Q2 2024 INmune Bio Inc Earnings Call
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Speaker Change: Greetings and welcome to the INmune Bio second quarter 2024 earnings call.
Speaker Change: At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question and answer session. You may register to ask a question over the phone at any time by pressing the star and 1 on your telephone keypad.
Speaker Change: As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. David Moss, CFO of INmune Bio. David.
David Moss: Thank you, Operator, and good afternoon, everyone. We thank you for joining us for the call for INmune Bio's second quarter 2024 financial results.
Speaker Change: With me on the call today are Dr. R.J. Tesi, CEO and Co-Founder of INmune Bio, and Dr. Mark Lowdell, Chief Scientific Officer and Co-Founder of INmune Bio, who will provide an update on INCMUNE, our memory-like natural killer cell oncology platform.
Speaker Change: Also on the call is Dr. C.J. Barnum, Head of Neuroscience, who will provide some details on our ongoing Phase 2 Alzheimer's study.
Speaker Change: Before we begin, I remind everyone that except for statements of historical facts, the statements made by management in response to questions on this conference call are forward-looking statements under the Safe Harbors provisions of the Private Securities Litigation Reform Act of 1995.
Speaker Change: These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward-looking statements.
Speaker Change: 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.
Speaker Change: There is no assurance of any specific outcome. Undue reliance should not be placed on forward-looking statements which speak only as to the date they're made as the facts and circumstances underlying these forward-looking statements may change.
Operator: Unless as required by law, INmune Bio disclaims any obligation to update these forward-looking statements to reflect future events or circumstances. With that behind us, now it's my pleasure to turn the call over to Dr. R.J. Tesi.
ImmuneBio: Accept as required by law, INmune Bio disclaims any obligation to update these forward-looking statements to reflect future information events or circumstances.
ImmuneBio: With that behind us, now it's my pleasure to turn the call over to Dr. R.J. Tesi. R.J.
R.J. Tesi: Thank you, David, and good afternoon to everyone.
R.J. Tesi: We will keep our prepared remarks brief. I will review the key takeaways from the second quarter, relevant news from recent weeks.
R.J. Tesi: and provide updates on our platform programs. I will then pass it to C.J. Barnum, VP of CNS Drug Development, for more details on the ongoing Phase 2 trial on Alzheimer's disease.
Raymond Tesi: Dr. Mark Lowdell will follow with Alzheimer's Disease Diagnosis and Treatment. We don't know if the EU's decision is going to be unique to leucanomab or affect other drugs in the anti-amyloid class. But at this meeting, there is conscious hope for the future of therapeutic options for patients with Alzheimer's disease. Much excitement has been focused on the anti-inflammatory treatment strategies, and obviously, we like to think we are leaders in this particular area. Independent third-party statisticians and neuropsychologists have determined the ADO-2 trial is appropriately powered and concluded the trial design, operational execution, data collection, and management are of the highest quality.
Speaker Change: Dr. Mark Lowdell will follow with an update on our INCMURN program in prostate cancer and David Moss will conclude with a review of our financial results for the second quarter before we take your questions.
Speaker Change: Since our first quarter conference call in May, we continue to make steady progress in both clinical programs. Before I comment on our AD, on our program in AD, or in Alzheimer's disease,
Speaker Change: I want to make a couple comments about the rapidly changing landscape of Alzheimer's disease diagnosis and treatment.
Speaker Change: Just in the last month, a second drug, Donanumab, was approved for the treatment of Alzheimer's disease.
Speaker Change: It is an anti-amyloid drug.
Speaker Change: And it does have a black box warning for highlighting the increased risk of AREA, which is edema in the brain, in patients with two copies of ApoE4 gene.
Speaker Change: Last week, the EU regulatory authorities did not approve the Assay Biogen's drug Leucanomab for the treatment of Alzheimer's disease.
Speaker Change: We don't know if the EU's decision is going to be unique to Leucanomab or affect other drugs in the anti-amyloid class.
