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Post by JHam on Jul 31, 2020 17:24:40 GMT
Doubled down here at $11.10. Finally have my average under $12.
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Post by JHam on Aug 6, 2020 14:26:04 GMT
Pretty interesting comment from Roth today:
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Post by jamesjohnson12 on Aug 6, 2020 16:03:50 GMT
I thought it was a pretty solid conference call as well. I believe he mentioned that they would receive approval from USA and Australia to begin their Covid trials in August, which would imply 2 pretty good near term catalysts.
I also liked the fact that the Alzheimers patients in the study were fighting to continue receiving treatment even after the trial had concluded. This resulted in them creating an "extension" trial where the patients who elected could continue treatment and would be assessed every 3 months. I may not have explained this exactly properly, but it seemed to be a tell that the therapy is subjectively effective (since the patients want to keep on the treatment).
Other note: It was interesting that they specifically thought that their Covid therapy could target the multisystem inflammatory syndrome (MISC) that has been showing up in children's COVID cases and seems similar to Kawasaki syndrome - both very awful. He had some very technical reasons for why the treatment may be particularly effective in those cases. He did mention that they would need data and results from adults before going after those indications in children, but I thought it was interesting none the less.
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Post by JHam on Aug 8, 2020 2:43:16 GMT
I thought it was a pretty solid conference call as well. I believe he mentioned that they would receive approval from USA and Australia to begin their Covid trials in August, which would imply 2 pretty good near term catalysts. I also liked the fact that the Alzheimers patients in the study were fighting to continue receiving treatment even after the trial had concluded. This resulted in them creating an "extension" trial where the patients who elected could continue treatment and would be assessed every 3 months. I may not have explained this exactly properly, but it seemed to be a tell that the therapy is subjectively effective (since the patients want to keep on the treatment). Other note: It was interesting that they specifically thought that their Covid therapy could target the multisystem inflammatory syndrome (MISC) that has been showing up in children's COVID cases and seems similar to Kawasaki syndrome - both very awful. He had some very technical reasons for why the treatment may be particularly effective in those cases. He did mention that they would need data and results from adults before going after those indications in children, but I thought it was interesting none the less. I actually haven't been able to listen to the call yet Tailwinds just posted a transcript though which I am going to read through now and will get back to you. I do agree though that there are some very good near term catalysts. If they can get an >85% response in total from all AD patients in this P1b trial it would be paradigm-shifting. Tailwinds transcript: tailwindsresearch.com/2020/08/inmune-earnings-conference-call-transcript/
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Post by JHam on Aug 8, 2020 4:47:42 GMT
Lot's of great info in the call. They have cash now through the 1H 2022 and are looking for non-dilutive funding for all trials in all countries where trials take place. If AD P1b data holds up, they should be able to secure some grants for P2. Here are some highlights:
David J. Moss (CFO)
First, we expect to report additional results of the Phase 1b XPro1595 Alzheimer’s disease trial, expected to complete towards the second half of 2020. As RJ has said earlier, this trial is on extension and will continue into 2021, but you should see additional data towards the end of this year.
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Jonathan Aschoff
Thank you. Hey guys, I was wondering if you can tell me how big the Phase 1 AD trial will ultimately be, now that you’ve seen encouraging neuroinflammation results in the first few patients, and how long will you dose them in the extension program you have?
Raymond J. Tesi (Roth Capital Partners)
Good question. So, you know, I expect that we will end up instead of treating 18 patients, I think it’ll get closer to 24 or 28....
Now the extension trial is a completely different trial. It’s actually not the Phase 1. We actually had to put a new protocol in place for the extension trial, so they get rolled into the extension. The history of this is kind of interesting. Some of the patients had such good results that they started campaigning very early to say that, you know, if you don’t allow me to stay on this drug after three months, I’m going to pitch a hissy fit, to actually use the term. I was not originally, the Company was a little reluctant to do this, because it costs money, and the number of patients ends up being small. But one of our Board members, who is Tim Schroeder, is the founder and the CEO of CTI which is a CRO which has been ranked, year after year, as one of the top ten CROs in the country. One of the things he counseled us was that, when you go to regulatory agencies, if you have patients who have been on drug for prolonged period of time, that kind of data is very valuable for just from a communication point of view.
