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Corporate Presentation

Developing next generation pain management and inflammation therapeutics

Regeneus Ltd (ASX:RGS)

October 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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Company overview

Background

Regeneus (“RGS”) is a pioneer cell therapy company founded in Sydney in 2007
The company went public (ASX:RGS) on the Australian Securities Exchange in 2013
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(21 Sep 2021)	A$ 0.075
Shares issued	303.5m
Market capitalisation	A$ 22.8m
Cash(as of 30 Jun 2021)	A$ 3.8m
Debt(as of 30 Jun 2021)	A$ 1.5m
Enterprise value	A$ 20.5m

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
20+ years experience as a director, business executive, and corporate lawyer
20+ years in pharma
Former President of Allergan
• Executive Director of and Merck Japan
Sherman Group
MD of Newstar Ventures
Former CEO of three listed biotechnology, cancer immunotherapy and software companies
17 years experience in healthcare and technology
Co-founder and CEO of SingCell and OME Health
VP at HSBC M&A in London
Regeneus co-founder
20+ years in managing • 10 years experience in product development and biotechnology industry innovation
Co-founder of BTF, sold to BioMerieux in 2007
- Directed Progenza STEP Trial
- • PhD in Biotechnology • Joined Regeneus in 2009
PhD in microbiology
Adjunct Professor at Macquarie University • Joined Regeneus in 2012

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Regeneus investment highlights

Pioneering regenerative medicine company developing next generation cell-based therapies to manage pain and inflammation

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
Progenza 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 years • Opportunities beyond osteoarthritis in Japan: — Progenza OA Phase 2 trial in the United States (mid 2022) — Potential Sygenus Pain Phase 1 trial in Australia (early 2022)

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Technology and products

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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
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
No genetic modification of cells

Superior efficacy

✓ Sustained pain relief for 3, 6, 12 months
✓ Disease modifying cartilage repair
✓ Potentially, first-in-class disease modifying osteoarthritis drug (DMOAD)

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How Regeneus platform technology is different to other regenerative medicine technologies

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MSCs / iPSCs only
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Extracellular vesicles (EVs)

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• Generation 1.0 therapies • Emerging novel, early-stage modality
 Now well understood to provide only limited  Expensive isolation and purification process
functionality through differentiation and
 Manufacturing scalability not proven yet
engraftment
 Have underperformed in clinical trials Progenza  Still unknown mechanism of action of
individual EVs
MSCs and Bioactive Secretome
 Years away from regulatory approvals
✓ Secretome enhances viability and
functionality of MSCs
✓ Secretome has independent immuno-
modulatory functions in inflamed
environment
✓ Scalable and cost-effective
manufacturing process
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Established Progenza mechanism of action in knee osteoarthritis

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
Ongoing
partnering
MSCs and
discussions
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 & clinical data supports platform development across multiple indications

Progenza

Osteoarthritis

Phase 1 (STEP)[1]

Confirmed the Primary Endpoints of safety and tolerability at both low and high doses with a single injection
Confirmed the Secondary Endpoints of efficacy:
Pain : significant, rapid and sustained pain relief achieved via VAS and WOMAC Pain scores
Cartilage : halting of disease progression 12-months post-treatment

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Progenza

Neuropathic pain is central in many disease indications (chronic lower back pain, trigeminal neuralgia, etc.) with no cure for the underlying causes

Neuropathic pain

Performed a study on Chronic Constriction Injury (CCI) model using rats and touch stimulator

Preclinical

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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Well established chemistry, manufacturing and controls (CMC) process

Adipose-derived: adipose contains 500-1000 times more MSCs than bone marrow

Source material

Allogeneic: multiple patients from a single donor. Improved product safety, potency, and consistency
Rigorous donor screening process
No genetic reprogramming of cells

Process overview

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Screen healthy donors Isolation, MCB and Expansion of cells to MSC long-term cryoSingle healthy adult based on strict cGCP expansion of MSCs into manufacture millions of storage under GMP lipoaspirate and proprietary criteria two-tiered cell bank MSC doses conditions

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Millions of doses from single donor

✓ Optimised, highly scalable manufacturing process of up to 100 million doses from a single donor

Advantages

✓ No source material or process variability , resulting in a homogenous final product

✓ Lower cost of goods (COGS) compared to autologous therapies, pluripotent stem cell therapies, or EV therapies

✓ Potential for further COGS reduction by transitioning to a 3D bioreactor-based manufacturing process

cGMP Master Cell Bank (MCB) ready

Current status

Final Product (FP) will be available in mid 2022 for the Progenza OA Phase 2 trial in the US
Well characterised Final Product
Established Quality Control (QC) and product release criteria

