CAMBIUM BIO LIMITED — AGM Information 2018

Nov 21, 2018

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Annual General Meeting

22 November 2018

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.

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2

Agenda

1. FY18 Achievements

2. Japan Update

3. FY18 Financial Results

4. Patent Portfolio Update

5. Outlook

6. Investment Summary

Supporting Information

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3

FY18 Achievements

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4

FY18 Achievements

Progenza

• Significant progress to establish AGC’s manufacturing capabilities of Progenza to prepare for commercial-scale production and further clinical trials in Japan

• Second Japanese licence deal on track for H1 FY19 , as management significantly advances discussions to secure a partner for the Phase 2 trial and clinical development and commercialisation of Progenza

• Journal of Translational Medicine[1] publishes positive results from Progenza Phase 1 STEP safety trial, showing disease modification in patients with knee osteoarthritis

• Progenza granted Advanced Therapy Medicinal Products (ATMP) classification by Committee of Advanced Therapies of the European Medicines Agency, recognising it as a regenerative therapy within the EU’s legal and regulatory framework

• US[2] and EU Patents[3] to be granted for the composition, manufacture and use of Progenza

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1. Kuah et.al. JTranslMed (2018) 16:49. 2. US Patent Application Number 14/342479 “Therapeutics using adipose cells and cell secretions.” 3. EU Patent EP 2 744 892 “Therapeutics using adipose cells and cell secretions” . Patent allowed in October 2018.

5

FY18 Achievements

Sygenus

• Sygenus preclinical trial delivers positive results in post-operative pain study, demonstrating a sustained analgesic affect, which was longer lasting than morphine

• Positive trial results from the topical application of Sygenus gel, which was shown to significantly reduce the appearance of non-inflammatory lesions and significantly reduced patients’ acne global severity score after a 6-week period

• Positive trial results from the topical application of Sygenus gel, which was shown to significantly lighten the colour and size of age spots, increase skin smoothness and was well tolerated by patients

• Broad Australian patent granted for the topical application of Sygenus in the treatment of aging skin and age spots

• Chinese patent for the use of Sygenus in the topical treatment of Acne, providing commercial rights in China to 2032

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FY18 Achievements

RGSH4K Cancer Immunotherapy Vaccine

• Completed Phase 1 ACTIVATE trial

• Primary endpoint of safety and tolerability met

• Signs of immune stimulation in patients, as demonstrated in changes in cancer markers, immune cells and cytokines, with some patients showing preliminary indications of anti-tumour activity

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Japan Update

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Update on Japan: AGC Manufacturing Licence

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Progenza knowCell production how successfully facility established transferred to at AGC’s Yokohama AGC Research Centre

Knowledgeable The AGC team is AGC developing team with able to replicate the processes to further considerable cell processes for the industrialise and therapy Progenza production scale-up the experience method used in the manufacturing recruited STEP trial process

This foundation underpins AGC's goal to manufacture Progenza under Current Good Manufacturing Practices (cGMP) for clinical studies and commercial supply in Japan

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Japan Update: Poised for clinical and marketing partnership

Licence represents inflection point which will drive growth in long term shareholder value

• Significant progress made towards finalising terms and conditions to secure Regeneus’ first clinical partner for Progenza in Japan

• Management anticipates the partnership to be secured and details of this collaboration will be announced this quarter

• This clinical collaboration will be an inflexion point for Regeneus, complementing the existing manufacturing relationship and commercial venture with AGC and positioning the company in Japan to grow long-term shareholder value

• Collaboration will provide a foundation for new collaborations in other key markets

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Marketing
Secure Clinical Conditional
Phase 2 Trial &
Partner Approval
Distribution
Clinical and marketing partner
Secure
Technology GMP
Manufacturing transfer Manufacture Full Scale production
Partner
Exclusive licensed
manufacturer
Q2 FY 2017 Q2 FY 2019
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Clinical and marketing partner
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Japan: Significant Regenerative Medicine Corporate Activity

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$102.5 million acquisition

• Universal Donor Cell technology

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$630 million acquisition

• Belgian BioTech

• Exploiting anti-inflammatory properties of stem cells

• Developing novel therapies for serious medical conditions in areas of high unmet medical need

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• Therapeutic cell therapy products that do not require Human Leukocyte Antigen (HLA) matching

• • Developing potential innovative cell therapies for numerous diseases with high unmet medical needs

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$56 million license expansion

• US Bone Marrow derived MSC company

• Developing novel therapies for neurological, cardiovascular, inflammatory and immune disease areas.

