INmune Bio Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
March 28, 2024

There are 7 speakers on the call.

Operator

Ladies and gentlemen, greetings and welcome to the Immune Bio 4th Quarter 20 23 Earnings Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call.

Operator

At this time, it is my pleasure to introduce Mr. David Moss, CFO of Immune Bio. David, the floor is yours.

Speaker 1

Thank you, Ryan, and good afternoon, everybody. We thank you for joining us for the call for Immune Bio's year end 2023 financial results. With me on the call is Doctor. R. J.

Speaker 1

Tessie, CEO and Co Founder of Immune Bio and Doctor. Mark Lodell, Chief Scientific Officer and Co Founder of Immune Bio, who will provide an update on Inc. Vume, our memory like natural color 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.

Speaker 1

Please see the forward looking statements disclaimer on the company's earnings press release as well as risk factors in the company's SEC filings, including our most recent quarterly filing with the SEC. There is no assurance of any specific outcome. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made as the facts and circumstances underlying these forward looking statements may change. To reflect future information, events or circumstances. To reflect future information, events or circumstances.

Speaker 1

Now, I'd like to turn the call over to Doctor. R. J. Tessie, CEO of Innu Bio. R.

Speaker 1

J?

Speaker 2

Yes. Thank you, David, and thank you, everyone, for joining the call. As usual, I will arrange my remarks to highlight the key takeaways for the Q4 and subsequent period and provide updates on our platform programs. I will start by reviewing developments on our Xpro platform and then pass it over to Mark Liddell, who will provide an update on Incubion. David will conclude with a discussion of our final results and providing an update on upcoming and new milestones.

Speaker 2

During the Q4 in early 2020 4, there were several positive developments in our Phase II trial in patients with early Alzheimer's disease. First, we received acceptance of our clinical trial application by several EU countries to allow us to initiate the Phase II trial in those countries. Clinical trial sites in Poland, Spain, France, Czech Republic and Slovakia will soon be enrolling patients. The UK continues to be very active in recruiting patients to the Phase 2 trial and the UK is ideal, an ideal jurisdiction to expand or to develop our program because it possesses one of the highest rates of Alzheimer's disease in the rest of the world, coupled with a robust for profit medical research infrastructure. Patient enrollment tends to be faster in the private for profit sites compared to academic or government owned hospitals.

Speaker 2

The FDA lifted the clinical hold for the AD program in January of this year. We have previously announced we will not be enrolling patients or adding trial locations in the U. S. This is a simple issue of timing. The time and cost to open U.

Speaker 2

S. Sites is such that we probably would not be successful getting any patients enrolled before the Phase 1 Phase 2, excuse me, enrollment is completed. That cost just can't be justified. We expect no U. S.

Speaker 2

Patients to be enrolled in this trial period. We are often asked if this strategy will compromise the EXPAREL development program in Alzheimer's disease. The answer is a loud no. There is no requirement that U. S.

Speaker 2

Patients be included in any drug trial. The FDA's preference for including U. S. Patients in clinical trials is due to demographic considerations, not due to doubts about the validity of non U. S.

Speaker 2

Clinical trial results. Although the FDA has issued guidance recommending demographic diversity of the U. S. Population, this goal has not been achieved in the recent pivotal trials for the anti amyloid treatments. We expect the U.

Speaker 2

S. Will be a skewed jurisdiction for clinical trials and patient enrollment in the pivotal AV trial that will follow this trial. One of the realities of a 6 month clinical trial is that Phase III planning must begin well before patient enrollment in the Phase II trial is complete. Our goal is to complete end of Phase II meetings the FDA and other regulatory authorities in mid-twenty 25 to get a clear outline of what would be required for an approvable Phase 3 trial. Discussions of patient diversity in the U.

Speaker 2

S. Cohort will be had at that time. This does not mean we are not in communication with the FDA on Xpro for Alzheimer's disease. We plan to submit for accelerated approval pathways for Pax Pro in Alzheimer's disease. The first submission will be a fast track pathway.