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Pain and osteoarthritis market opportunity

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Pain is large, growing problem worldwide, with significant unmet need

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Prevalence of chronic pain [(1)] Large addressable market
Lower back pain 28.1%
1.5bn
Knee pain 19.5%
people worldwide suffering from pain [(2)]
Severe headache or migraine 16.1%
Neck pain 15.1%
50%
Shoulder pain 9.0%
of patients report inadequate relief [(2)]
Finger pain 7.6%
Knee Osteoarthritis
Hip pain 7.1%
is pain and inflammation around the joint
0.0% 10.0% 20.0% 30.0%
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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Knee osteoarthritis pathophysiology

Osteoarthritis is the most common joint abnormality affecting humans

Osteoarthritis is an active dynamic disease of the entire joint involving an imbalance between joint tissue repair and joint destruction. Complex pathogenesis involving mechanical, inflammatory and metabolic factors leading to joint destruction.

Pain is central clinical issue for patients

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Healthy joint Osteoarthritic joint
✓ Healthy articular cartilage  Synovial fibrosis and inflammation
 Subchondral bone remodelling
✓ Non-inflamed synovium  Cartilage degradation
 New nerve growth
✓ Intact subchondral bone  Osteophyte formation
 New blood vessel formation
✓ Stable environment  Pro-inflammatory and degradative environment
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Continuum of treatment options for knee osteoarthritis

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Low
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High
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Interventional
Lifestyle modification Analgesics & Opioids Surgery treatments
• Weight loss • Paracetamol • Steroid injections • Total knee arthroplasty (TKA) • Exercise • Oral and topical NSAIDs • Hyaluronic acid injections • Physio therapy • Opioids • Nerve ablation • PRP, BMAC, amniotic tissue
Limited uptake  Target symptoms, not the cause  Safety concerns from repeat  Invasive surgical intervention  Short-term adherence  Short-term relief, limited efficacy injections  Long rehabilitation time  Risk of opioid addiction  Risk of accelerated cartilage  Limited prosthesis lifespan degradation  High cost (US$35k)
Hyaluronic acid not endorsed by medical associations Opportunity for diseasemodifying therapeutics

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Large addressable market with strong growth fundamentals

Large addressable market – interventional knee osteoarthritis treatments to manage advanced pain (steroids, hyaluronic acid, other therapies)

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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)] $6.1bn $2.6bn $1.5bn $2.0bn
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Attractive market characteristics

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Ageing population
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Increasing prevalence
of obesity
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Dissatisfaction with No disease-modifying
existing treatments treatments
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Sources:

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) GlobalData, Bruder Consulting, SmarTRAK, internal estimates

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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 Kyocera in Japan
Explore licensing opportunities for Progenza OA worldwide, ex-Japan
Progenza licensing opportunities in other indications (e.g. neuropathic pain)
Licensing of Sygenus
Progenza OA Phase 2 trial in the US
Grant opportunities in the US and Australia
Sygenus co-development with medical dermatology, cosmetics companies, and Government agencies
Research partnerships with Monash University, University of Adelaide, UTS, and A*STAR Singapore
Consider strategic exit to a large pharma or a biotech company with significant potential for synergies
Assess synergistic bolt-on acquisitions

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Advanced clinical 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
Japan 2015 2017 2022 2025 • PMDA Conditional Approval expected in 2024 1
Knee • FDA Pre-IND consultation scheduled in Q4 2021
osteoarthritis US 2015 2017 2022 2024 2027 • IND Application planned in Q2 2022 2
• EU ATMP designation obtained in 2018
RoW 2015 2017
• Out-licensing options being explored
Neuropathic pain Global 2019 • Co-development and out-licensing options being explored
Pain Australia 2018 2022 • Phase 1 trial to commence in Q1 2022 3
Burns, wounds
Inflammatory skin Global 2018 • Co-development and out-licensing options being explored
conditions
Rare/orphan skin
diseases
Progenza
bioactive secretome
Allogeneic ad-MSCs with
Sygenus secretome
MSC-derived bioactive
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Collaboration and licensing agreement with Kyocera for osteoarthritis in Japan

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Regeneus is well on track to fulfil its obligations under agreement and earn future milestone payments and royalties

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Kyocera is Japan headquartered global diversified conglomerate
Revenue $15.5bn, market capitalisation $23.6bn
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
Entering into the agreement with Regeneus demonstrates Kyocera’s belief in the Progenza technology
Kyocera responsible for product development, manufacturing, regulatory, and commercialisation processes in Japan
Regeneus retains the right to negotiate licenses with parties within Japan for indications other than knee OA and outside of Japan for all indications

