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]

Core Viewpoint - Dyadic International, Inc. is set to report its financial results for Q3 2024 and will host a corporate update conference call on November 12, 2024, highlighting its focus on large-scale protein manufacturing for vaccines and therapeutics [1]. Company Overview - Dyadic International, Inc. specializes in the efficient large-scale manufacture of proteins for human and animal vaccines, therapeutics, and non-pharmaceutical applications such as food, nutrition, and wellness [4]. - The company utilizes the fungus Thermothelomyces heterothallica for its gene expression and protein production platforms, aiming to lower production costs and improve the performance of biologic vaccines and drugs [5]. Technology and Innovation - Dyadic's lead technology, the C1-cell protein production platform, is designed to enhance the development and production of biologic products at flexible commercial scales [5]. - The Dapibus™ platform enables rapid development and large-scale manufacture of low-cost proteins and other biologic products for non-pharmaceutical uses [5]. Strategic Goals - The company is committed to advancing its proprietary microbial platform technologies to support the development of effective preventative and therapeutic treatments globally [6]. - Dyadic aims to facilitate the faster market entry of vaccines and biologic products at greater volumes and lower costs [7].

JUPITER, Fla., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the "Company") (NASDAQ: DYAI), a biotechnology company focused on the efficient, large-scale manufacture of proteins for use in non-pharmaceutical applications including food, nutrition and wellness, as well as animal and human health therapeutics and vaccines, today provided an update on business progress and announced its attendance at the Bioprocess International Conference in Boston, September 2 ...

Financial Data and Key Metrics Changes - Revenue for Q2 2024 decreased to approximately $386,000 compared to $837,000 for the same period a year ago, attributed to the winding down of several large research collaborations [19][20] - Research and development expenses for Q2 2024 decreased to approximately $516,000 from $918,000 in the same period last year, reflecting the winding down of activities related to the company's Phase 1 clinical trial of DYAI-100 [20] - General and administrative expenses increased to approximately $1.608 million from $1.403 million year-over-year, driven by increases in share-based compensation, legal expenses, and business development costs [20][21] - Net loss for Q2 2024 was approximately $2.045 million or $0.07 per share, compared to a net loss of $2.153 million or $0.07 per share for the same period last year [21] Business Line Data and Key Metrics Changes - The company is focusing on high-value, high-volume recombinant protein products, with a recent partnership for combat serum albumin unlocking opportunities in the approximately $6 billion serum albumin market [6][7] - The Dapibus protein expression platform is gaining momentum and generating revenue in the alternative protein and bio-industrial sectors [5] - The company has developed DNase-1 and a recombinant transferrin strain, targeting markets valued at over $809 million and $4.73 billion respectively, both projected to grow significantly [10][11] Market Data and Key Metrics Changes - The global animal-free dairy products market was valued at over $26 billion in 2022 and is projected to reach more than $75 billion by 2032 [12] - The recombinant transferrin market is expected to grow, with the average cost of a kilogram of transferrin being approximately $400,000 to $500,000 [28][30] - The alternative protein sector is the primary focus for near-term growth, with significant interest in non-animal dairy products and recombinant proteins [14][19] Company Strategy and Development Direction - The company is strategically positioned to achieve mobile revenue streams through commercialization of products, technology licensing, and advancing its pipeline [4][19] - The focus is on three distinct market sectors: alternative proteins, animal health, and human health, with significant activity reported in each sector [23] - The company aims to leverage its microbial protein production platforms to develop recombinant proteins across various sectors, driving substantial value creation [5][19] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the company's strategy centered on licensing and product candidates, aiming to enhance shareholder value [3][4] - The company is committed to driving near-term revenue growth in the alternative