Bio-Gene focuses product pipeline on crop protection, public health, and consumer opportunities

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Green peach aphid

Quarterly Activities Report and Appendix 4C

Q2 FY24 Highlights

  • Major review of Bio-Gene product opportunities confirms focus on priority use patterns across crop protection, public health and consumer applications
  • Bio-Gene commits to Flavocide® manufacturing program with large contract toll manufacturer to support regulatory programs and to meet future product demand
  • Scale-up of Qcide® production continues to keep pace with expected demand from commercial collaborations
  • Professor Catherine Hill shares insights into how Bio-Gene’s novel insecticides will help solve global public health challenges from diseases spread by mosquitoes and ticks by overcoming insecticide resistance
  • Bio-Gene appoints Mr Roger McPherson as interim Chief Financial Officer and Company Secretary

Bio-Gene Technology Limited (Bio-Gene or the Company), an agtech company developing and commercialising the next generation of novel insecticides derived from nature, provides this update on activities for the quarter ended 31 December 2023 (Q2 FY2024) and to date, alongside the Company’s Appendix 4C.

Tim Grogan, CEO & Managing Director, Bio-Gene Technology Limited. (ASX:BGT)

Commenting on the Company’s progress over Q2 FY24, CEO & Managing Director, Tim Grogan said:

“This quarter we have focused our pipeline on specific areas where Bio-Gene’s products will have the greatest impact. The world is facing growing challenges of how crop yields can be optimised, how to limit mosquito-borne diseases, and crucially, how to address increasing levels of insecticide resistance. These challenges represent significant opportunities for Bio-Gene.

“Following a comprehensive commercial and technical strategic review, we identified eight clear priority product opportunities for Flavocide® and Qcide® in crop protection, public health and consumer applications.

 “This targeted focus enables us, and our partners STK, Evergreen and Clarke, to take advantage of the market trend towards biological and botanically derived products as large agrochemical companies start to move away from using purely synthetic products.

 “Professor Catherine Hill, a global expert on vector-borne diseases, shared her insights into the impact mosquitos and other vectors have on human health. Annual sales of mosquito insecticides used in public health applications is approximately US$840 million per annum, with the global mosquito control market projected to grow 38% by 2026. Bio-Gene is well placed to take advantage of this market as our naturally-derived technology effectively controls pests with low toxicity to humans and the environment.”

 Focussing on eight product pipeline opportunities

During the quarter, Bio-Gene undertook a detailed strategic review of the company’s extensive data base of product and market related information, and patent portfolio. Consideration of where to focus our resources and effort was based on key commercial and technical factors such as product efficacy, market size and location, existing commercial arrangements, the nature and scale of the unmet market need, IP coverage, product competitiveness, regulatory requirements, and time to market. The review identified eight initial product opportunities across crop protection, public health and consumer applications as high priority to bring Bio-Gene products to market.

  • Crop protection: (1) grain protectant
  • Public health: (2) outdoor space spray, (3) indoor barrier spray, (4) outdoor barrier spray, (5) indoor space spray
  • Consumer applications: (6) indoor space spray, (7) outdoor barrier spray, (8) outdoor garden spray

Competitive assessment of Bio-Gene’s product pipeline will be an ongoing process and attractive new opportunities may be added in future.

R&D projects

Flavocide scale-up program: During the quarter Bio-Gene commenced working with a large contract manufacturer in India for the custom scale-up of Flavocide synthesis. The purpose of this work is to produce pilot-scale batches of GLP (Good Laboratory Practices) standard Flavocide for use in key toxicology and other studies. These are required to support the registration application for Flavocide in Australia and other jurisdictions. This scale-up program also adds to Bio-Gene’s future capacity to supply high quality technical grade Flavocide to commercial partners on a cost competitive basis.

Qcide production and tree improvement programs: Bio-Gene has continued to invest in scaling both tree and oil production. Bio-Gene has renewed an agreement with James Cook University to provide engineering input into developing scalable processes and is working with commercial operators to support tree and seed production programs. The Development and License Agreement with STK and arrangements with other commercial partners provide the commercial basis to expand Qcide area and production.

