased to $10,690,424 as of September 30, 2024, from $8,067,335 as of December 31, 2023, reflecting a growth of 32.4%[25] - Total assets as of September 30, 2024, were $10,805,666, up from $8,219,236 as of December 31, 2023, indicating a growth of 31.7%[25] - Total liabilities increased to $7,393,554 as of September 30, 2024, compared to $2,340,651 as of December 31, 2023, representing a significant rise of 215.5%[25] - Stockholders' equity decreased to $3,412,112 as of September 30, 2024, from $5,878,585 as of December 31, 2023, a decline of 41.1%[25] Operational Performance - Loss from operations decreased to $203,000 in Q3 2024, down from $1,720,000 in the same period last year, primarily due to increased licensing revenue[16] - The net loss for the three months ended September 30, 2024, was $(203,460), an improvement from $(1,614,259) in the same period of 2023[24] - Basic and diluted net loss per common share for the three months ended September 30, 2024, was $(0.01), compared to $(0.06) for the same period in 2023[24] Research and Development - Research and development expenses decreased to approximately $460,000 in Q3 2024, compared to $716,000 in the same period last year, reflecting the winding down of a Phase 1 clinical trial[14] - Research and development revenue for the nine months ended September 30, 2024, was $1,253,013, down 40% from $2,079,918 in the same period of 2023[24] - The company has initiated development efforts for research grade DNA/RNA Polymerases, DNA Ligase, and RNase Inhibitor products, essential tools in molecular biology[6] - The company has made progress in developing recombinant transferrin for cell culture media, with a Certificate of Analysis issued for the product[6] - The company is co-developing a C1-produced ferritin nanoparticle Mpox antigen with ViroVax LLC, with preclinical studies scheduled to begin in Q4 2024[10] Collaborations and Partnerships - The company is advancing its collaborations with two top ten pharmaceutical companies and a leading biotech, successfully expressing antigens for various infectious diseases[10] - The anticipated launch of the first recombinant human serum albumin product is expected in the first half of 2025, following a partnership with Proliant Health[6] - The company received a $1 million milestone payment for animal-free recombinant albumin products and $425,000 in success fees for achieving production targets in a dairy enzyme collaboration[1]

Revenue and Financial Performance - Total revenue for Q3 2024 was $1.96 million, a significant increase from $397,060 in Q3 2023[10] - Research and development revenue for Q3 2024 was $532,500, up from $352,942 in Q3 2023[10] - License revenue for Q3 2024 was $1.43 million, compared to $44,118 in Q3 2023[10] - Total revenue for the nine months ended September 30, 2024, was $2.68 million, up from $2.21 million in the same period in 2023[10] - Revenue for the nine months ended September 30, 2024, was generated from 16 customers, with two significant customers accounting for 54.1% of revenue[31] - Revenue from European customers for the nine months ended September 30, 2024, was $854,000, representing 31.9% of total revenue[33] - The company recognized $1.0 million in license revenue from the Proliant Agreement for the three and nine months ended September 30, 2024[66] - Under the Amended Inzymes Agreement, the company received an upfront payment of $0.6 million and recognized $425,000 in license revenue from success fees for the three months ended September 30, 2024[68][69] - The company recorded research and development revenues of $0 and $25,000 for the three and nine months ended September 30, 2024, respectively, under the Inzymes Agreement[69] - The company recognized $44,000 and $132,000 of license revenue for the three and nine months ended September 30, 2023, respectively, under the Janssen Agreement[74] - The company recorded research and development revenues of approximately $0 and $565,000 for the three and nine months ended September 30, 2023, respectively, under the JDA with GFIC[72] Net Loss and Earnings Per Share - Net loss for Q3 2024 was $203,460, an improvement from a net loss of $1.61 million in Q3 2023[10] - Basic and diluted net loss per common share for Q3 2024 was $0.01, compared to $0.06 in Q3 2023[10] - Net loss for the nine months ended September 30, 2024, was $4.26 million, compared to $4.72 million in the same period in 2023[10] - Basic and diluted net loss per common share for the nine months ended September 30, 2024, was $0.15, compared to $0.16 in the same period in 2023[10] - Net loss for the nine months ended September 30, 2024, was $4.26 million, compared to $4.72 million in the same period in 2023[14] Cash Flow and Liquidity - Net cash used in operating activities for the nine months ended September 30, 2024, was $3.28 million, compared to $5.80 million in the same period in 2023[14] - Net cash provided by financing activities for the nine months ended September 30, 2024, was $5.82 million, primarily from the issuance of convertible notes[14] - The company issued $6.0 million of 8.0% Senior Secured Convertible Promissory Notes on March 8, 2024, with net proceeds of $5.82 million[20] - The company expects its existing cash and cash equivalents, along with proceeds from the Convertible Notes, to meet liquidity requirements for at least the next 12 months[24] - Cash and cash equivalents totaled $5,921,614 as of September 30, 2024, with money market funds accounting for $4,825,756 of that total[62] - Cash and cash equivalents totaled $6,515,028 as of September 30, 2024, with money market funds accounting for $6,489,253[64] - The company received discounts of $70,495 and $33,982 to purchase held-to-maturity investment securities for the nine months ended