Investor Presentation
Released
Released
Announcement PDF
Building a Portfolio
of Differentiated
Specialty Therapies
1
Investor Update | March 2026
Important Notice and Disclaimer
2
‣ Nature of Document: This presentation has been prepared and issued by LTR Pharma Ltd
(Company or LTP) to provide general information about the Company. The information in this
document is in summary form and should not be relied upon as a complete and accurate
representation of any matters that a reader should consider in evaluating the Company. While
management has taken every effort to ensure the accuracy of the material in this presentation,
the Company have not verified the accuracy or completeness of the material contained in this
presentation.
‣ Not an offer: This presentation is NOT a recommendation, offer or invitation to subscribe for or
purchase LTP securities. This presentation is not exhaustive and does not contain all of the
information a potential investor, or their professional advisers would require, and it does NOT
constitute a “Prospectus" or a "Disclosure Document” (as defined in the Corporations Act 2001
(Cth), and has not been, and will not be, lodged with the Australian Securities and Investments
Commission or any other regulatory authority. This presentation should not be distributed,
transmitted, or viewed by any person in any jurisdiction where the distribution, transmission or
viewing of this document would be unlawful under the securities or other laws of that or any
other jurisdiction. In particular, this presentation may not be released to US wire services or
distributed publicly in the United States. See the section of this presentation captioned
“International Offer Jurisdictions” for more information. This presentation does not constitute an
offer to sell, or a solicitation of an offer to buy any securities in any jurisdiction. Any failure to
comply with such restrictions could constitute a violation of applicable securities laws.
‣ Not financial product advice: You should not act and should refrain from acting in reliance on this
presentation. Nothing contained in this presentation constitutes investment, legal, tax or other
advice. This presentation does not take into account the individual investment objectives, financial
situation and particular needs of potential investors. Before making a decision to invest in the
Company at any time, you should conduct, with the assistance of your broker or other financial or
professional adviser, your own investigation in light of your particular investment needs,
objectives and financial circumstances and perform your own analysis of the Company before
making any investment decision.
‣ Forward looking statements: This presentation contains forward-looking information about the
Company and its operations. In certain cases, forward-looking information may be identified by
such terms as "anticipates", "believes", “should”, "could", "estimates", “target”, “likely”, “plan”,
"expects", "may", “intend”, "shall", "will", or "would". These statements are based on information
currently available to the Company and the Company provides no assurance that actual results
will meet management's expectations. Forward-looking statements are subject to risk factors
associated with the Company’s business, many of which are beyond the control of the Company.
It is believed that the expectations reflected in these statements are reasonable but they may be
affected by a variety of variables and changes in underlying assumptions which could cause actual
results or trends to differ materially from those expressed or implied in such statements. There
can be no assurance that actual outcomes will not differ materially from these statements.
‣ Disclaimer: No representation or warranty, express or implied, is made by the Company that the
material contained in this presentation will be achieved or proved correct. Except for statutory
liability which cannot be excluded, the Company, its directors, officers, and employees expressly
disclaim any responsibility for the accuracy, fairness, sufficiency or completeness of the material
contained in this presentation and excludes all liability whatsoever (including in negligence) for
any loss or damage which may be suffered by any person as a consequence of any information in
this presentation or any effort or omission therefrom. The Company will not update or keep
current the information contained in this presentation or to correct any inaccuracy or omission
which may become apparent, or to furnish any person with any further information. Any opinions
expressed in the presentation are subject to change without notice.
‣ LTR Pharma Limited ACN 644 924 569
Executive Summary
3
Differentiated Lead Program – SPONTAN / ROXUS
Rapid-acting intranasal PDE5 therapy demonstrating 5x faster absorption versus
oral tablets at half the dose, with a validated safety and tolerability profile.
Dual U.S. Pathway Strategy
Advancing SPONTAN via the 505(b)(2) regulatory pathway following successful
Pre-IND engagement. In parallel, progressing commercial discussions to support
U.S. launch of ROXUS through the personalised medicine (503A) channel.
Early Commercial Validation (Australia)
1,000+ prescriptions under the TGA Special Access Scheme (SAS), supporting
prescriber adoption and expanding real-world safety and efficacy data.
