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ENTROPY NEURODYNAMICS LIMITED — Investor Presentation 2020
Jul 21, 2020
64855_rns_2020-07-21_a0ce74f9-ed74-4830-a070-c2f70e03f8b4.pdf
Investor Presentation
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Monsoon “Twilights” 22 July 2020 Chris Baldwin
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IMPORTANT INFORMATION
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Purpose of presentation: This presentation (including this document, any related video or oral presentation, any question and answer session and any written or oral material discussed or distributed in relation to this presentation) has been prepared by Exopharm Limited (ACN 163 765 991) ( Exopharm or Company ). This presentation is intended for sophisticated or professional investors (as those terms are defined in the Corporations Act 2001 (Cth)), and their professional investment advisors and has been prepared for the sole purpose of providing general high-level information on Exopharm and its operations.
Not an offer or solicitation: This presentation is not investment advice nor an offer to subscribe for securities or otherwise invest in Exopharm, and it should not be relied upon to make any investment decision.
Nature of presentation: This presentation is not a prospectus, product disclosure statement or other investment disclosure document, and the level of disclosure in this presentation is less than such disclosure documents. This presentation does not purport to contain all of the information that a prospective investor may require to make an evaluation of Exopharm or its business activities and nothing in this presentation is, or is intended to be, a recommendation to invest in Exopharm. Exopharm does not purport to give financial or investment advice. No account has been taken of the objectives, financial situation or needs of any recipient of this presentation.
Forward-looking statements: This presentation may contain forward-looking statements which may be predictive in nature and incorporate an element of uncertainty or risk, such as ‘intends’, ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘targets’ or ‘expects’. These statements are based on an evaluation of current economic and operating conditions, as well as assumptions regarding future events. These events are, as at the date of this presentation, expected to take place, but there cannot be any guarantee that such will occur as anticipated, or at all, given that many of the events are outside Exopharm’s control. The stated events may differ materially from results ultimately achieved. Accordingly, neither Exopharm nor any of its directors, employees, contractors or advisors make any warranty or assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this presentation will actually occur. Further, other than as required by law, Exopharm may not update or revise any forward-looking statement if events subsequently occur or information subsequently becomes available that affects the original forward-looking statement.
Disclaimer: Neither Exopharm nor its officers, employees, contractors or advisors give any warranty or make any representation (express or implied) as to the accuracy, reliability, relevance or completeness of the material contained in this presentation. Nothing contained in this presentation is, or may be relied upon as a promise, representation or warranty, whether as to the past or the future. Except for statutory liability which cannot be excluded, Exopharm, its officers, employees, contractors and advisors expressly disclaim any responsibility for the accuracy or completeness of the material contained in this presentation and exclude all liability whatsoever (including in negligence) for any loss or damage which may be suffered by any person as a consequence of any information in this presentation or any error or omission therefrom.
Professional advice: Recipients of this presentation should consider seeking appropriate professional financial, taxation and legal advice in reviewing the presentation and all other information with respect to Exopharm and evaluating its business, financial performance and operations.
Confidentiality and copyright: While this is a non-confidential presentation, it still provides confidential and commercially sensitive information which is provided for the intended recipient only. Organisations or Persons viewing this presentation must not disclose the presentation or its contents to any third parties other than external consultants of the recipient for the purposes of obtaining a professional review, financial, taxation or legal advice, or as required by law or court order. Exopharm holds the copyright in this paper. Except as permitted under the Copyright Act 1968 (Cth), this paper or any part thereof may not be reproduced without Exopharm’s written permission.
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© Exopharm Ltd.
