INmune Bio Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 9, 2024

There are 8 speakers on the call.

Operator

Greetings, and welcome to the Immune Bio First Quarter 20 24 Earnings Call. At the end of the presentation, there will be a question and answer session. 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.

Operator

David Moss, CFO of Immune Bio. David?

Speaker 1

Thank you, James, and good afternoon, everybody. We thank you for joining us for the call for Immune Bio's Q1 2024 financial results. With me on the call is Doctor. R. J.

Speaker 1

Tessy, CEO and Co Founder of Immune Bio and Doctor. Mark Liddell, Chief Scientific Officer and Co Founder of Immune Bio, who provide an update on Inpune, our memory, life, 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 provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward looking statements. Please see the forward looking statements disclaimer on the company's earnings release as well as risk factors in the company's SEC filings, including our most recent quarterly filings with the SEC.

Speaker 1

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, Immune 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 Doctor. R.

Speaker 1

J. Tessie, CEO of Inuvial. R. J?

Speaker 2

Thank you, David, and I thank everyone for joining the call. As usual, I will arrange my remarks to highlight the key takeaways from the Q1 and the subsequent period and provide updates on our platform programs. I will start by reviewing developments in the Xpro platform and then pass it over to Mark O'Gell, who will update the Incoming program. David will conclude with a discussion of our financial results, including some commentary around the recent equity capital infusions and provide an update on upcoming milestones. At a high level, steady progress on all fronts has continued over the last 6 weeks since we held our Q4 conference call in March.

Speaker 2

We continue to enroll patients globally in our early Phase 2 trial in Alzheimer's disease called ABO2 and we expect to meet our target enrollment by mid-twenty 24. Clinical trial sites continue to enroll patients at a good clip and we reiterate our commitment to complete enrollment mid year. I know you want to know the exact date of our last patient enrollment, but we will not predict this because of the vagaries of predicting exact enrollment rates and pace. I promise you that as soon as we enroll that last patient, we will let everyone know. Like you, we eagerly await the conclusion of the Phase 2 and the corresponding data readout that will occur about 6 weeks or 6 months or so after that last patient is enrolled.

Speaker 2

Recently, we provided an update on the long term use of X PRO in patients with Alzheimer's disease. And in that press release a week ago, we described 2 patients who participated in the Australian Phase 1 trial, one with MCI and the other with mild actually moderate Alzheimer's disease. Both have been taking EXPAREL for roughly 3 years. Due to the rules of clinical development in Australia, we cannot communicate directly with the patients. But there are but the anecdotes that we see from their treating physicians highlighted the positive impact of EXPAREL on their the patient's cognitive health and overall quality of life.

Speaker 2

If you haven't viewed the video links associated with that press release, I strongly encourage you to do so as they exemplify what we are trying to achieve with EXPAREL in patients suffering with early AD. Obviously, this is a small sample, but the results speak for themselves. Long term treatment with EXPAREL in patients with Alzheimer's disease been shown to be safe, well tolerated and made a difference in the lives of these patients and their caregivers. The ongoing blinded randomized placebo controlled trials are a necessary step in the development process and we believe we are helping these patients, their families and their caregivers who live with this dreadful disease every day. We want to help you better understand 3 important elements of our ongoing Phase 2 trial.

Speaker 2

The elements are duration, size and primary endpoint. I'll start with the endpoint primary endpoints. The clinical trial is powered on the cognitive scale called CDR. CDR is a validated endpoint that has been used in the recent Phase 3 anti amyloid trials that will all result in approval of those drugs. The endpoint is acceptable to regular authorities, certainly in the U.

Speaker 2

S. And we suspect globally. In the Phase in our Phase 1 trial, 8 of the 9 evaluable patients had stable or better cognition at 3 months. 3 of those patients had improved cognition. 2 of those were highlighted in the recent press release.

