Announcement PDF Fast-acting nasal spray treatment for erectile dysfunction Investor Update | March 2025 Important Notice & Disclaimer ‣ 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. 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Any opinions expressed in the presentation are subject to change without notice. ‣ LTR Pharma Limited ACN 644 924 569 Investor Update | March 2025 2 Executive Summary Bringing to market the first nasal spray for ED LTR Pharma is commercialising SPONTAN® and ROXUS® ‘First-in-Class’ rapid, on-demand nasal spray treatment for Erectile Dysfunction (ED) Successful pivotal pharmacokinetic study Demonstrated rapid onset and consistency of delivery Disrupting the blockbuster PDE5 inhibitor market Targeting to be the first PDE5 inhibitor nasal spray registered in market estimated to reach US$6.0B in 2028 Clear commercial pathway Expedited pathway to market – SPONTAN in market now in Australia under Early Access Scheme – ROXUS targeting US entry in 1H CY26. FDA 505(b)(2) pathway being progressed in parallel Additional nasal spray products planned for development Plan for additional SPONTAN® products for ED, different variations, price points and other indications in 2025 Investor Update | March 2025 3 Investment Highlights LTR Pharma positioned in a clear gap in the market Multiple path to market ‣ SPONTAN® is available now in Australia via TGA's early access scheme ‣ ROXUS accelerating US entry through personalised medicine ‣ Regulatory approvals progressing with the FDA and TGA Compelling pivotal pharmacokinetic study data Blockbuster market with issues 5x faster absorption than oral tablets 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 ‣ Expanding product portfolio ‣ Manufacturing Scale up ‣ Roxus Product Development completion ‣ Growing Online Prescribing ‣ Regulatory studies & meetings ‣ Published data ‣ Potential partnerships/licensing Investor Update | March 2025 4 Market Problem & Opportunity Understanding the Market Need A significant healthcare challenge affecting relationships and quality of life Physical causes Psychological Impact ‣ Heart health ‣ Relationship problems ‣ Hormone balance ‣ Mental wellbeing ‣ Diabetes ‣ Day to day stress ‣ Medical treatments ‣ Hair loss ‣ Weight loss 50% ‣ Antidepressants Stop purchasing PDE5 tablets1 men over 60% Of 45 experience ED 2 Growing prevalence with age impacts quality of life Prevalence of ED with individuals with cardiovascular risk factors, hypertension and diabetes, is reported as high as 50% 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 Investor Update | March 2025 6 In Key Markets As risk factors become more prevalent, so does ED USA China Aus EU ~30m ~33m Source: Frost and Sullivan Report, The Erectile Dysfunction Medicines Market, September 2023 ~150m 60.7% of males 45y/o+ Investor Update | March 2025 7 Estimated Market Size Forecast to be US$6.0B market by 2028 $5.94B US$6000.00.B 7.0% CAGR US$5000.00.B US$ billions US$4000.00.B $3.68B US$3000.00.B $2,577.00 $2,757.39 $2,950.41 $3,156.94 $3,377.92 $3,614.38 $3,867.38 $4,151.00 US$2000.00.B US$1000.00.B $1,105.00 $1,183.00 $1,267.00 $1,357.00 $1,454.00 $1,557.00 $1,667.00 $1,786.00 2021 2022 2023F 2024F 2025F 2026F 2027F 2028F US$.00.B ROW US Online sales expansion: Majority of ED medication is now sold through online channels Investor Update | March 2025 8 Current Treatments Gold standard are PDE5 inhibitors which have several drawbacks Phosphodiesterase-5 (PDE5) inhibitors are first-line treatments Issues with PDE5 inhibitors Product Main Brand(s) Time before sexual activity for dose Approval Date (US) Generic availability Does not work 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 Varendafil Levitra, Staxyn 1 hour+ 2003 Yes Avanafil Stendra 30 minutes+ 2012 No Adverse reactions in up to 35% of patients = High discontinuation rate Investor Update | March 2025 9 The Search for a New Branded Option Significant opportunity for branded assets Opportunity to capture market share at higher margins Generics have grown to 700M* units annually ‣ Rapid erosion of branded volume following patent expiries ‣ No product differentiation in a fragmented market ‣ Low margins for currently marketed generics Branded drugs ‣ Commands significantly higher price points / margins ‣ Demonstrates pricing power and demand for premium brands SPONTAN® as a branded asset ‣ Market participants seeking new branded options to differentiate in the marketplace ‣ Opportunity to capture market share through improved therapy profile with higher margins than generics Note: * 700M units claimed and does not include self-funded purchases Investor Update | March 2025 10 Solution Nasal Administration Delivery mechanism can solve many of issues facing PDE5 inhibitors Advantages vs oral administration More rapid onset of action Higher rate of absorption Lower adverse reactions Less active pharmaceutical ingredients required Less drug degradation due to bypassing the digestive system Investor Update | March 2025 12 SPONTAN® Pivotal Pharmacokinetic Study Rapid onset effect, consistent delivery and improved safety profile ‣ 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. ‣ Parameter Vardenafil (5mg) (10mg) oral ‣ Cmax (ng/ml). ‣ 13.0 ‣ 16.7 ‣ Tmax (min) ‣ 12 (range 9-15) 56 (Longest 150) ‣ Adverse Events ‣ 0 ‣ 1 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. Investor Update | March 2025 13 SPONTAN® The Fast-Acting Solution Transforming ED treatment with speed and confidence Speed Matters Healthcare Professional Insight ‣ Peak concentration in as little as 9 mins, 470% faster than oral tablets Average onset: 12 mins vs 56 mins Patients can respond in as little as 5 minutes, well before peak concentration is reached*. *Based on healthcare professional feedback Less is More ‣ Half the dose ‣ Similar effectiveness ‣ Better delivery consistency Time to peak concentration (minutes) Proven Safety ‣ Validated safety profile ‣ No severe events ‣ Clinically proven Tablets 0 20 40 60 Investor Update | March 2025 14 Company Overview Company History Progressed company substantially derisking the proposition 2020 - 2021> Acquired exclusive worldwide rights to develop, manufacture and market SPONTAN® through a licence agreement with SDS 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 < 2023 2020 Proof of Concept trial results published in 2023 in The Journal of Sexual Medicine Developed the protocol for its bioequivalence study, and gained ethics approval Initial Public Offer (IPO) Completed an oversubscribed IPO. Listed on the ASX on 11 December 2023 and raised AU $7M. < 2022 Received early acceptance from IP Australia for our product trademark name “SPONTAN®” Adopted Mayne Health as a commercial manufacturing partner to product SPONTAN® to GMP standards 2024 > Completed packaging studies for final commercial product ahead of bioequivalence study and commercial sales Conducted crucial derisking activities before moving into clinical development Optimised delivery and commercial development of its nasal formulation with drug stability data from nasal spray device developer 2025 > Study results released SPONTAN's clinical study to support regulatory filings, enable early Australian market access and preparation for licensing and partnering discussions Australian Early Access Scheme commencement Provision of SPONTAN® for unmet needs Co-development with Aptar Pharma Partnership for the commercialisation of SPONTAN® in the USA and other key markets Online Platform (Q1 CY25) Increasing access through telehealth FDA pre-IND meeting complete ROXUS Development initiated Investor Update | March 2025 16 Global Co-Development Agreement Nasdaq listed Aptar Pharma Strategic partnership driving regulatory success and market readiness Partnership Foundations Regulatory & Development Activities ‣ Focuses on commercialisation in the US and other key markets Extractables & Leachables (E&L) studies ‣ Utilises Aptar's VP7 model nasal spray technologies ‣ Essential for regulatory submission ‣ Potential to develop additional next-gen nasal spray products ‣ Validating FDA compliance standards