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RECCE PHARMACEUTICALS LTD — Investor Presentation 2021
Jul 26, 2021
65669_rns_2021-07-26_bc2825dc-9335-4a1e-9fef-a550eb5c08e1.pdf
Investor Presentation
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ASX Announcement

Recce to Present at Healthcare Day Hosted by Spark Plus
Sydney Australia, 27 July 2021: Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q), the Company developing New Classes of Synthetic Anti-infectives, is pleased to announce its participation in Spark Plus' Healthcare Day.
Presentation is to be given by Chief Executive Officer James Graham via a zoom Webinar on 27 July 2021 from 1pm AEST / 11.00am AWST.
Event: Spark Plus Healthcare Day Date: 27 July 2021, Thursday Time: 1pm AEST / 11am AWST
Please find attached a copy of the presentation. To join, please click the webinar link below:
https://us02web.zoom.us/webinar/register/3016254855865/WN\_6Dp2jRa7S\_mOyEbPn0mrQA
This announcement has been approved for release by Recce Pharmaceuticals CEO


July 2021
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 presentation, or any information provided in connection with it, as financial advice, financial product advice or advice relating to legal, taxation or investment matters.
No representation or warranty (whether express or implied) is made by the Company or any of its officers, advisers, agents or employees as to the accuracy, completeness or reasonableness of the information, statements, opinions or matters (express or implied) arising out of, contained in or derived from this presentation or provided in connection with it, or any omission from this presentation, nor as to the attainability of any estimates, forecasts or projections set out in this presentation.
This presentation is provided expressly on the basis that you will carry out your own independent inquiries into the matters contained in the presentation and make your own independent decisions about the affairs, financial position or prospects of the Company. The Company reserves the right to update, amend or supplement the information at any time in its absolute discretion (without incurring any obligation to do so).
Neither the Company, nor its related bodies corporate, officers, their advisers, agents and employees accept any responsibility or liability to you or to any other person or entity arising out of this presentation including pursuant to the general law (whether for negligence, under statute or otherwise), or under the Australian Securities and Investments Commission Act 2001, Corporations Act 2001, Competition and Consumer Act 2010 or any corresponding provision of any Australian state or territory legislation (or the law of any similar legislation in any other jurisdiction), or similar provision under any applicable law. Any such responsibility or liability is, to the maximum extent permitted by law, expressly disclaimed and excluded. Nothing in this material should be construed as either an offer to sell or a solicitation of an offer to buy or sell securities. It does not include all available information and should not be used in isolation as a basis to invest in the Company.
FUTURE MATTERS
This presentation contains reference to certain intentions, expectations, future plans, strategy and prospects of the Company.
Those intentions, expectations, future plans, strategy and prospects may or may not be achieved. They are based on certain assumptions, which may not be met or on which views may differ and may be affected by known and unknown risks. The performance and operations of the Company may be influenced by a number of factors, many of which are outside the control of the Company. No representation or warranty, express or implied, is made by the Company, or any of its directors, officers, employees, advisers or agents that any intentions, expectations or plans will be achieved either totally or partially or that any particular rate of return will be achieved.
Given the risks and uncertainties that may cause the Company's actual future results, performance or achievements to be materially different from those expected, planned or intended, recipients should not place undue reliance on these intentions, expectations, future plans, strategy and prospects. The Company does not warrant or represent that the actual results, performance or achievements will be as expected, planned or intended.
US DISCLOSURE
This document does not constitute any part of any offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, or for the account or benefit of any "US person" as defined in Regulation S under the US Securities Act of 1993 ("Securities Act"). The Company's shares have not been, and will not be, registered under the Securities Act or the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold in the United States or to any US person without being so registered or pursuant to an exemption from registration including an exemption for qualified institutional buyers.

Management Structure

Dr John Prendergast – Chairman BSc (Hons), MSc (UNSW), PhD (UNSW), CSS (HU)
US based, current Chairman and Co-founder of Palatin Technologies, Inc. (NYSE: PTN) and Lead Director of Heat Biologics, Inc. (NASDAQ: HTBX) – extensive experience in the international commercialisation of pharmaceutical technologies.