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Strategic 9% equity stake

• Australian stem cell and regenerative medicine company

• Stem-cell platform technology (IPSCs) with starting material with unlimited expansion potential

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11

FY18 Financial Results

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FY18 Financial Results

• Revenue of $611k (FY17:$10.1m)

• FY17 includes $8.9m in AGC licence fees

• Appointment of second licensing partner expected to contribute to FY19 licence fee income and triggers milestone payment under existing AGC licence

• Operating loss of $5.2m (FY17: $3.3m profit)

• Operating expenses maintained at $7.96m (FY17: $8.05m)

Update

• R&D tax incentive $2.4m (FY:$2.6m) received in Q1

• Loan facility of $1.9m secured and drawn down

• Ongoing quarterly cash used in operations remains consistent in FY19 of <$1.7m

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13

Patent Portfolio Update

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14

Patent Portfolio Update

80+

patents or patent applications across 14 patent families

Key patents granted

• Patent granted or allowed in US, Europe Australia, NZ and Japan covering Progenza technology – allogeneic stem cells and secretions for the treatment of osteoarthritis and other inflammatory conditions in humans and animals

• 14 patents in Australia

• 3 patents in New Zealand

• 3 patents in the US

• 1 patent in EU, 2 allowed

• Patent granted in EU, USA and China covering Sygenus stem cell secretions for topical treatment of acne

• 3 patents in Japan

• 1 patent in China & Singapore

Patents cover:

methods of manufacture, compositions and delivery; use of products for treatment of a broad range of indications

• Patent granted in Australia, New Zealand and Japan covering cancer vaccine technology for the treatment of cancers in humans (RGSH4K) and animals (Kvax)

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15

Outlook

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Outlook

The Company remains poised to deliver on a number of important commercial, clinical and R&D milestones FY19 and into FY20, including:

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Securing its first clinical development and marketing partner for Progenza in Japan

Progressing the clinical development of Progenza for osteoarthritis and other indications in Japan

Commencing manufacturing of cGMP Progenza in Japan under the Company’s existing strategic collaboration and licensing agreement with AGC

Securing additional licensing opportunities for Progenza in additional key territories, including the USA, China and the European Union

Progressing the development of Progenza for specific pain indication

Progressing the development of Sygenus for specific pain and dermatological indications

Advancing licensing discussions for RGSH4K following positive ACTIVATE trial results

Reporting on CryoShot canine pre-pivotal trial and advancing licensing discussions

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Investment Summary

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Investment Summary

Global regenerative medicine market presents a strong and growing market opportunity, growing from US$10billion in 2020 to US$380 billion by 2050

Well positioned with novel, validated, scalable and commercially viable stem cell and immuno-therapy technologies combined with a successful licence driven business model

Multiple licence opportunities for Regeneus’ portfolio of assets across each platform: manufacturing rights; clinical indications; and territories

Validated technology through published clinical data; technology licensing and collaborations, business partnerships and granted patents

Imminent clinical licence of Progenza in Japan following AGC manufacturing licence and collaboration in FY17

Management team with track record of developing and licensing novel regenerative medical technologies and translating into the clinic

Low ‘cash burn’ funded by Japanese partner licence fees

Significant value creation milestones over the next 3 months

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19

Contact

Sandra McIntosh

Company Secretary & Investor Relations M: +61 450 253 059 P: +61 2 9499 8010 E: investors@Regeneus.com.au

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Supporting Information

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Corporate Overview

Regeneus Ltd (ASX: RGS) – Australian-based clinical-stage Regenerative Medicine Company

Regeneus is developing a portfolio of novel cell-based therapies , using stem cell and immuno-oncology technologies

• These therapies will address unmet medical needs in the human and animal health markets and focus on osteoarthritis and other musculoskeletal disorders, oncology and dermatology

• Technology is validated by:

• Positive preclinical and clinical data

• Collaboration with AGC, leading biopharma manufacturer in Japan

• Substantial IP portfolio >70 patents and patent applications

• Regeneus only the 17[th] Australian company to secure a significant technology licensing agreement in Japan in past 20 years

ASX code	RGS
Share price (19 Nov 2018)	$0.21
Market Capitalisation	43.9 million
Shares on issue	209 million
Options –avg exercise price $0.19	5 million
Board & Executives shares/options	>15%
Cash (30 Sep 18)	$2.7 million
Investment since commencement 2009
Capital raised	$31.1 million
R&D expenditure	$45.6 million
R&D tax incentive	$20.1 million

Share Price Chart

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52 week share price range $0.10 - $0.27

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Japan: Fast Track Approval for Regenerative Medicine Products

