An Emerging Global Leader in a New Generation of Anti-Infectives

Fact SheetRecce Pharmaceuticals Ltd (ASX:RCE) August 2020

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Date listed

52 week range

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Cash balance

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RCE

January 2016

144.17m

Pharmaceuticals, Biotechnology& Life Sciences

Board and Management

Dr Alan Dunton

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 synthetic anti-infectivesactivity designed to address the urgent globalhealth issue of antibiotic resistant superbugsand emerging viral pathogens.Recce anti-infective pipeline is unique and comprised ofbroad-spectrum synthetic polymer antibiotics RECCE 327and RECCE 435, and RECCE 529 for viral infections withunique mechanisms of action against hyper-mutation onbacteria and viruses, respectively.

Patented lead candidate RECCE 327 has been developed for the treatment of blood infections and bacterial sepsisderived from E. coli and S. aureus bacteria - including theirsuperbug forms. Recce’s new compound, RECCE 435, hasbeen formulated for oral use.

Sepsis affects over 30 million people worldwide a 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 wholly owns its automated manufacturing, ready tosupport first-in-human clinical trials. Recce’s anti-infectivepipeline seeks to exploit the unique capabilities of RECCEtechnologies targeting synergistic, unmet medical needs.

AUD $0.20 - $1.52

AUD $194m

AUD $2.63m (30 July 2020)

(Outsourced - Automic Group)

(Outsourced - Pitcher Partners Sydney)

Non-Executive Director

Executive Director

Executive Director

Non-Executive Chairman

3 month avg. vol 582.11k (per trading day)

(priced at $1.35)

RECCE 327 Mechanism of Action®

1

cell membrane

nucleoid (DNA)

cell wall

RECCE 327®

Hydrophobicattraction

3

Hydrophobicinteraction

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 Anti-Infective 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 InfectionsRECCE 327 Priority 1 Candidate Group - SARS-CoV-2 Antiviral Program with CSIRO and The Peter Doherty InstitutePath BioAnalytics & leading US academic institution to evaluate RECCE 327 and RECCE 529 anti-viral activity in SARS-CoV-2

Gastritis (H. pylori)Reproductive Organs (N. gonorrhoeae)New RECCE 435 compound being evaluated in animal model studies

Pre Sepsis - Kidney and UTI Infections

Other Infections

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Efficacy - RECCE 327• 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 - RECCE 327•••

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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-producing

2

• 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• RECCE 327 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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