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ENTROPY NEURODYNAMICS LIMITED — Capital/Financing Update 2020
Aug 20, 2020
64855_rns_2020-08-20_62b4ae05-5644-4883-ab2d-cad776f7668e.pdf
Capital/Financing Update
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ASX ANNOUNCEMENT
Exopharm Shareholder Update
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HREC approval received for PLEXOVAL II safety study, first-in-human, off-the-shelf Plexaris™
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Canary Capital engaged
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Updated shareholder presentation and reminder for webinar 10:30am Wednesday 2 September at https://exo.ph/Sept2020Webinar (open to all)
21 August 2020, Melbourne, Australia: Exopharm Limited (ASX:EX1) is a clinical stage Australian company using exosomes (extracellular vesicles (EVs)) from cells to generate a new class of cell-free medicines. Exopharm is a leader in the manufacture and experimental clinical use of EV medicines.
PLEXOVAL II clinical study update
As announced on 19 August 2020, Exopharm has applied for approval from the Human Research Ethics Committee (HREC) to conduct an allogeneic (off-the-shelf) Plexaris safety trial in Melbourne. HREC approval has now been received. The study, “PXR002: A Prospective, Randomised, Double Blind, placebo controlled, single dose, single site Phase I study to assess the safety and biological activity of a human nonautologous platelet derived Extracellular Vesicle therapy vs placebo on wound healing rate following skin punch biopsy in healthy volunteer adults,” is being managed by Emeritus Research (Emeritus). The final step before study start is Research Governance Office delegate approval by Emeritus. Further information will be provided once the trial is open for enrolment.
Canary Capital engaged
The Company is also pleased to advise that it has executed a mandate with Canary Capital Pty Ltd (Canary Capital), a boutique Sydney headquartered investment management and corporate advisory firm, to provide corporate advisory and investor marketing services to the company.
Mr Paul Hart from Canary Capital says “Canary Capital prides itself on creating value for its clients with long term strategic investments and will be profiling the company on its website.” (https://canarycapital.com.au)
EXOPHARM LIMITED ACN: 163 765 991 ASX:EX1 Address: Level 17, 31 Queen Street Melbourne 3000 Telephone: 03 9111 0026 Email: [email protected] Web: www.exopharm.com
Under the terms of the mandate:
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The mandate will commence on September 1[st] , 2020 and continue for 12 months;
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Exopharm will pay Canary Capital a monthly fee of $6,000 (exclusive of GST);
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The Company will issue Canary Capital 1,500,000 unlisted options with a $0.60 exercise price and 1,500,000 options with an exercise price of $0.90 with a five year expiry.
Updated shareholder presentation and reminder for science webinar
Attached is an update to the shareholder presentation. Shareholders and other interested people are reminded to join a Webinar update at 10:30am Wednesday 2 September at https://exo.ph/Sept2020Webinar. Dr Karen Holden, Head of Translation and Dr Patrick James, Head of Product Development, will provide a look into some of the scientific developments at Exopharm in the last three months. There will be a Q&A session with Ian Dixon (CEO) and Chris Baldwin (CCO) at the end of the Webinar.
By the Board - this announcement has been authorised for release by the Board.
Company and Media Enquiries:
Dr Ian Dixon, MBA Founder and Managing Director P: +61 (0)3 9111 0026 [email protected]
Rudi Michelson Monsoon Communications Tel: +61 (0)411 402 737 [email protected]
Join our mailing list to receive updates: http://exo.ph/ExoMails www.exopharm.com P: +61 (0)3 9111 0026
ABOUT EXOPHARM
Exopharm Limited (ASX:EX1) is a clinical-stage Australian regenerative medicine company developing therapeutic exosome products as regenerative medicines and precision medicines.
Exosomes are small particles naturally produced by cells, which deliver therapeutic ‘cargoes’ to other cells to reduce inflammation and promote regeneration. Exosomes are plentiful in our youth but decline with age. Recent research points to exosomes as a way to extend the number of healthy, functional years (extending health span).
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Exosomes secreted by stem cells could be used instead of stem-cell therapy with equal or greater benefit – and without the problems of stem-cell therapies. They could be used to deliver targeted ‘novel’ drugs and have potential as diagnostics.
While trillions of exosomes are produced by stem cells, the real challenge is to ‘purify’ them as drug products. Exopharm owns a purification technology called Ligand-based Exosome Affinity Purification (LEAP). LEAP technology and associated know-how places Exopharm at the forefront of this emerging field worldwide. Exopharm is at clinical stage with pending and current trials for wound healing, dry aged-related macular degeneration and osteoporosis.
