RECCE PHARMACEUTICALS LTD — Investor Presentation 2021

Jan 7, 2021

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10[th] Annual Corporate Access Event

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January 2021

Disclaimer

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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.

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1

About Recce Pharmaceuticals Ltd

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Listed on ASX 2016 (ASX:RCE)

Unique and universal Mechanism of Action

Water soluble over a broad range of pH levels

Recce Pharmaceuticals (ASX:RCE) is commercialising a New Class of Synthetic Anti-Infectives to address the global health issue of antibiotic resistant superbugs and emerging viral pathogens.

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New Class of Synthetic Anti-Infectives that kill emerging viral pathogens as well as Gram + & Gram – bacteria, including their superbug forms - even with repeated use!

RECCE[®] 327 awarded Qualified Infectious Disease Product designation under GAIN Act

Patented Qualified Infectious Disease manufacturing, Product designation under producing to GAIN Act Phase I & II 10 years market exclusivity volumes (post approval)

RECCE[®] 327 & RECCE[®] 435 – bacterial indications

Fast track

(life of regulatory process)

RECCE[®] 529 – viral indications

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Recce Pharmaceuticals Ltd - Capital Structure

Snapshot

Major Shareholders – 6 January 2021	Major Shareholders – 6 January 2021
G & O Melrose*	23.6%
HSBC Nominees LDU Pty Ltd	4.0% 4.0%
J Graham**	3.4%
Acuity Capital	2.6%
JP Morgan Nominees Aus.	2.6%
M Dilizia Acewood Investments**	2.1% 1.8%
Querion Citicorp Nominees	1.2% 1.2%

ASX code

Shares on issue

6 January 2021

Share price 6 January 2021

Market Cap (approx.) 6 January 2021

Cash and deposits 30 September 2020

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RCE

173.71 million

USD $0.82

AUD $1.065

USD $144 million*** AUD $185 million

USD $20.1 million*** AUD $25.7 million

ASX:RCE 6 months

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USD 0.16c - $1.45 AUD 0.21c-$1.875

Trading range 52 week

336.61K

Average daily volume 3 months

Debt

Nil

• Inventor & Former Head of J&J Research (Australasia)

** Held by Executive Directors

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*** Price converted to USD 7 January 2021: 1 AUD = 0.77 USD

Board and Management Structure

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Dr John Prendergast – Non-Executive 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 – Managing Director & 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 earlystage technologies.

Dr Alan Dunton – Non-Executive Director

BSc (BioChem) Hons, M.D. (NYU)

US based, Director of Palatin Technologies. Over three decades of senior pharmaceutical experience incl. President and MD of Janssen Research Foundation (J&J Research). Dr Dunton has advanced a number of blockbuster antibiotics through regulatory review and commercialization at fortune 500 companies including J&J and Roche.

Alistair McKeough – Company Secretary (Outsourced – Automic Group)

Alistair is a qualified lawyer and Principal of Automic Legal Pty Ltd, Alistair has broad experience as a commercial litigator and Company Secretary to ASX Listed companies

Justin Reynolds – CFO (Outsourced - Pitcher Partners Sydney)

Justin is a qualified accountant and Partner of Pitcher Partners Sydney, Justin has broad experience covering all areas of accounting, taxation and assurance. Particularly, Justin’s areas of expertise are business services and outsourced accounting

Arthur Kollaras – Principal Engineer & Head of Manufacturing

BSc Beng (Chem), PhilEng (Enviro), MIEAust, MISPE

Highly qualified in chemical engineering and microbiology, has significant experience taking a new technology concept to pilot plant and full-scale FDA standards and production internationally

Dr David Bowers – Chair of Clinical Advisory Committee

Leading spinal injury physician at Royal North Shore Hospital. Dr Bowers has a specialist interest in the treatment of complex and life-threatening antibiotic resistant infections, particularly among patients with severe spinal cord injuries.