CDC program: Work commenced on the US$10 million US Center for Disease Control (CDC) funded vector control program targeting the tick vector of Lyme disease, a significant health challenge in the USA. Bio-Gene is working with Purdue University to test Flavocide and Qcide for tick control. Efficacy studies produced results that met USEPA standards, enabling the program to move to small cage and semi-field trials to further evaluate residual efficacy in real-life conditions.

Commercial partnership updates

STK: Bio-Gene is working closely with STK’s regulatory experts on the registration pathway for Qcide, with product testing and registration-related activities on-track. STK is undertaking an extensive testing program to develop a comprehensive data package to support registration of Qcide as an active ingredient in Australia, USA and other countries targeted for commercialisation for pest control in both crop and non-crop applications.

Clarke: Bio-Gene has recently expanded programs to develop formulations to optimise performance for mosquito control. This includes programs with specialist contract research organisations targeting the surface residual barrier spray application use pattern for mosquito control.

Evergreen: Bio-Gene’s work with Evergreen Garden Care continues in Europe and Australia involving field testing of Bio-Gene products targeting home and garden pests. Potential new trials in Australia are being examined as part of the opportunity for consumer applications for both Flavocide and Qcide.

Additional commercial opportunities: Bio-Gene continues to engage significant global players to expand additional product opportunities for Bio-Gene’s products. Over 2QFY24, these testing programs have progressed, positively expanding the potential pipeline for additional commercial development opportunities in both crop, non-crop and public health applications.

Professor Catherine Hill webinar

Professor Catherine Hill, Head of the Department of Entomology at Purdue University in the United States, participated in a webinar hosted by Bio-Gene where she shared insights on the global challenges relating to mosquitoes and ticks, the increasing resistance to current insecticides and the threat this poses to human health from diseases such as malaria and Lyme disease. Dr Hill highlighted the benefits of Bio-Gene’s naturally derived insecticides with a novel mode of action to overcome insecticide resistance, and referenced the partnership between Bio-Gene and Purdue in evaluating Flavocide and Qcide against ticks as part of a national program funded by the US Centre for Disease Control targeting Lyme disease.

Patent update

During the quarter several patents relating to the use of Flavocide were granted, strengthening Bio-Gene’s IP platform:

  • Australia AU 2021232737 – Flavocide use against insects and arachnid pests when used in combination with another pesticide;
  • New Zealand NZ 760403 – Flavocide use against resistant pests; and
  • Japan JP 7374921 – Flavocide use against certain aphid species.

Bio-Gene remains committed to applying for patents and plant breeder’s rights (for superior tree lines to support Qcide production) and building an extensive body of knowhow relating to the use, manufacture, registration and formulation of Flavocide and Qcide.

Financial update

As at 31 December 2023, Bio-Gene held $3.12m in cash, a $255k decrease over the quarter (30 September 2023 cash $3.5m). The cash position this quarter was supported by a further $549k received in respect of the successful $2.0 million capital raise, with $1.5m receipt received via the Placement in the first quarter. The additional $400k raised as part of the Placement and the $144.5k raised via the Share Purchase Plan were received in the current quarter.

Cash flows from operating activities was $747k with funds being used on:

  • R&D ($423)k;
  • Commercialisation expenses ($82)k;
  • Intellectual property expenses ($64)k; and
  • Administration and corporate costs ($226)k, mainly insurance premiums.

On 19 January 2024, the Company announced it had received the R&D Tax Incentive from the Australian government of $504,000 which is not included in the December 2023 cash balance.

Management update

In November, Mr Roger McPherson was appointed interim Chief Financial Officer and Company Secretary, replacing Mr Rodrigo Valencia.

Outlook

The company has provided the base line which will enable cost effective and faster pre-registration manufacturing and safety studies into various formulations for Flavocide and Qcide. In addition, Bio-Gene will continue to develop the most commercially attractive products for partnered programs (both as stand-alone and combination products).

Approved for release by the Board of Directors.

 

 

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