Speaker 2

Then once we have compelling Phase 2 human data, we will submit a breakthrough status. Recently, in fact, a month ago, more or less, the FDA released draft guidance on the development of drugs for the treatment of patients with early and prodromal Alzheimer's disease. The guidance supports many of the strategies we have been including in our trials, including enrichment and novel endpoints. The guidance also provides direction on how to think about prevention of Alzheimer's in patients with prodromal disease. This is something we think EXPAREL will be very good at and we will be talking about more in the future.

Speaker 2

I want to take a moment to address 2 unique elements of our Phase 2 clinical trial, the endpoint and the 6 month duration of the trial. We are often reminded that we do not look like excuse me, that we look different than the gold standard set by a big pharma in their anti amyloid trials, but looks can be deceiving. A look below the surface shows many similarities between those large and long trials and our trial. Despite all of the talk about EMAC as our primary endpoint for AD002, the trial is powered on CDR. CDR is a well accepted cognitive endpoint used in all of the antiamyloid trials.

Speaker 2

In fact, let's compare our trial with EXPAREL for the treatment of early AD with the positive Phase 3 trials that use the anti amyloid drugs for the treatment of early AD. The three trials have two things in common, the use of CDR and a 6 month trial and time point. Both lecannamab and donamimab Phase 3 trials showed statistically significant advantages of the anti amyloid treated patients compared to placebo at 6 months. Put another way, both those trials could have been stopped at 6 months with positive results. The difference seen between the placebo and treatment groups in the anti amyloid trials is exactly the same difference we expect to see between XPRO treated and placebo treated patients.

Speaker 2

In summary, we are very confident that the XPRO trial is well designed, statistically sound and substantially derisked. The EXTRO trial looks almost exactly what has been successful with leucanumab and dronomimab. In early March, Inc. Unit issued a joint press release with Cumulus Bioscience highlighting advanced AV patients who received weekly EXPAREL treatment for 4 weeks had a statistically significant increase in alpha wave frequency and power. Reduced alpha wave power has been linked to cognitive decline and progression in MCI and Alzheimer's disease.

Speaker 2

The EEG law considered a gold standard in objectively measuring brain activity provides valuable insight into brain function and neural connectivity. Studies have consistently highlighted a progressive decline in alpha valentine power in patients like ours. To our knowledge, we are unaware of reports of drugs in AD development that show consistent decreases in alpha wave power. We believe this is an easily measured biomarker of improved brain function in patients with Alzheimer's disease. But without a roadmap, that is other results, we need to wait for the results of our trial to determine if an increase in alpha wave power correlates with cognitive improvement.

Speaker 2

Just to be clear, the 7 patients in this pilot study are patients with moderate to severe Alzheimer's disease. And so they're very different than those in the early Alzheimer's trial. We sought to evaluate the utility of EEG as a functional biomarker in this group. We believe this is just the beginning or as we like to say, the tip of the iceberg of what we can expect to be positive news on Alzheimer's, not only in halting the progression of cognitive decline in Alzheimer's disease, but hopefully in restoring cognitive functionality. This last point is why we're using EMAC.

Speaker 2

EMAC has the ability to demonstrate improved cognitive function after EXPLO treatment. Standard cognitive measures in Alzheimer's disease can only measure stable or decreasing cognitive function. We like to boast that targeting neuroinflammation with EXPAREL provides many market expansion opportunities into other neurodegenerative and behavioral diseases. Go no further than our website to see 87 publications in more than 12 different diseases where EXPAREL has been effective in clinical models, preclinical models. Treatment resistant depression or TRD will be the first disease beyond Alzheimer's that we develop.

Speaker 2

We will be making further announcements on the TRD Phase 2 trial using EXPAREL in the near future. Our goal is to enroll the 1st patient in this NIH supported Phase II trial in the second half of twenty twenty four. I now pass the mic to Mark Liddell, the Co Founder and CSO of Immune Bio to update progress on the Inc. Immune program. Before I do so, I and the entire Inimmune Bio team want to recognize and congratulate Mark for a recent significant achievement.

Speaker 2

2 weeks ago, we received notice that Mark was awarded a Career Achievement Award in Cell and Gene Therapy by the International Society of Cell and Gene Therapy. The ISCT is the society in cell and gene therapy and the organization considers this award its highest honor. The award was announced as part of the annual ISEP major awards announcement and Professor Liddell received the award during the organization's annual meeting in Vancouver on May 29. We couldn't be happier for Mark and believe this recognition is well deserved. Congratulations.