protein segment while building long-term value in animal and human health markets [19][23] - There is a focus on evaluating product opportunities with financial rigor to fully capture the value of the company's technology and expertise [19] Other Important Information - The company has initiated over 14 fully funded human health vaccine and antibody projects, showcasing its ability to produce both standard and complex molecules [15] - The successful completion of the first in-human Phase 1 study for a C1 produced protein has generated significant interest from various sectors [15][16] - The company is actively providing samples of its H5 avian influenza vaccine candidate to pharmaceutical companies for evaluation [18] Q&A Session Summary Question: What is the size of the alpha-lactalbumin market and who are the customers? - The alpha-lactalbumin market is approximately $700 million, with the recombinant segment estimated at $30 million to $40 million. Customers include large dairy companies like Danone and Nestlé [25][26] Question: Is there a clear pathway to revenues outlined in the JDA with the dairy company? - Yes, there are milestones and royalty payments associated with the development based on the performance of the strain [27] Question: Can you elaborate on the transferrin opportunity? - The transferrin market is high-growth, with an average cost of $400,000 to $500,000 per kilogram. Recombinant production is increasing due to its high price point and regulatory acceptance [28][30] Question: How has the C1 expression system evolved over the last five years? - The C1 cell line has transitioned from industrial use to biopharmaceuticals, demonstrating the ability to produce stable, high levels of low-cost proteins, which has opened up significant market opportunities [32][34] Question: What is the relative margin on the C1 produced product versus Proliant's current offerings? - Proliant currently works with bovine albumin and does not have a recombinant product. The company aims to provide a cost-effective recombinant human serum albumin for various applications [36][37]

Exhibit 99.1 Dyadic Announces Second Quarter 2024 Financial Results and Highlights Recent Company Progress Alternative Proteins ● Entered into a development and commercialization partnership for the sale of animal-free recombinant albumin products with Proliant Health and Biologicals ● Entered into a joint development agreement with a Top 10 global dairy company for the development of non-animal alpha-lactalbumin ● Ongoing development of a robust pipeline of non-pharmaceutical recombinant product candidates ...

[FINANCIAL INFORMATION](index=3&type=section&id=PART%20I) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited consolidated financial statements for Dyadic International, Inc. and its subsidiaries, including balance sheets, statements of operations, stockholders' equity, and cash flows, with detailed notes [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) | Metric | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :---------------------------------- | :-------------------------- | :-------------------------- | | **Assets** | | | | Cash and cash equivalents | $6,133,398 | $6,515,028 | | Short-term investment securities | $3,964,517 | $748,290 | | Total current assets | $10,502,601 | $8,067,335 | | Total assets | $10,630,372 | $8,219,236 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $1,948,516 | $2,251,781 | | Convertible notes, net | $3,893,602 | — | | Convertible notes, net - related party | $1,557,441 | — | | Total liabilities | $7,462,190 | $2,340,651 | | Total stockholders' equity | $3,168,182 | $5,878,585 | | Total liabilities and stockholders' equity | $10,630,372 | $8,219,236 | - Total assets increased from **$8.2 million** at December 31, 2023, to **$10.6 million** at June 30, 2024, primarily driven by an increase in short-term investment securities and the issuance of convertible notes[9](index=9&type=chunk) - Total liabilities significantly increased from **$2.3 million** to **$7.5 million**, mainly due to the issuance of **$6.0 million** in convertible notes during the period[9](index=9&type=chunk) [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development revenue | $385,896 | $793,042 | $720,513 | $1,726,976 | | License revenue | — | $44,117 | — | $88,235 | | Total revenue | $385,896 | $837,159 | $720,513 | $1,815,211 | | Costs of research and development revenue | $301,956 | $792,944 | $445,911 | $1,519,862 | | Research and development expenses | $515,629 | $917,552 | $1,038,352 | $1,728,118 | | General and administrative expenses | $1,607,756 | $1,402,569 | $3,396,350 | $2,882,609 | | Loss