Investor Presentation - TechKnow Invest Roadshow
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patrys.com
1
Bridging Gaps in
Therapeutic Care
TechKnow Presentation July 2026
ASX:PAB
Disclaimer
The following material is for general information purposes only and is not to be relied upon for the making of an investment decision.
Any investment in Patrys Limited ACN 123 055 363 (Patrys) is subject to investment risk including the possibility of loss of capital
invested and no return of income or payment of dividends. Neither Patrys nor any other entity or person in or associated with the
Patrys group of companies guarantees any return (whether capital or income) or generally the performance of Patrys 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 Patrys securities. It is not for
general distribution or third party reliance or use. While it has been prepared from sources Patrys believe to be reliable, Patrys cannot
guarantee its accuracy or completeness and undertakes no obligation to advise of changes or updates to any such materials.
These materials are not exhaustive of all of the information a potential investor or their professional adviser would require. Nor do
these materials take into account any specific objectives, financial situation or needs of investors. In addition, the past performance of
Patrys cannot be assumed as indicative of the future performance of the company. For these and other reasons, before making any
investment decision regarding Patrys securities 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.
Where this presentation does contain any forward looking statements, those statements are only made as the date of the presentation
and are to be considered “at-risk statements” not to be relied upon as they are subject to further research and to known and unknown
risks, uncertainties and other factors that may lead to actual results differing from any forward looking statement. This is particularly
the case with companies such as Patrys which operate in the field of researching, discovering, developing, and commercialising
potential drugs intended for safe and effective for human treatments or therapies.
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A Faster, Lower-Risk Path to a >US$2B Delirium Market
Reformulating a proven drug to deliver a faster, lower-risk path to market
Proven Drug Reformulated for ICU Accelerated
Development Pathway
✓ Quetiapine already widely used
in clinical practice
✓ Safety and efficacy well
understood
✓ Extensive human clinical data
available
✓ New proprietary Injectable
formulation with patent
protection extending to ~20421
✓ Immediate onset vs oral dosing
✓ Suitable for ICU, palliative and
aged care settings
✓ FDA 505(b)(2) regulatory
pathway
✓ 3–5 year development timeline
✓ ~$20–30M development cost vs
~$1.2B for new drugs
Traditional Biotech Patrys Reformulation
New molecule discovery Known drug reformulated
10–15 years 3–5 years
~$1.2B ~$20–30M
3
Patrys Limited (ASX:PAB)
Executive & Board of Directors
Peter
Christie
CHAIRMAN
• 25+ years ASX
governance and board
experience
• Chairman of multiple
ASX-listed companies
• Current Chairman of
ASX:MOH and Non-
Executive Director of
ASX:MRD.
Leanne Kite
DIRECTOR
• Capital markets,
finance and investor
relations executive
with 20+ years’
experience
• Investor relations for
ASX 200 lithium
producer Liontown
Resources
• Co-founder Reliis
Dino
Cercarelli
DIRECTOR
• Clinical trial and
healthcare operations
leader
• COO of Australian
Clinical Trials Alliance
• Co-founder of Reliis
Brian
Leedman
DIRECTOR
• Biotech entrepreneur
with strong ASX
healthcare track record
• Co-founder of ResApp
Health (acquired by
Pfizer)
• Chairman or Director of
multiple ASX-listed
companies including
Blinklab, Alcidion,
Oncosil and
NeuroScientific
Biopharmaceuticals.
Dr Anton
Uvarov
DIRECTOR
• Healthcare and biotech
investment specialist
• Former Citigroup healthcare
equities analyst
• Co-founder and director of
multiple ASX-listed
companies, including
BlinkLab (ASX:BB1), Elsight
(ASX:ELS), Dimerix
(ASX:DXB), Actinogen
(ASX:ACW) and
Neuroscientific
Biopharmaceuticals
(ASX:NSB).
