Slide 1: Investor Presentation May 2024
(ASX:MEM) INVESTOR PRESENTATION MAY 2024
Slide 2: Disclaimer
DISCLAIMER This presentation is not and does not form part of any offer, invitation or recommendation in respect of securities. Any decision to buy or sell Memphasys securities or other products should be made only after seeking appropriate financial advice. Reliance should not be placed on informat
Slide 3: Contents
CONTENTS 1. Who is Memphasys 04 2. Felix System 10 3. RoXsta 23 4. AI Port 34 5. Reducing Methane (CH4) Emissions from ruminants through cost effective elite DNA multiplication 39 6. Financial Snapshot 44 7. Appendix 48 3
Slide 4: Who is Memphasys
1. WHO IS MEMPHASYS jit al 1p 52 rill MW x
Slide 5: Underpinned by strong fundamentals, already commercialised
ALREADY COMMERCIALISED UNDERPINNED BY STRONG FUNDAMENTALS A reproductive biotechnology company already Highly credentialled innovation team and an 1 1 selling its first commercial product experienced board, executing commercialisation strategy 2 Diverse and innovative pipeline focusing on Exceptiona
Slide 6: Our Leaders
OUR LEADERS Distinguished Emeritus Professor John Aitken ▪ Memphasys Scientific Director ▪ Global leader in reproductive biology, heading up world-class research team at University of Newcastle. ▪ Leads development of MEM’s pipeline products through R&D, proof-of-concept to commercial strategy stage
Slide 7: Leadership Team
LEADERSHIP TEAM Experienced at bringing products to market Robert Cook Dr. David Ali Paul Wright Michael Atkins Assoc. Prof Chairman Acting CEO NE Director NE Director Hassan Bakos Director Operations ▪ 40 years’ experience in healthcare ▪ 35 years’ experience in Animal and ▪ More than 25 years’ exp
Slide 8: Product Suite & Pipeline
PRODUCT SUITE & PIPELINE Media FelixTM Device RoXsta* AI Port Development Sperm separation Rapid in vitro Ambient temp. semen Sperm device for IVF antioxidant transport for animal extension, transport and assessment Artificial Insemination cryopreservation Early Highly Early Highly Early Access Earl
Slide 9: Cross-over in product development: Felix, RoXsta, AI Port
CROSS-OVER IN PRODUCT DEVELOPMENT FELIX SYSTEM FELIX TM ROXSTA • Electrophoretic system selects RoXsta sperm with both low DNA • Point of care diagnostic device damage & oxidative stress • Six-minute process • Device consists of a console which Better technology A rapid in vitro • Sensitive & accura
Slide 10: Felix System: Better Technology for IVF Sperm Preparation
2. FELIX SYSTEM: BETTER TECHNOLOGY FOR IVF SPERM PREPARATION
Slide 11: The Issue
THE ISSUE Average total fertility rate Fertility rate (births per woman) Global fertility decreasing – males account for ~50% ▪ 1 in 6 couples experience fertility issues ▪ Sperm dysfunction is the single most common cause of infertility Assisted human reproduction market size -globally ▪ Little pro
Slide 12: Felix System: Better technology for IVF sperm preparation
FELIX SYSTEM: Better technology for IVF sperm preparation Electrophoretic system selects sperm with both low DNA damage & oxidative stress Device consists of a console which applies a controlled 1 2 charge to a disposable cartridge Console Cartridge contains the novel electrophoretic technology Cart
Slide 13: Felix System: Advantages over traditional methods
FELIX SYSTEM: Advantages over traditional methods Conventional DGC (Density Gradient Centrifugation) and/or swim-up processes* VS Felix System Process: 30-60+ minutes Multi-step & labour intensive Rapid - six minutes Single vessel & automated Specialised clinical operators Easy to train and operate
Slide 14: Felix System: Commercialisation Strategy
FELIX SYSTEM: Commercialisation Strategy Global Opportunity - starts with early Initial focus is to build sales in four early access markets: access markets Country Fresh IVF Expected % growth KOL % of global ▪ Initial focus - rollout of commercial sales in early access Cycles in fresh IVF rate enga
Slide 15: Commercialisation Model – Japan with Vitrolife
FELIX SYSTEM: Commercialisation Model – Japan with strategic partner Vitrolife Phase 1 Phase 2 Phase 3 Achieve on-boarding Identify immediate into distributor's Build BRAND unregulated markets sales/distribution reputation channels Build specific sales Identify and work with Establish standing colla
Slide 16: Japan Early Access Market – expanding into Canada & New Zealand
FELIX SYSTEM: Japan Early Access Market – expanding into Canada & New Zealand Choosing the right partner – Vitrolife Japan KK (subsidiary of the Vitrolife Group) ▪ Exclusive distribution agreement signed for a 5-year term ▪ Vitrolife Group is a world-leading global provider of medical devices, consu
Slide 17: Japan Early Access Market: Next Steps
