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General Company Information

Who is Recce Pharmaceuticals Ltd (ASX:RCE)?

Recce Pharmaceuticals is committed to addressing the global health threat posed by superbugs and emerging viral pathogens by pioneering a new class of synthetic anti-infectives to treat serious and life threatening bacterial and antibiotic resistant infections as well as common and emerging viral pathogens.

How did Recce get started?

Dr. Graham Melrose, inventor of RECCE® anti-infectives, discovered the Company’s lead compound RECCE® 327 (327 being experimental book 3 – page 27) while experimenting in his retirement in a small laboratory of his Perth (Western Australia) home. Following the discovery, Dr. Melrose brought his experimentation to the attention of James Graham (Chief Executive Officer and Managing Director) and Michele Dilizia (Executive Director and Chief Scientific Officer) who assisted in getting Dr. Melrose into a proper laboratory facility at Bentley’s Technology Park to expand upon the promising research.

What stage is the company at?

R327 is currently undergoing two clinical trials, a Phase I safety study to assess IV infusion of RECCE 327 in 80 healthy male subjects as a single ascending dose.

Recce is also undergoing a Phase I/II study to assess topical application of RECCE 327 in burn wound infections with Fiona Stanley hospital, where Professor Fiona Wood is the principal investigator.

Recce has entered into an agreement with Murdoch Children’s Research Institute to evaluate in-vivo antimicrobial activity of RECCE® 435 oral formulation against H. pylori in preclinical studies program.

Are they supported by grants or funding from the government?

Recce received two Innovation Connections grants, totaling AU$87,508 plus goods and services tax from the Australian government's Department of Industry, Science, Energy and Resources as part of its Entrepreneurs’ Programme. The grant supports the development of Recce’s lead candidate, RECCE® 327, as a treatment for COVID-19.

On 3 February 2021, the Company announced a further cash receipt of A$925,981 Research and Development Tax Incentive rebate from the Australian Tax Office, bringing the total R&D rebate to $1,566,030 for the year ending 30 June 2020.

The Company has also been awarded the AusIndustry Advanced Overseas R&D Finding. This Finding will support the Company’s Synthetic Antibiotic Development program with a 43.5% cash rebate on $17,150,000 of R&D applicable expenditure. This extended the R&D cash rebate to include the Company’s overseas R&D activities, for a period of three years (1 July 2019 to 30 June 2022).

Where can I get Recce stockholder and financial information?

The company has been trading on the ASX since 2016 under ticker: RCE. As of March 2021, the Company listed on the Frankfurt Stock Exchange under ticker: R9Q.

You can find the latest stock information by visiting our Share Price and Tools page.

Where can I get a copy of the company’s annual report?

Please click here to view and download the annual report.

Where can I get a copy of the company’s latest fact sheet?

Please click here to view and download the latest RCE Fact Sheet.

What is the company’s patent portfolio comprised of?

Recce Pharmaceuticals currently has four wholly owned patent families, which include over 30 patents or patent applications and are constantly expanding, broadening, and developing the intellectual property portfolio.

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.

Development Pipeline

What compounds are in Recce’s pipeline?

Recce’s anti-infective pipeline is comprised of RECCE® 327, RECCE® 435, and RECCE® 529. All with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively.

RECCE® 327 is the lead candidate developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.

RECCE® 435 has been formulated as an antibiotic for oral use with indications against Helicobacter pylori.

RECCE® 529 is a new synthetic polymer formulation with indication against viruses including emerging viral pathogens.

What is the mechanism of action for Recce’s compounds?

Recce’s anti-infectives have a universal mechanism of action that allow its compounds to overcome antimicrobial resistance. They are attracted to the plasma membranes of pathogens via hydrophobic interactions, subsequently weakening microbial cell walls. Due to the unique high metabolic pressure in bacteria and viruses, the cell walls collapse or burst (cell lysis), leading to cell death. Importantly, non-bacterial (eukaryotic) cells remain intact since they do not contain high internal pressures to result in cell lysis.

More information on our Mechanism of Action can be found here

What bacteria and viruses do Recce’s anti-infectives kill?

The emergence of drug-resistant bacteria, commonly known as superbugs are increasingly challenging healthcare systems around the world by making common infection difficult, even impossible to treat. Of these the majority of life-threatening nosocomial infections are caused by a group of six bacteria, collectively called ESKAPE pathogens due to their propensity of ‘escaping’ the biocidal action of antibiotics.

Dubbed ESKAPE for their propensity of ‘escaping’ the biocidal action of antibiotics, the acronym stands for six different commonly found multi-drug resistant pathogens: Enterococcus faecium (E. faecium), Staphylococcus aureus (S. aureus), Klebsiella pneumoniae (K. pneumoniae), Acinetobacter baumannii (A. baumannii), Pseudomonas aeruginosa (P. aeruginosa) and Enterobacter species.

RECCE® 327 has demonstrated in preclinical studies it is a fast acting, broad-spectrum antibiotic effective against Gram-positive and Gram-negative bacterial pathogens Staphylococcus aureus (staph), Escherichia coli, Pseudomonas aeruginosa, Helicobacter pylori, and Streptococcus pyogenes (Strep) with further testing underway for other pathogens.

RECCE® 435’s oral formulation has demonstrated efficacy against Helicobacter pylori in an independent study model in rats. Further testing to be conducted in pre-clinical studies program.

The Company’s viral formulation RECCE® 529 has shown concentration-dependent reductions in the SARS-CoV-2 (COVID) virus in an in-vitro study. Further testing will be conducted on other major viral infections.

What about the good bacteria?

Any bacteria in the bloodstream is harmful therefore when RECCE® 327 is administered intravenously it does not come into contact with good bacteria.

