INmune Bio - Q3 2024

Transcript

Operator (participant)

Greetings and welcome to INmune Bio Q3 2024 earnings call. As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. David Moss, CFO INmune Bio. David.

David Moss (CFO)

Thank you, Chloe, and good afternoon, everyone. We thank you for joining us for the call INmune Bio's Q3 2024 financial results. With me on the call today are Dr. RJ Tesi, CEO and Co-Founder INmune Bio, Dr. Mark Lowdell, Chief Scientific Officer and Co-Founder INmune Bio, and Dr. CJ Barnum, our Head of Neuroscience. Before we begin, I remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward-looking statements.

Please see the forward-looking statements' disclaimer on the company's earnings press release, as well as the risk factors in the company's SEC filings, including our most recent quarter filing with the SEC. There's no assurance of any specific outcome. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change. Except as required by INmune Bio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. With the forward-looking statements behind us, it's now my pleasure to turn the call over to Dr. RJ Tesi. RJ.

Raymond J. Tesi (CEO)

Thank you, David, and good afternoon to everyone. For our Q3 2024 call, I will review the key takeaways and provide an update on our platform programs. Following my review of recent developments INmune Bio, i will pass the microphone to Dr. CJ Barnum, who runs our CNS development efforts for updates on the Alzheimer's program and the treatment-resistant depression program. Then I will pass it to Dr. Mark Lowdell, Founder INmune Bio CSO and the Inventor of INKmune, who will provide an update on the CaRe-PC INKmune program and metastatic castration-resistant prostate cancer. David will include our prepared remarks with a review of our financial results for the Q3, after which we will be happy to take your questions.

First and foremost, we announce that we closed enrollment to our AD02 global blinded randomized phase II trial of XPro in patients with Alzheimer's disease and biomarkers of inflammation. This milestone was reached on September 27th and symbolizes a major achievement for our team. This was a huge and visible milestone that really overshadowed the incredible work that was required to get there. The complexity of managing a clinical trial in eight countries with 30 sites forced us to work fast, smart, and efficiently. In doing so, our team demonstrated remarkable perseverance by successfully navigating the complex regulatory landscapes outside of the U.S. Despite the many hurdles, we are delivering a program that is being conducted with the highest quality standards, and we've had a couple of very careful reviews of the trial to ensure that this continues.

This experience may provide or should provide preparation for a global Phase III study that will most likely include more countries and more sites in the Alzheimer's program. The achievement not only underscores our commitment to advancing our program in AD but can translate to our other programs in treatment of resistant depression, prostate cancer, and beyond. Furthermore, we are confident that the data we are generating and our diverse international sites will provide robust insights into XPro's efficacy and safety profile, and I emphasize the critical safety profile in patients with early Alzheimer's disease. While XPro is our most advanced program, it is not the only clinical asset INmune Bio. INKmune, a novel NK-focused cancer program, is currently enrolling patients with metastatic castration-resistant prostate cancer in a Phase I/II trial. We call this open-label trial CaRe-PC.

We have recently enrolled the first patient into the highest dose cohort, that is, the highest of three dosing cohorts, and are also enrolling patients into the phase II extension portion of the middle dose cohort. This is a Bayesian design that allows you to overlap the phase I and phase II parts of the trial. Results from the first low-dose cohort were released late in September and showed consistent immunologic effects in the NK cell compartment and confirmed the excellent safety profile, which we've come to expect from INKmune. Do not underestimate the importance of the safety when treating men with metastatic castration-resistant prostate cancer. The average age of men in the U.S. with mCRPC is 76 years old, and these patients become increasingly frail as their disease progresses. Patients and clinical teams are looking for effective therapies that do not cause significant toxicities.