from operations | $(2,042,591) | $(2,290,427) | $(4,168,149) | $(4,340,921) | | Net loss | $(2,045,223) | $(2,152,960) | $(4,054,819) | $(3,109,404) | | Basic and diluted net loss per common share | $(0.07) | $(0.07) | $(0.14) | $(0.11) | - Total revenue decreased significantly for both the three-month and six-month periods ended June 30, 2024, primarily due to the winding down of several large research collaborations and the completion of the Janssen license agreement in 2023[12](index=12&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) - Net loss increased for the six months ended June 30, 2024, to **$4.05 million** from **$3.11 million** in the prior year, largely influenced by a decrease in the gain on sale of Alphazyme LLC and increased general and administrative expenses, despite lower R&D expenses[12](index=12&type=chunk)[134](index=134&type=chunk) [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) | Metric | January 1, 2024 | June 30, 2024 | | :---------------------------------- | :-------------- | :------------ | | Common Stock Shares | 41,064,563 | 41,731,141 | | Common Stock Amount | $41,065 | $41,732 | | Additional Paid-In Capital | $105,044,756 | $106,388,505 | | Accumulated Deficit | $(80,277,321) | $(84,332,140) | | Total Stockholders' Equity | $5,878,585 | $3,168,182 | - Total stockholders' equity decreased from **$5.88 million** at January 1, 2024, to **$3.17 million** at June 30, 2024, primarily due to the net loss incurred during the period[14](index=14&type=chunk) - The company issued **666,578 shares** of common stock during the six months ended June 30, 2024, from convertible note conversions, RSU vesting, and stock option exercises[14](index=14&type=chunk)[92](index=92&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :---------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(3,077,354) | $(3,841,654) | | Net cash (used in) provided by investing activities | $(3,127,551) | $3,888,358 | | Net cash provided by financing activities | $5,824,326 | — | | Net (decrease) increase in cash and cash equivalents | $(381,630) | $47,319 | | Cash and cash equivalents at end of period | $6,133,398 | $5,841,591 | - Net cash used in operating activities decreased to **$3.1 million** for the six months ended June 30, 2024, from **$3.8 million** in the prior year, mainly due to a lower net loss and favorable changes in operating assets and liabilities[17](index=17&type=chunk)[140](index=140&type=chunk) - Net cash provided by financing activities was **$5.8 million** for the six months ended June 30, 2024, driven by the issuance of convertible notes, compared to no financing activities in the prior year[17](index=17&type=chunk)[141](index=141&type=chunk) - Cash and cash equivalents decreased by **$0.38 million** to **$6.1 million** at June 30, 2024, primarily due to significant cash used in investing activities for purchasing investment securities, partially offset by financing proceeds[17](index=17&type=chunk)[141](index=141&type=chunk) [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) [Note 1: Organization and Summary of Significant Accounting Policies](index=9&type=section&id=Note%201:%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) - Dyadic International, Inc. is a global biotechnology company focused on developing gene expression platforms (C1 and Dapibus™) for producing biologic products for human and animal health, as well as non-pharmaceutical applications like food and nutrition[19](index=19&type=chunk)[20](index=20&type=chunk)[21](index=21&type=chunk) - The company expects to incur losses and negative cash flows from operations as it continues R&D and expands its platforms, relying on capital raises and sublicensing for success[22](index=22&type=chunk) - On March 8, 2024, Dyadic issued **$6.0 million** in 8.0% Senior Secured Convertible Promissory Notes, with net proceeds of **$5.824 million**, to support near-term revenue growth and commercialization efforts[23](index=23&type=chunk)[25](index=25&type=chunk) [Note 2: Cash, Cash Equivalents, and Investments](index=17&type=section&id=Note%202:%20Cash,%20Cash%20Equivalents,%20and%20Investments) | Metric | June 30, 2024 (Fair Value) | December 31, 2023 (Fair Value) | | :---------------------------------- | :------------------------- | :------------------------- | | Cash | $683,233 | $25,775 | | Money Market Funds | $5,450,165 | $6,489,253 | | Short-Term Investment Securities (Corporate Bonds) | $3,962,295 | $748,105 | | Total | $10,095,693 | $7,263,133 | - The company classifies debt securities as held-to-maturity at amortized cost and money market funds as available-for-sale securities, presented as cash