Workflow
Dyadic(DYAI)
icon
Search documents
Dyadic to Present at World Vaccine Congress | Washington
Newsfilter· 2025-04-16 18:00
Core Viewpoint - Dyadic International, Inc. is advancing its proprietary C1 expression platform for the production of non-mRNA antigens, aiming to address global health challenges such as avian influenza and future pandemics through efficient biomanufacturing [1][3]. 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 including food and wellness [4][5]. - The company utilizes microbial production platforms, particularly the C1-cell protein production platform based on the fungus Thermothelomyces heterothallica, to enhance the development and reduce costs of biologic vaccines and drugs [5][6]. Upcoming Presentation - CEO Mark Emalfarb will present at the 2025 World Vaccine Congress in Washington, D.C., discussing the urgent need for smarter biomanufacturing in relation to avian influenza and future pandemics [2][3]. - The presentation will include recent preclinical research data demonstrating the effectiveness of Dyadic's C1 platform in producing non-mRNA antigens that generate high neutralizing antibodies [3]. Strategic Focus - Dyadic is leveraging its microbial platform technologies for various applications, including human and animal vaccines, therapeutics, and food-related products, to meet the growing demand for rapid-response solutions in global health [6].
Dyadic(DYAI) - 2024 Q4 - Earnings Call Transcript
2025-03-27 02:58
Financial Data and Key Metrics Changes - As of December 31, 2024, cash, cash equivalents, and investment-grade securities increased to approximately $9.3 million from $7.3 million as of December 31, 2023 [35] - Revenue for the year ended December 31, 2024, rose to approximately $3.495 million compared to $2.899 million the previous year, driven by license revenue of $1 million from ProLiant and approximately $890,000 from enzymes [35][36] - Loss from operations decreased to approximately $5.901 million in 2024 from $8.230 million in 2023, while net loss was approximately $5.809 million or $0.20 per share compared to a net loss of $6.795 million or $0.24 per share the previous year [39] Business Line Data and Key Metrics Changes - The company emphasized strong revenue performance from non-pharmaceutical products, particularly in alternative proteins and life sciences, with significant progress in recombinant human serum albumin and transferrin [8][14] - Recombinant human serum albumin is on track for commercial launch in 2025, while recombinant transferrin is showing promising results in initial studies [14][15] - The dairy enzyme portfolio achieved a productivity milestone of $425,000 in 2024, with a commercial launch anticipated in late 2025 [18] Market Data and Key Metrics Changes - The human albumin market is approximately $5.6 billion and is expected to grow at double digits annually, driven by increased vaccine production [106] - The DNase I and DNA ligase market is around $900 million, also growing at nearly double digits per year [106] - The non-animal dairy proteins market is valued at $26 billion, indicating significant opportunities for products like alpha-lactalbumin and lactoferrin [107] Company Strategy and Development Direction - The company is focused on near-term product commercialization and technology licensing, aiming to capitalize on immediate revenue opportunities while building a robust biopharmaceutical pipeline [7][10] - Dyadic is strengthening its global impact through partnerships with various organizations, including CEPI and the Gates Foundation, to enhance the development and adoption of its C1 platform for vaccines and treatments [11][25] - The dual-track strategy involves commercializing non-pharmaceutical products while advancing mid- to long-term opportunities in human and animal health [9][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growing interest in the company's platforms and products, highlighting the potential for significant revenue generation from upcoming commercial launches [50][112] - The company is committed to ensuring high-quality product specifications before market entry, particularly for recombinant products [56] - Management noted that the current environment has shifted focus towards non-pharmaceutical applications to drive revenues sooner, while still pursuing funding opportunities for pharmaceutical developments [117] Other Important Information - The company received a $3 million grant from the Gates Foundation in November 2024 and a $4.5 million grant from CEPI, which will support the development of recombinant protein vaccines [40][26] - Dyadic is actively pursuing additional grant applications to expand the development of its C1 platform across various vaccine and antibody programs [27][29] Q&A Session Summary Question: Can you explain the Gates Foundation and CEPI grants and their significance? - Management confirmed ongoing interest from both organizations and highlighted the importance of these grants in advancing the company's platform and products [45][46] Question: What is the status of albumin commercialization? - Management indicated that progress is being made towards commercialization, with expectations to launch in early 2025 [52][54] Question: Can you clarify the components of research and development revenue? - Management explained that a significant portion of R&D expenses is covered by grants, allowing for profit margins [61] Question: What is the market size opportunity for various products? - Management provided insights into the market sizes for human albumin, DNase I, and non-animal dairy proteins, emphasizing the high-value segments being targeted [106][107] Question: What is the status of the collaboration with Rubicon in South Africa? - Management noted that Rubicon is currently focusing on animal health vaccines, with potential clinical studies expected by the end of the year [119][120]
Dyadic(DYAI) - 2024 Q4 - Annual Results
2025-03-26 20:06
Exhibit 99.1 DYADIC REPORTS 2024 YEAR-END FINANCIAL RESULTS AND BUSINESS UPDATES JUPITER, FL / March 26, 2025 (GLOBAL 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 and for use in non- pharmaceutical applications including food, nutrition, and wellness, today announced its financial results for the full year 2024, hig ...
Dyadic(DYAI) - 2024 Q4 - Annual Report
2025-03-26 20:05
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 ______ ...
Dyadic Reports 2024 Year-End Financial Results and Business Updates
GlobeNewswire· 2025-03-26 20:05
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].
Dyadic Announces Funding Award from CEPI to Use C1 to Accelerate Development of Protein-Based Vaccines
GlobeNewswire· 2025-03-20 12:30
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]
Dyadic to Report 2024 Full Year Financial Results and Host Conference call on Wednesday, March 26, 2025
GlobeNewswire· 2025-03-12 20:00
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]
Dyadic to Attend Multiple Industry Events in March
GlobeNewswire· 2025-03-06 13:30
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].
Dyadic Provides Business Update; Dyadic to Attend the 43rd Annual J.P. Morgan Healthcare Conference
GlobeNewswire· 2025-01-06 13:30
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]
Dyadic Receives $3 Million Grant to Develop Cost-Effective Monoclonal Antibodies for RSV and Malaria Using C1 Platform Technology
GlobeNewswire News Room· 2024-11-21 13:30
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].