Bio-Gene Advances Flavocide Registration and Secures Japan Deal for Qcide

Flavocide Regulatory Milestones on Track

Bio-Gene Technology Limited (ASX:BGT) is steadily advancing the regulatory dossier for its novel bio-insecticide Flavocide, aiming for a first Australian Pesticides & Veterinary Medicines Authority (APVMA) registration submission in March 2027. Two pivotal toxicology studies, the rat acute neurotoxicity study (OECD 424) and the extended one-generation reproductive toxicity study (OECD 443), are underway, with preliminary reports expected in the coming months. These studies are crucial for establishing Flavocide’s safety profile and supporting global regulatory acceptance under the OECD’s Mutual Acceptance of Data framework.

The OECD 443 study, designed to evaluate reproductive and developmental effects, is expected to complete its in-life phase by July 2026, with a preliminary report due in September. Meanwhile, the OECD 424 neurotoxicity study is scheduled to conclude its in-life phase by April 2026, with initial results anticipated in May. These data will underpin Bio-Gene’s registration dossier, initially targeting professional and domestic insecticide markets in Australia, with plans to follow in the US and other major jurisdictions.

Strategic Partnership Targets Japan’s $1 Billion Household Pest Market

In a significant commercial development, Bio-Gene has signed a non-binding term sheet with Sumitomo Corporation and Nakashima Trading Co. to develop and market Qcide® insecticide products in Japan. The deal targets a late 2026 launch into Japan’s US$1 billion household nuisance insect pest market, which is seeing growing consumer demand for safer, natural pest control alternatives. Under the agreement, Bio-Gene will supply Qcide oil produced at its Queensland plantation, while Sumitomo and Nakashima will manage import logistics, formulation, and retail distribution through home improvement centres, pharmacies, supermarkets, and e-commerce channels.

This partnership builds on the company’s earlier announcement of the term sheet in March 2026, reflecting Bio-Gene’s strategic push to commercialise Qcide internationally. The move taps into a rapidly expanding market segment where natural insecticides are gaining traction against synthetic incumbents. The definitive binding agreements are expected by May 2026, setting the stage for Bio-Gene’s first major overseas product launch. This follows the company’s recent Bio-Gene Teams with Sumitomo and Nakashima to Launch Natural Insecticide in Japan announcement outlining the partnership details.

Qcide Production Scaling and Plantation Expansion

Operationally, Bio-Gene completed its 15th harvest of Qcide oil at its far north Queensland plantation during Q3 FY26. The harvest confirmed consistent oil quality under standardised processing, while ongoing optimisation of extraction techniques aims to maximise yield and reduce costs ahead of commercial scale-up. The company’s tree improvement program is delivering superior biomass, with newly planted areas expected to be ready for initial harvest in Spring 2026. Seed production has also advanced, supporting plans to expand plantation acreage to meet anticipated market demand from the Japan partnership and other future customers.

Financial Position and Leadership Update

Bio-Gene reported a net operating cash outflow of A$407,000 for the quarter, with cash and cash equivalents standing at A$674,000 as at 31 March 2026. The company’s cash runway is estimated at approximately 1.66 quarters at the current burn rate. To address this, Bio-Gene is in advanced planning for a capital raise, which it believes will be successful based on ongoing discussions with advisors. This financing is critical to support the completion of regulatory studies, commercialisation activities, and operational expansion.

On the leadership front, Bio-Gene appointed Drew Speedy as Chief Financial Officer and Company Secretary during the quarter. Mr Speedy brings over 20 years of senior finance and governance experience, including roles with ASX-listed companies, which should bolster the company’s financial management as it approaches key commercial milestones.