Speaker 2

We and this is where we differ a little bit from what the other companies do. We believe some of the patients in ADO2 on EXPAREL will respond like those in the Phase 1 trial. We need to be able to measure clinical improvement. To do that, we need a better, more sensitive cognitive scale than CDR. And that is why we're using EMAC.

Speaker 2

EMAC will allow us to accurately determine if patients have improved cognitive function. And we believe that will be an important finding of the Phase 2 trial. To be clear, the primary endpoint that will be used in the Phase 3 pivotal trial will come after discussion and after agreement with the regulatory agencies that we work with, including the FDA, EMA and MHRA. It may be CDR or it may be EMAC. That decision will be driven by data and the regulatory authorities, not by immune vial.

Speaker 2

The size and duration of ADO2, the Alzheimer's trial are both smaller and shorter respectively compared to the other trials in Alzheimer's disease. This trial design was based on careful analysis of our preclinical data, clinical data and publicly available databases. First, I want to make a personal statement as a clinician. This is me talking. This is not the company.

Speaker 2

But when you put a patient into a clinical trial and they get randomized to placebo, we are asking that patient to allow their disease to progress under our care. In my opinion, we need to do everything possible to limit the number of patients who receive placebo and how long they're on that placebo because we're really not benefiting that patient. The AD002 trial exposes patients to 6 months of placebo. This is just 1 third of the time in the anti amyloid trials. They were 18 months long.

Speaker 2

GERDA trials are good for patients, but is it bad for drug development in Alzheimer disease? And the answer is clear, it is not bad for drug development in Alzheimer's disease. 8,002 is fully powered to demonstrate a benefit at 6 months with EXPAREL. And in fact, you realize that both the leucanumab and the daunumimab trials were statistically positive at 6 months. They could have stopped those trials at 6 months and had the same results that we have today.

Speaker 2

That is the drug therapy is better than placebo. There's nothing magical about an 18 month trial or 12 month trial. The issue is statistical power. And this is where our unique trial design matters. To our knowledge, 8,002 is the only Alzheimer's trial that uses enrichment criteria to enroll patients.

Speaker 2

AD002 enrolled early Alzheimer's patients with biomarkers of information. There is a biologic and statistical advantage to this simple enrollment strategy. The biological advantage is that the mechanism of action of EXPAREL targeting neuroinflammation is matched with the patient's disease that is the pathology that's driving their cognitive decline. Trials that don't use enrichment gamble that a large number of patients treated for a long time will overcome physical noise. That's a risky and expensive strategy.

Speaker 2

The benefits of enrichment are best seen in oncology drug development. Oncology clinical trials routinely use enrichment to derisk clinical trials. This is called precision medicine. Precision medicine is the standard in clinical oncology drug development excuse me, It should be the standard in CNS drug development too. We are using a precision medicine approach.

Speaker 2

The second advantage is statistical and it's more subtle than this enrichment strategy. Patients with neuroinflammation with Alzheimer's disease progress more quickly and more reliably than patients without neuroinflammation. This is kind of a terrible thing to say, but it's a biologic reality. Put in the language of a statistician who are critical in the design of the trial, the increased delta difference between placebo and active and arm and the lower variance provide important statistical advantages. Overall, the trial is well designed, derisked and relevant to today's patients with Alzheimer's disease.

Speaker 2

To be smart with drug supply and capital resources, we have closed enrollment of the Phase 2 open label extension. Remember the open label extension was patients who are going to be offered 12 months of therapy in an open label trial as sort of a reward for being in the randomized blinded trial and also to give us additional safety and efficacy data. This was a practical consideration by the company. Having a large patient population on drugs for 12 months consumes both drug and treasure. The first question many ask is what will the FDA say?

Speaker 2

I remind you the Phase 2 trial is not a registration trial. The purpose of the Phase 2 is to demonstrate safety and efficacy of EXPAREL in the target population, patients with early ADM biomarkers of neuroinflammation. At the end of the Phase 2 trial, we'll have a end of Phase 2 meetings with the regulatory authorities where we will negotiate the design of the Phase 3 clinical trial. The FDA worries about both safety and efficacy. There's no question the FDA will want more patients treated with EXPAREL who have Alzheimer's disease.