James Graham – Chief Executive Officer BCom (Entrepreneurship), GAICD
5 years as former Executive Director. Invested along-side shareholders in most capital rounds since inception. Background in marketing, business development and commercialisation of early-stage technologies.

Michele Dilizia – Chief Scientific Officer BSc (Med Sci), Grad Dip Bus (Mkting), BA (Journ), GAICD, MASM
Co-inventor and qualified medical scientist; specialisation in medical microbiology and regulatory affairs requirements.

A Versatile Technology Platform
- Anti-infective focused Biotech company targeting both bacterial and viral indications
- Strong IP and own manufacturing capability
- Versatile platform delivering oral, intravenous and spray formulations for a range of usecases
- Designed to safely provide treatment without developing resistance over time
- Multiple opportunities with RECCE® 327 interim first in human data expected in 2021



Strong Pipeline Over Various Indications and Upcoming Inflection Points
| AssetRoute of administration | Indications | Discovery | Preclinical | Phase I | Phase II | Phase III | Next data readout | Market Size | |
|---|---|---|---|---|---|---|---|---|---|
| Anti-bacterial programs | Indication | Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 | Next inflectionpoint | Market SizeEU/US/AU | |
| R327 | Serious/life threateningbacterial infectionsincluding sepsis | Phase I interimdata readout Q42021 | 47-50 million casesworldwide | ||||||
| Intravenous &Intranasal | Pre-sepsis -kidney &UTI infections | To startpost PhaseII in sepsis | |||||||
| R327Topical | Wound infectionsincluding infected burns | Phase I/II interimCY Q3 2021 | 11 million burnwound casesrequiring medicalintervention.Majority of whichescalate to infection | ||||||
| R435Oral R529 | Helicobacter pylori instomach ulcers | Up to 4.4 billionworldwide | |||||||
| Anti-viral programs | |||||||||
| R327Nasal | COVID & Influenza | ||||||||
| R529IV and Intranasal | COVID | 4 |

Sepsis – it's a big problem!
48.9 million incident cases of sepsis recorded worldwide 11 million sepsis related deaths recorded One in three patients who die in hospital have sepsis 1 2 3
- Sepsis is a life-threatening inflammatory response to infection that has spread in the body.
- ‒ Kills more people in the US than prostate, breast cancer and HIV/AIDS combined. 4
- Has been the most expensive condition to treat in the last 8 years double the average cost per stay across all other conditions. 5
- Currently no drug therapies specifically for the treatment of sepsis. 6
1,2,3 – The Lancet
4 – BioMed Central
5 – University of Texas 6 – International Medicine Journal RACP

Treatment Paradigm

- Current treatment paradigm relies on:
- Introducing broad spectrum antibiotic(s)
- Running antibiograms
- Adjusting antibiotics based on antibiogram results


Early treatment with the correct antibiotic is key to patients' outcome
Mortality from sepsis increases by as much as 8% for every hour that treatment is delayed2
Natural Antibiotics vs Synthetic Antibiotics

- Pre-formed natural superbugs
- All Fungi or Bacteria based
- ‒ "Penicillin allergy is the most common drug allergy and is reported in up to 15 percent of hospitalized patients" 1
- Only as good as what's found in nature
- Natural Antibiotics

Synthetic Antibiotics
- NO pre-formed natural superbugs
- Entirely man-made and designed with purpose
- Universal Mechanism of Action detailed experimentation demonstrates it does not succumb to superbugs
- Contains only what we want not reliant on what's found in nature
- Broad Spectrum capability and maintains its activity even with repeated use!
Has always had naturally occurring superbugs, now multiplying out of control!

