This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk00: Greetings and welcome to the ImmuneBio third quarter 2022 earnings call. At this time, all participants have been placed on a listen-only mode. A question and answer session will follow the formal presentation. If you would like to have an opportunity to ask questions during today's event, please press star 1 on your telephone keypad. If anyone should require operator assistance, please press star 0 on your telephone keypad. 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 ImmuneBio. David, thank you. The floor is now yours.
spk01: Thank you, Donna, and good afternoon, everybody. We thank you for joining us for the call for ImmuneBio's third quarter 2022 financial results. With me on the call is Dr. RJ Tessie, CEO of ImmuneBio, and Dr. CJ Barnum, head of neuroscience. who together will provide a business update on our dominant negative TNF platform, or DNTNF for short. Also on the call is Dr. Mark Liddell, Chief Scientific Officer of Immune Bio, who will provide an update on IncMune, our memory-like natural killer cell oncology platform. 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 Harbors Provision 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 disclaimers on the company's earnings press release as well as risk factors in the company's SEC filings, including our most recent quarterly 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 law, ImmuneBio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. With the forward-looking statements behind us, now I'd like to turn the call over to Dr. RJ Tessie, CEO of ImmuneBio. RJ.
spk06: Yes, thank you, David. And today's call is organized a little bit differently. We have both Mark Liddell and CJ Barnum on the call, and I believe going forward, you will see this larger cast on the calls because, you know, we are a complicated company with a lot of programs going on. And we believe that investors learn the most when they hear directly from the people that are responsible for those programs. So I will begin with ExPro with some just top line comments. And obviously the most important issue is the clinical hold. that we are under from the FDA. As we have stated previously, the clinical hold was placed on Expo 1595 due to manufacturing issues. These issues are technical in nature, and they are related to the fact that manufacturing batches were separated by many years and by geography, i.e., different manufacturing plants, and this has caused some problems related to the manufacturing controls and release testing. We have been working very closely with the FDA and our manufacturing teams to resolve these problems, and we continue to look forward to clearing these hurdles. Despite this delay, we continue to make progress with the ADO2 trial in mild Alzheimer's disease patients in Australia. and we are exploring other regulatory venues that we will hopefully be able to open the trial and continue to enroll patients or begin to enroll patients. The EXPRO program is like a coiled spring. Once the clinical hold is lifted, we will work to have both ADO2 in mild AD and ADO3 in MCI, or mild cognitive impairment, enrolling in all regulatory jurisdictions. Soon after those two programs are enrolling, we plan to launch the treatment resistant depression program in the U.S. Importantly, we will update guidance on the timing of top line readouts in the Alzheimer's trials at the end of the year. Obviously, the timing of those readouts depends on our discussions with the FDA. I will now pass it back to Dr. C.J. Barnum, the VP of Neurosciences, to speak about the Alzheimer Phase II programs.
spk05: Thank you, RJ. As RJ mentioned, we continue to enroll patients in Australia for the ADO2 study. ADO2 is a blinded, randomized, placebo-controlled study evaluating cognition in patients treated with XPRO for six months. We are pleased to announce that the first patient has completed the six-month phase two study. Notably, this patient has elected to enroll in our open-label extension study. This open-label extension is a 12-month study where safety and efficacy are evaluated in an unblinded fashion. All patients that enroll in the open-label extension study receive XPRO. The Open Label Extension has three purposes. First, it is a recruiting tool. Patients are offered a year of therapy after participation in the trial. Second, this helps in our product approval strategy. The FDA and other regulatory authorities focus on both efficacy and safety. The Open Label Extension provides the expanded and extended safety database required for approval. the Open Label Extension provides long-term efficacy data. In the phase one trial, MRI biomarkers showed continuous improvement through 12 months. While the data from the Open Label Extension are not placebo controlled nor blinded, they do provide additional information that will inform the clinical development strategy. We expect to report data from the Open Label Extension in 2023. Finally, We remain as confident as ever that we have the right drug for the right target. Two recent developments reinforce this belief. The first comes from the literature that continues to provide evidence for targeting TNF. Yet another nationwide study has reported that TNF inhibitors reduce the risk of dementia. There are now five epidemiological studies examining more than 60 million records that show anti-TNF therapies reduce the risk of AD and or dementia by up to 75%. The second comes from patients treated in the Phase 1 study. We have been extremely encouraged by their desire to remain on therapy. As a result of their persistence, we have opened a special access program in Australia, like Compassionate Use in the United States. As a result, Patients now have another avenue to get access to EXPRO in Australia, and we have another means of collecting long-term safety information. Now, I'd like to pass the call back to RJ.