Speaker Change: Today, the last day of AIC in Philadelphia. AIC is the Alzheimer's Disease International Conference, which is the largest meeting in AD that occurs every year.
Speaker Change: But at this meeting, there is conscious hope for the future of therapeutic options for patients with Alzheimer's disease.
Speaker Change: and a lot of discussion about alternatives to amyloid therapy.
Speaker Change: People understand the risk and efficacy profile of this class of drugs, and they look forward to other options in the future.
Speaker Change: Much excitement was focused on the anti-inflammatory treatment strategies and obviously we like to think we are leaders in this particular area.
Speaker Change: All in all, it was a very bullish meeting for X-Pro and Alzheimer's disease.
Speaker Change: In June , we completed a plant-blinded interim analysis of ADO2, our Phase 2 trial of X-Pro.
Speaker Change: in patients with neuro early Alzheimer's disease with biomarkers of inflammation. The purpose of the analysis was to evaluate the power and performance characteristics of the primary endpoint.
Speaker Change: The primary endpoint is EMAC, which is Early Mild Alzheimer's Cognitive Composite Score.
Speaker Change: Independent third-party statisticians and neuropsychologists determined the ADO-2 trial is appropriately powered and concluded the trial design, operational execution, data collection, and management are of the highest quality.
Speaker Change: As of today, we have many patients in the screening process and pipeline and are on track to reach full enrollment of this trial by the end of September .
Speaker Change: We eagerly await top-line data readout on the primary endpoint approximately six months later, or excuse me, approximately six months after the last patient is enrolled.
Speaker Change: At AAIC this week, we presented additional data on the effects of X-Pro in the brain of patients with Alzheimer's disease.
Speaker Change: The data demonstrate Expo's direct impact on synaptic proteins and provide
Speaker Change: Biologic support for the improvement in synaptic function that we recently demonstrated with EEG. I remind you that synapses are the...
Speaker Change: are the
Speaker Change: The things that allow nerve cells to talk to each other and they are a critical part of neurologic disease in general and Alzheimer's disease specifically.
Speaker Change: These data are another example of how Xpro normalizes the brain's immune system to improve the biology of the aging brain.
Speaker Change: That includes less neurodegeneration, that's nerve cell death, increased remyelination, and improved synaptic function. We predict the ongoing Phase II trial will demonstrate these biologic benefits correlate with cognitive benefits.
Raymond Tesi: We predict the ongoing Phase 2 trial will demonstrate these biologic benefits correlate with cognitive. The data show the unique ability of INmune to create cancer-killing memory like NK cells in situ, in situ meaning within the patient's blood system, using NK cells of their own. For now, I'll turn it over to C.J. Barnum, VP of CNH Drug Development, to provide a more in-depth discussion of our ongoing Phase 2 trial in patients with Alzheimer's disease. C.J.?
Speaker Change: The importance of controlling neuroinflammation extends well beyond Alzheimer's disease, and we continue to move forward with our plans to initiate a treatment-resistant depression phase two study. The trial is sponsored by the NIH, and we expect to enroll patients later this year.
Speaker Change: Inge Meehan, our novel NK-focused cancer program, also continues to make progress. We announced the publication of the paper in the prestigious high-impact Journal of Immunotherapy of Cancer.
Dr. Lowdell: The data show the unique ability of INmune to create cancer-killing memory like NK cells in situ, in situ meaning within the patient's blood system, using NK cells of their own. Dr. Lowdell will provide more detail on this in a moment.
Speaker Change: We're excited by these data and their implications for treating multiple types of solid tumors with INCM in the future.
Speaker Change: We plan to provide patient-level data from the ongoing Phase 1-2 trial and cachet-resistant metastatic prostate cancer later this year.
C.J. Barnum: For now, I'll turn it over to C.J. Barnum, VP of CNH Drug Development, to provide a more in-depth discussion of our ongoing Phase II trial in patients with Alzheimer's disease. C.J.?
