Hello, I'm James Graham, Managing Director and CEO of ASX-listed Recce Pharmaceuticals. Today we have Dr. John Prendergast, our Executive Chairman, joining us, as well as Dr. Alan Dunton, a Fellow Director and our Chief Medical Advisor. It is a pleasure to present to you Recce Pharmaceuticals commercializing a new class of synthetic anti-infectives. Usual disclaimers. We will start with a brief executive summary here, then elaborate upon some of the commerciality of Recce Pharmaceuticals, then introduce Dr. Prendergast and Dr. Alan Dunton, and expand upon the significant clinical data that has been achieved to date and what we can look forward to over the time ahead. Recce Pharmaceuticals is clinically the world's most advanced new class of antibiotic according to the World Health Organization. In fact, it's clinically the most advanced in over 40 years.
Recce has a strong pipeline of new anti-infectives, in fact, in their late-stage Phase II and early-stage Phase III s across unmet medical needs of large patient populations, with significant revenue catalysts over the next 12 months. The key milestones we look forward to, in fact, is a registration of Phase III in Indonesia, the gateway to the ASEAN region and group of countries. In Australia, as pointed towards the U.S. FDA, having delivered a successful ABSSSI, or acute bacterial skin and skin structure infection study, where we had a 93% clinical response positive response rate in as little as 14 days, we are launching a Phase III study which we expect to start middle of this year. We've very positively started with the U.S. Department of Defense, who in fact awarded us a government grant of around AUD 3 million.
For the time ahead, we have a memorandum of understanding with a leading Indonesian pharmaceutical company, ATANA, which is positioned for sales and distribution post the present registration of Phase III study for diabetic foot ulcer infections. This study has been, of course, approved by the Indonesian BPOM, as they're known, providing not only support of our clinical data to date, but expedited regulatory review for the data that will follow in this registration of Phase III program. This program in Indonesia is positioned as the gateway to the ASEAN group of countries. Indonesia itself, or certainly that region, have around an 11% diabetes rate. As we talk to the statistics beyond, the opportunity to support the diabetic foot ulcer patient population that comes from having diabetes is an opportunity and an unmet medical need that Recce is now faced.
We have significant bilateral support by way of the Australian and Indonesian governments, and we really launch forward to tackle this major unmet medical need. We had a very positive response from an individual, an existing shareholder, who's put up AUD 5 million at AUD 0.28 per share, and we now make that same offer available to all existing shareholders to raise around AUD 15 million at AUD 0.28 per share. Post completion, Recce will have a pro forma, as I suppose it is, of around AUD 17 million. As we discussed further in, we have non-dilutionary catalysts to build that out to about AUD 35 million over the coming 12 months. Company overview. Recce is clinically the most advanced new class of antibiotic in the world according to the World Health Organization.
The late-stage Phase III status, with expedited regulatory review that we have approved in Indonesia, positions us for the gateway of the ASEAN group of countries, potentially across into the Middle East and beyond, whilst in Australia maintaining that U.S. focus running in parallel. We have multiple clinical candidates, which gives us a portfolio approach, the upside opportunity of clinical success that can come from our endeavors, whilst protecting the downside nature of investigating new unmet medical needs. We are the only FDA qualified infectious disease designated awarded company for bacteremia. Bacteremia is the technical term for broad-spectrum sepsis, and that provides us market exclusivity, plus fast-track regulatory review with the U.S. FDA for bacteremia itself. What makes us different? All existing antibiotics are naturally derived. So they're bacteria or fungi. They're cultivated out, and you're only as good as what's found in nature.
Generally, they have very expensive methods of manufacture and very, very narrow mechanisms of action and a very select use and focus. We don't. We're entirely synthetic. We have no superbugs or no drug-resistant bacteria to our compound, and we never expect there will be. We work and we keep on working with repetitive use, a fundamental challenge of existing antibiotics to date. We work against all spectrum of bacteria, eliminating the clinical guesswork of one antibiotic for one type of bacteria. Our antibiotic works against all types of bacteria, which means the clinician can be re-empowered to administer a patient presentation to get on top of those deadly superbugs. Our universal mechanism of action means we work across all. We work in multiple formulations, from IV being straight into the vascular system, topical straight onto the infected wound itself, inhalant, of course, and so on.
We work in minutes, not hours, reducing the time of exposure and, of course, ultimately leading to a quicker clinical outcome. The markets we tackle are enormous. Touching briefly to one segment of that market, which is diabetic foot ulcer infections, in Indonesia alone, if we break that market down, it is worth many hundreds of millions per annum in U.S. Dollars. We've got a patient population in Indonesia of about 11% of the overall population. You've got 270 million people in Indonesia. 11% have diabetes. So 30 million have diabetes, and around 45% of those get a diabetic foot ulcer. Around 90% of those ulcers get infected, which means you have an active patient population for just diabetic foot ulcer infections of around 15 million persons per year. That's a very large patient population that is unmet and right before us to treat.
Of course, as we broaden out across the ASEAN group of countries, we see around $1 billion per year, or globally some $5.2 billion per year. When we step across to the macro space of sepsis, certainly the market, like the diabetes market, is large. Some $5 billion per year, growing at a CAGR of around $6 billion per year. When we look to unmet medical needs of large patient populations, we really see unserved medical categories where we believe we've got the ideal compound to meet that market need. This is from a portfolio perspective. Here, of course, we see in the top sections our topical programs. You'll see for diabetic foot infections, which through the presentation you'll see abbreviated to stand for DFI.
