Recce Pharmaceuticals (ASX: RCE: FSE: 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, 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 notes that antimicrobial resistance one of the greatest global health threats. Investors are also looking closely at the sector. The Former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb is focused on investing in companies developing new antibiotics. “I’m very interested in finding opportunities in the anti-infective space, particularly around multi-drug resistant organisms,” Gottlieb said in an interview. “Anti-infectives have been unloved for a very long time. There’s a huge clinical need.”
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According to global leaders in biotech investing, Ballie Gifford, they focus on 3 criteria when investing in biotech:
1. Is it credible?
2. Is it scalable?
3. Is it differentiated?
We examine these criteria for Recce.
Recce 327 (the company’s main compound) was co-invented by the company’s founders, Dr Graham Melrose and Michele Dilizia, a medical scientist. The company was incorporated in 2007. Dr Melrose was executive director and chief research officer at Johnson & Johnson’s Australian arm. Recce-327 works on a unique mechanism of action involving hydrophonic interaction with the offending cells.
The antibiotic travels through the blood and is attracted to a protein in the bacteria’s outer membrane. This weakens the cell wall, causing the germs to burst (cell lysis). The binding properties of Recce-327 mean that it is more effective in tackling superbugs and it is effective on both Gram negative and Gram positive bacteria (the bugs fall into these two classes, as determined by the structure of the cell walls). Recce-327 is classed as a qualified infectious disease product (QIDP) by the US Food and Drug Administration, under the US Generating Antibiotic Incentives (GAIN) Act.
This designation is for what the FDA believes to be “serious life-threatening infections caused by an antibacterial or antifungal resistant pathogen”.
A comprehensive review of the technology and credible research behind the company can be reviewed from the company’s recent ‘white paper’ which can be downloaded below:
Recce have invested in establishing scalable infrastructure and manufacturing capabilities ensuring their manufacturing facility is well equipped to produce RECCE® products in volumes to support Phase I and II human clinical trials whilst de-risking the expansion beyond. Investment has also been made in establishing strong management and regulatory expertise needed to support our clinical and regulatory pathway towards product approval.
The company’s Patented lead candidate RECCE 327 has been developed for the treatment of blood infections and bacterial sepsis derived from E. coli and S. aureus bacteria - including their superbug forms. Recce’s new compound, RECCE 435, has been formulated for oral use. Sepsis affects over 30 million people worldwide a year. There are currently no drug therapies specifically for the treatment of severe sepsis and is by far the most expensive condition treated in US hospitals.
Recce’s technology can be scaled across multiple markets and product categories.
In March 2021, Recce announced that RECCE-327 has been include in in The Pew Charitable Trusts’ annual assessment of non-traditional antibiotic treatment in clinical development and is the only synthetic polymer drug candidate for treating sepsis currently in development. The CEO of Recce, James Graham, said “We welcome inclusion of our lead compound in this important annual global record of efforts underway to address the urgent unmet medical need to develop new antibiotic treatments,”
The Non-traditional Products in Development to Combat Bacterial Infections register is a key part of the respected independent non-profit organization’s efforts to help health and medical researchers better understand bacterial infections and address antibiotic resistance. The Pew Charitable Trusts’ stated mission is to serve the public interest by improving public policy, informing the public, and invigorating civic life.
The company has a significant portfolio of global patents which protect the differentiated technology.
The growing threat of global super-bugs is very real and provides an enormous addressable market for a company like Recce Pharmaceuticals. It is estimated that at least 10 million people could die annually from superbugs if nothing is done.
There have been some recent value-drivers and key event milestones achieved, including:
In March 2021, The Pew Charitable Trust added RECCE 327 to list of antibiotic treatments in clinical development. RECCE 327 is the only synthetic polymer drug candidate for treating Sepsis currently in development.
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 companys tow 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.
Europe represents one the largest anti-viral therapy addressable markets in the world, valued at € 9.3 billion in 2019 and is expected to reach € 17 billion by 2027.
On 7 April 2021, the company 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). This was the result of a single patient use where the medical practitioner was provided access under the Special Access Scheme (SAS) Category A.
The company was recently admitted to the Australian All Ordinaries Index (top Australian 500 companies).
March 2021 English and German Investor Decks are Below: