Greetings and welcome to the INmune Bio Third Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] 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 of INmune Bio. David, the floor is yours.

Thank you, Claudia, and good afternoon everybody. We thank you for joining us for INmune Bio's third quarter 2023 financial results. With me on the call is RJ Tesi, CEO of INmune Bio and Mark Lowdell, Chief Scientific Officer of INmune Bio who will provide an update on INKmune our memory-like natural killer cell oncology platform. Before we begin, I remind everyone that except for statements of historical fact, 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 in such forward-looking statements. Please see the forward-looking statements disclaimer on the company's earnings press release, as well as risk factors in the company's SEC filings including our most recent quarterly filings with the SEC. There is 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 law, INmune Bio disclaims any obligations to update these forward-looking statements to reflect future information events or circumstances. With that behind us, now I'd like to turn the call over to Dr. RJ Tesi, CEO of INmune Bio RJ?

Thank you, David, and thank you everyone for joining the call. As usual I will arrange my remarks to highlight the key takeaways for the third quarter and the subsequent period and include updates on our platform programs. I will start by reviewing our developments of XPro before passing it over to Mark Lowdell who will provide an update on INKmune. And then David Moss will continue conclude with a discussion of our financial results, and provide an update on upcoming and new milestones then we move to Q&A. During the third quarter, our primary focus remained enrolment of patients in the AD02. Our blinded randomized Phase 2 trial in patients with early Alzheimer's disease with information. And we focused on increasing our geographic footprint of that trial. We had notable success on both fronts. The MHRA, the UK equivalent of the FDA approved our clinical trial application in August, five of the six sites in the UK are already screening and enrolling patients into AD02. The UK is an ideal jurisdiction to expand our Alzheimer's disease trial given it possesses one of the highest rates of Alzheimer's disease in the western world coupled with robust for profit medical research infrastructure. Re:Cognition Health, our lead vendor in the UK has five memory centers with a large Rolodex of clinical trial ready patients. This provides a ready pool of patients to screen for participation in the trial. Re:Cognition Health has a history of enrolling a large number of patients and are incentivized to find the right patients to enroll in our program. Australia where the trial is further advanced continue to see patients who have completed the six-month blinded trial and opt into the Phase 2 open label extension program. We have also submitted regulatory dossiers to additional countries with the…

Thank you very much, RJ. And once again, I'd like to pass my thanks to those that are listening in and joining this third-quarter report. So as from the last quarter report, we filed an IND with the FDA in April this year for a US trial of INKmune in metastatic castration resistant prostate cancer. We received subsequent clearance in May, for the use of INKmune in a Phase 1 Phase 2 open label trial across multiple US centers. And the response since then from potential clinical sites has really been overwhelming. We have eight sites already selected to participate in the trial. The first two sites will be initiated within two weeks' time, in November meaning that we are ahead of schedule for the planned first patient treatment, before the end of the year. The other sites will come online in the first quarter of 2024. Most importantly, the batch of INKmune has already been manufactured for the treatment of the first US cohort and is just about to be shipped to amplify via the US distribution center. Patients at each dose level will receive all three doses of INKmune, as an outpatient treatment during the six months trial this is really critical to our future development of the drug. Two types of INKmune efficacy will be measured, immunological efficiency and therapeutic efficacy. Immunologic efficacy will measure the increase in these memory-like NK cells for the INKmune generates in the blood of the patient and how long those cells remain in the patient's blood after treatment, just as we have done in the MDS patients in the Laurel drug. Therapeutic efficacy will measure tumour response to immune therapy using biomarkers of prostate cancer tumour burden, such as changes in blood PSA level PMSA scan and circulating tumour DNA. In…

Super, thank you, Mark. I'll provide a brief overview of our financial results and upcoming milestones before we head to the Q&A session. Net loss attributable to common stockholders for the quarter ended September 30th, 2023 was approximately $8.6 million compared with approximately $7.7 million for the comparable period in 2022. Research and development expense totaled approximately $6 billion for the quarter ended September 30th, 2023 compared with approximately $5.2 million for the comparable period in 2022. General and administrative expense was approximately $2.6 million for the quarter ended September 30th, 2023 compared with approximately $2.4 million for the comparable period in 2022. At September 30th, 2023, the company had cash and cash equivalents of approximately $41.8 million. Based our current operating plan we believe cash is sufficient to fund our operations into late 2024. As of November 1st, 2023, the company had approximately 18 million shares of common stock outstanding. As highlighted in the prior quarter's Investor Call we continue to focus on achieving our primary clinical trial objectives or remaining cost prudent with the potential recover a portion of R&D expenses in Australia and in the UK. Now, I'd like to move on to their list of upcoming and important milestones. First milestone that we have which is we hope to have before year end is the removal of the FDA hold. Second, we expect some topline results from our Phase 2 early AD program towards the end of 2024. Upon release of the FDA hold we'll initiate a Phase 2 trial of XPro in patients with Treatment-Resistant Depression. Additional open-label Phase 1 data of INKmune in high-risk MDS and AML in 2024 and the initiation of a Phase 1/2 program in metastatic castration resistant prostate cancer. With the first patient treated before year end and open label…

Thank you very much sir. At this time, we will be conducting a question-and-answer session. [Operator Instructions] The first question comes from Joel Beatty from Baird. Please proceed with your question, Joel.