We have a registrational Phase III candidate, which, if successful, as we'll see further on, would be approved for marketability around the middle of next year. Our diabetic foot infection study in Australia, in fact, rolls into the ABSSSI, or acute bacterial skin and skin structure infection study. We see there running in red. Outside of that, we have a late-stage candidate for IV administration according to urinary tract infections, which is the underlying cause of sepsis. Around 30% of patients who get sepsis have an underlying UTI. It is quite possible that we, or probable, I should otherwise say, that we may have a Phase II urosepsis study later in this year associated with that. Right at the base there, you see our Department of Defense burn wound program working very supportively with the U.S. Army, and we'd expect clinical data or data certainly surrounding that to flow.
For those who aren't familiar with us, it's been a busy 12 months, and I think it really is a sign of the 12 months to come. As a snapshot of where we've come from and where we're going, we've delivered a Phase I burn wound infection study, which, of course, set us up for success and grant funding with the U.S. Army. We've delivered well over a dozen Special Access Scheme cases, which are patients who were unresponsive to all existing therapies, but were cured with the use of Recce antibiotics. We've shown our compound when IV administered to be safe and well tolerated, and we've got a memorandum of understanding, which, of course, is one step before a potential license agreement with a leading Indonesian pharmaceutical company.
Our ABSSSI, or acute bacterial skin and skin structure infection study in Australia, as a late-stage Phase II, was incredibly successful and will allow Brad upon that. We've received money from the U.S. government, as we can tell, that's hard fought in this day and age. Of course, now we launch our registrational Phase III in Indonesia. What does the next 12 months look like? Registrational Phase III data out of Indonesia for diabetic foot ulcer infections. Why DFIs? They're the most expensive of the topical applications, so you position it for DFIs up there, knowing that there could be off-label use across the region, but at least they're paying a DFI premium. We'll be launching a Phase III acute bacterial skin and skin structure infection study in Australia, running in parallel to that Indonesian study to cater to the global application of our compound.
Indonesia, ASEAN, Middle East, and beyond, Australia, U.S. FDA, Europe, and beyond, running in parallel to each other. We expect to continue to advance our U.S. Department of Defense activities. We expect to make a submission to the U.S. FDA off the back of the success of our Australian data, I think complemented by our Indonesian data. As it says, we would expect to launch a Phase II-B IV uroseptic type clinical study as well. What does it look like from a macro time perspective? This is where you see the positive overlap taking place between our clinical studies. Indonesia, as you can see, has nicely launched the registrational Phase III, and running in parallel to that is Australia and the US.
Where we see the NDA submission positioned for around the end of Q1 or in Q1 itself of next year, that NDA submission is applicable for both Indonesia and Australia. If the U.S. requires additional data, a small snapshot of Phase III data among U.S. patients, that is where the U.S. can continue, but certainly that NDA submission would be applicable in both Indonesia and Australia, giving near-term commerciality to this magnificent clinical asset. I am now going to start to introduce, of course, my wider team, and touching briefly upon myself before passing the baton across to our Chairman and Dr. Alan Dunton himself. I have started actually as the founding investor of this company. My grandfather is the inventor of this technology. He is former head of Johnson & Johnson Research, Australasia, of about 10 years. He was Executive Director of their board about 10 years.
It was really in his retirement where he was looking to the challenge of antimicrobial resistance. As he says, he's no good at the carpentry, so he picked up the test tubes and had another go. I had a commercial success in a totally unrelated area to pharmaceuticals, but my endeavor was to support my grandfather, to get him out of the garage, out of man's hair, and into a laboratory to have a go. I made my founding investment there. I've invested in almost every capital round to date and will be investing in taking up part, if not all, of my entitlement. We'll see how I can go because my entitlement component's quite significant. Nevertheless, supporting this wonderful journey as I've since transitioned into Managing Director and CEO. John, perhaps would you like to introduce yourself and then pass across to Alan? Sure.
Thank you, James. Thank you, everyone, for listening into this webinar on Recce. My name is John Prendergast. I am based in the U.S., however, I am an Australian who trained at the University of New South Wales. My initial degrees, my bachelor's and master's, were actually in microbiology before I went into different fields, genetics of a certain disease. I then, through a course of training postdocs, ended up on Wall Street in a venture firm and have been involved with starting and forming companies over the last 25 to 30 years, serving on boards and also then being involved in their strategic financing and positioning.
I was then, about eight years ago, asked to join a company in Australia that was looking to bring forward a new clinical candidate for treating sepsis and other infections and was intrigued by the fact that this was totally new. I had the opportunity to review and then join the board of Recce initially under the auspices of our founder, Dr. Graham Melrose, who then subsequently retired, and I've been able to become the Executive Chairman and being involved in seeing what I believe is a truly transformational innovative product in the field of infectious disease. This is so needed. Anybody that's had any type of infection that has not responded to antibiotics understands what the need really is. What we're hoping to do is really provide something that will overcome broad-spectrum antibiotic resistance, and we've got data to prove that.
I'm delighted to be part of that team. Over to you, Alan.