So far, INKmune meets that low toxicity threshold. We look forward to better understanding efficacy as we continue to treat patients at the higher doses. The program was introduced to the prostate cancer community last weekend at the 31st Annual Scientific Meeting of the Prostate Cancer Foundation, a meeting that includes important clinical leaders in the U.S. prostate cancer community. The program was well received. Mark Lowdell will provide a more in-depth report on INKmune in a few moments, but for now, I'd like to turn it over to CJ Barnum, who INmune Bio's CNS drug development efforts. He will provide more details on our ongoing phase II trial and our soon-to-be-started treatment-resistant depression trial. CJ?

Christopher J. Barnum (Head of Neuroscience)

Thank you, RJ. I'm here to provide an update on our XPro clinical programs and outline what lies ahead in the coming months. I will start with our phase II Alzheimer's study. The primary objective of AD02 is to demonstrate that patients treated with XPro exhibit improved cognitive function compared to those receiving placebo. As reported last month, enrollment has been completed. During this critical phase between the last patient enrolled and the release of top-line data, our clinical team is diligently focused on data collection and preparation to expedite the delivery of these crucial results. Notably, our third-party vendors have continually highlighted two exceptional aspects of this trial: the superior quality of data collection and the outstanding performance of our primary endpoint, EMACC, which has surpassed our expectations in its ability to measure cognitive change in patients with early Alzheimer's disease.

While we're thrilled about EMACC's potential, it's important to note that AD02 is powered by the Clinical Dementia Rating Scale sum of boxes. This key secondary cognitive endpoint has served as a primary endpoint and been instrumental in gaining approval for all three anti-amyloid phase III trials. Empowering the study on the CDR, we mitigate risks in the regulatory pathway by providing a second, well-validated cognitive endpoint. To provide further insights into EMACC and our regulatory strategy, we will be hosting a webinar on November 7th. Our neuropsych consultants will lead the discussion, and you can expect additional details about the webinar shortly. On a parallel track, our operations team is making significant progress in launching our phase II trial for treatment-resistant depression. We anticipate opening the first site by the end of the year. This blinded, randomized, placebo-controlled, NIH-funded study will enroll 90 patients with biomarkers of inflammation.

Participants will receive XPro or placebo over the course of six weeks. The primary endpoint is change in functional MRI within a brain pathway that subserves depression and inflammation. This trial will also measure clinical scales that will provide the critical data necessary to conduct a future proof-of-concept study. We look forward to sharing more updates on this trial in future calls. Thank you, and I'll turn it back over to RJ.

Raymond J. Tesi (CEO)

Thank you, CJ. With that, I'll turn the microphone over to Mark to discuss the INKmune program. Mark.

Mark Lowdell (Chief Scientific Officer)

Thank you, RJ, and good afternoon, everyone. Thank you for joining the call. So, as RJ said, the CaRe-PC trial continues to recruit completely in line with our predicted timeline, and we now have opened the phase II extension of the intermediate dose cohort, which allows a further six patients to receive this dose of INKmune in the Bayesian design that RJ described. The first of these six extension patients are already identified and have begun screening. There is a queue, apparently, of patients awaiting treatment. Meanwhile, the first patient in the high-dose group was enrolled this week and will receive his first treatment on the 5th of November. We expect to complete treatment of all patients in this high-dose group during January 2025 and then progress immediately to the phase II extension for further six patients in February and March at the highest dose.

Monitoring of the immune response to INKmune in patients in the intermediate cohort is underway, and results will be communicated as soon as they're available. As RJ said, we saw INKmune-related changes in NK cell function in the first three patients at the lowest dose, with increases in activated NK cells in the peripheral blood and the generation of increased potency of these NK cells in tumor-killing assays. We're eagerly awaiting the data from the second dose cohort, which we'll be keen to share. We see metastatic castration-resistant prostate cancer as the first of many solid tumor targets for INKmune, and we've recently completed our preclinical study of renal cell cancer as a potential trial group. This adds to our preclinical data in ovarian cancer, B-cell lymphoma, and other blood cancers, and allows us to consider multiple options for future clinical development of this drug.

