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Recce Ltd©
AGM Presentation
22 November 2016
Presented by Dr Graham Melrose
(Executive Chairman)
ASX: RCE
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Disclaimer
ALL CURRENCY AMOUNTS ARE IN AUD UNLESS STATED OTHERWISE.
DISCLAIMER
This presentation has been prepared by Recce Ltd (the “Company”). It does not purport to contain all the information that a prospective investor may require in connection with any
potential investment in the Company. You should not treat the contents of this presentation, or any information provided in connection with it, as financial advice, financial product
advice or advice relating to legal, taxation or investment matters.
No representation or warranty (whether express or implied) is made by the Company or any of its officers, advisers, agents or employees as to the accuracy, completeness or
reasonableness of the information, statements, opinions or matters (express or implied) arising out of, contained in or derived from this presentation or provided in connection with it,
or any omission from this presentation, nor as to the attainability of any estimates, forecasts or projections set out in this presentation.
This presentation is provided expressly on the basis that you will carry out your own independent inquiries into the matters contained in the presentation and make your own
independent decisions about the affairs, financial position or prospects of the Company. The Company reserves the right to update, amend or supplement the information at any time
in its absolute discretion (without incurring any obligation to do so).
Neither the Company, nor its related bodies corporate, officers, their advisers, agents and employees accept any responsibility or liability to you or to any other person or entity arising
out of this presentation including pursuant to the general law (whether for negligence, under statute or otherwise), or under the Australian Securities and Investments Commission Act
2001, Corporations Act 2001, Competition and Consumer Act 2010 or any corresponding provision of any Australian state or territory legislation (or the law of any similar legislation in
any other jurisdiction), or similar provision under any applicable law. Any such responsibility or liability is, to the maximum extent permitted by law, expressly disclaimed and excluded.
Nothing in this material should be construed as either an offer to sell or a solicitation of an offer to buy or sell securities. It does not include all available information and should not be
used in isolation as a basis to invest in the Company.
FUTURE MATTERS
This presentation contains reference to certain intentions, expectations, future plans, strategy and prospects of the Company.
Those intentions, expectations, future plans, strategy and prospects may or may not be achieved. They are based on certain assumptions, which may not be met or on which views
may differ and may be affected by known and unknown risks. The performance and operations of the Company may be influenced by a number of factors, many of which are outside
the control of the Company. No representation or warranty, express or implied, is made by the Company, or any of its directors, officers, employees, advisers or agents that any
intentions, expectations or plans will be achieved either totally or partially or that any particular rate of return will be achieved.
Given the risks and uncertainties that may cause the Company’s actual future results, performance or achievements to be materially different from those expected, planned or
intended, recipients should not place undue reliance on these intentions, expectations, future plans, strategy and prospects. The Company does not warrant or represent that the
actual results, performance or achievements will be as expected, planned or intended.
US DISCLOSURE
This document does not constitute any part of any offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, or for the account or benefit of any “US
person” as defined in Regulation S under the US Securities Act of 1993 (“Securities Act”). The Company’s shares have not been, and will not be, registered under the Securities Act or
the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold in the United States or to any US person without being so registered or
pursuant to an exemption from registration including an exemption for qualified institutional buyers.
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Corporate and investment summary
Overuse of antibiotics has led to antibiotic resistant bacteria.
Antibiotic resistant bacteria or superbugs have become a major world health issue.
Recce is focused on developing a new class of synthetic anti-bacterials with a broad spectrum of activity against antibiotic resistant
bacteria.
Recce is also investigating the use of these compounds in the treatment of some cancers and viruses.
Recce was founded on the work of former Johnson & Johnson Australia Executive Director and Chief Research Executive
Dr Graham Melrose.
Based in Sydney with offices in the United States and research facilities in Sydney, NSW and Perth, Western Australia.
Business financed after successful oversubscribed listing on ASX in January 2016.
Recce’s focus is the scale-up of manufacturing and the preparation of a submission to the US FDA for first human studies.
