Q4 2023 INmune Bio Inc Earnings Call
Operator: Welcome to the Viovid Conference. Conference Center, may I have your name? Yes, David... And what is your company name? Era.
Welcome to the Viva Conference Center.
Conference and I'm I have your name.
None: And what is your company name.
Operator: It's A-I-E-R-A, and what conference are you joining? It's the INmune Bio Earnings Call, right? Sure. One moment.
None: And Whats conference with you joining.
Juan: Sure Juan.
Juan: Yes.
Juan: Thank you.
Juan: Yes.
Juan: [music].
Operator: Thank you. Ladies and Gentlemen, Greetings and welcome to the INmune Bio 4th Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode.
Juan: Hum.
Juan: Okay.
Juan: Okay.
Juan: [music].
Operator: A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please do not hesitate to contact us. Please press star and zero on the telephone keypad.
None: Ladies and gentlemen, greetings and welcome to the bio fourth quarter by <unk> 23 earnings call.
None: At this time all participants are in a listen only mode.
Operator: As a reminder, this conference call is being recorded, and 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, the floor is yours.
None: <unk> question answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star and zero on the telephone keypad.
None: As a reminder, this conference is being recorded.
None: A transcript will follow within 24 hours of this conference call.
David J. Moss: Thank you, Ryan. And good afternoon, everybody. Thank you for joining us for the call for INmune Bio's year-end 2023 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 InkBioN, our memory-like natural color cell oncology platform. Before we begin, I remind everyone that, except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those expressed in such forward-looking statements.
None: At this time it is my pleasure to introduce Mr. David Moss CFO of immune bio David the floor is yours.
Thank you Ryan and good afternoon, everybody. We thank you for joining us for the call for immune Bio's year end 2023 financial results with me on the call is Doctor RJ Tassie, CEO and co founder of IMMU Bio and Dr. Mark Labelle, Chief Scientific officer, and cofounder of <unk>.
Speaker Change: The new bio who will provide an update on a few or memory like natural killer cell oncology platform.
Speaker Change: 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.
Speaker Change: These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward looking statements. Please see the forward looking statements disclaimer on the company's earnings press release as well as risk factors in the company's SEC filings, including our most recent quarterly filing with the SEC.
David J. Moss: Please see the forward-looking statements disclaimer in the company's earnings press release as well as the risk factors in the company's SEC filings, including our most recent quarterly filing with the SEC. There is no assurance of any specific outcome. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change. Except as required by law, INmune Bio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. Now I'd like to turn the call over to Dr. R.J. Tesi, CEO of INmune Bio. R.J. Yeah, thank you, David. And I thank everyone for joining the call.
Speaker Change: 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 of fat as the facts and circumstances underlying these forward looking statements may change.
Speaker Change: Except as required by law <unk> bio disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.
Speaker Change: Now I'd like to turn the call over to Doctor RJ Test D. C E O of immune bile RJ.
RJ Test: Yeah. Thank you David and thank you everyone for joining the call.
Raymond Joseph Tesi: As usual, I will arrange my remarks to highlight the key takeaways from the fourth quarter and subsequent period and provide updates on our platform program. I will start by reviewing developments on our XPro platform and then pass it over to Mark Lowdell, who will provide an update on INcmune. David will conclude with the discussion of our final results and provide an update on upcoming and new models. During the fourth quarter of early 2024, there were several positive developments in our phase 2 trial in patients with early asthma. We first received acceptance of our clinical trial application by several EU countries to allow us to initiate the Phase II trial in those countries. Clinical trial sites in Poland, Spain, France, the Czech Republic, and Slovakia will soon be enrolling patients.
RJ Test: As usual I'll arrange my remarks to highlight the key takeaways from the fourth quarter and subsequent period and provide updates on our platform programs.
RJ Test: I will start by reviewing developments on our X Pro platform and then pass it over to Mark <unk>, who will provide an update on internet.
Mark: David will conclude with a discussion of our final results.
Mark: And providing an update on upcoming new milestones.
Mark: During the first fourth quarter and early 2020 or there were several positive developments in our phase II trial.
Mark: In patients with early Alzheimer's disease first three and received acceptance of our clinical trial application by several EU countries.
Mark: It will allow us to initiate the phase II trial in those countries.
Mark: Trial sites in Poland, Spain, France, Czech Republic, Slovakia.
Mark: Well soon be enrolling patients in the U K.
Raymond Joseph Tesi: The UK continues to be very active in recruiting patients for the trial. And the UK is ideal, an ideal jurisdiction to expand our, develop our program because it possesses one of the highest rates of Alzheimer's disease in the rest of the world, coupled with a robust for-profit medical research infrastructure. Patient enrollment tends to be faster in private for-profit sites compared to academic or government-run hospitals.
To be very active in recruiting patients for the phase II trial.
Mark: And the U K is ideal an ideal jurisdiction to expand our work to develop our program because it possesses one of the highest rates of Alzheimer's disease, and the rest of world coupled with a robust.
Mark: Core profit medical research infrastructure.
Mark: Patient enrollment tends to be.
Mark: Faster and the private for profit sites compared to academic or government hospitals.
Raymond Joseph Tesi: The FDA listed the clinical hold for the AV program in January of this year. As we have previously announced, we will not be enrolling patients or adding trial locations in the U.S. This is a simple issue of time. The time and cost to open U.S. sites are such that we probably would not be successful getting any patients enrolled before the Phase 1 and Phase 2, excuse me, enrollment is completed. That cost just can't be justified.
Mark: The FDA lifted the clinical hold for the a D program in January of this year. We have previously announced we will not be enrolling patients or adding trial with patients in the U S. This is a simple issue of timing.
I'm in cost to open U S sites.
Mark: As such that we.
Mark: We probably would not be successful getting any patients enrolled.
Mark: Before the phase one and phase two excuse me enrolment is completed that costs just cant be justified.
Raymond Joseph Tesi: We expect no U.S. patients to be enrolled in this trial. We are often asked if this strategy will compromise the X-Bow development program in Alzheimer's. The answer is a loud no. There is no requirement that U.S. patients be included in any drug trial.
Mark: We expect no U S patients to be enrolled in this trial.
Mark: Period.
We are often asked if this strategy would compromise the Expo development program in Alzheimer's disease.
None: Answer was allowed no.
None: There is no requirement that U S patients being included in any drug trial.
Raymond Joseph Tesi: The FDA's preference for including U.S. patients in clinical trials is due to demographic considerations, not due to doubts about the validity of non-US clinical trial results. However, although the FDA has issued guidance recommending that clinical trials reflect the demographic diversity of the U.S. population, this goal has not been achieved in recent pivotal trials for the anti-amyloid treatment. We expect the U.S. will be a key jurisdiction for clinical trials and patient enrollment in the pivotal AD trial that will follow this trial. However, one of the realities of a six-month clinical trial is that Phase III planning must begin well before patient enrollment in the Phase II trial is complete. Our goal is to complete end-of-Phase II meetings with the FDA and other regulatory authorities in mid-2025 to get a clear outline of what would be required for an approvable Phase III trial. Discussions of patient diversity in the U.S. cohort will be had.