Hi. Thanks for taking the questions and congrats on the progress. My first question is on XPro. Could you discuss a little bit more about what gives you confidence that the clinical hold will be lifted by the end of the year?

Yes. Thank you, Joel. RJ here. Although it took a while to get to an agreement with the FDA. As I think I highlighted at the last call they gave us a list of things they wanted done. Obviously, those are that list was different than any of the other regulatory agencies. And we have gone through that list. And the data is been completed. It is being packaged and will be sent to the FDA for to meet the goal to have a soft hold by the end of the year. They ultimately gave us quite a clear list. And we have fulfilled it.

Great. And then as a follow-up for the ADO2 to study in early Alzheimer's. Are you able to provide any more information on where you're at in enrollment or what the approximate geographic split could end up looking like?

Yes I think we mentioned this last time we're changing our geography so quickly that we've been reluctant to really give names -- numbers and names yet. I think later in early in 2024 will when things have kind of settled down I guess that's the way to describe it. We'll be able to give you a clear direction on where we are outside of as far as clinical sites how many sites are involved, but I would be willing to bet they'll be more than 50 sites open by the end of this process. I won't promise that any will be in the US because we're really expanding so quickly outside of the US. But as we said last time this is really setting us up for the Phase 3 trial I mean its global -- multiple continents. And I know this has been a very frustrate us. But the one thing we are careful about is we don't want to -- when we give you enough information we want it to be perfect. In other words we want to be able to back it up and things are just changing so quickly and quite frankly to our advantage. And I think the UK is a good example we have. We're ahead of where we expected to be in the UK. They had a great backlog of patients that hopefully will all be screened and many of those will end up in the trial. So all I can say Joel hang tough and I think right now we have not changed our guidance. We still expect to be able to provide top line data by the end of the 2024. And I can tell you that everyone in this company is busting a gut to get us there.

That makes sounds great. Thank you.

Thank you. The next question comes from Tom Shrader from BTIG. Please proceed with your question, Tom.

Good afternoon. Thanks for holding the call. We enjoyed your CTAD presentations. Just to follow up on Joel's line of questioning. The late 24 data could that be done with no US participation or are they linked?

So, yeah, it couldn't be done we're driving forward Tom. And by the way Tom this is RJ. Thank you for the question. No, it could be done without US participation. I mean remember from the time -- let me use the prostate cancer trial that we're running as a great example. Mark said we got the green light in I believe it was May and we didn't do any front-loading planning there because that's expensive. And as you know we're careful with our money. So from the time we got the green light to the time we got to get our first enrolled patient enrolled will be six months to seven months, right? That's just what it takes. If you go from a standing start high. So, in the US, that's what will happen. If we once we get off hold, we'll start casting the US net. But by the time those sites get ready to go. We may have enrolled the trial. Now, there's a lot of other things we can do. We don't want to frustrate clinical sites, but I couldn't -- I think I've said it before. Maybe I've just said it privately. One of the things that frustrates us is that clearly what the FDA is doing is different from what are the other regulatory agencies are doing. All these other countries, their patients are getting access to what we think is a pretty good drug XPro for Alzheimer's disease. The US patients are sitting on the sidelines because of regulatory challenges both with the FDA. I can promise you the US will be involved in the Phase 3 trial and will probably be the main driver of the Phase 3 trial. But I wouldn't be surprised if we complete the Phase 2 trial without US patients.

Good. If I can follow-up given we have Mark on the line. Mark, in INKmune prostate cancer trial, who are these patients, are they post taxing? And I guess is the trial monotherapy? Then the final question is the oncology world has bent over backwards trying to get prostate cancer to be an INKmune reactive tumor that XTANDI Nevo went on for years. And now it's Nevo Ap and do you see INKmune playing there that it might be the final piece to make prostate cancer Nevo reactive? Is that interesting to you? Or is this pretty much a monotherapy endeavor for at least a while?