Good afternoon, and thanks. I'll thank you to joining us this afternoon. My background is in internal medicine and biochemistry. As you can tell from my language is American, I am from the United States. I'm here now. My training in medicine was not only in adult internal medicine, but also focused in clinical pharmacology, study of drug action in human. I joined the pharmaceutical industry a long time ago, over 40 years ago now. My last real job in the pharma world was as worldwide head of the Janssen Organization for J&J, which was the true engine of their pharma group and was the first American managing director of that group. We introduced products on a very regular basis. I also was head of clinical research for Roche and a number of other companies.
As I mentioned, my last position in the industry was with J&J. I also ran a number of smaller biotech companies. My introduction into Recce was through John. John and I have worked on a number of companies and as board members in the United States together quite successfully. John introduced the products to me and the approach. It was quite fascinating since I have a lot of experience in developing drugs. I've had about 10 antibiotics, antifungals, or antivirals approved in the United States and other major markets around the world. This profile is incredibly unique and is exactly what the world needs exactly at this time. Drug-resistant species are just killing off at prodigious numbers. We're in the right place at the right time. Back to you, John and James.
Thanks, Alan. I'll just jump across to the next slide.
Perhaps my last major slide here, which is in reference to our capital snapshot. That share price is obviously not reflective of the share price today. You will see, of course, the cash at bank is obviously cash at bank at the end of the last quarter. What is important here is, of course, you see that we have no debt, we are caveat-free. The top 20 shareholders retain around 50% of the company itself. For what it is worth, my family has some 25 or so % of the company still. Of course, we are advancing as these near-term commerciality of our Phase III candidates allow. This is where we start to really take a bit of a technical deep dive. For the scientists in the room, I suppose this is a particularly keen area of interest. John, you might like to speak to the mechanism of action.
Sure.
Thanks, James. On this slide, what we're trying to show is really why we're unique. Basically, for those who are not technical, the simple thing is that every cell in our body derives and needs energy to thrive and survive and replicate. It simply translates also into bacteria. In this particular case, what we're able to do and the way we attack bacteria and their protein layers that are surrounding them is through shutting down their ability to derive energy. Therefore, they're unable to replicate. What that means is simply every type of bacterium, no matter whether it's one species or another, one type of bacteria that has a certain type of composition versus another type of composition, it's totally independent and random. What we are doing is a universal type of approach that shuts down what's called bacterial cellular energetics.
Next slide, please. Just as importantly as being universal in terms of our mechanism of action, what we're able to do in terms of being able to irreversibly shut down bacterial energy production is do it in a faster fashion than any other known antibiotic. What we've got up here on this slide is really a comparison between RECCE 327 in the bottom blue and other antibiotics that are traditionally used in many indications. You'll see that literally at two hours post giving these antibiotics, there really isn't that much killing, whereas you can see immediately over time there's killing with RECCE 327. What that has allowed us to do is to be recognized as really one of the only products that has been placed on the WHO list with the ability to do this, to have this type of mechanism of action. It really is unique.
We gained recognition of this from the WHO last year. This really gives us an ability to treat a broad range of life-threatening and resistant bacteria that I'll show in the next slide or the next couple of slides. If we go back, sorry, yes, if I could go to this slide. This really is one of the most critical slides that demonstrates the ability of what we've been talking about in terms of universal mechanisms of action. This is a list of bacteria that are called escape pathogens. Simply, it refers to the initial of each of these bacteria that are the critical pathogen list of the CDC. These are the ones that are responsible for about 70% or more of infections and infectious disease deaths throughout the world.
What we're showing here, very, very crucially, is that we're able to kill almost six log orders of these particular bacteria with RECCE 327 at usable concentrations in less than an hour. This is really what we want to profile as being one of the key characteristics of this new compound, its ability to kill and shut down irreversibly, but to kill irreversibly in an incredibly short amount of time. When we talk about six log reductions, just to be practically speaking about that, it represents 99.999% of the bacteria that we have tested were killed within the space of one hour. This is rather dramatic. Next slide, please.
What this also shows is that these are three of the worst of those escape pathogens that are responsible pretty much for most of all the things of the infections largely that we are going to talk about with diabetic foot infections. In this particular slide, we show that with comparison to other antibiotics that are used to try and kill them, you'll see in the second last column that the majority of these species are resistant to existing antibiotics. In the final column, what you can see is there is no resistance whatsoever developed by these bacteria when they're tested against RECCE 327. That's absolutely critical because one of the things we want to be able to show is just and truly prove out in our clinical trials is the broad-spectrum nature of this.
When it comes to a wound infection, you can have multiple species of bacteria that are resistant within a wound or a diabetic foot infection. We want to be able to demonstrate that these particular bacteria were killed repeatedly, no matter what the type of strain was, by RECCE 327.
Thank you, John. Now we'll move on to our clinical programs. Dr. Alan Dunton will address this. Here, Alan.
Thanks, James. We've had quite a clinical program ongoing with multiple formulations of RECCE 327 and other products. Let me take you through a bit of that history. We started our clinical program by doing an intravenous safety and PK or pharmacokinetics study. The reason you do an IV is, one, it could be a potential product, but also it avoids any doubt: was the drug absorbed if you give it orally?
