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RECCE PHARMACEUTICALS LTD AGM Information 2021

Nov 21, 2021

65669_rns_2021-11-21_721d113c-7eee-4b7a-962d-1764b009585e.pdf

AGM Information

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Annual General Meeting

22 November 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.

12 Months of Announcements

Since our last AGM:

  • Anti-Viral Patent Granted in Japan for RECCE® Anti-Infectives (23/11/20)

  • Recce Awarded AusIndustry Advanced Overseas (R&D) Finding for Synthetic Antibiotic Development Program (26/11/20)

  • Recce Awarded AusIndustry Advanced Overseas (R&D) Finding for Synthetic Anti-Viral Development Program (8/12/20)

  • Positive Intranasal Animal Data against SARS-CoV-2 in International Study (23/12/20)

  • R&D Incentive Rebate Received (3/2/21)

  • Encouraging Results from Anti-viral Screening Program at The Doherty Institute Evaluating R327 Against SARS-CoV-2 (12/2/21)

  • Fiona Stanley Hospital Phase I/II Clinical Trial Evaluating Topical Spray-On Antibiotic R327 on Chronic Burn Wounds (16/2/21)

  • Recce Pharmaceuticals Applies for Dual Listing on FSE (Frankfurt Stock Exchange) (24/2/21)

  • Recce Pharmaceuticals Dual Lists on Frankfurt Stock Exchange (8/3/21)

  • Recce Pharmaceuticals Presenting at the H.C. Wainwright Global Life Sciences Conference (10/3/21)

  • The Pew Charitable Trusts adds Recce's Lead Compound R327 to List of Antibiotic Treatments in Clinical Development (15/3/21)

  • Anti-Viral Patent Granted in Europe for RECCE® Anti-Infectives (30/3/21)

  • Positive Sinusitis Data Against Infection (1/4/21)

  • Positive Sinusitis Patient Update Special Access Scheme (7/4/21)

  • R327 Registered in the Australian New Zealand Clinical Trials Registry for Phase I/II Topical Burns Study in Humans (15/4/21)

  • Positive Data on Bactericidal Activity of R327 Against All Six ESKAPE Pathogens (4/5/21)

  • R327 Progresses to Stage 2 of SARS-CoV-2 Antiviral Screening Program at CSIRO (19/5/21)

  • R327 Demonstrates World First Multiple Mechanisms of Action against E. coli bacteria (27/5/21)

  • Recce to Present at MST Access Investor Conference (17/6/21)

  • Recce Pharmaceuticals to Present at World Microbe Forum (18/6/21)

  • Bonus Canadian Scientific Research & Experimental Development Rebate Received (5/7/21)

  • Multiple Patients Dosed in Topical Phase I/II Clinical Trial (12/7/21)

  • R327 Demonstrates Outstanding Efficacy Against Necrotizing Fasciitis 'Flesh-Eating' Bacteria (19/7/21)

  • Anti-Viral Patent Granted in China for RECCE® Anti-Infectives (20/7/21);

  • Anti-Viral Patent Granted in USA for RECCE® Anti-Infectives (22/7/21)

  • Recce Pharmaceuticals Receives Entrepreneurs' Programme Innovation Connections Grant (11/8/21)

  • R327 Trial Registered in the Australian New Zealand Clinical Trials Registry for Phase I Intravenous Study in Humans (30/9/21)

  • Recce Pharmaceuticals Receives Ethics Approval to Start Phase I Intravenous Clinical Trial of R327 (25/10/21)

  • Recce Pharmaceuticals Opening R&D Address at World Anti-Microbial Resistance Congress 2021 (8/11/21)

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 use-cases.
  • Designed to safely provide treatment without developing resistance over time.
  • Multiple clinical opportunities with R327 interim first in human data expected in 2021.

Recce's Anti-infective Platform:

Addressing the Historic Lack of Innovation

  • R327 has a universal, multi-layered Mechanism of Action (MoA) that kills bacteria and keeps on killing with repeated use, including multi-drug resistant superbug forms.
  • Recce's anti-infectives show no tendency for the emergence of resistance, even after repeated use.
  • Broad-spectrum capability and fast-acting MoA empowers clinicians to confidently and quickly administer the antibiotic at first patient presentation.
  • When patients are rapidly deteriorating from infections, there is no time to wait for clear diagnostics which, despite advances in technology, remains a challenge.

Topical RECCE® 327 - Phase I/II

  • Phase I/II to assess Topical R327 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).
  • Data expected in CY Q4 2021

Topical Burns Study

Bacteria we've come across so far…

Gram-positive

  • Staphylococcus aureus
  • Staphylococcus lugdunensis

Gram-negative

  • Pseudomonas aeruginosa
  • Klebsiella pneumoniae
  • Morganella morganii
  • Proteus vulgaris
  • Proteus Mirabilis
  • Bacterial species encountered often Multi-drug resistant and especially include those with biofilms

Phase I Human Clinical Trial

Study to assess IV infusion of R327 in 80 healthy male subjects as a single ascending dose. Formal subject recruitment expected to open for enrolments shortly. Randomized, double blind, placebo controlled, safety, tolerability and pharmacokinetics study. Single dose of a 1-hour via IV infusion at a uniform rate in hospital setting. Primary endpoint: vital signs, 12-lead ECG parameters, clinical chemistry, hematology, and urinalysis. Pre-administration screening -28 0 Safety follow up 28 Day Low Dose 10 subjects in each cohort: 2 control, 10 R327 High Dose 10 subjects in each cohort: 2 control, 8 R327 150 mg 50 mg 1,000 mg 500 mg 4,000 mg 2,000 mg 16,000 mg 8,000 mg Interim data expected late 2021 Full data expected H1-2022

Phase I (R327) Intravascular Clinical Trial – Patient dosing on track for December power with unique MoA & strong cash position

6 months* Ahead – Global Infectious Disease Crisis!

Phase I/II (R327) spray-on antibiotic burn wound studies – Broad Spectrum antibiotic resistant infections among patients dosed

Pre-Clinical

Clinical

  • Murdoch Children's Research Institute - H. Pylori, Sinusitis in-vivo studies, dose optimisation
  • Mechanism of Action studies – Expanded mechanistic insights, journal submission/s – world first
  • R327 Australia COVID studies – Advanced to Stage 2 of the program
  • R327 & R529 COVID (US) – 'gold standard' animal study model underway

Corporate

  • Continue big-pharma discussions position of
  • Expand international awareness particular focus on USA and EU
  • Intellectual Property will continue to strengthen Strong patent standing & Regulatory Incentive Focused
  • New Clinical trials to begin Expect existing activities to bring online new clinical trials e.g. diabetic foot ulcers

Recce Pharmaceuticals Ltd – Capital Structure

Thank you

James Graham Chief Executive Officer Recce Pharmaceuticals ASX:RCE, FSE:R9Q

+61 2 9256 2571

[email protected]