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CAMBIUM BIO LIMITED — Investor Presentation 2021
Mar 2, 2021
64666_rns_2021-03-02_92d3df7d-a88f-4e84-85c1-3a3cc37dad3d.pdf
Investor Presentation
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ASX Announcement
3 March 2021
Regeneus Company Update Investor Webcast Presentation
Regeneus Ltd (ASX: RGS) ( Regeneus or the Company ), a clinical-stage regenerative medicine company, today advises it has released an updated investor presentation.
The presentation will be delivered to investors by CEO Karolis Rosickas during Regeneus’ Company Update Investor Webcast taking place at 11:00am Australian Eastern Daylight Time (AEDT) this morning via Zoom.
To register for the webcast, please follow this link: https://us02web.zoom.us/webinar/register/WN_YyKYF3USS0WusNbNBlafAQ
Registered participants will receive a confirmation email containing the Zoom access link and alternative phone dial-in details.
-ENDS-
About Regeneus
Regeneus Ltd (ASX:RGS) is a Sydney-based clinical-stage regenerative medicine company using stem cell technologies to develop a portfolio of novel cell-based therapies. The regenerative therapies seek to address unmet medical needs in human health markets, focusing on neuropathic pain, including osteoarthritis and various skin conditions, with its platform technologies Progenza and Sygenus. Visit www.regeneus.com.au for more information.
Authorisation & Additional information
Investor and Media Contact
This announcement was authorised by WE Communications the Board of Directors of Regeneus Ltd T: (03) 8866 1200 E: [email protected]
2 Paddington Street, Paddington, NSW 2021 Ph: +61 2 9499 8010 • www.regeneus.com.au • ABN 13 127 035 358
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Company update presentation
Developing next generation pain management and inflammation therapeutics
Regeneus Ltd (ASX:RGS)
03 March 2021
Disclaimer
Summary Information: This Presentation contains summary information about the current activities of Regeneus as at the date of this Presentation. The information in this Presentation is of a general nature and does not purport to be complete. This Presentation does not purport to contain all the information that an investor should consider when making an investment decision nor does it contain all the information which would be required in a disclosure document or prospectus prepared in accordance with the requirements of the Corporations Act. It should be read in conjunction with Regeneus’ other periodic and continuous disclosure announcements lodged with the ASX, which are available at www.asx.com.au. Neither Regeneus nor its directors, employees or advisers give any warranties in relation to the statements and information in this Presentation.
Not an offer: This Presentation is for information purposes only and is not a prospectus, disclosure document, product disclosure statement or other offering document under Australian law or any other law (and will not be lodged with ASIC or any other regulator and is not approved by or registered with any regulator). The Presentation is not and should not be considered an offer or an invitation to acquire New Shares or any other financial products. This Presentation may not be released or distributed in the United States. This Presentation does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or in any other jurisdiction in which such an offer would be illegal. The New Shares have not been, and will not be, registered under the U.S. Securities Act or the securities laws of any state or other jurisdiction of the United States. Accordingly, the New Shares may not be offered or sold, directly or indirectly, in the United States unless such New Shares have been registered under the U.S. Securities Act, or are offered and sold in a transaction exempt from, or not subject to, the registration requirements of the Securities Act and applicable U.S. state securities laws. The distribution of this Presentation in other jurisdictions outside Australia may also be restricted by law and any such restrictions should be observed. Any failure to comply with such restrictions may constitute a violation of applicable securities laws.
Not financial product advice: This Presentation does not constitute financial product or investment advice (nor tax, accounting or legal advice) nor is it a recommendation to acquire New Shares and does not and will not form any part of any contract for the acquisition of New Shares. This Presentation has been prepared without taking into account the objectives, financial situation or needs of any particular investor. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs and seek appropriate advice, including financial, legal and taxation advice appropriate to their jurisdiction. Regeneus is not licensed to provide financial product advice in respect of Regeneus’ shares or any other investment. Cooling off rights do not apply to the acquisition of New Shares.
Financial data: All dollar values are in Australian dollars (“A$”, “AUD”), unless indicated otherwise. Any pro forma financial information included in this Presentation is for illustrative purposes only and is not represented as being indicative of Regeneus’ views on its future financial condition and/ or performance. Any pro forma financial information has been prepared by Regeneus and may not have been prepared in accordance with the measurement and recognition requirements or the disclosure requirements, of applicable accounting standards and other mandatory requirements in Australia.
