Q1 2024 INmune Bio Inc Earnings Call

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Operator: Greetings, and welcome to the INmune Bio first quarter 2024 earnings call. At the end of the presentation, there will be a question and answer session. To ask a question, you will need to press star 1 on your telephone keypad. As a reminder, this conference is being recorded. A transcript will be available within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. David Moss, CFO of INmune Bio. David

Greetings and welcome to the immune bio first quarter 2024 earnings call.

Operator: At the end of the presentation, there will be a question and answer session to ask a question you will need to press star one on your telephone keypad.

Operator: As a reminder, this conference is being recorded a transcript will fall within 24 hours of this conference call.

Operator: At this time, it's my pleasure to introduce Mr. David Moss, CFO I Didnt Nubile David.

David J. Moss: Thank you, James, and good afternoon everybody. We thank you for joining us for the call for INmune Bio's first quarter 2024 financial results. With me on the call is 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 INMUNE, our memory-like natural killer cell onc

David J. Moss: Thank you James and good afternoon, everybody. We thank you for joining us for the call for immune Bio's first quarter 'twenty 'twenty four financial results with me on the call is Doctor RJ, <unk>, CEO and co founder of Indian bile and Dr. Mark Hood, Our Chief Science Officer, Scientific officer, and cofounder be nubile, who provided in <unk>.

David J. Moss: Update on it being a memory like natural killer cell oncology platform.

David J. Moss: 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 expressed in such forward-looking statements. Please see the forward-looking statements disclaimer in the company's earnings release, as well as the risk factors in the company's SEC filings, including our most recent quarterly filings with the SEC.

David J. Moss: 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 <unk>.

David J. Moss: Pivot Securities Litigation Reform Act of 1995.

David J. Moss: These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward looking statements.

David J. Moss: 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.

David J. Moss: 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, INmune Bio disclaims any obligation to update these forward-looking statements to reflect future events or circumstances. With that behind us, now I'd like to turn the call over to Dr. R.J. Tesi, CEO of INmune Bio. R.J.

David J. Moss: Theres no assurance of any specific outcome.

David J. Moss: Undue reliance should not be placed on forward looking statements, which may which speak only as of the date. They are made as the facts and circumstances underlying these forward looking statements may change.

David J. Moss: Except as required by law immune bio disclaims any obligations to update these forward looking statements to reflect future information events or circumstances.

Speaker Change: With that behind US now I'd like to turn the call over to Doctor RJ Test D. C E O the nubile RJ.

Raymond Joseph Tesi: 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 first quarter and the subsequent period and provide updates on our platform program. I will start by reviewing developments in Expo 5, and then pass it over to Mark Lowdell, who will update us.

Raymond Joseph Tesi: Thank you David and I, thank everyone for joining the call.

Raymond Joseph Tesi: As usual I'll arrange my remarks will highlight key takeaways from the first quarter and the subsequent period.

Mark William Lowdell: I'll provide updates on our platform programs I will start by reviewing developments in the X Pro platform and then pass it over to Mark who will update the E&P program.

Raymond Joseph Tesi: David will conclude with a discussion of our financial results, including some commentary around the recent equity capital infusion, and provide an update on the future. At a high level, steady progress on all fronts has continued over the last six weeks. Since we held our fourth quarter conference call in, we continue to enroll patients globally in our early... phase 2 trial for Alzheimer's disease called ADO2, and we expect to meet our target enrollment by mid-2020.

Raymond Joseph Tesi: David will conclude with a discussion of our financial results, including some commentary around the recent equity capital infusions.

Raymond Joseph Tesi: And provide an update on upcoming milestones.

Raymond Joseph Tesi: At a high level steady steady progress on all fronts has continued over the last six weeks since we held our fourth quarter conference call in March.

Raymond Joseph Tesi: We continue to enroll patients globally and our early.

Raymond Joseph Tesi: Phase two trial in Alzheimer's disease called <unk> two and.

Raymond Joseph Tesi: And we expect to meet our target enrollment by mid 'twenty 'twenty four.

Raymond Joseph Tesi: 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.

Raymond Joseph Tesi: Clinical trial sites continue to enroll patients at a good clip and we were able to reiterate our commitment.

Raymond Joseph Tesi: To complete enrollment midyear.

Raymond Joseph Tesi: I know you want to know the exact date of our last patient enrollment.

Raymond Joseph Tesi: 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.

Raymond Joseph Tesi: We will let everyone know.

Raymond Joseph Tesi: Like you, we eagerly await the conclusion of Phase 2 and the corresponding data readout that will occur about six months or so after that last patient is enrolled. Recently, we provided an update on the long-term use of X-Pro in patients with Alzheimer's. And in that press release a week ago, we described two patients who participated in the Australian Phase 1 trial, one with MCI and the other with mild. [inaudible] Both have been taking Expo for roughly three years.

Raymond Joseph Tesi: Like you, we eagerly await the conclusion of the phase two and of course down the data readout will occur about six weeks six months or so after that last patient is enrolled.

Raymond Joseph Tesi: Recently, we provided an update on the long term use of EXPAREL in patients with Alzheimer's disease.

Raymond Joseph Tesi: And in that press release, a week ago, we described two patients who.

Raymond Joseph Tesi: Participated in the Australia and phase one trial.

Raymond Joseph Tesi: One with Mci and the other with miles.

Raymond Joseph Tesi: Actually moderate Alzheimer's disease.

Raymond Joseph Tesi: Both have been taking X broker roughly three years.

Raymond Joseph Tesi: Due to the rules of clinical development in Australia, we cannot communicate directly with the patient, but the anecdotes that we get from their treating physicians highlight the positive impact of Expro on the patient's cognitive health and overall quality. 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 Expro in patients suffering with early AIDS. Obviously, this is a small sample, but the results speak for themselves.

Raymond Joseph Tesi: Due to the rules of our clinical development in Australia, we cannot communicate directly with patients.

Raymond Joseph Tesi: But there are ana, but the anecdotes that we see from their treating physicians highlighted the positive impact of EXPAREL on there the patients cognitive health.

Raymond Joseph Tesi: Overall quality of life.

Raymond Joseph Tesi: If you haven't used the video links associated with that press release I strongly encourage you to.

Raymond Joseph Tesi: So as they exemplify what we are trying to achieve.

Raymond Joseph Tesi: With EXPAREL in patients suffering with the early a D.

Raymond Joseph Tesi: Obviously this is a small sample, but the results speak for themselves.

Raymond Joseph Tesi: Long-term treatment with Expro in patients with Alzheimer's disease has been shown to be safe, well-tolerated, and has 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 three important elements of our ongoing Phase 2 trial. The elements are duration, size, and primary input.

Raymond Joseph Tesi: Long term treatment with <unk> in patients with Alzheimer's disease has been shown to be safe well tolerated and made a difference in the lives of these patients and their caregivers.

Raymond Joseph Tesi: Ongoing blinded randomized placebo controlled trials are a necessary step in the development process.

Raymond Joseph Tesi: And we believe we are helping these patients their families and their caregivers who live with this dreadful disease every day.

Raymond Joseph Tesi: We want to help you better understand three important elements of our ongoing phase II trial.

Raymond Joseph Tesi: Elements our duration.

Raymond Joseph Tesi: And primary endpoint I'll start with the S.

Raymond Joseph Tesi: I'll start with the primary endpoint, primary. The clinical trial is powered on a 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. The endpoint is acceptable to regular authorities, certainly in the U.S., and I would expect globally.

Raymond Joseph Tesi: Primary them.

Raymond Joseph Tesi: The clinical trial is powered on the cognitive.

Raymond Joseph Tesi: <unk> called C D R.

Raymond Joseph Tesi: <unk> is a validated endpoint that has been used in the recent phase III and anti amyloid trials will all result.

Raymond Joseph Tesi: And improvement improve all of those drugs.