equivalents[37](index=37&type=chunk)[39](index=39&type=chunk)[58](index=58&type=chunk) - As of June 30, 2024, and December 31, 2023, no investments were considered other-than-temporarily impaired, and no allowance for credit losses was recorded[58](index=58&type=chunk) [Note 3: Research and Collaboration Agreements, Sublicense Agreements, and Investments in Privately Held Companies](index=17&type=section&id=Note%203:%20Research%20and%20Collaboration%20Agreements,%20Sublicense%20Agreements,%20and%20Investments%20in%20Privately%20Held%20Companies) - Dyadic entered a License and Development Agreement with Proliant Biologicals, LLC on June 27, 2024, for recombinant serum albumin production, with an initial upfront payment of **$0.5 million** received in July 2024[59](index=59&type=chunk)[61](index=61&type=chunk) - Under the Inzymes Agreement, Dyadic recorded research and development revenues of **$0.052 million** and **$0.092 million** for the three and six months ended June 30, 2024, respectively, following an upfront payment of **$0.6 million** in October 2023[62](index=62&type=chunk)[63](index=63&type=chunk) - The Janssen Agreement for therapeutic protein manufacturing was wound down by December 31, 2023, resulting in no revenue recognized from it in the first half of 2024, compared to **$0.044 million** in license revenue and **$0.191 million** in R&D revenue for the three months ended June 30, 2023[66](index=66&type=chunk) - Dyadic received an additional cash payment of **$0.062 million** in Q1 2024 from the sale of its equity interest in Alphazyme, LLC, recorded as a gain on sale[69](index=69&type=chunk) [Note 4: Convertible Notes Payable](index=20&type=section&id=Note%204:%20Convertible%20Notes%20Payable) - On March 8, 2024, Dyadic issued **$6.0 million** in 8.0% Senior Secured Convertible Promissory Notes due March 8, 2027, with **$2.0 million** sold to related parties[70](index=70&type=chunk)[72](index=72&type=chunk) - The notes are convertible into common stock at **$1.79 per share**, and **$0.4 million** of notes were converted into **223,463 shares** of common stock by June 30, 2024[73](index=73&type=chunk) - The company incurred **$0.176 million** in debt issuance costs, amortizing **$0.027 million** as interest expense for the six months ended June 30, 2024[75](index=75&type=chunk) [Note 5: Commitments and Contingencies](index=23&type=section&id=Note%205:%20Commitments%20and%20Contingencies) - Dyadic is not currently involved in any litigation expected to have a materially adverse effect on its financial condition or results of operations[79](index=79&type=chunk) - The company extended its contract with VTT Technical Research Centre of Finland Ltd. to January 31, 2025, for C1 fungal expression system development, with payments totaling **€0.186 million**[80](index=80&type=chunk) [Note 6: Share-Based Compensation](index=23&type=section&id=Note%206:%20Share-Based%20Compensation) - As of June 30, 2024, Dyadic had **5,830,222 stock options** outstanding and **117,925 unvested restricted stock units**, with **2,040,004 shares** available for grant under the 2021 Plan[82](index=82&type=chunk) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :---------------------------------- | :----------------------------- | :----------------------------- | | Total non-cash share-based compensation expense | $604,081 | $664,955 | | - Stock option expense | $433,807 | $554,914 | | - Restricted stock units expense | $170,274 | $110,041 | - Stock-based compensation expense is recognized based on grant date fair values using the Black-Scholes model for options and closing market price for RSUs, with forfeitures recorded as they occur[83](index=83&type=chunk)[86](index=86&type=chunk)[89](index=89&type=chunk) [Note 7: Shareholders' Equity](index=27&type=section&id=Note%207:%20Shareholders'%20Equity) - For the six months ended June 30, 2024, **666,578 shares** of common stock were issued at a weighted average price of **$1.61 per share**, including conversions of convertible notes, vesting of restricted stock units, and exercise of stock options[92](index=92&type=chunk) - As of June 30, 2024, the company held **12,253,502 shares** of common stock in treasury at a cost of **$18.9 million**[93](index=93&type=chunk) [Note 8: Subsequent Events](index=27&type=section&id=Note%208:%20Subsequent%20Events) - Management has evaluated subsequent events through August 13, 2024, and is not aware of any material events requiring adjustment or disclosure, except for those already mentioned in the notes[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting business overview, recent developments, critical accounting estimates, and a detailed