Future performance: This Presentation contains certain “forward looking statements”. Forward looking statements can generally be identified by the use of forward looking words such as, “expect”, “anticipate”, “likely”, “intend”, “should”, “could”, “may”, “predict”, “plan”, “propose”, “will”, “believe”, “forecast”, “estimate”, “target” “outlook”, “guidance” and other similar expressions within the meaning of securities laws of applicable jurisdictions and include, but are not limited to, indications of, or guidance or outlook on, future earnings or financial position or performance of Regeneus, the outcome and effects of the Offers and the use of proceeds.
The forward looking statements contained in this Presentation are not guarantees or predictions of future performance and involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Regeneus, and may involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct. Refer to the risks section of this Presentation for a summary of certain general and Regeneus specific risk factors that may affect Regeneus. There can be no assurance that actual outcomes will not differ materially from these forward-looking statements. A number of important factors could cause actual results or performance to differ materially from the forward looking statements, including the risk factors set out in this Presentation. Investors should consider the forward looking statements contained in this Presentation in light of those disclosures. The forward looking statements are based on information available to Regeneus as at the date of this Presentation. Except as required by law or regulation (including the ASX Listing Rules), Regeneus undertakes no obligation to provide any additional or updated information whether as a result of new information, future events or results or otherwise. Indications of, and guidance or outlook on, future earnings or financial position or performance are also forward looking statements.
Effect of rounding: A number of figures, amounts, percentages, estimates, calculations of value and fractions in this Presentation are subject to the effect of rounding. Accordingly, the actual calculation of these figures may differ from the figures set out in this Presentation.
Investment risks: An investment in New Shares is subject to investment and other known and unknown risks, some of which are beyond the control of Regeneus including possible loss of income and principal invested. Regeneus does not guarantee any particular rate of return or the performance of Regeneus, nor does it guarantee the repayment of capital from Regeneus or any particular tax treatment. In considering an investment in Regeneus shares, investors should have regard to (amongst other things) the risks outlined in this Presentation.
Disclaimer: To the maximum extent permitted by law, no representation or warranty, express or implied, is made as to the currency, accuracy, reliability or completeness of information in this Presentation and Regeneus and its advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents excludes and disclaims all liability, including without limitation for negligence or for any expenses, losses, damages or costs incurred by you as a result of your participation in the Offer and the information in this Presentation being inaccurate or incomplete in any way for any reason, whether by negligence or otherwise. Regeneus and its advisors make no recommendations as to whether investors or their related parties should participate in the Offers. Statements made in this Presentation are made only as at the date of this Presentation. The information in this Presentation remains subject to change without notice. Regeneus reserves the right to withdraw all or part of the Offers or vary the timetable for the Offers without notice.
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Confidential
2
Company overview
Background
-
Regeneus (“RGS”) is a pioneer cell therapy company founded in Sydney in 2007
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The company went public (ASX:RGS) on the Australian Stock Exchange in 2013
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Two platform technologies leveraging proprietary IP in allogeneic adipose-derived mesenchymal stem cells (“MSC”) and their bioactive secretome (incl. cytokines, extracellular vehicles, miRNA)
-
Successful Phase I trial of Progenza in knee osteoarthritis completed in 2017
-
Signed Progenza collaboration and licensing partnership with Kyocera in Japan in 2020
-
The company has filed or obtained over 80 patents in key geographies
| Financial information | Financial information |
|---|---|
| Share price(02 Mar 2021) | A$ 0.115 |
| Shares issued | 300.3m |
| Market capitalisation | A$ 34.5m |
| Cash(as of 31 Dec 2020) | A$ 4.1m |
| Debt(as of 31 Dec 2020) | - |
| Enterprise value | A$ 30.4m |
Experienced Board and management team
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Barry Sechos
Independent Chairman
Leo Lee
Non-Executive Director
John Chiplin
Non-Executive Director
Karolis Rosickas
Chief Executive Officer
Prof Graham Vesey
CSO & Executive Director
Dr Charlotte Morgan Dr Sinead Blaber Head of R&D Clinical Director
-
President, Novartis Japan
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20+ years experience as a director, business executive, and corporate lawyer
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20+ years in pharma
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Former President of Allergan
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• Executive Director of and Merck Japan
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Sherman Group
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MD of Newstar Ventures
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Former CEO of three listed biotechnology, cancer immunotherapy and software companies
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17 years experience in healthcare and technology
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Co-founder and CEO of SingCell and OME Health
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VP at HSBC M&A in London
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Regeneus co-founder
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20+ years in managing • 10 years experience in product development and biotechnology industry innovation
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Co-founder of BTF, sold to BioMerieux in 2007