Sure. It’s a really, really excellent question. And I would love to spend a long time of size and put my academic hat on, and so I think with the first question is, yes, these are going to be post tax same patients the end-stage patients because that's what you always do it get into Phase 1 trial. The question about failure of the checkpoint inhibitors, every immunotherapy that's been tried in prostate so far has targeted T cell responses and the immune suppressive microenvironment of the tumour is high and whether that be checkpoint inhibitors or whether it be antibody conjugates. [indiscernible] If you look -- if you read the literature. And if you go and speak to a histopathologist, they'll tell you that very few. If you look at patients who do well in interventional therapy in prostate cancer, their patients who have a large NK cell infiltrate in their tumor there is no association with the T-cell infiltrate. So what we're targeting ourselves are already in the tumor. We just trying to switch them on to be better like we are in AML and MDS. And we know that the dirty little secret about solid tumors. This thing called neutrophil extracellular traps that coat the tumor and they inhibit NK cell activity. It means the NK cells and the T cells can't get the tumor, but we're targeting tumour infiltrating NK cells that are already there. So that overcomes part of that problem. But the really interesting thing about these neutrophil extracellular traps that let's stop particularly T cells invading from the peripheral blood is that they are broken down by M2 macrophages. So one of the great things that might come out of the XPro trial is that there are three, you could actually combine those two drugs in a very, very nice way to break down the trap to enhance the T cell entry into the tumor. And then respond to initial responses generated by the NK cells that are there. So that's a really exciting combination drug I'd love to that could also be combined with a checkpoint activation T-cell checkpoint inhibitor because once the T-cells are there we want to make certain that are not inhibited further by the inhibitory checkpoints in the tumor. So yes, I'd love to think further down the line we would look at combination therapy. The immune system never works on a single cell. There's never been I think the process works. So, it's be really nice to think that we could provide long-term benefit by combining these.

Great. Thank you.

Thank you. [Operator Instructions] The next question comes from Daniel Carlson from Tailwinds Research. Please proceed with your question, Daniel.

Hey guys. I'm just a couple of follow-up questions here regarding INKmune. And I just saw that Amgen pulled a drug from clinical trials yesterday in prostate and wrote down about $600 million. I was wondering if you could comment on, how that impacts, your thinking about your program at all if at all.

Yeah. I have a stab at that. I think you most as I said just now. I don't think T cells immediately are the answer in prostate cancer and the anti-T47, antibody you're talking about is a good example of that. And the checkpoint inhibitor somewhat the anti-CD3 combination of antibodies work, so I think we need to look at -- excuse me -- we need to look at activating cells are actually there. And so it just makes me more enthusiastic about the prospects where it need.

Great. And that's what I thought, thanks. Thanks mark. And then a question about them rep missed their top line yesterday as well. I know there is leader in DMD, is this something that you think might push them towards working with you guys or how do you see that items following [Indiscernible].

David?

You're asking me to guess what corrupt is going on. I can tell you; they're going through probably pipeline reorganization. I think that you recently had a steroid that was approved that supposed to be a slightly better steroid than the current standard of care. As I spoke about earlier we believe that XPro going down a completely different pathway than where steroids, than what steroids pathway provides significant benefit over a lot of the problems that we are that are associated with steroids. DMD is really an interesting space, because the Exon-Skipping drugs all have confirmation trials which are still ongoing there kind of along that been taken a long time while they keep these drugs on the market. It's going to be interesting to see what the FDA does with the fact that the confirmation trial for the Gene Therapy that Sarepta ran it failed. And there's some thought on the street that they keep the market keep the program on the market. I don't know what's going to happen. My guess is with what the FDA's done with regard to that program have been wrong. So I wouldn't hold any of that water. But the bottom-line is that we feel that there needs to be a new approach to DMD beyond Exon-Skipping, beyond steroids and beyond Gene Therapy. And we think that the DN-TNF is a really creative approach. We like it a lot.

Thanks. Thanks David. That's it for me guys. All my other questions were asked already. So thank you.

Thank you very much. Ladies and gentlemen, we have reached the end of the question-and-answer session. And I'd like to turn the call back to RJ, for closing remarks. Thank you, sir.

So thank you. INmune Bio has making progress on two-fronts. Each of our platforms have had a significant increase in shall we say profile and then last quarter. With XPro we hope to have a therapy that stops the progression of cognitive client in patients with ADI with Alzheimer's Disease, that's very different than what is offered patients today. With INKmune in Metastatic Castration-Resistant Prostate Cancer, we hope to control a disease that in many men can be quiet and indolent. But in many is lethal. We are confident in these ambitious goals. We thank you for your attention today and to those of you that are shareholders, we thank you for your continuing support. With that, have a good day.

Thank you. This concludes today's conference. You may disconnect your lines at this time. And thank you very much for your participation.