analysis of revenue, expenses, and liquidity [Overview](index=28&type=section&id=Overview) - Dyadic is a global biotechnology company leveraging its C1-cell and Dapibus™ protein production platforms for human and animal health biopharmaceuticals and non-pharmaceutical applications like food and nutrition[97](index=97&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) - The company retained co-exclusive rights to the C1-cell platform for human and animal pharmaceutical applications after selling its industrial technology business to Danisco USA in 2015[98](index=98&type=chunk) - Recent developments include a partnership with Proliant Health and Biologicals for recombinant serum albumin, progress in DNASE-1 and recombinant transferrin for non-food applications, and successful development of recombinant alpha-lactalbumin and lactoferrin for food applications[102](index=102&type=chunk)[103](index=103&type=chunk) - In animal health, collaborations with Phibro Animal Health continue, and C1-produced H5 A/Astrakhan ferritin nanoparticle antigen shows potential as a vaccine candidate against avian influenza in poultry and cattle[106](index=106&type=chunk) - In human health, pre-clinical animal testing of an adjuvanted H5 avian influenza ferritin nanoparticle vaccine candidate demonstrated a strong immune response in rabbits, and the C1 Platform successfully expressed multiple infectious disease antigens and delivered mAbs for evaluation[107](index=107&type=chunk) [Critical Accounting Estimates](index=30&type=section&id=Critical%20Accounting%20Estimates) - Revenue recognition for research collaborations and agreements follows a 5-step process under ASC Topic 606, primarily using the cost-based input method to measure progress, which requires significant judgment in estimating costs to complete performance obligations[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk)[113](index=113&type=chunk) - Accrued research and development expenses are estimated based on open contracts, purchase orders, and communication with personnel, with periodic adjustments[119](index=119&type=chunk) - Stock-based compensation fair value for options is estimated using the Black-Scholes model, considering volatility, risk-free interest rate, and expected life, while RSUs are based on closing market price[120](index=120&type=chunk) - Income taxes are accounted for under the asset and liability method, with a **100% valuation allowance** against deferred tax assets due to a history of operating losses and uncertainty of future taxable income[123](index=123&type=chunk)[124](index=124&type=chunk) [Off-Balance Sheet Arrangements](index=34&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company does not have any off-balance sheet arrangements[126](index=126&type=chunk) [Recent Accounting Pronouncements](index=34&type=section&id=Recent%20Accounting%20Pronouncements) - The company refers to Note 1 for information on recent accounting pronouncements, including ASU 2023-09 (Income Taxes) and ASU 2023-07 (Segment Reporting), neither of which are expected to have a material impact on financial position or results of operations[54](index=54&type=chunk)[55](index=55&type=chunk)[126](index=126&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development revenue | $385,896 | $793,042 | $720,513 | $1,726,976 | | License revenue | — | $44,117 | — | $88,235 | | Cost of research and development revenue | $301,956 | $792,944 | $445,911 | $1,519,862 | | Research and development expenses | $516,000 | $918,000 | $1,038,000 | $1,728,000 | | General and administrative expenses | $1,608,000 | $1,403,000 | $3,396,000 | $2,883,000 | | Loss from operations | $(2,043,000) | $(2,290,000) | $(4,168,000) | $(4,341,000) | | Net loss | $(2,045,000) | $(2,153,000) | $(4,055,000) | $(3,109,000) | - Research and development revenue decreased for both periods due to the winding down of several large collaborations in 2023, with no license revenue in 2024 after the Janssen agreement completion[126](index=126&type=chunk)[127](index=127&type=chunk) - R&D expenses decreased by **$0.402 million** (three months) and **$0.690 million** (six months) due to the winding down of the DYAI-100 COVID-19 vaccine clinical trial and fewer internal research projects[128](index=128&type=chunk)[129](index=129&type=chunk) - General and administrative expenses increased by **14.6%** (three months) and **17.8%** (six months), driven by higher share-based compensation, legal, and business development expenses[131](index=131&type=chunk) - Net loss for the six months ended June 30, 2024, increased to **$4.055 million** from **$3.109 million**, primarily due to a **$0.957 million** decrease