Human Factors Study program ‣ Evaluating user experience Strategic Benefits ‣ Access to Aptar's comprehensive regulatory services ‣ Supports 505(b)(2) expedited pathway ‣ De-risks regulatory submissions ‣ Foundation for future collaborations with global leader in nasal spray products ‣ Optimising product usability Regulatory Documentation ‣ FDA-compliant instructional videos ‣ Instructions For Use (IFU) development ‣ Supporting educational materials Investor Update | March 2025 17 SPONTAN - FDA Regulatory Milestone Clear Path Forward Pre-IND Meeting Completed Strategic Advantage ‣ FDA endorsement of overall development approach ‣ Regulatory clarity enhances development efficiency ‣ Alignment on streamlined clinical development plan ‣ Clear understanding of regulatory requirements Key Development Components ‣ Access to Aptar's comprehensive regulatory services ‣ One pivotal safety and efficacy clinical trial ‣ Multi-dose pharmacokinetic (PK) study ‣ Chemistry, Manufacturing and Controls (CMC) plan Regulatory Program Check Points ‣ Leveraging Aptar Pharma's established FDA relationships Pre-IND Meeting ‣ Expert team with track record in 505(b)(2) submissions Development Plan (CMC, Non-clinical, Clinical) ‣ Potential for global regulatory synergies with multi-market approach NDA Submission FDA Review Market Approval ‣ Non-clinical (toxicology) program Investor Update | March 2025 18 Introducing ROXUS® Personalised ED Care Product Features ‣ Vardenafil-based nasal spray ‣ Identical active ingredient to SPONTAN® ‣ Targeting the personalised medicine sector Development Status ‣ Stability testing underway with Australian pharmaceutical partner 5.2% CAGR $10B ‣ Positioned for fast-acting, on-demand ED relief ‣ Leveraging the established safety profile of SPONTAN® $6B ‣ Completion expected in next two quarters ‣ Targeting US market entry in early-mid 2026 Strategic Advantages ‣ Initial focus on specialised clinics and personalised care groups ‣ Real-world patient and prescriber insights ‣ Targeting top KOLs in US market Personalised Care Compounding Pharmacy Market* ‣ Early entry into the US market ‣ Market positioning validation ‣ Positioned for high growth 2023 *Source: Nova1Advisor: Compounding Pharmacies Market Size, Share & Trends Analysis. 2033 Investor Update | March 2025 19 Accelerating US Market Entry Dual-Track Strategy Path 1: SPONTAN® > Full Approval ‣ FDA 505(b)(2) pathway ‣ Real-world patient and prescriber insights ‣ Full market authorisation upon approval ‣ Target: Mass market Path 2: ROXUS > Personalised Medicine ‣ Revenue generation from the US market 2026 ‣ US 503(a) pathway ‣ Building prescriber relationships and brand recognition ‣ Early market entry in 2026 ‣ Enabling US based KOL and Health Care Professionals engagement ‣ Target: Personalised healthcare sector ‣ Accessing $6B US compounding market ‣ Establishing strategic commercial footprint in world’s largest market Investor Update | March 2025 20 Clear path to Market In-Market NOW Growing Telehealth and Online Prescribing via TGA’s Early Access Programs 1 ‣ RHC – experts in treating ED and early adopters of SPONTAN JV with Restorative Health Clinic (RHC) ‣ Online bookings, consults, men’s health education, telehealth solutions and prescribing SPONTAN on ‣ https://rshealth.com.au/ and https://makehardeasy.com.au/ 2 ‣ Australia’s largest men’s health pharmacy clinic network Men’s Health Downunder (MHDU) 3 ‣ Significant referral network of GPs, urologists, and sexual health clinics ‣ Online telehealth appointment / SPONTAN Nasal Spray prescribing on ‣ https://menshealthdownunder.com.au/ ‣ Specialist GP Men’s Health Services Kangaroo Point ‣ Online telehealth appointments on ‣ https://kangaroopointmedicalcentre.com.au/ Corporate Presentation Expedited path to market Seeking FDA and TGA approvals in the US & Australia and then other key markets FDA TGA United States Australia Targeting a 505 (b)(2) approval pathway regulatory strategy, on basis it is “repurposing” of an existing approved drug Targeting Category 1 - Type F Application