Investor Presentation
Released
Released
Announcement PDF
ASX:PAB
INVESTOR PRESENTATION · OCTOBER 2026
Bridg ing Gaps in
Therapeutic Care
Developing the potential first treatment for delirium
approved broadly
In the clinic Known molecule FDA 505(b)(2) pathway
Global unmet need
patrys.com
Disclaimer
Patrys Limited (ASX:PAB) 2
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. Targets and timelines are subject to regulatory and ethics approvals and are not guarantees.
Patrys at a Glance
¹Ely EW et al. JAMA 2004;291(14):1753–62. ²Patrys estimate. ³Target only, subject to regulatory approvals.
Patrys Limited (ASX:PAB) 3
RLS-2202: proprietary IV quetiapine for delirium in acute care.
Leveraging an established blockbuster molecule, and now in the clinic.
UNMET NEED
~80%
of ventilated ICU patients
developed delirium¹
LARGE MARKET
>US$2B
estimated serviceable
addressable market per year²
PROTECTED IP
~2042
patent protection for the new IV
formulation
CLEAR PATHWAY
Q1 2027
target FDA pre-IND submission
on the 505(b)(2) pathway3
Delirium: The Hidden Crisis in Acute Care
*Tomlinson et al., Drugs Aging 2024;41:455–486. ¹Ely EW et al., JAMA 2004;291(14):1753–62 (224 ventilated ICU patients).
²Dziegielewski et al., Crit Care Res Pract 2021:6612187. 3Richardson et al., Age and Ageing 2021; 50: 914–920 Patrys Limited (ASX:PAB)
81.7%
of ventilated ICU patients developed delirium¹
3.2×
higher adjusted 6-month
mortality risk¹
+7 days
longer in hospital²
2–3×
higher ICU and hospital
costs²
8–9×
higher risk of developing
Dementia3
4
A g lobal opportunity with no approved therapy *
Patrys Limited (ASX:PAB) 5
MARKET
>US$2B
estimated serviceable addressable market, per year¹
RLS-2202 is positioned as the potential
first widely approved therapy for delirium.
ICU
*No approved acute-care therapy; 8 of 27 EU states approve IM haloperidol for delirium in limited circumstances.
¹Patrys estimate
4
COMMON ACROSS ACUTE CARE*
Intensive care
30–80%
Palliative care
22–62%
Aged care
15–40%
No Approved Treatment, Only Workarounds*
*Only in 8 of 27 EU member states IM haloperidol is approved for delirium, and only where non-pharmacological approaches fail
(not for prevention or post-operative delirium). Patrys Limited (ASX:PAB) 6
WHAT CLINICIANS HAVE
Off-label oral tablets, designed for
chronic psychiatric conditions
Off-label injectables, designed for
sedation or psychosis that don’t work
THE GAP WHAT ACUTE CARE NEEDS
A rapid IV option for agitated,
sedated or ventilated patients
RLS-2202 is designed to fill this gap.
Quetiapine: A Blockbuster, Optimised for Acute care
Seroquel® is a registered trademark of the AstraZeneca group of companies; Patrys is not affiliated with AstraZeneca. FDA
approval for schizophrenia, 1997. Sales: Seroquel IR + XR, 2011, as reported by AstraZeneca (via Statista). Patrys Limited (ASX:PAB) 7
From oral tablet
to IV injection
Proprietary intravenous quetiapine RLS-2202, designed
designed for rapid, predictable treatment.
Intensive care Palliative care Aged care
LEVERAGING ASTRAZENECA’S SEROQUEL®
1997
First FDA approval
US$5.83bn
Seroquel® sales in 2011
Decades
of clinical use
Why IV: Straig ht to the Bloodstream
¹SEROQUEL® (quetiapine) US prescribing information: peak plasma concentrations in 1.5 hours; extensively metabolised by
the liver. ²Design objectives; IV pharmacokinetics and dosing are being assessed in the Phase 1A trial. Patrys Limited (ASX:PAB) 8
Oral tablet
Off-label today
Swallow Gut absorption Liver first-pass Bloodstream Brain
Needs a patient who can swallow; peak levels about 1.5 hours after a dose¹
RLS-2202
Intravenous
IV injection Gut and liver first-pass bypassed Bloodstream Brain
Designed for rapid onset, titratable dosing; can be used in patients who cannot swallow²
Desig ned to Fit the Clinical Workflow
¹Alghadeer et al., 2024. Initial target product profile: ICU and post-operative delirium. Patrys Limited (ASX:PAB) 9
RLS-2202 is designed to replace today’s off-
label treatments within the existing ICU and post
label
-
operative workflow.
46.8%
of delirium patients given an
antipsychotic received quetiapine, the
most used (n=47)¹
Pre-operative
nursing
Fasting
Intra-operative
Anaesthesia, many
medicines
Intensive care
(ICU)
Delirium screening
and treatment
Post-operative
care
Hospital discharge After discharge
Rehabilitation
Poorly managed delirium delays physical therapy, ICU and hospital discharge, adding cost to the health system.
