INmune Bio, Inc. (NASDAQ:INMB) Q3 2022 Results Conference Call November 2, 2022 4:30 PM ET
Company Participants
David Moss – Chief Financial Officer
Dr. RJ Tesi – Chief Executive Officer
Dr. CJ Barnum – Head of Neuroscience
Dr. Mark Lowdell – Chief Scientific Officer
Conference Call Participants
Tom Shrader – BTIG
Mayank Mamtani – B. Riley Securities
Daniel Carlson – Tailwinds Research
Operator
Greetings, and welcome to the INmune Bio Third Quarter 2022 Earnings Call. [Operator Instructions].
At this time, it is my pleasure to introduce Mr. David Moss, CFO of INmune Bio. David, thank you. The floor is now yours.
David Moss
Thank you, Donna, and good afternoon, everybody. We thank you for joining us for the call for INmune Bio’s Third Quarter 2022 Financial Results. With me on the call is Dr. RJ Tesi, CEO of INmune Bio; and Dr. CJ Barnum, Head of Neuroscience, who together will provide a business update on our dominant negative TNF platform, or DN-TNF for short. Also on the call is Dr. 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 facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor’s 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, 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, now I’d like to turn the call over to Dr. RJ Tesi, CEO of INmune Bio. RJ?
Dr. RJ Tesi
Thank you, David. And today’s call is organized a little bit differently. We have both Mark Lowdell and C.J. Barnum on the call. And I believe going forward, you will see this larger cast on the calls because — 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 expo 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 stated previously, the clinical hold was placed on XPro1595 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 AD02 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 XPro program is like a coiled spring. Once the clinical hold is lifted, we will work to have both AD02 and mild AD and AD03 in MCI or mild cognitive impairment, enrolling in all regulatory jurisdictions.
Soon after those 2 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. CJ Barnum, the VP of Neurosciences, to speak about the Alzheimer’s Phase II programs.
Dr. CJ Barnum
Thank you, RJ. As RJ mentioned, we continue to enroll patients in Australia for the AD02 study. AD02 is a blinded, randomized, placebo-controlled study evaluating cognition in patients treated with XPro for 6 months. We are pleased to announce that the first patient has completed the 6-month Phase II 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 received XPro.
The open-label extension has 3 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.
Finally, the open-label extension provides long-term efficacy data in the Phase I 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. 2 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 5 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 I 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 expo in Australia, and we have another means of collecting long-term safety information.
Now I’d like to pass the call back to R.J.
Dr. RJ Tesi
Thank you, CJ. I’ll now move to INKmune, our natural killer cell priming program. The MDS/AML program Phase I clinical trial program in the U.K. 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 suggest that INKmune 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 INKmune towards solid tumors meets an unmet medical need with great potential.
I’ll pass it to Dr. Mark Lowdell, the Chief Scientific Officer of INmune Bio to describe this in more detail. Mark?
Dr. Mark Lowdell
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 INKmune 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 focused on the 10% of cancers that are hematologic cancers or liquid tumors.
The recent data we’ve obtained build on data we’ve had for some years and provide insights into why the company believes that INKmune 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 TME with infiltrating immune cells and with the resident cancer cells drives tumor progression. And it’s still 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 with a TMEs hostile because of 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 immune overcomes that environment. So cell therapy has to overcome these impairments to see — to treat solid tumor successfully.
So we’ve shown that immune 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 INKmune primes the NK cells from patients and from healthy donors to lies 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 NK, which are normal NK cells from healthy donors or patients peripheral blood before treatment with immune, the immune prime cells demonstrated enhanced ability 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 19.
And a video of that presentation is available on the company’s website under the Therapies tab or the immune 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’s in the field is called a BLA. And all companies in the cell and gene therapy field are heavily science-driven and we are no different in this attempt to better understand the mechanism of action. Now we’re very lucky because INmune Bio, the work of immune is based upon data going back to the early 2000s, and we’ve been focused on the mechanism of action since our first publication in 2006. And our latest data from proteomics, genomics and metabolomics clearly explained how Immune works, and they delineate the differences between INKmune-primed NK cells and NK cells 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. So in parallel with increasing our knowledge about INKmune mechanism of action, we continue to treat patients and expand our clinical trial activity. 4 patients have received the complete 3-dose regimen so far with complete safety and obviously, in a Phase I trial setting, that’s our driving aim. 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 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 are post treatment and is enjoying much improved quality of life with only occasional hospital visits. The second patient was a young lady with acute mild leukemia, which had transformed from MDS, obviously, the targeted disease of the trial and with bone marrow failure.
