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Dyadic Receives $3 Million Grant to Develop Cost-Effective Monoclonal Antibodies for RSV and Malaria Using C1 Platform Technology

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Dyadic International (NASDAQ: DYAI) has received a $3 million grant from the Gates Foundation to develop cost-effective monoclonal antibodies (mAbs) for RSV and malaria using its C1 platform technology. The initiative aims to provide affordable therapeutics for underserved populations, particularly in low-income and middle-income countries (LMICs). RSV causes 3.2-36 million hospitalizations and over 100,000 deaths annually, while malaria affected 249 million cases and caused 608,000 deaths globally in 2022. The C1 platform is designed to accelerate development, reduce production costs, and improve scalability of biologic vaccines and therapeutics. Dyadic plans to commercialize successful antibodies through licensure to expand access to affordable treatment options globally.

Dyadic International (NASDAQ: DYAI) ha ricevuto un contributo di 3 milioni di dollari dalla Fondazione Gates per sviluppare anticorpi monoclonali (mAbs) economici per l'RSV e la malaria utilizzando la sua tecnologia di piattaforma C1. L'iniziativa mira a fornire terapie accessibili per le popolazioni svantaggiate, in particolare nei paesi a basso e medio reddito (LMIC). L'RSV causa annualmente da 3,2 a 36 milioni di ospedalizzazioni e oltre 100.000 decessi, mentre la malaria ha colpito 249 milioni di casi e causato 608.000 morti a livello globale nel 2022. La piattaforma C1 è progettata per accelerare lo sviluppo, ridurre i costi di produzione e migliorare la scalabilità dei vaccini e delle terapie biologiche. Dyadic prevede di commercializzare anticorpi di successo attraverso licenze per ampliare l'accesso a opzioni di trattamento economico a livello globale.

Dyadic International (NASDAQ: DYAI) ha recibido una de la Fundación Gates para desarrollar anticuerpos monoclonales (mAbs) rentables para el RSV y la malaria utilizando su tecnología de plataforma C1. La iniciativa tiene como objetivo proporcionar terapias asequibles para poblaciones desatendidas, particularmente en países de ingresos bajos y medianos (LMIC). El RSV causa entre 3.2 y 36 millones de hospitalizaciones y más de 100,000 muertes anuales, mientras que la malaria afectó a 249 millones de casos y causó 608,000 muertes a nivel mundial en 2022. La plataforma C1 está diseñada para acelerar el desarrollo, reducir los costos de producción y mejorar la escalabilidad de las vacunas y terapias biológicas. Dyadic planea comercializar anticuerpos exitosos a través de licencias para expandir el acceso a opciones de tratamiento asequibles a nivel mundial.

다이아딕 인터내셔널(Dyadic International)(NASDAQ: DYAI)은 게이츠 재단(Gates Foundation)으로부터 300만 달러의 보조금을 받아 C1 플랫폼 기술을 사용하여 RSV 및 말라리아용 비용 효율적인 단클론 항체(mAbs)를 개발하고 있습니다. 이 이니셔티브는 저소득 및 중간 소득 국가(LMIC)에 있는 underserved 인구를 위해 저렴한 치료제를 제공하는 것을 목표로 합니다. RSV는 매년 320만에서 3600만 건의 입원 환자와 10만 건 이상의 사망을 초래하며, 2022년에는 말라리아가 2억 4900만 건의 사례를 초래하고 전 세계적으로 60만 8000명의 사망을 초래했습니다. C1 플랫폼은 생물학적 백신 및 치료제의 개발을 가속화하고 생산 비용을 줄이며 확장을 개선하도록 설계되었습니다. 다이아딕은 성공적인 항체를 상용화하여 전 세계적으로 저렴한 치료 옵션에 대한 접근을 확대할 계획입니다.

Dyadic International (NASDAQ: DYAI) a reçu une subvention de 3 millions de dollars de la Fondation Gates pour développer des anticorps monoclonaux (mAbs) rentables pour le RSV et le paludisme en utilisant sa technologie de plateforme C1. L'initiative vise à fournir des thérapies abordables aux populations défavorisées, en particulier dans les pays à revenu faible et intermédiaire (LMIC). Le RSV entraîne entre 3,2 et 36 millions d'hospitalisations et plus de 100 000 décès chaque année, tandis que le paludisme a touché 249 millions de cas et causé 608 000 décès dans le monde en 2022. La plateforme C1 est conçue pour accélérer le développement, réduire les coûts de production et améliorer la scalabilité des vaccins et des thérapies biologiques. Dyadic prévoit de commercialiser des anticorps réussis par le biais de licences pour étendre l'accès à des options de traitement abordables à l'échelle mondiale.

Dyadic International (NASDAQ: DYAI) hat einen Zuschuss in Höhe von 3 Millionen Dollar von der Gates-Stiftung erhalten, um kosteneffiziente monoklonale Antikörper (mAbs) gegen RSV und Malaria mit seiner C1-Plattformtechnologie zu entwickeln. Die Initiative zielt darauf ab, erschwingliche Therapien für unterversorgte Bevölkerungsgruppen bereitzustellen, insbesondere in einkommensschwachen und einkommensmittleren Ländern (LMIC). RSV verursacht jährlich 3,2 bis 36 Millionen Krankenhausaufenthalte und über 100.000 Todesfälle, während Malaria im Jahr 2022 249 Millionen Fälle und 608.000 Todesfälle weltweit verursachte. Die C1-Plattform ist darauf ausgelegt, die Entwicklung zu beschleunigen, die Produktionskosten zu senken und die Skalierbarkeit von biologischen Impfstoffen und Therapien zu verbessern. Dyadic plant, erfolgreiche Antikörper über Lizenzen zu kommerzialisieren, um den Zugang zu erschwinglichen Behandlungsoptionen weltweit zu erweitern.