Speaker 2

The question is, will they want patients treated for a longer period of time? In my mind, the FDA is very focused on doing no harm. That is part of their charter. And to ask a patient to be on placebo for 12 or 18 months when we are in one day and we already have data to show that you get an effective clinical readout after 6 months may prove to be an epacoprolab. That the FDA will want a larger trial, but not necessarily a longer trial.

Speaker 2

The FDA does provide mechanism to speed drugs through the development process. The accelerated approval pathways are in place for this purpose. We believe EXPAREL for Alzheimer's disease will qualify for accelerated approval pathway. We will apply for a fast track approval based on our preclinical and Phase 1 data. We may be eligible for a breakthrough status after we complete the Phase II clinical trial.

Speaker 2

We cannot predict how the FDA will respond to our application, but we believe EXPARO's unique mechanism of action, the importance of neuroinflammation and glial activation in the pathophysiology of Alzheimer's disease combined with our clinical data will be a compelling story. Finally, you've heard us talk about the many CNS diseases that EXPARO can be applied to all that have neuroinflammation as part of their underlying pathophysiology. We have 87 publications on our website with 12 different disease. This is the future of EXPAREL. It is a CNS franchise and a drug.

Speaker 2

For now, treatment resistant depression will be the first disease beyond Alzheimer's disease that we develop. We will have further announcements on the treatment resistant depression Phase 2 program using EXPAREL in the near future. Our goal is to enroll that first patient in this NIH supported Phase 2 trial in the second half of this year. I will now pass the mic to Mark Waddell, Co Founder and CSO of Inpune Bio to update progress on the Inpune program. Mark?

Speaker 3

Thanks, RJ, and thanks everyone for dialing in. Yes, I am going to tell you where we've got to with our prostate cancer trial called CarePC. And it's unique in many ways as it appears to be typical for our company. First, the concept. This is an NK targeting therapy that doesn't actually administer NK cells or use cytokines, which are the typical historical use of NK targeting therapies.

Speaker 3

Intune converts the patient's own NK cells in their circulation and probably actually within their tumor from resting non cancer killing state to what we now know are memory like NK cells that are able to destroy NK resistant cancer cells. Unlike more conventional adoptive immunotherapies with NK cells from donors, patients don't require any type of preconditioning chemotherapy, nor do they require NK stimulating cytokines as is common to other NK activating therapies. The immune patients sitting in a chair as an outpatient get an intravision infusion over about 20 minutes and then having received their dose of IMMU, they're able to leave. We've given over 20 doses of InpMune in outpatient settings so far. Each infusion has been remarkably boring for the patient.

Speaker 3

And as importantly, boring for the clinical team because it's been so well tolerated. Each patient in the trial is monitored for immunological endpoints as you would expect. And these include NK cell number, phenotype of those NK cells, their ability to kill NK resistant tumor cells. We also measure tumor related variables. In this metastatic castrate resistant prostate cancer trial, we measure anti tumor effects by following blood prostate specific antigen levels, tumor volume with PMSA scans, and we measure circulating tumor DNA.

Speaker 3

So this rich data set will allow us to determine whether the drug is ready for a pivotal trial at the end of Phase II. The Phase I Phase II trial is expected to enroll 30 patients. And the men enrolled in CarePC have all received previous high dose therapy, but now have metastatic castrate resistant disease. In the trial, they received 3 infusions of immune, as I said, on an outpatient basis with a 6 month follow-up. We have 3 centers enrolling patients at the moment, a 4th opening this month and 4 more are planned to open over the next few months.

Speaker 3

The Phase I portion of the trial will be completed by September this year. And we expect patient enrollment in the Phase II portion to be completed by the Q2 of next year, with data available for all of the patients by the end of 2025 at the latest. It is an open label trial, which means that we're looking forward to some snapshots of the data in 2024 or early 2025. Equally important is the trial. The Inimmune team has been working very hard on perfecting the manufacturing and logistics elements of Inpune for future clinical and commercial development.