process is expected to be available to the Company Previous approval of oral tablet Vardenafil by the FDA would allow inclusion of existing safety and efficacy clinical and nonclinical data Given the existing safety profile of Vardenafil, the regulatory pathways for repurposed drugs allows for expedited application Milestones for FDA 1. Preparation of regulatory documentation 2. E&L Studies (with Aptar) Milestones for TGA 1. Preparation of regulatory documentation 2. Targeting pre submission meeting (Q2 CY 25) 3. Human Factors Studies (with Aptar) 4. Pharmacokinetic (PK) Study 5. Safety and Efficacy Trial 6. Animal Toxicology study 7. New Drug Application (NDA) ROXUS® is expected in the US market 1H CY26 SPONTAN® is available to patients via the TGA's SAS and APS for unmet needs Investor Update | March 2025 23 Commercialisation Pathways Seeking FDA and TGA approvals in the US & Australia and other key markets 1. Australia’s TGA SAS & APS early access ‣ The successful clinical study results outlining the strong efficacy and safety profile enables access in Australia through the TGA’s early access schemes, SAS and APS ‣ Early access schemes permit the supply of SPONTAN through healthcare professionals on a compassionate use basis 2. Personalised Healthcare Market ‣ ROXUS is expected to roll out to commercial pharmacies In 1H CY26 ‣ LTR Pharma will advance these discussions in conjunction with progressing regulatory approval pathways 3. Partnering / Licensing ‣ Exploration of partnership/licensing opportunities with significant global pharmaceutical industry participants has begun ‣ LTR Pharma will advance these discussions in conjunction with progressing regulatory approval pathways 4. Sales post Regulatory Approval ‣ Targeting an expedited path to market in the US, Australia and other key markets ‣ Following regulatory approval, SPONTAN® will be a new branded erectile dysfunction drug leveraging online sales channels and partner networks ROXUS to be launched in the US in early 2026 targeting the personalised medicine market Investor Update | March 2025 25 Capturing the Digital Health Revolution Building tomorrow's ED treatment platform today Explosive Growth of telehealth Strategic Position Commercial Pathway Key Differentiators US$140B+ ‣ Positioning SPONTAN® for online access Online Prescribing Q1 CY25 ‣ 1st test market in Australia early 2025 – replicate success globally ‣ Specialist sexual health practitioners providing personalised care ‣ Test rollout in Q1 CY25 market size by 2032* ‣ Digital health revolution transforming patient care ‣ 22% CAGR outpacing traditional healthcare* ‣ telehealth integration and electronic prescribing ‣ Partner with other online prescribers in 2025 ‣ Platform development – Q4 CY24 ‣ Direct patient access through experts in ED ‣ Comprehensive medical assessment, not just medications ‣ Telehealth platform complementing established clinical expertise ‣ Privacy-focused patient solution * Source: Fortune Business Insights, Global Telehealth Market Report 2024-2032 Investor Update | March 2025 26 Multiple Value Inflection Points Key milestones and catalysts anticipated in 2025/26 Early Access Expansion in Australia Expanding Product Portfolio Range ‣ Growing Online prescribers ‣ SPONTAN® derivatives (Multiple product versions for sale) ‣ General Practitioner awareness engagement ‣ New indications ‣ Symbion coming online Q2 CY25 ‣ Manufacturing Scale ups –bar coding / packaging ‣ Clinical data – publications Regulatory / Marketing Studies Strategic Development ‣ Chemistry, manufacturing and Control (CMC) studies (i.e., extractable and leachables) ‣ FDA/TGA pre-submission meetings ‣ Animal toxicology studies ‣ Potential partnerships/licensing ‣ Clinical – registration/marketing study ‣ ROXUS development for early US market entry ‣ USA manufacturing & distribution preparations ‣ Investigator initiated led studies (i.e. post prostate cancer, etc) Investor Update | March 2025 27 Contact investors@ltrpharma.com Authorised for release by the Board of Directors www.ltrpharma.com