Raymond Joseph Tesi: The endpoint is acceptable to regulate authorities certainly in the U S. We suspect globally.

Raymond Joseph Tesi: In our Phase 1 trial, 8 of the 9 evaluable patients had stable or better cognition at 3 years. Three of those patients had improved cognition, Two of those were highlighted in the recent press. We, and this is where we differ a little bit from what the other companies do.

Raymond Joseph Tesi: And the phase in our face.

Raymond Joseph Tesi: One trial eight of the nine evaluable patients had stable or better cognition at three months.

Raymond Joseph Tesi: Three of those patients had improved cognition two of those were highlighted in a recent press release.

Raymond Joseph Tesi: We and this is where we differ a little bit on what the other companies, who we believe some of the patients in a D O to.

Raymond Joseph Tesi: We believe some of the patients in ADO2 on X-ray will respond like those in the Phase 1 trial. We need to be able to measure clinical improvement. To do that, we needed better, more sensitive cognitive scales and CDR. That is why we're using it.

Raymond Joseph Tesi: On EXPAREL.

Raymond Joseph Tesi: I'll respond like those in the phase one trial.

Raymond Joseph Tesi: We need to be able to measure clinical improvement.

Raymond Joseph Tesi: To do that we need a better more sensitive cognitive scale and CVR.

Raymond Joseph Tesi: That is why are we using.

Raymond Joseph Tesi: EMAC will allow us to accurately determine if patients have improved cognitive function, and we believe that will be an important finding of the face to try. To be clear, the primary endpoint that will be used in the Phase III Pivotal Trial will come after discussion and after agreement with the regulatory bodies that we work with, including the FDA, EMA, and MHC. It may be CDR, or it may be EMA.

Raymond Joseph Tesi: E Mac will allow us to accurately determine if patients have improved cognitive function and.

Raymond Joseph Tesi: And we believe that will be an important finding.

Raymond Joseph Tesi: The phase III trial.

Raymond Joseph Tesi: To be clear the primary endpoint that will be used in the phase III pivotal trial will come after discussion and after agreement with the regulatory agencies that we work with including the FDA EMA and nature.

Raymond Joseph Tesi: It may be CD or where it may be.

Raymond Joseph Tesi: That decision will be driven by data and regulatory, not by INmune. The size and duration of ADO2, the Alzheimer's trial, are both smaller and shorter, respectively, compared to the other trials. This trial design was based on careful analysis of preclinical data, clinical data, and publicly available data. First, I want to make a personal statement as a clinician. This is me talking; this is not the company.

Raymond Joseph Tesi: That decision will be driven by data and the regulatory authorities not by any means.

Raymond Joseph Tesi: The size and duration of video to the Alzheimer's trial are both smaller and shorter.

Raymond Joseph Tesi: Secondly, compared to the.

Raymond Joseph Tesi: Other trials in Alzheimer's.

Raymond Joseph Tesi: This trial design was based on careful analysis of our fleet.

Raymond Joseph Tesi: Clinical data clinical data publicly available databases.

Speaker Change: First I want to make a personal statement as a clinician. This is me talking this is not the company, but when you put a patient into a clinical trial and they get randomized to placebo, we are asking that patients who allow their disease to progress under our care.

Raymond Joseph Tesi: 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 placebos and how long they're on them, because we're really not benefiting. The ADO-2 trial exposes patients to six months of placebo, which is just one-third of the time in the anti-amyloid treatment. They were 18 months old.

Raymond Joseph Tesi: In my opinion, we need to do everything possible to limit the number of patients who received placebo and how long they're on placebo.

Raymond Joseph Tesi: Because we're really not benefiting patients.

Raymond Joseph Tesi: The a D O two trial exposes patients to six months of placebo. This is just one third of the time and the anti amyloid trials. They were 18 months long.

Raymond Joseph Tesi: Shorter trials are good for patients, but is it bad for drug development?

Raymond Joseph Tesi: Georgia trials are good for patients.

Raymond Joseph Tesi: But is it bad for drug development in Alzheimer disease.

Raymond Joseph Tesi: And the answer is clear; it is not bad for Drug Development Analysis. ADO2 is fully powered to demonstrate a benefit at six months with X-Pro. And, in fact, you realize that both the Leucanomab and the Donimimab trials were statistically positive at 60. They could have stopped those trials at six months and had the same results that we have today. 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..., and this is where our unique trial was. Who I know is AB202 is the only house trial that uses enrichment criteria to enroll patients. ADO-2 in all early Alzheimer's patients with biomarkers

Raymond Joseph Tesi: And the answer is clear it is not that.

Raymond Joseph Tesi: For drug development announcements.

Raymond Joseph Tesi: <unk> is fully powered to demonstrate a benefit at six months with EXPAREL.

Raymond Joseph Tesi: And in fact, you realize that both of the Cana and the Dawn of me Mab trials were statistically positive at six months.

Raymond Joseph Tesi: They could have stopped those trials at six months and had the same results that we have.

Raymond Joseph Tesi: That is the drug therapy is better than placebo.

Raymond Joseph Tesi: There is nothing magical about an 18 month trial at 12 months.

Raymond Joseph Tesi: The issue of statistical power.

Raymond Joseph Tesi: And this is where our unique cloud was on that.

Raymond Joseph Tesi: So our knowledge ADT, Oh Tuesday, only Alzheimer's.

Raymond Joseph Tesi: While that uses enrichment criteria to enroll patients.

Raymond Joseph Tesi: A D O two enrolled early Alzheimer's patients with Biomarkers of inflammation.

Raymond Joseph Tesi: There is a biological and statistical advantage to this simple enrollment strategy. The biological advantage is that the mechanism of action of X-flow, targeting neuroinflammation, is matched to 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 statistical noise. That's a risky and expensive strategy.

Raymond Joseph Tesi: There is a biologic and statistical advantage to this simple enrollment strategy the biological advantages that the mechanism of action of EXPAREL targeting neuro inflammation is matched with the patients disease that is the pathology that's driving their cognitive decline.

Raymond Joseph Tesi: Browse the don't use enrichment gamble that a large number of patients treated for a long time, well overcome statistical noise.

Raymond Joseph Tesi: So that's a risky and expensive strategy.

Raymond Joseph Tesi: The benefits of enrichment are best seen in oncology drug development; oncology clinical trials are routinely used and recommended. [inaudible] This is called Precision Medicine. Precision medicine is the standard in clinical oncology drug development.

Raymond Joseph Tesi: The benefits of enrichment are best seen in oncology drug development oncology clinical trials routinely used in Richmond.

Raymond Joseph Tesi: Derisk clinical trial.

Raymond Joseph Tesi: This is called precision medicine.

Raymond Joseph Tesi: Precision medicine is the standard in clinical oncology drug development.

Speaker Change: Excuse me.

Raymond Joseph Tesi: It should be the standard in CNS drugs. We are using a precision medicine approach. The second advantage is statistical, and it's more subtle than this enrichment.

Raymond Joseph Tesi: It should be the standard in CNS drug development.

Raymond Joseph Tesi: We are using a precision medicine approach.

Raymond Joseph Tesi: The second advantage is physical and it's more subtle than this enrichment strategy patients.

Raymond Joseph Tesi: Patients with neuroinflammation with Alzheimer's disease progress more quickly and more reliably than patients without. This is kind of a terrible thing to say, but it's a biological reality, put in the language of a statistician who is critical in the design of the trial. The increased delta difference between placebo and active, and the lower variants provide important statistical advances. Overall, the trial is well-designed, de-risked, and relevant to Today's Patients Without Borders.

Raymond Joseph Tesi: Patients with neuro inflammation with Alzheimer's disease progress more quickly.

Raymond Joseph Tesi: And more reliably than patients without no information.

Raymond Joseph Tesi: It's kind of a terrible thing to say, but it's a biologic.

