Regeneus Investor Presentation ASX Small & Mid Cap Conference Developing the next generation of pain management and inflammation therapeutics September 2020 Regeneus Ltd (ASX:RGS)
Disclaimer Forward-Looking Statements This Presentation contains certain statements which constitute forward-looking statements or information ("forward-looking statements”) . These forward- looking statements are based on certain key expectations and assumptions, including assumptions regarding the general economic and industry conditions in Australia and globally and the operations of the Company. These factors and assumptions are based upon currently available information and the forward-looking statements contained herein speak only as of the date hereof. Although the Company believes the expectations and assumptions reflected in the forward-looking statements are reasonable, as of the date hereof, undue reliance should not be placed on the forward- looking statements as the Company can give no assurances that they will prove correct and because forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could influence actual results or events and cause actual results or events to differ materially from those stated, anticipated or implied in the forward-looking statements. These risks include, but are not limited to: uncertainties and other factors that are beyond the control of the Company; global economic conditions; risks associated with biotechnology companies, regenerative medicine and associated life science companies; delays or changes in plans; specific risks associated with the regulatory approvals for or applying to the Company’s products; commercialisation of the Company’s products and research and development of the Company’s products; ability to execute production sharing contracts, ability to meet work commitments, ability to meet the capital expenditures; risks associated with stock market volatility and the ability of the Company to continue as a going concern. The Company assumes no obligation to update any forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements, except as required by securities laws. No offer to sell, issue or recommend securities This document does not constitute an offer, solicitation or recommendation in relation to the subscription, purchase or sale of securities in any jurisdiction. Neither this presentation nor anything in it will form any part of any contract for the acquisition of securities. 2
Regeneus Company Snapshot Regeneus Ltd (ASX:RGS) is a clinical-stage regenerative medicine 1 Year Share Price Chart company using stem cell technologies to address unmet medical needs in pain and inflammation. $0.17 $0.15 • Targeting pain and inflammation diseases - inc. osteoarthritis (OA) $0.13 and various skin conditions, with stem cell platform technologies $0.11 Progenza and Sygenus $0.09 • Clear commercailisation pathway – recent deal licence and $0.07 commercialisation deal with Japanese giant Kyocera for Progenza for the treatment of Knee Osteoarthritis in Japan. $0.05 • Clinically-validated technology with strong IP • Addressing significant unmet need for regenerative, non-invasive, ASX Code RGS pain treatments as markets move away from opioids : Shares on Issue (million) 277.8 • ‘ Multiple shots at goal’ – various clinical development opportunities Trading Range (12 months to 4 September 2020) $0.049 - $0.200 • Experienced leadership and board - strong track record of bringing Market capitalisation as at 4 September 2020 51.4m medical technologies to market. 1 Osteoarthritis market set to be worth $3.5B by 2026 https://www.globaldata.com/osteoarthritis-7mm-market-set-to-be-worth-3-5-billion-by-2026/ 2 Boston University, Chronic Pain and the Health of Populations (2017) 3
The Problem with Pain & Regeneus’ role in this • ~1.5 billion people worldwide suffer from pain; ~ 50% report inadequate relief 1 • Current treatments vary, but only address symptoms, not cause of pain. Pain is a global • Opioids block pain signals to brain market • Neuropathic pain = pain caused by damage or disease affecting the somatosensory nervous system. • Mesenchymal Stem Cells (MSCs) Regenerative • Differentiate into other cells medicine’s role • Have anti-inflammatory and anti-scarring applications • in treating pain Autologous (own cells) vs allogenic (donor) • MSCs can alleviate pain symptoms and modify underlying cause of disease causing pain • MSCs and their Secretrome (‘bioactive soup’) Regeneus’ • Clinically validated – Phase I trial for MSC and Secretome technology (Progenza) point of for Knee Osteoarthritis difference • Platform technology can target multiple diseases and indications 1 Boston University, Chronic Pain and the Health of Populations (2017) 4
Why invest in Regeneus? Targeting growing pain and inflammation market Significant Global pain management drugs market estimated to reach $85.5B by 2027 1 market Significant unmet clinical need for regenerative, non-invasive, pain treatments US$3.5B market in Osteoarthritis (OA) alone; Japan market to be worth $350M opportunity in 2026 2 Two platform technologies: Innovative • Progenza™ (stem cells and their secretions) – Phase I study complete • platform Sygenus (secretions) – pre-clinical stage Backed by high quality R&D partners – scientific partnership model technologies Comprehensive IP portfolio across key markets Exclusive licensing & collaboration agreement for Progenza OA in Japan with Kyocera Transformative Significant upfront & milestone payment (A$27M) + future royalties against sales commercialisat Kyocera to invest in Japan Manufacturing, Clinical Study, Registration & ion deal signed Commercialisation. Fully funded to Japan commercialisation (expected in 2023-24) 1 Allied Market Research, Pain Management Drugs Market by Drug Class, (NSAIDS, Anesthetics, Anticonvulsant, Anti-Migraine Drug, Antidepressant Drugs, Opioids, and Non-Narcotic Analgesics) and 5 Indication (Arthritic Pain, Neuropathic Pain, Cancer Pain, Chronic Pain, Post-Operative Pain, Migraine, and Fibromyalgia): Global Opportunity Analysis and Industry Forecast, 2019 – 2027 (2020) 2 Osteoarthritis market set to be worth $3.5 billion by 2026
Upcoming Milestones Phase II trial for Progenza™ OA – expected 2021-22 Target Progenza OA commercialisation in Japan in 2023-24 Expansion of clinical pipeline into other indications in neuropathic pain Continue to execute revised company strategy and streamline operations New scientific partnership model allows for technology licensing Invest in manufacturing capabilities to facilitate technology scale up 6
Thank you Investor Relations WE-AURegeneus@we-worldwide.com www.Regeneus.com Twitter.com/Regeneus Linkedin.com/company/regeneus-ltd 7
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