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Directed Progenza STEP Trial
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• PhD in Biotechnology • Joined Regeneus in 2009
-
-
PhD in microbiology
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Adjunct Professor at Macquarie University • Joined Regeneus in 2012
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Confidential
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Technology and products
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4
Proprietary allogeneic mesenchymal stem cells and secretome platform
Mesenchymal stem cells
- Multipotent stem cells, which perform multiple functions in human body including direct differentiation, activation of resident stem cells and secretion of bioactive molecules (secretome)
Bioactive Secretome
-
Bioactive molecules (cytokines, chemokines, growth factors, extracellular vesicles) secreted by MSCs
-
- • Reduces inflammation and promotes tissue repair
-
Improves functionality and viability of MSCs
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The combination of MSCs and the bioactive MSC secretome exerts a more powerful therapeutic effect
Allogeneic cells
-
Derived from a single donor
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Can be used in millions of patients
Adipose-derived
- Adipose contains 500-1000x more MSCs than bone marrow or other sources
Safe
-
MSCs are immune-privileged cells, which escape patient’s immune system without the risk of rejection
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No genetic modification of cells
Established mechanism of action
-
Immuno-modulatory properties of MSCs and bioactive secretome
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Direct cell differentiation
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Endogenous repair
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How Regeneus platform technology is different?
MSCs / iPSCs only
-
Generation 1.0 therapies
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Provide only limited functionality through differentiation and engraftment
Progenza MSCs and Bioactive Secretome
Extracellular vesicles (EVs)
-
Novel, early-stage modality
-
Expensive isolation and purification process
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Manufacturing scalability not proven yet Still unknown mechanism of action of individual EVs
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Years away from regulatory approvals
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✓ Secretome enhances viability and functionality of MSCs
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✓ Secretome has independent immunomodulatory functions in inflamed environment
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✓ Scalable and cost-effective manufacturing process
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Established mechanism of action
PROGENZA
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✓ Promotes endogenous
✓ Tissue repair ad-MSCs + Bioactive secretome cartilage repair
Soluble factors:
Cytokines
Chemokines
Growth factors
Differentiation
EVs: ↑ ECM protein secretion
Exosomes ↑ chondrocytes
Micro vesicles
Cell-cell contact
Macrophages NK cells
X
Immune cell Pro-inflammatory Anti-inflammatory Immature Mature ↓ pro-inflammatory cytokines
↑ anti-inflammatory cytokines
Lymphocytes Dendritic cells ↑ anti-catabolic factors
X ↑ matrix remodeling
✓ Immune modulation
↓ T- and B-cells Immature Mature
✓ Reduces inflammation and pain
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The combination of MSCs and the bioactive MSC secretome in Progenza exerts a powerful therapeutic effect via repair and regeneration of endogenous joint tissues, reducing inflammation, modulation of the immune system and pain relief
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Scalable product platforms
Multiple opportunities in pain and inflammation focused indications
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Progenza
MSCs and
Secretome
United States Osteoarthritis
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Orphan
diseases
Wound
healing
Sygenus
Cell free
Neuropathic Secretome
pain
Inflammatory
skin conditions
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The product platforms are protected by a portfolio of 80+ patents covering multiple indications in key markets and expiring in late 2030s
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Strong nonclinical and clinical data
Progenza
Osteoarthritis
Phase 1 (STEP)[1]
-
Confirmed the Primary Endpoints of safety and tolerability at both low and high doses with a single injection
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Confirmed the Secondary Endpoints of efficacy:
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Pain : significant, rapid and sustained pain relief achieved via VAS and WOMAC Pain scores
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Cartilage : halting of disease progression 12-months post-treatment
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Progenza
Neuropathic pain
Preclinical
• Neuropathic pain is central in many disease indications (chronic lower back pain, trigeminal neuralgia, etc.) with no cure for the underlying causes
-
Performed a study on Chronic Constriction Injury (CCI) model using rats and touch stimulator
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Demonstrated that a single injection of Progenza modifies disease in 14 days
Sygenus
Various indications
Preclinical
| Primary indication | Study Type | RoA | End Date | Subject # | Conclusions | ||||
| Topical safety | Safety & tolerability | Topical | Aug 2017 | 33 humans | ✓Safety:Safe & well tolerated in acne prone patients | ||||
| Topical safety | Safety – RIPT | Topical | Oct 2017 | 50 humans | ✓Safety:non-sensitizing and non-irritating | ||||
| Acne | Safety & efficacy | Topical | Jan 2018 | 30 humans | ✓Safety:Safe and well tolerated ✓Efficacy: Significant improvement in acne measurements |
||||
| Age spots | Safety & efficacy | Topical | Mar 2018 | 36 humans | ✓Safety:Safe and well tolerated ✓Efficacy: Significant reduction in age spot size andpigmentation |
Source: (1) Kuah D, Sivell S, Longworth T, et al. Safety, tolerability and efficacy of intra-articular Progenza in knee osteoarthritis: a randomized double-blind placebo-controlled single ascending dose study. J Transl Med 2018;16:49.