Raymond Joseph Tesi: Oh.

Raymond Joseph Tesi: Putting the language of a statistician, who are critical and design of the trial.

Raymond Joseph Tesi: The increase delta difference between placebo and active.

Raymond Joseph Tesi: Arm and the lower variance provide important physical advantages.

Raymond Joseph Tesi: Overall, the trial is well designed derisked and relevant to.

Raymond Joseph Tesi: Today's patients without.

Raymond Joseph Tesi: To be smart with drug and, Drug Supply, and Capital Resources, we have closed enrollment in the Phase 2 Open Label Extension. Remember, the open label extension was patients who were 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. This was a practical consideration by the government because having a large patient population on drugs for 12 months consumes both drugs and treasure.

Raymond Joseph Tesi: To be smart with drug in <unk>.

Raymond Joseph Tesi: Drug supply and capital resources, we have closed enrollment of the phase two open label extension.

Raymond Joseph Tesi: Remember the open label extension was patients we're going to be offered 12 months of therapy in an open label trial.

Raymond Joseph Tesi: As sort of a reward for being in the randomized blinded trial and also to give us additional safety and efficacy.

Raymond Joseph Tesi: This was a practical consideration by the company.

Raymond Joseph Tesi: Having a large patient population on drug for 12 months consumes both drug and treasury.

Raymond Joseph Tesi: The first question many ask is, what will the FDA do? I remind you that the Phase 2 trial is not a registration. The purpose of the Phase II trial is to demonstrate safety and efficacy of Xpro in the target population, patients with early AD, and biomarkers of the neuron. At the end of the phase two trial, we'll have end of phase two meetings with the regulatory authorities, where we will negotiate. The design of the Phase III cloud

Raymond Joseph Tesi: The first question.

Raymond Joseph Tesi: <unk>. Many asked is what will the FDA.

Raymond Joseph Tesi: I'll remind you the phase II trial is not a registration trial.

Raymond Joseph Tesi: The purpose of the phase two is to demonstrate safety and efficacy and the export of EXPAREL in the target population patients with early a D and biomarkers.

Raymond Joseph Tesi: <unk>.

Raymond Joseph Tesi: At the end of the phase two trial will have a end of phase II meetings with the regulatory authorities, where we will negotiate.

Raymond Joseph Tesi: The design of the phase III clinical trial.

Raymond Joseph Tesi: The FDA worries about both safety and efficacy. There's no question the FDA will want more patients treated with that who have vows. The question is, will they want patients treated for longer? In my mind, the FDA is very focused on doing no harm. That is part of their mission.

Raymond Joseph Tesi: The FDA worries about both safety and efficacy.

Raymond Joseph Tesi: There's no question the FDA will want more patients treated with EXPAREL, who have Alzheimer's.

Raymond Joseph Tesi: The question is will they want patients treated.

Raymond Joseph Tesi: For a longer period.

Raymond Joseph Tesi: In my mind, the FCA is very focused on doing though on that as part of their chart.

Raymond Joseph Tesi: And to ask a patient to be on placebo for 12 or 18 months when they, and we, already have data to show that you get an effective clinical readout after six months may prove to be ethical. At this time, we cannot predict what the FDA will want with the Phase 3 trial. I predict, and once again, this is RJ Tesi talking, not INmune Bio, that the FDA will want a larger talk, but not necessarily a longer one. The FDA does provide mechanisms to speed drugs through the development process. The accelerated approval pathways are in place for this purpose.

Raymond Joseph Tesi: And to ask the patient to be on placebo for 12 or 18 months. When we are a Wednesday and we already have data to show that.

Raymond Joseph Tesi: You get.

Raymond Joseph Tesi: Active clinical readout at six months may prove to be unethical to Atlanta.

Raymond Joseph Tesi: At this time, we cannot predict what the FDA will want with the phase III trial, I predict and once again this is RJ tsetse talking not a new bio.

Raymond Joseph Tesi: That the FDA will want a larger trial.

Raymond Joseph Tesi: But not necessarily a longer trough.

Raymond Joseph Tesi: The FDA does provide mechanism to speed drugs through the development process. The accelerated approval pathways are in place for this purpose.

Raymond Joseph Tesi: We believe Xpro for Alzheimer's disease will qualify for accelerated approval. We will apply for fast track approval based on our preclinical and phase 1 data. We may be eligible for breakthrough status after we complete the phase 2 clinical trial. However, we cannot predict how the FDA will respond to our applications.

Raymond Joseph Tesi: I believe Expo for Alzheimer's disease will qualify for accelerated approval.

Raymond Joseph Tesi: Pathway, we will apply for a fast track approval based on our preclinical and phase one data we may.

Raymond Joseph Tesi: To be eligible for breakthrough status. After we complete the phase II clinical trial.

Raymond Joseph Tesi: We cannot predict how the FDA, which bond or application, but we believe <unk> unique mechanism vacuum action importance of neuro inflammation glial activation in the pathophysiology of Alzheimer's disease.

Raymond Joseph Tesi: But we believe XPRO's unique mechanism of action, the importance of neuron formation and glial activation in the pathophysiology of Alzheimer's, combined with our clinical data, will be a compelling one. Finally, you've heard us talk about the many CNS diseases that Expo can be applied to all but have neuroinflammation as part of their underlying pathophysiology. We have 87 publications on our website with 12 different diseases.

Raymond Joseph Tesi: Bind with our clinical data will be a compelling story.

Raymond Joseph Tesi: Finally, you've heard us talk about the many CNS diseases that expo can be applied to all but have neuro inflammation part of that underlying pathophysiology.

Raymond Joseph Tesi: We have 87 publications on our website with 12 different disease. This is the future of Expo. It is a CNS franchise and a drug.

Raymond Joseph Tesi: It is a CNS franchise and a drug. 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 Expro in the near future. Our goal is to recruit that first patient in this NIH-supported Phase 2 trial. This is the second half. I will now pass the mic to Mark Lowdell, co-founder and CSO of INmune Bio, to update progress on the INkmune program. Mark?

Mark William Lowdell: For now treatment resistant depression will be the first disease beyond Alzheimer's disease that we develop.

Mark William Lowdell: I'll have further a mountain announcements on the treatment resistant depression phase II program using EXPAREL in the near future.

Mark William Lowdell: Our goal is to arrive that arrived enrolled that first patient in this NIH funded phase II trial in the second half of this year.

Mark William Lowdell: I will now pass the mic to Mike with Dal co founder and CSO and bio to update progress on the ATM program Mark.

Mark William Lowdell: Thanks, RJ, and thanks everyone for dialing in. Yes, I'm going to tell you where we've got to with our prostate cancer trial called CARE-PC, and it's unique in many ways, as 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. INmune converts the patient's own NK cells in their circulation, and probably actually within their tumor, from a resting, non-cancer-killing state to what we now know are memory-like NK cells that are able to destroy NK-resistant 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 with other NK-activating therapies.

Mark William Lowdell: Thanks Andre.

Mark William Lowdell: Thanks, everyone for dialing in.

Mark William Lowdell: Yes.

Speaker Change: Got it.

Mark William Lowdell: We've got to with prostate.

Mark William Lowdell: Prostate cancer trial.

Mark William Lowdell: CT CAD P C.

Mark William Lowdell: And it's unique in many ways.

Mark William Lowdell: Typical for our company first the concept.

Mark William Lowdell: K targeting therapy that doesn't actually administer NK cells or cytokines, which are the typical.

Mark William Lowdell: Could you just incase chuckling therapies.

Mark William Lowdell: Converts the patient centered NK cells in the circulation and probably actually within that Sheila.

Mark William Lowdell: Resting non cancer, killing state to what we now know a memory like NK cells.

Mark William Lowdell: That are able to destroy NK resistant cancer cells.

Mark William Lowdell: Unlike most conventional adoptive immunotherapies with NK cells from patients.

