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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?

Recce has finalised its preclinical studies for RECCE® 327 and is expected to commence Phase I clinical trials in the second half of 2020.

Recce has finalised an agreement with Fiona Stanley hospital to conduct a Phase I/II topical study.

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 an Innovation Connections grant of AU$37,508 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. The company is eligible for an additional grant of up to AU$50,000 upon successful completion of milestones.

The Company has received a cash receipt of $640,049 as a research and development tax incentive rebate from the Australian Tax Office for the year ending 30 June 2020. The amount received reflects Australian R&D expenditure only.

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 extends 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. 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’s patent portfolio has more than 15 issued patents and patent applications in major markets including the US, EU, Japan, China and Australia.

Patent Family 1 – Antimicrobial Polymers and Their Compositions

Patent Family 2 – Copolymer for use in Method of Treatment of a Parenteral Infection.

Patent Family 3 – Anti-Virus Agent and Method for Treatment of Viral Infection.

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.

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 that result in cell lysis.

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

Initially developed for the treatment of sepsis, a life-threatening blood infection for which no specific treatments exist, 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-19) 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® 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.

Is RECCE® effective against SARS-CoV-2?

RECCE® 327 is currently being investigated in the Priority 1 group Antiviral SARS-CoV-2 Screening Program by CSIRO and the Doherty Institute for its efficacy against SARS-CoV-2, the virus that causes COVID-19. Preliminary results showed encouraging inhibition advancing RECCE® 327 to the next stage of testing. This stage will involve confirmatory in vitro testing and a cytotoxicity assessment, due for completion in near weeks.

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.

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.

The randomized, double blind, placebo-controlled single-ascending dose study will involve 48 healthy subjects to evaluate safety, tolerability, pharmacokinetic and pharmacodynamic properties of RECCE® 327.

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 has formalised an agreement with Fiona Stanley Hospital to conduct a Topical Phase I/II clinical study in patients with Gram-positive and Gram-negative bacterial burn wound infections.

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?

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

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Media contacts

Media and Investor Relations (AU)

Andrew Geddes

CityPR

+61 (02) 9267-4511

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Media and Investor Relations (US)

Meredith Sosulski, PhD

LifeSci Communications

+1 (929) 469-3851

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