Exopharm was founded in 2013 by Dr Ian Dixon, co-founder of the ASX-listed stem-cell therapy developer Cynata Therapeutics. He was also a director of Cell Therapies, which produced adult stem cells for ASX-listed stem cell company Mesoblast. Exopharm listed on the ASX in December 2018.
FORWARD LOOKING STATEMENTS
This announcement contains forward-looking statements which incorporate an element of uncertainty or risk, such as ‘intends’, ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘targets’, ‘aims’, ‘plans’ or ‘expects’. These statements are based on an evaluation of current corporate estimates, economic and operating conditions, as well as assumptions regarding future events. These events are, as at the date of this announcement, expected to take place, but there cannot be any guarantee that such events will occur as anticipated or at all given that many of the events are outside of Exopharm’s control or subject to the success of the Development Program. Furthermore, the Company is subject to several risks as disclosed in the Prospectus dated 6 November 2018.
INHERENT RISKS OF INVESTMENT IN BIOTECHNOLOGY COMPANIES
There are a number of inherent risks associated with the development of biopharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialisation and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Exopharm are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specialising in drug development must be regarded as highly speculative. Exopharm strongly recommends that professional investment advice be sought prior to such investments.
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August 2020 Investor Presentation
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’, ‘clear path to’ 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.
© Exopharm Ltd.
Exopharm Ltd
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Overview
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Exopharm is an Australian clinical stage biotechnology company with unique manufacturing IP for turning exosomes (or EVs) into medicines
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26 staff based in Melbourne, Victoria
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Publicly-traded on the ASX (ASX:EX1) (listed Dec 2018)
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95.47 million shares outstanding, market cap of ~ $30 million
What Makes Us Unique
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LEAP™ process for purifying EVs provides world-beating capability
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One of three companies worldwide with a platform for engineering EVs
Where We are Going
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Monetising LEAP with partnership deals to fund development programs
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Using non-dilutive funding to advance Exopharm’s Naïve EV clinical assets
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Creating EEV assets with pharmaceutical partners to derive near-term revenue
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© Exopharm Ltd.
LEAP is the Only - Commercial scale EV Purification Technology
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State of the Art, EV Purification as of June 2020*
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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
Cost
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- Adapted from https://doi.org/10.1016/j.tibtech.2020.05.012
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) (iv) is a proprietary process that creates proprietary products
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- ** LEAP assessment from Exopharm, based on industrial use to date; LEAP Patents processing through National phases at present
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© Exopharm Ltd.
Exopharm IP Assets are Comprehensive and Provide Essential EV Capabilities
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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
© Exopharm Ltd.
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Naïve EV Program: NEVs are the Future of Regeneration
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2000 AD
Mesenchymal stem cells (MSCs) regenerate tissue, so grow them and transplant them into patients
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“Off-the-shelf” stem cells
2020’s
MSC EVs are what make MSCs work, and could deliver a truly off-the-shelf treatment
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Potential EV Medicine
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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© Exopharm Ltd.
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)
1
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FIRST and ONLY reported human dosing (Jan 2020)
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© Exopharm Ltd.
Naïve EV Factory
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Mobility Sensory
Platelets
Activator
Commercial
Scale EV
Purification
Company Company
Cell Line C Product A Product
Bioreactor
(MSCs)
Respiratory (ARDS) Cardiovascular
Company Company
Company A Cell Bioreactor A ProductCompany
Line Company B Cell Bioreactor B ProductCompany Company B
C Cell
Line Bioreactor C Product Franchise
Line Company
C Product
Company
A Product
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Disease Areas
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© Exopharm Ltd.
Naïve EVs: Strategy and Progress
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Strategy: When adult stem cell companies score wins, follow with more economical, safer offering
Progress: Plexaris™ (EVs from platelets)
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Demonstrated manufacturing process for delivering safe EV treatments
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Demonstrating allogeneic safety
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Cevaris™ (EVs from MSCs)
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Demonstrated efficacy in non-clinical work on sensory and mobility indications
Milestones:
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Autologous Phase I Allogeneic Phase I Allogeneic Phase I
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- Preparing for Phase I study in humans
Potential markets >>$10 billion/yr
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= Achieved in CY 2020
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= Targeted for CY 2020
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© Exopharm Ltd.
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Adult stem cell companies are pivoting their businesses to commercialize exosomes as therapeutics.