If you give it IV, you know it's absorbed, so you can make claims about its safety when it's broadly distributed in the body. The pharmacokinetics is really just a measurement of the amount of drug in the body over time and where it potentially goes in the body. We conducted an 80 healthy participant, healthy volunteer study in Australia in a dose-response fashion, going up and escalating the doses that these patients were exposed to. We went all the way up to 6,000 milligrams. As I go through my presentation, that's quite an astronomical high dose. This is what you want to do in these early trials: prove that the drug is safe. We did prove that the drug is safe. The only thing we saw at the highest dose of 6,000, there was some irritation and discomfort at the infusion site.
It was not even all patients. It was also seen in some patients who received placebo. We measured all the laboratories we could in terms of chemistry, blood cell counts, coagulation, electrocardiograms, telemetry. The drug did absolutely nothing to change those counts or electrocardiograms or heart rates, etc. It is absolutely totally safe, except for what I noted to you about the irritation at incredibly high doses. The drug increased with the dose as well, so the concentrations went up as the dose went up. It has a half-life. That means the amount of time it spends in the body that you can measure it is about three to five hours. If you measure the maximum amount in three to five hours, half of it is gone. That half-life increased to the higher doses. At lower doses, the half-life is one or two hours.
We got up to about three to five hours. Of significance in this trial is we noted that in the urine, the concentrations of RECCE 327 were about 20 times higher than we actually saw in the plasma. That tells us that the drug is being excreted in the urine and is being concentrated in the urine. What does that tell you also is that this is a potentially excellent product for patients with urinary tract infections, especially complicated urinary tract infections with bugs that may be resistant to other more common antibiotics. Next slide. The next study we did was understanding how quickly we could get into the how quickly we can infuse the drug. Let me show you the urine concentrations we saw in contrast to the human plasma. In the blue is what we're seeing in the urine.
It is up to 20 times higher in terms of micrograms per mL than we see in the human plasma. This is not unique to our product, but it is very unique to antibiotics overall that you get this amount of concentration. What is important is it occurred safely. When we looked at the urinalysis of these patients, there was nothing abnormal comparing the pre-drug urinalysis to the post-drug urinalysis. There was no irritation throughout the urinary tract or in the bladder, etc. It was completely safe. Next slide, James. This is the results from the rapid infusion study that we conducted. We asked multiple questions here, not only how quickly we could administer the antibiotic intravenously, but how quickly the drug could kill bacteria once it got into human urine. These patients were intensely studied.
They not only had a catheter to infuse the drug, they had a catheter to draw blood on a very regular basis, looking at concentrations of the drug, and also a catheter to collect urine directly from their bladder. It was both male and female patients. We collected those urine as we collected plasma samples as well. What we saw was that the urine, when the drug got into the urine, when we put bacteria, because these were normal healthy volunteers, into that urine after it had been taken from the patient, it would kill the bacteria very efficiently and very quickly. If we go to the next slide, we can take a look at that data as well. As John mentioned earlier, excuse me, the drug not only kills, it kills bacteria very, very quickly.
On the left is a graph of the concentration of drug in the urine and the time at which it kills on the x-axis. You can see the viable bacterial cell count, that's normal healthy bacteria. You don't want those cells around, and they're killed very quickly. At the highest concentrations, the drug kills the bacteria to six logs. That's six logs equals 99.9999% of the bacteria are killed and so reduced. As you went down in the concentrations, the killing was somewhat slower. To put this into perspective, most antibiotics don't start working at all until after two hours. This is a dramatic, dramatic improvement in that rate and time of kill for an antibiotic. Very, very unique. It also kills resistant bacteria, as we've shown in in vitro studies.
Now, in the background, we were also developing a topical formulation of the drug. We started with a spray and then developed a gel. What we had ongoing in Australia, and you can go to the next slide, James, was something called a special access scheme. We do not have this in the U.S. What it is is if a physician requests use of the drug because they have a particularly problematic patient, they can get access. Some of them did that with our topical gel. This is a patient who had a significant diabetic foot infection and a diabetic ulcer. They had one on their left malleolus or their ankle and inside the lower aspect of their right foot. This patient failed systemic antibiotics, a very common antibiotic used called cephalexin, treated for 10 days, did absolutely nothing.
You can see the redness, swelling, and irritation in the patient on the left. The gel was applied, and within one to two days, that infection had been cleared, and the wound also healed after 30 days of observation, but it only took a few days of treatment. Wounds just don't close overnight. It takes some time for the body to catch up, although the infection had been cured. This is our first indication that this drug had some additional remarkable properties in this type of patient. We did study other types of patients. In the next slide, this is a patient who experienced an infection in their great toe. I believe it's on the left side. I mean, it's the big toe. This was a very deep infection. They actually had osteomyelitis in their bone in the great toe.
As you can see, before the patient was treated, you can see that whiteness right below the nail bed. That's a biofilm. This is a conglomeration of bacterial cells that just are very difficult to treat because it's very difficult to penetrate that biofilm. After three days of treatment, in the second slide, you can see the wound is almost completely healed. By day seven of treatment, there was no evidence of infection in this patient. Quite remarkable for a topical drug product that we would clear up in that rate of time. This patient avoided an amputation of that toe, and I'm sure he was extremely grateful to this antibiotic and Recce for helping them out. Next slide, please.
