Evans and Partners Healthcare Conference Presentation
Released
Released
Announcement PDF
ASX RELEASE
9 September 2025
Paradigm to Present at the Evans & Partners Small Cap Healthcare
Conference
Paradigm Biopharmaceuticals Ltd (ASX:PAR) (“Paradigm” or “the Company”), a
late-stage drug development company focused on delivering new therapies to address
unmet medical needs, today announced it will be presenting at the 4th Annual Evans &
Partners Small Cap Healthcare Conference on 9 September 2025.
The presentation, delivered by Paradigm’s Founder and Managing Director Paul Rennie,
will outline the significant burden of osteoarthritis disease and how Paradigm is seeking
to address this unmet need through its ongoing global Phase 3 clinical trial of injectable
pentosan polysulfate sodium (iPPS) for the treatment of knee OA.
A copy of the presentation is available attached, or available via the company’s website
via:
https://investors.paradigmbiopharma.com/link/PBJlmP
-EndsAbout Paradigm Biopharmaceuticals
Paradigm Biopharmaceuticals Ltd. (ASX: PAR) is a late-stage drug development
company driven by a purpose to improve patients’ health and quality of life by discovering,
developing, and delivering pharmaceutical therapies. Paradigm’s current focus is
developing iPPS for the treatment of diseases where inflammation plays a major
pathogenic role, indicating a need for the anti-inflammatory and tissue regenerative
properties of PPS, such as in osteoarthritis (phase 3).
Forward Looking Statements
This Company announcement contains or may contain forward-looking statements,
including statements regarding anticipated commencement dates or completions dates
of preclinical or clinical trials, regulatory developments, and regulatory approval. These
forward-looking statements are not guarantees or predictions of future performance, and
involve known and unknown risks, uncertainties, and other factors, many of which are
beyond our control, and which may cause actual results to differ materially from those
expressed in the statements contained in this presentation. Readers are cautioned not to
put undue reliance on forward-looking statements.
To learn more please visit: https://paradigmbiopharma.com
Approved for release by the Paradigm Board of Directors.
FOR FURTHER INFORMATION PLEASE CONTACT:
Simon White
Director of Investor Relations
Tel: +61 404 216 467
Paradigm Biopharmaceuticals Ltd
ABN: 94 169 346 963
Level 15, 500 Collins St, Melbourne, VIC, 3000, AUSTRALIA
Email: investorrelations@paradigmbiopharma.com
Evans & Partners
4 th A n n u a l S m a l l C a p
Healthcare Conference
MD | Paul Rennie
Paradigm Biopharma
Sep 2025
2
Disclaimer
This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd ASX:PAR (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively,
“Information”) is confidential, and has been prepared by the Company on the condition that it is for the exclusive information and use of the recipient. The Information is proprietary to Paradigm and may not be disclosed to any third party or used for any other
purpose without the prior written consent of the Company. Except as otherwise expressly stated in this presentation, Paradigm has not authorised any person to give any information or make any representation which is not contained in this presentation. Any
such information or representation not contained in this presentation must not be relied upon as having been authorised by, or on behalf of, Paradigm.
The Information should not to be relied upon for the making of any investment decision. Any investment in Paradigm is subject to a number of investment risks including the possibility of loss of capital invested and no return of income or payment of dividends.
Neither Paradigm nor any other entity or person in or associated with Paradigm guarantees any return (whether capital or income) or generally the performance of Paradigm or the price at which its securities may trade.
In particular, this presentation is not a recommendation, offer or invitation to subscribe for or purchase Paradigm securities. This presentation is not exhaustive of all of the information a potential investor or their professional advisers would require. This
presentation does NOT constitute a “Prospectus" or a "Disclosure Document” (as defined in the Corporations Act 2001 (Cth) (“Corporations Act”)) and has not been, and will not be, lodged with the Australian Securities and Investments Commission or any other
regulatory authority. Accordingly it is not required to contain, and may not necessarily contain, all of the information that a Prospectus or like Disclosure Document would be required to contain pursuant to the Corporations Act.