Speaker 3

So I still have a part time university post and wearing my academic hat over the last 35 years, I've seen an awful lot of promising therapeutic strategies in the cell and gene therapy space fail due to manufacturing and logistical problems. And I'm sure you'll all be aware of some of those associated with adoptive immunotherapies like CAR T cells. We're scaling up the manufacturing process for IMU in preparation for the pivotal trial, and we perfected the quality and release assays, which will be required by the regulatory authorities as we move forward. Because the product ships on dry ice, logistics and storage at treatment centers are easy and they fit with many other commercial drugs. So in summary, we can make the drug, we can quality control release the drug, we can ship it and hospitals can store the drug.

Speaker 3

The clinical trials will determine the drug's therapeutic value as we move forward. Our pivot from hematological malignancies to solid tumors was not a one tumor project and it's been well planned as an initial transition into the solid tumor space. The unique attributes of immune primed NK cells make them ideal to treat a wide variety of solid tumors, And we've published papers on some of those. Prostate cancer is a test case, but we've sound preclinical work in ovarian cancer, and we're developing the same data in renal cell carcinoma at the moment. As we obtain resources, these will be the next targets for immune therapy.

Speaker 3

So that ends my update on the immune platform. And I'd like to turn the call over to David Marsau, CFO and other co founder to discuss the financials. Thank you, David.

Speaker 1

Thank you, Mark. As usual, I'll provide a brief overview of our financial results and upcoming milestones before we head to our Q and A session. However, I'd like to begin with some comments on our recent capital equity raises as we get closer to our Phase 2 Alzheimer's readout and INKMUNE data. We are pleased to have raised $14,500,000 in gross proceeds from 2 separate equity offerings over the past weeks at an average price of $8.35 $9.84 per share. In the two transactions, the company issued an aggregate of approximately 1,500,000 shares of common stock and warrants to purchase an aggregate of approximately 1,500,000 shares of common stock.

Speaker 1

The exercise price of the warrants is $9.15 $9.84 respectively. The warrants are exercisable on the earlier of 2 year anniversary of the initial exercise date or 30 days following the reporting of top line data in the Phase 2 Alzheimer's program for EXPAREL. In the first $4,800,000 raise, management, employees and members of the Board of Directors purchased over $1,000,000 worth of stock. I cannot underscore how financially committed and aligned the entire Immune team is to the success of the company. We greatly appreciate the support from our existing shareholders and the support we saw in both offerings for mostly existing investors, our team here at Immune, but also we welcome a few new holders to the registry.

Speaker 1

Now moving on to the financials. Net loss attributable to common stockholders for the quarter ended March 31, 2024 was approximately $11,000,000 compared with approximately $6,500,000 for the comparable period as we've reached a scale with both of our clinical programs. Research and development expenses totaled approximately $8,700,000 for the quarter ended March 31, 2024 compared with approximately $4,100,000 for the comparable period. General and administrative expenses was approximately $2,300,000 for the quarter ended March 31, 24 compared with approximately 2,300,000 dollars for the comparable period in 2023. At March 31, 2024, the company had cash and cash equivalents of approximately 26,000,000 dollars This figure does not include the recent raises.

Speaker 1

Based on our current operating plan, we believe our cash is sufficient to fund our operations into 2025. As of May 9, 2024, the company had approximately 19,800,000 shares of common stock outstanding. Now I'd like to focus on some Canadian upcoming milestones. Full enrollment in the Phase 2 EXPAREL trial for the treatment of neuroinflammation as a cause of Alzheimer's disease our expected mid-twenty 24, followed by top line data approximately 6 months from the last patient enrolled. We will initiate a Phase 2 trial of EXPAREL in patients with treatment resistant depression in the second half of this year.