7
Hypothesized Mechanism of Action

RECCE® 327 Mechanism of Action in practice

E. coli bacteria cells (10e6 cfu/ml) having their outer membrane weakened – and bursting from treatment with R327 (1000 ppm)
After application of R327, the E. coli bacteria cell membrane begins to weaken and is disrupted
Before application of R327, the E. coli bacteria cells are healthy, smooth and intact
This is a high-definition electron microscope image generated in February 2017 by Dr Peta Clode and Lyn Kirilak of the Centre for Microscopy, Characterisation and Analysis, University of Western Australia. It was taken to demonstrate RECCE® 327's unique mechanism of action
RECCE® 327 Kills at Practical Speeds

Standard Bacteria

Concentration of RECCE antibiotic was 1,000 ppm against all bacteria except P. aeruginosa for which 2,000 ppm was used
ESKAPE Pathogens Can't Escape R327
- Bactericidal activity of R327 demonstrated a three-log or 99.9% reduction against all ESKAPE strains over 24 hrs at various concentrations and times
- R327 remains effective against hypermutated ESKAPE superbugs, including multi-drug resistant (MDR) forms
- Additional time kill concentration studies are underway with drug-resistant bacterial and are expected to be in-line with existing MIC/Time Kill.
- On-track to be the only clinical stage company shown to be efficacious against the full suit of ESKAPE pathogens globally

Broad spectrum antibiotic efficacy – drug resistant ESKAPE pathogens especially susceptible to R327 in comparison to standardised bacterial forms

ESKAPE Pathogens Can't Escape R327
On-track to be the only clinical stage company shown to be efficacious against the full suit of ESKAPE pathogens globally

Time-kill curves of R327 at various concentrations against strains of ESKAPE pathogens. In the time kill assay, each R327 dilution was tested in duplicate with the average plot shown**.**
The minimum inhibitory concentration was first determined to define the test concentrations for the time-kill study. The time-kill study was performed to determine the bacterial killing effect of R327 at a total of five concentrations, ranging from 0.5X to 8X, MIC and to measure killing kinetics of treatment with R327 against each strain.
RECCE® 327 Does Not Lose Activity! 1
327 435 529
Number of repetitive uses before displaying loss of antibiotic activity

After repetitive use, the commercial antibiotic loses activity; >25 repeats RECCE® 327 DOES NOT 1

13 *'Commercial Antibiotic' generates over US $10bn in revenue
Phase I Human Clinical Trial
Safety and Tolerability Interim Data Expected Late 2021


Topical RECCE® 327 - Phase I/II
Burn wound infections – Interim Data expected in CY Q3 2021
- Phase I/II to assess Topical RECCE® 327 Topical in burn wound infections
- Sponsored by the South Metropolitan Health Service, Department of Health, Government of Western Australia
- Multiple patients have been dosed with R327
Trial Investigators:
- o Dr Edward Raby (Clinical Microbiologist and Infectious Diseases expert at Royal Perth and Fiona Stanley Hospitals)
- o Professor Fiona Wood (Head of Burns) worldrenowned burns specialist and spray-on skin pioneer
- o Dr Chris Heath (Head of Infectious Diseases)
- Full data expected in CY Q4 2021

10 patients – daily dosing for 2 weeks duration


R435 Pre-clinical Studies
Further Pre-clinical Studies planned with R435 against H. pylori
- Murdoch Children's Research Institute (MCRI) to evaluate in-vivo antimicrobial activity of RECCE® 435 oral formulation against H. pylori in pre-clinical studies program
- Study led by H. pylori infectious disease expert Prof. Philip Sutton
- Using mice as a highly validated animal model for H. pylori
- MCRI is one of the top three children's health research institutes worldwide for research quality and impact
- Recce and MCRI will work together on the oral antibiotic dosing program with a particular focus on optimal dosing and the effect of RECCE® 435
- Anticipated completion at approximately mid-2022, at which time Recce may pursue a human clinical trial second half of 2022


SARS-CoV-2 Antiviral Program

Despite vaccinations availability, an effective pharmaceutical treatment against all current and future strains of COVID-19 is needed to gain control over the global pandemic
RECCE® 327 was selected as priority 1 test candidate for testing against COVID-19 - in the Australian government SARS-CoV-2 Antiviral program