This presentation does not take into account any specific objectives, financial situation or needs of investors. For these and other reasons, you are strongly recommended to obtain your own up to date independent legal, financial and investment advice – those
acting without such advice do so at their own risk.
This presentation may contain "forward-looking statements" which are not historical facts. Words such as “expect(s)”, “feel(s)”, “believe(s)”, “will”, “may”, “anticipate(s)” and similar expressions are intended to identify forward-looking statements. Any forward
looking statements in this presentation are statements that are not historical facts, should be considered “at-risk statements” and not to be relied upon. These statements include, but are not limited to, statements regarding future clinical trial results, regulatory
approvals, production targets, sales, staffing levels etc. All of such statements are subject to risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from
those expressed in, or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include, but are not limited to: (i) the possible delays in and the outcome of pre clinical and clinical trials, (ii) risks relating to possible partnering or other like arrangements, (iii) the potential for delays in regulatory approvals, (iv) the
unknown uptake and market penetration of any potential commercial products and (vi) other risks and uncertainties related to the Company’s prospects, assets / products and business strategy. This is particularly the case with companies such as Paradigm
which operate in the field of researching, discovering, developing and commercialising potential treatments or other therapies.
You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof and Paradigm does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances
after the date hereof, or to reflect the occurrence of or non-occurrence of any events. In addition, the past performance of Paradigm cannot be assumed as indicative of the future performance. There is NO guarantee of future performance, Including that
Paradigm will achieve its stated objectives / milestones, that its forecasts will be met or that forward looking statements will be realised - actual results and future outcomes will in all likelihood differ from those outlined herein.
Neither Paradigm nor any of its advisers, agents or employees make or give any express or implied representation, warranty or guarantee that the information contained in this presentation or otherwise supplied by or on behalf of Paradigm is complete or
accurate or that it has been or will be audited or independently verified, or that reasonable care has been or will be taken in compiling, preparing or furnishing the relevant information. Paradigm does not take any responsibility for any inference, interpretation,
opinion or conclusion that any person may draw or form from this presentation.
To the maximum extent permitted at law, Paradigm and all of its representatives, directors, partners, employees or professional advisers exclude all direct and indirect liability arising out of or in connection with any use or reliance of the information contained or
described within this presentation. Other than to the extent required by law (and only to that extent), the Parties do not make any representation or give any assurance, guarantee or warranty (express or implied) as to, nor assume any responsibility or liability for,
the authenticity, origin, validity, accuracy, suitability or completeness of, or any errors in or omissions from, any information, statement or opinion contained in this Presentation or any accompanying, previous or subsequent material or presentation.
Not an offer
This presentation may not be released to US wire services or distributed in the United States. The new fully paid ordinary shares in Paradigm have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the
United States except in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws. The distribution of this presentation in the United States and elsewhere outside Australia may be
restricted by law. Persons who come into possession of this presentation should observe any such restrictions as any non-compliance could contravene applicable securities laws. See “International Offer Restrictions" for more information
Paradigm Biopharma
Sep 2025
What is Osteoarthritis
Kellgren and Lawrence Grade
Overview
•
A degenerative joint
disease causing pain,
swelling, and stiffness.
•
Restricts movement,
daily activities, and
quality of life.
•
Affects entire joints
(cartilage, bone,
ligaments, muscles).
•
Can lead to mental
health issues, sleep
disturbance, and social
withdrawal.
•
•
Most common in
knees, hips, spine, and
hands.
Chronic, progressive,
and a leading cause of
disability.
Risk Factors &
Management
Impact
•
Age, sex, obesity,
joint injury, overuse,
metabolic disease,
genetics.
•
Exercise, weight
management,
physical therapy,
braces.
•
NSAIDs, Opioids for
pain control.
•
Joint replacement
surgery in severe
cases.
Schematic from BioRender.com
Paradigm Biopharma
Osteoarthritis
By Numbers
Zilosul® is a non-opioid
subcutaneous
injectable aimed to treat
pain and function in
moderate-to-severe
osteoarthritis.
1.
2.
3.
4.
5.
GBD 2019: Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019:
a systematic analysis for the Global Burden of Disease Study
2019. https://vizhub.healthdata.org/gbd-results/.