Strategic Partnerships
Co-development agreement with Aptar Pharma (Nasdaq). Commercial manufacturing
with Mayne Pharma (ASX). National distribution via EBOS/Symbion (ASX).
Funded Through Key Milestones
$25.9M cash, zero debt, funding Phase II data readout and continued regulatory
and commercial advancement.1
LTR Pharma: Late-Stage Pharmaceutical Platform with Validated Early Market Access
1. Source: Appendix 4C for quarter ended 31 December 2025. Cash figures in Australian Dollars.
Market Inefficiency:
High Discontinuation
and Delayed Onset
Global Erectile Dysfunction Treatment Market
5
Global ED drug market estimated at ~US$5B annually1
Oral PDE5 inhibitors currently dominate prescribing
High discontinuation rates (>50%) reported with oral PDE5
inhibitors due to delayed onset, inconsistent response and tolerability2
Rapid growth in telehealth prescribing channels
Opportunity for differentiated therapies with faster onset and alternative delivery
Potential adoption in difficult-to-treat ED segments
(e.g., post-prostatectomy, performance anxiety, BPH)
1) Source: Frost and Sullivan Report, The Erectile Dysfunction Medicines Market, September 2023
2) Carvalheira et al., "Dropout in the Treatment of Erectile Dysfunction with PDE5: A Study on Predictors and a Qualitative Analysis of Reasons for Discontinuation,"
Journal of Sexual Medicine, May 2012.
Prevalence of ED with individuals with cardiovascular risk factors,
hypertension and diabetes, is reported as high as 50%
Understanding
the Market Need
6
A significant healthcare
challenge affecting
relationships and
quality of life
Physical causes
‣ Heart health
‣ Hormone balance
‣ Prostate Cancer
‣ Diabetes
‣ Medical treatments
‣ Hair loss
‣ Weight loss
‣ Antidepressants
Psychological Impact
‣ Relationship problems
‣ Mental wellbeing
‣ Day to day stress
60%
50%
Growing prevalence with
age impacts quality of life
Of men over
45 experience ED2
Stop purchasing
PDE5 tablets1
1) Carvalheira et al., "Dropout in the Treatment of Erectile Dysfunction with PDE5: A Study on Predictors and a Qualitative Analysis of Reasons for Discontinuation,"
Journal of Sexual Medicine, May 2012. 2) Source: Frost and Sullivan Report, The Erectile Dysfunction Medicines Market, September 2023
First and only PDE5 nasal spray, available now in Australia under TGA early access.
Product Main
Brand(s)
Time before sexual
activity for dose
Approval
Date (US)
Generic
availability
Sildenafil Viagra 1 hour+ 1998 Yes
Tadalafil Cialis 1 hour+ 2003 Yes
Vardenafil
Levitra,
Staxyn
1 hour+ 2003 Yes
Avanafil Stendra 30 minutes+ 2012 No
Current Treatments
7
Oral Phosphodiesterase-5 (PDE5)
inhibitors are first-line treatments
Issues with oral
PDE5 inhibitors
Does not work
for 30-35% of patients
Long response time of
1 hour + affects spontaneity
Adverse reactions
in up to 35% of patients
= High discontinuation rate
Oral PDE5 inhibitors and SPONTAN® Nasal Spray
Where SPONTAN Fits in the ED Treatment Landscape
8
Current first-line therapy: Oral PDE5 inhibitors (Viagra, Cialis, Levitra)
May offer advantages for patients who do not respond optimally to oral PDE5 inhibitors
SPONTAN ® intranasal delivery bypasses first-pass metabolism and enables
faster systemic absorption
Limitations of oral therapies include delayed onset, food interactions,
and high discontinuation rates
Rapid onset potential supports more spontaneous use compared
with traditional oral treatments
Applicable across the broad ED population, particularly for patients seeking faster
onset and improved spontaneity, with potential advantages in difficult-to-treat
segments such as post-prostatectomy and performance-related ED.
in Key Markets
9
As risk factors become more prevalent, so does ED
Source: Frost and Sullivan Report, The Erectile Dysfunction Medicines Market, September 2023
~30m ~33m ~150m
60.7%
of males 45y/o+
USA
EU
China
Aus
Solution
Parameter
SPONTAN®
Pivotal Pharmacokinetic Study
11
‣ SPONTAN® nasal spray achieved rapid absorption and
faster onset of action compared to oral PDE5 inhibitors.
