fact sheet june 2020 - recce.com.au · recce pharmaceuticals ltd patent portfolio has continued to...
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An Emerging Global Leader in New Generation Antibiotic Therapies
Fact SheetRecce Pharmaceuticals Ltd (ASX:RCE) June 2020
SnapshotASX Code
Date listed
52 week range
Market Cap
Cash balance
Shares on issue
Sector
RCE
January 2016
136.07m
Pharmaceuticals, Biotechnology& Life Sciences
Board and Management
Dr Graham Melrose
Michele Dilizia
James Graham
Dr John Prendergast
Company SecretaryC
Chair of Clinical Advisory Committee
FOAlistair McKeoughJ
Dr David Bowers
ustin Reynolds
Arthur KollarasDr Justin Ward
Head of ManufacturingExecutive Director
Recce Pharmaceuticals Ltd is an Australianbased globally-focussed, biotech companyengaged in the development & commercialisationof a new class of antibiotics with broad spectrumactivity designed to address the urgent globalhealth issue of antibiotic resistant superbugs.
Its patented lead candidate known as RECCE 327 has beendeveloped for the treatment of blood infections and bacterial sepsis, affecting over 30 million people worldwidea year. There are currently no drug therapies specifically for the treatment of severe sepsis and is by far the most expensive condition treated in US hospitals.
Following recent pre-clinical data submissions to theUS Food & Drug Administration (FDA), RECCE 327 wasawarded Qualified Infectious Disease Product (QIDP) designation under the Generating Antibiotic Incentives Now (GAIN) Act, labelling RECCE 327 with 10 years of market exclusivity (post approval) and Fast Track regulatory status.
Recce Pharmaceuticals Ltd was invited to meet with a13-member panel of the FDA’s Division of Anti-InfectiveProducts, where it received formal guidance on itsclinical and regulatory pathways in the US for its leadantibiotic compound RECCE 327, which the Company is now actively pursuing.
The Company’s wholly owned and patented method ofmanufacture is established for RECCE 327 with capacity at amounts suitable for Phase I and II clinical trials.
Recce Pharmaceuticals Ltd has a manufacturing facilityin Macquarie Park (Sydney), R&D in Bentley TechnologyPark (Perth) and is expanding its USA activities.
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RECCE 327 Mechanism of Action®
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AUD $0.20 - $0.925
AUD $108m
AUD $4.09m (29 April 2020)
(Outsourced - Automic Group)
(Outsourced - Pitcher Partners Sydney)
Executive Director & Chief Research Officer
Executive Director
Executive Director
Non-Executive Chairman
3 month avg. vol 497.02k (per trading day)
1
cell membrane
nucleoid (DNA)
cell wall
RECCE 327®
Hydrophobicattraction
3
Hydrophobicinteraction
(priced at 0.80 cents)
4
BURST!
2
RECCE 327at work
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0 mins 20 mins 3 hoursTreatment – BacteriaDestroyed & Ready forHealthy Cell Absorption
Treatment – Significantcell-membrane weakeningand disruption
Nil Treatment –Bacteria Pressurised& Active
recce.com.au
Estimated timelines/indications are subject to change in development plans and regulatory requirements/clarifications
RECCE Multiple Antibiotic Applications
DISCOVERY PRE-CLINICAL FIH SAFETY & EFFICACY REGULATORY SUBMISSIONINDICATION
Topical Administration
Intravenous Administration
Viral Infections
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Severe Sepsis - Blood Poisoning
Skin and Skin Structure Infection - Wound Infection, Contraction
Influenza A and Other Significant Respiratory Infections
Gastritis (H. pylori)Reproductive Organs (N. gonorrhoeae)
Pre Sepsis - Kidney and UTI Infections
Other Infections
Efficacy• Performs as a broad spectrum antibiotic• Acts against bacteria in both normal and mutated superbug
forms•
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Rate and MIC/MKC data demonstrates potency and broadspectrum activity against a range of bacteriaContains a patented polymeric structure, intentionallydesigned to overcome the traditional challenges ofbacterial mutation/resistance
Multiple studies of toxicity in small and large animalsMultiple studies of mutagenicity (cancer) are clearNumerous studies to date indicate the safety ofRECCE 327Is suited to administration against sepsis by intra-venous dripIndicates a safe therapeutic dosing window
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In-vivo (mice) study against influenza virus
Multiple tests demonstrate efficacy against Gram-positive(S. aureus) and Gram-negative (E. coli) including theirsuperbug forms
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Safety•••
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Patent PortfolioPatents covering the manufacturing process run until 2029.Granted provisional patents covering additional modes ofdelivery and anti-viral uses, run until 2035.
