Dyadic’s C1-Produced RSV and Malaria Antibodies Advance into Animal Studies Following Positive Independent Evaluations

Development-stage production reached approximately 12.1 g/L for the RSV antibody and 13.2 g/L for the malaria antibody.

Rhea-AI Summary

Dyadic International (DYAI) announced that Gates Medical Research Institute initiated animal studies of its C1-produced RSV and malaria antibodies on October 20, 2026. The studies compare RSM01 for respiratory syncytial virus (RSV) and MAM01 for malaria with versions produced using mammalian cells (CHO). Four groups of mice will assess pharmacokinetics, or how the antibodies move through the body. Results are expected in the first quarter of 2027.

The studies follow independent binding evaluations of both antibodies and neutralization testing of RSM01. Under its Gates Foundation-funded program, Dyadic achieved development-stage yields of approximately 12.1 g/L for RSM01 and 13.2 g/L for MAM01 in seven-day fermentation runs. Positive animal results could support further development.

Positive

• Minor pointAnimal studies initiated October 20, 2026 advance comparisons of C1-produced RSV and malaria antibodies with CHO-produced counterparts.
• Minor pointIndependent evaluations covered binding for both antibodies and neutralization testing for RSM01.
• Minor pointRSM01 production yield reached approximately 12.1 g/L in seven-day fermentation runs under the Gates Foundation-funded program.
• Minor pointMAM01 production yield reached approximately 13.2 g/L in seven-day fermentation runs under the Gates Foundation-funded program.
• Minor point. Forward-looking: it has not happened yet and may not happen.Animal-study results are expected in the first quarter of 2027.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Further development support depends on positive animal-study outcomes; those results are not yet available.

Key Figures

Study groups: 4 groups of mice RSV antibody production yield: approximately 12.1 g/L Malaria antibody production yield: 13.2 g/L +1 more

Study groups

4 groups of mice

Preclinical comparisons of C1-produced and CHO-produced antibodies

RSV antibody production yield

approximately 12.1 g/L

RSM01; seven-day fermentation run

Malaria antibody production yield

13.2 g/L

MAM01; seven-day fermentation run

Expected study results

First quarter of 2027

Results from the newly initiated animal studies

Key Terms

pharmacokinetics, gmp, glycosylation

3 terms

pharmacokinetics medical

"evaluating the pharmacokinetics of a C1-produced RSV antibody"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

gmp regulatory

"against GMP CHO-produced versions of each mAb"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

glycosylation technical

"targeted human-like glycosylation profiles"

An enzymatic process that attaches sugar chains (oligosaccharides) to proteins or lipids inside cells, usually during or after protein synthesis. Glycosylation most commonly occurs in the endoplasmic reticulum and Golgi apparatus and includes major types such as N-linked (to an asparagine residue) and O-linked (to serine or threonine); it influences a molecule’s folding, stability, location, and interactions. Distinct from non‑enzymatic 'glycation,' glycosylation is a controlled, enzyme-driven modification whose specific pattern can alter a biologic drug’s behavior or a cell-surface protein’s function.

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Preclinical Studies Will Compare C1-Produced Antibodies to Their CHO-Produced Counterparts

JUPITER, Fla., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic” or the “Company”) (NASDAQ: DYAI), operating as Dyadic Applied BioSolutions, today announced that the Gates Medical Research Institute has initiated preclinical animal studies comparing monoclonal antibodies (mAbs) against respiratory syncytial virus (RSV) and malaria, produced using Dyadic’s proprietary C1 protein production platform, with their respective mammalian-cell (CHO)-produced counterparts.

The studies include four distinct groups of mice, evaluating the pharmacokinetics of a C1-produced RSV antibody, RSM01, and a C1-produced malaria antibody, MAM01, against GMP CHO-produced versions of each mAb.

The studies represent an important preclinical advancement in evaluating C1 as a potentially faster, lower-cost, and more scalable alternative to conventional mammalian-cell manufacturing of therapeutic antibodies.

RSV is a major cause of lower respiratory tract disease in children worldwide. Malaria also remains a significant cause of morbidity and mortality, with the greatest burden occurring in sub-Saharan Africa. Dyadic is pursuing this work in the context of potential future applications in low- and middle-income countries (LMICs), where access to biologic medicines may be constrained by manufacturing complexity, cost and healthcare infrastructure.