spk06: Thank you, CJ. I'll now move to IncMUNE, our natural killer cell priming program. The MDS-AML program, phase one clinical trial program in the UK, continues to progress. The oncology landscape for cell therapies is mainly focused on liquid tumors. This is only 10% of cancers. We have generated compelling human preclinical data in solid tumors that suggests that IncMUNE may be an ideal therapy for the treatment of solid tumors. That is 90% of cancers are solid tumors. Historically, or even not even historically, currently, This group of cancers is not well served by cell therapies. We believe refocusing ink urine towards solid tumors meets an unmet medical need with great potential. I'll pass it to Dr. Mark Liddell, the Chief Scientific Officer of Immune Bio, to describe this in more detail. Mark?
spk08: Thank you, RJ, and thank you, everyone, for joining today's call. So, a couple of weeks ago, we shared with the investment community our recent positive efficacy data in multiple solid tumor cancer cell lines with ink immune, as RJ just alluded to. And as we highlighted in our recent press release on the topic, solid tumors, as RJ just said, are the majority of human cancers, and licensed cell therapies currently only focus on the 10% of cancers that are haematologic cancers or liquid tumors. The recent data we've obtained builds on data we've had for some years and provide insights into why the company believes that IncMune arms natural killer cells or NK cells to override the immunosuppressive nature and hypoxia and regulatory cells within the active tumor microenvironment or what the field calls the TME for short. So the interaction of the TMA with infiltrating immune cells and with the resident cancer cells, drives tumor progression. And it's thought to be the reason why most or many, maybe all, cell therapies are ineffective in that setting at the moment. So these complex interactions have to be considered when designing cell therapies to treat solid tumors where the TME is hostile because, one, the presence of immunosuppressive regulatory cells, and two, the low levels of oxygen. That's what we call hypoxia. And so we've been doing a lot of our experiments in the hypoxic setting in vitro to see how IncMune overcomes that environment. So cell therapy has to overcome these impairments to treat solid tumors successfully. So we've shown that IncMune converts patients' normal resting NK cells into what are called memory-like NK cells, and that these target solid tumors even in the presence of immunosuppressive immunoregulatory cells, and extreme hypoxia that, as I've said, we see in the TME. And the company's preclinical data with human NK cells targeting cancer cells shows that IncMune primes the NK cells from patients and from healthy donors to lyse NK-resistant solid tumors from ovarian cancer, breast cancer, prostate cancer, renal cell carcinoma, and most recently, nasopharyngeal cancer cells. So when comparing resting NK cells or RNK which are normal NK cells from healthy donors or patients' peripheral blood before treatment with IncMune, the IncMune prime cells demonstrated enhanceability to kill all of these resistant tumor cell lines. So I was fortunate enough to be invited to present these data at a recent conference, the Innate Killer Summit in Europe on October the 19th. And a video of that presentation is available on the company's website under the therapies tab. or the InCNN videos or the company's YouTube channel. But in the field of cell and gene therapies, it's becoming increasingly apparent that regulatory agencies, such as the FDA, require extensive understanding of the mechanism of action of these type of novel drugs before they'll consider licensing them for commercial supply, so getting what in the field is called a BLA. And all companies in the cell and gene therapy field are heavily science-driven, and we're no different. in this attempt to better understand the mechanism of action. Now, we're very lucky because the work of IncMune is based upon data going back to the early 2000s, and we've been focused on the mechanism of action since our first publications in 2006. And our latest data from proteomics, genomics, and metabolomics clearly explain how IncMune works, and they delineate the differences between IncMune-primed NK cells and in case those prime with cytokines used by our competitors. The recent video presentation explains some of these very complex data, and I encourage you, if you're interested, to go and watch them. In parallel with increasing our knowledge about immune mechanism action, we continue to treat patients and expand our clinical trial activity. Four patients have received the complete three-dose regimen so far with complete safety, and obviously in a phase one trial setting, that's our driving aid. Indeed, the most recent patient was treated on an outpatient basis, which is our planned treatment scenario. And of course, it's a world away from the days of hospitalization associated with current adoptive cell therapies. As I've said, all patients treated so far have shown evidence of NK cell activation in vivo. And we're analyzing the biomarker data to identify those which best predict clinical outcome. The first MDS patient treatment remains well, 15 months post-treatment. and is enjoying