Mark William Lowdell: Patients don't require any type of pre conditioning chemotherapy, nor do they require NK stimulating cytokines that has come in to other NK activating therapies.

Mark William Lowdell: The immune patients sitting in a chair as an outpatient get an intravenous infusion over about 20 minutes, and then, having received their dose of INmune, they're able to leave. We've given over 20 doses of INmune in outpatient settings so far, and each infusion has been remarkably boring for the patient, and, as importantly, boring for the clinical team because it's been so well tolerated.

Mark William Lowdell: When patients sitting in a chair as an outpatient getting introduced infusion I have about 20 minutes and then having received that day.

Mark William Lowdell: They're able to leave.

Mark William Lowdell: We've given in every 20 doses of <unk>.

Mark William Lowdell: And outpatient assessing safer.

Mark William Lowdell: <unk> fusion has been remarkably boring for the patient and as importantly boring for the clinical team because its been well tolerated.

Mark William Lowdell: 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, and their ability to kill NK-resistant tumor cells. We also measure tumor-related variables. For example, 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

Mark William Lowdell: Each patient in the trial, it's Melissa.

Mark William Lowdell: Trickle endpoints as you would expect and these include NK cell number.

Mark William Lowdell: Phenotype, if those NK cells.

Mark William Lowdell: To kill NK resistant tumor cells.

Mark William Lowdell: We also measure chemo related variables.

Mark William Lowdell: And this metastatic castrate resistant prostate cancer trial, we measure antitumor effects by suddenly and blood pressure.

Mark William Lowdell: Prostate specific antigen levels she loves it.

Mark William Lowdell: PMA say scans and we measure circulating tumor DNA.

Mark William Lowdell: So this rich data set will allow us to determine whether the drug is ready for a pivotal trial at the end of Phase 2. The Phase 1 and Phase 2 trial is expected to enroll 30 patients, and the men enrolled in CARE-PC have all received previous high-dose therapy but now have metastatic, castrate-resistant disease. In the trial, they received three infusions of INmune, as I said, on an outpatient basis, with a six-month follow-up. We have three centers enrolling patients at the moment, a fourth opening this month, and four more are planned to open over the next few months.

Speaker Change: So this rich data set will allow us to determine whether the drug is ready for a pivotal trial at the end of phase two.

Mark William Lowdell: The phase one phase two trial is expected to enroll 30 patients.

Mark William Lowdell: And the men enrolled in Cat PC have all received previous high dose therapy, but now have metastatic castrate resistant disease.

Mark William Lowdell: And the trials they receive three infusions thing is as I said on outpatient basis.

Mark William Lowdell: With a six month follow up.

Mark William Lowdell: We have three centers enrolling patients at the 90 to source opening this month in <unk>.

Mark William Lowdell: More plan.

Mark William Lowdell: She loves.

Mark William Lowdell: The Phase 1 portion of the trial will be completed by September this year, and we expect patient enrollment in the Phase 2 portion to be completed by the second quarter 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 itself.

Mark William Lowdell: The phase one portion of the trial will be completed by September this year, and we expect patient enrollment in the phase III portion to be completed by the second quarter of next year with data available for all of the patients by the end of 2025 at the latest.

Mark William Lowdell: It is an open label trial, which means that we're looking forward to some snapshots of the data in 2024 or early 2025.

Mark William Lowdell: Okay.

Mark William Lowdell: The INmune team has been working very hard on perfecting the manufacturing and logistics elements of INmune for future clinical and commercial development. But 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.

Mark William Lowdell: Equally important is the trial.

Mark William Lowdell: The team has been working very hard on perfecting the manufacturing and logistics elements into future clinical and commercial development.

Mark William Lowdell: So I still have a part time University place to Larry My academic has over the last 35 years I've seen an awful lot of promising therapeutic strategies in the cell and gene therapy space.

Mark William Lowdell: Q2 manufacturing and logistical problems and I'm sure you will be aware some of that is associated with adult, particularly the therapies like car T cells.

Mark William Lowdell: We're scaling up the manufacturing process for INmune in preparation for the Pivotal trial, and we've 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.

Mark William Lowdell: We're scaling up the manufacturing process for <unk> in.

Mark William Lowdell: In preparation for the pivotal trial and we perfect. It the quality release assays, which will be required by the regulatory authorities as we move forward.

Mark William Lowdell: Because the product ships on dry ice logistics and storage at treatment centers.

Mark William Lowdell: And they fit with many other commercial trucks.

Mark William Lowdell: So, in summary, we can make the drug... We can quality control release the drug, we can ship it, and hospitals can store it. 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 INmune primed NK cells make them ideal to treat a wide variety of solid tumors, and we've published papers on some of them.

Speaker Change: So in summary, we can make the drug.

Mark William Lowdell: We can of course, you control released the drug we can ship it and hospitals can store the drug.

Mark William Lowdell: The clinical trials will determine the drugs therapeutic value as we move forward.

Mark William Lowdell: Now pivot from Hematological malignancies to sell the achievements was enough to one chiller project and it's been well planned for initial try and say transition into somebody Chinas space.

Mark William Lowdell: The unique attribute sitting in front of NK cells and make them ideal to treat a wide variety of so they choose at least published papers on some of those.

Mark William Lowdell: Prostate cancer is a test case, but we've got sound pre-clinical 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 INMUNECOM. So that ends my update on the INmune platform, and I'd like to turn it over to David Moss, our CFO and other co-founder, to discuss the financials. Thank

Mark William Lowdell: Firstly cancer, it's a test case, but we've found preclinical work in this area in cancer and really developing the same data in renal cell carcinoma at the moment.

David J. Moss: We obtain resources these will be the next target is healthy.

David J. Moss: So that ends my architecture and platform localized tenants. Currently this is David Lhasa CFO.

David J. Moss: The other case founder to discuss the financials. Thank you David.

David J. 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. 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 INMUNE data. We are pleased to have raised $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.

David J. 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.

David J. Moss: In the two transactions, the company issued an aggregate of approximately 1.5 million shares of common stock and warrants to purchase an actuary of approximately 1.5 million shares of common stock. The exercise price of the warrants is $9.15 and $9.84, respectively. The warrants are exercisable on the earlier of the two-year anniversary of the initial exercise date or 30 days following the reporting of top-line data in the Phase II Alzheimer's Program for Exercise.

David J. Moss: However, I would like to begin with some comments on our recent capital equity raises as we get closer to our phase two allshouse <unk> read out any new data.

David J. Moss: We're pleased to have raised $14 5 million in gross proceeds from two separate equity offerings over the past weeks at an average price of $8 35.

David J. Moss: And $9 84 per share.

David J. Moss: In the two transactions the company issued an aggregate of approximately one 5 million shares.

David J. Moss: A common stock and warrants to purchase an accurate yet of approximately one 5 million shares of common stock.

David J. Moss: The exercise price of the warrants is $9 in 15 and $9 84, respectively.

David J. Moss: <unk> are exercisable on the earlier of two year anniversary of the initial exercise date or 30 days following the reporting of top line data in the phase two all timers program for EXPAREL.

David J. Moss: In the first $4.8 million raise, management, employees, and members of the Board of Directors purchased over $1 million worth of stock. It cannot be underscored how financially committed and aligned the entire INmune 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 from mostly existing investors, our team here at INmune, but we also welcome a few new holders to the registry.

David J. Moss: In the first $4 $8 million raise management employees and members of the board of directors purchased over $1 billion worth of stock.

David J. Moss: I cannot underscore how financially committed and align the entire immune team is the success of the company.

David J. Moss: 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.