C.J. Barnum: Thank you, RJ. As you said, I'd like to take some time to discuss the ongoing phase two trial in Alzheimer's and the recent unblinded analysis we performed.
C.J. Barnum: The clinical trial is powered on the Clinical Dementia Rating Scale, or CDR, and is using both EMAC and CDR as our primary and key secondary endpoints, respectively.
Speaker Change: These clinically valid endpoints were chosen based on their ability to accurately assess cognition in our target population of early Alzheimer's patients with biomarkers of inflammation.
C.J. Barnum: It's our belief that patients on expo for the treatment of early AV will have stable or possibly improved cognition, and our endpoints were selected to give us the best chance of a successful outcome.
Speaker Change: It's our belief that patients on expro for the treatment of early AV will have stable or possibly improved cognition and our endpoints were selected to give us the best chance of a successful outcome.
Speaker Change: As RJ said, we are close to completing enrollment.
RJ: This has admittedly taken slightly longer than originally forecast, and I think it's important to address why that is the case as it plays right into why we believe we'll get a positive result.
Speaker Change: At INmune, we are running the first clinical trial in Alzheimer's using biomarkers as selection criteria. Our trial is designed to have a small enrollment and a very short duration.
Speaker Change: Smaller studies require higher quality data to minimize the impact of variants.
Speaker Change: As such, patient selection is key to success. We need to enroll patients who are not only likely to benefit from our therapy, but are also highly likely to complete the duration of the trial. This selectivity leads to a slower enrollment process.
Speaker Change: We could easily relax our criteria to speed enrollment, however, there is a tradeoff between speed and quality. We are very biased towards the latter.
Speaker Change: This focus on execution is demonstrated through the recently completed blinded interim analysis of our data.
Speaker Change: As that independent evaluation revealed, and I quote, the assumptions made during the planning are being met within the conduct of the trial. In other words, the EMAC is performing exactly as expected.
Speaker Change: This is a testament to our operational and clinical teams who continue to exceed my expectations in executing a trial of the highest quality.
Speaker Change: While the final results from the trial have yet to be determined, I can say with great confidence that the trial is being conducted in such a way that, at completion, we will know without a doubt if we have a successful therapy.
Mark: With that, I'll turn the microphone over to Mark to discuss the INCME program, and I look forward to answering questions investigators might have about the Alzheimer's program. Mark?
Mark: Thanks CJ and good afternoon everybody. Thank you for joining us. As INmune announced recently, together with several of my colleagues, I was pleased to lead the publication of a landmark paper entitled Proteomic and Phenotypic Characteristics of Memory-like Natural Killer Cells for Cancer Immunotherapy, which as RJ said, was published in the Journal for the Immunotherapy of Cancer.
Mark Lowdell: As INmune announced recently, together with several of my colleagues, I was pleased to lead the publication of a landmark paper entitled Proteomic and Phenotypic Characteristics of Memory-Like Natural Killer Cells for Cancer Immunotherapy, which, as RJ said, was published in the Journal for the Immunotherapy of Cancer. However, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that NK cells from cancer patients can be primed with INmune and are equally as potent as those generated from healthy volunteers, providing further support for our in vitro treatment strategy. This research also provides new insights into the metabolic and proteomic mechanisms underlying NK cell memory, paving the way for innovative treatments in both haematological malignancies and, more importantly for us, multiple solid tumors.
Speaker Change: So in this study, we demonstrated that memory-like natural killer cells, or MLNK cells, generated by INmune are the same as the more traditional cytokine-driven MLNK cells, and both type of NK cells show increased cytotoxicity against multiple tumor types.
Mark: However, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that NK cells from cancer patients can be primed with INmune and are equally as potent as those generated from healthy volunteers.
Speaker Change: providing further support for our in vivo treatment strategy.
Mark: This research also provides new insights into the metabolic and proteomic mechanisms underlying NK cell memory, paving the way for innovative treatments in both hematological malignancies and, more importantly for us, multiple solid tumours.
