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Recce Pharmaceuticals Limited – a global leader in fighting antibiotic resistance

Multiple indications including Sepsis, ESKAPE pathogens, 
SARS-CoV-2, and Influenza. 

Frankfurt am Main, 02/06/2021: Recce Pharmaceuticals (ASX: RCE: FWB: R9Q) is a global leader in the new generation of anti-infective therapies. The company is listed on the Australian Stock Exchange (ASX) and Frankfurt (FWB), Tradegate, Munich and Stuttgart exchanges in Germany.

The company is pioneering a new class of synthetic anti-infectives to address the urgent global health threats posed by superbugs and emerging viral pathogens.

The World Health Organization has declared anti-microbial resistance (AMR) as one of the top 10 global public health threats facing humanity. And anti-infectives have been unloved for a very long time” as the former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb explains in an interview: “there is huge clinical need”. His investments are heavily focused on companies developing new antibiotics, particularly around multi-drug resistant organisms.

The need for new antibiotics has never been greater as resistance has developed to most, if not all, currently approved antibiotics; with almost every antibiotic on the market based on scientific discoveries from more than 30 years ago. 

The growing threat of superbugs is significant and provides an enormous addressable market for a company like Recce Pharmaceuticals. If medical advancements are not made, the annual death toll due to superbugs could reach 10 million by 2050, potentially costing the world economy $100 trillion each year.  

Value drivers and key-milestones

There have been some recent value-drivers and key event milestones achieved, including: 

  • In March 2021, The Pew Charitable Trust added RECCE 327 to the annual list of Non-traditional products in development to combat bacterial infections, in clinical development. The list saw RECCE 327 as the only synthetic polymer drug candidate for treating Sepsis currently in development. Each day in Germany over 130 people die from Sepsis related causes, which can amount to almost 48,000 a year. The economic cost is also immense with severe sepsis patients costing over €50,000 to treat. Around 700,000 Europeans die each year from Sepsis related disease, so there is a huge addressable market in Europe alone.
  • Also in March, the European Patent granted the company Patent Family 3 “Anti-Virus Agent for Treatment of Viral Infections”. The claims are in respect of the company’s two major drugs RECCE 327 and RECCE 529 for composition and manufacture of RECCE anti-infectives, treatment of viruses having a lipid envelope or coat (examples including HIV, Hepatitis, Herpes, and SARS-CoV-2) and administration of the drugs by oral, inhalation, and transdermal dose applications.
  • On 7 April 2021, Recce announced to the market that RECCE 327 had delivered a positive human clinical response against multidrug resistant, Gram-negative P. aeruginosa sinusitis infection, in a single patient use pursuant to the TGA Special Access Scheme Category A (SAS – Category A).  The patient outcome follows positive results from animal study in sinusitis with Gram-positive bacteria and supports broad spectrum potential of Recce’s anti- infective compounds against life-threatening bacteria
  • On 15 April, Recce had announced its lead compound R327 had been registered in the Australian New Zealand Clinical Trial Registry for its Phase I/II Topical Burns Study in Humans. The Company’s clinical trial is registered under ‘Proof of Concept Study of RECCE 327 Topical Antibiotic Therapy for Infected Burn Wounds in Adults’ and involves 30 patients to assess safety and efficacy of R327.
  • In early May 2021, it was announced that RECCE 327 had proven more than 99.9% effective against the full suite of ESKAPE pathogens. According to the EU Commission antibiotic resistance poses an alarming threat to global health and of most concern is the “ESKAPE” pathogens (E. faecium, S. aureus, K. pneumoniae, A. baumanii, P. aeruginosa, and Enterobacter species). These organisms are able to escape the effects of almost all conventional antibiotics. The EU Commission further states that it is essential to develop “new antibacterial targets […] and unconventional antibiotics”. Recce Pharmaceuticals is on track to be the only company developing an efficacious anti-infective against ESKAPE pathogens globally.
  • In late May, the company further announced positive results from a pre-clinical study investigating the Mechanism of Action (MOA) of its lead compound R327. The results were “unlike that of any antibiotic seen before” and outperformed best in class commercial antibiotics against Gram-negative bacteria. The results will be presented at World Microbe Forum in June 2021.
  • The company was recently admitted to the Australian All Ordinaries Index (top Australian 500 companies). This will result in buying from larger Australian institutional investors who invest on an index-weighted basis.
  • The company has delivered significant shareholder returns since listing. The 12-month increase in shareholder value to 11 May 2021 has been 112%.
  • As per the recent quarterly, Recce ended the quarter with a cash balance of AUD $22.92 million (USD $17.81 million). The Company is in a strong cash position and is well placed to continue to deliver on its globally relevant objectives over the time ahead.