We had conducted in the background a topical spray study too of burn wounds as well as diabetic foot ulcer infections out at the Liverpool Hospital outside of Sydney. It worked quite well. We decided to conduct a Phase II trial, controlled clinical trial in diabetic foot infection and acute bacterial skin and skin structure infections. That is all the other skin wounds and infections that you get. We enrolled 30 patients, 29 completed. The reason the 30th patient did not complete is they complained of pain, but they had the pain prior to enrolling in the study, and they did not tell the investigator. That patient was dropped on day one. What we saw after seven days of treatment, 86% of the patients responded and either had been cured or had a significant clinical response.
Now, that endpoint is the FDA-approved endpoint for these types of infections, and drugs have been approved based on that endpoint, and they will continue to be approved on that endpoint. After 14 days of treatment, and not all patients required 14 days, up to 93% of the patients had a positive clinical response or cured. Again, that was the primary efficacy endpoint of the study. The drug was completely safe. There were no significant adverse events to speak of. This is a very good formulation and is very pleasant to use going forward. We showed that it was safe and well tolerated, achieved all of our endpoints. At that point, we felt that we had a great opportunity to proceed with advanced clinical trials as we are starting to do as we speak. In the next slide, this is the design of.
If I may interject, I'm sorry, because it's relevant to today's announcement. This study, particularly for the diabetic foot ulcer infections, was so successful that the clinicians initiated this today announced additional or expanded on a compassionate basis Phase II study. We actually had many diabetic foot ulcer infection patients cured. When they come back, as many of them do come back with another ulcer, the study itself was closed. Today's announcement is actually an announcement which shows a reopening of a component of this study. The component is particular to diabetic foot ulcer infections only to allow the patients clinical access when they otherwise really couldn't in the clinical setting. Just to add to that on the basis of the success of what was achieved, that was reaffirming in today's announcement why it has been opened for expanded access there. Thank you, Alan.
Thank you.
Thank you, James. Very, very good point and very helpful. We are initiating a Phase III registration trial in Indonesia in diabetic foot infection. Indonesia has a very significant problem with, number one, diabetes, and then corollary to that, diabetic foot ulcer infection. In fact, they have up to 24% incidence in their diabetics of foot ulcer infection, diabetic foot ulcer infection, and they recur at a very high rate as well in that environment. In this study, it's going to be a placebo-controlled trial in a parallel group in up to 300 patients. Two hundred will receive the active drug, and one hundred will receive placebo. The drug is applied once daily. They are seen at the clinic actually daily. In Indonesia, these patients, most of the patients are very close to the clinics they will be going to.
The clinics will have up to seven sites in Australia, in Indonesia, which are across the country. It's a very wide country. I didn't get to know the country until visiting there. It will be a very representative section of the patients who have this experience. They will be using the drug, and the clinicians will be measuring clinical response based on the same endpoint we used in our Phase II study. We are very confident in terms of the outcome here. We will be conducting, excuse me, an interim analysis. When we have completed 106 patients, we estimate that will be in the calendar first quarter of next year, 2026. With success, if that's a positive, we can actually file for approval in Indonesia.
We will most probably continue the trial in an open label fashion then so that we can continue to study the drug and prove its safety and efficacy. We're really excited about this trial and excited about our close collaboration with the Indonesian government, their drug approval process, and our partners at Etana. Next slide, please. I'll pass it back to you, James and John, on the commercialization opportunity we have.
Thank you, Alan. That was a wonderful update on our clinical activities and the opportunity ahead. The commercialization opportunity. Our commercialization opportunity by way of our nearest revenue catalyst is in Indonesia, the gateway to the ASEAN group of countries and beyond. As announced, we have an approval for a registrational Phase III study for diabetic foot ulcer infections.
That approval comes with expedited regulatory review so that when we submit that statistically significant data point, which we expect to be in the first quarter of next year, we could be approved within as little as 60 days. Indonesia, of course, as a gateway to the ASEAN group of countries, represents a patient population, or a population, I should begin with, of around 680 million people. The program has significant bilateral support from both the Indonesian and the Australian governments. It has a memorandum of understanding with a leading Indonesian pharmaceutical company positioned for sales and marketing and distribution across Indonesia, if not across beyond. We expect near-term commerciality or revenue opportunities in early 2026. How does it work from a global perspective? The below columns do not represent the countries or buckets that we drop those methods of administration or indications in.
We really see strategically across the top expansion into the ASEAN, expansion across Australia and New Zealand, and then entry into the United States in both the civilian and the Department of Defense markets. The two really do run parallel into each other. The products mentioned beneath are products applicable to all countries. Diabetic foot ulcer gel, ABSSSI gel, burn wound gel. What is it? It's gel. It's the same stuff. We make it in our facility currently, and we package it according to the indication, geography, or need and beyond. The compound is an IV administration. It's the same compound, just missing the gelulation formulation. Of course, it has the applicability in the major unmet medical needs of UTIs, urosepsis, sepsis, ventilated-assisted pneumonia, and beyond. Globally, we position for success.
Geographically, entry into the ASEAN group of countries, whilst running in parallel, Australia and the U.S., gives us the best near-term commerciality to do so. How do we do it? We make it. We make it in our own manufacturing facility. We do not own the facility itself, but our people and equipment are producing at around 5,000 doses per week to both volume and quality, suitable for Phase II, Phase III, and early commercialization. Unlike existing antibiotics, which are very expensive to cultivate, they require a lot of CapEx and about a 50% yield. Our raw materials are plentiful. Water, that is easy. Polyethylene glycol or PEG is in about 50% of drugs. And a material called acrolein. Acrolein is a derivative from the propane industry. It is known for its hypercombustible state, but also for its hyper antimicrobial properties for well over 100 years.