Capital structureASX symbol: RCE
Market cap (approx.) $12.19 million
Shares on issue: 76.18 million
Cash and deposits: $2.55m
Industry: Pharmaceuticals and Biotechnology
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Recce synthetic antibiotics
• Recce has synthesized and patented a new class of antibiotics.
• These new compounds have demonstrated safety and efficacy in a range of pre-clinical tests to kill a number of common antibiotic
resistant bacteria.
• Recce’s new synthetic antibiotic compounds show positive activity against a broad range of multi-drug resistant gram-negative and
gram-positive bacterial infections.
Recce’s Patent portfolio covers all key geographies, manufacturing and mode of use
Filed Status Expiry
Patent Family 1 Australia Granted 2028
USA Granted 2029
Europe Granted 2028
Japan Granted 2028
China Granted 2028
Patent Family 2 All PCT Countries Pending 2034
Patent Family 3 Provisional 2034
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Lead RECCE® 327 compound
RECCE® 327 is our lead synthetic antibiotic candidate in pre-clinical development
Extensive pre-clinical studies have demonstrated positive in-vitro (in the lab) and in-vivo (in animals) to date:
• Demonstrates anti-infective properties against S. aureus and E. coli.
• Important for addressing the rise of antibiotic resistant superbugs and tackling the treatment of bacterial sepsis and gastritis.
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RECCE® antibiotics
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Sepsis
• “Sepsis affects over 26 million people worldwide each year - one third die”
• “It is the largest killer of children and new-born infants in the world”
• “Sepsis is increasing at an annual rate of 8-13%”
• “In the United States, sepsis kills more people than colon cancer,
breast cancer and HIV/AIDS combined”
“Probability of life-survival recedes 6% for each hour-delay in treatment”
This limitation makes the choice of antibiotic against sepsis,
dangerous guess-work. RECCE® antibiotics kill ALL – no guess-
work.Global Sepsis Alliance
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Technology: Very resistant – P. aeruginosa (Gr-ve superbug)
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Full infectionPre-infection After 1 hour treatment with
RECCE® 327
Complete kill
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RECCE® 327 kills at practical speeds*
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Rates of kill of standard bacteria
S. aureus E. coli P. aeruginosa S. pyogenes C. difficile
20 – 60
minutes
20 – 60
minutes
1 – 24
hours
20 – 60
minutes
20 – 60
minutes
20 – 60
minutes
20 – 60
minutes
1 – 24
hours
S. aureus E. coli P. aeruginosa
Rates of kill of Superbugs
The same kill-rates for
standard bacteria and
their superbugs
*Using concentrations of 1000ppm
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RECCE® 327 does not Fail
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Number of repetitive uses before displaying loss of antibiotic activity
S. aureus E. coli P. aeruginosa
RECCE® Antibiotic >25
Commercial
antibiotic
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Commercial
antibiotic
4
Commercial
antibiotic
10
After repetitive use, the commercial antibiotic loses activity; RECCE® 327 DOES NOT
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Technology – How it works
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RECCE® antibiotics attack protein in the cell wall of bacteria – outward pressure in the bacteria, causes only them to rupture.
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Technology – How it works
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Natural vs Synthetic
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• Commercial antibiotics are naturally derived – superbugs to them have been forming for millenniums – and will continue to
do so
• RECCE® 327 is wholly synthetic – superbugs never formed in nature – designed for a purpose!