Speaker 1

Last week, we announced completion of Cohort 1 for the first of our 3 patients taking part in the metastatic castration resistant prostate program. We expect Cohort 2 to start shortly. We expect complete enrollment in the Phase 1 portion of the metastatic castration resistant prostate trial by the end of Q3 2024 and the Phase 2 portion is expected to complete enrollment Q2 of 2025. Although we've secured additional funding, as always, we continue to focus on achieving our primary clinical objectives while remaining cost prudent with the potential recover a portion of R and D expenses in Australia and the UK. Further, the recent changes R.

Speaker 1

J. Mentioned with regards to the open label extension will save the company a couple of $1,000,000 in drug and trial related expenses. In summary, we secured a meaningful equity refusion recently that puts us in good position heading into data and our focus remains solely on execution. At this point, I'd like to thank you for your time and attention. I'd like to turn it back to James to poll for questions.

Speaker 1

James?

Operator

Thank you, Mr. And we'll take our first question today from Tom Schroeder with BTIG.

Speaker 4

Good afternoon. Thanks for taking the question. So, RJ, you must be thinking about the role of abeta antibodies in your Phase 3. Is there any guidance or thoughts? Are you going to be able to stratify?

Speaker 4

Or could you still do a monotherapy trial? I'm just curious if there's any sort of thought yet. And then a quick one for Mark. I understand, Mark, boring is good, but would you expect some fever if you're turning on NK cells? Just your historical thoughts on why things are so safe.

Speaker 4

So thanks.

Speaker 2

Yes. So let me thank you, Tom, for those. Very interesting question about the anti amyloid. We have signaled very strongly. We are aware that we're going to have to be able to answer the question about combination therapy.

Speaker 2

And I think we've said that you should expect some preclinical data to that regard from us mid year. What's more important though is how will it affect the Phase 3 point of the trial. And at least in the United States, the only place these drugs are currently approved, adoption has been slow. So I believe that there will be plenty of patients who are not on the anti amyloid drugs, who will be potential clinical trial participants in the United States. And other regulatory jurisdictions like the Europe, UK, Canada and beyond, we don't know when those drugs are going to be approved.

Speaker 2

They'll be approved by the time we start our Phase 3, no doubt. But once again, those drugs have had slow adoption. So I am we are not concerned at this point. We believe a combination trial is actually a different development pathway that may be answering a different question than whether EXPAREL works alone for patients in Alzheimer's with neuroinflammation. David, do you want me to comment on is Mark on the phone?

Speaker 2

I think his call may have dropped. Mark, you there?

Speaker 1

Mark? Yes.

Speaker 2

Mark is not

Speaker 1

I'll tell you what, Mark got dropped. He's got a they'll try and add him back in. He's over in Europe having problems. But in relation to your question, Tom, why you don't see a fever or some sort of inflammatory response, why the drug is so safe?

Speaker 2

Yes. Mark, David. Yes.

Speaker 3

So the answer the question was about no fever. Why no inflammatory reactions with IMGUNE? Well, IMGUNE activates NK cells and it doesn't activate T cells. And we've spent a lot of time looking at that. So the inflammatory response you see in cytokine release syndrome is entirely T cell mediated.

Speaker 3

So that's released in inflammatory cytokines from CD4 T cells. And NK cells, which are activated by immune or even by cytokines, don't secrete inflammatory cytokines. So no NK therapy itself and it has been associated with inflammatory type reactions.

Speaker 4

Got it. Okay. Thanks for the thoughts on both.

Speaker 3

No, not at all. And it's a very smart question actually because it's normally the cytokines that are administered to sustain NK cells that cause side effects. And of course, immune doesn't require the administration of cytokines. So it's specifically NK cell targeting.

Speaker 4

Got it. Okay. Thank you.

Operator

Our next question will come from Joel Beatty with Baird.

Speaker 5

Hi. Thanks for taking the questions. The first one is for the ongoing Phase II trial in early AD. Can you remind us of the mix of patients you're targeting in enrollment between the ones that have mild cognitive impairment versus mild AD and how enrollment is tracking with that?