Our bodies, in fact, naturally produce just a little bit of acrolein, but we take that hypercombustible, incredibly high-yield antimicrobial property, and we polymerize it to a stable state. We get 100% yield, and we then export out into the markets we've mentioned. That method of manufacture process is supported by all families of our granted patents. Family one, method of manufacture. Family two, methods of manufacture. Again, broadening on the method of manufacture, but including methods of administration and the broad range of antibacterial properties that our compound has. Family three, you'll see again, we say method of treatment, which includes method of manufacture, but touching upon the antiviral properties the compound has. In essence, if a virus has invaded a proteinaceous cell, we bind to the proteinaceous layer of that cell, and then we interact with the internal virus itself.
Family four is process for preparation, which is a fancy term for method of manufacture, expanding our manufacture and market monopolies out to 2041. We have over 40 granted patents around the world, representing around 95% of the world pharmaceutical market. As a summary, the compound works and keeps on working with repeated use. It's valuable today and will be valuable into the future based upon its ability not to succumb to antimicrobial resistance, as has been demonstrated in hundreds of clinical isolates and repeat exposure experimentation. We work broader than any other antibiotic known to date and work faster than any other antibiotic known to date as well.
We've brought forward the commerciality of the development of this new medicine through the opportunity of registrational Phase III status that we have achieved for entry into Indonesia and the ASEAN region for diabetic foot ulcer infections, assuming the clinical success of our near-term studies. We've demonstrated our Phase II candidate, which is now into a Phase III status, to be incredibly effective against all the clinical claims that we have lodged to date. We are the first new class of antibiotic in over 40 years, according to the World Health Organization. We are positioned for success in the United States and beyond, working with the U.S. FDA, according to our qualified infectious disease designation, or the U.S. Department of Defense, according to the U.S. Army. The equity raising.
The equity raising is really launched off the initial offer by an individual existing private shareholder who came to us a week or two ago and said, "Guys, I love what you're doing. I'd like to give you AUD 5 million at the near-term price." We said, "Look, we'd love to support your interest, but we must launch a raise to all shareholders on the same basis." We have done that, and we have made it therefore a one for six, a non-renounceable entitlement offer, which basically means shareholders are welcome to apply for at the same price and on the same terms as all other shareholders. They're, in fact, welcome to apply for more than their otherwise allocated entitlement. Many have done so.
In fact, I just spoke with the director who's asking the same question to apply for more than their stated entitlement. The use of funds is particularly highlighted in this next slide here. You see, we really deploy our funds according to the near-term commerciality of two registrational Phase III studies. Phase III diabetic foot ulcer infection study in Indonesia as a gateway to the ASEAN. As we've mentioned, the study, we expect to have a clinical data readout in Q1 of next year, which would see commerciality really imminently thereafter. Running in parallel to that, a registrational Phase III study for diabetic foot ulcer infections in Australia as a registrational Phase III study done to U.S. FDA standard for submission to the U.S. FDA and beyond. We're supporting our U.S. Department of Defense program.
That's an expanding program that you'll hear a little more about over the next week or so. Of course, supporting our associated regulatory submissions to the Indonesian BPOM, the Australian TGA, the U.S. FDA, and general working capital. The key pieces I would highlight here is how could we possibly do two Phase III studies with only AUD 15 million? The answer is with additional non-dilutionary support in the background. As we see by the three last bullet points here, a pro forma cash position, ideally some couple of weeks from where we are today, would be around AUD 17 million. Soon after that, I'd actually then immediately point to the last bullet point there, which shows that we have up our sleeve an R&D advance opportunity, which is a non-dilutionary cash advance against future R&D accumulated credits for approximately AUD 10 million, maybe AUD 11 million, depending on how that goes.
Separate to that. On top of that, we have the addition of what we expect to be about AUD 8.5 million from an R&D rebate itself. We've positioned the R&D advance to be non-repayable for up to three years. If we have our present equity raise of AUD 15 million, plus a little bit of cash at bank, that takes us to about AUD 17 million. We add about AUD 10 million. That brings us to about AUD 27 million. We add about AUD 8 million there, which brings us to about AUD 35 million. With AUD 35 million and only AUD 15 million of that from an equity perspective, we will deliver these two registrational Phase III studies, the U.S. Department of Defense activities and surrounding activities that positions this compound to be as it well is the first new class of antibiotic to market in over 40 years. This really concludes the formal presentation.
I’d particularly like to thank Dr. Alan Dunton and Dr. John Prendergast for their support in doing so. We open the floor now for a question and answer session for among the three of us. Please submit your questions via the presentation link. Okay. I’m going across to the Q&A. I’ll read this out for us, guys. Oops. Let me just move my thing here. All right. First question, do you expect the U.S. tariffs on pharmaceuticals to impact Recce now or into the future? I’d love to answer that, but I’m actually going to pass it across to Alan or Dr. Dunton, if I may.
Yeah, it’s unlikely that those tariffs will have any impact on us in the short term or even the longer term. These things will be worked out. It’s just going to take some time.