• In late 2014, new laws came into force in Japan allowing conditional approval of RMPs after confirmation of safety and “probable efficacy” – same level as orphan indications

• Smaller trial numbers

• All cell therapy products have potential to qualify for conditional approval as RMP – open to foreign companies

• Removes need for expensive Phase 3 trials

• 70% Government reimbursement

Second largest healthcare market in the world Japan Regen Med sector projected to grow to US$5.5b by 2030

• 5-7 years to gain clinical data

[Traditional Approval Process]

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Clinical Trial
Preclinical Research Approval Marketing
(confirmation of efficacy and safety)
[New Scheme for Regenerative Medicinal Products]
 Earlier Patient Access !
Marketing
Preclinical Research Clinical Trial Conditional/time limited authorization (further confirmation of efficacy & Approval Marketing
safety)
Probable benefit and confirmation of
safety Informed Consent and Post Market Safety Measures
Re-Application
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[New Scheme for Regenerative Medicinal Products]
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• Probable benefit: Confirmation of efficacy with small population

**Safety: Evaluation of acute adverse events etc.

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https://www.jetro.go.jp/ext_images/australia/JVBFPresentations/FIRM.pdf

Collaboration with World Leading Bio-pharma Manufacturer

Regeneus and AGC, the leading Japanese manufacturer of biopharmaceutical products, enter into collaboration and licence agreement for the manufacture and joint licensing of the clinical development of its off-the-shelf stem cell therapy platform, Progenza, in Japan

	Received US$5.5M Upfront licence fee	Entitled to US$11.0M Specific milestone payments	Established 50/50 JV for licensing clinical development and marketing rights of Progenza for OA and all other indications in Japan	Entitled to 50% of Progenza clinical licensing, milestone payments and sales royalties
	Exclusive manufacturer of Progenza in Japan	Funds product development for GMP manufacture for Phase 2 Progenza trial

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Product Profiles

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Development Pipeline

Human Health Development Pipeline

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TECHNOLOGY
PROGRAM PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVAL
PLATFORM
Osteoarthritis
Allogeneic Adipose
Progenza
MSCs & Secretions
Pain
Immunotherapy
RGSH4K Solid Tumours
for oncology
Dermatology
Allogeneic Adipose
Sygenus
MSC Secretions
Pain
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Animal Health Development Pipeline

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TECHNOLOGY MANUFACTURING & SAFETY & EFFICACY
PROGRAM PIVOTAL TRIAL MARKET APPROVAL
PLATFORM PROCESS DEVELOPMENT STUDIES
CryoShot Allogeneic Osteoarthritis
Adipose MSCs
Immunotherapy
Kvax Naturally Occurring Advanced Cancers (Conditional Approval))
for oncology
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26

Progenza

World Class Stem Cell Platform

Progenza is a patented, scalable, off-the-shelf stem cell technology platform to treat osteoarthritis and a range of other inflammatory conditions

Safe and Scalable

Competitive Advantages

Mesenchymal stem cells (MSCs) are sourced from adipose tissue from healthy adult donor

• High safety and tolerability profile

Includes cell secretions with cells:

• Improves the viability, stress resistance and functionality of cells

• Adipose tissue is a readily available source of MSCs – 500x more MSCs than bone marrow per gram

• Provides protection for cells to improve proliferation post-thawing, compared to cryoprotective solutions

• Scalable: capacity to produce millions of standardized Progenza doses from single donor

• Minimises cell loss post-thawing and improves cell viability and functionality

MSCs (aka medicinal signaling cells) secrete a diverse variety of bioactive factors including cytokines, growth factors, extracellular vesicles and exosomes

Secretions respond to the local environment and are the driving force for reducing inflammation, promoting tissue repair and reducing scarring

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Live Apoptotic Dead
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Cryopreserved Cryopreserved Progenza Progenza
t = zero t = post- stress t = zero t = post- stress
Percentage
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Progenza: Phase 1 Knee Osteoarthritis

Primary Endpoints Met - Safe and Tolerable

• Progenza at both doses was found to be safe and tolerable

• No serious adverse events occurred

• The majority of adverse events (AEs) were of mild severity

• No meaningful differences between placebo and PRG groups in incidence and nature of adverse events

• No trends or findings of concern were identified

• from patients’ vital signs, laboratory tests, physical examination, ECGs or other safety measurements

• Double-blind, placebo controlled and randomised 20 patient trial

  • Sydney - late 2015 through April 2017 (reported May’17)

• Single intra-articular injection and monitored for 12 months for safety – 2 cohorts, placebo (4:1)