September 30, 2024 and 2023, respectively[64] Research and Development - The company is focused on developing its C1-cell protein production platform for biologic products, including vaccines and drugs for human and animal health[17] - Two CROs accounted for $690,000 or 94.6% of total research services purchased for the three months ended September 30, 2024, compared to three CROs accounting for $977,000 or 93.4% in the same period in 2023[35] - For the nine months ended September 30, 2024, two CROs accounted for $1,647,000 or 92.0% of total research services purchased, compared to three CROs accounting for $3,639,000 or 96.4% in the same period in 2023[35] - Research and development expenses for accounts payable decreased to $376,608 as of September 30, 2024, from $575,436 as of December 31, 2023[46] - Research and development costs for the three months ended September 30, 2024, were $460,241, compared to $716,351 for the same period in 2023[50] - VTT Research Contract extended to January 31, 2025, with a total payment of EUR €186,000, of which EUR €93,000 was paid as of September 30, 2024[92] Convertible Notes and Financing - As of September 30, 2024, $600,000 of the Convertible Notes were converted into 335,195 shares of Common Stock[23] - The company issued senior secured convertible promissory notes with an aggregate principal amount of $6.0 million on March 8, 2024[80] - Interest paid on the Convertible Notes was $114,933 for the three months ended September 30, 2024, and $149,778 for the nine months ended September 30, 2024[87] - $600,000 of Convertible Notes were converted into 335,195 shares of common stock as of September 30, 2024[88] - Total outstanding convertible notes payable as of September 30, 2024: $1,400,000 (related party) and $4,000,000 (third party)[88] - Accrued interest as of September 30, 2024: $20,000 (Francisco Trust), $2,000 (Bradley Emalfarb), $4,200 (Bradley Scott Emalfarb Irrevocable Trust), and $1,800 (Descendant Trust)[89] Stock-Based Compensation and Equity - Stock-based compensation expense for the nine months ended September 30, 2024, was $306,478[12] - As of September 30, 2024, the company had 5,845,035 stock options outstanding and 117,925 unvested restricted stock units[94] - Stock options granted in 2024: 837,600 shares with a weighted-average exercise price of $1.31[100] - Restricted stock units outstanding as of December 31, 2023: 213,044 shares with a weighted-average grant date fair value of $1.43[101] - The company's 2021 Equity Incentive Award Plan increased the number of shares available for grant by 3,000,000 as of April 16, 2021[93] - The company granted 212,709 RSUs with immediate vesting to executives and key personnel in lieu of cash bonuses for the year ended 2023, and 141,510 RSUs to the Board of Directors, vesting upon the one-year anniversary of the grant[102] - Total non-cash share-based compensation expense for the three months ended September 30, 2024, was $247,390, with $235,024 allocated to general and administrative expenses and $12,366 to research and development expenses[105] - For the nine months ended September 30, 2024, the company issued 778,310 shares of common stock with a weighted average issue price of $1.63 per share, including 335,195 shares from the conversion of Convertible Notes and 437,546 shares from the vesting of restricted stock units[107] - As of September 30, 2024, the company held 12,253,502 shares of common stock in treasury at a cost of $18.9 million[108] - The company recognized $9,000 and $50,000 in forfeitures for the three and nine months ended September 30, 2024, respectively[104] - Share-based compensation expense for stock options was $200,387 for the three months ended September 30, 2024, and $634,194 for the nine months ended September 30, 2024[106] - Share-based compensation expense for restricted stock units was $47,003 for the three months ended September 30, 2024, and $217,277 for the nine months ended September 30, 2024[106] Accounts Receivable and Payable - Accounts receivable as of September 30, 2024, was $262,000 from four customers, representing 74.1% of total accounts receivable[32] - As of September 30, 2024, two CROs accounted for $341,000 or 60.8% of accounts payable, compared to three CROs accounting for $620,000 or 94.4% as of December 31, 2023[35] - Billed receivables decreased to $212,939 as of September 30, 2024, from $410,617 as of December 31, 2023, while unbilled receivables increased to $139,995 from $55,542 over the same period[45] - Accrued expenses for employee wages and benefits decreased to $442,604 as of September 30, 2024, from $561,720 as of December 31, 2023[47] Deferred Tax Assets and Investments - Deferred tax assets increased to $17.7 million as of September 30, 2024, from $16.4 million as of December 31, 2023[54] - Short-term investment securities in corporate bonds had an adjusted cost of $4,000,832 as of September 30, 2024, with gross unrealized holding losses of $1,202[62] Legal and Compliance - The company is not currently involved in any material litigation as of September 30, 2024[91] - The company's disclosure controls and procedures were deemed effective as of the end of the period covered by the report[110] - No changes in internal control over financial reporting were identified during the three months ended September 30, 2024, that materially affected the company's internal control[174] Accumulated Deficit and Equity Transactions - Accumulated deficit as of September 30, 2024, was $84.54 million, compared to $78.21 million as of September 30, 2023[12] - The company received a total cash payment of $1.3 million from the sale of its equity interest in Alphazyme, LLC for the year ended December 31, 2023, and an additional $60,977 in the first quarter of 2024[79]