Therapeutic anti-viral treatment focus with added potential benefit against secondary bacterial infections

Studies in mammalian cells showed safety and efficacy in preclinical studies

RECCE® 327 and RECCE® 529 have shown concentration-dependent reduction of SARS-CoV-2 virus in Vero (monkey) cells

SARS-CoV-2 Antiviral Program

- At 4,000ppm, RECCE® 327 demonstrated in-vitro:
- 99.9% efficacious with a 3-log drop in viral genome copies
- No virus detectable by virus titration
- Some cytotoxicity detected at 4,000ppm but not at lower concentration
- International in-vivo studies expanded to include new UK and South African COVID strains.

RECCE 327 RT-PCR and Cell Viability Data

Nasal administration RECCE® 327 and RECCE® 529 in Hamsters

R529 200 mg/kg

A 2-log kill is a 99% reduction A 3-log kill is a 99.9% reduction
Saline nasal wash R327 200 mg/kg R327 400 mg/kg R529 100 mg/kg
Drug administrated twice daily for 5 days qPCR of samples from nasal wash at day 2,4,6
5 groups with 8 hamsters each, administrated with:
- RECCE® 327 and RECCE® 529 demonstrated dose-dependent activity in-vivo against SARS-CoV-2 virus in Syrian golden hamsters
- Data conveyed a mean log reduction within groups on Day 4 where low R529 dose achieved a log reduction in the order of 1.5 logs and a high dose of R327 achieved log reduction of 1.25 logs

Patents
Three families across all major markets
Recce's patent portfolio includes more than 20 issued patents and patent applications in the world's major markets, including the United States, Europe, Japan, China and Australia**.**
| Filed | PatentFamily 1 | Expiry | PatentFamily 2 | Expiry | PatentFamily 3 | Expiry |
|---|---|---|---|---|---|---|
| Australia | ✓ | 2028 | ✓ | 2035 | Pending | 2037 |
| USA | ✓ | 2029 | ✓ | 2035 | ✓ | 2037 |
| Europe | ✓ | 2028 | ✓ | 2035 | ✓ | 2037 |
| Japan | ✓ | 2028 | ✓ | 2035 | ✓ | 2037 |
| China | ✓ | 2028 | Pending | 2035 | ✓ | 2037 |
✓ Granted
Patent Family 1 – Antimicrobial Polymers and their Compositions
Family 1 group relates to the Company's unique and highly economical manufacturing process and use of the polymer in treatment of diseases
Patent Family 2 – Copolymer for use in Method of Treatment of a Parenteral Infection
Family 2 relates to the method of manufacture, administration and application to treat a broad range of common human infections.
Patent Family 3 – Anti-Virus Agent and Method for Treatment of Viral Infection
Family 3 relates to a method of treatment of a broad range of viral infections, particularly parenteral viral infection

Insourced Manufacturing Capabilities

Wholly owned, automated 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 approximately 1 hour
- 500 doses per fully automated run

Currently producing in volumes to support planned Phase I & II clinical trials.

Facility built to pharmaceutical specification. Packaging and labelling to international 'tamper-proof' standards

Recce Pharmaceuticals Ltd – Capital Structure


Investment Summary
Proprietary new class of anti-infectives against bacteria and viruses, protected by Composition of Matter Patent.
Fast development plans initially targeting: Sepsis, Burn wounds, Helicobacter Pylori and COVID-19.

Strong pre-clinical data package demonstrating high bactericidal activity combined with very good safety at expected human therapeutic range.
State of the Art manufacturing capacities ensuring highly attractive manufacturing costs and scalability.

R327 Phase I clinical trial patient dosing in Q3 2021 delivering interim data by late 2021. Topical Phase I/II human clinical study of R327 is underway delivering full data Q4 2021 with interim data throughout.

Robust financial position to deliver clinical data.
Thank you
James Graham Chief Executive Officer Recce Pharmaceuticals ASX:RCE; FSE:R9Q
+61 2 9256 2572
