18-07-19 OBS July presentation - Opalopalbiosciences.com/.../18...July-presentation_s.pdf · This...

Julie Phillips, Managing Director

Investor PresentationJuly 2018

Opal Biosciences Limited is an innovative player in infectious disease treatment An Australian biotechnology company committed to tackling a serious global health threat

Safe Harbour StatementThis presentation is provided to you for information purposes only and should not be construed as investment advice or an offer, and shall not form part of an offer, or solicitation to buy or sell any securities or derivatives. It should not be considered as an invitation to subscribe for or purchase any securities in Opal Biosciences Limited (“Opal”), or as an inducement to make an offer or invitation with respect to those securities. No agreement to subscribe for securities in Opal will be entered into on the basis of this presentation.

This presentation contains forward-looking statements which are based on an assessment of present economic and operating conditions, and on a number of assumptions regarding future events and actions that, at the date this presentation was prepared, are expected to take place. Such forward looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors, many of which are beyond the control of Opal. Opal cannot and does not give any assurance that the results, performance or achievements expressed or implied by the forward looking statements contained in this presentation will actually occur and you should not place reliance on these forward looking statements.

To the maximum extent permitted by applicable laws, Opal and its affiliates make no representation and can give no assurance, guarantee or warranty, express or implied, as to, and take no responsibility for the authenticity, validity, accuracy, suitability or completeness of, or any errors in or omission, from any information, statement or opinion contained in this presentation.

The contents of this presentation are confidential. The presentation is being provided to you on the condition that you do not reproduce or communicate it to, or disclose it to, or discuss it with, any other person without the prior written permission of Opal.

What causes an infection?

Strep ThroatBacteria Group A Streptococcus

Food poisoningBacteria Salmonella

Common coldVirusRhinovirus

FluVirusInfluenza

Athlete’s footFungiTrichophyton

MalariaParasitePlasmodium

Examples of Disease-Causing Microbes

The Golden Age of Antibiotics

Age of pestilence (1930) – US figures• Approximately 300,000 died of bacterial illnesses

(~22% of all deaths) • Most common bacterial cause of death was pneumonia= ~100,000 people

Tuberculosis (TB) ~85,000 Diarrhoea/enteritis = 30,000• > 5,000 women died in childbirth due to septicemia

Age of degenerative [chronic] diseases (2002)• Antibiotics virtually eliminated entire disease categories

like tuberculosis (800 deaths in 2002), and acute rheumatic fever (no deaths separately reported in 2002)

1930’s to 1950’s

Other Benefits of Antibiotics

Complications from rheumatic fever, syphilis, gonorrhoea, children’s ear infections

Battlefield choices

Immunosuppression cover: Organ transplant Cancer treatment

Joint replacement

The Discovery Void

In The Headlines

In The Headlines

“Antimicrobial resistance poses a fundamental threat to human health, development, and security

… We are running out of time.”

Dr. Margaret Chan, Director-General of WHO21 September 2016, NEW YORK

Media release following UN General Assembly

In The Headlines

23,000 people die yearly from antibiotic resistant bacterial infections in the U.S. and more than

2 million fall ill, according to the Centers for Disease Control. (ref http://www.cdc.gov/drugresistance/threat-report-2013/)

An average of 10 million people will die every year and it could cost the

global economy up to $100 trillion.(J. O’Neill: Antimicrobial Resistance: Tackling a Crisis for the Health and Wealth of Nations, Dec 2014)

NOW

By 2050…

What Happens if we Fail to Act?

Opal’s BDM-I

1. BDM-I has demonstrated

activity against a wide range of human disease causing germs.

2. Potential to combat dangerous superbugs

3. Being assessed as a bioterrorism

counter-measure

4. Potential applications:

injections, eye drops, tablets, creams, inhaler

Opal-I Potential Targets(examples)

Lung infections

Wound infections

Blood poisoning

Sexually transmitted infections

Urinary tract infections

Opal-I Infection Targets(examples where BDM-I has shown activity in vitro)

In The Headlines

In The Headlines

Pelvic inflammatory disease from chlamydia and gonorrhoea on the rise

Jocelyn Wright 4th May 2018

Increasing rates of pelvic inflammatory disease (PID) linked to chlamydia and gonorrhoea infections has Australian sexual health experts concerned.

www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf

Antibiotic Resistance Threats in the US 2013, US DHHS CDC, April 2018BDM-I has shown activity against (some strains of) Fluconazole-resistant Candida

Opal Products Pipeline

Global Collaborations

http://www.niaid.nih.gov/LabsAndResources/resources/dmid/invitro/Pages/invitro.aspxhttp://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/Pages/default.aspx

Expert Advisors for Antimicrobial Program

Tania C Sorrell AM AHMS

Deputy Dean, Sydney Medical School & Head, WestmeadClinical School; Professor and Director Marie Bashir Institute for Infectious Diseases & Biosecurity, University of Sydney; Director, Centre for Infectious Diseases and Microbiology, WestmeadInstitute for Medical Research; Service Director, Infectious Diseases and Sexual Health, Western Sydney Local Health District.

Hak-kim ChanPhD, DSc

Professor of Pharmaceutics (Advanced Drug Delivery)Faculty of PharmacyUniversity of Sydney

Slade Jensen PhD

Associate ProfessorInfectious Diseases and Microbiology, School of Medicine Antibiotic Resistance and Mobile Elements Group, Ingham Institute Western Sydney University

Richard Buchta PhD MBA

Managing Director,Formulytica Pty Ltd

Sharon Chen PhD

Clinical Associate Professor Medicine (Immunology and Infectious Diseases)Westmead Clinical SchoolCentre for Infectious Diseases & Microbiology

Market Size

Global antifungals

market, US$17.43 billion

by 2023

Global antibacterials

market, US$44.54 billion

by 2021

Global anti-infectives

market, US$190.28 billion

by 2025

Ref: Antifungal Drugs Market by Drug Type - Global Opportunity Analysis and Industry Forecast, 2017-2023 Allied Market Research June 2017Anti-Infectives Market Analysis & Trends - Product (Antibacterials, Antifungals and Antivirals) - Forecast to 2025 (Report October 2016 Accuray Research LLP )Global Antibacterial Drugs Market 2017-2027 ReportBuyer March 2017

www.pewtrusts.org/en/research-and-analysis/articles/2017/12/21/the-world-is-running-out-of-antibiotics

US Government Incentives

1. The GAIN (Generating Antibiotic Incentives Now) Legislation

2. FDA’s Priority Review: FDA’s goal is to take action on an application within 6mths (compared to 10mths).

3. Orphan Drug Designation: Sponsor of the drug entitled to development incentives (tax credits, extended market exclusivity).

4. FDA’s Fast Track Process: Designed to facilitate the development, and expedite the review of much needed new treatments.

International Antimicrobial R&D Incentives

Investment Potential

• Anti-infectives market large and growing

• Few competitors in development

• Government incentives in place

• Major pharmas returning to the sector and buying innovation

• Opal Technology’s potential

• Experienced international team

Contact Us

For further information contact:

Julie Phillips | Managing DirectorEmail jphillips@opalbiosciences.com