None: The fda's preference for including U S patients in clinical trials is due to Denver demographic considerations not do get doubts about the validity of non U S clinical trial results.
None: Although the FDA has issued guidance recommending that clinical trials reflect demographic diversity of the U S. Population. This goal has not been achieved in the recent pivotal trials or the anti amyloid treatments.
None: We expect the U S will be a new.
None: Jurisdiction for clinical trials and patient enrollment in the pivotal trial that will follow this trial.
One of the realities of a six month clinical trial is a phase III planning must began well before patient enrollment in the phase II trial is complete our goal is to complete end of your end of phase two meetings with the FDA and other regulatory authorities in mid 2025, you get a clear outline of what would be required.
None: An approvable phase.
None: <unk> III trial discussions of patent patient diversity in the U S cohort will be had at that time.
Raymond Joseph Tesi: This does not mean we are not in communication with the FDA on Expo for Alzheimer's. We plan to submit for accelerated approval pathways for AXPRO in Alzheimer's disease. The first submission will be a fast track pathway.
None: This does not mean, we are not in communication with the FDA on Expo for Alzheimer's disease, we plan to submit for accelerated approval pathways for tax pro in Alzheimer's disease. The first submission will be a fast track pathway.
Raymond Joseph Tesi: Then once we have compelling Phase 2 human data, we will submit a breakthrough step. Recently, in fact, a month ago or less, the FDA released draft guidance on the development of drugs for the treatment of patients with early and prodromal Alzheimer's. The guidance supports many of the strategies we have been including in our trials, including enrichment and novel endpoints. The guidance also provides direction on how to think about prevention of Alzheimer's in patients with progressive disease.
None: Then once we have compelling phase two human data, we will submit a breakthrough status.
None: Recently in fact, a month ago or less the FDA released draft guidance on the development of drugs for the treatment of patients with early and prodromal Alzheimer's disease.
None: The guidance supports many of the strategies, we have been including in our trials, including enrichment and novel endpoints.
None: The guidance also provides.
Direct shown on how to think about.
None: Prevention.
None: Prevention of Alzheimer's in patients with Prodromal disease. This is something we think expo will be very good at and we would be talking about more in the future.
Raymond Joseph Tesi: This is something we think Expro will be very good at, and we will be talking about more. I want to take a moment to address two unique elements of our Phase 2 clinical trial. The endpoint and the six-month duration. We are often reminded that we do not look like, excuse me, that we look different than the gold standards set by a big farmer in their anti-amylase. But looks can be deceiving.
None: I want to take a moment to address two of them.
None: Any elements of our phase II clinical trial.
None: The end point and the six month duration of the trial.
None: We are often reminded that we do not look like excuse me that we look different than the gold standards set by big pharma and their anti amyloid trials, but looks can be deceiving.
Raymond Joseph Tesi: A look below the surface shows many similarities between those large and long trials and our trials. Despite all of the talk... about EMAC as our primary endpoint for ADO2. The trial is powered by CDR, a well-accepted cognitive endpoint used in all of the anti-amyloid trials. In fact, let's compare our trial with Expo for the treatment of early AIDS with the positive phase 3 trials that use anti-amyloid drugs for the treatment of early AD. The three trials have two things in common, the use of CDR and a six-month trial and time period. Both the Canamab and Donamemab phase 3 trials showed statistically significant advantages in the anti-amyloid treated patients compared to placebo at six months. Put another way, both those trials could have been stopped at six months with positive results. The difference seen between the placebo and treatment groups in the anti-AMYLID trials is exactly the same difference we expect to see between X-probe treated patients and placebo treated patients.
None: Hey look below the surface shows many similarities between those long large and long trials in our trial.
None: Right all of the talk.
About <unk>, because our primary endpoint for a D O two.
None: The trial is powered on CVR CVR is a well accepted cognitive endpoint used in all of the anti amyloid trials.
None: Let's compare our trial with EXPAREL for the treatment of early D. With the positive phase III trials that use the anti amyloid drugs for the treatment of all.
None: The three trials have two things in common use of C. D R.
None: In a six month trial.
None: Time point.
None: Both the Panamax and <unk> phase III trial showed statistically significant advantages.
None: Of the anti amyloid treated patients compared to placebo at six months.
None: Another way both of those trials could have been stopped at six months with positive results.
None: The different seen between the placebo and treatment groups in the anti amyloid trials is exactly the same.
None: Difference, we expect to see between X pro treated and placebo treated patients.
Raymond Joseph Tesi: In summary, we are very confident that the XPRO trial is well-designed, statistically sound, and substantially de-risked. The X-Pro trial looks almost exactly like what has been successful with Leucanumab and Donamine. In early March, INCME initiated a joint press release with QNOS Bioscience, highlighting it as an Advanced AV patients who received weekly X-Pro treatment for four weeks had a statistically significant increase in alpha wave frequency. Reduced alpha wave power has been linked to cognitive decline and progression in MCI and Alzheimer's. The EEG, long considered the gold standard for objectively measuring brain activity, provides valuable insight into brain function and neural connectivity.
None: In summary, we are very confident that the extra trial is well designed statistically sound and substantially derisked.
None: The extra pro trial looks almost exactly what has been successful.
None: With Makena Mab Donna.
None: In early March and communicating the joint press release with Cumulus Bioscience, highlighting it advair.
None: Advanced <unk> patients, who received weekly Expo treatment for four weeks.
None: Statistically significant increase in alpha wave frequency empower.
None: Reduced alpha wave power has been linked to cognitive decline in progression and Mci in Alzheimer's disease.
E G long considered the gold standard and objectively measuring brain activity provides valuable insight into brain function and no connectivity.
Raymond Joseph Tesi: Studies have consistently highlighted a progressive decline in alpha-bam power in patients like us. To our knowledge, we are unaware of reports of drugs on in AD development that show consistent decreases in alpha wave power. We believe this is an easily measured biomarker of improved brain function in patients without Alzheimer's disease. But without a road map, that is, other results, we need to wait for the results of our trial to determine if an increase in alpha wave power correlates with cognitive improvement. Just to be clear, the seven patients in this pilot study are patients with moderate to severe Alzheimer's disease.
None: Studies have consistently highlighted the progressive decline in Alabama power.
None: And patients like ours.
None: So our knowledge, we are unaware of reports of drugs.
None: And a deep development that show consistent decreases in Alpha wave power.
We believe this is an easily measured biomarker of improve brain function in patients with ALS Alzheimer's disease, but without a roadmap that is other results we need to wait for the results of our trial to determine if an increase in alpha wave power correlates with cognitive improvement.
None: Just to be clear the seven patients in this pilot study of patients with moderate to severe Alzheimer's disease.
None: Disease.
Raymond Joseph Tesi: And so they're very different than those in the early Alzheimer's. We sought to evaluate the utility of EEG as a functional biomarker in this group. We believe this is just the beginning, or, as we like to say, the tip of the iceberg of what we can expect to be positive news on Alzheimer's, not only in halting the progression of cognitive decline in Alzheimer's disease but, hopefully, in restoring cognitive functionality. This last point is why we're using EMAC.
