Highlights:

-          Expansion and Acceleration of Clinical Programs

-          Phase I (I.V) Safety/Tolerability study to progress to Phase Ib/IIa multi-dose/sepsis efficacy study

-          Positive Safety Data from Seventh Cohort of Phase I Clinical Trial – 6,000mg Dosing Complete

-          Strengthened management team with Executive Chairman, Non-Executive Director, Vice President of Translational Sciences and Company Secretary appointments

-          Opening R&D Address at World Anti-Microbial Resistance Congress 2022

 

SYDNEY Australia, 28 October 2022: Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the Company developing a New Class of Synthetic Anti-infectives, today released its September 2022 quarter results and operational highlights.

 

Financial Update

 

The Company ended the quarter with a cash balance of $5.73 million. Net cash flows were $5.86 million, with Research and Development ($2.79 million) being the largest item of expenditures supporting two active human clinical trials, establishment of new additional clinical trials and the advancement of ongoing pre-clinical studies. Payments to related parties (Executive & Director fees) was ($0.730 million).

 

The Company anticipates a number of significant (imminent) cash inflows during the present quarter (e.g. R&D rebates) attributing to expectation of a net-positive outcome being reflected in now quarters cashflow

 

Operational Highlights

 

Positive Safety Data from Seventh Cohort of Phase I Clinical Trial – 6,000mg Complete

The Company completed dosing at 6,000mg (120-fold increase on Cohort One 50mg dose) over 1 hour I.V. infusion, with no serious adverse effects among 10 healthy male subjects. R327 dosing is now broadly in efficacy range based on data from animal models, demonstrating R327 to be safe and well tolerated and paving the way for a Phase Ib/IIa multi-dose and early-stage sepsis efficacy study.

 

Expansion and Acceleration of Clinical Programs

The company provided a full strategic update outlining clinical trial objectives and an updated timeline for its clinical programs with several significant data read-outs provided in 2022 and continuing in 2023.

Below are the key objectives outlined within the update:

 

-       Following successful conclusion of Phase I (I.V) Safety/Tolerability single-dose study – has progressed to Phase Ib/IIa multi-dose/sepsis efficacy study.

-       New Phase II clinical trial of R327 for treatment of Urinary Tract Infections (UTI) – the most common outpatient infections in the US.

-       New Phase II study on Diabetic Foot Ulcer infections to be conducted at a leading NSW teaching hospital – building upon the success of on-going burn would infection program.

-       Multiple Pre-clinical Programs progressed to advanced stage demonstrating activity against WHO Priority Pathogens including Streptococcus pneumoniae, Mycobacterium abscessus and Helicobacter pylori.

 

Opening R&D Address at World Anti-Microbial Resistance Congress 2022

Recce Pharmaceuticals, Executive Director and Chief Scientific Officer, Michele Dilizia delivered the Opening R&D Address at the World Anti-Microbial Resistance Conference, positioning Recce as a sign of new hope in the fight against superbugs on the international stage. The presentation can be viewed here.

 

The World AMR Congress took place in Washington DC and is the World’s largest AMR conference with more than 1,000 attendees from over 50 countries and has been the go-to event globally since 2015 for all stakeholders in the AMR space to meet and formulate initiatives to combat anti-microbial resistance.

 

 

 

Board and Management

During the reporting period, the Company strengthened its management and advisory teams with a number of important appointments to support the growth and development of the Company’s next phase of clinical programs and expanded pipeline.

 

Dr Philip Sutton Appointed as Vice President of Translational Sciences

Dr Philip Sutton joined the Company on a full-time basis as Vice President of Translational Sciences, taking a leading role advancing Recce’s compounds across a portfolio of infectious disease programs focussed on significant unmet medical needs. Dr Sutton was previously on Recce’s Scientific Advisory Committee whilst leading the Mucosal Immunology Group at Murdoch Children’s Research Institute.

 

Alistair McKeough Appointed to Board of Directors & Maggie Niewidok

as Company Secretary

The Company announced that Alistair McKeough was appointed to the Board of Directors as Non-Executive Director and Maggie Niewidok appointed as Company Secretary. Formerly Head of Professional Services at Automic Group, Alistair immediately stepped out of the Company Secretary role to become a Director of Recce, having previously served as Recce Pharmaceuticals’ Company Secretary and primary legal adviser.

 

Dr John Prendergast Appointed as Executive Chairman

The Company announced US-based Dr John Prendergast as Executive Chairman, having joined the Board of Directors as Non-Executive Director in April 2018, Dr Prendergast, then became Non-Executive Chairman in July 2019. As Executive Chairman, he will be working alongside CEO James Graham at an important and exciting time as the Company’s anti-infective programs advance locally and internationally.

 

Annual Report 2022 Released

The Company released its Annual Report for the 2022 financial year. The report documents commercial, clinical, and regulatory highlights. The Annual Report can be viewed here.

 

Looking Ahead

The Company is focused on its updated clinical trial objectives and timelines, with priority placed upon getting its products to market expediently. The Company remains well placed to deliver upon its overall goals and objectives over the time ahead.

 

This announcement has been approved for release by Recce Pharmaceuticals Board.

 

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.

 

Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.

 

The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

 

Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.