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RECCE PHARMACEUTICALS LTD — AGM Information 2022
Nov 13, 2022
65669_rns_2022-11-13_59862676-fffb-4c33-b5a1-6c4785027423.pdf
AGM Information
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Annual General Meeting

ASX:RCE FSE:R9Q
14 November 2022
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Board and Management Structure


Goals Stated at AGM 2021
AGM Presentation, Slide 8, 22 Nov 2021
Clinical Objectives ✓
- Phase I (R327) Intravascular Clinical Trial – Patient dosing on track for December ✓
- Phase I/II (R327) spray-on antibiotic burn wound studies – Broad Spectrum antibiotic resistant infections among patients dosed ✓
Pre-Clinical Objectives ✓
- R327 Australia COVID studies – Advanced to Stage 2 of the program ✓
- R327 & R529 COVID (US) – 'gold standard' animal study model underway ✓
- Murdoch Children's Research Institute - H. pylori, Sinusitis in-vivo studies, dose optimisation ✓
- Mechanism of Action (MoA) studies – Expanded mechanistic insights, journal submission/s – world first ✓
Corporate Objectives ✓
- Continue big-pharma discussions position of power with unique MoA & strong cash position ✓
- 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 has delivered!

12 Months of Announcements

Since our last AGM:
- Update on Phase I/II Clinical Trial for Burn Wound Infection (07/12/21)
- First Patients to be Dosed in Phase I I.V. Clinical Trial of R327 (15/12/21)
- Positive Safety Data from Cohort 1 Phase I I.V. Clinical Trial (07/01/22)
- Positive Safety Data from Second Cohort of Phase I I.V. Clinical Trial (18/01/22)
- Positive Initial Safety Data from Third Cohort of Phase I I.V. Clinical Trial (08/02/22)
- Final Subjects Dosed in Cohort 3 Phase I I.V. Clinical Trial (21/02/22)
- Safety Committee Clears Phase I I.V. R327 Dose Increase (07/03/22)
- $3.08m R&D Rebate Received (28/03/22)
- Positive safety data from 4th Cohort Phase I I.V. Clinical Trial (30/03/22)
- Anti-Viral Patent Granted in Hong Kong (11/04/22)
- Phase I Clinical Trial R327 Advances to High Dose Cohort 2,000mg (12/04/22)

- Phase I I.V. Positive Safety Data 4000mg Complete (21/06/22)
- Appointment of Dr Philip Sutton as V.P. of Translational Sciences (11/07/22)
- Phase I Clinical Trial of R327 I.V. 6000mg Complete (22/08/22)
- Appointment of Alistair McKeough to Board of Directors (01/09/22)
- Appointment of Dr John Prendergast as Executive Chairman (05/09/22)
- Michele Dilizia, CSO, delivers Opening R&D Address at World AMR Congress (07/09/22)
- Expansion and Acceleration of Clinical Programs (27/09/22)
- R327 COVID Study Update (18/10/22)
- Anti-Infective Portfolio Update and Webinar (19/10/22)


*Awarded by the US FDA in 2017 for R327 bacteraemia (broad-spectrum bacterial sepsis). Time starts only from potential market approval.
A Versatile Technology Platform
- Biotech company developing Anti-infectives targeting both bacterial and viral indications
- Strong IP and own manufacturing capability
- Qualified Infectious Disease Product designation
- 10 years market exclusivity plus fast track approval*
- Versatile delivery platform oral, intravenous and topical formulations
- Designed to safely provide treatment without developing resistance over time
- Multiple infectious disease opportunities with RECCE® 327
Strong Pipeline
Over Various Indications and Upcoming Inflection Points

| Indications | Discovery | Pre-Clinical | Phase I | Phase II | Phase III | Market |
|---|---|---|---|---|---|---|
| Serious/life threatening bacterialinfections including sepsis | ||||||
| Urinary tract infectionsincluding urosepsis | ||||||
| Multidose, early stage sepsisefficacy study | ||||||
| Wound infectionsincluding infected burns | ||||||
| Diabetic Foot Ulcers | ||||||
| Helicobacter pyloripre-clinical program | ||||||
| Bacterial Sinusitispre-clinical program | ||||||
| Mycobacterium abscessuspre-clinical program | ||||||
| COVID & Influenza | ||||||
| COVID | ||||||
*Anti-bacterial program **Anti-viral program
Phase I Intravenous Human Clinical Trial


- 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

*Dose increase fold based off 50mg

Reason for Optimism in Treating UTI/Sepsis

-
R327 primary route of elimination appears to be through the kidney to the ureters and bladder.
-
High concentrations of R327 noted in the urine of Phase I healthy subjects.
-
Insight consistent with pre-clinical in-vivo kidney and UTI bacterial infection studies.
-
Opportunities for therapeutic in array of UTIs (uncomplicated UTI - single dose, complicated UTI, recurrent UTI, treatment resistant etc).
-
Suggests broader anti-infective treatment model in pre-sepsis.