The studies follow independent laboratory evaluations of antibodies produced using Dyadic’s C1 platform. Duke University conducted binding studies of both C1-produced RSM01 (RSV) and MAM01 (malaria), while IQVIA conducted neutralization testing of C1-produced RSM01. The newly initiated animal studies will evaluate the pharmacokinetics of C1-produced RSV and malaria antibodies through direct comparisons with their respective CHO-produced counterparts and aim to generate additional preclinical data to support their continued advancement toward potential clinical development.

Under its Gates Foundation-funded program, Dyadic achieved production yields of approximately 12.1 g/L for RSV antibody RSM01 and 13.2 g/L for malaria antibody MAM01 in seven-day fermentation runs. These development-stage results, combined with C1’s ability to produce antibodies with targeted human-like glycosylation profiles, highlight the platform’s potential to manufacture complex biologics efficiently while reducing production costs and increasing manufacturing flexibility.

“This represents an important milestone in demonstrating the broader commercial potential of our C1 platform,” said Mark Emalfarb, Founder and Chief Executive Officer of Dyadic. “The combination of strong productivity, targeted human-like glycosylation and independent laboratory evaluations supports our continued development of C1 as a potentially competitive alternative to traditional mammalian-cell manufacturing. Importantly, advancing these antibodies into animal studies provides another opportunity to evaluate the platform’s capabilities as we work toward making biologics more accessible and affordable worldwide.”

Beyond the RSV and malaria programs, Dyadic believes these results have broader implications for the manufacturing of monoclonal antibodies and other complex therapeutic proteins. Conventional CHO-based manufacturing requires substantial capital investment and operating costs, which can limit the affordability and availability of biologic medicines.

Dyadic’s C1 platform is designed to address these challenges by combining high protein productivity, accelerated development and manufacturing timelines, and scalable, cost-efficient fermentation processes, with the potential to significantly reduce manufacturing costs, expand production capacity, and improve global access to a broad range of biologic medicines.

The animal studies, initiated October 20, 2026, are expected to generate results in the first quarter of 2027. Positive outcomes could support further development of these antibodies and provide additional validation of C1’s potential for broader applications in biologics manufacturing.

About Dyadic Applied BioSolutions

Dyadic Applied BioSolutions is a global biotechnology company that uses its proprietary microbial platforms to produce recombinant proteins that are sold or licensed to partners across the life sciences, food and nutrition, and bio-industrial markets. These high-quality proteins are designed to enable customers to develop more efficient, scalable, and sustainable products. Dyadic’s C1 and Dapibus™ expression systems support flexible, cost-effective manufacturing, and are the foundation of a growing portfolio of commercial and partnered programs.

For more information about Dyadic, please 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 and Section 21E of the Exchange Act, including those regarding Dyadic’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of Dyadic’s clinical trial and interest in its protein production platforms, Dyadic’s research projects and third-party collaborations, as well as the availability of necessary funding. Forward-looking statements involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the following: (i) Dyadic’s history of net losses; (ii) market and regulatory acceptance of Dyadic’s microbial protein production platforms and other technologies; (iii) failure to commercialize Dyadic’s microbial protein production platforms or its other technologies; (iv) competition, including from alternative technologies; (v) the results of nonclinical studies and clinical trials; (vi) Dyadic’s capital needs; (vii) changes in global economic and financial conditions; (viii) Dyadic’s reliance on information technology; (ix) Dyadic’s dependence on third parties; (x) government regulations and environmental, social and governance issues; (xi) intellectual property risks; and (xii) Dyadic’s ability to comply with the listing standards of the Nasdaq Stock Market LLC. For a more complete description of the risks that could cause Dyadic’s actual results to differ from its 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. All forward-looking statements speak only as of the date made, and except as required by applicable law, Dyadic assumes no obligation to publicly update any such forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in Dyadic’s expectations.

Contacts

Dyadic Applied BioSolutions
Ping Rawson
Chief Financial Officer
ir@dyadic.com
(561) 743-8333

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What are Dyadic's C1 antibody animal studies testing, and when are results expected?

The studies compare C1-produced RSV antibody RSM01 and malaria antibody MAM01 with their respective CHO-produced counterparts, with results expected in the first quarter of 2027. Four groups of mice will evaluate pharmacokinetics, meaning how the antibodies move through the body.

Which independent laboratories evaluated Dyadic's C1-produced antibodies?

Duke University conducted binding studies of C1-produced RSM01 and MAM01, while IQVIA conducted neutralization testing of C1-produced RSM01. These evaluations preceded the newly initiated animal studies.