Milestone	Payment			Timing (CY)
Execution of Agreement	JPY 100m	Q3-20

Data transfer	USD 4.0m	Q3-20	Q4-20
Establishment of manufacturing process	USD 3.0m		Q4-20	Q4-22


50% of patients recruited for Phase 2 trial	USD 1.5m				Q1-23

100% of patients recruited for Phase 2 trial	USD 1.5m					Q2-23

Submission of New Drug Application (NDA)	USD 3.0m						2024
National Health Insurance (NHI) price listing	USD 4.0m							2025
Total	USD 17.7m

Royalties from product sale	Single to double digit %							2025

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Large unmet need presents significant market opportunity in OA in United States

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Knee OA patients (global) 240M
Prevalent OA patients (US) 33M
Symptomatic prevalent knee OA cases 17M
Diagnosed knee OA cases 5M
Avg. OA knees per patient 1.5x
Diagnosed OA knees 7.5M
Steroid injections Hyaluronic Acid injections Opioids & other therapies Total knee arthroplasty
Annual procedures 4M 2M 900k 750k
Market size
$1bn $1bn $0.6bn $26bn
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Sources:

Osteoarthritis Action Alliance, https://oaaction.unc.edu/oa-module/oa-prevalence-and-burden/; Centers for Disease Control and Prevention (CDC); “ Osteoarthritis – Opportunity Analysis and Forecasts to 2026”

GlobalData, Bruder Consulting

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Regeneus has focused execution plan to commercialise Progenza in United States

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Regeneus is on track to launch Progenza knee osteoarthritis Phase 2 trial in 2022

Working with IQVIA on the FDA PreIND Consultation process
GMP manufacturing with the US based CDMO
Indicative pivotal clinical trial design includes 180 patients – 60 patients (low dose), 60 patients (high dose), 60 patients (control)
Primary endpoints – 12 months pain reduction, knee function and stiffness, cartilage volume and thickness (disease modification)

Master Cell Bank manufacturing FDA Pre-IND Consultation GMP Investigational Drug manufacturing Non-clinical study IND and IRB approvals Patient recruitment Follow-up period BLA and Approval Phase 3 trial End of Phase 2 FDA meeting Activity Timing (CY) Q4-20 Q3-21 Q1-24 Q4-21 Q3-21 Q2-22 Q3-21 Q1-22 Q2-22 Q3-22 Q3-22 Q4-22 Q3-22 Q4-23 2024 2026 2027 2028	Master Cell Bank manufacturing FDA Pre-IND Consultation GMP Investigational Drug manufacturing Non-clinical study IND and IRB approvals Patient recruitment Follow-up period BLA and Approval Phase 3 trial End of Phase 2 FDA meeting Activity Timing (CY) Q4-20 Q3-21 Q1-24 Q4-21 Q3-21 Q2-22 Q3-21 Q1-22 Q2-22 Q3-22 Q3-22 Q4-22 Q3-22 Q4-23 2024 2026 2027 2028	Master Cell Bank manufacturing FDA Pre-IND Consultation GMP Investigational Drug manufacturing Non-clinical study IND and IRB approvals Patient recruitment Follow-up period BLA and Approval Phase 3 trial End of Phase 2 FDA meeting Activity Timing (CY) Q4-20 Q3-21 Q1-24 Q4-21 Q3-21 Q2-22 Q3-21 Q1-22 Q2-22 Q3-22 Q3-22 Q4-22 Q3-22 Q4-23 2024 2026 2027 2028	Master Cell Bank manufacturing FDA Pre-IND Consultation GMP Investigational Drug manufacturing Non-clinical study IND and IRB approvals Patient recruitment Follow-up period BLA and Approval Phase 3 trial End of Phase 2 FDA meeting Activity Timing (CY) Q4-20 Q3-21 Q1-24 Q4-21 Q3-21 Q2-22 Q3-21 Q1-22 Q2-22 Q3-22 Q3-22 Q4-22 Q3-22 Q4-23 2024 2026 2027 2028	Master Cell Bank manufacturing FDA Pre-IND Consultation GMP Investigational Drug manufacturing Non-clinical study IND and IRB approvals Patient recruitment Follow-up period BLA and Approval Phase 3 trial End of Phase 2 FDA meeting Activity Timing (CY) Q4-20 Q3-21 Q1-24 Q4-21 Q3-21 Q2-22 Q3-21 Q1-22 Q2-22 Q3-22 Q3-22 Q4-22 Q3-22 Q4-23 2024 2026 2027 2028
Q4-21
Q3-21 Q2-22
Q3-21 Q1-22
	Q2-22 Q3-22
		Q3-22 Q4-22
		Q3-22 Q4-23
			Q1-24
			2024 2026
				2027 2028

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Progenza is well positioned to enter interventional knee osteoarthritis care in US

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n/a $26bn
•
Cell therapy Total knee arthroplasty .
$0.6bn
PRP, nerve ablation, BMAC
$1bn
Hyaluronic Acid (HA)

$1bn
Steroids, small mol.

