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BIO-GENE TECHNOLOGY LTD — AGM Information 2022
Nov 17, 2022
64521_rns_2022-11-17_49292884-1f1d-4103-ac2f-811611c3281a.pdf
AGM Information
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E N A B L I N G T H E N E X T G E N E R A T I O N O F N O V E L I N S E C T I C I D E S
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BIO-GENE TECHNOLOGY LIMITED
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1 8 N O V E M B E R 2 0 2 2 Annual General Meeting P R E S E N T E D B Y Robert Klupacs N O N - E X E C U T I V E C H A I R M A N Richard Jagger
C E O
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DISCLAIMER
This presentation has been prepared by Bio-Gene Technology Limited (ASX:BGT) (the Company). This presentation is not, and should not be considered, an offer or invitation to apply for or purchase securities in the Company or as a recommendation or inducement to make an offer or invitation in respect of securities in the Company. No agreement to subscribe for securities will be entered into on the basis of this presentation or any information contained in this presentation.
This presentation is not a prospectus, product disclosure document or other offering document under Australian law or under the law of another jurisdiction. This presentation is provided for general information purposes only and is selective, does not purport to contain all relevant information and has not been independently verified.
Neither the Company nor its advisors have any responsibility or obligation to inform any recipient of any matter arising or coming to their notice after the date of this presentation, which may affect any matter referred to in the presentation. The Company releases material information as announcements to the ASX (ASX:BGT). Recipients seeking further information in respect of the Company should review the Company’s announcements as released to ASX from time to time.
Nothing in this presentation constitutes investment, legal, tax, accounting or other advice. The recipient should consider its own financial situation, objectives and needs and conduct its own independent investigation and assessment, including obtaining investment, legal, tax, accounting or other advice as it considers necessary or appropriate.
The distribution of this presentation (including electronic copies) outside Australia may be restricted by law and persons who come into possession of this presentation outside Australia should seek advice on and observe any such restrictions. Any failure to comply with such restrictions may constitution a violation of applicable securities laws.
This presentation may contain statements relating to intentions, future acts and events (Forward Looking Statements). Forward Looking Statements involve subjective judgment and analysis, known and unknown risks, uncertainties and other important factors that cause those future acts, events and circumstances to differ from the way or manner in which they are expressly or impliedly portrayed. no representation, warranty or guarantee, express or implied, is given that any Forward Looking Statements will be achieved or proven correct, or that any assumptions or projections on which the Forward Looking Statements are based are reasonable.
No financial information (unless also contained in financial reports released to ASX), estimates or projections contained in this presentation or as derived from such financial information, estimates or projections can be relied upon as a promise or representation as to any present or future matter.
To the maximum extent permitted by law, neither the Company nor any of its associates, directors, officers, employees, advisors or representatives make any representation or provide any warranty, express or implied, as to the accuracy, reliability or completeness of the information contained in this presentation or any subsequent information provided to the recipient including, but not limited to, any financial projections, estimates or other historical information.
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OUR STRATEGIC OBJECTIVE
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Generate multiple revenue streams from technology licensing fees, milestone payments and royalties by
Securing & owning active ingredient product registrations
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Working with strong commercial partners on product development; marketing and distribution
Developing proprietary manufacturing and production know-how
Potential partnership agreements across multiple geographies and different end-use markets, with collaboration programs now underway in two of our target segments
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IMPORTANT POSITIVE PROGRESS OVER THE PAST 12 MONTHS
Significant improvements for Qcide and Flavocide production
Completion of Clarke commercial Agreement Additional MTAs signed with global companies to undertake preliminary analysis of our products Share Placement completed Appointment of Head of Regulatory Affairs Strategic placement to new shareholder Positive results for Stage 3 of the stored grain program
Registration review process with commercial partners and biochemical classification submission to US EPA Patent allowances granted in the U.S. (April), with further Additional efficacy data applications in other major (Purdue ) to support new patent applications commercial markets
Initiation of Plant Breeder’s rights program for Qcide International audit of toll manufacturers for Flavocide
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Nov 2021 to Nov2022
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PUBLIC HEALTH: COMMERCIAL AGREEMENT SIGNED ON CLARKE MOSQUITO PROJECT
Clarke is the largest vertically integrated company in public health mosquito control
Market Opportunity
Results of Phase 2 Testing
Very positive results indicate the suitability of Bio-Gene products as mosquito control technology
Commercial Development Agreement Signed
Development of novel formulations
Next Steps
Clarke undertaking Phase 3 trials (somewhat weather dependent) using new formulations
Initial Field of Use: US$100m[1]
Global market $650m[1]
Target formulations identified for progression to Phase 3 field trials Confidence for both companies to move forward with commercial negotiations as per the Option agreement
Phase 3 field testing
Agreement is for the U.S. market
Cost of studies borne by Clarke, with shared report of results
Field studies designed to confirm suitability of laboratory developed formulations for field use & EPA registration
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1 Global Mosquito Control Market, Research Report 2020, Forecast to 2026
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CONSUMER PRODUCTS: EVERGREEN COMMERCIAL DEVELOPMENT AGREEMENT
Evergreen is a market leader in consumer products across Europe and in Australia/New Zealand
Market Opportunity
Initial Field of Use
Fly & mosquito electric evaporator Ant bait gel and ant spray
ROFR to negotiate additional applications within consumer market
Initial Territory
E.U., U.K., A/NZ
ROFR to negotiate additional territories within consumer market
Revenue Model
Up-front licence fee
Milestone payments prior to registration
On-going royalties on end-use product sales
Development costs borne by Evergreen
Initial Field of Use: US$600m[1]
Total European consumer insecticide market: US$2b[1]
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- Research and Markets report, December 2019: Europe Household Insecticides Market to 2027 - Regional Analysis and Forecasts By Insect Type; Composition; Packaging; Distribution Channel .
