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Dyadic to Report Third Quarter 2024 Financial Results on Tuesday, November 12, 2024
GlobeNewswire News Room· 2024-11-04 21:30
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].
Dyadic Provides Alternative Proteins Business Update and Announces Attendance at Bioprocess International Conference
GlobeNewswire News Room· 2024-09-23 13:50
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 ...
Dyadic(DYAI) - 2024 Q2 - Earnings Call Transcript
2024-08-14 03:05
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]
Dyadic(DYAI) - 2024 Q2 - Quarterly Results
2024-08-13 20:17
Exhibit 99.1 Dyadic Announces Second Quarter 2024 Financial Results and Highlights Recent Company Progress Alternative Proteins â—Ź Entered into a development and commercialization partnership for the sale of animal-free recombinant albumin products with Proliant Health and Biologicals â—Ź Entered into a joint development agreement with a Top 10 global dairy company for the development of non-animal alpha-lactalbumin â—Ź Ongoing development of a robust pipeline of non-pharmaceutical recombinant product candidates ...
Dyadic(DYAI) - 2024 Q2 - Quarterly Report
2024-08-13 20:15
[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)
Dyadic to Report Second Quarter 2024 Financial Results on Tuesday, August 13, 2024
GlobeNewswire News Room· 2024-07-30 20:00
JUPITER, Fla., July 30, 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 human and animal vaccines and therapeutics, as well as in nonpharmaceutical applications including food, nutrition, and wellness, today announced that it will report its financial results for the second quarter 2024 and host a corporate update conference call on Tuesday, Augu ...
Dyadic International, Inc. and Proliant Health and Biologicals announce Recombinant Albumin Development and Commercialization Partnership
Newsfilter· 2024-06-28 12:30
Core Insights - Dyadic International, Inc. has entered into a partnership with Proliant Health and Biologicals (PHB) to develop and commercialize animal-free recombinant albumin products, with an upfront milestone payment of $1.5 million and profit-sharing from sales [2][3][12] - The partnership aims to target the approximately $6 billion serum albumin market, focusing initially on recombinant human serum albumin products, with the first product expected to launch in the first half of 2025 [2][3] - Dyadic's protein production platforms, C1 and Dapibus™, utilize the fungus Thermothelomyces heterothallica to produce high-quality proteins sustainably and cost-effectively, supporting applications in various sectors including life sciences and next-generation foods [4][7] Company Overview - Dyadic International is a biotechnology company focused on innovative microbial protein production to meet the growing demand for cost-effective recombinant proteins across industrial, animal health, and human health applications [7] - Proliant Health & Biologicals is a leading supplier of purified proteins, committed to high standards of consistency, traceability, and quality in the market, and is the world's largest manufacturer of purified bovine proteins [5][14] Market Context - The partnership is a strategic move to address the increasing interest and demand for alternative protein sources in the diagnostic and life sciences industries, allowing PHB to expand its product portfolio with animal-free options [12]
Dyadic International, Inc. and Proliant Health and Biologicals announce Recombinant Albumin Development and Commercialization Partnership
GlobeNewswire News Room· 2024-06-28 12:30
Core Insights - Dyadic International, Inc. has entered into a development and commercialization partnership with Proliant Health and Biologicals to enhance their product offerings in the animal-free protein market [1][6][10] - The partnership aims to leverage Dyadic's microbial protein production technology to develop recombinant protein products that can compete with traditional proteins in terms of value and quality [2][6] Company Overview - Dyadic International is a biotechnology company focused on innovative microbial protein production platforms to meet the demand for cost-effective recombinant proteins across various sectors, including industrial, animal health, and human health [7][11] - Proliant Health and Biologicals is a leading supplier of purified proteins, committed to high standards of consistency, traceability, and quality in the market [12] Partnership Details - The agreement includes an upfront milestone payment of $1.5 million to Dyadic, along with a share of profits from the sale of animal-free recombinant albumin products produced using Dyadic's technology [10] - The initial focus of the partnership will be on the commercialization of recombinant human serum albumin products, with the first product expected to launch in the first half of 2025 [10]
Dyadic to Attend Industry Events in June
GlobeNewswire News Room· 2024-05-30 20:30
Core Insights - Dyadic International, Inc. is a biotechnology company focused on large-scale protein manufacturing for vaccines and therapeutics, as well as non-pharmaceutical applications like food and wellness [3][4]. Event Participation - Dyadic management will attend several industry events in June 2024, including BIO 2024 in San Diego from June 3-6, Future Food Tech-Alt Proteins in Chicago on June 17-18, and the 2024 NIIMBL National Meeting in Washington, DC from June 25-27 [2]. Technology and Platforms - The company utilizes the fungus Thermothelomyces heterothallica for its gene expression and protein production platforms, specifically the C1-cell protein production platform, which aims to reduce costs and improve performance in biologic vaccines and drugs [4]. - Dyadic has developed the Dapibus™ platform for the rapid and large-scale production of low-cost proteins and other biologic products for non-pharmaceutical uses [4]. Product Pipeline - Dyadic is advancing its proprietary microbial platform technologies, including the DYAI-100 COVID-19 vaccine candidate, along with other biologic vaccines and antibodies [5].
Dyadic to Attend Industry Events in June
Newsfilter· 2024-05-30 20:30
Core Insights - Dyadic International, Inc. is a biotechnology company focused on large-scale protein manufacturing for vaccines and therapeutics, as well as non-pharmaceutical applications like food and wellness [3][4]. Event Participation - Dyadic management will attend several industry events in June 2024, including BIO 2024 in San Diego from June 3-6, Future Food Tech-Alt Proteins in Chicago on June 17-18, and the 2024 NIIMBL National Meeting in Washington, DC from June 25-27 [2]. Technology and Platforms - The company utilizes the Thermothelomyces heterothallica fungus for its gene expression and protein production platforms, with the C1-cell protein production platform being a key technology for biologic vaccines and drugs [4]. - Dyadic has developed the Dapibus™ platform for the rapid and cost-effective production of proteins and biologic products for non-pharmaceutical uses [4]. Product Pipeline - Dyadic is advancing its proprietary microbial platform technologies, including the DYAI-100 COVID-19 vaccine candidate, and is focused on developing biologic vaccines, antibodies, and other biological products [5].