Pre-Clinical Study Outlook
- Murdoch Children's Research Institute
- Bacterial Sinusitis Sufficient and compelling data -potential to start a Phase I/II clinical trial
- M. abscessus Proof of concept achieved Compelling data for a potential human study
- H. pylori - Further formulation work and dosing optimisation required to improve delivery to site of infection
- Mechanism of Action studies
- Results confirm that R327 is broad spectrum, bactericidal, effective against growing and non-growing cells
- R327 COVID Study (Netherlands)
- R327 was shown to significantly reduce SARS-CoV-2 levels in the throat in a dose-dependent manner
| Asset andRoute of Administration | Indications | Discovery | Pre-Clinical | Phase I | Phase II |
|---|---|---|---|---|---|
| RCE Compounds* | Bacterial Sinusitispre-clinical program | ||||
| Helicobacter pyloripre-clinical program | |||||
| Mycobacterium abscessuspre-clinical program |

Dr Philip Sutton's Pre-Clinical Update
Topical RECCE® 327 – Phase I/II
Patient examples from ongoing Burn Wound trial
- Patients suffered major burn injury.
- Multiple bacterial species in and surrounding wound.
- Growth swabs with organisms including pathogens from the ESKAPE group of bacteria.
- Post R327 treatment: healthy skin growth return, reduced swelling and infection, indications of tissue penetration to underlying infection.
Study data now under-review for next-step considerations.
• Building upon the success of these results, the Company has built out its topical treatment programs to include a new Phase II clinical study for Diabetic Foot Ulcer infections.

Pre-treatment, significant bacterial infection Post R327 treatment




Phase II Diabetic Foot Ulcer (DFU) Clinical Trial

Clinical Trial Overview
- The Phase II DFU Clinical Trial is expected to be held at a leading Australian teaching hospital.
- The clinical trial will assess R327 as a spray-on (topical) broad-spectrum antibiotic therapy for mild skin and soft tissue diabetic foot ulcers (DFU).
Market Opportunity
- The total medical cost for treating diabetic foot diseases in the United States is US $9-13 billion every year.¹
- DFU is a chronic and devastating condition affecting an estimated 43,147,000 (13%) of the United States population.¹

Recce Executives and NSW Health Clinical Trial Team

Upcoming Clinical Milestones
- In-vivo pre-clinical
- ‒ Pre-Sepsis UTI Models in Rats ✓
- Phase I clinical trials
- ‒ R327 I.V. Single Dose, Safety/Tolerability/PK study in healthy subjects ✓
- Phase II UTI clinical trial (Pre-Sepsis)
- ‒ Single (as now completed Phase I) efficacy study Q1 2023
- ‒ Multiple-dose treatment of UTIs complicated/resistant/chronic/etc. H1 2023
- Phase Ib/IIa Sepsis clinical trial
- ‒ R327 I.V. Multiple Dose, Safety/Tolerability/PK study in healthy subjects (First patient dosing Q4 2022)
- ‒ Multiple-Dose efficacy study in urosepsis* (sepsis derived from UTI infections) efficacy signal
- Phase II Diabetic Foot Ulcer (DFU) clinical trial
- ‒ R327 as a spray-on (topical) broad-spectrum antibiotic for mild skin and soft tissue DFU (First patient dosing expected Q4 2022)

Michele Dilizia Scientific Strategy Update


*Urosepsis – 25 percent of sepsis cases originate from the urogenital tract
2022 Corporate Goals


New Clinical Data Sets Phase I Intravenous Study data sets to be released

Global Strategy - Partnerships
Continued engagement in partnership opportunities with both domestic and international organisations

Strengthen Intellectual Property
Including internationally recognised drug designations

Peer-Reviewed Publications
Recognition of R327's Unique Mechanism of Action unique with clinical context


Recce Pharmaceuticals Ltd – Capital Structure

RCE Institution Retail Other

*Pre >$3.5m R&D rebate + other non-dilutionary cash in-flows expected this quarter - actual cash runway circa AUD $10 million

Thank you
James Graham Chief Executive Officer Recce Pharmaceuticals ASX:RCE, FSE:R9Q
+61 2 9256 2571