Speaker 2

Mark?

Operator

Ladies and gentlemen, the line of Doctor. Mark Laudel has been disconnected. Please stay connected while I connect him. Thank you.

Speaker 2

Okay. Mark, there's a storm in the U. K. Where Mark is.

Speaker 1

I'll tell you what, I'll go to my part and then we can come back to Mark, if you don't mind.

Speaker 2

Okay. That's fine. So I hope the audience doesn't mind that, but I think that's the way to go because Mark is really the one that needs to speak about anything. So, David?

Speaker 1

Yes, I'll jump on here. And yes, and RJ, maybe what you could do is just text Mark, so you can get him on the line.

Speaker 2

Yes. So

Speaker 1

I'm going to provide a brief overview of our financial results and upcoming milestones, and we'll go back to Mark, and then Mark will move on to Q and A. Net loss attributable to common stockholders for the year ended December 31, 2023 was approximately $30,000,000 compared to with approximately $27,300,000 for 2022. Research and development expenses totaled approximately $20,300,000 for the year ended December 31, 2023, compared with approximately $17,100,000 for 2022. General and administrative expenses was approximately $9,600,000 for the year ended December 31, 2023, compared with approximately 9,300,000 dollars for 2022. At December 31, 2023, the company had cash and cash equivalents of approximately 35,800,000 Based on our current operating plan, we believe our cash is sufficient to fund our operations into Q4.

Speaker 1

As of March 27, 2024, the company had approximately 18,000,000 shares of common stock outstanding. As highlighted in the prior quarter's investor call, we continue to focus on achieving our primary clinical objectives while remaining cost prudent with the potential to recover a portion of R and D expenses in Australia and the U. K. Now I'd like to move on and list our upcoming important milestones. Full enrollment in the Phase 2 X XPRO trial for the treatment of neuroinflammation as a cause of Alzheimer's disease are expected mid-twenty 24, followed by top line data approximately 6 months from the last patient enrolled.

Speaker 1

We will initiate a Phase 2 trial of EXPAREL in patients with treatment resistant depression in the second half of twenty twenty four. Cohort 1 of the metastatic castration resistant prostate cancer program is nearly complete with all three patients enrolled. We expect Cohort 2 to start in April with open label data to follow. We expect to complete enrollment in the Phase 1 portion of the metastatic castration resistant prostate cancer trial by the end of Q3 'twenty four and the Phase 2 portion is expected to complete enrollment in Q2 of 2025. An upcoming webinar on using EXPAREL to promote remyelination in neurodegenerative disease will be announced in Q2.

Speaker 1

We encourage you to look out for this event and do your best to try and join. It should be pretty exciting. And then at this point, I think, Mark, are you back on the line?

Operator

David, Mark is still not online.

Speaker 2

Yes. So he says he's going to try a web call, but let me go ahead and get started and he can jump in. So on to Inc. So we apologize for the technical problems. So we achieved I

Speaker 3

actually joined RJ?

Speaker 2

Okay. Go ahead, Mark. Mark, I've been you've got to I did give your accolades about your awards, so you can start from there.

Speaker 3

That's very kind of you. Yes. Sorry, everyone. I'm in the U. K, and we've got a thunderstorm going on, and I got dropped out.

Speaker 3

Anyway, thank you very much, Ajay. Of course, I'm very honored by the ICT's recognition. And obviously, pass my thanks to all of my current and former colleagues that I've had the pleasure to work with over the years. It's a great reflection on the entire research effort and success of everyone I've been lucky to work and collaborate with over the course of my career, and I hope it continues. So most notably for us, though, that we achieved a company milestone at the end of 2023, in the last weeks of before Christmas with the launching of the Phase III open label trial of Incmune in metastatic castration resistant prostate cancer or mCRPC for short, with the 1st patient dosing taking place in the final week of the end of last year.

Speaker 3

The trial is actually unique in many ways, as seems to be the trend of our company. First, the concept that this is an NK therapy trial that does not give NK cells or use cytokines. Immune converts the patient's own residual NK cells in their circulation 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. So unlike more conventional adoptive immunotherapies with NK cells from donors, patients don't require any type of conditioning chemotherapy and nor do they require NK stimulating cytokines as is common to other NK activating therapies. Inglia patients sitting in a chair as an outpatient get an IV or intravenous infusion over 20 minutes and then having received their dose of IMCUEN, they're able to leave.

