Recce Pharmaceuticals Ltd. · ASX:RCE
Recce Pharmaceuticals — Investor Presentation (March 2023)
25 slides from Recce Pharmaceuticals's investor presentation, Mar 23, 2023
Slide 1: Corporate Presentation
Corporate Presentation March 2023 ASX:RCE FSE:R9Q
Slide 2: Disclaimer
Disclaimer DISCLAIMER This presentation has been prepared by Recce Pharmaceuticals Ltd (the “Company”). It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Company. You should not treat the contents of this pre
Slide 3: Board Structure
Board Structure Dr John Prendergast James Graham Michele Dilizia Justin Ward Executive Chairman Chief Executive Officer Chief Scientific Officer Executive Director & (Shares: 250,000) (Shares: 6,031,932 – 3.39%) (Shares: 3,543,485 – 2.0%) Principal Quality Chemist (Options: 2,175,000) (Options: 2,25
Slide 4: Investment Highlights
Investment Highlights Proprietary first-in-class anti-infectives against bacteria and viruses Multiple shots on goal, initially pursuing four indications: Sepsis, UTI, Burn wounds and Diabetic Foot Ulcers Multiple Phase I and Phase II clinical programs, addressing unmet medical needs The global anti
Slide 5: A Versatile Technology Platform
A Versatile Technology Platform • Clinical-stage biotech company developing Anti-infectives targeting both bacterial and viral indications • Strong IP and own manufacturing capability • Qualified Infectious Disease Product designation • 10 years market exclusivity plus fast track approval* • Versati
Slide 6: Strong Pipeline
Strong Pipeline Over Various Indications and Upcoming Inflection Points Asset and Indications Discovery Pre-Clinical Phase I Phase II Phase III Market Route of Administration Serious/life threatening bacterial R327 Intravenous* infections including sepsis Urinary tract infections including urosepsis
Slide 7: Empowering Clinicians with a New Class of Antibiotics
Empowering Clinicians with a New Class of Antibiotics The need for new antibiotics has never been greater Physician perspectives on R327 • Initial resistance to use new approved drugs due to antibiotic resistance “We have so few options when patients have difficult pathogens. • “New antibiotics, abl
Slide 8: Independent Study Undertaken on R327 MoA
Independent Study Undertaken on R327 MoA1 By Leading Experts in Bacterial MoA Analysis Stage 1 Stage 2 R327 permeabilizes cell R327 interrupts bacterial membrane and enters cellular energetics via the cell ATP Synthesis Stage 3 Stage 4 Cellular division & non- R327 is rapidly and dividing cell funct
Slide 9: RECCE Activity Against Escherichia coli
RECCE® 327 Activity Against Escherichia coli • E. coli grows fast. Eukaryotic cells healthy and Without R327 R327 (3,000 ppm) not affected. • R327 at 3,000 ppm shown to be highly effective against E. coli without affecting growing, healthy eukaryotic cells. • R327 rapidly and irreversibly shuts down
Slide 10: RECCE Activity Against Staphylococcus aureus
RECCE® 327 Activity Against Staphylococcus aureus • S. aureus bacterial growth slower than E. coli, not Without R327 R327 (2,300 ppm) affecting eukaryotic cells. • R327 at 2,300 ppm shows to be highly effective against S. aureus without affecting growing, healthy eukaryotic cells. • R327 rapidly and
Slide 11: R327 faster acting than existing antibiotics
R327 faster acting than existing antibiotics – no prolonged exposure needed E. coli Xen14 BiXenofilm 180000 • R327 kills pathogenic bacteria at a faster rate. 150000 50% PEG 50% PEG Untreated • R327 designed to work faster than all 120000 B0076 existing antibiotics, reinforced by MoA Luminescence* C
Slide 12: Multiple Upcoming Clinical Milestones
Multiple Upcoming Clinical Milestones Burn Wounds Sepsis Key inflection points Q4 23: Readout of Phase H2 24: Initiate Phase III I/II Burn Wound Infection sepsis trial DFU Trial H1: Initiate Phase I/II DFU Sepsis DFU Clinical Q4 23: Readout of Phase Mid 24: Readout of I/II DFU Trial Phase II sepsis
Slide 13: Sepsis – it's a big problem!