And so they're very different than those in the early Alzheimer's trial.
None: We sought to evaluate the utility of <unk> as a functional biomarker in this group.
None: We believe this is just the beginning or like as we like to say the tip of the iceberg of what we can expect.
Can be positive news on Alzheimer's.
Not only in halting the progression of cognitive decline in Alzheimer's disease.
None: But hopefully and restoring cognitive functionality.
None: Okay.
None: This last point is why are we using EMACS E. Mac has the ability to demonstrate improved cognitive function after expo treatment.
Raymond Joseph Tesi: EMAC has the ability to demonstrate improved cognitive function after expo treatment, while standard cognitive measures in Alzheimer's disease can only measure stable or decreasing cognition. We like to boast that targeting neuroinflammation with Expro provides many market expansion opportunities into other neurodegenerative and behavioral diseases. Go no further than our website to see 87 publications and more than 12 different diseases where Xro has been effective in clinical models, and preclinical. Treatment-resistant depression, or TRD, will be the first disease beyond Alzheimer's that we develop.
None: Standard cognitive measures in Alzheimer's disease.
None: Only measure stable or decrease in cognitive function.
None: We'd like to boast that targeting neuro inflammation with EXPAREL provides many market expansion opportunities into other neurodegenerative and behavioral diseases go no further than our website to see 87 publications more than 12 different diseases, where extra has been effective in clinical models preclinical models.
None: Treatment resistant depression, or <unk> will be the first disease beyond Alzheimer's that we develop.
Raymond Joseph Tesi: We will be making further announcements on the TRD Phase 2 trial using Expro in the near future. Our goal is to enroll the first patient in this NIH-supported Phase 2 trial in second semester 2020. I now pass the mic to Mark Lowdell, the co-founder and CSO of INmune Bio, to update progress on the INK immune program. But before I do so, I and the entire INmune Bio team want to recognize and congratulate Mark for a recent significant achievement. Two weeks ago, we received notice that Mark was awarded a Career Achievement Award in Cell and Gene Therapy by the International Society of Cell and Gene Therapists. The ISDT is THE society in cell and gene therapy, and the organization considers this award its highest honor. The award was announced as part of the annual ISCT major awards announcement, and Professor Lowdell will receive the award during the organization's annual meeting in Vancouver on May 20.
None: We will be making further announcements on the <unk> phase II trial using extra in the near future. Our goal is to enroll the first patient in this NIH supported phase II trial in the second half of 2024.
None: I will now pass the mic to Mark the Delta co founder and CSO of immune bar to update progress on the <unk> program before I do so.
None: I and the entire immune bio team I want to recognize and congratulate mark for our recent significant achievement.
None: Two weeks ago, we received notice that Mark was awarded a career achievement award in cell and gene therapy by the International Society of cell and gene therapy.
Mark: The IFC T is D society in cell and gene therapy, and the organization considers this award its highest honor.
Mark: The award was announced as part of the annual ICT Major awards announcement.
Mark: And for vessel Adele will receive the award during the organizations annual meeting in Vancouver on May 29.
Operator: We couldn't be happier for Mark and believe this recognition is well-deserved. Congratulations, Mark. Ladies and gentlemen, the line to Dr. Mark Lowdell has been disconnected. Please stay connected while I connect you to him. Thank you. There's a storm in the UK where Mark...
Mark: Couldn't be happier for Mark and believe this recognition is well deserved.
Mark: <unk> Mark.
None: Ladies and gentlemen at the line of Dr. Mark <unk> has been disconnected.
None: Please stay connected while connecting thank you.
None: Okay Mark.
None: Theres a storm in the UK market so.
None: Okay.
None: Yeah.
Mark: That's right.
Raymond Joseph Tesi: I'll tell you what, I'll go do my part, and then we can come back to Mark if you don't mind. Okay, that's fine. So, I hope the audience doesn't mind that, but I think that's the way to go, because Mark is really the one that needs to speak about INmune. David, I'll jump on here. And yep, and RJ, maybe what you could do is just text Mark so you can get him on the line. So I'm going to provide a brief overview of our financial results and upcoming milestones, and we'll go back to Mark, and then Mark will move on to Q&A. The net loss attributable to common stockholders for the year ended December 31st, 2023 was approximately $30 million compared to approximately $27.3 million for 2022. Research and development expenses totaled approximately $20.3 million for the year ending December 31, 2023, compared with approximately $17.1 million for 2022. General and administrative expenses will be approximately $9.6 million for the year ended December 31, 2023, compared with approximately $9.3 million for 2022.
Mark: Yeah.
Mark: Wow.
Mark: I'll tell you what I'll go to my part and then we can come back to Mark If you don't mind.
None: Okay. That's fine so I hope the audience doesn't line up but I think that's the way to go because mark is really the one that needs to speak about it so.
None: David I'll jump on here.
David J. Moss: Yes, and RJ, maybe what you could do is just tax marks even get him on the line, yes, So I'm going to provide a brief overview of our financial results and upcoming milestones and will go back to Mark and then Mark will move on to Q&A net.
David J. Moss: Net loss attributable to common stockholders for the year ended December 31, 'twenty twenty-three was approximately $30 million compared to with approximately $27 3 million for 2022.
David J. Moss: Research and development expenses totaled approximately $20 3 million for the year ended December 31, 23, compared with approximately $17 1 million for 2022.
David J. Moss: General and administrative expenses was approximately $9 6 million for the year ended December 31, 23, compared with approximately $9 3 million for 2022.
David J. Moss: At December 31st, 2023, the company had cash and cash equivalents of approximately $35.8 million. Based on our current operating plan, we believe our cash is sufficient to fund our operations into Q4. As of March 27, 2024, the company had approximately 18 million shares of common stock outstanding.
David J. Moss: At December 31, 2023, the company had cash and cash equivalents of approximately $35 8 million.
David J. Moss: Based on our current operating plan, we believe our cash is sufficient to fund our operations into Q4.
David J. Moss: As of March 27th 2024, the company had approximately 18 million shares of common stock outstanding.
David J. Moss: As highlighted in the prior quarter's investor call, we continue to focus on achieving our primary clinical objectives while remaining cost prudent with the potential to recover a portion of R&D expenses in Australia and the UK. Now, I'd like to move on and list our upcoming important milestones. Full enrollment in the Phase 2 X-Pro 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. We will initiate a Phase 2 trial of XPro in patients with treatment-resistant depression in the second half of 2024. Cohort 1 of the Metastatic Castration-Resistant Prostate Cancer Program is nearly complete, with all three patients enrolled.
As highlighted in the prior quarter's investor call. We continue to focus on achieving our primary clinical objectives, while remaining cost prudent with the potential to recover a portion of R&D expenses.
David J. Moss: Australia and the UK.
None: Now I'd like to move on and list or upcoming important milestones.
None: Full enrollment in the phase two extra trial for the treatment of neuro inflammation is a cause of Alzheimers disease are expected mid 2024, followed by topline data approximately six months from the last patient enrolled.
None: We will initiate a phase two trial of EXPAREL in patients with treatment resistant depression in the second half of 2024.
