Recce Pharmaceuticals Ltd. provided an updated timeline on its clinical programs with several significant data read-outs in 2022 and 2023. Phase I (I.V) Safety/Tolerability study to Phase Ib/IIa multi-dose/sepsis efficacy study: Successful Phase Ia 1-hour single dose I.V. study has demonstrated R327 to be safe and well tolerated when administered over 60 healthy male adult volunteers, paving the way for a Phase Ib/IIa multi-dose and early-stage sepsis efficacy study with expected first subject dosing later this year and will run for approximately 12 months. New Phase II clinical trial of R327 for treatment of Urinary Tract Infections (UTI): Clinical data from the on-going Phase I (I.V.) clinical trial has revealed high concentrations of R327 residing in urine in the bladder of healthy volunteers.

This insight is consistent with pre-clinical in-vivo kidney and UTI bacterial infection studies and supports primary excretion through the urine, suggesting opportunities for therapeutic activity in the human urinary tract. UTIs are the most common outpatient infections in the US with a prevalence of 20% in women over the age of 65 and approximately 11% in the overall population with many being recurrent/antibiotic resistant infections. Moreover, approximately 25% of sepsis cases originate from the urogenital tract and specifically urosepsis represents a form of sepsis caused by a broad arrange of bacterial infections of the urinary tract, including cystitis, lower urinary tract and bladder infections and upper urinary tract and kidney infections.

While the Company works to finalise the study protocol, the Phase II clinical trial is expected to see first patient dosing in the early part of next year. New Phase II study on Diabetic Foot Ulcer infections at leading NSW teaching hospital Building upon success of the on-going topical burn wound infection program, the Company has built out its topical broad-spectrum bacterial infection treatment programs, through the design of a new Phase II clinical study for Diabetic Foot Ulcer infections 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) with first patient dosing expected fourth quarter 2022.

DFU is a chronic and devastating condition affecting an estimated 13% of NorthAmericans1. DFU is an extremely severe condition with a probability of amputation within one year after the first ulcer or gangrene of 34.1% and a mortality rate of 5.5%.Multiple Pre-clinical Programs Progressed to Advanced Stages: The Company's pre-clinical programs, focused on the treatment of significant unmetmedical needs of infectious disease landscape, have demonstrated strong in-vitro and in-vivo activity of R327, including against a variety of deadly pathogens such as Streptococcus pneumoniae, Helicobacter pylori, and Mycobacterium abscessus (M.abscessus) - a dangerous pathogen among cystic fibrosis patients.