Exopharm Ltd – Summary
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Overview
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Exopharm is an Australian clinical stage biotechnology company with a rapidlydeveloping technology platform for turning exosomes into medicines
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26 staff (currently) based in Melbourne, Victoria
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Publicly-traded on the ASX (ASX:EX1) (listed Dec 2018)
Financials (as of 01/01/2020)
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95.47 million shares outstanding with a market capitalisation of ~ $30 million
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Cash balance of $5.88 million (per Mar 4C)
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Quarterly burn rate (per Dec 4C) of $1.85 million
Priorities
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Leverage our unique access to exosomes to partner with established biopharmaceutical and cell therapy companies
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Advance novel products through early phase clinical development
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Accelerate the development of our exosome generation, manufacturing and characterization technologies
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Add institutional investors/strategic partners to the share register
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Three Development Areas
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Naïve EVs (NEVs)
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EVs from stem cells and blood donations
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Well-established safety profile from millions of transfusions and adult stem cells
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A replacement for stem cell therapies
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• Potential to treat age-related degeneration
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Engineered EVs (EEVs)
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EVs that deliver drugs, proteins and/or nucleic acids into specific cells
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• Nearly unlimited potential to treat untreatable diseases
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• Clear pathway to partnership deals
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Production, purification, formulation, engineering
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LEAP™ technology provides unique, high volume process for proprietary EVs
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Access to abundant EVs creates a virtuous circle of innovation within manufacturing and EV drug development
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From Bark to Medicine
1899
400 BC
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Willow Tree
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Hippocrates
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Manufacture of acetylsalicylic acid (aspirin)
Natural source of salicin
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Same active ingredient, different commercial outcome
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Once the active ingredient in willow bark was identified, Bayer discovered how to manufacture it
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Bayer’s aspirin fuelled its growth into one of the world’s greatest pharma companies
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From Cells to Medicine
2020’s
2000 AD
Mesenchymal stem cells regenerate tissue, so grow them and transplant them into patients
MSC EVs are the active ingredient, with the potential to deliver a truly off-the-shelf treatment
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Potential EV Medicine
“Off-the-shelf” stem cells
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Same active ingredient, different commercial outcome
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Exopharm solved core manufacturing problem with LEAP
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Let adult stem cell clinical companies identify uses and resolve regulatory pathways
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Follow quickly with safer, more economical offering
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Naïve EV’s are the Future of Regeneration , Exopharm is the World Leader in NEVs
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250
MSC Publications
EV Publications
200
150
100
50 EX1
IPO
0
2000 2005 2010 2015 2020
Publication
Pubmed Papers per 10k
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Adult stem cell companies are pivoting their businesses to commercialize exosomes as therapeutics.
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December 2019
14 Exosome companies reviewed globally
Naïve EVs (NEVs)
- Stem cell benefits, without the risks and costs
5 Companies planning Clinical Trials with exosome medicines
- Targeted to mobility and sensory indications (sight, osteoarthritis hearing, neural degeneration)
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FIRST and ONLY reported human dosing (Jan 2020)
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Naïve EVs Conclusion
EX1 Basic Strategy
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When adult stem cell companies score wins, follow with more economical offering (e.g. ARDS, GVHD, CLI, Cardiac)
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Partner with Pharma with a more ‘drug-like’ product
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Potential markets >>$10 billion/yr
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EX1 Milestones
Naïve EVs (NEVs)
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Autologous Phase I
Allogeneic Phase I
Allogeneic Phase I
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- = Achieved in CY 2020
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- = Targeted for CY 2020
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Engineered EVs: Key Exopharm IP Assets*
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Purification of EVs at Scale
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Developed internally – exclusive ownership and use
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Comprehensive application to EVs
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Family of resins and potential resins await development
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Addition of nucleic acids to EV Payloads