much improved quality of life with only occasional hospital visits. The second patient was a young lady with acute myeloid leukemia, which had transformed from MDS, obviously the target disease at the trial, and with bone marrow failure. In fact, she'd received three allogeneic stem cell transplants, and was now in marrow failure. So having been hospitalized for over six months due to her neutropenia, after Incommune, she stabilized her blood counts, and had neutral recovery such that she was allowed to discharge from hospital and get home a month after we treated her. Clinically, she experienced reduced bone pain, which is an indication of reduction in tumour load, and was scheduled for a fourth allogeneic stem cell transplant. But sadly, she relapsed unexpectedly and died quickly earlier this summer, seven months after her treatment with IncMu. The third patient treated has chemorefractory AML after two failed stem cell transplants. So like our second patient, this is a very, very severe, the unwell patient. Post-Inkmoan, his disease stabilized for four months before relapsing with a new leukemic clone of his acute myeloid leukemia. However, his disease is currently controlled with low-dose chemotherapy, and he too is awaiting a third transplant at the moment. Our most recent patient is a young 17-year-old MDS patient, another one who relapsed with acute myeloid leukemia back in 2020 after an unrelated transplant. And again, she relapsed after a second unrelated transplant in 2022. I can't emphasize enough how severely ill these patients are. After further chemotherapy, she achieved remission and was treated compassionately with IncMune as consolidation therapy in July this year. She showed evidence of improved NK cell function, and she remains well with very low-level detectable disease in her bone marrow and awaiting further treatment. So whilst we're very early in the development of INKBUNE and being restricted at the moment to using the lowest dose of the drug, so all of these patients have received the lowest dose of 10 to the 8 cells, the trial chief investigator who looks after the trial and has treated all four patients said recently, quote, all enjoyed an improvement in general fitness with resolution of fevers, stabilized or even improved blood counts, and were able to give breaks from the low-dose chemotherapy they'd been receiving. Definite improvement in subjective parameters of well-being, mood, appetite, and indeed clinical performance status. So that encourages greatly. And furthermore, the trial has now been selected for presentation at the American Society of Haematology annual conference in New Orleans in a few weeks' time. in December. Finally, we've received approval to widen the trial inclusion criteria to allow patients like the three compassionate cases to be enrolled in the trial in the future. Moreover, the second UK trial site is scheduled for initiation on the 9th of November after an 18-month delay, and a third UK trial site is in discussion at present, and I'm doing a presentation there this Friday. The company has also submitted an application to the Greek Medicines Agency to open the trial with colleagues of mine in Athens to speed up recruitment further. In preparation for the increased recruitment into the Laurel trial in MDS and the ongoing opening of new trials in solid tumour indications, the company has invested in upscaling the manufacturing process, and the validation of that new process to CGMP is now complete, and we're ready for the next manufacturing runs before the end of the year. The combination of the basic research into the methods of action, the manufacturing improvements, and the clinical trial operations put the company in an excellent position for capitalization of the Incneum product in 2023. I'll now pass the call back to RJ.
spk06: Thank you, Mark. As we enter the last couple months of the year, the company's events calendar turns towards oncology. Many forget that we actually have an oncology program with Expo with the DNTNF program. And in fact, our first phase one clinical trial was in patients with advanced solid tumors. We will have presentations at three oncology meetings in the next two months. CITC, which is the Society for Immunotherapy of Cancer, ASH, American Society of Hematology, and the San Antonio Breast Cancer Symposium. All occur in the last five weeks of the year. Mark has already mentioned the ASH presentation. The CITC and San Antonio Breast Cancer Symposium presentations are on the use of DNTNF to reduce resistance of immunotherapy in MUC4-expressing tumors. Particularly, the San Antonio Breast Cancer Symposium data will include combination therapy with an ADC and HER2-positive breast cancer. Her2-positive breast cancer has been in the news a lot. It is a large market that has doubled in size recently, but still more than half of the patients develop resistant disease even after therapy with the very best medicines available today. More details on each of these presentations will be provided as we get closer to each event. We will also, as you might expect, be attending CTAD, which is clinical trials in Alzheimer's disease, at the end of the month. At this point, I'd like to turn the call over to David Moss, our CFO, to review certain financial items. David.