Clinical trials are the poster children of drug development, but moving from trials to market requires much more, not least a full development of the drug manufacturing pathway, which meets regulatory requirements and is cost-effective at a scale which meets the likely global INmune Bio is laser-focused on this, rather less glamorous aspect of drug development, allowing I'm delighted to report that we've made significant progress in what's called the chemistry, manufacturing, and controls, or CMC, aspects and scaled-up manufacturing five-fold with associated cost efficiencies, but more work to further simplify manufacture is also underway. All of the drug doses for the phase I and intermediate phase II extension are in stock and ready for shipment.

Many are already in the United States, and we will complete manufacture of the remainder of the current trial products before the end of this year, with drug stability data to support over two years of storage at our U.S. distribution facility and up to one-month local storage at clinical sites, and we've worked with our clinical sites to engineer the drug delivery to the clinical team and the infusion protocols to make this the most easily delivered cellular medicine in the world, and I say that from many, many years of many trials of cellular medicines. If CaRe-PC provides the efficacy data we hope, then INKmune will be ready for commercial manufacture for future drug registration trial and subsequent BLA submission, so that ends my update of the INKmune platform, and I'd like to turn the call over to David Moss, our CFO, to discuss the financials.

David?

Christopher J. Barnum (Head of Neuroscience)

Thank you, Mark, RJ, and CJ. As usual, I'll provide a brief overview of our financial results and upcoming milestones before we head to our Q&A session. During our Q3, we were pleased to have raised $13 million in gross proceeds from a registered direct equity offering. In total, the company issued in aggregate approximately 2.3 million shares of common stock and warrants in aggregate of about 2.3 million shares of common stock. The warrants have a five-and-a-half-year term with the potential acceleration pursuant to the terms of the warrant agreement, which, if exercised, would raise additional capital. I'll note that the company has approximately 3.9 million warrants outstanding and the ability to all be accelerated, and this would raise just north of $30 million if it were to occur. In the financing, management, and employees and members of the board of directors purchased about $800,000 worth of stock.

Cannot underscore how financially committed and aligned the INmune Bio team is to the success of the company. We also greatly appreciate the support we saw in the offering from both new and existing investors, along with our team here INmune Bio. now, moving on to the financials. Net loss attributable to common stockholders for the quarter-ended September 30th, 2024, was approximately $12.1 million, compared with approximately $8.6 million for the comparable period in 2023. Research and development expenses totaled approximately $10.1 million for the quarter-ended September 30th, 2024, compared with approximately $6 million for the comparable period in 2023. General and administrative expenses were approximately $2.2 million for the quarter-ended September 30th, 2024, compared with approximately $2.6 million for the comparable period in 2023. At September 30th, 2024, the company had cash and cash equivalents of approximately $33.6 million.

Based on our current operating plan, we believe our cash is sufficient to fund our operations into Q3 of 2025. As of October 31st, 2024, the company had approximately 22.2 million shares of common stock outstanding. Now, I'd like to focus on some key upcoming milestones. We expect to have top-line cognitive data from our phase II trial in Alzheimer's disease in Q2 of 2025. We will initiate a phase II trial of XPro in patients with treatment-resistant depression, as CJ had mentioned, towards the end of this year. We expect to complete enrollment in the third cohort of the metastatic castration-resistant prostate cancer program, as Mark had mentioned, around January of 2025, and complete the phase II portion is expected to be completed either in Q2, Q3 of 2025. Results from the trial will be released as they become available.

Although we have secured additional funding, as always, we continue to focus on achieving our primary clinical objectives while remaining cost-prudent, with the potential to recover a portion of R&D expenses in Australia and the U.K. We will have further paid off our Silicon Valley Bank debt on December 1st of this year, which will help reduce our quarterly spend. I'll also note that in the beginning of next year, we should start to see sites wind down in the AD02 program and do expect some of those costs to get lower. In summary, we secured a meaningful equity infusion recently that puts us in good position into 2025, and we're focused on the execution of our programs. At this point, I'd like to turn the microphone back to RJ to conclude our prepared remarks. RJ?