None: Cohort one of the metastatic castration resistant prostate cancer program is nearly complete with all three patients enrolled we expect cohort two to start in April with open label data to follow we expect to complete enrollment in the phase one portion of the metastatic castration resistant prostate cancer trial by.
David J. Moss: We expect Cohort 2 to start in April, with open-label data to follow. We expect to complete enrollment in the Phase 1 portion of the Metastatic Castration-Resistant Prostate Cancer trial by the end of Q3-24, and the Phase 2 portion is expected to complete enrollment in Q2 of 2025. An upcoming webinar on using Expro to promote remyelination in neurodegenerative diseases will be announced in Q2. We encourage you to look out for this event and do your best to try and join. It should be pretty exciting.
None: The end of Q3 dollars 24 in the phase II portion is expected to complete enrollment in Q2 of 2025.
None: And upcoming webinar on using EXPAREL to part to promote re myelination and Neurodegenerative and Neurodegenerative disease.
None: That will be announced in Q2, we encourage you to look out for this event and do your best to try and join it should be pretty exciting.
None: Yeah.
Operator: And then at this point, I think, Mark, are you back on the line? Uh, David, uh, Mark is still not online. Yeah, so he says he's going to try a web call, but let me go ahead and get started, and you can jump in. So, um..., on to INcmune. So we apologize for the technical problem. So we achieved- I've actually joined, RJ, RJ has joined. Okay, go ahead, Mark. Mark, I've been, you've got to, I did give you accolades about your awards, so you can start from there. That's very kind of you. Yep. Sorry, everyone. I'm in the UK, and we've got a thunderstorm going on, and I got dropped out.
None: And then at this point I think Marc are you back on the line.
None: David Marcus or not online.
None: Yeah. So he is here he says he's going to try a web call, but let me go ahead and get started and you can jump in.
None: So.
None:
None: Onto Inc. Immune so we apologize for the technical problems.
None: So we achieve Julian J I'm, sorry go ahead, Mark Mark I've been it you've got to I I did give your accolades about your awards. So you can start from there that's very kind of you.
None: Sorry, everyone I'm in the UK and we've got a thunderstorm going on and I got.
Mark William Lowdell: Anyway, thank you very much, RJ. Of course, I'm very honored by the ISAT's recognition and obviously, I should pass my thanks to all of my current and former colleagues that I've had the pleasure of working with over the years. It's a great reflection on the entire research effort and success of everyone I've been lucky to work and collaborate with over the course of my career, and I hope it continues. So, most notably for us, though, that we achieved a company milestone at the end of 2023 in the last weeks before Christmas with the launching of the phase one to open-label trial of INmune in metastatic castration-resistant prostate cancer, or MCRPC The trial is actually unique in many ways, as seems to be the trend of our company. First, the concept.
Mark: Dropped out anyway. Thank you very much Andre of course, I'm very honored by the city's recognition and obviously pass my thanks to all of my current and former colleagues that I've had the pleasure to work with over the years. It is a great reflection on the entire research effort and success of everyone I've been lucky to work and collaborate with them over the course of my career.
Mark: And I hope it continues so a nice niche bifrost, though that we achieved to accompany milestone at the end of 2023 in the last weeks before Christmas with the launching of the Phase one two open label trial of <unk> in metastatic castration resistant prostate cancer and <unk>.
Mark: L. P C for short with the first patient dosing taking place in the final week AR at the end of last year.
Mark: The trial is actually unique in many ways. It seems that the trend of our company as a concept that this is an NK therapy trial does not give NK cells will use cytokines immune converts the patient residual NK cells in the circulation from resting a known cancer, killing stay.
Mark William Lowdell: This is an NK therapy trial that does not give NK cells or use cytokines. INmune converts the patient's own residual NK cells in their circulation from a resting, non-cancer-killing state to what we now know are memory-like NK cells that are able to destroy NK-resistant cancer cells. So unlike more conventional adoptive immunotherapies with NK cells from donors, patients don't require any type of conditioning chemotherapy, and nor do they require NK-stimulating cytokines, as is common with other NK activities.
Mark: Eight.
Mark: To what we now know a memory like NK cells that are able to destroy NK resistant cancer cells. So unlike more conventional adoptive immunotherapies with NK cells from donors patients don't require any type of conditioning chemotherapy and nor do they require NK stimulating cytokines as it's come into Arthur and captivating therapy.
Mark: Please.
Mark William Lowdell: INmune patients sit in a chair as an outpatient and get an IV or intravenous infusion over 20 minutes, and then having received their dose of INmune, they're able to leave. We've given over 20 doses of INmune in an outpatient setting so far, and each infusion was remarkably boring for the patient and, as importantly for the clinical team as it appears to be so well tolerated.
Mark: He named patient sitting in a chair.
Mark: Outpatient again, IV or intravenous infusion every 20 minutes and then having received the that does think mean, they're able to leave we give over 20 doses in an outpatient setting safer.
Mark: Each infusion was remarkably boring for the patient and as importantly for the clinical team as it appears to be say well tolerated.
Mark William Lowdell: In each patient in the trial, we're monitoring immunologic endpoints, as you would expect, that include NK cell number, the phenotype of those NK cells, and their ability to kill NK-resistant tumor cells. We also measure tumor-related variables. In this MCR-PC trial, we measure antitumor effects by following blood PSA levels, tumor volume with PMSA scans, and circulating tumor DNA.
Mark: And each patient in the trial, we are monitoring immunologic endpoints as you would expect would include NK cell number the phenotype concise NK cells and their ability to kill NK resistant tumor cells.
Mark: We also measured tumor related variables are in this M. A C. L. P. C trial, we measure antitumor effects by following blood Psa levels too.
Mark: Tumor volume with pay MSA scans and circulating tumor DNA.
Mark William Lowdell: So this rich data set will allow us to predict if the therapy warrants a pivotal trial at the end of phase two. The Phase 1 and Phase 2 trials are expected to enroll 30 patients. These men have all received premiers therapy and now have metastatic gastrate-resistant prostate cancer. They received three infusions of INmune as an outpatient treatment, as I said, during that six month trial. We have 3 centers enrolling patients, and another 5 are expected to open over the next few months.
Mark: So this rich data set will allow us to predict if the therapy warrants a pivotal trial at the end of phase two.
Mark: The phase one phase two trial is expected to enroll 30 patients. These men have who will receive premier's therapy and now have metastatic castrate resistant prostate cancer.
Mark: They received three infusions as an outpatient treatment as I said during that six months trial.
Mark: We have three centers enrolling patients and another five are expected to open over the next few months.
Mark William Lowdell: The Phase 1 portion of the trial will be completed by September this year, and we expect patient enrolment 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 moment. It is an open-label trial, and we expect some snapshots of the data in 2024 or early 2025. Equally importantly, the INcMUNE team has been working very hard on perfecting the manufacturing and logistics elements of INcMUNE therapy. So, when wearing my academic hat over the last 35 years, I've seen many promising therapeutic strategies in the cell and gene therapy space fail due to manufacturing and logistical problems, and you'll all be aware of some of those associated with adoptive immunotherapies like CAR-T. We're scaling up the manufacturing process Because the product ships on dry ice, logistics and storage at treatment centers are easy and fits in with many other drugs.