spk01: Thank you, RJ. I'll provide a brief overview of our financial results and upcoming milestones before we head to our Q&A session. Net loss attributable to common stockholders for the quarter ended September 30, 2022, was approximately $7.7 million, compared with approximately $9.5 million for the comparable period in 2021. Research and development expense totaled approximately $5.2 million for the quarter ended September 30, 2022, compared with approximately $6.5 million for the comparable period in 21. General and administrative expense was approximately $2.4 million for the quarter ended September 30, 2022, compared to $2.5 million for the comparable period in 2021. As of September 30, 2022, the company had cash and cash equivalents of approximately $57.4 million. Based on our current operating plan, we believe we have cash sufficient to fund our operations through 2023. As of November 2, 2022, The company had approximately 17.9 million shares of common stock outstanding, the same number we've had the last two quarters. I'd like to further point out that because our burn has been less than budgeted because of the delays in starting the trials in the U.S., further, because of the increased activity in Australia and the rise of the U.S. dollar or, alternatively, the fall of the Australian dollar, this has helped lower our anticipated budgeted costs of the trial overall. Further, as we've been doing in the past, we're eligible for rebates in Australia, which return cash that we reinvest into our clinical programs. Together, these developments help us manage our runway more efficiently. Now I'd like to move on and list our upcoming milestones. Although our Phase II Expo trial for treatment of neuroinflammation as a cause of Alzheimer's disease is currently on hold pending the FDA manufacturing review, We expect to continue enrolling patients over the coming months with attention to Australia in order to reach the enrollment target of 201. Top line results for the six-month program remains tentatively expected in late 23, but if the hold continues much longer, this date will slip into 24. We'll provide an update on timelines at the end of the year. Upon pending resolution of the FDA inquiry, we remain on path to initiate the three-month 90 patient phase II program for mild cognitive impairment. Bearing any unexpected delays, we anticipate having top-right results late 23, and again, if the FDA hold continues, this will slip into 24. Additionally, it remains our plan to initiate phase II trials of EXPRO in patients with treatment-resistant depression. That's partially funded by a $2.9 million NIH grant upon resolution of the FDA manufacturing review. Additional open-label Phase 1 data of INCMUNE and high-risk MDS-ML in the first half of 2023, along with the initiation of more sites in the UK and potentially Greece, as Mark Liddell had mentioned earlier. Finally, we plan to launch a second INCMUNE study in a solid tumor indication, which we'll announce upon approval with the FDA. We expect this to occur in the first half of 2023. At this point, I'd like to thank you for your time and attention. I'd like to turn it back to the operator to poll for questions. Donna?
spk00: Thank you. Ladies and gentlemen, the floor is now open for questions. If you would like to register a question, please press star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that is star one to register a question at this time. One moment, please, while we poll for questions. Thank you. Our first question today is going to be coming from Tom Schrader of BTIG. Please go ahead.
spk04: Good afternoon. It must be frustrating to hold. I just have a question. Question, at some point, do you have to worry you have too many patients from Australia? Could you, and presumably you want some fraction of U.S. patients. Are you at any risk of having to stop enrolling in Australia?
spk06: Yeah, thanks. I'll take this, CJ. No, I do not believe that will be a risk for really two reasons. The first is that we anticipate having other venues in place. in the near future. But more importantly, remember, this is a phase two trial. I do not, although, remember after Biogen got Aducanumab approved, I actually speculated that we might be able to get approval after a phase two. I no longer believe that after all of the brouhaha over the anti-amyloid drugs. We will have to do a phase three trial. Hopefully we only have to do one. It will be an international trial that include both Europe and the United States and undoubtedly Japan. So that's a reasonable question, but I do not worry at all. I think just as an aside, one of the things that the FDA is focused on is increasing the diversity in clinical trials. And that's an issue that we are focused on. And obviously, the best place to get diversity is in the United States. not in Australia.