FELIX SYSTEM: Japan Early Access Market Next Steps – Japan ▪ Japan’s national insurance system currently covers IVF, but not the Felix System, which limits sales to approximately 20% of the market. ▪ Memphasys building clinical data sets and working with distributor to position Felix for full insura
Slide 18: Other Early Access Markets
FELIX SYSTEM: Other Early Access Markets Next Steps – Other Markets ▪ Eligible for sale in both Canada and New Zealand ▪ Distribution agreement in place with Vitrolife ▪ Vitrolife able to deploy same model as in Japan ▪ KOLs in both nations familiar with the Felix System ▪ Vitrolife advancing prelim
Slide 19: Major Regulated Markets 2024-2025
FELIX SYSTEM: TM Major Regulated Markets 2024-2025* Recently published Regulator Pre-submission Clinical Trials Comments data on IVF cycle numbers Anticipated completion Australia TGA 102,157 (2021)1 of trial 4Q FY24 In-country (TGA) n/a Australian Clinical approval is standard India CDSCO trial ant
Slide 20: Felix Publications
FELIX PUBLICATIONS TM Memphasys has completed a number of published clinical studies into the use of the Felix device in comparison with more traditional sperm separation techniques. Studies include: Earlier prototype: CS-10 C. Ainsworth, B. Nixon & R.J. Aitken Development of a novel electrophoretic
Slide 21: Felix Project Timelines
FELIX PROJECT TIMELINES TM 2024 2025 2026 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Pre-TGA Monash Trial Japan Felix Trial Results Published TGA Approval TGA Submission TGA Review TGA Approval India Expansion MD-16 requirements (non- manufacturing) Explore manufact
Slide 22: Felix Q&A
FELIX TM Q&A 22
Slide 23: RoXsta: A Rapid In Vitro Antioxidant Assessment
3. RoXsta* A RAPID IN VITRO ANTIOXIDANT ASSESSMENT * Formerly titled ‘ROSA’
Slide 24: The Issue: Oxidative & Reductive Stress
THE ISSUE: Oxidative & Reductive Stress – Serious chemical imbalances ▪ Oxidative stress - an imbalance between reactive oxygen species and antioxidant protection within the body and can also severely affect fertility in both humans and animals. ▪ Reductive stress - an abnormal accumulation of reduc
Slide 25: The adverse effect of oxidative / reductive stress imbalance
THE ISSUE: The adverse effect of oxidative / reductive stress imbalance Oxidative stress Reductive stress ▪ Aging ▪ Chronic inflammatory disease ▪ Heart failure ▪ Impaired sperm production ▪ Cancer ▪ Neurogenesis inhibition and maturation ▪ Neurodegenerative disease ▪ Decreased cellular metabolism ▪
Slide 26: The Solution - RoXsta: A unique product offering
THE SOLUTION - RoXsta: A unique product offering ▪ Development of 4 separate point-of- ▪ The different stages of the oxidative process, in order, are : care assays, all using the same the ability of a given system to prevent the generation of free fundamental device structure to 1 radicals measure d
Slide 27: Unmet Diagnostic Need
UNMET DIAGNOSTIC NEED: RoXsta technology can address multiple needs and very large global market Current Practice RoXsta Testing for oxidative stress is Testing with Memphasys: rare: ▪ Point of care diagnostic device ▪ Complex equipment ▪ Six-minute process ▪ Time-consuming in lab ▪ Oxidative stress
Slide 28: RoXsta Device Schematic
ROXSTA DEVICE SCHEMATIC Principle on which Design concept for the cartridge Design concept for initial work station – RoXsta works first step before developing fully autonomous system Exploded view Assemble Outer Case Enclosure onto the Chamber assembly Cabling, control units and power supply units
Slide 29: Commercial Applications: Target Market and Opportunity
COMMERCIAL APPLICATIONS TARGET MARKET AND OPPORTUNITY Estimated User group Application Market Size Fertility researchers* ▪ Researching underlying etiology of infertility & gestational issues $3b IVF clinics ▪ Screening for infertility issues in male and female patients $3b Obstetricians ▪ Diagnosin
Slide 30: Update on Development
UPDATE ON DEVELOPMENT ▪ Proof of concept established by Prof. John Aitken’s research team at University of Newcastle ▪ Currently lodging IP, granted in 6-9 months ▪ Proof of concept publications ▪ External design house currently developing prototype and manufacturing pilot batch initially for resear
Slide 31: RoXsta: Pathway to market
RoXsta: Pathway to market Requirements prior to selling Application Industry Verification & Small Regulatory KOL testing validation studies clinical trial approval Fertility research market Early sales potential Food industry monitoring Diagnostic fertility market (male & female) Higher regulatory P
Slide 32: RoXsta Development Timeline
ROXSTA DEVELOPMENT TIMELINE TM 2024 2025 2026 2027 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Prototype testing to select best candidate cartridge Phase 1: Production of 1000 cartridges and test jigs for testing Test jig & disposable Cart