Mark: The phase one portion of the trial will be completed by September this year, and we expect patient enrollment in the phase II portion to be completed by the 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 and we expect some snapshots of the data in 2024.
Mark: Or in early 2025.
Mark: Equally importantly, the <unk> team has been working very hard on perfecting the manufacturing and logistics elements I think me and therapy.
None: So when wearing one academic hot over the last 35 years I've seen many promising therapeutic strategies in the southern gene therapy space fail due to manufacturing and logistical problems and you will be aware of of some of those associated with adoptive immunotherapies like car T.
We're scaling up the manufacturing process in preparation for the pivotal trial, and we perfected the quality and release assay assay as requested by the regulatory authorities.
None: Because the product ships on dry ice logistics and storage of treatment centers as easily as easy and fits in with many other drugs commercial drugs.
Mark William Lowdell: So simply put, we can make the drug, we can ship and store it, and the clinical trials will determine its therapeutic value in this setting. Our pivot from hematological malignancies to solid tumors was not a one-tumor project and has been well planned. The unique attributes of INmune primed NK cells make them ideal to treat a wide variety of solid tumors, and we've published on those.
None: So simply put we can make the drug we can ship and store it in the clinical trials will determine the therapeutic value.
None: In this setting.
None: Our pivot from Hematological malignancies, and solid tumors was not one chamber project and has been well planned.
None: Unique attributes of immune primed NK cells make them ideal to treat a wide variety of solid tumors and we've published on this prostate cancer is a test case, but we found it sound preclinical work in ovarian cancer and we are developing the same data in renal cell carcinoma.
Mark William Lowdell: Prostate cancer is the test case, but we've found sound preclinical work in ovarian cancer, and we're developing the same data in renal cell carcinoma. So given resources, these will be the next targets of INCUE and THERAPY. So that concludes my update on the INmune platform, and I'd like to turn the call over to David Moss, our CFO, to discuss the financials. Thank you, David. Well, I appreciate it, Mark, and thank you for the update. Since I've already gone through the financial and summary management fields of the company, it has two great platforms and is a small organization with limited resources.
None: So given resources these will be the next targets I think immune therapy.
None: So that ends up my update on the <unk> platform.
None: <unk> turned the corner over to David Moss, our CFO to discuss the financials. Thank you David.
David J. Moss: Well I appreciate it Mark and thank you for the update since I've already gone through the financials in summary management feels that the company has two great platforms and it's a small organization with limited resources, we'll try to expand the application of these platforms when resources allow we greatly greatly appreciate your continued belief in our small company and support.
David J. Moss: We'll try to expand the application of these platforms when resources allow. We greatly, greatly appreciate your continued belief in our small company and support of shareholders. At this point, I'd like to thank you for your time and attention. I'd like to turn it back to Ryan to poll for questions. Ryan?
None: Shareholders at this point I'd like to thank you for your time and attention I'd like to turn it back to Ryan to poll for questions Brian.
Operator: Thank you. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and 1 on your telephone. A confirmation tone will indicate your line is busy. You may press stars and 2 if you would like to remove your question from the list. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.
Ryan: Thank you.
Ryan: Ladies and gentlemen, we will now be conducting a question and answer session.
Ryan: If you would like to ask a question. Please press star and one on your telephone keypad.
Ryan: A confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue.
Ryan: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the stock east.
Operator: Ladies and gentlemen, we will wait for a moment while we poll for questions. Our first question is from Thomas Shrader with BTIG. Please go ahead. Hi, good morning, good afternoon.
Ladies and gentlemen, we will wait for a moment, while we poll for questions.
Ryan: Our first question is from Thomas <unk> with <unk>.
Thomas: Please go ahead.
Thomas: Hi, Good morning. Good afternoon. This is Tom on for Tom Thanks for taking my questions.
Operator: This is Salman from QAM. Thanks for taking my question. So two questions for us: first, for the plan study in TRD patients, is there an obvious criteria for patient stratification to enrich for patients who are likely to benefit from Xpro? And question number two is, for the recent EEG data that was presented, how established is the correlation between EEG changes and improvements in cognition and memory? Any additional insights? Yeah, so thanks. The first question is on TRD.
Thomas: Two for us So first for the planned study and TRT patients is there an obvious criteria criteria for patient stratification to enrich for patients who are likely to.
None: Benefit from extra.
Tom: And then question number two is the photo.
Tom: For the recent <unk> data that was presented how established as the correlation between these changes and improvements in cognition and memory any additional insight would be helpful. Thank you.
Yeah. So thanks. So first question is on <unk> and in fact, we will use CRP. So these patients have had they been.
Raymond Joseph Tesi: And in fact, we will use CRP. So these patients have been confirmed to be treatment resistant, which means they have failed two previous lines of antidepressant therapy, and they need to have an elevated CRP. So when we're not adding the other three biomarkers we use in the AD trial, but it's the same principle that patients with neuroinflammation will benefit from Expro. And it turns out that neuroinflammation makes patients resistant to traditional antidepressant drugs. So this is an ideal treatment group for us to treat. Now, I missed the first part of your second question, so ask it again, please. How established is the correlation between EEG changes and improvements in cognition and memory in Alzheimer's disease? Yeah, a good question.
Tom: Confirmed to be treatment resistance, which means they.
Tom: L two previous lines of the <unk>.
None: Anti depression therapy, and they need to have an elevated CRP. So when we're not adding the other three biomarkers we use in the a D trial, but it's the same principle that patients with neuro inflammation will benefit from Expo and it turns out that information makes patients resistant to two.
None: Tricia nutrition to traditional.
Anti depressant drugs.
None: So this is an ideal treatment group for us in the street.
None: I missed the first part of your second question. So ask it again please.
None: Just how establishes the correlation between easy to EG changes and improvements in cognition and memory in Alzheimer disease. Yeah. Good question in fact, it is not established.
Raymond Joseph Tesi: In fact, it's not established. As far as we, we obviously did a very deep dive here, and we could only, so we could only find published data on patients with head injuries. In other words, if you have a head injury, TBI, your alpha wave declines. And then four weeks later, when you get better, your alpha wave goes up. So there's an improvement in alpha waves in a patient who has cognitive dysfunction after TBI that improves, but that is not a drug trial. We looked hard at the drug literature and could find no data that really supports that correlation, and that's why I was saying we don't really have a roadmap. There's a couple; there's some debate with Danespazil whether it in fact increases alpha wave power in patients that respond, but I would say that's a moot point at this point.
None: We are we obviously did a very deep dive here and we could only so we could only find published data on patients with head and in other words, we have ahead and who tbi your alpha wave declines.
None: And then four weeks later when you get better your Alpha wave goes up so there is an improvement in alpha wave in a patient who is has cognitive dysfunction after tbi that improves.
None: That is not a drug trial, we looked hard at the drug literature and could find no data.
None: That really supports that correlation and that's why I was saying we don't really have a roadmap. There is a couple there is some debate with the net.
None: The net Brazil, whether in fact increases alpha.