Michele Dilizia – Executive Director & 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

Dr Justin Ward – Executive Director & Principal Quality Chemist

Professor Philip Sutton – Head of H. pylori Development Program

Global infectious disease expert with over 30 years of research and industry experience, having served as former Head of Immunology at CSL Ltd in Melbourne. Chief Editor of textbook “ Helicobacter pylori in the 21[st] Century” and has co-authored 92 manuscripts published in peerreviewed journals. Professor Sutton currently leads Mucosal Immunology Group at Murdoch Children’s Research Institute.

BSc (Chem), PhD (Chem), MRACI, CChem

A quality control expert who has worked with leading pharmaceutical companies, he is bringing Recce’s research and development, and manufacturing up to US FDA requirements

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RECCE[®] – Multiple Anti-Infective Applications Recce’s technology enjoys the added opportunity of multiple markets and product categories.

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*FIH – First-in-human

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Estimated timelines/indications are subject to change in development plans and regulatory requirements/clarifications

Natural Antibiotics vs Synthetic Antibiotics

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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

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Has always had naturally occurring superbugs, now multiplying out of control!

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Synthetic Antibiotics

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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!

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1

https://www.uptodate.com/contents/choice-of-antibiotics-in-penicillin-allergic-hospitalized-patients/abstract/1

Sepsis – it’s a big problem!

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One in three patients who die in hospital have sepsis 3

48.9 million incident cases of sepsis recorded worldwide1

11 million sepsis related deaths recorded2

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Sepsis is a life-threatening inflammatory response to infection that has spread in the body.

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• ‒ Kills more people in the US than prostate , breast and HIV/AIDS combined.

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Has been the most expensive condition to treat in the last 8 years - double the 5 average cost per stay across all other conditions . 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

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RECCE[®] 327 Phase I Human Clinical Trial

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Human safety and tolerability study to assess IV infusion of RECCE[®] 327 in 48 healthy subjects as a single ascending dose

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Phase I trial agreement with leading clinical research organization PAREXEL

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Trial will be held at CMAX Clinical Research – an independent trial facility

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Dispatched to Clinical Trial Facility (CMAX) Placebo and RECCE 327 (I.V.) via Recce’s Manufacturing facility (Sydney)

Facility meets international regulatory authority data entry and quality requirements including European Medicines Agency and US FDA

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Formal subject recruitment to open for enrolments shortly

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CMAX has more than 30,000 registered patient volunteers on file Patient screened Q1, 2021

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CMAX Phase I Clinical Unit

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RECCE[®] Antibiotics – Curative & Preventative IV Studies*

Number of mice that survived Sepsis from S. aureus (superbug)

Infection in mice from

S. pyogenes

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RECCE [®] 327 Oxacillin No treatment
132 mg/kg 500 mg/kg
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All ten mice treated with RECCE[®] antibiotic survived

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• Nine mice treated with efficacious dose of Oxacillin (500 mg/kg) survived

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• Four mice that had no treatment at all, survived

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• Results from an independent laboratory in USA

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• One group of ten mice were administered a 167 mg/kg dose of RECCE [®] 327 at 0 hours. Second group received no antibiotic.

• Both groups inoculated with the S. pyogenes burden into the bloodstream.

• Mice results first monitored after 12 hours allowing bacteria to develop and establish an infection.

Bacteria in the blood were rapidly killed and unable to establish an infection in the kidneys of mice who received RECCE[®] 327.

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Single Dose and Range-Finding Repeat Dosing - Rats

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• No Observed Adverse Effect Level (NOAEL) of 24-hour 500mg/kg (10x indicated efficacious dose)

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• Phase Ia (24-hour), Phase Ib (24-hour over 7 days)

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• A separate single 24-hour intravenous infusion administration of RECCE [®] 327 up to 12,000 mg/kg over the course of 7-days was carried out.