So in fact the way the extension trial works is these patients stay on drug, they get formal evaluations as far as MRI and safety labs every three months. Currently we have a number of patients who are out eight months. The protocol is written that they stay on a year. I suspect though that we will extend them. If their—the way the enrollment is written is if the patient and their clinician feel that they are getting benefit from the therapy, we will continue them on the trial. So, it was driven by the patients, it was supported by their clinicians, and they dragged us kicking and screaming to the table, but I’m very glad we’re doing this trial because at some point we’ll be able to report to you what therapy looks like in patients who have been on the drug for a year, which is not bad for where we are in development.
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Arthur He (H.C. Wainwright)
Hi, RJ and David, good afternoon.
So I just had two questions. One is, I just want to, regarding the COVID-19 study, have you guys have any further discussion with the FDA, and in your (inaudible) perspective, what the optimal time to starting the trial?
Raymond J. Tesi
Let me answer that. I mean, we’re fully engaged with the FDA, that’s the way I’m going to phrase it, I mean, and obviously, really the ball’s in their court. We are, as you can imagine, the clinical sites are interested in what we’re offering. So, there’s really a parallel track going on. There’s the regulatory track, which is the FDA, and then there’s the clinical development track, getting the sites up and running, which is another complete handful. Those things are going on in parallel.
I don’t want to give an exact date. But I will say, I don’t know if I’d mentioned this before. Originally we had thought about actually getting started in Australia, because as you know we already have our clinical programs going in Australia. I really turned my back on Australia because at the first go-round, they had a tremendous success in squashing the curve. Well, that success has unfortunately failed, and now Victoria and Melbourne, Melbourne is the largest city or second largest city in Australia, is just on fire.
So, in fact, we are sticking our nose back into Australia. So, we in fact—it’ll be the same protocol. We are in fact engaging two regulatory authorities, and so we think we’re in pretty good shape to getting this started quite soon. I think in the past I’ve said August. I’m hopeful for that. I won’t say what country it’ll be in. But I think it’s reasonable to assume that we’re pushing hard, and we’ll have that first patient enrolled pretty quickly, or within a reasonable amount of time.
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Post by magnus123 on Aug 12, 2020 11:21:54 GMT
Any reason for the recent drop here? Prices looking good to start a position below the offering price.
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Post by JHam on Aug 12, 2020 13:43:01 GMT
Any reason for the recent drop here? Prices looking good to start a position below the offering price. Just a shaking of the trees in my opinion. Volume has been pretty light so it doesn’t seem like anything fundamental. People probably getting antsy about the COVID trial not yet starting.
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Post by JHam on Aug 19, 2020 12:51:51 GMT
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Post by JHam on Aug 19, 2020 16:16:36 GMT
Good interview with the CEO today. He expects COVID trial green light from the FDA any day now. And you have to like this exchange at the very end... (paraphrasing) Reporter: “You’re probably a takeover target ?” CEO: “Give us some time and the phone will ring”. tdameritradenetwork.com/video/rB4AoXPwH-6BdAKrpQUF3A
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Post by JHam on Sept 1, 2020 12:03:47 GMT
BTIG Research just initiated coverage on INMB with a price target of $23? Not sure if that’s why it is up premarket (and up yesterday) or if it’s because COVID trial news is about to hit.