None: Alpha waves tower and patients that respond, but I would say that's a.
None: Abate at this point I would honestly, we believe and the experts believe that it is a it is consistent with improvements in optic function and brain function.
David J. Moss: I would honestly say, we believe, and the experts believe that it is a, it is consistent with improvement in synaptic function and brain function. We'll see after our phase two trial. We hope that's the case. And if you don't mind, RJ, I'd just like to add a little bit on the TRD, and I wish we had CJ on the call because CJ is really a TRD expert, but one of the reasons why we're very interested in TRD is that Andy Miller and Jen Felger, two KOLs that are in this space, there was a trial that was previously run It's a published paper, and I'd be happy to send it to you.
None: We'll see after a phase two trial, we hope it's the case.
None: And if you don't mind a R. J, just like that a little bit on the PRT and I wish we had C. J on the call because C. J as really a TRT expert, but one of the reasons why we're very interested in T. R. D is that Andy Miller, and Jen Selter too kols that are in the space.
None: There was a trial that was previously see run with a TNF inhibitors as the published paper on I'd be happy to send it to you I think it is listed on our slide on the TRT deck.
David J. Moss: I think it's listed on our slide on the TRD deck, and it shows a failed trial that just took all comers, but it shows that patients that had elevated CRP, elevated measures of neuroinflammation, had a very statistically different result, a positive result when treated. And so if you select your patient population and you use a better TNF inhibitor, i.e. Xpro, we feel very confident that that is a trial that will be successful, and really, Andy Miller has really been chomping at the bit to do this trial for many, many years. And that's the reason it's set up and one of the reasons why the NIMH, the National Institutes of Mental Health, gave the company a $2.9 million grant to do that trial. Thank you. Our next question is from the line of Joel Beatty with Baird. Please go ahead.
None: And it shows a failed trial.
None: That just took all comers, but it shows that patients that had elevated CRP elevated measures of neuro inflammation had a very statistically different result, a positive result, when treated and so if you select your patient population and you use a better TNF inhibitor I X pro we feel.
None: Very confident that that is a trial that will that will be successful in and really Andy Miller.
None: Has really been chomping at the bit to do this trial for many many years and ER and that's the reason that set up in one of the reasons why the Eni NIH National Institutes of mental health I gave the company a $2 9 million dollar grant to do that trial.
None: Thank you for all the detail.
None: Yeah.
None: Thank you.
None: Our next question is from the line of Joanne Betty.
Joel Lawrence Beatty: Bed. Please go ahead.
Operator: Great. Thanks, Shrader, for taking the questions and for the update today. The first question is, as you enroll in the Phase 2 Alzheimer's trial, what about the profile of expo or the previous data resonates the most with investigators? So, yeah, thank you, Joel. Remember that this trial is occurring in jurisdictions that do not have the anti-amyloid drugs approved. So, you know, that's Canada, Australia, Europe, and
Joel Lawrence Beatty: Great. Thanks for taking the questions and for the update today.
Joel Lawrence Beatty: The question is as you enroll the phase two Alzheimer's trial, what about the profile of extra or the previous debt resonates the most with investigators.
None: So yeah. Thank you Joel so.
None: Remember that this trial was occurring in jurisdictions that do not have the anti amyloid drugs approved. So you know, that's Canada, Australia, Europe and the U K. So in fact number one they're excited about the fact that they have something to offer their offer their patients.
Raymond Joseph Tesi: So, in fact, number one, they're excited about the fact that they have something to offer. Number two, you know, they read the literature like everybody else, and they, you know, especially those that haven't had hands-on experience with the anti-amyloids, they're just not sure. And here we are, giving them a drug that is both safe and, we think, and we've convinced them it's effective.
None: Two you know they read the literature like everybody else and they.
None: No.
None: Especially those that haven't had hands on experience with the anti amyloid. So they're just not sure and here, we are giving them a drug that is both safe.
None: And and we think and we've convinced them as effective so they like the eye they like the safety profile. They like the idea that it is not it is targeting something else besides amyloid.
Raymond Joseph Tesi: They like the idea that it is targeting something else besides the amyloid. And they also like the idea that the trial is only six months because if, in fact, the patient doesn't respond, then the patient can move on to another clinical trial and still probably qualify where, if it was an 18-month trial, that would be. Yeah, that's helpful.
None: And they also like the idea that the trial is only six months.
None: Cause if in fact, the patient doesn't respond.
None: Then the patient to move onto another clinical trial and still probably qualify where if it was an 18 month trial that would be the case.
None: Yeah. That's helpful and then a question on ink noon.
Mark William Lowdell: And then a question on INmune, with the prostate cancer trial now underway, do you share anything about the potential cadence of when you might be able to share data from the trial with investigators? Um, yeah, um, the... Best thing I can tell you is that today we treated the third patient, so the last patient in the first cohort, with the final dose of the drug. Obviously, that's the lowest dose, and we will start analyzing those data as they come through.
None: Prostate cancer trials now underway can you share anything about the potential of.
None: Cadence of when you might be able to sharing the data from that trial with investors.
None: Yeah.
None: The best thing I can tell you is that today.
None: They we treated the the third patient so the last patient in the first cohort with the final days of drug obviously, that's the lowest dose and we will start analyzing those data as they come through them.
Mark William Lowdell: We have got patients lined up now to start the second cohort, so we're right on schedule to deliver this trial on time. I believe we will be coming out with good news as it comes through, and I think September is when we will be looking for that, for those data to come out, because we'll be able to maturely analyze them across the three dose levels. But if we get any remarkable data prior to that, then plainly, you know, we'll, All right, thank you. Thank you. Our next question is from the line of Daniel Carlson with Tailwind Research. Please go ahead.
None: We have got patients lined up now for <unk> to start the second cohort. So we're right on schedule to deliver this trial on time.
None: I believe we will be coming out with good news as it comes through in I think September is when when we will be looking for that for those guys to come out because we will be able to materially analyze them across the three dose. So is it the.
None: The three dose levels, but if we get any remarkable data price that in plenty in it we will.
None: Go public with it.
None: Okay. Thank you.
None: Thank you.
None: Our next question is from the line of Daniel Carlson with tailwind research. Please go ahead.
Operator: Hi guys, thanks for taking my questions. Just, RJ, you've talked about comparing X-Pro to the anti-amyloid trials at six months. We know those trials are much larger in size than your expo trial. What gives you confidence that you'll be successful in comparing them?
Daniel Carlson: Hi, guys. Thanks for taking my questions.
Daniel Carlson: Mr. Jay you've talked about comparing X pro to the anti amyloid trials at six months.
Daniel Carlson: We know those trials are are much larger in size than than your expert trial, what what gives you confidence that you'll be successful and comparing them.
Raymond Joseph Tesi: preparing your trial of VAERS. Great question, Dan, and pretty easy to answer. This is where the enrichment criteria come in. You know, we've been touting the fact that we only enroll patients with neuroinflammation, and we define that by one of three blood tests or a team ApoE45. By doing a trial that matches the patient's disease, neuroinflammation, with a mechanism of action and a drug that treats neuroinflammation, you actually make the trial work at six months better than the anti-amyloid trial. So, to put it in geeky terms, The statistical power increases because the variance decreases.