Positive
  • Secured $3 million grant funding from Gates Foundation
  • Potential market expansion into RSV and malaria therapeutics
  • Development of cost-effective manufacturing process for mAbs
Negative
  • None.

Insights

The $3 million Gates Foundation grant marks a significant milestone for Dyadic's C1 platform development. The focus on RSV and malaria therapeutics addresses massive market opportunities, with RSV causing millions of hospitalizations annually and malaria affecting 249 million cases globally. The C1 platform's potential to reduce production costs of monoclonal antibodies could be transformative for both the company and global healthcare accessibility.

The platform's versatility and existing collaborations with major pharmaceutical companies provide multiple paths to commercialization. However, investors should note that success depends on clinical validation and regulatory approvals. While the grant provides important validation and non-dilutive funding, the $42.4 million market cap suggests the market is still cautious about execution risks and timeline to commercialization.

This development could significantly disrupt the mAb manufacturing landscape. Current monoclonal antibody production costs are prohibitively expensive for LMICs, creating a massive untapped market. The C1 platform's potential for cost reduction in manufacturing could open access to a market of billions of potential patients, particularly in the WHO African Region which accounts for 94% of malaria cases.

The Gates Foundation's involvement provides not just funding but also valuable networks and expertise in global health markets. The focus on RSV and malaria demonstrates strategic targeting of high-impact diseases with significant unmet needs in developing markets, potentially creating new revenue streams while addressing critical healthcare gaps.

Grant Received from the Bill & Melinda Gates Foundation to Fund Development of Affordable Therapeutics

JUPITER, Fla., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (NASDAQ: DYAI), a global biotechnology company, announced today that it has been awarded a $3 million grant from the Gates Foundation for the cell line development of monoclonal antibodies (mAbs) targeting respiratory syncytial virus (RSV) and malaria utilizing the company’s proprietary C1 protein production platform to provide globally accessible treatment options for underserved populations.

RSV is a major cause of lower respiratory tract infection morbidity and mortality in children globally, causing 3.2–36 million hospitalizations and more than 100,000 deaths annually, 99% of which occur in low-income and middle-income countries (LMICs). In 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths globally, with the WHO African Region accounting for 94% of cases and 95% of deaths.

“Thanks to this new grant from the Gates Foundation, we are advancing our C1 platform to develop affordable therapeutics, addressing RSV, malaria, and promoting global health equity," said Mark Emalfarb, Founder and CEO of Dyadic. "We believe C1's increased efficiency and cost-effectiveness can expand access to therapeutics and vaccines for populations impacted by health disparities.”

Despite the potential of monoclonal antibodies to treat and protect against infectious diseases like RSV and malaria, they’re expensive to produce and remain out of reach for many of the world’s most vulnerable people. Innovation in the manufacturing of monoclonal antibodies can help reduce costs and make these therapeutics more accessible and affordable in LMICs.

This grant will support the enhancement of the C1 platform, to enable rapid, cost-effective production of high-quality monoclonal antibodies (mAbs) to improve global access to critical treatments. Focusing on RSV and malaria, diseases that disproportionately impact LMICs, this initiative aims to deliver affordable, effective therapeutic solutions and help address urgent global health challenges.

The versatile C1-cell protein production platform is based on an industrially proven microorganism (C1) designed to accelerate development, reduce production costs, and improve the scalability and performance of biologic vaccines and therapeutics for both human and animal health markets. Currently, the C1 platform is being utilized in collaborations with leading pharmaceutical, biotech, academic, and government organizations to develop innovative vaccines and treatments. If these research efforts succeed, Dyadic plans to commercialize these and other antibodies through licensure, expanding access to affordable treatment options for patients worldwide and reducing the global burden of infectious diseases.

About Dyadic International, Inc.

Dyadic International, Inc., is 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.

Dyadic’s gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). Our lead platform, C1-cell protein production platform, is based on an industrially proven microorganism (named C1), which is currently used to speed development, lower production costs, and potentially improve performance of biologic vaccines and drugs at flexible commercial scales for the human and animal health markets. Dyadic has also developed the Dapibus™ filamentous fungal based microbial protein production platform to enable the rapid development and large-scale manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.

Dyadic is focusing on leveraging its microbial platform technologies for itself and its collaborators in a wide range of applications, including human and animal vaccines, therapeutics, food, nutrition, wellness, and internal biological products.

For more information about Dyadic International, visit www.dyadic.com.

Safe Harbor Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of our clinical trial and interest in our protein production platforms, our research projects and third-party collaborations, as well as the availability of necessary funding. Actual events or results may differ materially from those in the forward-looking statements because of various important factors, including those described in the Company’s most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether because of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com.

Contact:
Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: ir@dyadic.com


FAQ

What is the value of the Gates Foundation grant received by Dyadic (DYAI)?

Dyadic (DYAI) received a $3 million grant from the Gates Foundation to develop cost-effective monoclonal antibodies for RSV and malaria using their C1 platform technology.

What diseases will Dyadic (DYAI) target with the Gates Foundation grant?

Dyadic (DYAI) will target respiratory syncytial virus (RSV) and malaria, focusing on developing affordable monoclonal antibodies for these diseases that significantly impact low-income and middle-income countries.

How will Dyadic (DYAI) commercialize the antibodies developed through this grant?

Dyadic (DYAI) plans to commercialize successful antibodies through licensure to expand access to affordable treatment options for patients worldwide.

Dyadic International, Inc.

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