Bio-Gene Technology Case Study

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Peter May Executive Director R & D Collaborate 2019 Cairns 22 October 2019 Bio-Gene Technology Case Study

Transcript of Bio-Gene Technology Case Study

Peter MayExecutive Director – R & D

Collaborate 2019 – Cairns

22 October 2019

Bio-Gene Technology – Case Study

Summary

• Bio-Gene Technology overview

• Opportunity & approach

• Projects & stakeholders

• Challenges faced

• Solutions & successes

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Bio-Gene Technology & Strategy

BETA-TRIKETONES

Platform Technology

Products Flavocide™ & Qcide™

have demonstrated highly effective insect control properties

Product development through collaboration with private & public

research & development organisations

Targeting public health, animal health, consumer & crop protection sectors

ASX-listed agtechcompany developing natural insecticide

technology

Novel insecticide mode of action to address the increasing problem

of insecticide resistance

Business model to work with commercial partners to take end-use-products to

market

Bio-Gene Technology & Strategy

BETA-TRIKETONES

Platform Technology

Products Qcide™ & Flavocide™

have demonstrated highly effective insect control properties

Product development through collaboration with private & public

research & development organisations

Targeting public health, animal health, consumer & crop protection sectors

ASX-listed agtechcompany developing natural insecticide

technology

Novel insecticide mode of action to address the increasing problem

of insecticide resistance

Business model to work with commercial partners to take end-use-products to

market

Products

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Qcide™

Tasmanone-rich oil

extracted from

Eucalyptus cloeziana -

Gympie messmate

Well suited to consumer

product applications, also

public health & crop

protection uses where a

natural product is

preferred

Natural Compound

Flavocide™

Flavesone - synthesised

compound that occurs

naturally in plants

Well suited for larger

volume markets such as

crop protection, animal

health & public health

Nature Identical Compound

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OPPORTUNITY - INSECT CONTROL MARKET

Insect Pest Control

Market Share

Asia Pacific18.0%

Europe22.6%

Rest of World9.9%

Americas49.5%

0

1

2

3

4

5

6

7

China Brazil India USA Japan

US

$bn

Insecticide Sales by Country

16%

19%

13%

52%

US$31.1bnAddressable

Market

Crop Protection

Food, Fibre & Grain

Storage

Consumer Applications

Sprays, Creams, Oils,

Lotions & Personal

Repellents

Animal Health

Livestock & Pet-care

products

Public Health

Vector Control for

Malaria, Zika &

Dengue

Growth Drivers:

• Growing human population and increased demand for food

• Public health in urban environments

• Globalisation of pests due to movement of products & people

• Chemical control remains key in integrated pest management

• Major segments of insect control market:

1) Crop Protection

2) Consumer Applications

3) Animal Health

4) Public Health

Global pest control is a rapidly growing industry with chemical controls representing the largest component

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CURRENT INSECTICIDES

• ~30 Modes of Action (MoA’s) have been classified

• 4 major groups represent most of volumes used

• Insecticides subject to regulatory pressure due to:

- toxicity to humans e.g. organophosphates

- toxicity to non-targets e.g. neonicotinoids vs. bees

• All groups also subject to failure due to insect resistance

• Need for products with novel modes of action

Reliance on fewer insecticide that are under increasing regulatory & performance pressure

0

1

2

3

4

5

Organophosphates Pyrethroids Neonicotinoids Diamides

Annual S

ale

s (

US

$bn)

1

3

4

28

Group 1

Group 28

Group 3

Group 4

1977 1944

19902008

Major Modes of Action Groups

1

3

4

28

90 Products

8 Products 8 Products

30 Products

Major target markets

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Crop Protection Grain Storage

Public Health Consumer Products

Bio-Gene is

currently focused on

product & market

development in four

key applications

Pathway to Commercialisation

Intellectual Property Patents covering uses & other aspects of the technology

Knowhow & other IP protection e.g. manufacturing processes & plant breeders rights

Proof of Concept

Mode of action (MoA) understood in insect systems & classified under IRAC

Efficacy vs. key pests determined & target markets confirmed

Crop safety confirmed for crop protection markets

De-risking technologyMammalian toxicology – acute & chronic, metabolism, carcinogenicity, mutagenicity,

reproduction

Non-target & environmental toxicology – safety on beneficial organisms, environmental fate

Manufacturing Optimise production via agronomy, raw material & energy inputs, process improvements

Product specifications for quality & production consistency

Production costs & cost of goods determined & competitive

Commercialisation Strategic partnerships with public health, animal health & crop protection & consumer

companies

Product registrationRegulatory enabling studies – product chemistry, end-user safety, crop & food residues,

environmental impact, efficacy on pests, safety on non-targets

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COLLABORATIONS Product development through collaboration with private & public

research & development organisations

Bio-Gene collaborations - Australia

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Organisation Project

University of Sydney Qcide essential oil chemical characterisation

Western Sydney University Insect screening; initial use patent

Southern Cross University Qcide chemical characterisation & analytical support

University of Queensland Early synthesis of flavesone

CSIRO, Clayton Victoria Further development of flavesone synthesis process

Monash University, Clayton Mode of action studies

University of Melbourne Genetic investigations supporting mode of action

Adelaide University Dermal penetration studies to support tox de-risking

DAF Queensland Efficacy testing – grain storage pests, ectoparasites

James Cook University, Townsville Qcide oil extraction process engineering

James Cook University, Cairns Tree improvement & tissue culture program

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JCU PROJECTS – QCIDE OIL PRODUCTION