Sepsis – it’s a big problem! 2 What is Sepsis? Economic Impact Social Impact Sepsis is a life-threatening Is the most expensive Kills more people in the US inflammatory response to condition to treat in the than prostate, breast cancer infection that has spread in last 8 years5. and HIV/AIDS combine
Slide 14: Recently Approved Antibiotics – Benchmark for Pricing
Recently Approved Antibiotics – Benchmark for Pricing Anticipated Pricing Benchmarks1 USD $25,000 – $30,000 • Though Xigris (activated protein C) was pulled from the market in 2011, its pricing represents a potential premium benchmark for a novel sepsis agent • Fetroja, a recently approved agent for
Slide 15: Successfully Completing a Clinical Trial Phase Can Lead to Significant Share Price Increase
Successfully Completing a Clinical Trial Phase Can Lead to Significant Share Price Increase Case studies: Other antibiotic companies Price (US$) • Positive top line results from a global, pivotal Volume (m) Oct 2015: Ann. mixed results Phase III clinical trial of solithromycin oral $250.00 from 2nd
Slide 16: Successfully Completing a Clinical Trial Phase Can Lead to Significant Share Price Increase
Successfully Completing a Clinical Trial Phase Can Lead to Significant Share Price Increase Case studies: Other antibiotic companies Price (US$) Volume (m) • In December 2016, Achaogen announces $30.00 60.0 positive results in Phase III cUTI and CRE clinical trials of Plazomicin. $25.00 50.0 • EPIC
Slide 17: Large strategics are also paying attention
Large strategics are also paying attention Case studies: Partnering antibiotic assets creates value GSK and Spero Therapeutics announce exclusive licence US$66 million upfront and Up to US$525 million in potential agreement for late-stage antibiotic that may treat complicated UTIs milestones plus ro
Slide 18: Many recent deals within the anti-infectives space
Many recent deals within the anti-infectives space have seen larger companies with an entrenched presence acquiring smaller Biotech's Key Recent Deals in Infectious Disease Companies Involved Deal Details Total Value Key Takeaways • Amplyx was developing therapies for patients with • Deal Date: Apri
Slide 19: Phase I Human Clinical Trial Complete
Phase I Human Clinical Trial Complete 120x dose amount* 6,000 mg ✓ • Study to assess IV infusion of RECCE® 327 in healthy male subjects as a single High Dose 80x dose amount* 4,000 mg ✓ 7-10 subjects in each ascending dose. cohort: 2 control, 8 R327 40x dose amount* 2,000 mg ✓ • Randomized, double-b
Slide 20: Reason for Optimism in Treating UTI/Sepsis
Reason for Optimism in Treating UTI/Sepsis Dr Alan Dunton’s Clinical Update Concentration of R327 in Ratio Urine Compared to Urine/Plasma - Plasma 15x 13x 15x 17x In over 60 healthy 14x subjects 20x 13x – R327 primary route of elimination appears to be – Opportunities for therapeutic in array of UTI
Slide 21: RECCE Kills Quickly in the Urine
RECCE® 327 Kills Quickly in the Urine E. coli ATCC 25922 Viable Cells Treated with RECCE® 327 in Urine + 10%LB 10.00 • R327 in the presence of human urine was able to 9.00 have a fast (near minutes effect against E. coli and irreversible 8.00 • Bacteria could not be ‘washed out’ and regrown 7.00 • R
Slide 22: Patents
Patents Four families across all major markets Patent Patent Patent Expiry Expiry Expiry Filed Family 1 Family 2 Family 3 Australia ✓ 2028 ✓ 2037 Accepted 2037 USA ✓ 2029 ✓ 2037 ✓ 2037 Europe ✓ 2028 ✓ 2037 ✓ 2037 Germany ✓ 2028 ✓ 2037 ✓ 2037 Spain ✓ 2028 ✓ 2037 ✓ 2037 France ✓ 2029 ✓ 2037 ✓ 2037 UK
Slide 23: In-house Manufacturing Capabilities
In-house Manufacturing Capabilities Manufacturing facility in Sydney’s Macquarie Park • Raw materials plentiful and cheap – few $/Kg • No expensive waste – 99.9% product yield • Automated manufacture process taking approx. 1 hour • 500 doses per fully automated run • Quality and Quantity demonstrate
Slide 24: Recce Pharmaceuticals Ltd – Capital Structure
Recce Pharmaceuticals Ltd – Capital Structure 7% Snapshot Tickers ASX:RCE, FSE:R9Q Market Cap (approx.) AUD $107 million 28% Priced at AUD $0.60/share Top 20 Cash and deposits* AUD $8.05 million** Shareholder Distribution 30 January 2023 Outstanding shares 178.25 million Average daily volume 57.6k 3
Slide 25: Thank you
Thank you James Graham Managing Director and Chief Executive Officer Recce Pharmaceuticals Ltd ASX:RCE; FSE:R9Q +61 2 9256 2505 james.graham@recce.com.au recce.com.au
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