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LTR PHARMA LIMITED — AGM Information 2025
Oct 23, 2025
65273_rns_2025-10-23_0629078f-4ba3-4c49-b3fe-609c3995c77f.pdf
AGM Information
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2025 Annual General Meeting Presentation
24 October 2025
LTR Pharma Limited (ASX:LTP) (“LTR Pharma ” or “the “ Company ” ) advises that the Annual General Meeting (“ AGM will be held today, Friday, 24 October 2025, at 2:00pm (AEST), at the offices of K&L Gates 16/66 Eagle Street, Brisbane City QLD 4000.
Attached is the AGM presentation to be delivered at the 2025 Annual General Meeting.
- ENDS –
This announcement has been approved by the Board of Directors.
About LTR Pharma
LTR Pharma is a commercial-stage pharmaceutical company delivering innovative therapies for significant unmet medical needs through its proprietary intranasal drug delivery platform. The Company has successfully commercialised its rapid-acting treatment technology in Australia and is expanding access whilst advancing regulatory pathways in the US and other key markets.
LTR’s lead products, SPONTAN[®] and ROXUS[®] , are fast-acting intranasal sprays for the treatment of erectile dysfunction, enabling onset of action in 10 minutes or less. Building on this proven technology, the Company is now advancing OROFLOW[®] , a novel intranasal spray under development for the treatment of Oesophageal Motility Disorders (OMD) – a debilitating group of conditions affecting swallowing function.
Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint to deliver differentiated, patient-centric treatments that enhance quality of life.
For further information please contact:
Media enquiries Investor enquiries Haley Chartres Peter McLennan [email protected] [email protected]
1800 519 711 | ltrpharma.com | [email protected]
LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
Annual General Meeting 24 October 2025
AGM Presentation | October 2025
Important Notice & Disclaimer
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Investor Presentation 2
A transformative year of clinical and commercial success
Australian Financial Year
Q1 2024/25
SPONTAN
prescribed to first patient under TGA
Q2 2024/25
Online JV Platform launch
Q3 2024/25
ROXUS Development initiation
Q4 2024/25 OROFLOW agreement signed
Q1 2025/26 US-based ED specialists join Advisory board
Co-development agreement signed with Aptar Pharma
SPONTAN final study results demonstrating 5 x faster absorption
Symbion National Pharmacy Distribution Agreement
SPONTAN Extractables Study completed
SPONTAN demonstrates strong PostProstatectomy Results
Men's Health SPONTAN FDA Pharmacy pre-IND meeting Q3 2023/24 Distribution completed Agreement
LTR Pharma secures 43% of LevOmega
AGM Presentation 3
Investment Highlights
LTR Pharma positioned in a clear gap in the market
Diversified
Compelling pivotal pharmacokinetic study data
Commercial Strategy Reducing Risk
-
‣ SPONTAN[®] active ‣ 5x faster absorption than in Australia via SAS oral tablets
-
‣ ROXUS[®] targeting US personalised medicine H1 CY2026
-
‣ Regulatory approvals expanding market access
Blockbuster market with issues
- ‣ Existing PDE5 inhibitors have a high discontinuation rate due to poor efficacy and side effects
Blue chip partners
-
‣ Aptar Pharma: Strategic Co-development partner - Nasdaq listed;
-
‣ Mayne Pharma: Commercial
-
manufacturing partner (CMO) - ASX listed
-
‣ Symbion – Australian distributor, owned by ASX listed EBOS Group
Multiple upcoming milestones
-
‣ SPONTAN Phase II PK Study
-
‣ ROXUS[®] development completed
-
‣ ROXUS launch H1 CY 2026
-
‣ Growing Online Prescribing
-
‣ SPONTAN Animal Tox Study
-
‣ Published data
-
‣ Partnership discussions
-
‣ OROFLOW[® ] development for OMD
AGM Presentation 4 4
A significant healthcare challenge affecting relationships and quality of life
-
Psychological Impact
-
Physical causes ‣ Relationship problems
-
‣ Heart Health ‣ Mental Wellbeing
-
‣ Prostate Health ‣ Day to day stress
-
‣ Diabetes ‣ Medical Treatments ‣ Hair loss ‣ Weight loss
-
‣ Antidepressants
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Prevalence of ED with individuals with cardiovascular risk factors,
hypertension and diabetes, is reported as high as 50%