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• Results of up 12,000 mg/kg/day was well tolerated from Days 1 to 4 (inclusive); with no mortalities or clinical signs.

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• 24-hour dosing up to 4,000 mg/kg (80x indicated efficacious dose) in Dogs well tolerated.

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• RECCE[®] 327 is indicated to be efficacious from as little as 50mg/kg and here shows tolerability can be sustained over at least 7 days of continuous daily exposure at doses up to and including 500 mg/kg.

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Single Dose and Range-Finding Repeat Dosing - Dogs

No Observed Adverse Effect Level (NOAEL) of 24-hour 500mg/kg (10x indicated efficacious dose)

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Phase Ia (24-hour), Phase Ib (24-hour over 7 days)

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A single 24-hour intravenous infusion administration of RECCE[® ] 327 up to 4000 mg/kg and 7-day continuous intravenous infusion administration of RECCE[®] 327 up to 500 mg/kg/day were well tolerated; with no mortalities, clinical signs, changes in body weight, coagulation, clinical chemistry or salient macroscopic abnormalities.

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RECCE[®] 327 is indicated to be efficacious from as little as 50mg/kg

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Therapeutic dose window appears considerably wider than Vancomycin and other antibiotics.

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RECCE[®] 327 Phase I/II Topical Human Trial in burn wound infections

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The topical study will assess RECCE[®] 327 as a broadspectrum antibiotic for patients with Gram-positive and Gram-negative bacterial burn wound infections

• Sponsored by the South Metropolitan Health Service, Department of Health, Government of Western Australia

Fiona Stanley Hospital nominated as the study site

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Principal Investigator Professor Fiona Wood

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• Dr Wood pioneered the innovative the worlds-first ‘sprayon skin’ technique, which greatly reduces permanent scarring in burns victims.

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• Over 14 days, 10 patients will receive RECCE[®] 327 daily while a further 20 receive treatment 3 times per week

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• Phase I/II clinical trial approved by Human Research Ethics Committee

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Topical Efficacy – Wound Infection & Contraction

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Superbug Methicillin-Resistant S. aureus (MRSA)

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The Study Director noted: “ RECCE[®] 327 (100 µl (19.15 mg/ml), topical, once daily, over three days), and Soframycin (30 mg, topical, twice daily, Q=12hr, over three days) showed a significant reduction wound on day four (p<0.05) when compared to day one, when compared to the vehicle control .”

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The Study Director noted: “ RECCE [®] 327 (100 µl (19.15 mg/ml), topical, once daily over three days) showed significant reduction in bacterial load on day four when compared to day one. Soframycin (30 mg, topical, twice daily, Q=12hr, over three days), the current standard of care antibiotic did not show significant efficacy on day four...”

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*Significantly different from vehicle control (p<0.05, 1-way ANOVA) Results from an independent laboratory in USA

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RECCE[®] 435 Pre-clinical Studies Program with H. pylori

Murdoch Children’s Research Institute (MCRI) to evaluate in-vivo antimicrobial activity of RECCE[®] 435 oral formulation against Helicobacter pylori (H. pylori) in pre-clinical studies program

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• RECCE[®] 435 is a new broad-spectrum synthetic polymer antibiotic formulated for oral use

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Study led by H. pylori infectious disease expert Professor Philip Sutton

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• Research program will be carried out by Mucosal Immunology Group at the MCRI Royal Children’s Hospital

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• MCRI is one of the top three child health research institutes worldwide for research quality and impact

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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

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• Anticipated completion in approximately 12 months, at which time Recce will pursue a human clinical trial

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RECCE[®] 435 Efficacy Against H. pylori

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• New RECCE [®] 435 oral showed dose-dependent and significant efficacy against Helicobacter pylori (H. pylori) bacteria

• Bacteria isolated from a patient with a duodenal ulcer compared to control vehicle in independent study model in rats

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• Five groups of 10 rats each were observed. Three groups were treated with varying doses of RECCE [®] 435 (250, 500, 1,000 mg/kg)

• Dose-dependent efficacy was seen at all doses with significant reduction in bacterial load.