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Established chemistry, manufacturing and controls (CMC) process
- Adipose-derived: adipose contains 500-1000 times more MSCs than bone marrow
Source material
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Allogeneic: multiple patients from a single donor. Improved product safety, potency, and consistency
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Rigorous donor screening process
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No genetic reprogramming of cells
Process overview
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Screen healthy donors based on strict cGCP and proprietary criteria
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Isolation, MCB and Expansion of cells to MSC long-term cryoSingle healthy adult Millions of doses from expansion of MSCs into manufacture millions of storage under GMP lipoaspirate single donor two-tiered cell bank MSC doses conditions
- Optimised, highly scalable manufacturing process of up to 300 million doses from a single donor
Advantages
-
No source material or process variability, resulting in a homogenous final product
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Lower cost of goods (COGS) compared to autologous therapies, pluripotent stem cell therapies, or EV therapies
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Potential for further COGS reduction by transitioning to a 3D bioreactor-based manufacturing process
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Advanced process development work for manufacturing cGMP Master Cell Bank (MCB) with a US contract manufacturing organisation
Current status
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Final Product (FP) will be available in late 2021 for Progenza OA Phase 2 trials in the US and Australia
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Well characterised final product
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Established Quality Control (QC) and product release criteria
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Pain and osteoarthritis market opportunity
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Pain – large and growing problem
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Prevalence of chronic pain [(1)]
Lower back pain 28.1%
Knee pain 19.5%
Severe headache or migraine 16.1%
Neck pain 15.1%
Shoulder pain 9.0%
Finger pain 7.6%
Hip pain 7.1%
0.0% 10.0% 20.0% 30.0%
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Large addressable market
1.5bn
people worldwide suffering from pain [(2)]
50%
of patients report inadequate relief [(2)]
Knee Osteoarthritis
is pain and inflammation around the joint
from ‘wear and tear’ on the tissue
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Figure: Age-adjusted prevalence rates of select causes of chronic pain in US adults Sources:
(1) Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research . Washington DC: The National Academies Press; 2011 (2) Chronic Pain and the Health of Populations. Boston University; 2017
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Opportunity in knee osteoarthritis
Large addressable market
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Worldwide United States Japan 5EU: DE, FR, GB, IT, ES
Patients 240m [(1)] 33m [(2)] 25m [(3)] 52m [(4)]
Market size [(4)] $3.5bn $2.6bn $330m $520m
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Attractive market characteristics
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Ageing population Increasing prevalence
of obesity
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Dissatisfaction with No disease-modifying
existing treatments treatments
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Sources:
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1) Osteoarthritis Action Alliance, https://oaaction.unc.edu/oa-module/oa-prevalence-and-burden/ 2) Centers for Disease Control and Prevention (CDC)
-
3) Knee osteoarthritis only. Epidemiology of osteoarthritis in Japan : the ROAD study . 2011
-
4) Estimate for 2026. OpportunityAnalyzer: Osteoarthritis – Opportunity Analysis and Forecasts to 2026 . GlobalData
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Current osteoarthritis treatment market
Current treatments only provide pain relief – not disease modification
less severe OA 50% of diagnosed and prevalent knee OA is moderate-severe ~5% cartilage loss per year as disease progresses
less invasive therapies
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Lifestyle changes
Pain relief
Disease modification
Weight management, exercise Pharma: Paracetamol, non-steroidal and self-management anti-inflammatory drugs, opioids Injectables: Hyaluronic Acid or Corticosteroid Injections
No existing therapies
-
Limited uptake Target symptoms, not the cause
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Short-term adherence Safety concerns Short-term relief, limited efficacy Risk of cartilage degradation with injectables
more severe OA more invasive therapies
Surgery & invasive procedure
Knee Replacement Revision Surgery Bone Marrow Stimulation Bone Realignment
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Invasive surgical intervention