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AGM Presentation 5
Global Market Need
ED can impact physical and psychological health
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USA China
Aus
EU
60.7%
~30m ~33m ~150m
of males 45y/o+
Source: Frost and Sullivan Report, The Erectile Dysfunction Medicines Market, September 2023
AGM Presentation 6
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Estimated Market size
Forecast to be US$6.0B market by 2028
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US$6.0B
7.0% CAGR
US$5.0B
US$4.0B $4.15B
$3.87B
$3.61B
US$3.0B $3.16B $3.38B
$2.95B
$2.76B
$2.58B
US$2.0B
US$1.0B $1.11B $1.18B $1.27B $1.36B $1.45B $1.56B $1.67B $1.79B
US$0.0B
2021 2022 2023F 2024F 2025F 2026F 2027F 2028F
US ROW
US$ billions
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Online sales expansion
Majority of ED medication is now sold through online channels
AGM Presentation 7
Current Treatments
Oral PDE5 inhibitors & SPONTAN[®] Nasal Spray
Oral Phosphodiesterase-5 (PDE5) inhibitors are first-line treatments
Issues with oral PDE5 inhibitors
Product Main Time before sexual Approval Generic Does not work Brand(s) activity for dose Date (US) availability for 30-35% of patients Sildenafil Viagra 1 hour+ 1998 Yes Long response time of 1 hour + affects spontaneity Tadalafil Cialis 1 hour+ 2003 Yes Adverse reactions in up to 35% of patients Levitra, Varendafil 1 hour+ 2003 Yes Staxyn = High discontinuation rate Avanafil Stendra 30 minutes+ 2012 No
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First and only PDE5 nasal spray, available now in Australia under TGA early access.
AGM Presentation 8 8
SPONTAN[®] The Science of Superior Delivery Faster and More Potent
Speed Superiority
-
‣ Tmax: 5 x faster than oral tablets
-
‣ Peak concentration in as little as 9 mins
Healthcare Professional Insight
Patients can respond in as little as 5 minutes, well before peak concentration is reached[*]
- ‣ Average onset: 12 mins vs 56 mins
Potency Advantage
*Based on healthcare professional feedback
-
‣ Half the dose
-
‣ Dose-normalised Cmax is 155.6% higher than orals
-
‣ Consistent effectiveness
-
‣ Direct bloodstream delivery bypasses liver metabolism
Proven Safety
-
‣ Validated safety profile
-
‣ No severe events
-
‣ Clinically proven
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Time to peak concentration (Tmax)
- (minutes)
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Tablets
0 20 40 60
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AGM Presentation 9 9
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Making headlines
in FY25
Throughout FY25, LTR
Pharma maintained a strong
media presence across
Ausbiz, The Australian, The
West Australian, and
Medical Forum, reinforcing
SPONTAN awareness and
commercial progress.
The Company's Conversation Series
expanded with expert-led content from
Dr Thomas Silva and sexual health
counsellor Melissa Hadley Barrett,
establishing LTR as a thought leader in
erectile dysfunction.
AGM Presentation 10
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Company History
Progressed company substantially derisking the proposition
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2020 - 202 ~~1>~~ Acquired exclusive worldwide rights to develop, manufacture and market SPONTAN[®] through a licence agreement with SDS
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Completed packaging studies 2020 Proof Developed the protocol for final of Concept trial results for its bioequivalence commercial product ahead published study, and gained of bioequivalence study in 2023 in The Journal ethics approval and commercial sales of Sexual Medicine
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2022 >
Establishment of the Scientific Advisory Board in the field of Men’s Health
Validated the US FDA’s 505(b)(2) regulatory pathway through an expert regulatory review
Optimised delivery and commercial development of its nasal formulation with drug stability data from nasal spray device developer
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~~< 2023~~
Initial Public Offer (IPO) Completed an oversubscribed IPO. Listed on the ASX on 11 December 2023 and raised AU $7M.