Slide 33: RoXsta Q&A
ROXSTA Q&A 33
Slide 34: Animal Applications – AI Port
4. ANIMAL APPLICATIONS – AI PORT
Slide 35: The Issue: AI technology is antiquated and needs improvement
THE ISSUE: AI technology is antiquated and needs improvement Current Process Step 1 Step 2 Step 3 Step 4 • Semen straws • Semen • Sperm count, • Semen are kept in liquid Collection motility and cryopreserved at nitrogen until morphology -196 oC. they are assessed • Cryopreservation required for AI c
Slide 36: AI Port: New protocol to prepare sperm for AI without freezing
AI PORT: MEM’s new protocol to prepare sperm for AI without freezing Step 1 Step 2 Step 3 • Semen Collection • Seminal plasma is • No freezing removed • Sperm extended in MEM’s proprietary medium for up to 4 days Viable motile sperm 36
Slide 37: Spring '23 Study Design
SPRING ‘23 STUDY DESIGN FIELD TRIAL AIM: Achieve pregnancies that are at least as good as those obtained with traditional sperm cryopreservation and AI* Step 1 Step 2 Step 3 Frozen semen Current industry method New method - Bulls from studs Raw ejaculate Isolated (centrifugation) achieve as good as
Slide 38: Cross-over in product development
CROSS-OVER IN PRODUCT DEVELOPMENT FELIX SYSTEM FELIX TM ROXSTA • Electrophoretic system selects RoXsta sperm with both low DNA • Point of care diagnostic device damage & oxidative stress • Six-minute process • Device consists of a console which Better technology A rapid in vitro • Sensitive & accura
Slide 39: Cross-over Development Example: Reducing Methane Emissions
5. CROSS-OVER DEVELOPMENT EXAMPLE ANIMAL AI: REDUCING METHANE (CH4) EMISSIONS FROM RUMINANTS THROUGH COST EFFECTIVE ELITE DNA MULTIPLICATION
Slide 40: The Issue: Methane emissions in livestock
THE ISSUE: Methane emissions in livestock ▪ Agriculture is projected to be the third largest source of emissions globally by 2030 ▪ Methane emissions from livestock are the largest source of greenhouse gas in the agriculture sector1 ▪ The Australian red meat & livestock industry has set a target to
Slide 41: Why is genetics so important?
WHY IS GENETICS SO IMPORTANT? ▪ Shaping emissions intensity in livestock systems will be heavily influenced by genetics as we move toward 2030. ▪ Increasing production per unit of emission is costly to identify and will be based on a small subset of elite animals. ▪ The small population of elite ani
Slide 42: MEM Products could be the "Game Changer"
MEM PRODUCTS COULD BE THE “GAME CHANGER” ▪ MEM is developing a process of extending the viability of sperm cells in an ambient temperature receptacle. ▪ Fresh semen storage via MEM processes aims to reduce the fragmentation (breakdown) of DNA within a sample. ▪ The capacity to reduce DNA breakdown t
Slide 43: AI Port / Animal AI Q&A
AI PORT / ANIMAL AI Q&A 43
Slide 44: Financial Snapshot
6. FINANCIAL SNAPSHOT
Slide 45: Memphasys Financial Snapshot
MEMPHASYS FINANCIAL SNAPSHOT: As at 16/05/2024 KEY DATA1 A$ OWNERSHIP STRUCTURE1 % Share price $0.008 Peters Investments 19.5 A Goodall 12.7 Shares on issue 1,367.7M A Coutts 7.0 Market capitalisation $11M Top 20 62.5 Cash (31 March 2024) $436K CONVERTIBLE NOTES 1 Source: ASX website (as at 16/05/20
Slide 46: Memphasys: Set for growth
MEMPHASYS: Set for growth NEW OPENING PIPELINE UNMET NEED TALENT MARKETS BUILDING ▪ Acting CEO ▪ Clear pathways to ▪ Product R&D ▪ Prof John Aitken ▪ Director Business market for each strategy (Scientific Development product exclusively Director) & ▪ Appointments ▪ Commitment addressing unmet Univer
Slide 47: Thank you
Thank you CONTACT INFORMATION: Dr David Ali Managing Director and CEO (Acting) Memphasys Limited 30-32 Richmond Rd, Homebush NSW 2140 Australia P +612 8415 7300 E david.ali@memphasys.com M + 61 428794909 W www.memphasys.com
Slide 48: Appendix
7. APPENDIX
Slide 49: Artificial Insemination (AI)
ARTIFICIAL INSEMINATION (AI) The most efficient method to improve herd genetics Degree of heritability ▪ Initial target: beef cattle - growing need Heritable production traits Low Medium High to improve genetics in high end cattle “Mothering” ability ✓ breeds e.g. wagyu, Black Angus Fertility ✓ ▪ La
Slide 50: Spring '23 Cattle Field Trial Results
SPRING ‘23 CATTLE FIELD TRIAL RESULTS • MEM conducted a field trial at a beef cattle stud in the Hunter region using 144 cows and 4 bulls • Overall pregnancy rate was low, even with traditional AI (30% compared with industry norm of 50- 60%). • Sperm motilities of 3 out of the 4 bulls were also subs
Slide 51: Spring '24 Trial Preparation
SPRING ‘24 TRIAL PREPARATION Insights gained from the last field trial are being used to prepare for the next trial: • Provide an on-site lab • Will enable centrifuging of semen at point of collection rather than two-hour transport of semen back to Uni Newcastle. • Seminal plasma is toxic to sperm a