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Long rehabilitation time Limited prosthesis lifespan Expensive
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Where Progenza™fits in current osteoarthritis treatment market
Progenza addresses an unmet need in the current treatment market by providing disease modification and pain relief to address patient symptoms without having to undergo surgery and invasive procedures
less severe OA 50% of diagnosed and prevalent knee OA is moderate-severe ~5% cartilage loss per year as disease progresses
more severe OA
PROGENZA Long-term pain relief, DMOAD, delayed surgery Lifestyle changes Pain relief Disease modification Weight management, exercise Pharma: Paracetamol, non-steroidal and self-management anti-inflammatory drugs, opioids No existing Injectables: Hyaluronic Acid or therapies Corticosteroid Injections
Surgery & invasive procedure Knee Replacement Revision Surgery Bone Marrow Stimulation Bone Realignment
-
Limited uptake Target symptoms, not the cause ✓ Progenza - a safe, potent treatment before
-
Short-term adherence Safety concerns invasive surgical intervention is required Short-term relief, limited efficacy Risk of cartilage degradation with injectables
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Invasive surgical intervention
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Long rehabilitation time Limited prosthesis lifespan Expensive
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Competitive landscape
Progenza is well positioned to become the first in class disease modifying therapy in knee osteoarthritis
| Product | Progenza | Tanezumab | Fasinumab | AlloJoin | Cymerus | PPS | Invossa |
| Stage | P2 | BLA | P3 | P2 | P3 | P3 | P3 (tbc) |
| Treats symptoms (pain) | ✓ | ✓ | ✓ | ✓ | unknown | ✓/ | ✓ |
| Potentially disease modifying | ✓ | | | unknown | unknown | | ✓ |
| Safety profile | ✓ | | | ✓ | unknown | ✓ | |
| Cost of manufacturing | ✓ | ✓ | ✓ | ✓ | ✓/ | ✓ | |
Source: GlobalData, internal company analysis
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Value creation plan
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Value drivers for Regeneus
Multiple levers to create shareholder value
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Licensing Independent Strategic
-
and development M&A
-
partnerships
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• Launch Progenza OA in partnership with • Prepare for Progenza OA Phase 2 trial in • Consider strategic exit to a large pharma or Kyocera in Japan the US a large cap biotech company
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Explore licensing opportunities for Progenza OA worldwide, ex-Japan
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Prepare for Progenza OA Phase 2 trial in Australia
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Progenza licensing opportunities in other • Grant opportunities in the US and Australia indications (e.g. neuropathic pain) • Sygenus co-development with medical
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• Licensing of Sygenus dermatology, cosmetics companies, and Government agencies
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Grant opportunities in the US and Australia
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Assess synergistic bolt-on acquisitions
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Research partnerships with Monash University, University of Adelaide, UTS, and A*STAR Singapore
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Development pipeline
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Platform Technology Indication Geography Stage Current status
Preclinical Phase 1 Phase 2 Phase 3 Approval
• Collaboration with Kyocera signed in 2020
2015 2017 2022 2024
Japan •
PMDA Conditional Approval expected in 2024
• FDA pre-IND consultations expected in Q2 2021
US 2015 2017 2022
Knee • Potential for RMAT designation and NIH funding
osteoarthritis
Australia 2015 2017 2022 • NHMRC grant application submitted, expected outcome in Q2 2021
• ATMP designation obtained in 2018
Europe 2015 2017 • Licensing options being explored
Neuropathic pain Global 2019 • Co-development and licensing options being explored
Burns, wounds
Neuropathic pain
• Expected Phase 1 trial in pain
Global 2018 2021
• Co-development and licensing options being explored
Inflammatory skin
conditions
Rare/orphan skin
diseases
Progenza
with bioactive secretome
Allogeneic adipose-derived MSCs
Sygenus secretome
MSC-derived bioactive
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Collaboration and licensing agreement with Kyocera for osteoarthritis in Japan
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Expedited path to market in Japan
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Background
Deal
-
Japan headquartered global diversified conglomerate
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The Collaboration and License Agreement was signed in August 2020
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Revenue $15.5bn, market capitalisation $23.6bn
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Life & Environment division manufactures medical products, including orthopaedic joint implants
-
With no. 4 position in prosthetic knee market, Kyocera has an established network of orthopaedic physicians to distribute Progenza™knee OA cell therapy