Tree farming

agreement for

oil supply from

FNQ growers

Improvements

in oil content &

chemical profile

via JCU cloning

program

Improvements

to oil extraction

processes via

JCU engineering

project

Improved trees

Improved oil

production

IP in systems,

processes, PBR

JCU Collaborations

• Access to expertise in plant science, tissue culture, biotechnology

• Access to facilities, laboratories, growth chambers, nurery shadehouses

• Access to engineering expertise in extraction processes, steam distillation

• Access to facilities, analytical laboratories, lab scale processing, instrumentation

• Access to funding opportunities via. JCU programs

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Tree farming agreement for oil supply from FNQ growers

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Improvements in oil content & chemical

profile via JCU cloning

program

Image J analysis of E.cloeziana oil glands

Tissue culture of tree lines selected

on oil content & chemical analysis

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Improvements to oil extraction

processes via JCU

engineering project

Leaf biomass harvested into bins for steam distillation to

extract oil from leaves, then separation of oil from condensate

Bio-Gene Support Programs

Support programs utilised:

• R&D Tax Incentive – qualifying research programs & activities

• Innovation Connections – CSIRO synthesis project, JCU engineering project

• CSIRO – kick start program – Flavesone synthesis project

• JCU Masters Program – JCU engineering project

• Monash Global Executive MBA Project – Advanced Manufacturing

Programs for consideration:

• Cooperative Research Centre – Projects, CRC Northern Australia

• Advance Queensland - Business Development Fund (BDF) & Industry Tech Fund (ITF)

• Manufacturing Modernisation Fund (MMF)

• Australian Post Graduate Research (APR) Intern.

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Bio-Gene Issues & Challenges

• Financial support – shareholders, commercial partners, third party non-dilutive funding

• Expertise – mode of action, toxicology, insecticide discovery, testing protocols

• Facilities – safety testing, metabolic/toxicokinetics ecotoxicity/environmental fate

• Global target market & pests – international network, access to exotic pests

• Regulatory data package – multiple regimes, local & international

• State vs. state vs. federal – Bio-Gene HO Victoria, directors Qld & WA

• Australia vs. overseas – balance of programs esp. for R&D Tax Incentive

• Risk management – technology, manufacturing, regulatory, competition, markets

• Agtech [agricultural/pest management] vs. Biotech [medical & health]

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Solutions & successes

• Support of private sector to agtech companies with innovative technologies

• Strong services base – financial, legal, IP, media, technical services

• Scientists & institutions world class, nationally integrated & global outlook

• Centres of expertise in key areas – integrated pest management (IPM) &

insecticide resistance management, mosquito control, grain storage pests

• Supporting technologies to assist development programs

• Regulatory systems well structured, reliable & science based (APVMA/TGA)

• Broad-based government support to R&D & SME’s, including regional

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Conclusion

• Bio-Gene Technology overview – Qcide & Flavocide, novel MoA

• Opportunity & approach – regulatory pressure & insecticide resistance

• Projects & stakeholders – integrated programs, multiple disciplines

• Challenges faced – funding, expertise, global market, risk management

• Solutions & successes – prioritisation, collaboration, project teams

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Bio-Gene Technology

Richard Jagger

CEO

M: +61 418 125 646

E: [email protected]

Peter May

Exec. Dir., R&D

M +61 412 251 016

[email protected]

Roger McPherson

CFO, Co. Sec.

M +61 418 416 237

[email protected]

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BOARD MEMBERS & MANAGEMENT

RICHARD JAGGER

CEO & Managing Director

DON BRUMLEY

Non-Executive Chairman

ROGER MCPHERSON

Chief Financial Officer &

Company Secretary

ROBERT KLUPACS

Non-Executive Director

PETER MAY

Executive Director, R & D

• 25+ years as a senior partner & leader of

Ernst & Young – Oceania

• Significant experience across IPOs,

transactions, audit & advising growing

entrepreneurial companies

• 20+ years working in agriculture globally

• Most recently employed as Managing

Director of Sinochem Australia

• Previously spent 15+ years at Monsanto in

various management roles

• 20+ years experience in crop protection

market with companies Orica & Crop Care

Australasia (now Nufarm)

• Founded Xavca, consulted to companies

such as Syngenta & Sorex (BASF)

• Former CEO & Chairman of BioProspect

(now Medibio, ASX:MEB)

• 30+ years corporate experience in

international tech development

• Previously MD & CEO of ASX-listed

Circadian Technologies Ltd

• Previously MD & CEO of ES Cell

International Pte Ltd

• Registered Australian patent attorney

• 15+ years experience as CFO & Company

Secretary across both listed & unlisted

companies

• Experience in the pharma manufacturing,

biotech & biopharma industries

• Previously CFO & Co-Sec of TPI

Enterprises (ASX:TPI)

KEVIN RUMBLE

Non-Executive Director

• Founding Director of Bio-Gene

• 20+ years experience in new plant

propagation, farming & live plant

transport techniques

• Involved in the development of QcideTM

& development of Flavesone as a first

step in the commercialisation of

FlavocideTM

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KEY ADVISORS TO THE BOARD

PROF. CATHERINE HILL

Purdue University

BGT Scientific Advisory

Board Member

DOUG RATHBONE

Advisor to the BGT Board

• 40+ years experience in agriculture,

most recently as Managing Director

of Nufarm, a position he held for 15+

years

• Under his leadership, Nufarm became

one of Australia’s most successful

agricultural firms with global sales

>$2.5B

• Purdue University, Dept. of

Entomology

• Showalter Faculty Scholar

• President’s Fellow for the Life

Sciences

• Authority in new insecticide

development & novel chemistry

NEIL ANDERSON

Chemistry & Manufacturing

Consultant

• Industrial Chemist

• Employed by Monsanto for 40 years

• Specialist in formulation

development, production, & process

management

• Qualified for manufacturing plant

audits, quality & environmental

management