Activity of RECCE® anti-infectives oral formulations kills the harmful bacteria in the upper duodenum of the stomach; by the time it reaches the lower intestine RECCE® is no longer active and will have no impact on intestinal microbiome.

Are Recce® Anti-Infectives effective against SARS-COV-2?

RECCE® 327 has progressed to stage 2 of SARS-CoV-2 Antiviral Screening Program at CSIRO. R327 received a qualified recommendation to advance to Stage 2 of the Program for further testing to be conducted by the Commonwealth Scientific and Industrial Research Organisation (CSIRO).

RECCE® 327 and RECCE® 529 are both in an international study taking place in collaboration with Path BioAnalytics Inc. and the University of Tennessee to test efficacy against the SARS-CoV-2 virus.

How long does it take to manufacture the drug candidate?

Recce has an automated manufacturing process that takes approximately an hour – producing 500 doses per automated manufacture output in less than an hour with a 99.9% product yield. This enables Recce to quickly and efficiently scale up production to meet demand for the first-in-human clinical trials.

What indications is Recce exploring and how big are the respective markets?

Recce’s initial focus is on sepsis, a life-threatening blood infection and one of the greatest unmet medical needs with a high margin in large markets. Sepsis represents the costliest condition for hospitals to treat, accounting for more than $24B in U.S. hospital expenses annually with no approved treatment options at this time. By 2026, the sepsis and septic shock space is expected to be worth $5.9B USD.

There is a global unmet medical need for the treatment of H. pylori, infecting more than four billion people worldwide, with no first-line therapy curative in all patients. The World Health Organisation (WHO) also lists H. pylori as a priority pathogen on its list of antibiotic-resistant bacteria that pose the greatest threat to human health.

Influenza A is a highly contagious respiratory illness and may be caused by infection with a virus; it is often called the flu. There are three types of Influenza virus: A, B and C. Influenza A is more serious than B and C and is the only type known to cause widespread outbreaks. The Centre for Disease Control estimates Influenza has resulted in between 9m-45m illnesses annually in the USA since 2010.

Most commonly, hospital acquired infections are caused by deadly Gram-positive and Gram-negative bacterial infections known collectively as ‘ESKAPE’ pathogens, which are especially dangerous due to their multi-drug resistant properties. Dubbed ESKAPE for their propensity of ‘escaping’ the biocidal action of antibiotics, the acronym stands for six different commonly found multi-drug resistant pathogens.

An independent study was conducted by a contract research organisation to assess the in vitro efficacy of R327 against all ESKAPE pathogen bacterial strains. The results demonstrated R327 to be 99.9% effective against the full suite of ESKAPE pathogens, within hours of exposure.

More information can be found here: Sepsis, Burn Wound Infections, Helicobacter Pylori, COVID-19.

Clinical trials

What clinical trials is Recce conducting?

Recce has formalised a Phase I clinical trial agreement to conduct a first-in-human study of its lead compound RECCE® 327.

Randomized, double blind, placebo controlled, safety, tolerability and pharmacokinetics study to assess IV infusion of RECCE ® 327 in 80 healthy male subjects as a single ascending dose.

The clinical trial will be conducted at CMAX Clinical Research, an independent trial facility located adjacent to The Royal Adelaide Hospital, centrally positioned in Adelaide South Australia.

Recce is also undergoing a Phase I/II study to assess topical application of RECCE 327 in burn wound infections with Fiona Stanley hospital, where Professor Fiona Wood is the principal investigator.

Professor Wood pioneered the innovative the worlds-first ‘spray-on skin’ technique, which greatly reduces permanent scarring in burns victims.

The trial is sponsored by the South Metropolitan Health Service, Department of Health, Government of Western Australia.

The trial will run over 14 days, where 10 patients will receive RECCE® 327 daily while a further 20 patients will receive treatment 3 times per week.

The Phase I/II clinical trial has been approved by Human Research Ethics Committee.

What about Recce’s other compounds?

Recce has entered into an agreement with the Murdoch Children’s Research Institute to conduct pre-clinical studies assessing the potential of RECCE® 435 for the treatment of H. pylori infections.

The research program will be carried out by the Mucosal Immunology Group at the MCRI, Royal Children’s Hospital.

Researchers will evaluate the antimicrobial activity of RECCE® 435 against H. pylori across a range of internationally recognised in-vitro & in-vivo study models.

RECCE® 529 has advanced to animal (ferret) in-vivo COVID-19 studies after showing concentration-dependent reductions in the SARS-CoV-2 virus in an in-vitro study using organoids made from human airway epithelial cells.

Claims to RECCE® 529 have been lodged in a provisional Patent Family 4 submission and are expected to be built upon as independent COVID study data becomes available.

Media Relations

How do I get photos or videos from you to use in my story?

Please contact our media relations personnel listed below.

How do I request for an interview with a Recce executive?

Please contact our media relations personnel listed below.

How do I invite a Recce executive to speak at my event?

Please contact our media relations personnel listed below.

Media contacts

Head of Marketing
     ▪ Daniel Astudillo
     ▪ Recce Pharmaceuticals Ltd
     ▪ +61 (02) 9256 2571
     ▪ This email address is being protected from spambots. You need JavaScript enabled to view it.

Media and Investor Relations (AU)
     ▪ Andrew Geddes
     ▪ CityPR
     ▪ +61 (02) 9267-4511
     ▪ This email address is being protected from spambots. You need JavaScript enabled to view it.

Media and Investor Relations (US)
     ▪ Jordyn Temperato
     ▪ LifeSci Communications
     ▪ 919-413-2644
     ▪ This email address is being protected from spambots. You need JavaScript enabled to view it.

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