Daniel Carlson: Comparing your travels there at six months.
Jay: Great question, Dan and pretty easy to answer.
This is where the enrichment criteria come in you know we've been touting the fact that.
Jay: We only enrolled patients with neuro inflammation and we define that.
Jay: One of three blood blood tests are being equally.
Jay: Yes.
By doing a trial that matches the patient's disease neuro inflammation with our mechanism of action of the drug that treats neuro inflammation.
Jay: You actually make the trial work at six months better than the anti amyloid trial. So that is to put it in different terms.
Jay: The statistical power increases because the variance.
Jay: Decreases so because theres less noise. The data we get is cleaner so whereas they need it turns out if you look at the results that they got they would've needed about 700 patients.
Raymond Joseph Tesi: So because there's less noise, the data we get is cleaner. So where they need it, it turns out, if you look at the results they got, they would have needed about 700 patients. So, 350 per arm to actually have a positive trial at six months, but we only need 200. So, it's all related to the enrichment criteria. That's, we've always called it, a little bit of our secret sauce, and this is a good example of why it's so good. Got you.
Jay: Total so $3 50 per arm to actually have a positive trial at six months, but we only need 200. So it's all related to the enrichment criteria. That's we've always called it a little bit of our secret sauce and this is a good example of why it's the secret sauce.
None: Got you that makes perfect sense. Thanks.
Mark William Lowdell: That makes perfect sense. Thanks. Mark, question for you on INCMUNE. The profit market has certainly heated up with, In these radioconjugate companies, some of them have been acquired, and some finance things with great valuations, etc. Can you compare or just tell us how INcmune competes with radioconjugate? Yeah, thanks Dan, that's a very good question and plainly they're much further down the line than we are in their trials and getting their drugs licensed. The fact is that radiopharmaceuticals are tough to deliver, you know, just getting the isotopes. And if you think about Plovicto, the Lutetium-177 that they use for Plovicto, there's only one manufacturer of Lutetium-177 in the entirety of the United States, and I think there's probably only three globally. So you do end up looking, as we've seen with the Strontium-89 in Metastron, a challenge in getting the availability of the radioligand. The other problem, of course, is, or one of the other problems is, of course, the short shelf life. Lutetium has a shelf life of 6.7 days or seven days.
None: Mark.
None: For you on <unk>.
None: The prostate market is certainly heated up with.
None: In these radio conjugate companies that some of them have been acquired and some financings with great valuations et cetera can you compare or just tell us how it competes with radio conjugates.
Mark: Yeah. Thanks, Dan that's a very good question and unplanned eaten or that they're much further down the line that we are in in that trials and getting their drugs license, but.
None: The fact is that radio pharmaceuticals are tough to deliver it just getting the isotopes and if you think about predicting them. The lutetium 177 that they use for predictable.
None: One manufacturer lutetium, one 717, the entirety of the United States and I think there's probably only three globally.
None: So you do end up looking at as we've seen with a strong team 89, a message strong a challenge and in and getting them on the way.
The ability of the of the radio ligand are the other problem of course is one of the other provinces of course, there's the short shelf life situations go to shelf life of $6 seven days or seven days. So your manufacturing issues are very considerable and I think as these drugs get more widely used we're going to see.
Mark William Lowdell: So your manufacturing issues are very considerable, and I think as these drugs get more widely used, we're going to see bigger problems with that. But I guess that the real difference is the sort of recall effect that you get, which leads to off-target toxicity, even with these relatively well-tolerated drugs like Plovicto. You know, you've got bone marrow suppression; these patients become anemic. And so that's fine in the metastatic castration-resistant prostate cancer setting, where you've got patients who are very far down the therapeutic line. But it does make them more challenging to deliver earlier in the treatment process.
None: <unk> problems are we with that but I guess that the real difference is the sort of recall effects that you get which leads to to off target toxicity, even with with these well relatively well tolerated drugs like predicted.
None: Got my marrow suppression in these patients become anemic and so that's fine in the metastatic castration resistant prostate cancer, setting where you've got patients who are very far down the therapeutic line, but it does make them more challenging to deliver earlier in the treatment Oh, the treatment process and the <unk>.
Mark William Lowdell: And the great thing about InkMUNE is its complete lack of toxicity in the patients we've treated so far and in the animal models that we used beforehand. So I think the great difference, if you wanted to look at one now, is that if we're successful with InkMUNE, I see it moving earlier in the treatment paradigm. So you end up treating patients with early-stage disease, which is where we are with many of the other immunotherapies. So that's where I think the difference will be; we'll have a wider population of less, and Severi.
None: Thing about <unk> is its complete lack of toxicity and the patients we've treated so far and in the animal models that we use beforehand. So I think the great difference. If you wanted to look at one now if we're successful in I see it moving earlier in the treatment paradigm.
None: Paradigm. So you in a triple regimen, rather say you end up treating patients with our with early stage disease, which is where we are with many of the other immunotherapies.
None: That's where I think the difference will be will have a wider population of less.
None: Severity.
None: Sick patients.
Mark William Lowdell: Awesome, that's great, thank you, that's good input. RJ, just, um, if you can comment, I mean, it seems like both, and the Alzheimer's trial, enrollment seems to be on track. Can you just talk about the trends you're seeing in enrollment right now?
None: Awesome.
None: Great. Thank you that's good input pace and then wasn't didn't always too right.
None: R. J just if you can comment I mean, it seems like both in commune and and the Alzheimer's trial. The enrollment seems to be on track can you just talk about the trends you're seeing in enrollment right now.
None: Okay.
R. J: Yeah, well, so I'll start with Engineering, Inc. And has actually enrollment has been constrained by the Fda's requests in other words. They wanted in the phase one portion of the trial 28 days between.
Raymond Joseph Tesi: Yeah, well, I'll start with INmune. Enrollment in INmune has actually been constrained by the FDA's requests. In other words, they wanted, in the phase one portion of the trial, 28 days between each patient in the cohort. By definition, the first, You know, getting all three cohorts done will take nine months.
R. J: Each patient in the cohort so by definition the first.
R. J: Getting all three cohorts done will take nine months now there is some speed up because of the Bayesian design because there is some overlap with the phase two groups, but the bottom line is we've had more patients actually contacting.
Raymond Joseph Tesi: Now, there is some speed up because of the Bayesian design because there is some overlap between the phase two groups. But the bottom line is, we've had more patients actually contacting us who want to be enrolled in the trial than we have slots for right now. Now, knock on wood, let's hope that continues when we get to the phase two portion where we have a little more flexibility in enrollment rates. But the bottom line is... You know, prostate disease is common.
R. J: Contacting us we want to be enrolled in the trial then we have slots for right now now knock on wood, but let's hope that.
R. J: <unk> when we get to the phase II portion, where we have a little more flexibility and an enrollment rates, but the bottom line is.