Raymond J. Tesi (CEO)

Thank you, David. I'd like to wrap up our prepared remarks by saying we are busy. It is heads down INmune Bio as we work towards data in our AD02 phase II in Alzheimer's disease and our CaRe-PC trial in metastatic castration-resistant prostate cancer. We hope to open another chapter in our TNF story with the phase II in treatment-resistant depression before our next quarterly call. We have strong science backing our cutting-edge programs and may provide unique solutions to difficult medical problems and have the funding to see them through important milestones. We appreciate our strong and committed shareholder base, and we all thank you for investing alongside us as we work to achieve our goals. Operator, I'd like to poll for questions.

Operator (participant)

Certainly. At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may withdraw yourself from the queue at any time by pressing star two. And once more, for your questions, that is star and one. We'll take our first question from Gary Nachman with Raymond James. Your line is open.

Gary Nachman (Analyst)

All right. Great. Thanks, guys. Good afternoon and congrats on the progress. So, a few questions. First, in the XPro phase II in Alzheimer's, when you think of how selective you've been with patient enrollment, looking for the right inflammatory biomarkers, talk about what that process has been like, and would it be a challenge if you end up moving to a bigger phase III down the road, or even when you think about XPro commercially? So, start with that, and then I have a couple of follow-ups.

Raymond J. Tesi (CEO)

Yeah. Let me start, and then I'm sure CJ will have something to add to my comments. This is RJ. So, as you know, this was really based on two things, Gary, and we've been very transparent about this. One, we believe that matching the mechanism of XPro, which is targeting glial activation and neuroinflammation with the patient's disease, is important to allow us to de-risk the clinical program. So, we are focused on patients that have inflammation driving their Alzheimer's disease. And that turns out to be, in Caucasians, probably about 50% of patients. And let me give you a good example. One of the biomarkers we use is APOE4. And I'm here in Madrid at the CTAD meeting, which is a large clinically focused Alzheimer's meeting, and virtually every trial that is presented, 50% of the patients have APOE4.

So, I'm very comfortable saying we are targeting 50% of the patients. And for a small company to have a strategy that de-risk the clinical trial so we can gain success early is we're willing to accept 50% of a large market. Now, the regulatory issue is a different question, and I think that we have some ideas, but this will be a major topic of discussion, I'm sure, at the end of phase II meeting with the FDA. I do not expect. I don't know what to predict that will be, but we'll be able to manage around it, I'm confident. CJ, anything you want to add there?

Christopher J. Barnum (Head of Neuroscience)

I'll add something, Gary, and maybe if I don't quite answer your question, please correct me. I think the simple answer is, and RJ's right, is I don't think the biomarker is going to be a major issue as we move into phase III and beyond because there are plenty of patients with inflammation. Our sort of restrictiveness or our selectivity with the trial really has more to do with an early-phase study comparing apples to apples. So, you really want to make sure that you're in this study that patients have similar pathology, and that's in some ways what makes it a little more challenging for enrollment. So, I think that's probably the bigger issue as I look at the data compared to the inflammatory stuff.

Gary Nachman (Analyst)

Okay. That's helpful. And then I think you sent the press release. If you still have patients that are already screened, that'll end up enrolling at some point. Just could that push out the timing of the data readout potentially to later in Q2, given the 24-week endpoint? So, just confirm within Q2 that we should be thinking about that, I don't know whether the first half or the second half. And then just also remind us of your confidence in a 24-week endpoint on the EMACC score, given some challenges that we've seen in other Alzheimer's studies when they look out six months.

Raymond J. Tesi (CEO)

Yeah. Well, let me start with the length. I mean, one of the things that I noted at the meeting is we're seeing a lot more short trials. And when I say short, I mean not 18 months, which is 76 weeks. We've seen a raft of 48-week trials. We've seen some six-month trials. And people are designing trials smarter, and so they can be short. And we have been very loud in our claims that we're very comfortable with a six-month endpoint. So, we're not concerned there. And we actually believe the field is really kind of waking up to the fact that 18-month trials are not necessary, particularly if you know the mechanism of action of your drug. You're right. There are some patients in screening. There's a few extra patients who are in the screening process.