Long H, Liu Q, Yin H, Diao N, Zhang Y, Lin J et al. Prevalence trends of site-specific osteoarthritis
from 1990 to 2019: Findings from the global burden of disease study 2019. Arthritis Rheumatol
2022; 74(7): 1172-1183.
Cieza A, Causey K, Kamenow K, Wulf Hansen S, Chatterji S, Vos T. Global estimates of the need
for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the
Global Burden of Disease Study 2019. Lancet. 2020 Dec 19; 396(10267): 2006–2017.
National Institute of Health; Emerging drugs for osteoarthritis; Hunter DJ and Matthews G 16(3):
479–491; 2011 September.
Global Pricing Research conducted by Paradigm.US, UK Germany, France
People affected by OA Globally1
Moderate – to – Severe OA3
m+
528
65
Knee OA most prevalent2
OA patients dissatisfied with current
treatments4:
m+
365
81
Knee OA is the most common form of OA, accounting for
around 69% of all cases, followed by hip and hand OA2.
•
•
Sep 2025
Significant TAM
Prevalence continues to rise due to
ageing, obesity and injury.
%
of all OA
%
Target uptake: 10%
dissatisfied market
Zilosul indicative price:
US$2500 per year5
4
Paradigm Biopharma
Unmet
Need
•
•
•
Effective
Non-validated
Ineffective
Opioids
*Royal Australian College of General Practitioners hold a ‘strong against’ recommendation
High economic burden:
OA costs the US
healthcare system over
$136B annually1.
Strong demand for
alternatives: A safe,
effective treatment with
long-term benefits is
urgently needed.
CV = Cardiovascular; GI = Gastrointestinal
*Hyaluronic Acid
Injectable*Plateletrich Plasma, *Stem
Cells
Steroid injectable
Surgery - Total Knee
Arthroplasty
Grafe 1
Minor OA
Grade 2
Mild OA
5
Invasive
Analgesics,
NSAIDS
Limited treatment
options: Current
treatments (NSAIDs,
steroids, HA) focus on
short-term pain relief.
Sep 2025
Grade 3
Moderate OA
•
•
Daily use
GI, CV risk with
prolonged use.
•
•
Severe side-effects
Addictive
•
•
Limited pain relief
Royal Australian
College of General
Practitioners hold a
‘strong against’
recommendation.
•
•
Limited pain relief
Evidence of further
cartilage
degradation
•
•
High cost
Patients opting for
alternative
treatments
Grade 4
Severe OA
1. Source: https://www.tandfonline.com/doi/full/10.1080/03007995.2023.2234727?scroll=top&needAccess=true&role=tab
Paradigm Biopharma
The picture can’t
be displayed.
Advancing iPPS
Toward a
Differentiated
OA Therapy
Robust data and regulatory
01
SAFTEY & EFFICACY PROFILE
• Strong efficacy and safety shown across a broad dataset
• Durable benefits sustained to 12 months in Phase 2 studies
• Imaging and biomarker data suggest effects beyond
symptom relief
02
PHASE 2 AND REAL-WORLD EVIDENCE
• Multiple Phase 2 studies underpin Phase 3, showing
consistent efficacy across patient types and timepoints
• Real-world insights from Australia's SAS program show
long-term benefits with repeat courses.