Mark: But this is an area of NK cell biology research that is evolving very rapidly, and our study is the first to identify the unique characteristics of mRNA NK cells.
Mark: Most significantly, the study is the first to report in-vivo generation of MNNK cells, as RJ said, and that's something which cannot be done with the cytokine cocktail used in vitro by other groups because of the toxicity of the cytokines.
Speaker Change: So our research successfully showed that these MLNK cells, primed by INmune, can be found in patients' blood after they've been treated with the drug, which is a critical step in improving our claimed mechanism of action.
Mark: We also believe this points ways to enhance the potential of MLNK cells in further advances in cancer immunotherapy.
Mark: Our paper highlighted the improved metabolic function of MNNK cells, which predicts better performance in the tumor microenvironment, or TME.
Mark: We believe these findings are particularly noteworthy, as NK cell dysfunction in the TMA has been reported by many others to be due to impaired metabolic function.
Mark: So showing that INkmune priming can overcome these metabolic barriers encourages our belief that INkmune will target solid tumors and this is further supported by our observation in the same paper that INkmune priming increases survival proteins and nutrient receptors expressed on NK cells.
Unnamed Speaker: And this combination of changes following immune priming is exciting for our ongoing clinical trial in metastatic castration-resistant prostate. Elsewhere in our INcMUNE development program, we're pleased to announce a new formulation of INcMUNE that supports the highest trial dose with a single bag administration, which makes it much more easily delivered in the clinic, and the expansion of our bioreactor capacity in preparation for more scalable manufacturing. So an IND amendment to the FDA with the improved formulation has been submitted.
Mark: And this combination of changes following immune priming is exciting for our ongoing clinical trial in metastatic castration-resistant prostate cancer.
Speaker Change: This research study was a commercial and academic collaboration led by INmune over many years and we were delighted to see the results of the work published in a high-impact peer-reviewed scientific journal.
Mark: Elsewhere in our INcMUNE development program we're pleased to announce a new formulation of INcMUNE that supports the highest trial dose with a single bag administration.
Mark: which makes it much more easily delivered in the clinic, and the expansion of our bioreactor capacity in preparation for more scalable manufacturing.
Mark: So an IND amendment to the FDA with the improved formulation has been submitted, it also includes additional validation data supporting an alternative critical reagent used in the manufacture of INMUNE to improve our supply chain redundancy.
Unnamed Speaker: It also includes additional validation data supporting an alternative critical reagent used in the manufacture of INMUNE to improve our supply chain redundancy. All of these seem minor, but they're essential steps in preparation for commercial development and supply of the drug.
Mark: And all of these seem minor, but they're essential steps in preparation for commercial development and supply of the drug.
Mark: Since our last call we've completed the first cohort in our phase 1, phase 2 open-label trial of INcmune in metastatic castrate-resistant prostate cancer called CARE-PC.
Mark: Following review by the Safety Review Committee, approval was granted to proceed with the second dose level, cohort 2, and we're nearly halfway through that cohort, with patients in line waiting to be recruited.
Mark: Data from this open labelled trial are expected to be released intermittently as they become available from us.
Mark: But most importantly at the moment, the safety record of INcmune remains excellent. There have been 12 administrations of INcmune in the CARE-PC study, given as an outpatient, with no significant adverse events and zero cases of cytokine release syndrome.
Mark: and combining those data with the experience for INcMUNE from the MDS AML trial, over 25 infusions of INcMUNE have now been given safely without the need for conditioning therapy, pre-medication or cytokine support.
David Moss: So that ends my update on the INkmune platform and I'd like to turn the call over to David Moss, our CFO , to discuss financials. David.
David Moss: Thank you, Mark. As usual, I'll provide a brief overview of our financial results and upcoming milestones before we head to our Q&A session.