We're not going to cut a patient off who's in the screen and say you can't be involved after they've already made the commitment to the program. So, the drop-dead date is about 10 days from now, that everyone will have been rung out of the system by that point. So, I think you can start thinking about the clock from that perspective. I mean, David and I, and I think CJ have mentioned that we expect data in Q2, and we are quite comfortable with that claim, but it requires CJ's clinical operations team to be working 24/7 to make sure the data's clean, correct, and so we can lock the database and publish the results quickly.

Gary Nachman (Analyst)

Okay. Great. And then just last question, RJ, a bigger picture. So, with the news of AbbVie acquiring Aliada for $1.4 billion to have an early-stage starting goal in Alzheimer's, how does that impact your thinking about potential M&A in this space, if at all, how it might be evolving? And just on that, have you been having any potential partnership discussions, just sort of what the interest level is out there? Thanks.

Raymond J. Tesi (CEO)

Yeah. Well, I'm going to really pair it with David Moss's every time anyone talks to him, is that we strongly believe that everybody's waiting for data. Since we're not walking down the amyloid or tau path, which is where most of the M&A has been occurring, they are really buying assets that they consider de-risk. I can tell you all of the anti-amyloid programs I predict will have similar efficacy profiles. The safety profiles may be different, but those drugs do an excellent job of getting rid of amyloid from the brain, and we know what the results are. So, we believe that once we show that targeting glial activation makes a difference, people will be starting conversations. And people, the phone rings every once in a while, but they're really very how-is-the-weather kind of calls. We have no real deep-seated business development discussions in place.

Quite frankly, it goes back to what I said, that David always says, "It's all about data. When we get data, people will talk.

Gary Nachman (Analyst)

Okay. Great. Thanks, guys.

Operator (participant)

We'll move next to George Farmer with Scotiabank. Your line is open.

George Farmer (Analyst)

Hi. Good afternoon. Thanks for taking my questions. I was wondering if you could comment on your depression study that you're gearing up to do, and you mentioned some inflammatory biomarkers that you're going to be screening for as well. Are these the same as the ones in Alzheimer's disease, or are they different? To the extent that you can talk about them, that would be great. And then I have a follow-up.

Raymond J. Tesi (CEO)

CJ?

Christopher J. Barnum (Head of Neuroscience)

Yeah. Thanks. Great question. Thanks for asking. This is the program that I'm really excited about. So the simple answer to that is yes, we are enriching for patients that have inflammation. And this is based on really well-researched studies, both in the clinic with animal data support by a group at Emory University that's led by Andrew Miller and Jennifer Felger. So we have two biomarkers that we're using. One is blood C-reactive protein, and the other one is a behavioral biomarker of anhedonia. So anhedonia is a core symptom of depression. And for those of you that don't know what anhedonia is, it's the lack of pleasure, of deriving pleasure in things that you enjoy. It's a very difficult symptom to treat, and it is tightly regulated with inflammation. So we will be selecting patients based on those two inflammatory biomarkers.

And again, we expect that about somewhere between 45% and 55% of patients will meet criteria for those biomarkers. And by the way, you'll see this consistent theme across any program that we start, is that the inflammatory biomarkers are somewhere around 40%-50%. So, those are the two key biomarkers associated with that.

George Farmer (Analyst)

Okay. Great. Very interesting. And then a question on INKmune. What do you need to see in this trial to really give you confidence that continued investment is worthwhile? Specifically, you talk about reductions in PSA, which is great, but have you seen any impact on measurable tumors, and do you need to see that in order to move forward with this program?

Raymond J. Tesi (CEO)

I think that's a very good question.

Christopher J. Barnum (Head of Neuroscience)

You want to go ahead?

Raymond J. Tesi (CEO)

Yeah.

Christopher J. Barnum (Head of Neuroscience)

Yep.