‣ SPONTAN® delivered similar bioavailability (Cmax)
at half the dose of oral PDE5 inhibitors.
‣ Significantly faster (Tmax) with SPONTAN® in as little
as 9 min (avg. 12 min) vs oral (56 min) - longest 2.5 hours.
‣ Confirmed safety and tolerability profile of
SPONTAN® vs oral dosing PDE5 Inhibitors.
‣ SPONTAN® demonstrated more consistent
dosing than oral PDE5 Inhibitors.
‣ Data to be used in regulatory filings in US,
Australia and other key markets.
Rapid onset effect, consistent delivery
and improved safety profile
‣ Cmax (ng/ml)
(5mg)
Vardenafil
(10mg) oral
‣ 13.0 ‣ 16.7
‣ Adverse Events ‣ 0 ‣ 1
‣ Tmax (min) ‣ 12 (range 9-15) 56 (Longest 150)
SPONTAN® the Science of Superior Delivery
12
Potency Advantage
‣ Half the dose
‣ Dose-normalised Cmax
is 155.6% higher than orals
‣ Consistent effectiveness
‣ Direct bloodstream delivery bypasses
liver metabolism
Speed Superiority
‣ Tmax: 5x faster than oral tablets
‣ Peak concentration in as little as 9 mins
‣ Average onset: 12 mins vs 56 mins
*Based on healthcare professional feedback
Time to peak concentration (Tmax)
(minutes)
Patients can respond in as little as 5 minutes,
well before peak concentration is reached*
Proven Safety
‣ Validated safety profile
‣ No severe events
‣ Clinically proven
Tablets
Healthcare Professional Insight
0 20 40 60
Faster and more potent
¹ APCC 2025 Case Series (ASX: 25 Aug 2025) ² Performance-Related ED Observations (ASX: 2 Feb 2026)
Australian Early Access Program:
Real-World Clinical and Prescriber Validation
13
TGA Special Access Scheme - 1,000+ prescriptions
supporting real-world clinical and prescriber validation
Prescriber
Adoption
‣ 1,000+ prescriptions and growing
‣ Expanding prescriber base
‣ Repeat prescribing behaviour
observed
Real-World
Clinical Data
‣ Published case series (APCC 2025)
‣ Positive patient preference
versus oral PDE5 in
post-prostatectomy cohort¹
‣ Positive outcomes in
performance-related ED²
‣ Growing real-world safety
and efficacy dataset
Commercial Infrastructure
Established
‣ 600+ pharmacies via Symbion /
TerryWhite Chemmart
‣ Telehealth integration underway
‣ Distribution and fulfilment
processes operational
Why LTR Pharma Can Win in the ED Treatment Market
14
Efficient regulatory strategy via the FDA 505(b)(2) pathway
Potential early U.S. market entry via personalised medicine (503A)
pathway while advancing toward FDA approval
Strategic partnerships supporting development and
commercialisation (Aptar, Mayne, EBOS/Symbion)
Real-world validation: 1,000+ prescriptions under the Australian TGA
Special Access Scheme
Clinically differentiated product: SPONTAN demonstrates ~5x faster absorption
versus oral PDE5 tablets
Intranasal delivery bypasses first-pass metabolism, enabling rapid systemic exposure
US Market Strategy
15
Primary Value Pathway – FDA 505(b)(2)
‣ Pre-IND meeting completed with FDA
‣ Agreed development framework
‣ Phase II PK study underway
‣ Single pivotal Phase III Safety and Efficacy study required
‣ CMC and human factors programme progressing with Aptar
‣ Designed to support NDA submission under the 505(b)(2) pathway
Complementary Commercial Pathway – ROXUS (503A)
‣ Progressing commercial discussions with U.S. personalised medicine pharmacies and telehealth
‣ Intended to support early market presence
‣ Generates commercial experience and real-world insights
‣ Complimentary to the FDA regulatory programme
FDA Regulatory
Program Check Points
Dua Pathway Approach
Pre-IND Meeting
CMC, Non-clinical, Clinical
Non-Clinical Program (toxicology)
Phase II PK Study
Phase III Safety & Efficacy
NDA submission
FDA Review
Portfolio Overview
and Development
Focus
16
Lead Clinical Program ‣ TGA Early Access – ACTIVE