Unnamed Speaker: During our second quarter, we were pleased to have raised approximately $14.5 million in gross proceeds from two separate equity offerings over the past weeks at an average price of $8.35 and $9.84 per share, compared with approximately 2.3 million for the comparable period in 2023. Although we have secured additional funding, as always, we continue to focus on achieving our primary clinical objectives while remaining cost prudent with the potential to recover a portion of R&D expenses in Australia and the UK. In summary, we secured a meaningful equity infusion. At this point, I'd like to turn the microphone back to RJ to conclude our prepared remarks and then go to Q&A. RJ?
David Moss: During our second quarter, we were pleased to have raised approximately $14.5 million in gross proceeds from two separate equity offerings over the past weeks at an average price of $8.35 and $9.84 per share.
Mark: In the two transactions, the company issued an aggregate of approximately 1.558 million shares of common stock and warrants to purchase an aggregate of approximately 1.558 million shares of common stock.
Mark: The warrants have a two-year term with acceleration on positive phase 2 data from our AD program Which if exercised would raise additional cash for the company
Speaker Change: In the first approximate 4.8 million raise, management employees and members of the board of directors purchased over a million dollars in stock. I cannot underscore how financially committed and aligned the entire INmune team is to the success of the company.
Speaker Change: We greatly appreciate the support we saw on both offerings from mostly existing investors and our team here at INmune Bio, but we also welcome a few notable holders to the registry, including a sole investor in the approximately $9.7 million offering, a person that I've had a relationship with for more than a decade.
Mark: In addition, we received approximately $2.5 million in R&D rebates in July as we continue to manage our shareholder resources carefully while completing our clinical programs.
Mark: Now moving on to financials.
Mark: Net loss attributable to common stockholders for the quarter that ended June 30, 2024 was approximately $9.7 million, compared with approximately $6.5 million for the comparable period in 2023.
Mark: Research and development expense totaled $7.1 million for the quarter ended June 30th, 2024, compared with approximately $4.1 million for the comparable period in 2023.
Mark: General and administrative expenses were approximately $2.8 million for the quarter ended June 30, 2024, with approximately $2.8 million.
Mark: compared with approximately $2.3 million for the comparable period in 2023. As of June 30, 2024, the company had cash and cash equivalents of approximately $31.1 million. Based on our current operating plan, we believe our cash is sufficient to fund our operations into 2025.
Mark: As of August 1st, the company had approximately 19.8 million shares of common stock outstanding.
Mark: Effective as of July 1st, the company joined the Russell 3000 Index as part of its 2024 reconstitution, a positive development for our company and our shareholders that we believe will increase our visibility within the investment community and help broaden our shareholder base.
Mark: This is the first significant index the company has joined since going public in 2019.
Speaker Change: in early Alzheimer's, treatment-resistant depression, and metastatic castration-resistant prostate cancer.
Mark: Now I'd like to focus on some key upcoming milestones.
Speaker Change: As R.J. and C.J. have mentioned, we expect full enrollment in our Phase 2 X-Pro trial for the treatment of neuroinflammation as a cause of Alzheimer's disease.
Speaker Change: before the end of Q3 and top-line data is expected to read out approximately six months from the last patient enrolled.
Speaker Change: We will initiate a Phase 2 trial of X-Pro in patients with treatment-resistant depression in the second half of 2024.
Speaker Change: We expect to complete enrollment in the second cohort in the metastatic castration-resistant prostate cancer by the end of Q3-24.
Speaker Change: and complete the phase one.
Speaker Change: Mark Lowdell, David Moss
Speaker Change: Although we have secured additional funding, as always, we continue focus on achieving our primary clinical objectives while remaining cost-prudent with the potential to recover a portion of R&D expenses in Australia and the UK.
Speaker Change: In summary, we secured a meaningful equity infusion.
Speaker Change: that puts us in a good position into 2025 with our focus remaining on execution. At this point, I'd like to turn the microphone back to RJ to conclude our prepared remarks and then go to Q&A. RJ?
RJ: Yes, thank you, David. This is an exciting time for the company. The therapeutic landscape of Alzheimer's disease is changing rapidly.
Speaker Change: And the changes are making the Expo program in Alzheimer's disease more...