spk04: And then I have a question. One of the surprises I thought in the Lecanumab readout is how good the CDR sum of boxes did after so many people have talked about alternate endpoints. Does that change your thinking at all? You're one of the companies most focused on better endpoints, but do you think CDR sum of boxes should be a co-primary because it seems to have worked very well and the only trial that's really worked very well?
spk05: CJ? Yeah, I can take this. Thanks, Tom. So you may recall the CDR is a secondary endpoint, and we actually powered the study to see an effect on the CDR. So to your point, we're not going to try to reinvent the wheel if we don't have to. We think there are better cognitive endpoints for this group, but the combination of cognitive and functional The CDR still performs fairly well, and it does perform fairly well. So I think the jury's still out. The Phase II study, as RJ mentioned, is not a registration study, and we have enough patients. Again, it's powered towards that to know exactly how to do the Phase III study. So I think we're in a really good position. Okay. Thanks.
spk00: Thank you. The next question is coming from Mayanka Mamtani of B. Reilly Securities. Please go ahead.
spk02: Uh, good afternoon team. Thanks for taking our questions. So just on the Australia phase two study cohort, did you say how many patients you have enrolled there? And, um, and then, uh, as, as these, uh, AD02 study data sets, um, you know, advanced, like what, what components of the data, I know you're looking at a number of biomarkers and safety parameters. As you get into the open label section, what parameters do you get unblinded to? I'm just curious if you can give us information.
spk06: Yeah, so let me clarify a couple of things. Remember, the phase two portion of the trial is blinded randomized, right? So there is no readout before all patients get six months. And what we've been promising is top line data, know by the end of 2023 that may slip if the fda hold continues much longer the the open label extension that cj mentioned what happens is patients who were on when they get unblinded are on expo continue if they want to for up to 18 months and patients who are on placebo actually i guess the technical term might be get crossed over to Expo if they want to for up to 12 months of therapy. And in those patients, that's the open label portion. But it's a totally different clinical trial. It even has a different study number. CJ, I'll let you comment on what kind of information will be available for the patients who are in the open label extension that we'll be talking about.
spk05: Thanks, RJ. So, Mike, I think the thing to point out is that the endpoints are similar in terms of the clinical and the biomarkers will be doing MRI collecting bloods and that sort of thing. It'll be, you know, how are we going to look at the data? I think the most important thing as it relates to clinical data, I am not a big fan of open label. Cognitive data, it doesn't really tell me anything if patients know they're on the drug. We absolutely know that there is a placebo effect. So that's of limited value in my opinion. But the biomarker data will be interesting. We know what it looks like in the phase one study. Part of what we'll want to see, assuming that the open label extension data is available before close of the phase two blinded study, is that the biomarkers are performing the same way. Are we continuing to see an improvement in the metrics that are important to us in white matter in particular and some of these other things that we're looking at? We've got a more homogenous group here, and I think that's really going to help us. And the expectation is that we'll see a difference. I think where it's going to get interesting is in the patients that come into the study from being on ExPro versus those that come in from not being on ExPro. to see if there's a difference in their trajectory. I don't know what the answer is. And, of course, we're not going to know by the time they enroll in the study whether or not they have been on active drug or placebo. But that data will be of value, as I mentioned, as it relates to clinical development and how we think about it moving forward in terms of duration and number of patients. It will all get put into the bucket. primarily it's not, I'm talking about efficacy, but it really is about safety and to build up that database of safety and long-term safety that we will absolutely need before we can get approval. Does that answer your question?
spk02: Yes. Thank you for all that detail. Did you say how many are now in the study? Did I miss that?
spk05: So we have said that we are going to update enrollment numbers at the halfway mark, and we're still planning to do that. So stay tuned.
spk02: Got it. And then just quickly a process question on manufacturing hold. What sort of kind of regulation does this fall under with the agency? Just trying to understand, you know, the turnaround times now that you submitted the process. the procedure query and how do these discussions, are they written and also oral?