Speaker 3

We've given over 20 doses of IMCGMUNE in an outpatient setting so far. Each infusion was remarkably boring for the patient and as importantly for the clinical team as it appears to be so well tolerated. In each patient in the trial, we're monitoring immunologic endpoints as you would expect, that include NK cell number, the phenotype of those NK cells and their ability to kill NK resistant tumor cells. We also measure tumor related variables. In this MCRPC trial, we measure anti tumor effects by following blood PSA levels, tumor volume with PMSA scans and circulating tumor DNA.

Speaker 3

So this rich data set will allow us to predict if the therapy warrants a pivotal trial at the end of Phase II. The Phase I, Phase II trial is expected to enroll 30 patients. These men have all received PREMIER's therapy and now have metastatic castrate resistant prostate cancer. They received 3 infusions of IMGUNE as an outpatient treatment, as I said, during that 6 month trial. We have 3 centers enrolling patients and another 5 are expected 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 all of the patients by the end of 2025 at the latest. It is an open label trial, and we expect some snapshots of the data in 2024 or in early 2025. Equally importantly, the Equinine team has been working very hard the manufacturing and logistics elements of immune therapy. So when wearing my academic hat over the last 35 years, I've seen many promising therapeutic strategies in the cell and gene therapy space fail due to manufacturing and logistical problems, and you'll all be aware of some of those associated with immunotherapies like CAR T. We are scaling up the manufacturing process in preparation for the pivotal trial, and we perfected the quality and release assays requested by the regulatory authorities.

Speaker 3

Because the product ships on dry ice, logistics and storage at treatment centers is easy and fits in with many other drug conventional drugs. So simply put, we can make the drug, we can ship and store it, and the clinical trials will determine the therapeutic value in this setting. Our pivot from hematological malignancies to solid tumors was not a one tumor project and has been well planned. The unique attributes of ink being primed NK cells make them ideal to treat a wide variety of solid tumors and we've published on those. Prostate cancer is the test case, but we found sound preclinical work in ovarian cancer and we're developing the same data in renal cell carcinoma.

Speaker 3

So given resources, these will be the next targets of inkling therapy. So that ends up ends my update on the inkling platform. And I'd like to turn the call over to David Moss, our CFO, to discuss the financials. Thank you, David.

Speaker 1

Well, I appreciate it, Mark, and thank you for the update. Since I've already gone through the financials, in summary, management feels that the company has 2 great platforms and is a small organization with limited resources. We'll try to expand the application of these platforms when resources allow. We greatly, greatly appreciate your continued belief in our small company and support of shareholders. At this point, I'd like to thank you for your time and attention.

Speaker 1

I'd like to turn it back to Brian to poll for questions. Brian?

Operator

Thank Our first question is from Thomas Schrodert with BTIG. Please go ahead.

Speaker 4

Hi, good morning. Good afternoon. This is Song on for Tom. Thanks for taking my questions. So 2 for us.

Speaker 4

So first, for the planned study in TRD patients, is there an obvious criteria for patient stratification to enrich for patients who are likely to benefit from EXPAREL? And then question number 2 is, so for the recent EEG data that was presented, how established is the correlation between these changes and improvements in cognition and memory? Any additional insights

Speaker 2

will be helpful. Thank you. Yes. So thanks. First question is on TRD and in fact, we will use CRP.

Speaker 2

So these patients have had been confirmed to be treatment resistant, which means they failed 2 previous lines of anti depression therapy and they need to have an elevated CRP. So we are not adding the other 3 biomarkers we use in the AV trial, but it's the same principle that patients with neuroinflammation will benefit from EXPAREL and it turns out that neuroinflammation makes patients resistant to traditional antidepressant drugs. So this is an ideal treatment group for us to treat. Now, I missed the first part of your second question, so ask it again please.

Speaker 4

Just, how established is the correlation between EEG changes and improvements in cognition and memory in Alzheimer disease?