Raymond J. Tesi (CEO)

Yeah. Thank you. So, first of all, it's a phase I trial, so we're treating very, very advanced-stage patients with very bulky disease. So, from an immunological perspective, what I want to know is that we're changing their ability to make an immune response against their tumor because that means that moving it into a better-risk patient group in further drug development is indicated because we know from other research that patients with good NK responses have a better prognosis with prostate cancer. With this particular group, because we've got the PSMA PET scans, we are able not only to look at their total tumor load, but to look at individual tumors within the individual patients. And that, I think, is going to be very informative. We've probably got some evidence already that some tumors do shrink while others are growing.

So, basically, what I'm looking for is any form of a clinical outcome that convinces Matt Rettig as the chief investigator that there's been a clinical response. And it really falls to him to believe in the data. So, it'll be data that he's able to say, "Yes, that convinces me we're having a clinical response.

George Farmer (Analyst)

All right. Thanks very much.

Christopher J. Barnum (Head of Neuroscience)

If I may just add one comment, and I want to go back to the safety bit. One of the things Matt Rettig has said, who spends his life treating these men, is that having a therapy that significantly prolongs life, even if you don't completely eradicate the tumor, but you prolong life with a good quality of life, is a very important metric in this patient group because a lot of the metastatic castration-resistant programs are really targeting the subset of patients that are below the mean age. So, they're in their late 50s or early 60s. And I already mentioned that the median age is 76. So, in fact, a lot of patients really don't get much care because they can't tolerate the toxicity of the more traditional regimen. So, I keep coming back to the safety profile.

If we see the kind of immunologic effects and tumor effects that we're expecting, this is going to be really attractive for a big segment of the prostate cancer community.

George Farmer (Analyst)

All right. Thanks, RJ.

Operator (participant)

We'll move next to Joel Beatty with Baird. Your line is open.

Joel Beatty (Analyst)

Okay. Hi, team. Thanks for the update and congrats on finishing enrollment in the phase II Alzheimer's disease trial. First question is, earlier this summer, you shared a favorable interim analysis of the trial. Any changes in the trial or operations since then that would lead to any differences since that time?

Christopher J. Barnum (Head of Neuroscience)

CJ?

Raymond J. Tesi (CEO)

Thanks, Joel. So, I'm not sure I completely understand your question, but I think I can let me take a stab at it. There are no changes as it relates to the interim data analysis. If anything, what we've done is we've continued to follow that. And you're going to hear more about that in the webinar. So, I'll sort of save the comments for next week. So, I'm not sure if I have your question answered correctly.

Joel Beatty (Analyst)

Yeah. Yeah. I think you're getting at it. And I guess what I'm asking is, in the enrollment that has occurred since the interim analysis, would the data, such as the variance or data collection, be expected to be any different? I don't know if the enrollment criteria of patients might be different since the time of the interim.

Christopher J. Barnum (Head of Neuroscience)

Yeah. Okay. Understood. So, the answer is no. We haven't changed the enrollment criteria. It hasn't changed. But as we get more data, actually, what we're seeing are better numbers. And again, well, this is going to be described in more detail in the webinar. But the short answer is yes. The more data we get, the better it looks.

Joel Beatty (Analyst)

Very good. Yeah. Look forward to more on the webinar. And then I guess maybe a question on INKmune. It's been highlighted in the past on the call today that it can be the most easily delivered cellular medicine in the world. Could you elaborate more on the delivery of INKmune kind of now and as it might look in the future?

Christopher J. Barnum (Head of Neuroscience)

Mark?

Raymond J. Tesi (CEO)

Yeah. Certainly. Yeah. So, if you think about other better-known cellular medicines like CAR T-cells, virtually every one of them is shipped in, I think, with a dry shipper in vapor phase nitrogen at minus 160 degrees centigrade or below. And then when they get into hospitals, they have to go through a special handling route. Quite often, they're delivered direct to the patient bedside. And that's not the route that most drugs go into hospital. Every other drug comes in through pharmacy and is held in pharmacy and then issued from pharmacy to go to the patient. And so, we've done a lot of work from get-go to make INKmune fit into that. So, it comes in at minus 80, like COVID vaccines. It goes into a minus 80 freezer. And since COVID, every pharmacy has many, many, many of those.