03
MECHANISM OF ACTION
• Demonstrated across preclinical models and human studies
• Anti-inflammatory, cartilage-protective, and matrix-restoring
properties
• Biomarker data from Phase 2 suggests activity beyond
symptom relief
momentum underpin a welldefined path through Phase 3
04
OPTIMISED PHASE 3 PROGRAM
• Fast Track designation granted by FDA
• Protocol refined following extensive FDA engagement (Type
C and D meetings)
• Endpoints, statistical powering, and assessment windows
aligned with regulatory expectations
Sep 2025
29/12/20
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Paradigm Biopharma
Confidence in IPPS
Sep 2025
Clinical & Real-World Evidence
iPPS Study
Study Type
Dosing Regimen
Key Findings
Ghosh et al. (2005)
Randomised, double-blind,
placebo-controlled (n=114)
3 mg/kg IM once weekly for 4
weeks
Significant pain reduction at rest (out to 24 weeks);
Improved joint stiffness and global assessment
Kumagai et al. (2010)
Open-label clinical trial (n=20)
2 mg/kg SC once weekly for 6
weeks
Improved range of motion and pain reduction (out to 52
weeks); Reduced serum C2C (cartilage degradation
marker)
PARA_OA_005
Phase 2b (n=128)
2 mg/kg SC twice weekly for 6
weeks
Clinically significant pain & function improvement; 5x lower
rescue medication use; Sustained relief to 6 months
PARA_OA_008
Phase 2 (n=61)
2 mg/kg SC twice weekly for 6
weeks
Significant pain and function improvement out to 12
months; Reduced cartilage degradation biomarkers; MRI
evidence of bone marrow lesion reduction
PARA_OA_002
Phase 2b/3 (n=601)
Dosing study, 6-week
treatment, 18-week follow-up
Confirmation of minimum effective dose for Phase 3 trial;
Safety profile consistent across all doses
TGA SAS
Real-World (n>700)
2 mg/kg SC twice weekly
Meaningful clinical improvements in pain and mobility
7
Paradigm Biopharma
Phase 2: PARA_OA_008
Sep 2025
8
2 mg/kg IBW SC twice weekly v placebo for 6
weeks, followed up for 12 months (n=61)
A single 6-week course of twice-weekly iPPS demonstrates durable clinical outcomes out to 12 months
least squares adjusted mean
Function WOMAC
change from baseline. FAS.
least squares adjusted mean
Pain Reduction WOMAC
change from baseline. FAS.
p=0.045
p=0.054
Rescue medication use
•
5x lower cumulative use of rescue medication in iPPS group.
p=0.017
p=0.048
LS Mean Change +/- Standard Error
FAS: Full Analysis Set
WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index
Paradigm Biopharma
PARA_OA_008
Sep 2025
9
Top-Line Day 168
Quantitative MRI Results
Changes in Cartilage Thickness from baseline
• Twice weekly iPPS arm, demonstrated a
consistent pattern of improvement in cartilage
thickness across all key regions of medial and
lateral compartments at 6 months
• Placebo showed a loss in cartilage thickness in all
key regions at 6 months.
Cartilage Thickness (µm) Adj. CFB (abs.) LSM results by key regions of the
medial and lateral compartments in knee
• iPPS increased the cartilage thickness in the
central medial femur by 60µm (0.06mm)
compared to a reduction of -20µm (-0.02mm) in
the placebo group at 6 months.
• Placebo group demonstrated cartilage loss rate
consistent with the natural progression of knee OA
(-40µm or 0.04mm per year).
Osteoarthritis
Pivotal PH3 Trial
Paradigm Biopharma
Phase 3 Objectives
Key objectives for the Phase 3
PARA_OA_012 study
Primary Objectives
• To evaluate the treatment effect of PPS on knee pain in participants with knee OA pain. (Weekly Average ADP Day 112)
Key Secondary Objectives
• To evaluate the treatment effect of PPS on knee pain function in participants with knee OA pain. (WOMAC Day 112)
• To evaluate the effect of PPS treatment on PGIC in participants with knee OA pain. (PGIC Day 112)
• To evaluate the efficacy of PPS treatment on knee pain, function, stiffness, and overall, in participants with knee OA pain.
Secondary Objectives
•
WOMAC Pain and function assessments at multiple timepoints to Day 404.
•
IPPS effects on Rescue Medication use.
•
Structural changes via X-Ray and MRI from baseline day 168, 404
Sep 2025 11
29/12/20
Paradigm Biopharma. Sep 2025
PARA_OA_012
Interim Analysis (IA)
Phase 3 trial design
Follow-up Period:
52 weeks
Treatment Period:
6 weeks
• Conducted once 50% of subjects (~233)
reach Day 112.
• Plan assess efficacy and possible early
conclusion of trial based on target effect size.
• DSMB to conduct Interim Analysis.
• Interim Analysis expected mid-CY26.