in gain on sale of Alphazyme LLC and increased interest expenses from convertible notes[134](index=134&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) - The company expects to incur losses and negative operating cash flows, with success dependent on technology development, regulatory approval, revenue generation, or sublicensing, and the ability to raise capital[135](index=135&type=chunk) - The **$5.824 million** net proceeds from the **$6.0 million** convertible notes issued in March 2024 are intended for working capital and general corporate purposes, supporting near-term revenue growth and commercialization[136](index=136&type=chunk) - Existing cash, cash equivalents, convertible notes proceeds, investments, and operating cash flows are expected to meet liquidity requirements for at least the next twelve months, though this estimate is based on assumptions that may change[139](index=139&type=chunk) | Metric | June 30, 2024 | December 31, 2023 | | :---------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $6.1 million | $6.5 million | | Investment grade securities (carrying value) | $4.0 million | $0.8 million | [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Dyadic International, Inc. is not required to provide quantitative and qualitative disclosures about market risk - Dyadic is a smaller reporting company and is exempt from providing quantitative and qualitative disclosures about market risk[142](index=142&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures, confirming their effectiveness, and notes no material changes in internal controls over financial reporting during the quarter. It also acknowledges the inherent limitations of any control system - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective as of June 30, 2024[142](index=142&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2024[143](index=143&type=chunk) - The company acknowledges that control systems have inherent limitations, providing only reasonable, not absolute, assurance, and can be circumvented by individual acts, collusion, or management override[144](index=144&type=chunk) [OTHER INFORMATION](index=40&type=section&id=PART%20II) [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any litigation that is expected to have a materially adverse effect on its financial condition or results of operations, though it may encounter routine legal proceedings - Dyadic is not currently involved in any litigation believed to have a materially adverse effect on its financial condition or results of operations[146](index=146&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) There have been no changes to the company's risk factors from those disclosed in its Annual Report for the 2023 fiscal year - No changes to risk factors have occurred since the Annual Report for the 2023 fiscal year filed on March 28, 2024[147](index=147&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds for the period - There were no unregistered sales of equity securities and use of proceeds to report[147](index=147&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - This item is not applicable[147](index=147&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period - This item is not applicable[147](index=147&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) This section discloses that several key executives and directors adopted Rule 10b5-1 trading arrangements during the quarter ended June 30, 2024, for potential sales of common stock - During the quarter ended June 30, 2024, Mark Emalfarb (President and CEO), Jack Kaye (director), Ronen Tchelet (VP of Research and Business Development), and Ping Wang Rawson (CFO) adopted Rule 10b5-1 trading arrangements[148](index=148&type=chunk) - These arrangements include potential sales of up to **1 million shares** for Mr. Emalfarb, **292,367** for Mr. Kaye, **250,000** for Mr. Tchelet, and **282,485** for Ms. Rawson, with various expiration dates[148](index=148&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the report, including corporate governance documents, a license and development agreement, and certifications - Exhibits include the Restated Certificate of Incorporation, Third Amended and Restated Bylaws, and the License and Development Agreement with Proliant Biologicals, LLC[150](index=150&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents, are also filed[151](index=151&type=chunk) [Signatures](index=42&type=section&id=Signatures) - The report was duly caused to be signed on behalf of Dyadic International, Inc. by Mark A. Emalfarb, President and Chief Executive Officer, and Ping W. Rawson, Chief Financial Officer, on August 13, 2024[153](index=153&type=chunk)