‣ FDA 505(b)(2) regulatory pathway
‣ Phase II PK Study Underway
‣ 503A Commercial Discussions Progressing
Early Development
OROFLOW – Platform Expansion
‣ Pre-clinical / proof-of-concept Stage
‣ Evaluating additional intranasal indications
‣ Capital prioritised to lead program
Strategic Investment
LevOmega
‣ Equity Investment – 43%
‣ Focused on development of nature-identical omega-3
products
‣ Separate development pathway and capital structure
‣ Complementary to LTR’s core intranasal programs
Validated Platform
Supporting Multiple
Indications
Intranasal Sprays for Erectile
Dysfunction
Intranasal Spray for
Oesophageal Motility Disorders (OMD)
Nature-Identical omega-3 Products
Strategic
Execution
Milestones, Partnerships
and Regulatory Progress
Combination product
expertise
‣ Co-development agreement
with Aptar Pharma (Nasdaq)
‣ VP7 multidose nasal spray platform
‣ Integrated drug-device
development programme
Regulatory and development
‣ Extractables study completed
‣ Leachables study underway
‣ Human factors studies progressing
‣ Supporting FDA combination product
requirements
Global Co-Development Agreement
Aptar Pharma
18
Strategic significance
‣ Global supply and FDA expertise
‣ Alignment with 505(b)(2)
development pathway
‣ Established pharmaceutical partner
Strategic partnership driving regulatory
success and market readiness
US Market Entry Preparations
Cash in Bank
$25.9 million
Quarterly Operation Cash Outflow
$2.8 million
Debt Position
Zero debt
Financial Position
19
Funded Value Inflection Points
Completion of Phase II PK Study
In progress
Ongoing
Funded to deliver near-term clinical milestones
Source: Appendix 4C for quarter ended 31 December 2025. Cash figures in Australian Dollars.
Disciplined capital management supporting clinical and commercial execution
Human factors programme
Underway
Non-clinical toxicology programme
Progressing
$25.9M cash | Zero debt | Supporting key clinical and regulatory milestones
Key Milestones
20
Executing across clinical, regulatory and commercial programmes
Achieved
‣ Pre-IND meeting completed with FDA
endorsement
‣ Phase II PK dosing commenced
‣ Extractables study completed — all
compounds below ICH thresholds
‣ 1,000+ prescriptions under TGA early access
‣ Clinical data published in European Journal
of Pharmaceutical Sciences
Near-Term
(H1 2026)
‣ Phase II PK initial data readout
‣ Human factors study completion
‣ Leachables study completion
‣ Progression of commercial discussions in
support of entering the U.S. personalized
medicine (503A) pathway.
Development Progression
(H2 2026+)
‣ Full Phase II data set
‣ Animal toxicology completion
‣ Phase III planning
‣ OROFLOW® proof-of-concept progression
‣ Strategic partnership discussions
Clinical proof. Contracted partners. Funded to deliver
Why Invest in LTR Pharma
21
Capital and
Strategic Position
‣ $25.9M cash, zero debt,
disciplined capital allocation.
‣ Partnerships with Aptar
(Nasdaq), Mayne (ASX),
and EBOS/Symbion (ASX).
Clear and Efficient
Regulatory Pathway
‣ Advancing via the FDA 505(b)(2)
framework following successful
Pre-IND engagement, requiring
a single Pivotal Phase III study.
Early Validation
and U.S. Strategy
‣ 1,000+ prescriptions under
Australia’s SAS programme
supporting prescriber adoption.
‣ Dual U.S. approach: FDA
pathway complemented by
potential personalised medicine
(503A) entry.
Clinical
Differentiation
‣ SPONTAN / ROXUS
demonstrates 5x faster
absorption at half the dose
versus oral PDE5 tablets, with
validated safety and tolerability
supported by peer-reviewed
publication.
Contact
investors@ltrpharma.com www.ltrpharma.com
Authorised for release by the Board of Directors
Share your feedback
Discover