In fact, she received 3 allogeneic stem cell transplants and (inaudible) marrow failure. So having been hospitalized for over 6 months due to her neutropenia, after in INKmune she stabilized her blood counts and had neutral recovery, such that she was allowed to discharge from hospital and get home in a month after we treated her. Clinically, she experienced reduced bone pain, which is an indication of a reduction in tumor load. And we’re scheduled for a fourth allogeneic cell transplant. But sadly, she relapsed unexpectedly and died quickly earlier this summer, 7 months after treatment with INmune.
The third patient treated has chemo-refractory oral low-dose chemotherapy, and het 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 immune 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 immune 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. Our chief investigator, who looks after the trial and has treated all 4 patients, said recently, “all enjoyed improvement in general fitness with resolution of fevers, stabilized or even improved blood counts and were able to give brakes from the low-dose chemotherapy they’ve been receiving.” Definite improvement in subjective parameters of well-being mood, appetite and indeed clinical performance status. So that encourage us greatly.
And furthermore, the trial has now been selected for presentation at the American Society of Hematology 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 3 compassionate cases to be enrolled in the trial in the future.
Moreover, the second U.K. trial site is scheduled for initiation on the 9th of November after an 18-month delay and a third U.K. 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 trials in solid tumor indication — the opening of new trials in solid tumor 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 mechanism of action, the manufacturing improvements in the clinical trial operations put the company in an excellent position for capitalization of the INKmune product in 2023. I’ll now pass the call back to RJ.
Dr. RJ Tesi
Thank you, Mark. As we passed — as we enter the last couple of months of the year, the company’s events calendars turns towards oncology. Many forget that we actually have an oncology program with Expo with the DN-TNF program, and in fact, our first Phase I clinical trial was in patients with advanced solid tumors. We will have presentations at 3 oncology meetings in the next 2 months. SITC, 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 5 weeks of the year.
Mark has already mentioned the ASH presentation. The SITC and San Antonio Breast Cancer Symposium presentations are on the use of DN-TNF to reduce resistance of immunotherapy in MUC4 expressing tumors. Particularly the San Antonio Breast Cancer Symposia 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, to be ending 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?
David Moss
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 30th, 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, 22 compared to $2.5 million for the comparable period in ’21.
As of September 30th, 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 2nd, 2022, the company had approximately 17.9 million shares of common stock outstanding, the same number we’ve had the last 2 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 lowered our anticipated budgeted costs of the trial overall. Further, we’ve — as we’ve been doing in the past, we’re eligible for rebates in Australia, which returned 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 it cause 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 6-month program remains tentatively expected in late ’23, but if the whole continues much longer, this date will slip into ’24. We’ll provide an update on time lines at the end of the year.
Upon pending resolution of the FDA inquiry, we remain on path to initiate the 3-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 XPro 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 I data of INmune and high-risk MDS/AML in the first half of ’23, along with the initiation of more sites in the U.K. and potentially Greece, as Mark Lowdell had mentioned earlier. Finally, we plan to launch a second INKmune study in a solid tumor indication, which we announced 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?
Question-and-Answer Session
Operator
[Operator Instructions]. Our first question today is going to be coming from Tom Shrader of BTIG.
Tom Shrader
I just have a 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 have any risk of having to stop enrolling in Australia?
Dr. RJ Tesi
Yes. Thanks. I’ll take this, CJ. No. I do not believe that will be a risk for really 2 reasons. The first is that we anticipate having other venues in place in the near future. But more importantly, remember, this is a Phase II trial. I do not — although remember after Biogen got out of lecanemab approved. I actually speculated that we might be able to get approval after a Phase II. I no longer believe that after all of the bruhaha over the anti-amyloid drugs. We will have to do a Phase III trial.
Hopefully, we only have to do one. It will be an international trial that includes 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.
Tom Shrader
And then I have a question, one of the surprises I thought in the lecanemab 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 end points. But do you think CDR sum of boxes should be a co-primary or because it seems to have worked very well in the only trial that’s really worked very well.
Dr. RJ Tesi
CJ?
Dr. CJ Barnum
Yes, 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 is 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.
Operator
The next question is coming from Mayank Mamtani of B. Riley Securities.
Mayank Mamtani
So just on the Australia Phase II study cohort, did you say how many patients you have enrolled there? And then as these A02 study data sets advanced, 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 unblind into? I’m just curious if you can give a…
Dr. RJ Tesi
So — yes, so let me clarify a couple of things. Remember, the Phase II portion of the trial is blinded, randomized. So there is no readout before all patients get 6 months. And what we’ve been promising is top line data by the end of 2023, that may slip if the FDA hold continues much longer. The open-label extension that CJ mentioned, what happens is patients who were on when they get unblinded are on XPro 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 XPro 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 that even has a different study number. CJ, I’ll let you comment on what information will be available for the patients who are in the open-label extension that we’ll be talking about.
Dr. CJ Barnum
Thanks, RJ. So Mayank, 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 blood and that sort of thing. It will be — 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 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 I study. Part of what we’ll want to see, assuming that the open-label extension data is available before close of the Phase II blinded study is that the biomarkers are performing the same way?