David J. Moss: Now moving on to the financials. The net loss attributable to common stockholders for the quarter ended March 31, 2024, was approximately $11 million, compared with approximately $6.5 million for the comparable period, as we've reached scale with both of our clinical programs. Research and development expenses total approximately $8.7 million for the quarter ended March 31, 2024, compared with approximately $4.1 million for the comparable period. General and administrative expenses were approximately $2.3 million for the quarter ended March 31, 2024, compared with approximately $2.3 million for the comparable period in 2023. At March 31, 2024, the company had cash and cash equivalents of approximately $26 million. This figure does not include the recent raise.

Speaker Change: Now moving on to the financials.

David J. Moss: Net loss attributable to common stockholders for the quarter ended March 31, 2024 was approximately $11 million compared with approximately $6 5 million for the comparable period as we've reached.

David J. Moss: Our scale with both of our clinical programs.

David J. Moss: Research and development expenses totaled approximately $8 7 million for the quarter ended March 31, 2024, compared with approximately $4 1 million for the comparable period.

David J. Moss: General and administrative expenses was approximately $2 3 million for the quarter ended March 31, 24, compared with approximately $2 3 million for the comparable period from 23.

David J. Moss: At March 31, 2024, the company had cash and cash equivalents of approximately $26 million. This figure does not include the recent raises beeston.

David J. Moss: Based on our current operating plan, we believe our class is sufficient to fund our operations into 2025. As of May 9th, 2024, the company had approximately 19.8 million shares of common stock outstanding. Now I'd like to focus on some key upcoming milestones. Full Enrollment in the Phase 2 Expo Trial for the Treatment of Neuroinflammation as a Cause of Alzheimer's Disease is expected in mid-2024, followed by top-line data approximately six months from the last patient enrolled.

David J. Moss: Based on our current operating plan, we believe our class is sufficient to fund our operations into 2025.

David J. Moss: As of May nine 2024, the company had approximately $19 8 million shares of common stock outstanding.

David J. Moss: Now I'd like to focus on some key upcoming milestones full enrollment in the phase two extra trial for the treatment of neuro inflammation is a cause of alzheimers disease are.

David J. Moss: Our expected mid 2024, followed by topline data approximately six months from the last patient enrolled.

David J. Moss: We will initiate a Phase 2 trial of Xpro in patients with treatment-resistant depression in the second half of this year. Last week, we announced completion of Cohort 1 for the first of our three patients taking part in the Metastatic Castration-Resistant Prostate Program. We expect Cohort 2 to start shortly, and we expect complete enrollment in the Phase 1 portion of the metastatic castration-resistant prostate trial by the end of Q3-24. And the Phase 2 portion is expected to complete enrollment in Q2 of 25.

David J. Moss: We will initiate a phase two trial of EXPAREL in patients with treatment resistant depression in the second half of this year.

David J. Moss: Last week, we announced completion of cohort one for the first of our three patients.

David J. Moss: <unk> part in the metastatic castration resistant prostate program, we expect cohort two to start shortly.

David J. Moss: We expect complete enrollment in the phase one portion of the metastatic castration resistant prostate trial by the end of Q3 24, and the phase II portion is expected to complete enrollment Q2 of 'twenty five.

David J. Moss: 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 to recover a portion of R&D expenses in Australia and the UK. Further, the recent changes RJ mentioned with regard to the open label extension will save the company a couple million dollars in drug and trial related expenses. In summary, we secured a meaningful equity refusion recently that puts us in a 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. James? Thank you.

David J. Moss: 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 the U K.

David J. Moss: Further the recent changes RJ mentioned with regards to the open label extension will save the company a couple of million dollars in drug and trial related expenses.

David J. Moss: Summary, we secured a meaningful equity infusion recently that puts us in good position heading into data and our focus remains solely on execution.

David J. Moss: 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 James.

Operator: Thank you, Mr. Moss. At this time, if you'd like to ask a question, please press the star and 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star and 1 to ask a question. And we'll take our first question today from Tom Shrader with BTIG.

James: Thank you Mr. Mas at this time, if you'd like to ask a question. Please press the star and one on your telephone keypad you may remove yourself from the queue at any time by pressing star to once again it is star and wanted to ask a question.

Operator: And we'll take our first question from Tom Shrader with BTG.

Thomas Eugene Shrader: Good afternoon. Thanks for taking the time to answer the question. So, RJ, you must be thinking about the role of A-beta antibodies in your Phase 3 study. Are there any guidance or thoughts? Are you going to be able to stratify, or could you still do a monotherapy trial? I'm just curious if there's any sort of thought about that yet. And then a quick one for Mark. I understand, Mark, that 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. So, thanks.

Thomas Eugene Shrader: Good afternoon, thanks for taking the question.

Thomas Eugene Shrader: So RJ you you must be thinking about the role of a beta antibodies in your phase three is there any guidance or thoughts or are you going to be able to stratify or could you still do a monotherapy trial I'm just curious if there's any.

Thomas Eugene Shrader: Any sort of thought yet and then a quick one for mark.

Thomas Eugene Shrader: I understand Mark boring is good but do you would you expect some fever, if you're turning on NK cells. Just your historical thoughts on why things are so safe so thanks.

Raymond Joseph Tesi: Yeah, so let me talk. Thank you, Tom, for those very interesting questions about the anti amyloid. You know, we have... signaled very strongly that we're going to have to answer the question about combination therapy, and I think we've said that you should expect some preclinical data in that regard from us mid-year. What's more important, though, is how will it affect the phase-three clinical trial? And, you know, at least in the United States, the only place these drugs are currently approved, adoption has been slow.

Speaker Change: Yeah. So let me Todd Thank you Tom for those.

Raymond Joseph Tesi: Very interesting question about the anti amyloid.

Speaker Change: We have.

Raymond Joseph Tesi: There's no very strongly we are aware that we're going to have to be able to answer the question.

Raymond Joseph Tesi: <unk> combination therapy, and I think we've said that you should expect some preclinical data to that regard from us a mid year.

Raymond Joseph Tesi: What's more.

Raymond Joseph Tesi: Important though is how will it affect the phase III clinical trial.

Raymond Joseph Tesi: At least in the United States. The only place. These drugs are currently approved adoption has been slow.

Raymond Joseph Tesi: 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 Europe, the UK, Canada, and beyond. We don't know when those drugs are going to be approved. They'll be approved by the time we start our phase three, 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 path that may be answering a different question than whether Expo works alone.

Raymond Joseph Tesi: I believe that there will be plenty of patients who are not.

Raymond Joseph Tesi: The anti amyloid drugs, who will be potential clinical trial participants in the United States.

Raymond Joseph Tesi: In other regulatory jurisdictions like Europe U K, Canada beyond that we don't know when those drugs are going to be approved.

Raymond Joseph Tesi: It will be approved by the time, we start our phase III no doubt, but once again.

Raymond Joseph Tesi: Have had slow adoption so I am.

Raymond Joseph Tesi: We are not concerned at this point, we believe a combination trial is actually a different development pathway.

Raymond Joseph Tesi: That may be answering a different question.

Raymond Joseph Tesi: Then whether extra works alone for patients with Alzheimer's with.

Raymond Joseph Tesi: Audit with the neuro inflammation.

Raymond Joseph Tesi: David, do you want me to comment on whether Mark is on the phone? I think his call may have dropped. Mark, are you there?

Raymond Joseph Tesi: Okay.

Raymond Joseph Tesi: David do you want me to comment on his mark on the phone I think it's called May have dropped Mark you there.

Raymond Joseph Tesi: Mark.

Operator: Mark is not...

Raymond Joseph Tesi: Yes, sure Mark is not.

Speaker Change: Yeah, I'll tell you what Mark Mark got dropped he's a he's got the they'll try and add them back and he's over in Europe, having problems.

Operator: I'll tell you what, Mark got dropped, 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.

Operator: But you know.

Operator: In relation to your question Tom.

Operator: Why you don't see a fever or some sort of Hello inflammatory response, why the drug is safe as you know.