Speaker Change: I guess the right word is relevant. As people get frustrated with
Speaker Change: The anti-amyloid strategies, they look towards neuroinflammation as a potential way to improve patients' lives.
Raymond Tesi: We expect to be reporting meaningful data from both the X-PRO and INMUNE programs in what now seems to be the near future. Each of our programs has a strong scientific foundation, and our clinical trials are designed to take advantage of the unique biology each drug brings.
Speaker Change: We expect to be reporting meaningful data from both the X-Pro and INMUNE programs in what now seems to be the near future.
Speaker Change: Each of our programs has a strong scientific foundation. Our clinical trials are designed to take advantage of the unique biology each drug brings to patients.
Speaker Change: The company has funding to see the development through important milestones and we are grateful for the strong and committed shareholder base that continues to support INmune Bio.
Speaker Change: And in particular, we thank those who have invested alongside us in management as we work to achieve our goals.
Speaker Change: So now I'd like the operator to poll for questions.
Speaker Change: At this time, if you'd like to ask a question, please press the star and 1 keys on your telephone keypad. Keep in mind, you may remove yourself from the question queue at any time by pressing star and 2.
Speaker Change: Again, it is star and one if you would like to ask a question today.
Speaker Change: And we'll take our first question from Tom Shrader with BTIG. Please go ahead, your line is open.
Tom Schrader: Good afternoon, thanks for taking the questions. Congratulations on all the progress. I wanted to ask a kind of a remedial question first on the synaptic markers.
Tom Schrader: And one of the most exciting things at AAIC is Phospho-Tau as a temporal treatment marker. Where do synaptic markers fit in there? Are they early? Are they late? You know, you've done a lot of work to measure them. Are they useful treatment markers? I'm going to have an inconvenient follow-up. Thank you.
Speaker Change: DJ, I'll let you handle this one. It's a fairly sophisticated question. Go ahead.
Tom Schrader: Thanks, RJ. Hi, Tom.
Speaker Change: So, I'm not sure they're a long-term solution as it relates to biomarker measurement. It's something you can do if you collect CSF, which is where the analysis was performed. It hasn't really translated to blood yet. But what we know about...
Speaker Change: synaptic proteins and synaptic dysfunction and synaptic loss in Alzheimer's. We've actually known for quite a while there's been a little bit of a resurgence to this at this point and and I think that's
Speaker Change: That's something that...
Speaker Change: The other thing is it aligns really nicely with EEG, so changes in EEG are likely to be subserved by
Speaker Change: changes at the level of the synapse.
Speaker Change: as opposed to an improvement.
Speaker Change: and, uh, you know...
Speaker Change: cell building or even axons as well. It tends to be a little bit faster, but EEG is a nice surrogate outcome for that. I would say that while they're great, they add to the story. They're probably not a long-term biomarker solution, but it does reinforce the biology.
Speaker Change: of what we understand X-Pro can do. And I think that's really exciting to us because it targeted really what we were able to show is that we saw broad changes and networks of proteins that are critical for symaptic function.
Speaker Change: So, to us, it's another biomarker to help support our decision-making and that the biology is aligning as we expect. But I don't know, aside from maybe EEG in the future, that the biomarker proteins themselves are particularly useful in later stages.
Mark Lowdell: And then Mark...
Speaker Change: Got it. And then Mark...
Speaker Change: Where are you or is it a priority to try to understand what is in INcMune that's driving the biology? It sounds like from the cytokine profile it's not a cytokine.
Speaker Change: which suggests it might be an additive with cytokines, but do you have a sense of what it is? Is it a lot of things? Is it something that you might purify? Where are you on understanding what exactly INmune depends on?
Speaker Change: Yeah that's a very good question and I wish I knew all of the answers but we've been looking at INmune since 2005 so we've done a lot of work.
Speaker Change: and we initially thought, exactly as you've alluded to, that we could find the magic signals that INmune gives to the NK cell and make them artificially.