spk06: Yeah.
spk02: And if you're able to comment on the shelf life of, you know, the volume of doses that you had in hand, you know, earlier in the year as you were getting rammed up for the program.
spk06: Yeah, so two things. First of all, these, the communication is very inefficient. It is, it goes on somewhere about a 60 day, 45 to 60 day turnaround, and that's just the nature of the beast. We have been campaigning very hard to get a face-to-face or a video conference with them because we believe that will be a more efficient process. We think we're almost there, I hope. There's no concern about running out of drug or drug going out of date. Not only is the current drug still well within date, but we have We actually manufactured a subsequent batch as part of the original campaign that has additional dating. So there's no concern that we're going to run out of drug. There is just this continued frustration over a couple of these assays that... you know, didn't exist. The first go-around when the drug was manufactured in the past and is now causing us some conversations with the FDA. As David always says, we will get through this. This is not a safety issue. This is a manufacturing technical issue. It's just an inefficient process that the FDA has in place, and we're trapped by it.
spk02: I understood that, and I'm sure you will get through that. And then just quickly for Dr. Odell, on the open-label high-risk MDS AML sort of update that you look to have, you know, in 2023, and I think what I heard from you were about three patients' data, you know, you presented, Ash, like what, I guess, you know, you want to see in first half of 2023, to sort of make that determination, you know, of the right patient population you want to be helpful here. And can you just give color on what we may learn in that first half 2023 readout?
spk08: Yes, I think we have to remember this is a phase one trial in cancer, where from a regulatory perspective, we are expected to design a trial to show safety or to test safety, not to test efficacy. So this is one of the big balancing acts that all biotech companies have. How do you choose your patient population? So as we've always said, and we continue to believe, we will use this trial, the MGS trial, to get safety data and to build on our biomarker data to try to identify which changes we see in patients are associated with any clinical benefit we find. And that's going to roll out throughout the trial recruitment. And as I said, we're putting in place ways to speed up trial recruitment. But what we're In parallel, focusing on, we had a very, very constructive dialogue with the FDA over our move towards solid tumor. And that's allowing us to put together the IND for the solid tumor work. So we will have that IND submitted to the FDA in January. And the data we've obtained already from our four patients treated in the Laurel trial make that possible. So we could never have gone to the FDA for a trial in a solid tumor without those data. So they've already paid off in just four patients. Obviously, we intend to get more out of it with time. But our time schedule for the solid tumor pivot is to have the IND filed as soon as January. In fact, we would have it in ready for Christmas, but we'll delay it because paperwork dropping on the FDA's desk in the run-up to Christmas, in my past experience, isn't good news. So we will turn around an IND submission in really quite record time with the aim to enroll our first patients in the first solid tumor trial in the U.S. and have our first ink immune trial in the U.S. by the end of Q2 or very early in Q3 next year. And that's what excites me enormously at the moment. But as you've applied, we will be following up the MDS patients as we enroll them and increasingly using those data. I have to say, you know, from a trialist perspective and a drug development perspective, I'm very disappointed that we haven't enrolled more patients in the MDS trial. On the plus side, had the patients all been enrolled in the trial, we wouldn't have been able to present them at the American Society of Hematology because you're not allowed to present in-trial data at that conference. So the fact that we've got compassionate use patients to present does give us the opportunity to share those data with hematologists around the world in December. So, yeah, I hope that answered your question.
spk02: Yeah, and look forward to seeing you at C&Rs in the coming weeks. Thanks for taking our question.
spk00: Thank you. Once again, that's star one to register any questions at this time. The next question is coming from Daniel Carlson of Tailwinds Research. Please go ahead.
spk03: Hey, guys. Thanks for taking my questions. This is for CJ. Just regarding the special access scheme, it sounds like things are being well-received in Australia in terms of the patients there. And I'm wondering what you would – to get out of this in terms of data? Can you give us any feedback on how the patients have done since being off drug? And where do you expect to go with this?
