Recce Pharmaceuticals Limited (ASX:RCE) Executive Director, James Graham provides an update on the company's lead product RECCE 327, including significant progress with manufacturing and patent protection out to 2035.
Jessica Amir: Thanks for tuning into the Finance News Network. My name is Jessica Amir, and today I'm with Recce Pharmaceuticals Limited (ASX:RCE) Executive Director, James Graham. Welcome back, James. And great to see you again.
James Graham: Likewise, Jessica. Hello.
Jessica Amir: So firstly, James, it's been about a year since we last caught up, so how has the business evolved and grown in that time?
James Graham: The company's progressed very well. We have submitted a number of data packs to the US FDA, and we've started to receive preliminary feedback from the FDA themselves. And I'm pleased to report that that feedback has been positive and should be consistent with the journey ahead.
Jessica Amir: And now to the case for synthetic antibiotics, how do they differ from natural-occurring antibiotics?
James Graham: There's a big difference. Really, the challenge of natural antibiotics is you're as good as what's found in nature, deepest of oceans, darkest of caves. You find the fungi or the bacteria, you cultivate it out, and you're only as good as what nature's given to you.
We've designed ours with first principles in mind, not reliant on what's given to us. And that's allowed us to do a number of things. Thinking particularly, bacteria... Much like a lock and a key, you've got the bacteria and you've got the antibiotic. Bacteria mutates, that lock and key no longer works.
We have designed ours to not only be attracted to the bacteria, but adhere to the bacteria regardless of its mutated form, take advantage of the high metabolic processes internally, causing the bacteria to burst, and gotten rid of any of the properties that we don't want, such as toxicities or any potential side effects.
So, you've got a broad spectrum capable of killing all and something that's 100 per cent water soluble at all PHs, intravascularly, orally, or topically. And, you know, one that really represents not only good today, but should be good tomorrow even with bacterial mutation.
Jessica Amir: Wonderful. And now to your lead drug candidate, RECCE 327, for those who are unfamiliar, just tell us about what you're targeting.
James Graham: The primary target of RECCE 327 is sepsis, septicaemia or blood poisoning. The challenge you have is when there's a break in the skin, be it an operation or an accident, bacteria gets in and it spreads very, very quickly through the bloodstream. Any bacteria in the blood is bad bacteria.
So it's an intravascular application. It gets into the blood system. It spreads very quickly. It adheres to the bacteria regardless of its gram stain. And there's only gram-positive, gram-negative, or superbug forms when it comes to bacteria. And we've shown very good capability of eradicating that bacteria quickly, excreting through the kidneys. No more bacteria. No more problem.
Jessica Amir: And what are your manufacturing milestones?
James Graham: The manufacturing has been an amazing journey. I mean, when you start from a manual process in a laboratory, you really seek to automate that process. Not only to investigate the scale-up opportunity, but to give surety and reproducibility around the manufacture of the product itself, so that you know when it goes into humans, which should be very, very soon, that it is the same product every single time. And I'm pleased to report not only have we done that, the insights of the scalability look pretty good, too.
Jessica Amir: And you mentioned it very, very shortly. Can you give us a little bit more insight into that?
James Graham: I can report quite proudly that, increasingly, Australian hospitals are approaching us, not us approaching them, as they're recognising the opportunity of what Recce may represent. They've got patients with multi drug-resistant infections, allergic to penicillins, or simply not responding to the antibiotics they are giving them. So this is representing new hope to those patients, and the access too, being an Australian company, I think will be an exciting opportunity ahead.
Jessica Amir: And can you give us an update on your patent position?
James Graham: Family 1 is fully granted, and it's granted in all the major jurisdictions around the world. Family 2 has recently being granted in Australia and the US. So really, Family 1 -- think composition of matter. Family 2 is broadening into the preventative role, so not just the curative, which is curing the infection, but preventing the infection ever taking place.
We were recently awarded the US grant. That's 50 per cent of the world antibiotic market out to November 2035. But the beauty about the US is we've also got a market exclusivity of 10 years post product approval, so patents are great. We rely on them. Might like to sell them along the way. But that market exclusivity -- no one's going to challenge the government in the time ahead.
Jessica Amir: And we're seeing international press really ramp up their coverage of superbugs. How is Big Pharma responding to this massive threat that this places on society?
James Graham: It's fascinating. I mean, the problem has never been greater. The pipeline has never been drier. The challenge of Big Pharma traditionally and even to this day is they're doing the same thing, expecting a different answer. And what might work today doesn't work tomorrow.
So increasingly, where their R&D pipelines are drying up through failed R&D research, they're looking beyond. They're looking for the innovation of early-stage companies. And it's not unusual for those large pharmaceutical companies to speak with companies such as ourselves.
Jessica Amir: And in a recent update, you mentioned the TGA special access scheme. So, tell us what this means, and how this is a real pathway for Recce Pharmaceuticals.
James Graham: Doctors can utilise RECCE 327 now for patients who are in a life-threatening scenario or likely to die within near months, if not for the opportunity that Recce may represent to that patient.
So, as I mentioned earlier, we are in advanced discussions with hospitals about the procurement of RECCE 327 to sit in their pharmacies, so the doctors can have it at their fingertips for quick utilisation of those patients. And I know with the problem of superbugs, if you bring a patient back from a multi drug-resistant infection, that would be a world first.
Jessica Amir: And just lastly, James, can you tell us about your financials and give us an update on your share price?
James Graham: We did a private placement with sophisticated and institutional investors around early February. So, often I look to capital raises as, you know, a discount to market, the share price will hold there for a while. But we did the placement, got cash into the company, and have effectively doubled the share price from 14 cents to have about 26.5 cents in near months thereafter.
Jessica Amir: Wonderful. James Graham, thank you so much for the update.
James Graham: Thanks Jessica.