Australia is very close to the United States. I'm sure if there is any tariff on anything coming out of Australia, it's going to be based on very optimal terms. We've also been doing a significant amount of backwork in the United States. We've even thought about manufacturing over here. We're very close with the Department of Defense. I don't think there would be any significant impact whatsoever, if at all, going forward.
Thank you, Alan. The next question, how fast can you roll out or how fast can the rollout occur for successful data readouts of the registrational Phase III clinical studies through to commercialization? John, perhaps you might like to answer that.
Yes, thanks, James. What we have planned is we're starting a Phase III trial in Indonesia momentarily. As we said on one of the slides, up to 10 sites.
Most likely, it'll be around seven. What we've calculated and based on the clinical interactions we've had with the folks in Indonesia, we anticipate that this will unroll very quickly. What we've projected internally and what we're happy to disclose is really, as we've said, is the first quarter next year, we will get to the interim data. The reason why that's significant is because of the success of the Phase II trial. We were quite surprised that we actually achieved the type of response rates that we saw and the cure rates that we saw. Those same type of primary milestones, primary endpoints are employed in our Phase III trial that Alan can elaborate on more than me. However, what that does mean on a practical basis is that we really do anticipate looking at the first 106 patients.
The statistical plan is based on the original Phase II data. The folks that are behind devising that statistical plan that give us confidence are somebody that's actually worked as a director of the biostatistics division of the FDA. The second person is someone who teaches biostatistics to the FDA. We are confident in their statistical approach. That gives us also confidence in being able to deliver interim data within that first quarter, which is critical going forward. As James mentioned, what that allows us also to do is then have expedited review from the BPOM, the Indonesian FDA.
Thank you, John. The next question we have here is, what are the key catalysts for Recce for the remainder of 2025? I'll answer that question. This is the year of efficacy. This is the year of late-stage clinical data and early commercialization.
Looking to the remainder of 2025, I would expect us to, or certainly to the early 2026, just by way of the nature of the data points, I would expect Q1 of next year to have two major clinical data readouts: the interim data readout of our registrational Phase III study in Indonesia for diabetic foot ulcer infections. Running in parallel to that, in Q1 of next year, I would expect the interim data readout of our ABSSSI, or acute bacterial skin and skin structure infection study, which is a registrational Phase III study, to read out in Australia as well.
Leading up to the readout of those studies, I would in fact expect our existing memorandum of understanding to transition from a memorandum of understanding or a letter of intent across to a full-blown license agreement, particularly in Indonesia for the near-term commerciality, which is sales, marketing, and distribution with that leading Indonesian pharmaceutical company. Further, I would expect some data readouts from the U.S. Department of Defense activities, Department of Army, looking at burn wound infections.
I would also expect our open Phase II study that we announced today, driven by the patient demand for access to the medicine, to have some clinical data that comes through treating those patients according to clinical trial protocol, because we designed it that not just to give drug out for drug and clinical sake, but in fact to ensure success of those patients, that they follow the existing protocol, that we capture the data that comes from them utilizing the compound or the clinicians utilizing the compound on their infections and benefit from the data capture that comes from that. Next question, what is the offer price and is it the same as the placement price to the individual investor? Absolutely. The offer price is AUD 0.28 per share. No options.
It is the same price as the private investor who bought another $5 million worth of stock and is treated equal and or pari passu to all other shares. When does the offer open? Will it open today? It is expected to close 5:00 P.M. Monday, the 5th of May. This is one probably for John, because I know you love your spreadsheet on this one. The question asks, how quickly do we anticipate enrollment of our Phase III study to occur?
For whoever asked that question, I do have a spreadsheet, and I do have a green visor that helped me devise that spreadsheet. The point being that one of the critical things when we go into a Phase III trial is obviously how quickly it does enroll. This is a very important question.
Based on our calculation, we feel very comfortable with the fact that getting to the first 106 patients, as I just previously described, should take us about five or six months at the most. That depends on, obviously, the number of sites we have and when we have put into the clinical trial at the first instance. We anticipate five, expanding that to up to 10, as we suggested in the slides. On a conservative basis, we anticipate that we would get to data in the early first quarter of next year. I don't know that I should show the spreadsheet, but there is a number of contingent spreadsheets. Based on conservative estimates, we should have data by the end of the first quarter. Frankly, our estimates on a moderate basis have us having data very early in the first quarter.
This is, from a Phase III perspective, a very rapid clinical trial, unlike other types of therapeutic areas like oncology, cardiovascular, metabolism, obesity studies, which are so long. The beauty about our trial and with infectious disease is that there is a very quick readout, and that is what allows us to be confident about the timeline and achieving that timeline, given what we have already experienced through our Phase II and Phase I studies.
If I can add something here, we have been up to Indonesia, and our clinical team has been up to Indonesia multiple times. We know these sites. We have visited them. Indonesia has some of the highest rates of diabetic foot infection in the world. Unfortunately, they do recur in that environment quite frequently. They have a big problem. We are hoping to help with this problem. That is why we are there.
That's why we're optimistic about these recruitment timelines that John has laid out. This is a very efficient trial, as John has said. Why? Number one, you don't have to wait for months for the answer. You actually look at the ulcer. Is it infected? And there are multiple questions you have to ask yourself to make that assessment. It is the FDA-accepted endpoint as well. It's a clinical endpoint. It's not a fancy biotech DNA answer. You look at the wound, and that's infectious disease. It's inexpensive. It's fast. That's why we chose to go down this road.