Speaker Change: What we did publish back in 2011 was that INmune is a cell, and obviously it has millions of molecules on its surface, and those molecules, we found three that were absolutely critical to its function, and they're published.
Speaker Change: What we tried to do was to produce an artificial version of those.
Speaker Change: and we were able to do that, but we could never get the concentrations. So imagine you've got three variables, each of those can be at different intensities, and we could never get the intensities right to be as good as the natural cell.
Speaker Change: The other thing that INmune has that you could not reproduce artificially is that when INmune binds to the NK cell
Speaker Change: Like any tumor cell, the NK cell rips a membrane out of INkmune, so INkmune is just a replication incompetent tumor cell.
Speaker Change: and it's the ripping out of that membrane, it's called trogocytosis.
Speaker Change: and its incorporation into the NK cell, which allows the NK cell that's been primed by INkmune not only to function, but to go on and prime other resting NK cells, and we believe that's why we see such a long tail of effect after just three injections.
Unnamed Speaker: So we haven't been able to find a way of producing an artificial version of INkmune; it's certainly a complex raft of proteins that come from the surface of the INkmune cell, and they are incorporated into the NK cell in a way that making them artificially just wouldn't be able to provide that function.
Speaker Change: So, we haven't been able to find a way of producing an artificial version of INkmune.
Speaker Change: It's certainly a complex raft of proteins that come from the surface of the INK immune cell and they are incorporated into the NK cell in a way that making them artificially just wouldn't be able to provide that function.
Speaker Change: Having said that, INmune is very cheap to manufacture and easy to ship.
Speaker Change: Yeah and just I want to re-emphasize your point about cytokines Tom because you know we think one of the really big deals about INmune is that it doesn't require cytokines.
Unnamed Speaker: because, as you said, the safety profile is markedly improved, and, as Mark just implied, the cost.
Speaker Change: [inaudible]
Speaker Change: Got it. Okay. Thank you.
Speaker Change: And as a reminder, if you'd like to ask a question, please press the star and one keys on your telephone keypad. We'll take our next question from George Farmer with Scotiabank. Please go ahead, your line is open.
Unnamed Speaker: Hi, good afternoon. Thanks for taking my questions. Um, you mentioned, uh, you know, the way you're enriching for enrollment in the Phase 2 AD trial, uh, uh, two things. One is, um, selecting patients with specific biomarkers that, um.
Speaker Change: Hi, good afternoon. Thanks for taking my questions. Um, you mentioned, uh, you know, the way you're enriching for enrollment in the Phase 2 AD trial, uh, uh, two things. One is, um, selecting patients with specific biomarkers that, um,
George Farmer: that would indicate a higher inflammatory state, and then also patients who will likely complete the study. The first one is understandable, but how are you enriching for the second?
Speaker Change: CJ
Speaker Change: Yeah, so this is a great question, and there's really a couple answers to that, and what I gave you was a simplified, what you got was a simplified explanation.
Speaker Change: So the study itself, because we opted to go for a shorter study, six months, requires quite a bit of monitoring, probably much more so on a, you know, per day or per week basis.
Speaker Change: if you will, than you would see in other studies. There are some times where patients...
Speaker Change: and other studies, they need to come in, you know, once a month, and in our study, you need to come in at least once a week.
Speaker Change: and we're doing multiple measurements as well. And so that can be quite challenging for some patients to come in and do that. And so a lot of times what will happen is you enroll a patient and you end up with patients that, you know, miss visits or they end up leaving the study early. And of course that creates problems as it relates to data analysis.
Speaker Change: So, what we try to do at the very beginning is really have the conversation with the patients, let them, you know, get them to understand that the commitment
Speaker Change: is pretty high. And, you know, we really need their participation to to make sure that they can complete all of those different things.
Speaker Change: And I think to the testament of our investigators, they've done a really good job to make sure that the patients that get into the trial are really willing to make that commitment. And we're seeing that in our...