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Includes upfront and milestones payments of US$19m, and single to double-digit royalties on product sale
-
Kyocera responsible for product development, manufacturing, regulatory, and commercialisation processes in Japan
-
Exclusivity for knee osteoarthritis in Japan
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Entering into the agreement with Regeneus demonstrates Kyocera’s belief in the Progenza™technology
-
Regeneus retains the right to negotiate licenses with parties within Japan for indications other than knee OA and outside of Japan for all indications
Accelerated timeline to Conditional Approval
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License
Comprehensive DD and
Agreement Tech transfer GMP Final Product manufacturing
negotiations
signed
PD, nonclinical work
2018 Aug-20 Apr-21 Sep-21 mid-22
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License PMDA
Agreement Tech transfer GMP Final Product manufacturing Phase 2 trial Conditional
signed Approval
PD, nonclinical work
Aug-20 Apr-21 Sep-21 mid-22 2023 2024
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Progenza™osteoarthritis opportunity in United States
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Regeneus plans to initiate a Phase 2 trial in the US in 2022
Market opportunity
US osteoarthritis therapeutics market (USD bn)
US osteoarthritis patients
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75% of
global OA
market
33 million
CAGR:
9.1%
2.6
1 in 7
adults
1.1
2016 2026
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Source: GlobalData
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Source: Osteoarthritis Action Alliance
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Expected Progenza™osteoarthritis US Phase 2 trial timeline
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| 2021 | 2021 | 2021 | 2021 | 2021 | 2021 | 2021 | 2021 | 2021 | 2021 | 2021 | 2022 | 2022 | 2022 | 2022 | 2022 | 2022 | 2022 | 2022 | 2022 | 2022 | 2022 | 2022 | 2023 | 2023 | 2023 | 2023 | 2023 | 2023 | 2023 | 2023 | 2023 | 2023 | 2023 | 2023 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| month | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
| Regulatory GAP analysis | |||||||||||||||||||||||||||||||||||
| FDA Pre-IND Meeting | |||||||||||||||||||||||||||||||||||
| NIH grant funding process | |||||||||||||||||||||||||||||||||||
| Non-GMP product | |||||||||||||||||||||||||||||||||||
| Nonclinical study | |||||||||||||||||||||||||||||||||||
| GMP product available | |||||||||||||||||||||||||||||||||||
| IND submission | |||||||||||||||||||||||||||||||||||
| IRB approval | |||||||||||||||||||||||||||||||||||
| Recruitment | |||||||||||||||||||||||||||||||||||
| Follow-up period | |||||||||||||||||||||||||||||||||||
| Initial read-outs |
Regulatory Financial CMC Nonclinical Clinical
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Other near term value accreting opportunities
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| Product | Geography | Stage | Indication | Status | Timing |
|---|---|---|---|---|---|
| Progenza | Australia | Phase 2 | Knee osteoarthritis | • Similar clinical trial design to the Progenza OA Phase 2 trial in the US • Ability to use the same Progenza cGMP product as in the US • A grant application to fund the trial is being reviewed by the NHMRC |
Q2 2021 |
| Sygenus | Australia | Phase 1 | Pain | • Phase 1 trial with human subjects in a pain indication | Q2 2021 |
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Regeneus investment highlights
| Leading, differentiated technology platform |
• A unique combination of stem cells and their bioactive secretome exerts superior therapeutic effect • Applicable in a broad range of pain and inflammation indications • A scalable and cost effective manufacturing process • IP has been developed and is fully owned by Regeneus |
|---|---|
| Attractive market potential |
• Global pain management market is a growing and significant multi billion-dollar opportunity • Large unmet market need for disease-modifying therapeutics in osteoarthritis • Secular tailwinds in the osteoarthritis market – ageing population and increasing prevalence of obesity |
| ProgenzaTM OA Phase 2 ready asset |
• Progenza OA is a Phase 2 ready asset with strong nonclinical and Phase 1 data — validated by Kyocera during the extensive technology due diligence process • Active pipeline of potential licensing opportunities in key geographies |
| Near term value accreting opportunities |
• Kyocera partnership to deliver additional US$13m in milestone payments in the next 3-4 years • Opportunities beyond osteoarthritis in Japan: — Progenza OA Phase 2 trial in the United States (2022) — Progenza OA Phase 2 trial in Australia (2022) — Sygenus Pain Phase 1 trial in Australia (2021) |
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Contact details
[email protected] www.regeneus.com
Regeneus Ltd
2 Paddington Street Paddington, NSW 2021 Australia
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/regeneus-ltd
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@regeneus /regeneus
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