Wholly owned IP, protected to ~ 2042
*If patent protection is granted, subject to any extensions. Patent protection is not guaranteed
Applications: PCT/AU2023/050316; Australian provisional patent 2022901032. Patrys Limited (ASX:PAB) 10
PATENT PROTECTION TO
~2042
*
*
WHAT THE PATENT APPLICATIONS COVER
New formulation composition
Method of use in delirium
Delivery formulation
US · EU/UK · Australia
National phase entered Q4 2024
100% owned
No trailing obligations
New filing in 2026
Further provisional patent application
Why Reformulation De-Risks the Opportunity
*New efficacy data in delirium patients are still required, and the IV formulation itself still has to be manufactured at
scale. Cost and timeline advantages are not guaranteed. Patrys Limited (ASX:PAB) 11
New Drug Reformulated Existing Drug
Unknown safety profile Extensive known safety profile
Full development program
FDA 505(b)(2) pathway, leveraging decades of
existing data*
New manufacturing process to develop and
scale up
Quetiapine made at scale for decades*
Higher cost Lower cost
Longer timelines Faster timelines
Precedent: Reformulations Attract Major Buyers
¹Cadence Pharmaceuticals Form 8-K, 11 Feb 2014 (approximately US$1.3 billion, fully diluted). ²Fierce Biotech, 22 Sep 2022.
³US FDA CDER, 2025. Illustrative only; not a forecast for Patrys. Patrys Limited (ASX:PAB) 12
ORAL TO IV · PAIN CARE
Ofirmev® (IV paracetamol)
~US$1.3bn
Mallinckrodt’s acquisition of Cadence Pharmaceuticals,
maker of Ofirmev®, 2014¹
KNOWN ANTIBIOTIC · NEW USE
Tebipenem HBr (Spero Therapeutics)
Up to US$591M
GSK licence: US$66M upfront plus up to US$525M in
milestones, 2022²
47
FDA approvals via the
505(b)(2) pathway in
2025³
Familiar molecules, optimised for new settings, can attract large acquirers
and partners.
Path to Value: N ear-Term Catalysts
All dates are targets, subject to regulatory and ethics approvals, and are not guarantees.
Patrys Limited (ASX:PAB) 13
We are here
Now
Phase 1a
Healthy volunteers:
safety and PK
Q1 2027
FDA pre-IND
Regulatory alignment on
the 505(b)(2) plan
2027
Phase 1b/2a
ICU patients: safety,
feasibility, first efficacy
data
2028
Pivotal study
Global ICU delirium
registrational study
Goal
Approval or
partnering
Partnering and licensing
discussions along the
way
NEAR-TERM CATALYSTS (TARGETS)
Q4 2026
Phase 1a dosing complete
Q1 2027
Phase 1a complete; FDA
pre-IND submission
Q2 2027
Phase 1b/2a: first patient
dosed
Q4 2027
Phase 1b/2a complete
Q1 2028
IND submission; late-stage
development begins
World-Class Clinical Guidance
Patrys Limited (ASX:PAB) 14
International Clinical Advisory Committee, formed September 2026
CHAIR · AUSTRALIA
JI
Dr Johnny Iliff
Senior emergency and critical care
clinician, Royal Perth Hospital and St
John of God Murdoch; aeromedical
consultant, Royal Flying Doctor
Service
UNITED STATES
JD
Prof John W. Devlin
Chaired the 2018 SCCM PADIS ICU
guidelines; past president, American
Delirium Society; Professor of
Pharmacy, Northeastern University
NETHERLANDS
MB
Prof Mark van den
Boogaard
Professor of Nursing Science,
Radboudumc ICU; developed the E-
PRE-DELIRIC prediction model;
Executive Board, European Delirium
Association
Corporate Snapshot
¹Shares on issue shown undiluted. ²Share price as at 8 October 2026. ³Cash balance per June quarterly, disclosed 22 July
2026. Patrys Limited (ASX:PAB) 15
Capital structure
Shares on issue¹ 674,845,324
Share price² 3.0c
Market capitalisation $20.2M
Cash³ $3.36M
Debt Nil
Enterprise value $16.8M
Board and management
Dr Samantha South
Chief Executive Officer
Extensive CNS medical research background;
founding Director and COO, Argenica Therapeutics
(ASX:AGN)
Peter Christie
Chairman
25+ years of ASX governance and board
experience; chairs multiple ASX-listed companies
Brian Leedman
Director
Biotech entrepreneur; co-founder of ResApp Health,
acquired by Pfizer; Director Blinklab (ASX:BB1) and
NeuroScientific Biopharmaceuticals (ASX:NSB)
Dr Anton Uvarov
Director
Healthcare and biotech investment specialist; former
Citigroup healthcare equities analyst. Director
NeuroScientific Biopharmaceuticals (ASX:NSB) and
Blinklab (ASX:BB1)
Leanne Kite
Director
20+ years in capital markets, finance and
investor relations; co-founder of Reliis
Dino Cercarelli
Director
20+ years leading clinical trial operations and
governance; co-founder of Reliis
Why Patrys, Why N ow
Patrys Limited (ASX:PAB) 16
Five reasons to
look at Patrys now
now
1 Major unmet need, no approved treatment
treatment
2 Blockbuster molecule, de-risked pathway
3 Already in the clinic
4 Near-term catalysts, continuing this quarter
5 World-class clinical advisors
Patrys Limited (ASX:PAB)
Proven drug, better delivery. De-risked investment.
Contact
Dr Samantha South, Chief Executive Officer
+61 421 117 241 · info@patrys.com
patrys.com
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