And then when it goes to the patient bedside, it goes in a cool box rather than in nitrogen and gets stored in an automated thawing device that we have developed that we buy in, but the program for thawing has been developed by us. And it's a bit like a microwave. It goes in. The lid's closed. And when it's ready, it detects that the thawing has been done. It goes ping. And there's no washing thereafter. The bag gets hooked up like any other chemotherapy-type bag and is delivered through a peristaltic pump. So, the nurses like it because it's exactly what they're familiar with using in these patients. Patients like it because there's nothing scary about it. There isn't a vapor phase of nitrogen gases coming off and lots of vapor spilling around their bed. And this is meant to be delivered in the outpatient setting.

So, these patients don't even have to be hospitalized. And we've been able to go into veterans' hospitals in the U.S., which are not delivering CAR T therapies and other cellular medicines. So, we really have nailed the delivery of this, the local storage at a temperature that fits in with other drugs and makes it very easy and therefore cost-effective. So, that's what we meant about that. We've tailored the delivery to fit in with routine clinical practice of other regular medicines that are not cellular medicines. Yeah. And if I can just re-emphasize the point Mark made, that this does not need to be used in centers that are used to giving cellular medicines. This can be given in any infusion site. And in fact, our first two patients were treated at sites that were commercial sites that had never given a cellular medicine.

And Mark and his team have videos and training tools for them. And this group was of the staff of the pharmacy and nursing staff. I mean, it went through it, and they were very comfortable, and things have gone perfectly well. So, it's really, really user-friendly. It's patient-friendly. And now we're waiting to hopefully show that it's not so friendly to the cancer and helps clear the patient's disease. But that will take a little bit more time to determine.

Joel Beatty (Analyst)

Thank you.

Operator (participant)

We'll move next to Tom Schrader with BTIG. Your line is open.

Thomas Shrader (Analyst)

Good afternoon. I wanted to return to the TRD area because we never really talk about that. How have you thought, and I know it's early, but about commercialization of an injectable drug in the TRD setting? And I guess specifically, is this something that could go into the ketamine clinics? Is the delivery close enough that the infrastructure will have been built for you? And then I have a follow-up.

Christopher J. Barnum (Head of Neuroscience)

CJ?

Raymond J. Tesi (CEO)

So, yeah, I can answer that. I would not put this in the category of ketamine. I think this is going to be more like an insulin shot, an injectable that the patients will be able to take home and do by themselves. So, I think this is a qualitatively different process. And there are other drugs in psychiatric disease that are injectable, perhaps not so much as in depression. But the patients that we're going to be targeting, which are these treatment-resistant or these inflamed depressions, these are the ones that typically have more severe disease, whereas people who have more mild disease, maybe they're more inclined to try a pill first. But I don't think we're going to have any issues with the injectables.

And when you talk to some of the clinicians that treat this and you ask that specific question, they don't even give it two thoughts. So, I think obviously, it remains to be seen how it plays out. But at this point, we don't think we'll have any issues.

Thomas Shrader (Analyst)

It's an auto-injected infusion?

Raymond J. Tesi (CEO)

Tom?

Christopher J. Barnum (Head of Neuroscience)

Correct.

Thomas Shrader (Analyst)

I'm sorry?

Christopher J. Barnum (Head of Neuroscience)

Yeah. It's the same as what we give for the AD patients. Yeah.

Raymond J. Tesi (CEO)

Then one more sort of slightly wacky CJ question. Does inflammation play a role in the psychedelics? Is that known? Seems like it easily could, given all the changes going on.

Christopher J. Barnum (Head of Neuroscience)

This is your turn.

Raymond J. Tesi (CEO)

I don't have a. I'm not ready for that answer. I'd have to spend some time on it.