Screening
PPS 2 mg/kg
N = 233*
Placebo
N = 233*
Day
1
39
First Injection
Last Inj.
56
84
112
Interim
Analysis
140
168
224
280
336
404
End of Study
Primary endpoint: Change from baseline in weekly ADP NRS pain score at Day 112.
Secondary endpoints: Function, PGIC, rescue medication, biomarkers of disease progression, including MRI & X-Ray.
*May be subject to change
12
Paradigm Biopharma
The picture can’t
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29/12/20
Sep
2025
13
PARA_OA_012 – Powered for Success
Statistical Power Based on Phase 2 Data Validates
The table summarises modelled power at
effect sizes established in Phase 2
studies.
Effect Size (ES)
Estimated Power
(n=233/arm)
• High statistical power supports confidence
in replicating prior Phase 2 clinical benefit.
• Model assumes observed Phase 2
variance and full sample size.
0.3 (Phase 2 pooled)
>86%
0.4
>98%
• Success estimates based on historical trial
performance and standard assumptions*.
* Does not account for executional risk.
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Sep 2025
14
Valuation (Market Capitalisation $Am)
Company
ASX PH3
Comparison
Table
Upside from
current
valuation
P3 Trial Indication
FDA
Designations
At IND Clearance
Current
Mesoblast Ltd (MSB)
GVHD (paediatric
refractory to standard of
care)
~A$1,500
~A$2,931
Immutep Ltd (IMM)
Metastatic non-small cell
lung cancer
~A$535
~A$382
Dimerix Ltd (DXB)
Focal segmental
glomerulosclerosis
(FSGS)
Orphan
~A$90
(May-22)
~A$291
Neuren
Pharmaceuticals Ltd (NEU)
Phelan-McDermid
syndrome (PMS)
Orphan
~A$500
(Mar-22)
~A$2,250
Botanix
Pharmaceuticals Ltd (BOT)
Primary axillary
hyperhidrosis
~A$190
(Oct-23)
~A$314
Paradigm
Biopharmaceuticals Ltd
(PAR)
Osteoarthritis of the
knee
Fast track
~A$112
Source: Market capitalisations are approximate only. IRESS as of 12 August 2025. NEU, MSB and BOT have since completed PH3 studies and are in
production likely to positively effect current market capitalisation above.
The picture can’t
be displayed.
Paradigm Biopharma
Sep 2025 15
29/12/20
Investment Highlights
ü Multiple Positive Phase 2 Trials: Consistent efficacy and safety demonstrated across
studies, with signals of disease-modifying activity on MRI and biomarkers.
ü Real-World Evidence: Long-term benefits observed in Australia’s SAS program, including
sustained improvements with repeat courses.
ü Optimised Phase 3 Design: Refined following extensive FDA engagement, aligned with
regulatory expectations, and powered to detect clinically meaningful effects.
ü Fast Track Designation: Accelerated regulatory pathway secured with the FDA.
ü Large, Unmet Global Market: 500M+ people affected by OA, 81% of patients dissatisfied
with current treatments
ü Near-Term Inflection Point: Interim analysis expected mid-2026 at 50% patient completion,
representing a major value catalyst.
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Sep 2025
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News flow & catalysts
Event
Upcoming
Catalysts
Target Date
PARA_OA_012 – First participant dosed.
Q3 2025
PARA_OA_012 – 50% Recruitment of participants
2H 2025*
Regional licensing agreement(s) in OA
Ongoing
PARA_OA_008 – Phase 2 clinical trial data manuscripts peer reviewed and published.
End of
CY2025
PARA_OA_012 – 100% Recruitment
1H 2026*
PARA_OA_012 Interim Analysis – 50% participants reach Day 112
Mid-2026*
*The above is a statement of current intentions as at the date of this presentation. Investors should note that the above upcoming events are subject to funding or new circumstances.
Paradigm Biopharma
Paul Rennie
Managing Director
Email: prennie@paradigmbiopharma.com
Simon White
Director IR
Investor and Media Enquiries
For more information please visit:
https://investors.paradigmbiopharma.com
Email: swhite@paradigmbiopharma.com
Sep 2025 17
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