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Com anies Reviewed Plannin Clinical Trials: Clinical Trials Runnin : p g g 1. Aegle Therapeutics Aegle Therapeutics 2. Alxerion Biotech Alxerion Biotech 3. Anjarium Biosciences Anjarium Biosciences 4. Aruna Biomedical Aruna Biomedical 5. Capricor Therapeutics Capricor Therapeutics Aegle Therapeutics 6. Codiak Biosciences Codiak Biosciences 1.Codiak BiosciencesAegle Therapeutics 7. Evox Therapeutics Evox Therapeutics 2. Codiak Biosciences 8. ExoCoBio ExoCoBio 3.Capricor TherapeuticsCapricor Therapeutics 9. Exopharm Ltd Exopharm Ltd Evox Therapeutics first dosing Jan 2020 10. NeurExo Sciences NeurExo Sciences 4.Exopharm LtdEvox Therapeutics 11. PureTech Health PureTech Health 12. ReNeuron ReNeuron 13. Tavec Pharma Tavec Pharma 14. Versatope Therapeutics Versatope Therapeutics
© Exopharm Ltd.
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Engineered EV Program: EEVs are the Future of Precision Medicine
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Natural characteristics of Naïve EVs
Engineered EVs (EEVs)
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
>>$100 billion/year
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Cancers Viruses
Rare Neurol.
diseases Illnesses
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=
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EEV Opportunities
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Solve the major problem of drug delivery for pharma partners
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Multiple EEV products and variations
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• Multiple applications
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• Multiple deals
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© Exopharm Ltd.
Pharma Companies Investing Heavily in EEV Deals with Exopharm’s Peers
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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
Discussions underway
As of Jun 2020
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© Exopharm Ltd.
Repurposed Stem EV Companies (6) Cell Companies (4)
Academic (11)
November 11-12, 2020
Codiak (US) Evox (UK) Mantra (US)
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2020 Funding
$100 mln in deals
$100 mln in deals ~$30 mln Series A
ILIAS (Korea) Aegle (US) ~$7 mln
Exopharm
Exopharm Ltd is the only one:
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With IP in all EV technologies
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• To have dosed a human subject
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• That is publicly traded
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EEV Design 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
EV with spike protein attached using EVPS
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Naïve Engineered
Bioreactor
Cells Cells
Commercial
Scale EV
Purification
Naïve EV
CoV Spike on EV Surface RNAi packed into EVs to
targets ACE2+ cells stop CoV replication
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© Exopharm Ltd.
Precision Medicine Factory
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Cancers Viruses
Pharma A
Pharma A
Pharma A
Product 3
Product 3Pharma A
Product 3
Product 3Pharma A Pharma D Pharma A
Rare diseases Neurological diseases
Pharma B
B.1
Pharma B
B.2
Pharma E B.3
Pharma C
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Potential markets for ‘untreatable’ diseases >>$100 billion/year
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© Exopharm Ltd.
Engineered EVs: Strategy and Progress
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Strategy: Provide partners with evidence of Exopharm’s EEV platform and enter into development programs
Progress:
Milestones: EEVs
Plexodox™ (EEVs from platelets)
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Demonstrated ability to enhance generic cancer drug through EV loading
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Demonstrating proof of concept with CNS application
Fortrexo™ (EVs from MSCs)
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Designed program for addressing COVID-19
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Design program for CNS application
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Assembly of IP
Demonstrate Proof of Concept
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First Partnering Deal
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- = Achieved in CY 2020
Potential markets >>$100 billion
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- = Targeted for CY 2020
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© Exopharm Ltd.
Exopharm has Clear Paths to Revenue: Milestones Toward Revenue
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Jan – Jun 2020 Jul – Dec 2020 Jan – Jun 2021 Jul – Dec 2021
EEV IP Added Additional IP Bioprocessing Licensing Revenue
Economic results
PLEXOVAL I PLEXOVAL II
Non-clinical results Pre-IND Phase I US
Phase IIA Plan
Anti-CoV patent lodged POC results
CNS design POC results
EEV Partnership
Naïve EVs
Engineered EVs
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= Key Value Driver
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© Exopharm Ltd.
Our Team is Built to Succeed
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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
•
scientists Industrial know-how
• •
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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© Exopharm Ltd.
Exopharm: What We are Going to Do
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Engineered EV Exopharm’s
Exopharm’s
program offers team has the
EV medicines leads world in
high-value, experience and
will transform the clinical
near term capability to
healthcare development of
pathway to capture its
Naïve EVs
revenue
opportunities
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© Exopharm Ltd.
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