Received early Adopted Mayne Conducted crucial acceptance from Health as a commercial derisking activities IP Australia for our manufacturing partner to before moving into product trademark product SPONTAN[®] clinical development name “SPONTAN[®] ” to GMP standards
~~2024 >~~
Study results released SPONTAN's clinical study to support regulatory filings, enable early Australian market access and preparation for licensing and partnering discussions
Commercial platform activation through the Australian early access
~~2025 >~~ Co-development Online Platform with Aptar Pharma (Q1 CY25) Partnership for the Increasing access commercialisation of through SPONTAN[®] in the USA telehealth and other key markets
FDA pre-IND Platform Secured 33% stake meeting complete expansion in LevOmega NatureUS market into OMD with identical omega-3 preparation through OROFLOW platform addressing ROXUS development development $10B+ market
AGM Presentation 11
Board of Directors
Seasoned leadership driving innovation and growth in healthcare
Mr. LEE RODNE (Executive Chairman)
- 25 years in healthcare and tech sectors in both public ASX and private enterprises.
▲ Led a healthcare spin-out from ASX Fortescue Metals Group (Allied Medical, Admedus Ltd)
▲ Worked with Professor Ian Frazer on advancing therapeutic vaccines into clinical studies
▲ Track record of commercialising medical devices in Australia, North America, Europe and Asia with significant experience in Nasal Spray product sales.
Ms. MAJA MCGUIRE
(Independent Non-Executive Director)
-
15 years of experience providing corporate and compliance advice to ASX-listed public companies as an Australian-qualified lawyer.
-
This includes working with listed companies as a non-executive director, general counsel, company secretary and in private practice.
-
Current Non-Executive Chair of ASXlisted TechGen Metals (ASX: TG1), non-executive director of Kuniko (ASX: KNI) and non-executive director of Indiana Resources Limited (ASX: IDA).
Dr. JULIAN CHICK
(Independent Non-Executive Director)
-
20 years of experience in senior management and board positions, including in ASX-listed companies Avexa Ltd, Admedus Ltd, and
-
current CEO of ReNerve Ltd (ASX: RNV and current director of MABT Ltd and LTR Medical Ltd.
-
Over 8 years of experience in investment banking and reviewing healthcare and biotechnology investment opportunities for private equity investors and venture capitalists.
AGM Presentation 12
Global Team, Strategic US Presence Experienced leadership across key markets
Executive Chairman | Lee Rodne
25 years in healthcare and tech sectors in both public ASX and private enterprises.
General Manager & Business Development US | Tom Riester 25 years experience in sales and management in digital health, medical device and precision medicine.
Chief Finance Officer | Jacques Shipper
18 years of experience in Finance, Commercial Management and Controller roles.
Vice President – US Sales & Marketing | Mike Sweeting
30 years in the Pharmaceutical industry in US commercial sales and Market Access.
Chief Operating Officer | Peter McLennan
18 years of experience in investment banking, investor relations and operations.
Chief Medical Officer | Prof Geoffrey Strange
20 years of experience in the Pharmaceutical and medical industries as a Senior Executive and Medical Researcher.
Vice President Operations & Clinical Development | Dr Monil Shah
20 years of Pharmaceutical and biotechnology industry experience in drug development.
Vice President, Global Regulatory Affairs | Kip Vought
25 years across global markets - Senior Pharmaceutical R&D and regulatory executive.
Chief Commercial Officer | Danny Zanardo
25 years of commercial experience in the Australian and global healthcare sectors across pharmaceuticals and medical devices.
Program Director | Anthony Bishop
30 years experience in all aspects of pharmaceutical, medical device and diagnostic development for global markets
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AGM Presentation 13
2025-2026 Key Milestones
Calendar Year
2026 Q4 2025 Q1 2026 H1 2026 Additional Activities Animal Tox study Phase II enrolment ROXUS 1st US Sales Published data commencement Phase II completion and data PK study enrolment Partnerships discussions read out Human factor study TGA pathway completion OROFLOW development
AGM Presentation 14 14
Corporate Structure
| LTP ASX Code |
LTP ASX Code |
|---|---|
| Shares on issue | 181.61M |
| Market Capitalisation | A$96M |
| Cash and cash equivalents (30 June 2025) | A$31.84M |
| Top 20 shareholder percentage | 43.25% |
| As of 23 October 2025 |
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AGM Presentation 15