ASX Governance Biotech
Commercialisation
Capital Markets,
Finance & Investor
Relations
Clinical Trial
Operations
Healthcare &
Biotech Investment
Combining drug development, commercialisation and capital markets expertise
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Dr Samantha
South
CEO
• Extensive CNS medical
research background
• Founding Director and
COO of Argenica
• 10 yrs Director
experience at multiple
companies
• Technology transfer
and commercialisation
in medtech / biotech
over 15 yrs
Therapeutic
Development
Delirium: Severe and Acute Brain Dysfunction
Delirium: Severe and Acute Brain Dysfunction
Cognitive
Decline
Confusion
Disorientation
Altered Thinking
& Behavious
3 Forms
• Withdrawn (Hypoactive)
• Mixed
• Aggressive (Hyperactive)
1 Richardson et al., Age and Ageing 2021; 50: 914–920
Up to 80% of ICU
patients
experience
delirium
Increased
Risk Of
Dementia1
5
Patrys Limited (ASX:PAB)
Estimated Serviceable Addressable Market
>US$2 Billion per year
The Problem: Current Treatment Challenges
6
• No approved drug
treatments#
• Current treatments used
“ OFF-LABEL”
• Oral quetiapine difficult
to administer to
delirium patients
“OFF-LABEL”
Antipsychotic &
Benzodiazepine
• Haloperidol
• Risperidone
• Dexmedetomidine
• Benzodiazepines
• Sedatives
Limitations of current
“OFF-LABEL”
treatments
▪ Variable Effectiveness
▪ Low quality data supporting use
▪ Significant adverse side-effect profiles
Quetiapine: Atypical
Antipsychotic
• Only available as oral formulation
• Slow onset of action (1-2h)
• Difficult to administer to delirium patients
Oral Quetiapine demonstrated comparative Evidence of
Benefit in Delirium patients and a lower side effect profile2
# 8 of the 27 member States of the EU have approved oral and IM Haloperidol for delirium- only if non-pharmacological
approaches fail (not for prevention and not for post-operative delirium)
1.. Alghadeer et al., 2024 | 2. Devlin et al., 2010; Oztuzzi et al., 2020
40%
4%
47%
9% Haloperidol
Olanzapine
Quetiapine
Risperidone
Oral Quetiapine
commonly prescribed1
Quetiapine (QTP) Mechanism of Action in Delirium
7
NQTP (active metabolite):
Potent H1, M1–3, NET inhibitor - drives most side effects (sedation,
anticholinergic, weight gain). IV dosing minimises NQTP exposure.
↓ Agitation
↓ Nightmares
↓ EPS Risk
↓ Psychosis
↑ Cognition
Sleep
Improvement
Anxiolytic
Mood
Stabilising
Neuroprotection
Arousal Circuits
Rapid sedation
(tolerance develops rapidly)
5-HT / ACh / BDNF
Anxiolytic Antidepressant
Synaptic plasticity
Glutamate
Homeostasis
↓ Excitotoxicity
Anti-inflammatory
Adrenergic /
Monoamine
↑ NE in PFC Anxiolysis
Nigrostriatal /
Mesocortical DA
↓ EPS
↑ PFC dopamine
PFC &
Hippocampus
↑ DA & NE release
improves cognition
D2
Antagonist
weak,
transient
5-HT1A
Partial
Antagonist
CLINICAL
OUTCOME
DOWNSTREAM
PATHWAY
DOWNSTREAM
PATHWAY
CLINICAL
OUTCOME
~5-HT
Serotonin
Dysregulation
Glu
Glutamate
Excess
NE
Noradrenaline
Excess
DA
Dopamine
Excess
ACh
Acetylcholine
Deficit
~H1
Histamine
Dysregulation
NO IMPACT ON ACh
NEUROPROTECTIVE (BDNF)
ANTI-INFLAMMATORY (↓ IL-1β, IL-6, and TNF-α)
Solution: Proprietary Injectable Quetiapine
• Rapid control of acute agitation episodes
• Faster resolution of delirium
• Improved safety for patients and staff
• Shorter ICU and hospital stays
• Cost of care reduced
8
Patrys Limited (ASX:PAB)
Intellectual Property Protection
8
• Provisional
patent application
No. 2022901032
• Wholly owned by Patrys
with no trailing
obligations
• New IP developed:
Provisional Patent
Application filed in 2026
Australia
Australian Provisional Patent No. 2022901032
Entered National Phase* Q4 2024
World Intellectual Property Office
(WIPO) (PCT/AU2023/050316).