Are we continuing to see an improvement and the metrics that are important to us and white matter in particular and some of these other things that we’re looking at. We’ve got 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 what it’s going to get interesting is in the patients that come into the study from being on XPro versus those that come in from not being on XPro 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 that will all get put into the bucket. So it’s 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 to — before we can get approval. Does that answer your question?
Mayank Mamtani
Yes. Did you say how many are now in the study? I missed that.
Dr. CJ Barnum
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.
Mayank Mamtani
Got it. And then just quickly, process question on manufacturing hold, what kind of regulation does this fall under with the agency? Just trying to understand the turnaround times now that you submitted the procedure query. And how do these discussions are they waiting and also oral? And if you’re able to comment on the shelf life of the volume of doses that you had in hand earlier in the year as you were getting on that for the program.
Dr. CJ Barnum
Yes. So 2 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 we’re almost there, I hope. There is 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 we’re — 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 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 tracked by it.
Mayank Mamtani
Understood. And I’m sure you will get through that. And then just quickly for Dr. Lowdell. On the open label high-risk MDS/AML update that you look to have in 2023. And I think this — what I heard from you were about 3 patients data you presented ASH. Like what — I guess, you want to see in first half of 2023 to make that determination 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?
Dr. Mark Lowdell
Yes. I think we have to remember this is a Phase I 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 MDS 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 pay out rollout 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 the IND submitted to the FDA in January. And the data we’ve obtained already from our 4 patients treated 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 4 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 ready for Christmas. But will delay it because people were dropping on the FDA’s desk in January, Christmas in my past experience isn’t good news. So we will turn around IND submission in really quite a record time with the aim to enroll our first patients in the first solid tumor trial in the U.S. and have our first inn 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 we will – as you’ve implied, we will be following up the MDS patients as we enroll them and increasingly using those data. I have to say, from a trial list perspective, on 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 being enrolled in the trial, we wouldn’t have been able to present the American site 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 yes, I hope that answered your question.
Operator
[Operator Instructions]. The next question is coming from Daniel Carlson of Tailwinds Research.
Daniel Carlson
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 expect 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?
Dr. CJ Barnum
Thanks, Dan. 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 is there’s 2 reasons. One is, it really does reinforce what we believe the drug is going to do to have the few patients that really were in the Phase I 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 quite a that’s a pretty big expense for 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 we can share those. We haven’t really discussed that in detail. But I would say the longer the patients remain on the drug, the — I think it’s safe to assume that they’re seeing some benefit from it. And again, we get — 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?
Dr. RJ Tesi
Yes, I’d just like to add, that’s an interesting question, Dan. And remember, with my clinical background, I look at this from 2 sides here. But what I find intriguing that I haven’t seen in like oncology or even transplant trials, the clinical teams are very adamant that the patients not be taken off drug. Their 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 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 been 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.
Daniel Carlson
Got you. And then also just with regard to the FDA, I’m curious with the trial running in Australia and you having patients on drugs for over 6 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?
Dr. RJ Tesi
Well, as you can imagine, we’ve told them about these patients. And I think they listen. I think it will take us getting more — getting enough patients long enough in beating them over the head with it if it comes to that, we hope to have solve these technical problems well before that. But they’re not — I don’t think they’re completely tone death. You could argue, for instance that the Amylyx approval in ALS or the second ADCOM was really a result of the fact that they — 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.
Dr. CJ Barnum
Can I comment on this real quick, RJ?
Dr. RJ Tesi
Yes, please do.
Dr. CJ Barnum
So Dan, I think the real issue is, remember, this is a blinded study. So any data we bring that, we would need to break the blind to sharing you 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’re — we’ve got other avenues to take that can deal with the issue.
Daniel Carlson
Yes, that makes sense. And then one last question. I’m just wondering the solid tumor, what is the target cancer going to be for those?
Dr. Mark Lowdell
I’d like to be able to tell you that, but we’re going to say 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 run the — want to work on the trial with us. So one 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.
Dr. RJ Tesi
Yes. We’re not trying to be evasive here, Dan. It’s just that we are sensitive to making sure that when we give — make promises, they are very accurate. So 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 then progressive news, so to speak.
Daniel Carlson
That’s fine. And it’s good to hear that your partners are excited about it, and hopefully, enrolment will be a lot faster in the U.S. appreciate the good work.
Operator
Thank you. At this time, I’d like to turn the floor back over to Dr. Tesi for closing comments.
Dr. RJ Tesi
So I think this new format where we have — you’ve literally got 1/3 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 got to win 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, I appreciate your participation. INmune 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.
Operator
Ladies and gentlemen, thank you for your participation. This concludes today’s event. You may disconnect your lines and walk-off the webcast at this time, and enjoy the rest of your day.
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