• Mean age 53 years (40-64 years)

• Diagnosed with knee OA

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• mild OA 25% Moderate OA 75%

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Progenza: Phase 1 Knee Osteoarthritis

Significant Secondary Endpoints

• Significant reduction in knee pain in Progenza groups - rapid and sustained

• Significant improvement in cartilage volume compared to placebo in target dose

• Positive signs of disease modification

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Post-Treatment Change in WOMAC Pain Subscale Score Mean Percent Change 12 Months Post-
Treatment in
0
Baseline Day 28 Month 3 Month 6 Month 9 Month 12 Lateral Tibial Cartilage Volume
1
-0.5 p = 0.022
0
Placebo PRG 3.9 M
-1
-1
Placebo
-2
-1.5
Progenza Combined
-3
-2

-4
Within-group p values *
p =<0.001
-2.5 ** p = 0.005
-5
p <0.03 *** Average Annual Cartilage
Degradation in Untreated OA Patients
-3 -6
Untreated OA is estimated to lose 5% of Lateral Tibial Cartilage Volume per year
Change in Pain Subscale Score
Mean % Change in Lateral Tibial Cartilage Volume
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Progenza

STEP Trial Data Consistent with Preclinical Results

Safe and tolerable

• No Progenza-related systemic or local toxicities or dose related adverse effects

• Rabbit Osteoarthritis Model - partial meniscectomy

Significant Secondary Endpoints

• Significant reduction in cartilage degeneration scores with target dose

• Middle load bearing femur zone (zone 2)

• No further progression of OA

• Total degeneration scores in Progenza treated knees 4 weeks post-treatment showed no further progression of OA compared to the pre-treatment control group (21 days post surgery)

• Single Progenza intra-articular injection 21 days post-surgery

Cartilage Degeneration Scores- Lateral Femur

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4.0
p≤0.05 ANOVA to vehicle Total
3.5 Zone 1
Zone 2
3.0
2.5
2.0
1.5
1.0

0.5
0.0
21 day post surgery control n=6 Day 49 vehicle control n=10 Day 49 PRG Target Dose n=10
Treatment Group
Mean±SE Score (0-5)
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Conducted by US-based Pre-clinical Research Services, a degenerative OA model (partial meniscectomy) in rabbits (n=46; 23M, 23F)

Next steps

• Pursuing licensing of Progenza for clinical development and commercialisation in Japan and ROW

• Targeting Phase 2 Progenza trial for OA in Japan under new cell therapy early access regulations

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Progenza

Multiple Licensing Opportunities

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→ licensing opportunities
Progenza = Multiple
→ technology platforms
→
jurisdictions
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Product map

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Japan Conditional Approval
Marketing &
Discovery Preclinical Phase 1 Phase 2 Phase 3
Distribution
Manufacture licences
· AGC licence for Japan Upfront Fee Milestone Payments Royalties
· US, Europe etc Upfront Fee Milestone Payments Royalties
Clinical development licences
· Osteoarthritis - Japan Upfront Fee Milestone Payments Royalties
· Nerve Pain – Japan Upfront Fee Milestone Payments Royalties
· Osteoarthritis – rest of world Upfront Fee Milestone Payments Royalties
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Progenza: Third-Party Validation

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Positive Phase 1 World-leading Poised for 2 [nd]
Strong IP
Trial Results Manufacturer Licensing Deal
✓ Positive results ✓ AGC, a world-leading ✓ Discussions to secure
>70 patents a 2 [nd] Japanese partner
leading biopharma
from STEP Phase 1
for the Phase 2 trial
manufacturer in Japan or patent
safety trial and clinical
will manufacture applications
in patients with knee development and
Progenza across 14
osteoarthritis showing commercialisation of
disease modification patent families Progenza are nearing
Upfront fee received in
finalisation
FY17
Positive results Significant More patents in On-track for
published in progress in FY18 to FY18 including in
Q1 FY19
Journal of establish AGC’s EU and US
Translational manufacturing
Medicine capabilities of
Progenza
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RGSH4K

Cancer Immunotherapy Platform

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	Multiple	Potent	Ease of	Safety	Ease of	Low
	Relevant	Immunological	manufacture	Profile	Use	COGS
	Antigens	Response
AUTOLOGOUS THERAPIES
RGSH4K tumour cell vaccine	✓	✓	✓	✓	✓	✓
Dendritic cell vaccine		✓		✓
Peptide vaccine			✓	✓	✓
ALLOGENEIC THERAPIES
Peptide / HSP vaccine				✓	✓
Oncolytic virus		✓	✓	✓
Gene transfer		✓	✓		✓