• US • EU/UK • Australia
Covers
• New formulation composition
• Method of Use Delirium
• Delivery formulation
* ~75% of the global pharmaceutical market- 2023 EFPIA. The Pharmaceutical Industry in Figures
A Faster Path to Market
Reformulation strategy enables faster, de-risked drug development
10
Traditional Drug
Development
Full Clinical Studies
Required
High Cost
Extensive New Studies
Lengthy Process
Prolonged Trials & Research
High Investment Risk
505(b)(2) Pathway
Utilises Existing Safety
& Efficacy Data
Lower Cost
Leverage Existing Data
Faster Approval
Accelerated Timelines
Reduced Time & Expense
2–3X
Higher Success
Rate
vs Novel Drugs
40–60%
Lower Cost
& Shorter Timeline
Risk Factor Risk Typical Biotech This Asset Investor
Takeaway
Market Demand
& Unmet Need • Competing with approved drugs
• Must displace established therapies
• No approved drug
• Clear unmet need in large, growing market
Open market with clear demand -
no incumbent to displace
Intellectual
Property Defence • Workarounds feasible
• Weak IP
• Technical complexity creates a structural barrier
for workarounds
• Not relying on reg exclusivity (Hatch-Waxman)
Defensible IP supports premium
valuation and limits competition
Manufacturing
& Scale-Up Risk • Unproven scale-up
• Process risk
• Already manufactured at commercial scale
• No scale-up required
Low execution risk – no scale-up
required
Regulatory &
Reimbursement
Risk
• Long approval timelines
• Payer resistance without clear clinical
need
• Accelerated reformulation pathway
• Established efficacy profile supports
reimbursement
Clear and accelerated path to
approval and reimbursement
Clinical & Formulary
Adoption • Uncertain reimbursement coverage
• Slow adoption timelines
• Designed for clinical workflow
• Positioned for formulary inclusion
Strong adoption potential driven
by clinical need and workflow fit
A Structurally De-Risked Opportunity
11
Compared to a typical biotech program, this asset is de-risked across all major value drivers
HIGH
HIGH
HIGH
HIGH
MEDIUM
LOW
LOW
LOW
LOW
LOW
Reformulation Examples
12
Original
Indication
Reformulated
Indication Deal
(paracetamol)
Chronic pain
management
(oral)
Acute post
operative pain
management (IV)
Ofirmev®:
Mallinckrodt
$1.4B acquisition
Anxiety (1963)
Oral tablet
Epilepsy (2020)
Nasal spray
Global
Licensing
Agreements
Schizophrenia
(1993)
Oral tablet
Schizophrenia
(2003)
Injectable
Teva upfront Clinical
trial costs
$112M in milestones
plus royalties
Paediatric
respiratory
infection
(Oral)
cUTIs
(2022)
GSK
US$66M upfront
$525M milestones
Oral to IV Examples
Successful products specifically reformulated
from an oral to i.v. formulation to alleviate acute
conditions include:
• Zometa®: hypercalcemia of malignancy
• Caldolor®: perioperative pain management
• Ofirmev®: postoperative pain management
• Nexterone®: acute cardiac care
In 2024 the FDA approved
many (~25) drugs under the
505(b)(2) reformulation
pathway.