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• High solubility and antibacterial effect supportive of a ‘targeted’ oral therapy for stomach infection

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• Study assessed a combination of two broad spectrum antibiotics being used – Amoxicillin and Clarithromycin.

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RECCE[®] 435 Safety Oral Study

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Additional independent study was undertaken

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Purpose of the study examined the safety oral dosing of RECCE [®] 435 up to 500 mg/kg

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Compound was administered to groups of five mice each twice daily for seven days compared to water-only administration

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Data indicates their feeding habits, which contributes to weight gain

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No negative impact

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Supports overall general and gastrointestinal health

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SARS-CoV-2 Antiviral Program

RECCE[®] 327 compound selected as Priority 1 candidate group for testing in SARS-CoV-2 Antiviral Program. The program is run by CSIRO and The Peter Doherty Institute for Infection and Immunology. Compounds were chosen by a Science Selection Panel including field experts in the areas of: Virology, Antivirals, Medicinal Chemistry & Clinical Trials of Antiviral drugs. Therapeutic anti-viral treatment focus with added potential benefit against secondary bacterial infections. All intellectual property rights are retained by the Company

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SARS-CoV-2 International Study

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RECCE[®] 327 and RECCE[®] 529 have shown concentration-dependent reductions in the SARS-CoV-2 virus

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• Concentrations of R327 and R529 tested, further indicated an excellent toxicity profile (<0.25%) on Vero (monkey) cells, in a separately related study

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• COVID-19 studies will be advancing to goldstandard animal in-vivo models (e.g. ferret)

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• Method of administration will be via

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• intranasal to target viral infection in the airways/lungs

• Ferret international study expected to begin September and be completed prior to end of 2020

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SARS-CoV-2 Intranasal Study**

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• RECCE[®] 327 and RECCE[®] 529 demonstrated dosedependent activity in-vivo against SARS-CoV-2 virus in Syrian golden hamsters

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• Intranasal administration of both compounds supports multiple potential modes of administration against SARS-CoV-2

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• Study consisted of five groups of eight hamsters , each receiving a different treatment

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• Placebo control of saline nasal wash, low dose of R327 (200mg/kg), high dose of R327 (400mg/kg), low dose of R529 (100mg/kg), and high dose of R529 (200mg/kg)

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• 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

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• This hamster study is the first indication of the potential for nasal administration of Recce’s anti-infective compounds, specifically when used against viruses

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Understanding logs (example of a small colony of 1 million MRSA bacteria)*

A 1-log kill reduces the colony to 100,000 MRSA bacteria after a 90% reduction

A 2-log kill reduces the colony to 10,000 bacteria after a 99% reduction

A 3-log kill reduces the colony to 1,000 bacteria after a 99.9% reduction

A 4-log kill reduces the colony to 100 bacteria after a 99.99% reduction

A 5-log kill reduces the colony to 10 bacteria after a 99.999% reduction

A 6-log kill reduces the colony to 1 MRSA bacterium after a 99.9999% reduction

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https://halosil.com/what-are-logs-and-why-do-they-matter-in-preventing-infections/ *Statistical significance was not assessed in this study

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RECCE[®] 327 kills at practical speeds

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Standard Bacteria

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S. aureus E. coli P. aeruginosa S. pyogenes C. difficile
20-60 minutes 20-60 minutes 3-24 hours 20-60 minutes 20-60 minutes
Superbugs
S. aureus E. coli P. aeruginosa
The same kill-rates
for standard bacteria
and their superbugs
20-60 minutes 20-60 minutes 3-24 hours
All concentrations of bacteria (germ) were 10 cfu/ml
Concentration of RECCE antibiotic was 1,000 ppm against all bacteria except P. aeruginosa 2,000 ppm was used against P. aeruginosa
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1 RECCE[®] 327 Does Not Lose Activity!