0 $500 $2,500 $4,000 $15,000+
Average Selling Price (Medicare)
Sources: Bruder Consulting, company websites, Medicare, SmarTRAK Note: * denotes Phase 3 asset
12 months & DM
12 months
6 months
Efficacy – pain relief and disease modification (DM)
3 months
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Sygenus collaboration with Department of Defence in Australia

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Opportunity to commercialise Sygenus cell free platform in clinical applications

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Timing (CY)	Timing (CY)	Timing (CY)

Q2-21

Q2-21 Q3-21

	Q3-21 Q4-21

		Q1-22 Q2-22

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Regeneus investment highlights

Pioneering regenerative medicine company developing next generation cell-based therapies to manage pain and inflammation

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
Progenza 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 years • Opportunities beyond osteoarthritis in Japan: — Progenza OA Phase 2 trial in the United States (mid 2022) — Potential Sygenus Pain Phase 1 trial in Australia (early 2022)

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Appendix: Glossary

Stem cells are special human cells that are able to develop into many different cell types. Typical sources of stem cells are adipose (fat), bone marrow, placenta, and umbilical cord.
Mesenchymal stem cells (MSCs) - multipotent adult stem cells present in tissues including bone marrow, fat tissue. MSC’s can differentiate into multiple tissue including bone, cartilage, muscle and fat cells, and connective tissue.
Secretome - proteins secreted by cells into extra-cellular space (outside of cells), and includes bioactive molecules like enzymes, growth factors and signaling proteins such as cytokines and chemokines which regulate immune response.
Adipose tissue – fat tissue
Allogeneic cells – single donor cells used with multiple patients
Pluripotent cells – cells that can develop into any cell type in the body
Multi-potent cells – cells that can develop into more than one cell type, but differentiation is more limited compared to pluripotent cells
iPSC – induced pluripotent stem cells, a type of pluripotent stem cell derived from adult cells that have been genetically reprogramed to an embryonic stem cell-like state
FDA – Food and Drug Administration, the regulatory body in the United States
PMDA – Pharmaceuticals and Medical Devices Agency, the regulatory body in Japan
cGMP – Current good manufacturing practice regulations enforced by the FDA. Provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities. All drug manufacturers have to comply with cGMP regulations
PRP – Platelet Rich Plasma, treatment for knee osteoarthritis
BMAC – Bone Marrow Aspirate Concentrate (bone marrow stem cell treatment) for knee osteoarthritis
EV – extracellular vesicles

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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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AI assistant

CAMBIUM BIO LIMITED — Investor Presentation 2021

64666_rns_2021-10-27_98159025-9677-4bd3-80ad-99eae9afec1e.pdf

Corporate Presentation

Disclaimer

Company overview

Background

Experienced Board and management team

Independent Chairman

Non-Executive Director

Non-Executive Director

Chief Executive Officer

CSO & Executive Director

Regeneus investment highlights

Proprietary allogeneic mesenchymal stem cells and secretome platform

Mesenchymal stem cells

Bioactive Secretome

Allogeneic cells

Adipose-derived

Safe

Superior efficacy

How Regeneus platform technology is different to other regenerative medicine technologies

Extracellular vesicles (EVs)

Established Progenza mechanism of action in knee osteoarthritis

PROGENZA

Scalable product platforms

Multiple opportunities in pain and inflammation focused indications

Strong nonclinical & clinical data supports platform development across multiple indications

Well established chemistry, manufacturing and controls (CMC) process

Source material

Pain and osteoarthritis market opportunity

Pain is large, growing problem worldwide, with significant unmet need

Knee osteoarthritis pathophysiology

Continuum of treatment options for knee osteoarthritis

Large addressable market with strong growth fundamentals

Large addressable market – interventional knee osteoarthritis treatments to manage advanced pain (steroids, hyaluronic acid, other therapies)

Attractive market characteristics

Sources:

Value drivers for Regeneus

Advanced clinical development pipeline

Collaboration and licensing agreement with Kyocera for osteoarthritis in Japan

Large unmet need presents significant market opportunity in OA in United States

Sources:

Regeneus has focused execution plan to commercialise Progenza in United States

Progenza is well positioned to enter interventional knee osteoarthritis care in US

Sygenus collaboration with Department of Defence in Australia

Regeneus investment highlights

Appendix: Glossary

Contact details

Regeneus Ltd

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CAMBIUM BIO LIMITED Investor Presentation 2021