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Post by JHam on Sept 1, 2020 13:15:48 GMT
BTIG Research just initiated coverage on INMB with a price target of $23? Not sure if that’s why it is up premarket (and up yesterday) or if it’s because COVID trial news is about to hit. BAM! There is is: newsfilter.io/a/0e4c5ee37192e586b4976bf6eefbcb95INmune Bio, Inc. Announces FDA Acceptance of IND Application to Evaluate Quellor™ in a Blinded Randomized Phase 2 Trial for Immune Mediated Complications in COVID-19 Patients
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Post by JHam on Sept 5, 2020 3:25:12 GMT
Some good thoughts from Tailwinds:
Here's my thought of the day in INmune. We could know in November (when Covid trial gets extended or canceled) if XPro-1595 is going to be a blockbuster drug or not. Three short months...And, remember, it's not sales for Covid that will drive this necessarily. If they quell cytokine release syndrome, the off-label use in conjunction with CAR-T and checkpoint inhibitors alone should be worth billions per annum in sales. Using Covid to backdoor their way into cancer is genius.
I mentioned this the other day and I think many people are missing this point. We don't need to see interim or top-line data to know whether or not Quellor is working. If the final 266 (out of 366 patients) are given the green light by the DSMB then we'll know we're onto something. I didn't know it would only be 3 months, but given that it's a 28-day trial protocol that makes sense. I still have a large position here for my standard despite dumping some the other day. If everything goes as planned I'll add those shares back before we know whether or not they can extend the trial.
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Post by JHam on Sept 17, 2020 3:00:23 GMT
Of course this decides to head upward right after I sell 😭
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Post by tacomafunk on Sept 18, 2020 14:25:41 GMT
yeah, i bought this based on DD on this board. Did what I normally never do and actually sold on the announcement of p2 COVID trial initiation. Very strange price action with no news. will look to establish a new starter position today.
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Post by JHam on Sept 18, 2020 14:59:16 GMT
yeah, i bought this based on DD on this board. Did what I normally never do and actually sold on the announcement of p2 COVID trial initiation. Very strange price action with no news. will look to establish a new starter position today. I still believe in that DD and this company. As I mentioned in the other thread, I really had no choice but to sell. I was about to get a margin call. I am hoping to get back in again in the next month or so. So much to like about this company.
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Post by JHam on Nov 9, 2020 12:45:59 GMT
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Post by magnus123 on Dec 9, 2020 21:14:26 GMT
I'm just looking at Greenwich (GLSI) right now and thinking that a similar move could just happen here with great Alzheimer results in January, or not?
Still evaluating about taking a position...
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Post by JHam on Dec 10, 2020 3:00:07 GMT
I'm just looking at Greenwich (GLSI) right now and thinking that a similar move could just happen here with great Alzheimer results in January, or not? Still evaluating about taking a position... I just woke up and was about to post about this. For those who don't know, GLSI at one point today was up 2400% after they presented data showing that their treatment showed 0% reccurence in breast cancer: www.businesswire.com/news/home/20201209005460/en/It got me thinking about INMB as well. GLSI only has a tiny 1.63M float which is why it had such an insane run. INMB's float is small by any other standard at 6.69M. If their P1b data follows the path of the first 6 patients, then I agree, it could very well follow the same path as GLSI. I was following INMB all day today looking to reopen a position. I was hoping to get back in in the $7s or low $8s at the very least, but after seeing GLSI I'll likely buy some tomorrow. As you said the AD data isn't expected until January, so there is a good chance the pps treads water until 2021. The problem is you never know when people start accumulating again in anticipation. INMB could also release it early as a Christmas surprise. No biggie though holding for a few months. December corporate presentation: www.inmunebio.com/images/pdf/Presentation/INMB_Dec_Presentation.pdf
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Post by JHam on Dec 10, 2020 3:09:17 GMT
Re-quoting this from above: Pretty stunning statement from ROTH's $INMB update put out today ($26 PT fwiw): "We believe that compelling Phase 1b AD results alone would leave our price target in the dust".
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Post by magnus123 on Dec 10, 2020 11:57:51 GMT
Yes, the bigger float will likely not allow this to explode 2000% But if we get great data... Alzheimer is hot and any positive data can obviously lead to massive gains. The $26 PT looks like a joke, if the results are really good.
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