Hello, i’m Ana Napoli for the finance news network and joining me now, from Recce Pharmaceuticals is executive director James graham, James welcome to FNN hello, Ana first up can you
Tell our audience just what Recce Pharmaceuticals does? Absolutely, so Recce is pioneering the global health problem of superbugs we’ve got a, whole new, broad-spectrum Antibiotic and we’re tackling that problem head-on So we’re focused on sepsis, septicemia or blood poisoning affecting around 30 million people worldwide every Year and we currently are listed on the Australian Stock Exchange with a market Capitalization of 20 million dollars. Thank you James before you tell us about your lead product could you tell us about the size of the Superbug problem? The superbug, problem is enormous and it’s getting bigger every, day So, by example for sepsis septicemia or blood poisoning it affects around 30 million people worldwide every Year about a third of those prove fatal it’s the number one most expensive Condition treated in hospitals and is actually it actually kills more people than breast cancer Prostate cancer and hiv aids combined so this big problem needs to be addressed And we’re addressing that as quickly as possible. Now to your synthetic antibiotic RECCE 327 can you, tell us how, it works? It’s fascinating it is a, whole new Class of antibiotic it’s got a completely different mechanism of action Traditionally you have a bacteria and you have a natural antibiotic Now if that bacteria mutates the specific fit no, longer works just like a lock-and-key Recce is actually designed from first principles We don’t rely on a specific fit we adhere to the outer membrane of the bacteria Cause the cells to separate and the bacteria inside burse the remaining bacteria is absorbed By the healthy cells and no more bacteria and no more problem and we do that in the blood any Bacteria in the blood, is bad bacteria gram positive gram negative or super bug It doesn’t matter to us okay fantastic and can you tell us about the effectiveness of? The trap it’s incredibly effective like i mentioned it doesn’t discern between a positive Strain of bacteria or gram positive as they’re known. A gram negative strain or a Superbug it’s all bacteria to us so we’ve tested in a large range of animal Small small species large, species mice rats rabbits dogs And we’ve tested against, some of the most deadly bacteria actually known to
Man with our primary indications being for staphylococcus Mosa or as people often known as golden staph and also e coli So, big big markets big applications and very urgent health needs that were tackling can You, tell us about the approvals for the dog, absolutely so earlier this, year, we submitted a, big data Pack to the USA FDA the US FDA because America is about 48% of the world pharmaceutical market? We presented that data pack and they actually responded. By awarding us a prestigious legal. Status called a QIDP status qualified infectious Disease status now what that does for us is it actually labels our lead compound recce 3 to 7 for fast-track status meaning it speeds the process of the regulatory Aspect of the FDA plus 10 years of market exclusivity post approval now we’ve got patterns to support the product but There’s nothing, better than a government-backed exclusivity post approval so that, also allows us to open up communications with the, FDA we’ve done that and we’ve recently met with them and Results will follow Fantastic and given the urgency of the superbug, problem how far off is a trial so we’ve completed the preclinical phase Tested in many many different animals dozens of tests thousands of pages of documentation presented to the FDA? With that and the present presentation to the FDA we’re seeking to start a phase 1 human trial We hope to have a response from the fda very soon which could Mean 12 months for safety studies 12 months for efficacy and about 18 months for a combination of both so all going a Well about three and a half years from market from accessing What is an enormous market and a very big problem that needs to be tackled urgently and? Now to your financials and strategy how, are you progressing our financing strategies going very, well Particularly as i think about a meeting later in the week We have we as an australian company receive a forty three and a half percent r&d rebate for our local r&d now thankfully we’ve Also got that extended for our international R&d so the australian government Has reviewed what we’re up to and actually awarded an advanced finding so all of our actuary as Well as local R&D is supported to the tune of forty three and a half percent and that greatly reduces our bottom line burn and opens up our opportunity to target You know or to advance our lead indication through the fda last question james why, should investors consider adding rocky to their portfolios Well we’re tackling such an urgent health problem i mean this could be the biggest thing since penicillin now Three and a half years from market of Significant sales potential heck this could be a real breakthrough and a breakthrough any investor would surely Want to be a part of. James graham thanks for the update thank you.