Speaker 2

Yes. Good question. So two things, two points to make. It's relevant considering my comments on placebo. We have a 2 to 1 enrollment of active to placebo.

Speaker 2

In other words, for every group of 3 patients, you take that trial and one patient gets placebo. So that's number 1. Number 2, the way the protocol is written, there will not be more than a 2 to 1 balance. In other words, there is although you don't specify whether it's twice as many mild AD as MCI or twice as many MCI as mild AD, it will not be a it will really be an early AD trial like all the other ones do. Statistically, I would expect you would expect more MCI patients.

Speaker 2

But as you recall, we started the trial with only enrolling mild AD patients. So I suspect it will be very close to a fifty-fifty mix. Don't hold me to that. That's a prediction. But it's the way it's looking right now, it's going to be about a fifty-fifty mix.

Speaker 5

Okay, great. And then a question on the open label extension study that's, I guess a clarification, has it just been enrollments that's closed, but some patients in the study are continuing to be dosed or is dosing complete in all patients? And then in any case, are there plans to share the open label extension data that you have collected?

Speaker 2

Yes. So that's a good question. The open label extension data that we have has always been complicated by the fact that we don't know what the patients were on at entry. Remember, they come into the trial after a blinded randomized trial. So we don't know.

Speaker 2

So we haven't figured out the best way to analyze those. Right now because of really, as I said, both drug supply and financial considerations abide really, drug supply is a financial consideration because making the stuff is not a small task. We are basically working with the sites to decide the best path. Some patients will go on to a kind of a scheme where they are they get compassionate use that if that's available to them and some will not be will be discontinued. It's not the company is not happy with this turn of events, but it is a practical consideration.

Speaker 2

Our goal and our commitment to investors is to make sure we finish the Phase 2 trial, get the result we're looking for and that's where we're focusing our resource.

Speaker 5

Thank you.

Operator

Our next question will come from Jason McCarthy with Maxim Group.

Speaker 6

Thanks for taking the questions. I guess this is RJ's thoughts type of question. RJ, can you kind of opine a little bit on what do you think regulators might want in terms of timing for this trial? So you said that the 2 approved amyloid drugs, 6 months they already saw that they were effective. But given what you know now about markers of inflammation, seemingly FDA willingness to accept correlation between biomarkers and outcomes in Alzheimer's disease and with any current standard of care in mild or early Alzheimer's, what is the expected rate of decline?

Speaker 6

Like can you get can you really get away with a trial that's just 3 to 6 months because of all the inflammatory biomarkers that are available that the FDA seems to be more accepting of?

Speaker 2

So, good question and I'm going to answer it in a series of statements. First of all, I'm not predicting 3 months. Our trial is 6 months. 3 months is pretty quick. We would we expect robust results after 6 months.

Speaker 2

Now let's talk a little bit about the biomarkers. Our biomarkers of neuroinflammation in the Phase 2 trial are enrichment criteria. In other words, there are things you need for enrollment. The FDA, I'm not convinced that the FDA will be will accept biomarkers of neuroinflammation as a biomarker of Alzheimer's. What they will accept are biomarkers of what they consider Alzheimer's, which are amyloid, tau, maybe GFAP, which is glial fibrillary acetic protein, a biomarker of astrocyte.

Speaker 2

Now the good news is there's very good blood tests for all of those. And I predict that we will actually show a decrease in those biomarkers in the Phase 2 trial in patients who get EXPAREL. So my bet is that what we've got is we're going to be focused on patients who have neuroinflammation because that's how the drug works. But we don't think that the FDA we make it surprised mind you, but we don't think the FDA will actually focus on neuroinflammation as a response. They're going to stick to the biomarkers they know and they know amyloid and tau and they might be interested in GFAPs and I don't think they'll be interested in NFL neurofilament light change analysis.