Speaker Change: and our retention rate as well. But we have had a number of patients at the beginning that say, you know what, I'm not sure that I can do that. And from our perspective, it's easier for us to move on. The other thing, the other aspect of that is
Speaker Change: We're a little more rigid as it relates to the clinical diagnosis criteria.
Speaker Change: of MCI and Mild AD, then we would normally be, again, because we have a small study. And believe it or not, there's quite a bit of variance across investigators in what Mild AD is and what MCI is.
Speaker Change: In terms of diagnosis and in order to compare apples to apples, we have to try to homogenize that that's not a problem when you get to a
Speaker Change: Phase 3 study where you have more patients. You can relax some of that criteria, but those two things really do Force us to slow enrollment and be more selective for patients and it takes a little bit longer The biomarker enrichment as relates to inflammation is about what we expected it to be I don't have the exact numbers on hand right now But it is somewhere around 40 to 55 percent of those patients that show up have those biomarkers
Unnamed Speaker: And then regarding those biomarkers, how do those patients fair relative to the general population with respect to, say, baseline?
Speaker Change: And then regarding those biomarkers, how do those patients
Speaker Change: They are relative to the general populations with respect to baseline characteristics.
Speaker Change: In terms of their, for example, their cognitive, yeah, yeah.
Unnamed Speaker: So good question. Obviously, I don't have that exact data for the study here, but generally speaking, what I can tell you is patients that have biomarkers of inflammation, if you look at the registry databases, they have more severe disease, and they have faster-progressing disease. And what's really unusual and really works in our favor is that the variance in progression between patients that have these biomarkers is smaller. So this allows us again to do these shorter trials with fewer patients.
Speaker Change: Okay, thanks very much.
CJ Barnum: And we have received a question from the web. It reads, CJ, you seem excited about the interim data. How does this update, even though it's blinded, give you insight into how the trial is progressing?
Unnamed Speaker: Yeah, so
CJ Barnum: Yes, so this is a great question and I get this, I've gotten this question quite a bit is, you know, why is blinded data so exciting? I think, you know,
Unnamed Speaker: You only have the data that's available to go on to do that. And of course, that's a sample. And so the biggest question is, was to me, A, do we have the right test? Can we capture those things? And is it performing as we expect? In other words, are we going to be able to, is it accurately powered? And not only see that
Operator: And there are no further questions on the line at this time. I'll return the call to Dr. Tesi for any additional or closing comments.
Speaker Change: The patient's out there, I mean, and you don't, you.
Speaker Change: You only have the data that's available to go on to do that.
Speaker Change: A, do we have the right test?
Speaker Change: Can we capture those things?
Speaker Change: and is it performing as we expect? In other words, are we going to be able to, is it accurately powered? And to not only see that.
Speaker Change: help us with. It really is incredible and what I can tell you is the independent consultants that we had, neuropsychologists that reviewed this, said this is the highest quality data that they've seen and that's all you can ask for. It means we have done absolutely everything we can do within our control and that's what really excites me about that.
Speaker Change: And there are no further questions on the line at this time. I'll return the call to Dr. Tesi for any additional or closing comments.
Speaker Change: The Alzheimer's space is added by the intrigue of honest disagreements on the value of recently approved drugs.
Raymond Tesi: And INcmune brings a unique perspective. Both of our platforms also show promise beyond their current indications. You've talked about treatment-resistant depression and Alzheimer's with Expo and other solid tumors.
Speaker Change: arena because of its safety profile. There are drugs in development for metastatic castrate-resistant prostate cancer, but you're not talking about young patients and these drugs.
Speaker Change: Cocktails tend to be quite toxic, so safety matters in patients like that.
Speaker Change: Look no further than our website to see more than 80 publications that point to the many uses of these drugs.
Speaker Change: We are grateful for shareholder support.
Speaker Change: We believe the future is bright.
Speaker Change: Thank you.
Speaker Change: [inaudible]
Operator: ? ? ? ? ? ? ? ? ? ?
Speaker Change: ♪♪ ♪♪ ♪♪ ♪♪ ♪♪