• Autologous cancer immunotherapy

• Uses patient’s own tumour as source coupled with a bacterial adjuvant

• Addresses tumour heterogeneity as all relevant tumour associated antigens are included

• Immune memory may be effective in reducing risk of tumour recurrence

• Straightforward and rapid manufacturing process

• Multi-tumour type potential

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RGSH4K - Update on Phase 1

Study for solid tumours – ACTIVATE Trial

• Single centre, open label, first-in-human Phase 1 study to evaluate the safety and tolerability

• 12 patients, received RGSH4K in 3 dose cohorts

• Various advanced solid tumours, heavily pre-treated with chemotherapy or radiotherapy

• 3 vaccines were administered at 3-week intervals, and patients had the option to continue dosing in an extension phase

• All dose levels were safe and well tolerated, achieving the safety primary endpoint

• There were no dose limiting toxicities and no serious adverse events related to the vaccine

• Injection site reactions were the most common adverse event related to RGSH4K administration

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• RGSH4K also showed encouraging signs of immune stimulation in some patients, as demonstrated by changes in cancer markers, immune cells and cytokines

• This immune stimulation was seen in one or more patients at all three dose levels

• Preliminary indications of anti-tumour activity were seen in some patients however long term follow up on 50% of the patients continues

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34

Sygenus: Emerging MSC Secretions Technology Platform

Sygenus is an allogeneic adipose MSC secretions-based technology platform

MSCs secrete a diverse variety of bioactive factors including cytokines, growth factors, extracellular vesicles and exosomes

• 3 main therapeutic effects

• reduce pain and inflammation;

• promote tissue repair; and

• reduce scarring

• Potential to treat a wide range of inflammatory conditions and pain where using cells is not

• an appropriate solution

• Various forms of administration such as topical, injection and potentially aerosol

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• Scalable technology: easy to prepare and handle for off-the-shelf use

• R&D focus on topical applications for acne and other inflammatory skin conditions, pain and wound healing

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Sygenus Shows Promise in Pain Model v Morphine

Significantly Greater and Longer Lasting Analgesic Effect

• Topical application of Sygenus in post-operative pain model shows significantly greater and longer lasting analgesic effect than a standardised dose of morphine

• Effect is above and beyond the anti-inflammatory effect observed with MSCs and secretions

• Powerful dose dependent response

• Results feed into ARC linkage research program with Adelaide and Macquarie Universities on pain

• Translate into clinical neuropathic pain studies

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36

Kvax - Canine Cancer Vaccine

Osteosarcoma Safety Study Results Study Results • Canine clinical trial complete >100 17 different No safety • Led by Dr Bergman dogs treated tumour types concerns of VCA, the largest US vet services group 71% exceeded survival time up to 22 • Single arm, Kvax only months (at Census, 25 dogs)

• B-Cell Lymphoma Study Ongoing

• • Study initiated at the Small Animal Specialist Hospital in Sydney

• • Placebo controlled with standard of care chemotherapy

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“Kvax after amputation is well tolerated and appears to confer increased progression free interval and survival compared to historically reported dogs with osteosarcoma treated with limb amputation only”

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CryoShot: Allogeneic Stem Cell Platform

• Leading in-field, practical experience with allogeneic MSCs in the veterinary field globally

• 90 vet practices involved

• 5,000+ field trial treatments

• Better pain relief than NSAIDs in uncontrolled studies for osteoarthritis in dogs

• Improved interim clinical results on early orthopaedic developmental disease in yearling thoroughbreds

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Activity / Milestone

Signed collaboration with top Animal Health Pharma to partner development and  commercialisation of CryoShot Canine



• Commenced pre pivotal dog trial at University of Pennsylvania for osteoarthritis (currently >50% complete)

Last patient last visit

Analysis and final report

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38

Value Creation Catalysts

Targeting 2[nd] Progenza licence following successful monetisation of 1[st] Progenza licence in Japan

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Progenza Sygenus RGSH4K Animal Health
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•	Secure initial clinical	• Further product	• Recruitment for	• Finalise CryoShot
	and marketing	development to	ACTIVATE trial	recruitment and
	partner for Progenza	target specific pain	closed and report	report results
	in Japan	and dermatological	trial results
		indications		• Partner on successful
•	Identify partners for		• Advance clinical	Cryoshot data
	further indications and territories for	• Explore licensing opportunities for	partnering discussions with	• Finalise KVax
	Progenza	pain and	further trial data	recruitment for B cell
		dermatology		lymphoma trial and
				report results
				• Partner on successful
				KVax data

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39