Christopher J. Barnum (Head of Neuroscience)

I apologize.

Raymond J. Tesi (CEO)

I don't know. Yeah. No, that's okay. It's a very psychedelic question.

Christopher J. Barnum (Head of Neuroscience)

Now, if I can just editorialize on your delivery question, Tom, I can remember many years ago when we first started, and there was considerable concern about the fact that this was a subcutaneous injection. And I think one of the big advantages of GLP revolution in obesity is everybody is completely comfortable now with subcutaneous delivery of drugs. And so, in fact, if you look at both at Lilly with donanemab, they're moving to a subQ formulation for their anti-amyloid drugs. I mean, it's just, infusions are a hurdle. Everything else, the patients can manage.

Thomas Shrader (Analyst)

All right. Got it. Thanks for all the thoughtful answers.

Operator (participant)

And we'll move next to Matthew Venuto with AGP. Your line is open.

Matthew Venuto (Analyst)

Hey, guys. This is Matt on for James Molloy. Congrats on the progress for the quarter. Just one question. Would you guys be able to provide a little more color on the AUD 2.5 million R&D rebate from Australia and what that can or has been spent on program-wise?

George Farmer (Analyst)

Sure. Appreciate the question, Matt. So, we run a lot of our operations through Australia. And Australia has an incentive program where you can get up to 44 cents back on every Australian dollar you spend over there. And you can convert that into an actual cash rebate. So, next year, you'll expect that number to be quite a bit higher than what we received the last time. And then also, in the U.K., we get a smaller amount. They've kind of pared the program back a bit. But because our INKmune program has been expanding in the U.K., mainly on the manufacturing front and the work that's done over in Mark's group, that rebate also will be going back up again. So, it was large in the U.K. They changed the program. It went almost to zero.

And now, let's just say it's probably about 20%-30% of what it was historically. So, we'll be able to get more money back from the U.K. So, does that help answer your question? And all of the R&D rebate that we got out of Australia is related to the AD02, mostly the AD02 program.

Matthew Venuto (Analyst)

Got it. Yeah. And then are there any restrictions on how you spend that, or that's just a cash rebate?

George Farmer (Analyst)

It's just a cash rebate. It's a benefit for doing R&D in Australia.

Matthew Venuto (Analyst)

Got it. Thank you, guys.

George Farmer (Analyst)

There are no restrictions. We can spend. We just reinvest that really into our clinical program.

Matthew Venuto (Analyst)

Understood.

George Farmer (Analyst)

So, that's one of the reasons going forward it will reduce part of our burn.

Matthew Venuto (Analyst)

Do you have any estimate in terms of how much it would reduce the burn? You did say it was going to increase in the coming quarters, the rebates.

George Farmer (Analyst)

Yeah. It varies. I'd say for just to be conservative going forward, I would use a $4 million number for next year. It'd probably be higher than that, but I would be very conservative and say 4 at this point.

Matthew Venuto (Analyst)

Gotcha. Thank you.

Operator (participant)

It does appear that there are no further questions at this time. I would now like to turn it back to RJ for any closing remarks.

Raymond J. Tesi (CEO)

Yeah. Thank you, operator. So, our website now has 88 scientific publications in 12 different diseases. A fresh example of that cutting-edge science that drives our programs was added a few days ago when Lesley Probert, leading an international team of scientists, published an important work on how XPro promotes remyelination. The work was published in the journal Cell Reports. This is timely and relevant to our clinical programs in neurodegenerative diseases. With excess of our funding raised, we now have the capital to complete both our trial in early Alzheimer's disease and our phase I INKmune trial in prostate cancer. And these programs are making very positive headway.

Our aim is to provide positive readouts for both of those programs that have been, so that the concept of these new strategies is well received by clinicians, regulators, investors, and potential partners. Providing new solutions to difficult clinical problems is why we're all here today, and our goal is to make patients and investors proud of our accomplishments. We appreciate your support. Thank you for listening to the call.