Speaker 2

Yes. Good question. In fact, it's not established. As far as we we obviously did a very deep dive here. And we could only so we could only find published data on patients with head injury.

Speaker 2

In other words, if you have a head injury, TBI, your alpha wave declines. And then 4 weeks later when you get better, your alpha wave goes up. So there's an improvement in alpha wave in a patient who has cognitive dysfunction after TBI that improves. That is not a drug trial. We looked hard at the drug literature and could find no data that really supports that correlation and that's why I was saying we don't really have a roadmap.

Speaker 2

There is a couple there is some debate with the net Brazil, whether it in fact increases alpha wave power in patients that respond. But I would say that's a debate at this point. I would honestly we believe and the experts believe that it is consistent with improvement in synaptic function and brain function. We'll see after our Phase II trial. We hope it's the case.

Speaker 1

And if you don't mind, RJ, I'd just like to add a little bit on the TRD. And I wish we had CJ on the call because CJ is really a TRD expert. But one of the reasons why we're very interested in TRD is that Andy Miller and Jen Felger, 2 KOLs that are in the space. There was a trial that was previously run with TNF inhibitors. It's a published paper on it.

Speaker 1

I'd be happy to send it to you. I think it's listed on our slide on the TRD deck. And it shows a failed trial that just took all comers, but it shows that patients that had elevated CRP, elevated measures of neuroinflammation, had a very statistically different result, a positive result when treated. And so if you select your patient population and you use a better TNF inhibitor, IE X Pro, we feel very confident that is a trial that will be successful. And really, Andy Miller has really been chomping at the bit to do this trial for many, many years.

Speaker 1

And that's the reason it's set up and one of the reasons why the NIMH, the National Institutes of Mental Health, gave the company a $2,900,000 grant to do that trial.

Speaker 2

Thank you for all the detail.

Operator

Thank you. Our next question is from the line of Joel Beatty with Baird. Please go ahead.

Speaker 5

Great. Thanks for taking the questions and for the update today. First question is, as you enroll the Phase II Alzheimer's trial, what about the profile of EXPAREL or the previous data resonates the most with investigators?

Speaker 2

So, yes, thank you, Joel. So, remember that this trial is occurring in jurisdictions that do not have the anti amyloid drugs approved. So that's Canada, Australia, Europe and the U. K. So in fact, number 1, they're excited about the fact that they have something to offer their patients.

Speaker 2

Number 2, they read the literature like everybody else and they, especially those that haven't had hands on experience with the anti amyloids, they're just not sure. And here we are giving them a drug that is both safe and we think and we've convinced them is effective. So they like the safety profile. They like the idea that it is not it is targeting something else besides amyloid. And they also like the idea that the trial is only 6 months because if in fact the patient doesn't respond, then the patient can move on to another clinical trial and still probably qualify where if it was an 18 month trial that wouldn't be the case.

Speaker 5

Yes, that's helpful. And then a question on INKMUNE with prostate cancer trial now underway, can you share anything about the potential of cadence of when you might be able to share data from the trial with investors?

Speaker 3

Yes. The best thing I can tell you is that today, we treated the 3rd patient, so the last patient in the 1st cohort with the final dose of drug. Obviously, that's the lowest dose, and we will start analyzing those data as they come through. We have got patients lined up now for to start the 2nd cohort. So we're right on schedule to deliver this trial on time.

Speaker 3

I believe we will be coming out with good news as it comes through. And I think September is when we will be looking for that for those data to come out because we will be able to maturely analyze them across the 3 dose levels. But if we get any remarkable data priced out, then plainly we'll go public with that.

Speaker 5

Okay. Thank you.

Operator

Thank you. Our next question is from the line of Daniel Carlson with Tailwinds Research. Please go ahead.

Speaker 3

Just

Speaker 6

RJ, you've talked about comparing EXPAREL to the anti amyloid trials at 6 months. We know those trials are much larger in size than your EXPAREL trial. What gives you confidence that you'll be successful in comparing them comparing your trial with theirs at 6 months?

Speaker 2

Great question, Dan, and pretty easy to answer. This is where the enrichment criteria come in. You know we've been touting the fact that we only enroll patients with neuroinflammation and we define that by 1 of 3 blood tests or a t MAPO equal to the positive. By doing a trial that matches the patient's disease, neuroinflammation with our mechanism of action, a drug that treats neuroinflammation, you actually make the trial work at 6 months better than the anti amyloid trials. That is, to put it in geeky terms, the statistical power increases because the variance decreases.