Raymond Joseph Tesi: So the answer, the question was about no fever, why no inflammatory reactions with INmune? Well, INmune 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, so it's released in inflammatory cytokines from CD4 T cells, and NK cells, which are activated by INmune or even by cytokines, don't secrete inflammatory cytokines, so no NK therapy itself has been associated with inflammatory type reactions.

David: David Yeah, Yeah.

Raymond Joseph Tesi: Yeah. So the answer the question was about no fever, why no inflammatory reactions.

Raymond Joseph Tesi: Well, it inactivates NK cells and it doesn't activate T cells, but we've we spent a lot of time.

Raymond Joseph Tesi: Looking at that so the inflammatory response, you've seen such kind of niche syndrome is entirely T cell mediated.

Raymond Joseph Tesi: Released sitting in front of such guidance from CD, four T cells, and NK cells, which ray tracing might mean or you can buy such kind of things.

Raymond Joseph Tesi: <unk> inflammatory cytokines, so no NK therapy.

Raymond Joseph Tesi: Itself.

Raymond Joseph Tesi: It has been associated with.

Raymond Joseph Tesi: Inflammatory.

Raymond Joseph Tesi: Type reactions.

Thomas Eugene Shrader: Got it, okay. Thanks for the...

Raymond Joseph Tesi: Got it okay. Thanks for thanks for the.

Raymond Joseph Tesi: Thoughts on both? No, not at all. 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, INmune doesn't require the administration of cytokines, so it's specifically targeting NK cells.

Thomas Eugene Shrader: Thoughts on both on the tool and it's a very it's a very smart question actually because it's normally the cytokines that are administered to sustain NK cells.

Raymond Joseph Tesi: Cool as side effects and of course, it doesn't require the administrations such guys. So it's specifically T NK cell targeting.

Thomas Eugene Shrader: Got it, got it. Okay, thank you.

Raymond Joseph Tesi: Got it okay. Thank you.

Operator: Our next question will come from Joel Beatty, with Baird.

Thomas Eugene Shrader: Our next question will come from Joel Beatty with Baird.

Joel Lawrence Beatty: Hi, thanks for taking the questions. The first one is for the ongoing phase two trial in early AD. Can you remind us of the mix of patients you're targeting in enrollment between ones that have mild cognitive impairment versus mild AD and how enrollment is tracking with that?

Joel Lawrence Beatty: Hi, Thanks for taking the questions.

Joel Lawrence Beatty: First one is for the ongoing phase two trial in early a D can you remind us of the mix of.

Joel Lawrence Beatty: Patients who are targeting an enrollment between ones that have mild cognitive impairment versus now they do.

Joel Lawrence Beatty: And how enrollment is tracking with that.

Raymond Joseph Tesi: Yes, good question. So, two things, two points to make. It's relevant considering my We have a team of one at the moment of active people with T-Bugs, and one patient gets placebo. So that's number one.

Speaker Change: Yes. Good question, so two things two points to make.

Speaker Change: It's relevant.

Speaker Change: Considering my comments, though we have a team of one one.

Raymond Joseph Tesi: Yes.

Speaker Change: In other words.

Raymond Joseph Tesi: Okay.

Speaker Change: Oh and.

Raymond Joseph Tesi: In one patient gets placebo. So that's number one number two the way. The protocol is written there will not be more than a two to one.

Raymond Joseph Tesi: Number two, the way the protocol is written, there will not be more than a two to one balance. In other words, there is... Oh, you don't specify whether there are twice as many mild AD as MCI or twice as many mild AD as MCI. It will not be a, it will really be an early AD trial like all the others. Statistically, I would expect... you would expect more MCI patients. But, as you recall, we started the trial by only enrolling mild AD patients.

Raymond Joseph Tesi: In other words there.

Raymond Joseph Tesi: Well you don't specify whether it's twice as many Earl mild a D as mci or twice as many.

Raymond Joseph Tesi: Many mci.

Raymond Joseph Tesi: As mild they D. It will not be a it will really be an early a trial like all the other ones do.

Raymond Joseph Tesi: Statistically.

Raymond Joseph Tesi: I would expect.

Raymond Joseph Tesi: You would expect more mci patients, but as you recall, we started the trial with only enrolling mildly.

Raymond Joseph Tesi: Mildly <unk> patients.

Raymond Joseph Tesi: So I suspect it will be very close to a 50-50 mix. Don't hold me to that. That's just a prediction. But the way it's looking right now, it's going to be about a 50-50 mix.

Raymond Joseph Tesi: Suspect it will be very close to a 50 50 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 50 50.

Raymond Joseph Tesi: Yeah.

Joel Lawrence Beatty: Okay, great. And then the question on the open label extension study, that's, I guess, a clarification: has it just been enrollment 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? Yeah, so that's a good question.

Speaker Change: Okay, Great and then a question on the open label extension study that some.

Joel Lawrence Beatty: A quick clarification has it just been enrollments that's close but some patients in the study are continuing to be dosed or is dosing complete in all patients.

Joel Lawrence Beatty: And then in any case are there plans to share.

Joel Lawrence Beatty: And then label extension data that you have collected.

Raymond Joseph Tesi: Yeah, so that's a good question. The open-label extension data that we have always been complicated by the fact that we don't know what the patients who are on it are like. Remember, they come into the trial after a blinded, randomized trial, so we don't know. So we haven't figured out the best way to analyze those right now because of, as I said, both drug supply and financial considerations. By the way, drug supply is a business; making the stuff is not a small task.

Speaker Change: Yeah. So that's a good question. The open label extension data that we have as 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.

Raymond Joseph Tesi: So we don't know 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 financial considerations abide related drug supply is a financial consideration because making this stuff is not a small task.

Raymond Joseph Tesi: You know, we are basically working with the sites to decide which is best. Some patients will go on to a kind of being where they are. They get compassionate use if that's available to them, and some will not, will not. It's not, you know, the company is not happy with this turn of events, but it is a practical consideration. Our goal and our commitment to investors is to make sure we finish the phase two trial, get the result we're looking for, and that's what we're focused on.

Raymond Joseph Tesi: No we are.

Raymond Joseph Tesi: We are basically.

Raymond Joseph Tesi: Working with the sites to decide the best.

Raymond Joseph Tesi: Patients will go onto what kind of a.

Raymond Joseph Tesi: Where they are.

Raymond Joseph Tesi: They get compassionate use that if that's available to them and some will.

Raymond Joseph Tesi: <unk> will be discontinued its not you know.

Raymond Joseph Tesi: The company is not happy with this turn of events, but it is a practical consideration our goal and our commitment to investors is to make sure. We finish the phase II trial get the result, we're looking for and that's where we're focusing our resources.

Speaker Change: Thank you.

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

Jason Mccarthy: Our next question will come from Jason Mccarthy with Maxim Group.

Operator: Okay.

Jason Mccarthy: Thanks for taking the questions. I guess this is a R.J.'s thoughts type of question.

Jason Mccarthy: Thanks for taking the questions I guess.

Jason Mccarthy: RJ as thoughts type of question Archie can you can you.

Raymond Joseph Tesi: R.J., can you kind of opine a little bit on what regulators might want in terms of timing for this trial? So you said that the two approved amyloid drugs, you know, six months, they already saw that they were effective, but given what you know now about markers of inflammation. Considering FDA's 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? Can you really get away with a trial that's just three to six months because of all the inflammatory biomarkers that are available that the FDA seems to be more accepting of?

Jason Mccarthy: Kind of opine, a little bit on what do you think regulators might want in terms of.

Raymond Joseph Tesi: Timing finished trials do you you said that the two approved amyloid drugs.

Raymond Joseph Tesi: Six months I already saw that they were affected but given what you know now about markers of inflammation.

Raymond Joseph Tesi: Seemingly FDA willingness to.

Raymond Joseph Tesi: Acceptance correlation between Biomarkers.