Comparable Reformulations
Accelerated Clinical Development Pathway
Bridging Studies
Required
• Human micro-dosing +
PBPK modelling
• Predict human dose and
administration
• Leverages existing
quetiapine safety data
Extensive prior safety
data reduces
development risk
1.Subjects and Patient numbers are subject to Regulatory and Ethics approvals
Phase 1A
Clinical Trial
• Healthy volunteers1
• PK and safety
Phase 1B
Study
• ICU delirium patients1
• Safety and feasibility
• First ICU efficacy data
Global pivotal ICU
delirium study
• Global ICU1 delirium
registrational study
• Safety and efficacy
FDA pre-IND
submission
FDA IND submission
Regulatory approval
Pre-Study
Preparation
• Finalise manufacturing
(CMC)
• CRO site setup and ethics
approvals
• Recruit healthy volunteers
Potential partnering /
licensing point
2026 H1 2026 H2 2027 2028
03
02
01
13
Clinical Development Timeline and Key Value Catalysts
Event Target Date
Ethics Approval for Phase 1A Q3 2026
Phase 1A trial Initiation Q3 2026
GMP clinical batch release Q4 2026
Phase 1A Completion Q4 2026
FDA pre-IND submission Q1 2027
6 months DP stability for CMC Q1 2027
Ethics approval Phase 1B Q2 2027
Phase 1B first patient dosed Q3 2027
Phase 1B completion Q4 2027
IND submission Q1 2028
Because we are reformulating a drug with extensive clinical
history, the bridging studies focus on confirming dosing and
clinical safety rather than discovery
Multiple near-term clinical and regulatory milestones
expected over the next 18–24 months.
Extensive existing
clinical data
Decades of clinical use of oral quetiapine
significantly reduces technical and regulatory
risk for the IV reformulation program
Capital efficient
development pathway
Key development activities are conducted
ahead of and alongside Phase 1A to enable
rapid progression into Phase 1B
Phase 1A: Dose
Confirmation
Phase 1A confirms dosing and safety for the IV
formulation using the established clinical
profile of quetiapine
Phase 1B: Safety in ICU
setting
Phase 1B evaluates safety of the IV formulation
in a small number of ICU patients
14
Corporate Snapshot
Notes:
1. Shares on issue is shown undiluted.
2. Share price as at 24 July 26
3. Cash balance as per June Quarterly disclosed on 22nd July 2026.
Capital Structure
Shares on issue 1 674,845,324
Share price 2 3.7c
Market capitalisation $25.64M
Cash 3 $3.36M
Debt Nil
Enterprise Value $22.3M
Share Price History
Market Opportunity
~US$2B
Serviceable addressable
delirium treatment market
15
Dr. Samantha South
Phone: +61 421 117 241 Email: info@patrys.com
Patrys Limited (ASX:PAB)
patrys.com
Contact
Proven drug, better delivery. De-risked investment.
Patrys Limited (ASX:PAB)
Watch online: https://www.youtube.com/watch?v=BNjPXENiSa0
Dr. Samantha South
Phone: +61 421 117 241 Email: info@patrys.com
Patrys Limited (ASX:PAB)
patrys.com
Contact
Proven drug, better delivery. De-risked investment.
Patrys Limited (ASX:PAB)
AQS
Oral
Quetiapine
IV
Haloperidol
IV
Dexmedetomide
SL
Olanzapine
Clinical efficacy + + + + + + + +++
Speed of onset + + + + +++ ++ ++
Injectable Quetiapine: Faster Onset. Superior Safety.
Current pharmacologic treatments for delirium are used off-label
+++ strong / favourable
++ moderate
+ limited
AQS combines rapid onset with a favourable safety profile versus current off-label treatments
AQS
Oral
Quetiapine
IV
Haloperidol
IV
Dexmedetomide
SL
Olanzapine
Adverse effects +++ +++ + + + + +
Cardiac risk (QTc) +++ +++ + +++ + +
Sedation risk ++ +++ + + + + +
+++ None / limited
++ Some negative
+ unfavorable
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Being
assessed
IL-6 INHIBITOR
MINOCYCLINE
Gap in IV Knowledge
What we know:
Oral pharmacokinetics
Know oral dose works delirium
(25–100 mg/day)
Lower than oral dose
schizophrenia >250-800 mg/day
Maximum tolerated dose (MTD) of
800-1000 mg/day
High oral variability due to first
pass metabolism
Need to confirm IV starting dose for clinical trial
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