Recce Pharmaceuticals Ltd patent portfolio has continuedto strengthen with granted patents in key pharmaceuticalmarkets such as USA, Europe, Japan, China and Australia.
Patent Family 1 - Granted
- Unique and highly economical manufacturing process
recce.com.auSydney – Head Office Level 36, 1 Macquarie PlaceGateway TowerSydney NSW 2000Australia
Macquarie Park – ProductionUnit 8, 64 Macquarie Park NSW 2113 Australia
Perth – R&D Centre Suite 10, 3 Brodie Hall Drive Technology Park Bentley WA 6102 Australia
North America – OperationsSuite 10251717 Pennsylvania Avenue Washington DC 20006 USA
Patent Family 1 Granted
Patent Family2/3
Expiry ExpiryFiled
Australia
USA
Europe
Germany
Spain
France
UK
Italy
Sweden
Japan
China
2028
2029
2028
2028
2028
2029
2028
2028
2028
2028
2028 Pending
2035
2035
2035
2035
2035
2035
2035
2035
2035
2035
2035
PRIORITY 1: CRITICAL RECCE 327
• Pseudomonas aeruginosa, carbapenem-resistant 1
• carbapenem-resistant,
ESBL-producing2
• Not Tested
PRIORITY 2: HIGH
• Enterococcus faecium, vancomycin-resistant 3
• Staphylococcus aureus, methicillin-resistant, vancomycin-intermediate and resistant
4
• Helicobacter pylori, clarithromycin-resistant 5
• Neisseria gonorrhoeae, cephalosporin-resistant, fluoroquinolone-resistant
6
• Campylobacter spp., fluoroquinolone-resistant Not Tested
• Salmonellae, fluoroquinolone-resistant Not Tested
PRIORITY 3: MEDIUM
• Streptococcus pneumoniae, penicillin-non-susceptible
7
• Haemophilus influenzae, ampicillin-resistant Not Tested
• Shigella spp., fluoroquinolone-resistant Not Tested
1 Active in vitro against Recce’s own superbug of this bacterium2 Active in vivo against a member of this family CRE E. coli 3 Active in vitro against a very closely related species, Enterococcus faecalis, 4 Active both in vitro and in vivo against MRSA, Methicillin-resistant S. aureus5 Active both in vitro and in vivo against three strains (2 of which were superbugs)6 Active in vitro (superbug not available)7 Active in vitro against related superbug Klebsiella pneumoniae
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Acinetobacter baumannii, carbapenem-resistant
World Health Organisation (WHO) List of MostThreatening Antibiotic Resistant BacteriaTo help governments, researchers and industry focus theirresources on antibiotic resistance, the WHO published apriority list of 12 antibiotic-resistant bacteria.
Enterobacteriaceae,
Corporate Summary• US FDA recognised under Qualified Infectious Disease
Product (QIDP) designation - reduced time/cost advantages• Product proprietary technology as a new class of antibiotics• Lead compound RECCE 327 addressing the most expensive
condition faced by hospitals worldwide• Early commercialisation potential - FDA support (QIDP/
Generating Antibiotic Incentives Now (GAIN) Act approved)• Initial focus on sepsis - potentially the first dedicated treatment
for sepsis• Favourable legislative and financial landscape• Experienced commercial management and board••
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Creating value by meeting key milestonesRECCE 327 cleared for use under Therapeutic GoodsAdministration (TGA) Special Access Scheme - Category AReceived positive feedback from FDA on RECCE 327’sChemistry, Manufacturing and Controls (CMC)
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Recce Pharmaceuticals Ltd makes no warranties or representations regarding the accuracy or completeness of the information contained in this investor fact sheet. Certain statements made may contain forward looking statements, which involve known and unknown risk, uncertainties and other factors, which may cause the actual results or performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements.
• Patent Family 3 - Pending
- Anti-viral use
Patent Family 2 - Pending
- Applications (Multi-drug delivery)
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