Speaker 2

So, because there's less noise, the data we get is cleaner. So, whereas they need it turns out, if you look at the results they got, they would have needed about 700 patients per total, so 3.50 per arm to actually have a positive trial at 6 months, but we only need 200. So it's all related to the enrichment criteria. That's we've always called it a little bit of our secret sauce, and this is a good example of why it's the secret sauce.

Speaker 6

Got you. That makes perfect sense. Thanks. Mark, question for you on Inc. Immune.

Speaker 6

The prostate market has certainly heated up with in these radio conjugate companies. Some of them have been acquired and some financings with great valuations, etcetera. Can you compare or just tell us how INKVENT competes with radio conjugates?

Speaker 3

Yes. Thanks, Dan. That's a very good question. And plainly, they're much further down the line than we are in their trials and getting their drugs licensed. But the fact is that radiopharmaceuticals are tough to deliver, just getting the isotopes.

Speaker 3

And if you think about Plavicto, the lutetium-one hundred and seventy seven that they use for Plavicto, there's only one manufacturer of lutetium-seventeen seventy in the entirety of the United States. And I think there's probably only 3 globally. So you do end up looking, as we've seen with the STRONGIUM-eighty nine in METASTRON, a challenge in getting the availability of the radio ligand. The other problem, of course, is one of the other problems is, of course, the short shelf life. The Tissue has got a shelf life of, I think, 6.7 days or 7 days.

Speaker 3

So your manufacturing issues are very considerable. And I think as these drugs get more widely used, we're going to see bigger problems with that. But I guess that the real difference is the sort of recall effects that you get, which leads to off target toxicity even with these relatively well tolerated drugs like Plavicto. You've got bone marrow suppression, these patients become anemic. And so that's fine in the metastatic castration resistant prostate cancer setting where you've got patients who are very far down the therapeutic line.

Speaker 3

But it does make them more challenging to deliver earlier in the treatment process. And the great thing about INKMIA is its complete lack of toxicity in the patients we've treated so far and in the animal models that we used beforehand. So I think the great difference, if you wanted to look at one now, if we're successful with IncynMune, I see it moving earlier in the treatment paradigm. So you end treatment regimen rather. So you end up treating patients with early stage disease, which is where we are with many of the other immunotherapies.

Speaker 3

So that's where I think the difference will be. We'll have a wider population of less severely sick patients.

Speaker 6

Awesome. That's great. Thank you. That's good input. Thanks.

Speaker 6

And then what about the

Speaker 4

And then

Speaker 3

on the stool, thank you.

Speaker 6

RJ, just if you can comment, I mean, it seems like both in incommune and the Alzheimer's trial, the enrollment seems to be on track. Can you just talk about the trends you're seeing in enrollment right now?

Speaker 2

Yes. Well, so I'll start with Incyune. Incyune is actually enrollment has been constrained by the FDA's request. In other words, they wanted in the Phase 1 portion of the trial, 28 days between each patient in the cohort. So by definition, the first getting all three cohorts done will take 9 months.

Speaker 2

Now there is some speed up because of the Bayesian design, because there is some overlap of the Phase II groups. But the bottom line is, we've had more patients actually contacting us who want to be enrolled in the trial than we have slots for right now. Now, knock on wood, let's hope that continues when we get to the Phase II portion where we have a little more flexibility in enrollment rates. But the bottom line is, prostate disease is common. The patients are actually quite sophisticated in searching for clinical options.

Speaker 2

And so they contact us as often as our clinical sites go looking for them, which is quite encouraging. Alzheimer's disease is more interesting. As I said earlier, because all of our studies are in jurisdictions where the anti amyloids aren't approved, in fact, we're only competing with clinical trial other clinical trials. Now, there's a lot of clinical trials in Alzheimer's disease, including both companies are running Phase 3s and other trials. So there's a lot of patients being consumed by the anti amyloid trial.

Speaker 2

But as I said to Joel, I mean, the EXPAREL is just kind of an attractive drug. It's a different mechanism. So we get a good listen. It's safe. It's a good mechanism.