Speaker 2

So those are my predictions. But I think I really think if we do as well as we think we are, where you've got a placebo group that's racing to really quite a significant cognitive impairment and the EXPAREL group, which is relatively stable, I don't think they're going to force us to treat patients on placebo for a very long time, but they're going to want to see more patients. 200 patients will not be the size of the next trial. It will be at least double that, probably 3 times that, my predictions.

Speaker 6

So from a in the placebo group, even with acetylcholinesterase inhibitors or something like that, how far out can they go even with a true placebo effect and then start to decline kind of like not fake it till you make it, but you know what I mean, where they will eventually Yes.

Speaker 2

So most of these yes, so two points. You see the colon SDA inhibitors. In general after 3 months, certainly after 6 months, you don't see any benefits with those drugs. Patients have to be on a stable therapy before they can be enrolled and that's for 3 months. So any patient that would be enrolled with any fetal Chloronecillary and heparin, and heparin, for instance, would have been on the drug long enough that they are no longer benefiting from the drug.

Speaker 2

As you know, many patients are on the drugs and it's really the doctors are treating themselves as much as they're treating the patients at least that's my clinical view. I think that the earlier question asked by the from Schraeder's group was regarding anti amyloid is interesting. I don't think the monotherapy trial will not patients won't be on maintenance anti amyloid. That will be a separate trial and a separate question that we'll ask hopefully with a partner that has an anti amyloid drug because they're the ones who I think will be the most curious if the addition of combination therapy may improve both the safety profile of those drugs and the efficacy profile. But that's the question of the future and the first thing we need to do is prove that the combination of safe and animal models and as I mentioned those studies are underway.

Speaker 6

Got it. Just one quick question on Inimmune. I think I heard earlier that potential to move towards renal cancer next, depending on resources, of course, but is the selection of renal cancer have similarities to prostate cancer choice in terms of there seems to be a higher proportion of NK cells versus T cells in those tumor types?

Speaker 3

Absolutely. So there's a long history. In fact, only last week I was examining a PhD student at the Karolinska who spent 4 years looking at the same issue. And yes, renal cell cancers are typically heavily infiltrated with NK cells. And there's a prognostic benefit to those patients who have a high NK cell infiltrate.

Speaker 3

And in fact, there's a negative prognostic effect of having a high CD8 T cell infiltrate. And of course, the drugs that have been approved for renal cell cancer have been NK targeting alpha-fifty RN IL-two. So yes, that's really the rationale behind that. And we've got some very nice data to demonstrate that NK cells do target renal cell carcinoma cell lines better after they've been primed with immune.

Speaker 6

Got it. Thank you, fellas.

Operator

Our last question will come from Daniel Carlson with Tailwinds Research.

Speaker 7

Hi guys. Thanks for taking my question. RJ, just you talk about hopefully showing flat on cognition as opposed to steep decline in the placebo group. I'm wondering if you do put up those type of numbers, is there any chance that conditional approval post the Phase

Speaker 2

2? Yes, right. You'll list the God's ears. I do as much as the FDA has tortured us, I do believe in general the FDA has their heart in the right place. And if the results are extraordinary, and I would consider that an extraordinary result, not only will investors be excited, not only will the company be excited, but the FDA gets excited.

Speaker 2

And who knows what will happen, Dan. They will do they will pull out all the stops to help push us along. I don't know what that looks like, but they get excited about groundbreaking data just like you and I do. So is there a chance? Yes.

Speaker 2

What I bet more than a steak dinner on it? At this point, no. But man, if we knock it out of the park, I think all bets are off. We'll just have to see what they say. As you know, patient advocacy groups make a big difference with the FDA.

Speaker 2

The Alzheimer's field or the Alzheimer's advocacy groups, although there are a lot of patients are not particularly vocal compared to some of the other indications, which are smaller such as ALS and DMD. I don't know. It's a great question. I like to dream about it, but I'm not going to hold my breath, Dan.

Speaker 7

Okay. And just sort of a follow-up on that. What about other jurisdictions? Are they all going to fall in line behind the FDA or might it get approved on those results elsewhere?

Speaker 2

I hesitate to ask that question because each of them is a little bit different. I think the MHRA tends to be one that I think is a little more independent thinking. The EMA tends to think very much like the FDA. And we certainly haven't seen a lot of innovation of regulatory innovation in Alzheimer's disease. But I have to say some of that is just because they haven't had many swings at the ball, right.

Speaker 2

For all practical purposes, the only drugs that have come through are the anti amyloids and that's kind of a they all look pretty much the same. I don't know. We'll see. And I think that let's we need right now to get this Phase 2 enrolled, number 1. We need to get it analyzed.

Speaker 2

And then when we see that top line data, then we'll both have the resources and the insight to move as quickly as we can. And believe me, we'll be making every attempt we can to move quickly.

Speaker 7

Yes. So that's great. I look forward to seeing what happens when you ring the bell there. So just one question about TRD. Now that you've got some more capital in, can you just sort of refresh the timeline and maybe get more resources to put there and tell us about this trial and when we can expect something out of

Speaker 2

it? Yes, expect something out of it. Once again, it's a blinded randomized placebo controlled trial. So actually getting data, the first thing you're going to hear is that this is the way it will go. The FDA will announce that the FDA has accepted the IND and the trial is open, 1st patient enrolled and then we'll be moving it forward.

Speaker 2

The amount of the speed of the trial will directly be related to how much resources we can put behind it. Right now, the NIH grant only funds about a third of the trial. So we have to be careful because our primary mission, as we've said, is number 1, Alzheimer's and then number 2, the increasing CarePC. But we think we'll be able to move that ahead. And then as our resources expand, we'll be able to put the pedal through the metal on treatment with distant depression.

Speaker 2

But this year, the 2 milestones you should hear from, as David said, is that the FDA has allowed us to open the IND because it is a U. S. Trial. And the second thing will be the 1st patient enrolled. That's our goal.

Operator

And that will conclude today's question and answer session. I will now turn the conference over to RJ for any additional closing remarks.

Speaker 2

Thank you. Yes, with the success of the fundraising, we now have the capital to comfortably complete 8,002, early Alzheimer's trial and support CAR PC into some of the open label data in metastatic castrate resistant prostate cancer. Our goal is to provide positive readout in these problems. With positive readouts, we expect we'll be able to access capital markets in a way to allow the company to become more aggressive in pursuing its goals. Both of these products have uses beyond their primary indication.

Speaker 2

And we believe that with the resources we need with given the resources we hope to get, we have the expertise and the teams who can to capitalize on those other activities either alone or with partners. For now, we appreciate your support. Thank you very much.

Operator

This does conclude today's conference call. Thank you for your participation. You may now disconnect.

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Key Takeaways

  • Mid-2024 target enrollment for the Phase 2 ABO2 trial in early Alzheimer’s disease, powered on the CDR cognitive scale with enriched neuroinflammation biomarkers and a sensitive EMAC endpoint, with top-line data expected ~6 months after last patient dosing.
  • Long-term Phase 1 data from two Australian patients treated with EXPAREL for ~3 years demonstrated a strong safety profile, stable or improved cognition, and meaningful quality-of-life benefits in mild cognitive impairment and moderate Alzheimer’s disease.
  • INKMUNE’s Phase I/II trial in metastatic castrate-resistant prostate cancer is progressing with over 20 outpatient infusions, no preconditioning or cytokines required, Phase I completion by Q3 2024 and Phase II enrollment by Q2 2025.
  • Q1 2024 financials showed an $11 million net loss and $8.7 million in R&D spend, with $26 million cash on hand (excluding $14.5 million raised in recent equity offerings), providing a runway into 2025.
  • Key upcoming milestones include full enrollment in the EXPAREL Phase 2 Alzheimer’s trial by mid-2024, NIH-supported Phase 2 trial initiation in treatment-resistant depression in H2 2024, and completion of the mCRPC Phase I cohort by end-Q3 2024.
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Earnings Conference Call
INmune Bio Q1 2024
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