Bio-Gene Technology Q3 FY24 Activities Report

Bio-Gene Technology Limited (ASX: $BGT) has reported strong progress against its strategic priorities for the quarter ended 31 March 2024. The company's scale-up synthesis and planned regulatory-enabling studies with Flavocide remain on track, with the milestone of filing the registration dossier with the APVMA planned for Q4 CY25. Pilot scale production of Flavocide has commenced, and additional opportunities to reduce the estimated commercial cost of manufacture have been identified. The company also made significant advancements in formulation development activities aligned with its product pipeline in crop protection, public health, and consumer applications. Furthermore, Bio-Gene received an R&D tax incentive of $504,000 and appointed Mr Edmond Tern as the Chief Financial Officer and Company Secretary.

Tim Grogan, Bio-Gene's Managing Director & CEO, on Q3 FY24 Progress

I am very pleased with the strong progress made during Q3 in accordance with our four strategic priorities. These are the timely filing of our Flavocide regulatory dossier with the Australian regulator, focused development of our product pipeline, further commercial validation to support the development and launch of products containing Flavocide and Qcide, and the efficient use of our shareholder capital. The scale-up synthesis of Flavocide AI and the required safety studies to include in our application to obtain regulatory approval for use of Flavocide AI initially in Australia are on track. Subject to external factors, the key milestone of filing our dossier with the Australian regulator is currently planned to take place in Q4 CY25. Our critical success factors include the generation of products supported by a strong data package, building a unique IP portfolio, creating multiple strong commercial partnerships for market access, our ability to manufacture Flavocide and Qcide cost-effectively and at scale, and access to capital required to achieve our development milestones ahead of post-launch royalties from our partners.

Bio-Gene's Outlook and Achievements

Bio-Gene Technology has made significant strides in its strategic priorities, particularly in the scale-up synthesis and regulatory-enabling studies for Flavocide. The company is on track to file the registration dossier with the APVMA in Q4 CY25, marking a transformative milestone for Flavocide AI and for Bio-Gene. Additionally, Bio-Gene has focused on formulation development activities aligned with its product pipeline in crop protection, public health, and consumer applications. The company's ambitions include securing additional and expanded commercial partnerships, further external validation, and funding from partnerships. With a strong cash position and the appointment of Mr Edmond Tern as the Chief Financial Officer and Company Secretary, Bio-Gene is well positioned to execute its Flavocide regulatory strategy and secure commercial partnerships for its innovative products.