Speaker 2

I have to say it's not it's rarely the patient that chooses on which trial to be in. They really follow the advice of their clinicians. But the clinicians like kind of like what we're doing and so far so good is all I can say. I will say that we every day, we get up and we think of ways that we can speed enrollment. And I think we've got some ideas and we're pushing hard.

Speaker 2

And so far, fingers crossed, toes crossed, everything is going to work out as we promised for the last few years despite our frustrations with the FDA.

Speaker 3

I'd just like to say that the I've been doing early phase clinical trials all my career, And I have never known a trial either the EXPARATE ADO2 trial or our IMMUNE trial in prostate cancer that has enrolled to schedule in the way that these two trials have. And so we can be really confident about the outcome, the delivery time point given the sheer enthusiasm for patients on both trials, which is, I'd say is remarkable in my experience.

Speaker 6

Thanks guys. I mean, after going through COVID with a number of companies missing their timelines because of enrollment issues, it's great to see these trends. So thank you for that. Appreciate

Operator

it. Thank you. As there are no further questions, I would now hand the conference over to Doctor. R. J.

Operator

Tessie for his closing comments.

Speaker 2

Yes. So thank you. So ImmuneBio is making progress on two fronts and we're pretty proud of that. I will say the drug development landscape for the treatment in cognitive decline in Alzheimer's disease is really changing rapidly. And we are impressed how quickly the conversation has pivoted from treatment of dementia to prevention of dementia.

Speaker 2

And I can't help wonder if this rapid pivot is because of dissatisfaction and frustration of the with the approved therapies. There's still a niggling concern that the risk profile is not ideal. But I have to say at ImmuneBio, we have a little bit of a different view. We believe the anti amyloid drugs are chasing the wrong target. We believe neuroinflammation is intimately involved in disrupting nerve cell function and survival and synaptic function, and those are the 2 essential elements needed for cognitive decline.

Speaker 2

With EXPAREL, we are attacking this pathology and have strong evidence that we changed the biology of the brain for the better. The ongoing Phase 2 trial will allow us to correlate these biologic benefits with cognitive change and we hope cognitive benefits. Stay tuned because the positive result there opens the door to other indications where neuro inflammation meets cognitive dysfunction. Likewise, Incomoon is an NK therapy of a different stripe. The biology is sound.

Speaker 2

It's a lifetime of work by Mark Liddell and he is getting finally recognized for what has been long due. We marvel at the safety profile of this immunotherapy. Could this be a cancer therapy that really has no side effects and only has benefits? Time will tell and we believe the metastatic castrate resistant prostate cancer trial will give the product Incum a good chance to shine. We remain optimistic about both our programs and we thank you for your support and your attention.

Operator

Thank you. The conference of Envion Bio has now concluded. Thank you for your participation. You may now disconnect your lines.

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Key Takeaways

  • Regulatory milestones: Received EU clinical trial application acceptance and FDA lift of the hold for the Phase II XPro (EXPAREL) Alzheimer’s trial, with sites in Poland, Spain, France, Czech Republic, Slovakia and the UK enrolling patients; full enrollment is expected by mid-2024 with top-line data ~6 months after last patient in.
  • EEG biomarker signals: In a pilot study of advanced Alzheimer’s patients, weekly EXPAREL dosing for 4 weeks produced a statistically significant increase in α-wave frequency and power—a gold-standard EEG measure—suggesting improved brain function pending Phase II cognitive correlations.
  • TRD Phase II trial launch: An NIH-supported Phase II study of EXPAREL in treatment-resistant depression, enrolling patients with elevated CRP to enrich for neuroinflammation, is slated to begin in H2 2024, leveraging the drug’s anti-inflammatory mechanism.
  • Inkmune oncology program: Initiated a unique Phase I/II open-label trial of Incmune in metastatic castration-resistant prostate cancer—administered outpatient without conditioning or cytokines—with Phase I completion by September 2024 and Phase II enrollment projected to finish by Q2 2025.
  • Financial position: Reported a net loss of ~$30 M in 2023 (vs. $27.3 M in 2022) and ended the year with $35.8 M in cash and equivalents, which is expected to fund operations into Q4 2024.
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