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Expected news flow next 12 months (calendar year)
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2016 2017
Additional RECCE® 327 safety and efficacy data Final toxicology and efficacy test data
Oral dosing toxicology and efficacy data in mice Rat pharmacokinetic results
Anti-viral efficacy results in mice Dog pharmacokinetic results
Anti-cancer efficacy results in mice Pre-IND meeting US FDA
Toxicology results in ratsAdditional data available from Rat and
Dog studies
Toxicology results in dogs Pilot-Manufacturing facility
Anti-bacterial (MRSA) efficacy results in mice IND application US FDA
Anti-bacterial (E. Coli) efficacy results in mice Half year results 2017
Full year results 2016 Phase 1 Human Trial
New Sydney production facility under construction Final toxicology and efficacy test data
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Recce business model –
strategy to create long-term value
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Recce synthetic
antibiotic platform
Pharma &
biotech
partnerships
Revenues, upfronts,
milestones, royalties
In-house
pipeline of drug
candidates in
multiple areas
Share-value returns
New class of
synthetic
antibiotics
Potential in multiple
disease indications Licensing of
distribution
to Pharma
Revenues: major
upfronts + royalties
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Board and management in place to deliver
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Peter Williams: CFO and Company SecretaryAccomplished senior ASX finance professional with significant
local and international experience. Former VP Finance with
BHP World Minerals reporting to the CEO.
Arthur Kollaras: Principal Engineer Highly qualified in chemical engineering and microbiology, has
significant experience taking a new technology concept to pilot
plant and full scale FDA standards and production
internationally.
Dr Justin Ward: Senior Quality Chemist A quality control expert who has worked with leading
pharmaceutical companies. He will bring Recce’s research and
development laboratory in Perth up to US FDA standard.
Dr Graham Melrose: Executive Chairman
Founder and inventor. Former Chief Research Executive of
Johnson & Johnson (Aust) Pty Ltd in Sydney, with global
responsibilities, particularly in Asia-Pacific.
Michele Dilizia: Executive Director
Co-inventor and qualified medical scientist; specialisation in
medical microbiology & regulatory affairs.
James Graham: Executive Director
Extensive experience in marketing, business development and
commercialisation of early stage technologies with global
potential.
Dr Dominic Barnes: Non-Executive Director
Practicing medical doctor and supervisor of over 20 human drug
trials Senior regulatory roles with Shire, AstraZeneca and
Johnson & Johnson.
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A supportive legislative and financial landscape
globally for new antibiotics
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The global need for new antibiotics is urgent and a major economic and social issue.
The rapid development of new antibiotics is supported by a range of initiatives by governments and private investors globally.
Legislation:
• US Generating Antibiotic Incentives Now (GAIN) Act to promote development of new antibiotics
• Extra five years patent exclusivity to new antibiotics that treat serious or life-threatening illnesses without generic
competition
• US FDA has created an Antibacterial Drug Development Task Force to support development of new drugs.
Non-dilutive grants:
• The US Biomedical Advanced Research & Development Agency (BARDA) Broad Spectrum Antimicrobials program
• European Innovative Medicines Initiative (IMI) New Drugs For Bad Bugs (ND4BB) program
• Both provide direct financial support to nearly 20 percent of all antibiotics currently under development globally.
• CARB-X is a public-private partnership focused on preclinical discovery and development of new antimicrobial products.
CARB-X funds come from the US government and a public-private initiative in the United Kingdom.
• US$44 million in first year and up to $350 million in the next five years in grants to companies developing new antibiotics
and diagnostics.
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Supportive legislative and financial landscape
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Economics:
• Former UK Prime Minister David Cameron commissioned a report analysing the economic and social costs of the problem
and propose concrete actions to tackle it internationally.
• The O’Neil Review on Antimicrobial Resistance published in 2015 made a number of recommendations including the need
to support and reward innovation to generate more new drugs.
Government and United Nations
• In 2016 the United Nations General Assembly agreed to develop strategies to combat the spread of antibiotic resistance.
• A declaration by member states outlined a coordinated global response along a similar path to the one used to combat
climate change.
• Signatories to the declaration have committed to encouraging innovation in antibiotic drug development, increasing public
awareness, lifting surveillance and improving regulatory systems to manage sales of antimicrobial medicines.
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RECCE® 327 – a Technology
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Compared to the risk of a single opportunity from a one-use product - Recce’s technology enjoys the
added security of multiple product opportunities.
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