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Number of repetitive uses before displaying loss of antibiotic activity

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RECCE [®] 327
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1

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

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*‘Commercial Antibiotic’ generates over US $10bn in revenue

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RECCE[®] 327 Mechanism of Action in practice

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00:00 minutes

Before application of RECCE[®] 327, the E.coli bacteria cells are healthy, smooth and intact

E.coli Facts1

• Part of the Enterobacteriaceae family

• $1.2bn USD estimated attributable healthcare costs in 2017

• CDC labels this bacteria as a Serious Threat

• • 50% increase in cases since 2012

• 1CDC Antibiotic Resistance Report 2019

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This is a high-definition electron microscope image generated in February 2017 by Dr Peta 22 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 Mechanism of Action in practice

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20 minutes

After application of RECCE[®] 327, the E.coli bacteria cell membrane begins to weaken and is disrupted

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Burst! – others already
redundant and breaking
down
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This is a high-definition electron microscope image generated in February 2017 by Dr Peta Clode and Lyn KirilakWestern Australia. It was taken to demonstrate RECCEof the Centre for Microscopy, Characterisation and Analysis, University of[®] 327’s unique mechanism of action 23

RECCE[®] 327 Mechanism of Action in practice

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180 minutes

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Bacteria compromised –
now consumable by
healthy blood cells
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E. coli bacteria cells (10e6 cfu/ml) having their outer membrane weakened – and bursting from treatment with RECCE[®] 327 (1000 ppm)

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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

24

Patents and trademarks

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Recce’s patent portfolio includes more than 15 issued patents and patent applications in the world’s major markets, including the United States, Europe, Japan, China and Australia.

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

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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.

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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

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	Filed	Patent Family 1 Granted	Expiry	Patent Family 2	Expiry	Patent Family 3	Expiry	Patent Family 4	Trademarks registered
	Australia	✓	2028	✓	2035	Pending	2037	Pending	✓
	USA	✓	2029	✓	2035	Pending	2037	Pending	✓
	Europe	✓	2028	✓	2035	Pending	2037	Pending	✓
	Germany	✓	2028	✓	2035	Pending	2037	Pending	-
	Spain	✓	2028	✓	2035	Pending	2037	Pending	-
	France	✓	2029	✓	2035	Pending	2037	Pending	-
	United	✓	2028	✓	2035	Pending	2037	Pending	-
	Kingdom Italy	✓	2028	✓	2035	Pending	2037	Pending	-
	Sweden	✓	2028	✓	2035	Pending	2037	Pending	-
	Japan	✓	2028	✓	2035	✓	2037	Pending	✓
	China	✓	2028	Pending	2035	Pending	2037	Pending	✓

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Manufacturing and Production

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Wholly owned, automated manufacturing facility in Sydney’s Macquarie Park

Raw materials plentiful and CHEAP – few $/KG No expensive waste – 99.9% product yield.

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Automated manufacture process taking approximately 1 ¼ hours .

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500 doses per automated manufacture output in less than 1 hour/run

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

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Facility built to pharmaceutical specification. Packaging and labelling to international ‘tamper-proof’

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Investment summary

R327 Qualified Infectious Disease Product (QIDP) Designation

R327 Generating Antibiotics Proprietary technology as a Incentive Now (GAIN) Act new class of approved synthetic anti-infectives

R327 initial focus on sepsisFavourable legislative and potentially the first treatment financial landscape for sepsis

Experienced commercial management and board

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R327 addressing the most expensive condition faced by hospitals worldwide

Early commercialisation potential

Creating value by meeting Established manufacturing key milestones (volumes suitable for Ph I/II)

27

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Thank you

James Graham

Managing Director and Chief Executive Officer Recce Pharmaceuticals

ASX:RCE

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+61 2 9256 2572 james.graham@recce.com.au

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recce.com.au