Just to kind of reiterate and expand upon that, Alan, if I can, James, when we think about Indonesia, people say, "Why Indonesia?" Okay, it's the fourth largest population in the world, for those that don't know.
I certainly didn't know until a year ago or about 15 months ago of 270 million people. It has the fifth largest incidence of diabetes. That's the metric that really is quite shocking. When you think about that metric, the number of actual patients with diabetes exceeds the population of Australia. Beyond that, 11% have, sorry, 50% will have DFI, a diabetic foot ulcer. Up to 90% of those can get willing to get infected over the course of their disease. This is a significant opportunity and allows us to demonstrate, number one, that the drug really does work, but also allows us to show the commercial viability of what our approach is going to be through not only Indonesia, but the expansion to other Asian regions that represent 700 million people.
Thank you, John.
Just recognizing we're coming around to the hour, I'll perhaps take one more question here. The question reads, "The typical route to market for most pharma companies is through the FDA in first instance, then the TGA, and then ASEAN. Can we explain our strategy to reverse this strategy and comment on the likely pricing consequences of it?" Great question. I'll admit nothing will all be the first to admit. We did not think to firstly go to Indonesia. What happened? Indonesia came to us. We'll recognize some 18 months ago, World Health Organization came out and said globally, "We are clinically the most advanced new class of antibiotic in the world." The Indonesian government saw that.
Politically, they wanted and what they continue to want to be seen, without seeking to speak for them, to be on the forefront of the access to new medicine. The generics they've been using for anti-infectives just don't work. They approached us and said, "We in Indonesia want to be on the forefront of new medicine, and we would like you to run your registrational Phase III study here. We have an 11% diabetic patient population. We'll dramatically subsidize the costs and access to this market, which, if approved, is then applicable across the ASEAN group of countries." That was very attractive to us because that brings forward the near-term commerciality in doing so. Further, we already knew that in Australia, we would expect to run a registrational Phase III study for either DFI or the broader spectrum ABSSSI or acute bacterial skin structure infection.
We knew that we could have a scenario where we could get some hundreds, if not early thousands, by way of the study data and the utilization across Indonesia itself to be running in parallel and submittable with the data that comes from the Australian study itself. If we went to just the FDA and said, "Hey, FDA, we're here. We've got some good data from Australia. It's a couple of hundred people. How about it?" We'd probably see, as they say with other companies, "Thanks, no thanks. Do it, do a little bit more." We would have to announce that, and the world would tumble. What we're instead doing is doing Indonesia, which we would expect to be approved and have commercial revenues coming from that.
In Australia, we would expect to have a significant clinical data pack so that when we submit it to the FDA, we would say, "We have your X hundreds of patients required from Australia, and we have X number of patients in addition to that as procured from Indonesia, and it's running in this market very successfully. FDA, how about an approval?" It's a stronger position to start from. On a pricing perspective, the reason we have chosen DFI for Indonesia is of the topical applications, DFI is your premium pricing. In Indonesia, around 10% of the population is considered high net worth or very high net worth. In fact, breaking it down to diabetic foot ulcer infections of high net worth category, there's about 1.5 million patients applicable to that category there each year.
It will be a lower cost than the U.S. health system, but it will be at a very economical or very viable price that is motivating our entry into that region, ASEAN, Middle East, and beyond, whilst maintaining our U.S. focus itself. John or Alan, did you want to add anything to that?
No, I think that's an excellent summary, James. Thank you.
Yeah, I know. I know you've got your two minutes. I think that also the one thing I would say about coming to the U.S., we want to come with a position of strength. Just as importantly, we also want to build out the opportunity in Australia.
Given the fact that we did the Phase II and it was so successful, this allows us to now bring forward the possibility of having a registrational set of data from the Australian population, albeit we'd also used New Zealand. That allows us to go into the United States and submit to the FDA with the potential to have an immediate approval, although Alan disagrees with me, although this would allow us to think about a smaller trial in order to be able to gain that approval. There is a way to get to the US, but at the same time, we have commerciality in the ASEAN region. By the way, if we didn't mention BPOM, because it's the FDA there, there is harmonization amongst the regulatory agencies. We wouldn't have to reproduce trials in every other country in the ASEAN region.
It will allow us to use our data package to submit to other agencies there to get approval.
Thank you, John. In conclusion, this is an entitlement offer. This is an offer exclusive to shareholders. You're all offered, as am I, shares at the same price ranked pari passu to all other shares on the same basis. These funds are used for two registrational Phase III studies with near-term commerciality. I'm looking forward to taking up my entitlement. All members of the board will be taking up at least part, if not all, of their entitlement. The offer has opened at AUD 0.28 per share, and it is expected to close in approximately two weeks from today. There are groups in the background that are not existing shareholders who are bidding in for any shortfall in any entitlement.
I put it to you, shareholders, to thank you for your support to date. Thank you for listening to this presentation, and we would welcome your continued support as we enter this exciting new chapter of commercialization. I'm James Graham. It's Recce Pharmaceuticals, ASX, RCE. A particular thanks to Dr. John Prendergast and Dr. Alan Dunton for joining us from the USA this late at night. We really look forward to keeping in touch along the way.
Thank you for your support, shareholders. We really appreciate it.
Thank you. Have a good day.
Thanks. Cheers.