R. J: You know prostate diseases common.
Raymond Joseph Tesi: The patients are actually quite sophisticated in searching for clinical options, and so they contact us as often as our clinical sites go looking for them, which is quite encouraging. Alzheimer's disease is more interesting, as I said earlier, because all of our studies are in jurisdictions where the anti-amyloids aren't. In fact, we're only competing with clinical trials, other clinical trials. Now, there are a lot of clinical trials in Alzheimer's disease, including, you know, both companies are running, you know, phase threes and other trials. So there are a lot of patients being consumed by the anti-amyloid. But as I said to Joel, I mean, X-Pro is just kind of an attractive drug. It's a different mechanism, so we get a good listen.
R. J: Ah patients are actually quite sophisticated and searching for clinical options and so they contact us as often as as our clinical sites go looking for them, which is quite encouraging.
R. J: Alzheimer's disease is a more interesting as I said earlier, because all of our studies are in jurisdictions.
R. J: Where the anti amyloid arent alright.
R. J: Crude in fact, we're only completing with clinical trial other clinical trials now.
R. J: A lot of clinical trials in Alzheimer's disease, including a you.
R. J: You know both companies are running you know phase three than in other trials. So there's a lot of patients being consumed by the anti amyloid trials, but as I said due to Joel I mean, the you know I was just.
R. J: Kind of an attractive drug it's different mechanism.
R. J: So we get a good listen you know it's safe it's a good mechanism.
Raymond Joseph Tesi: You know, it's safe, it's a good mechanism. But I have to say it's not. It's rarely the patient that chooses which trial to be in if they really follow the advice of their clinician. But the clinicians like kind of like what we're doing. And so far, so good is all I can say. I will say that we, you know, every day we get up, and we think of ways that we can. And I think, you know, I think we've got some ideas and we're pushing hard.
R. J: I have to say it's not.
R. J: It's rarely the patient chooses on what's trial to be in if they're really follow the advice of their clinicians lots of clinicians like kind of like what we're doing and so far. So good is all I can say I will say that we you know every day, we get up and we think of ways that we can speed enrollment and I think you know I think we.
R. J: Got some ideas and we're pushing hard.
Raymond Joseph Tesi: And so far, fingers crossed, toes crossed, everything's going to work out as we promised for the last two years, despite our frustrations with the FDA. I'd just like to say, Dan, that I've been doing early phase clinical trials all my career, and I have never known a trial, either the X-ProADO2 trial or our INmune trial in prostate cancer, that has enrolled on schedule in the way that these two trials have, and so we can be really confident about the outcome, the delivery time point, given the sheer enthusiasm for patients on both trials, which I say is remarkable in Well, thanks, guys. I mean, after going through COVID with a number of companies missing, you know, their timelines because of enrollment issues, it's great to see these trends. So, thank you for that. I appreciate it.
R. J: And so far.
R. J: Fingers crossed toes crossed everything's going to work out as we promised over the last few years, despite our frustration with the SBA.
R. J: I guess I can say that.
R. J: The the I've been doing early phase clinical trials, all my career and I have never known a trial either is that the the expert if you go to trial or ARINC me in trial in prostate cancer that has enrolled to schedule and the way that these two trials have and so.
R. J: We can be really confident about the outcome.
But the delivery time point, given the sheer enthusiasm for patients on both trials, which is to say it is remarkable in my in my experience.
None: Thanks, guys I mean after going through Covid with a number of companies.
None: Missing.
Their their timelines because of our enrolment issues, it's great to see these trends so think of it I appreciate it.
Raymond Joseph Tesi: Thank you. As there are no further questions, I will now hand the conference over to Dr. R.J. Tesi for his closing comments. Yeah, so thank you.
None: Thank you.
Speaker Change: As there are no further questions I would now have the constant silver to Doctor Archie Tessie for his closing comments.
Raymond Joseph Tesi: Yeah. So thank you so I mean by us making progress on two fronts and as we're pretty proud of that.
Raymond Joseph Tesi: So, INmune Bio is making progress on two fronts, and we're pretty proud of that. I will say the drug development landscape for the treatment of cognitive decline in Alzheimer's disease is really changing rapidly. And we are impressed how quickly the conversation has pivoted from treatment of dementia to prevention of dementia. I can't help wonder if this rapid pivot is because of dissatisfaction and frustration with the approved therapies. You know, there's still a niggling concern that the risk profile is not ideal.
Raymond Joseph Tesi: I will say the drug land development landscape for the treatment and cognitive decline in Alzheimer's disease is really changing rapidly.
Raymond Joseph Tesi: And we are impressed how quickly the conversation has pivoted from treatment of dementia to prevention of demand Gen. I can't help wonder is this rapid pivot is because of dissatisfaction and frustration.
The with the approved therapies, you know theres still a niggling concern that the risk profile was not ideal.
Raymond Joseph Tesi: But I have to say at INmune Bio, we have a little bit of a different view. We believe anti-amyloid drugs are chasing the wrong target. We believe neuroinflammation is intimately involved in disrupting nerve cell function and survival and synaptic function, which are the two central elements needed for cognitive function. With Expo, we are attacking this pathology and have strong evidence that we change the biology of the brain for the better. The ongoing Phase II trial will allow us to correlate these biologic benefits with cognitive change, and we hope cognitive benefits will be better. Stay tuned because a positive result there opens the door to other indications where neuroinflammation meets cognitive dysfunction. Likewise, INmune is an NK therapy of a different strength.
None: But I have to say it immune bio we have a little bit of a different view, we believe the anti amyloid drugs are chasing the wrong target. We believe neuro inflammation is intimately involved in disrupting nerve cell.
None: Function and survival in synaptic function and those are the two central elements needed for cognitive decline with extra we're attacking this pathology and have strong evidence that we change the biology of the brain for the better the ongoing phase II trial will allow us to correlate these biologic benefits with cognizant change Emily.
None: Cognizant benefits.
None: Stay tuned because of positive result, there opens the doors to other indications where neuro inflammation meets cognitive dysfunction.
None: Likewise and come in as an NK therapy or a different stripe biology sound. It's a lifetime work by Mark with Dell and he is getting finally recognize or what has been long do.
Raymond Joseph Tesi: The biology is sound. It's a lifetime of work by Mark Lowdell, and he is finally getting recognized for what has been long due. We marvel at the safety profile of this immunotherapy. Could this be a cancer therapy that really has no side effects and only benefits? Time will tell, and we believe the metastatic castrate-resistant prostate cancer trial will give the product INmune a good chance to shine. We remain optimistic about both our programs, and we thank you for your support and your attention.
None: We Marvel at the safety profile of this immunotherapy.
None: Could this be a cancer therapy that really has no side effects and only has benefits.
None: Time will tell and we believe the metastatic castrate resistant prostate cancer trial will give the product engineering.
None: A good chance to shine.
None: We remain optimistic about both our programs and we thank you for your support and your attention.
None: Yeah.
None: Thank you.
None: The conference off and wheel bio has now concluded.
None: And for your participation you may now disconnect your lines.
None: [noise].
Operator: Thank you. The conference of INmune Bio has now concluded. Thank you for your participation. You may now disconnect your lines. Researcher, Daniel Carlson, Joel Beatty, David Moss, Raymond Tesi, Mark Lowdell, INmune Bio
None: Yeah.
None: [music].