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CROP PROTECTION: UPDATE ON STORED GRAIN PROJECT
Grains Research and Development Corporation (GRDC) Department of Agriculture and Fisheries - Queensland (DAF)
Results of Phase 3 testing
Further Discussions
Data show the ability for Flavocide, when used in combination (at low rates) to control the full range of stored grain pests over 9 months for susceptible strains and 3-9 months for resistant strains (commercially acceptable time frame).
Bio-Gene is discussing next steps with potential partners to progress the commercial development of Flavocide as a stored grain protectant
Next we will discuss support from the GRDC
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Field testing completed Nov/Dec 2021
Final reporting on these results March 2022
Positive outcome allows us to move forward
Market opportunity in Australia is relatively small, but there is significant global potential (A$1b)[1]
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1 Market and markets report – grain protectants global market forecast to 2023
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IMPORTANT PROGRESS - COMMERCIAL
Other commercial discussions
Additional MTAs
Efficacy testing
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Recent visit to Europe
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Meetings with existing and new companies for product evaluation & commercial discussions
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Valuable to have the opportunity to conduct face to face meetings and develop relationships.
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Opportunities exist for further commercial development over the coming months as well as new relationships into 2023
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On-going process of adding new companies under MTAs to undertake formal testing program. Additional MTAs signed after recent Europe visit
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Studies performed by these companies ultimately give Bio-Gene additional options for going to market
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Additional studies underway for specific evaluation of technology
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Animal Health
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Consumer
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Crop Protection
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Public Health
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Extension work to identify additional key targets and applications to support our commercial discussions and further develop our I.P. portfolio
Continuing to develop our commercial relationships will ultimately provide further market access & revenue opportunities for Bio-Gene
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IMPORTANT PROGRESS ACROSS OTHER KEY AREAS
Patents
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Patent allowance in the United States
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1 additional recently submitted in Australia (Qcide)
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Applications under review in other key markets
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Other data collated for new submissions
Other I.P. Developments
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Recent research completed has the potential to identify new I.P. (patent) for the company
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Work on Qcide tree phenotypes has enabled commencement of Plant Breeders Rights program
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I.P. can be in the form of patents, technical
Review Of Registration Requirements
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Completed a regulatory review analysis with global consultants to look at the specific data requirements for USA, European Union and Australia across our different market segments
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Clear understanding developed relating to read-across potential for different applications and regulatory jurisdictions.
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Contact with regulatory agencies in key target jurisdictions with our commercial partners
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Submission made with EPA in the United States for a Biochemical classification of Flavocide.
Manufacturing
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Flavocide manufacturing validation – scale-up process has confirmed ability to produce larger quantities - 100Kg then 1,000kg
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Projects to further improve the economics of production of Flavocide are continuing
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Last Qcide harvest confirmed production improvements based on modified temperature & pressure
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Commercial plant tissue culture service provider has been initiated to establish the superior tree lines
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& manufacturing knowhow, trade secrets
On-going research is focused on developing data to support key commercial discussions as well as enhancing our I.P. portfolio
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KEY PRIORITIES FOR THE NEXT 12 MONTHS
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Progressing
Broadening our future
development work
opportunities via new Building our data to
associated with
partnerships support efficacy, novel
existing partnerships
update Mode of Action, and
strengthen our IP
Optimising our
Advancing our
manufacturing and
regulatory data and
production processes,
progress with
scaling up production
governing bodies
Advancing the terms
of our partnerships
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A CLEAR ROAD MAP FOR GENERATING VALUE – MEDIUM TERM
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2024-2026
– MEDIUM TERM
2022-2024
•
2021-2022 First regulatory
• Additional approval and
2020-2021 commercial sales
application testing -
internal and with • Additional
2018-2020 •
Manufacturing scale- partners registration
up of Flavocide & • submissions
Converting
•
Efficacy data in Qcide additional MTAs into • Potential new
multiple settings • Building regulatory collaborative product
•
• Advancing safety data package development development
Proof of principle
and tox testing • agreements program
efficacy testing Securing initial
• • Confirming novel agreements with (commercial) • Commercial
Preliminary safety data
Mode of Action commercial partners • Applying for formal production of
• Product formulation
claims (Evergreen & Clarke) recognition of novel Flavocide & Qcide
concepts Mode of Action
• •
Development Creating additional
•
Testing with 3 [rd] parties •
agreements and IP (patents technical Completing data
additional MTAs know-how) package for final
submission
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- Securing additional IP
POTENTIAL UPFRONT AND MILESTONE PAYMENTS, LICENSING FEES
AND ROYALTIES
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E N A B L I N G T H E N E X T G E N E R A T I O N O F N O V E L I N S E C T I C I D E S
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BIO-GENE TECHNOLOGY LIMITED 1 8 N O V E M B E R 2 0 2 2 Annual General Meeting
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T H A N K Y O U