spk05: Thanks, Stan. I think you cut out a little bit, but I think I got the gist of it. So I think the reason we bring up this is there's two reasons. One is it It really does reinforce what we believe the drug is going to do to have the few patients that really were in the phase one study that received what we consider an efficacious dose. For all intents and purposes, demand continued access to the drug I think speaks very well. As it relates to what we can get out of it, there's not much we can without putting together a full clinical protocol and going through all the regulatory hurdles. And that's a pretty big expense for sort of anecdotal data. But what we can get is we do get information from the clinician as it relates to safety. And we do get a commentary here and there. Now, whether or not that, you know, we can share those, you know, we haven't really discussed that in detail. But I would say the longer the patients remain on the drug I think it's safe to assume that they're seeing some benefit from it. And again, we have the ability to build our safety database and provide access to patients that maybe don't fit in one of our current trials. So these are things that we're looking at. And I think I'll point to the same thing, which is that we're on the right track here. RJ?
spk06: Yeah, I'd just like to add, that's an interesting question, Dan. And remember, with my clinical background, I kind of look at this from two sides here. But what I find intriguing that I haven't seen in like oncology or even transplant trials is the clinical teams are very adamant that the patients not be taken off drug. Their kind of position is, look, if the patient is doing well, I don't care that it's the end of your clinical trial. I don't want to have to take the patient off the drug. So you figure out how to make this happen. And you know, we're fine with that. At the end of the day, it's all about treating patients. And if the patients and the clinical teams think they're getting a benefit, we're thrilled. And CJ has put in all the mechanisms or is in the process of putting in the mechanisms So patients aren't removed from the product if they seem to be having a benefit. Gotcha.
spk03: And then also just with regards to the FDA, I'm curious with the trial running in Australia and you having patients on drugs for over six months now, does that factor into their thinking where it's easy for them to say no, but not if it's working elsewhere in terms of the safety, right?
spk06: Well, as you can imagine, we've told them about these patients, and I think they listen. I think it will take, you know, us getting enough patients long enough and beating them over the head with it if it comes to that. We hope to have solved these technical problems well before that. But, you know, I don't think they're completely tone deaf. I mean, you could argue, for instance, that the Amilex approval in ALS or the second ADCOM was really a result of the fact that the drug got approved in Canada. So I think the FDA is not completely tone deaf, but they have their ways and they change them carefully.
spk05: Can I comment on this real quick, RJ?
spk06: Yeah, please do.
spk05: Okay. So, Dan, I think the real issue is, remember, this is a blinded study. So, any data we bring them, we would need to break the blind to share any of that safety data. And I'm not sure how to do that without causing a big problem with the trial. As RJ said, I think we've got other avenues to take that can deal with the issue.
spk03: Yeah, that makes sense. And then one last question. I'm just wondering, the solid tumor, what is the target cancer going to be for this?
spk08: I'd like to be able to tell you that, but we're going to save that until we've filed our IND. It's a tumor that's a big issue globally and certainly has a very large unmet need in the United States. which is why we've got such a large number of clinicians in the States who want to work on the trial with us. So it's another reason why I'm so excited, because it's our first opportunity to work in a large patient population with a very significant unmet need.
spk06: Yeah, and we're not trying to be evasive here, Dan. It's just that You know, we are sensitive to making sure that when we make promises, they are very accurate. So, you know, we're being a little more cautious than we have in the past about providing news. And I'd rather in some ways provide stale news than, you know, progressive news, so to speak.
spk03: Yeah, that's fine. And it's good to hear that your partners are excited about it, and hopefully enrollment will be a lot faster in the U.S. So thanks, guys, for taking my questions. Appreciate the good work.
spk00: Thank you. At this time, I'd like to turn the floor back over to Dr. Tessie for closing comments.
spk06: So I think this new format where we have, you know, you've literally got a third of the company here speaking on the phone, but what we've brought to the quarterly call is really the real expertise in the company within each individual therapeutic silo and function. I thought it went well. Please let us know if you think it did not go well or is not appropriate. But I think this is going to be more of our standard for the future. So anyway, we appreciate your participation. Immune Bio is a complicated company. We have many promising programs. They are both biologically innovative and interesting. Despite the frustrations with the FDA, we are making progress in both CNS and oncology, and I can promise you that we will continue to move forward, and we will and are making a difference in patients' lives. So with that, thank you very much, and have a nice evening.
spk00: Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines or log off the webcast at this time and enjoy the rest of your day.
Disclaimer