Raymond Joseph Tesi: Al comes.

Raymond Joseph Tesi: And in all timers disease, and with any current standard of care and miles or early Alzheimers. What is the expected rate of decline like can you get can you really get away with a trial. That's just three to six months because of all the.

Raymond Joseph Tesi: Inflammatory biomarkers that are available that the FDA seems to be more accepting of.

Raymond Joseph Tesi: So, good question, and I'm going to answer it in a series of statements. First of all, I'm not predicting three months. You know, our trial is six months. Three months is pretty quick.

R.J.: So a good question and I'm going to answer it in a series of statements first of all I'm not predicting three months you know our trial of six months three months, it's pretty quick when you would we expect robust results. After six months now, let's talk a little bit about the biomarkers are biomarkers.

Raymond Joseph Tesi: We expect robust results after six months. 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, they're things you need for enrollment.

Raymond Joseph Tesi: Neuro inflammation and the phase III trial, our enrichment criteria in other words, there are things you need for enrollment.

Raymond Joseph Tesi: The FDA, I'm not convinced that the FDA 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 a glial fibrillary acidic protein. Now, the good news is there are very good blood tests for all of them.

Raymond Joseph Tesi: The SBA I'm not convinced that the FDA will be well accepted biomarkers of neuro inflammation as a biomarker of Alzheimer's what they will accept our biomarkers of what they consider Alzheimer's, which are amyloid Tau maybe G pack, which is glial there bill.

Raymond Joseph Tesi: Instead of protein.

Raymond Joseph Tesi: <unk> ask yourself.

Raymond Joseph Tesi: Now the good news is theres very good blood test for all of those and I predict that we will actually show a decrease in those biomarkers and the phase II trial in patients who've got Expo. So my bet is that what we've got is we're going to be focused on patients who have no information because that's how the.

Raymond Joseph Tesi: And I predict that we will actually show a decrease in those biomarkers in the Phase 2 trial. So my bet is that what we've got is we're going to be focused on patients who have neuroinflammation because that's and how the drug works. But we don't think that the FDA, we may be 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 GPAP, and I don't think they'll be interested in NFL, Marathon, and the like.

Raymond Joseph Tesi: Drug works.

Raymond Joseph Tesi: But we don't think that the FCA, we may get surprised but we don't think the FDA will actually focus on neuro inflammation is a response, they're going to get to the biomarkers. They know and they know amyloid and tau and they might be interested in <unk> and <unk>.

Raymond Joseph Tesi: I don't think there'll be interest in NFL neuro filament light change so.

Raymond Joseph Tesi: That was in my prediction, but I think I really think if we do as well as we think we are where you've got it.

Raymond Joseph Tesi: 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, you know, racing to really quite Significant Cognitive Impairment, and the Xpro 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, so 200 patients will not be the size of the next trial. It will be at least double that, probably three times that.

Raymond Joseph Tesi: Placebo group that you know.

Raymond Joseph Tesi: Racing to really quite.

Raymond Joseph Tesi: Significant cognitive impairment and the X Pro group, which is relatively stable I don't think they're going to they're going to.

Raymond Joseph Tesi: Force us to treat patients on placebo for a very long time, but they are what are 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 three times that my predictions.

Raymond Joseph Tesi: So, from a, in the placebo group, you know, even with acetylcholinesterase inhibitors or something like that and the placebo effect, and then start to decline, kind of like... [inaudible] you don't see any benefits with those drugs. Patients have to be on stable treatment before they can be enrolled, and that's for three months. So any patient that would be enrolled in, I mean, see the colonoscopy happens in epidural, would have been on the drug long enough that they are no longer benefiting from the drug.

Raymond Joseph Tesi: So strongly.

Raymond Joseph Tesi: And the placebo.

Raymond Joseph Tesi: Drew you know.

Raymond Joseph Tesi: Even with the Seattle, cholinesterase inhibitors or something like that.

Raymond Joseph Tesi: How far out can they go even with a.

Raymond Joseph Tesi: True placebo effect.

Raymond Joseph Tesi: And and then start to decline and kind of like.

Raymond Joseph Tesi: Let's take it to you and make it but you know what I mean, where they will eventually so most of it yes.

Speaker Change: Two points.

Raymond Joseph Tesi: See the cholinesterase inhibitors and.

Raymond Joseph Tesi: In general after three months certainly after six months new.

Raymond Joseph Tesi: You don't see any benefit for those drugs.

Raymond Joseph Tesi: <unk> have to be on a stable.

Raymond Joseph Tesi: Therapy before they can be enrolled and that's for three months. So any patients that would be enrolled within cortland explorations happened nothing Bill for instance would have been on the drug long enough that they are no longer benefiting from the drug.

Raymond Joseph Tesi: But as you know, many patients are on drugs, and it's really the doctors who are treating themselves as much as they're treating the patients, at least that's my cynical view. I think that the earlier question asked by Shrader's group was regarding anti-AMLOD as interesting.

Raymond Joseph Tesi: Many patients are on the drugs and and it's really the doctors are treating themselves as much as they're treating the patients at least that's my cynical view I think that the early question not asked by the.

Raymond Joseph Tesi: Traders group was regarding anti amyloid is interesting.

Raymond Joseph Tesi: I don't think the monotherapy trial will not, patients won't be on maintenance. 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 FDA. But that's a question of the future, and the first thing we need to do... prove that the combination of safe and animal models, and as I mentioned, those studies.

Raymond Joseph Tesi: I don't think the the monotherapy trial will not.

Raymond Joseph Tesi: Patients wont be on maintenance anti amyloid that won't be a separate trial separate question that will 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.

Raymond Joseph Tesi: The profile of those drugs and the efficacy profile, but that's a question of the future and the first thing we need to do is prove that the combination of safety and animal models and as I mentioned those studies are underway.

Raymond Joseph Tesi: Just one quick question on INmune. I think I heard earlier the potential to move towards renal cancer next, depending on resources, of course, but does 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. Absolutely.

Raymond Joseph Tesi: Just one quick question on <unk>, I think I heard earlier that potential to move towards renal cancer next depending on resources.

Raymond Joseph Tesi: Of course, but it is the selection of renal cancer.

Raymond Joseph Tesi: Have similarities to prostate cancer choice in terms of there seems to be a higher proportion of <unk>.

Raymond Joseph Tesi: NK cells versus T cells in those tumor types.

Mark William Lowdell: Absolutely. So there's a long history. Only last week, I was examining a PhD student at the Karolinska who spent four 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. 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 interferon and IL-2. 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 cancer cell lines better after they've been primed with

Raymond Joseph Tesi: Absolutely.

Raymond Joseph Tesi: So there's a lot of history.

Mark William Lowdell: Last week I was having a liquid AC Steve who took the countless guy who spent four years, let's say.

Mark William Lowdell: At the same issue and yes renal cell cancer.

Mark William Lowdell: Typically.

Mark William Lowdell: The infiltration of NK cells and is a poor prognostic benefit to those patients who have a high NK cell infiltrate.

Speaker Change: That's it.

Mark William Lowdell: Negative.

Mark William Lowdell: Prognostic effect of having a high C D. A T cell infiltrate and of course, the drugs that have been approved for renal cell cancer of P and K, telling me, how French fail or IL two.

Mark William Lowdell: So yes, that's that's really the rationale behind that at least goes through since I like what I stated it demonstrates that our NK cells do target renal cell carcinoma.

Mark William Lowdell: Cell lines better Oh, so they feel prime today.

Speaker Change: Got it thank you fellas.

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

Mark William Lowdell: Our last question will come from Daniel Carlson with <unk> research.

Daniel Carlson: Hi guys, thanks for taking my question. RJ, you talk about hopefully showing flat 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 will be granted post-phase 2?

Daniel Carlson: Hey, guys. Thanks for taking my question.