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Global, exclusive in-licensing agreement (2020)
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Comprehensive application to EVs
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Custom medicines loaded into EEVs
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Addition of proteins to EV Surfaces
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Global, exclusive in-licensing agreement (2020)
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Comprehensive application to EVs
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Custom addressing of EEVs to selected cells
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- Please refer to ASX Announcement 12[th] June Added IP for more information
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Engineering Platform Example: “ ” - CoV Specific Anti viral Fortrexo CoV
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The SARS-CoV-2 virus has spike proteins on the outside and a nucleic acid payload on the inside. The spike protein targets cells with ACE2 receptor on the outside and delivers the particle into the ACE2+ cell. The payload enables viral particle replication inside an infected cell
Exopharm has designed an EEV to reduce viral replication in ACE2+ cells by delivering RNAi that inhibit viral particle replication in an infected cell
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EV with spike protein
attached using EVPS
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Naïve Engineered
Bioreactor
Cells Cells
Commercial
Scale EV
Purification
Naïve EVs
CoV Spike on EV Surface RNAi packed into EVs to
targets ACE2+ cells stop CoV replication
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Engineered EVs: the Future of Precision Medicine
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Natural characteristics of Naïve EVs
Engineered EVs
Potential markets for ‘untreatable’ diseases
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EVs cross barriers
(including blood-
brain)
EVs naturally
reprogram cells
EVs control
immune
responses
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Custom medicines ‘Drug’ cargoes of many types e.g. small molecules, RNAi, siRNA, mRNA Custom addressing - targeting EEVs to selected cell types e.g. brain cells, cancer cells
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>>$100 billion/year
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Cancers Viruses Rare Age-related
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diseases Illnesses
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EEV Opportunities • Multiple companies to do deals with
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• Multiple EEV products and variations
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• Multiple applications
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Engineered EV Deals
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Only three companies globally have announced proprietary platforms for EEV Development:
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EV Company IP Status Pharma Partner Date Area Upfront Milestones
Jun
CNS > $50 mln $1.7 billion
2020
Mar Rare
$63 mln $1.3 billion
2020 diseases
Jan
Cancer $77 mln $1.8 billion
2019
Jun
CNS > $100 mln Not disclosed
2020
Target: 2021
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As of Jun 2020
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Engineered EVs Conclusion
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Basic Strategy
Milestones
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Demonstrate power of EVPS and LOAD with Fortrexo CoV
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Partner with multiple pharma companies with EEV products
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Use proceeds to fund NEV clinical trials
Engineered EVs (EEVs) Assembly of IP
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Demonstrate Proof of Concept First Partnering Deal
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= Achieved in CY 2020
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Potential markets >>$100 billion
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- = Targeted for CY 2020
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LEAP vs Other EV Purification Techniques
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State of the Art, EV Purification as of June 2020*
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Cost
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AF4
Research
Nano-FCM
UC Scale
Immunoaffinity
Commercial reagents
Diagnostic
Microfluidics Scale
Density gradient
Proof-of-Concept
Scale
SEC
Filtration Commercial
Manufacturing
Scale
Scalability
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- Adapted from https://doi.org/10.1016/j.tibtech.2020.05.012
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Unlike all other alternatives, LEAP technology
(i) is readily scaled up to over 1,000L scale,
(ii) uses industry-standard equipment and processes (iii) uses low-cost, reusable consumables (from validated sterilization process)
- ** LEAP assessment from Exopharm, based on industrial use to date; LEAP Patents processing through National phases at present
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Milestones Toward Revenue
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Naïve EVs (NEVs) Engineered EVs (EEVs)
Autologous Phase I Assembly of IP
Allogeneic Phase I Demonstrate Proof of Concept
Allogeneic Phase I First Partnering Deal
Demonstration via Clinical Trial
= Achieved in CY 2020
Expansion of EVs Know-how
= Targeted for CY 2020
Bioprocessing Partnering Deal
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Our Team
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Ian Dixon
Partnering Team CEO & MD Product Team
Lieven Huang Michael Whitmore
BD & Licensing Chris Baldwin Gregor Lichtfuss Process Development
CCO COO
Patrick James
Andy Coley
Product Development
Innovation
Angus Tester
Karen Holden Product Evaluation
Translation
Ivan Jasenko
• Dedicated BD Quality & Regulatory
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scientists Industrial know-how
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Tight integration Bringing pharma
between business processes to new
modelling and early medicines
proof of concept work
International experience from leading
companies
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~~Refreshing Medicine, Today~~
arm.com ~~chris.baldwin@exoph~~