Daniel Carlson: RJ, just you talk about hopefully showing flu.

Daniel Carlson: Lap on cognition as opposed to a 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 III.

Raymond Joseph Tesi: Yeah, right. Your lips to God's ears, huh?

RJ: Right, Yeah lips to God's ears.

Raymond Joseph Tesi: You know... I do, you know, 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... not only will the company be excited, but the FDA will get it, and who knows what will happen, Dan? They will pull out all the stops to help push us along, but I don't know what that looks like.

Speaker Change: I I do.

Raymond Joseph Tesi: You know as much as the FDA is fortunate to us.

Raymond Joseph Tesi: I do believe in general the FDA has their heart in the right place.

Raymond Joseph Tesi: And if the results are extraordinary and I would consider that an extraordinary result.

Raymond Joseph Tesi: Not only will investors now.

Raymond Joseph Tesi: Not only will.

Raymond Joseph Tesi: The company would be excited but the FCA gets excited.

Raymond Joseph Tesi: And who knows what'll happen and they will do they will pull out all the stops to help push us along I don't know what that looks like.

Raymond Joseph Tesi: But they get excited about groundbreaking data just like you and I do. So, you know, is there a chance? Yes, but would 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. You know, as you know. Patient advocacy groups make a big difference with the FDA. 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, though. I like to dream about it, but I'm not gonna hold my breath. Okay, and just, just sort of...

Raymond Joseph Tesi: But they they get excited about groundbreaking data just like you and I do so you know is there a chance yes.

Raymond Joseph Tesi: What I.

Raymond Joseph Tesi: What I bet more than a steak dinner on it at this point no.

Raymond Joseph Tesi: But man if we knock it out of the park.

Raymond Joseph Tesi: All bets are off we'll just have to see what they say.

Raymond Joseph Tesi: As you know.

Raymond Joseph Tesi: No.

Raymond Joseph Tesi: Patient advocacy groups make a big difference with the SBA.

Raymond Joseph Tesi: Alzheimer's.

Raymond Joseph Tesi: 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.

Raymond Joseph Tesi: Such as.

Raymond Joseph Tesi: S and D. M D. I don't know, it's a great question I would like to dream about it but I'm not going to hold my breath.

Daniel Carlson: Okay, 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 based on those results elsewhere?

Raymond Joseph Tesi: Okay, and just just sort of a follow up on that what about other jurisdictions that are they all going to fall in line behind the F D a or might it get approved and those results elsewhere.

Raymond Joseph Tesi: You know, I hesitate to ask that question because, you know, each of them is a little bit different. And I think the MHRA tends to be one that is a little more independent. The EMA tends to think very much like the FDA, and, you know, we certainly haven't seen a lot of innovation, 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. Then, you know, for all practical purposes, the only drugs that have come through are the anti-amyloids, and that's kind of a problem. They all look pretty much the same.

Speaker Change: You know I I hesitate to ask that question because you know each of them is a little bit different I think.

Raymond Joseph Tesi: I think the MH or a tends to be one that I think there's a little more independent thinking.

Raymond Joseph Tesi: MAA tends to think very much like the F D. A.

Raymond Joseph Tesi: And we certainly havent seen.

Raymond Joseph Tesi: 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 now for all practical purposes. The only drugs that have come through or are the anti amyloid and that's kind of a.

Raymond Joseph Tesi: They all look pretty much the same I don't know.

Raymond Joseph Tesi: I don't know. We'll see. And I think that, you know, let's get this phase two enrolled, number one. We need to get it analyzed. And then when we see that top-line data, then we'll both have the resources and the insights to move as quickly as we can. And believe me. We'll be making every attempt we can.

Speaker Change: We'll see.

Raymond Joseph Tesi: And I think that you know, let's we need right now to get this phase to enroll number one we need to get it analyzed and then when we see that topline data then we'll both have the resources and the insight.

Raymond Joseph Tesi: To move as quickly as we can and believe me we.

Raymond Joseph Tesi: We will be making every attempt with Canada to move quickly.

Raymond Joseph Tesi: That's great. I look forward to seeing what happens when you ring the bell there. Just one question about TRD. Now that you've got some more capital in, can you just sort of refresh the timeline and get more resources?

Speaker Change: Yeah, that's great I look forward to seeing what happens when you ring the bell there so well.

Raymond Joseph Tesi: One question about PRD now that you've got some more capital and can you just sort of refresh the timeline and you get more resources to put there and tell us about this trial when we could expect something out of it.

Raymond Joseph Tesi: Once again, it's a blind and randomized placebo-controlled trial, so we're actually getting data. The first thing you're going to hear is that, you know, this is how it will go.

Speaker Change: Yeah, that's something out of it once once again, it's a blinded randomized placebo controlled trial, so actually getting data. The first you know first thing youre going to hear is that you know.

Raymond Joseph Tesi: This is the way it will go the FDA announced that the FDA has accepted the.

Raymond Joseph Tesi: The FDA will announce that the FDA has accepted the IND and the trial is open, first patient enrolled, and then we'll be moving it forward. 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 one, Alzheimer's, and then number two, the INCREME Care PC.

Raymond Joseph Tesi: The IND and the trial is open.

Raymond Joseph Tesi: First patient enrolled and then we'll be moving it forward the amount of.

Raymond Joseph Tesi:

Raymond Joseph Tesi: Oh, the speed of the trial will directly be related to how much resources, we can put behind it right now the the you know the NIH grant only funds about third of the trial. So we have to be careful because our primary mission as we've said is number one Alzheimer's and then none.

Raymond Joseph Tesi: Two the increase care P C.

Raymond Joseph Tesi: But we think we'll be able to move that ahead. And as our resources expand, we'll be able to put the pedal to the metal on treatment of depression. But this year, the two... Milestones you should hear about, as David said, are that the FDA has allowed us to open the IND because it is a U.S., and the second thing will be the first patient enrolled. That's our goal.

Raymond Joseph Tesi: But we think we'll be able to move that ahead and then as our resources expand we will be able to put the pedal to the metal.

Raymond Joseph Tesi: Just depression, but this year the two the two <unk>.

Raymond Joseph Tesi: 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.

Raymond Joseph Tesi: And the second thing will be the first patient enrolled that's our goal.

Raymond Joseph Tesi: Okay.

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.

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

Raymond Joseph Tesi: So, thank you. Yeah, with the success of the fundraising... We now have the capital to comfortably complete ADL-2, the early Alzheimer's trial, and support CARE-PC with some of the open-label data. Our goal is to provide positive readouts on 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 goal. Both of these products have uses beyond their primary indication, and we believe that with the resources we meet with, given the resources we hope to get, we have the expertise and the teams we need. For now, we appreciate your support; thank you very much.

RJ: So thank you yeah with the success of the fundraising.

Raymond Joseph Tesi: We now have the capital comfortably the a D a.

Raymond Joseph Tesi: So too early Alzheimer's trial.

Raymond Joseph Tesi: To support care PC into some of the open label data in metastatic castrate resistant prostate cancer.

Raymond Joseph Tesi: Our goal is to provide positive readout. These problems with positive Readouts, we expect we will be able to access capital markets in a way.

Raymond Joseph Tesi: To allow the company to become more aggressive in pursuing at schools.

Raymond Joseph Tesi: Both of these products have uses beyond their primary indication.

Raymond Joseph Tesi: And we believe that with the resources we need.

Raymond Joseph Tesi: Meet with given the resources, we hope to get we have the expertise and the team.

Raymond Joseph Tesi: To capitalize.

Raymond Joseph Tesi: Other activities either alone or with partners.

Raymond Joseph Tesi: For now we appreciate your support.

Speaker Change: Thank you very much.

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

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

Operator: [inaudible]

Operator: Okay.

Operator: [music].

Operator: Mhm.

Operator: [music].

Operator: Hum.

Operator: [music].

Operator: Yeah.