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Post by JHam on Jul 15, 2020 16:44:12 GMT
Yesterday they released spectacular interim data from their P1b Alzheimer’s trial. Data on only 6 patients (out of 18), but in some of the patients they actually reversed the disease. The KOLs and trial investigators were clearly impressed by the results. One patient’s condition had deteriorated to the point that they were unable to speak, communicate, or take on any kind of daily tasks, and basically slept all day, is now being able to speak, tell jokes and is finishing writing a book they were working on prior to becoming ill. Obviously P1b is very early, but this data has matched preclinical data, and really does seem like they are onto something. They study is being funded by the Alzheimer’s Association ($1M grant), and if the data holds up through the rest of the patients in the trial I imagine they won’t have too much trouble securing more non-dilutive funding in further trials. With a disease like Alzheimer’s I also wouldn’t be surprised if they get fast tracked. They have enough cash for about a year, have big inside ownership, and have a COVID update coming soon as well. It jumped to $24 from single digits yesterday, and is headed back down to earth as I write this. I bought a handful of shares for the long haul, but as usual got in too early. Alzheimer’s is obviously a huge huge unmet market. If they prove to have a viable treatment then it will make the current price look like peanuts. It’s still early, but could be worth a gamble. Current pps: $13.50 Market cap: $146M o/s: 10.82M Float: 3.86M Insider ownership: 58% Zoom webinar discussing data: zoom.us/rec/play/ucB5IeD6qWo3GtCQswSDAqUoW9S5f_is1SEb-qBZmknjUSRRNAf1Z-YSZOB7dHQAXyrhmiR3nLiXcwWP?continueMode=true&_x_zm_rtaid=dW0SDbG6RTGROsVaGXkfcg.1594818718983.2c68913c6592252919d4a2e4615ce326&_x_zm_rhtaid=327
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Post by JHam on Jul 15, 2020 17:19:13 GMT
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Post by selluwud on Jul 15, 2020 23:59:24 GMT
As usual they have announced a public offering, no price given yet. Maybe a good time to get on board once the dust settles??
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Post by JHam on Jul 16, 2020 1:58:46 GMT
As usual they have announced a public offering, no price given yet. Maybe a good time to get on board once the dust settles?? Crap. I had a feeling they would do a raise, like you said, as usual, on the back of this news. Yeah, probably best to wait for now. Glad I only have a small position. It will be interesting to see the interest level. It would be a great sign if it is oversubscribed.
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Post by JHam on Jul 16, 2020 3:19:55 GMT
Tailwinds is saying the pricing may be $10. He usually has access to good info so it's probably accurate. That's a pretty good discount so we'll see:
$INMB Hearing deal priced at $10. Hoping it trades down to there so I can pick up some cheap shares. Likely I'll be paying a little higher, but that's life.
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Post by JHam on Jul 16, 2020 3:21:04 GMT
Also when asked if he had confidence in this, Tailwinds answered:
It's already BY FAR my biggest position after the move up from $5.50. And, I'm adding tomorrow if it trades down at all. Does that answer your question?
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Post by JHam on Jul 16, 2020 4:49:06 GMT
Just had a good exchange with Tailwinds.
He is hearing that the offering will be at $10. Likely for $20M or less. He said they are "GREAT" at finding quality banks and are very protective of dilution and their capital structure. He also confirmed that these 6 patients were the first 6 enrollees. I was worried that perhaps they picked the 6 patients with the best data out of the ultimate 18 trial participants. So they are 5/5 in getting a response in the reduction of neuroinflamation, reversing the symptoms of Alzheimer's disease??? Trading at a $140M market cap??
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Post by JHam on Jul 16, 2020 5:09:52 GMT
The more I read, the more I like about this company and their science. They have two platforms. The DN-TNF platform is the one I'm most interested in at this moment as it is addressing Alzheimer's (XPro1595) and COVID-19 (Quellor). They have two different clinical names, but it's the same exact treatment. The mechanism of action is quite compelling, novel, and really makes sense. If it works on Alzheimer's then I think there is a very good chance it will work in COVID-19 as well. The approach is to target and block/inhibit sTNF (bad TNF) expression which then leads to a "cytokine storm" in COVID-19 patients who have the worst outcomes, without blocking tmTNF (Good TNF). Until now, the only inhibitor treatments have blocked both TNFs and this is where INMB draws a very unique difference.
Overview
We are a clinical-stage immunotherapy company focused on reprogramming the patient’s innate immune system to treat disease. We do this by targeting cells of the innate immune system that cause acute and chronic inflammation and are involved in the immune dysfunction associated with chronic diseases such as cancer, neurodegenerative, metabolic and infectious diseases. The Company has two therapeutic platforms – dominant-negative TNF platform (“DN-TNF”) and the Natural Killer (“NK”) platform. The DN-TNF platform neutralizes soluble TNF (“sTNF”) without affecting trans-membrane TNF (“tmTNF”) or the receptors TNFR1 and TNFR2. This unique biologic mechanism differentiates the DN-TNF drugs from currently approved non-selective TNF inhibitors that inhibit the function of both sTNF and tmTNF. Protecting the function of tmTNF while neutralizing the function of sTNF is a potent anti-inflammatory drug that does not cause immunosuppression or demyelination. Currently approved non-selective TNF inhibitors are approved to treat autoimmune disease, however they are contraindicated in patients with infection, cancer and neurologic diseases because they increase the risk of infection, cancer and demyelinating neurologic diseases, respectively, because of off-target effects on inhibiting tmTNF. The NK platform targets the dysfunctional natural killer cells (“NK cells”) in patients with cancer. NK cells are part of the normal immunologic response to cancer with important roles in immunosurveillance to prevent cancer and in preventing relapse by clearing residual disease. Residual disease is the cancer left behind, often undetected, that can grow and cause relapse. The NK cells of cancer patients have the ability to kill cancer cells but are not effective because cancer cells mutate to evade NK cell immune surveillance. INKmune provides the missing signals needed to prime NK cells to overcome the immune evasion mutation to allow NK cells to kill the cancer cell. We believe INKmune is best used to eliminate residual disease after the patient has completed other cancer therapies. Both the DN-TNF platform and the INKmune platform can be used to treat multiple diseases. The DN-TNF platform will be used as an immunotherapy for the treatment of cancer, neurodegenerative, metabolic and infectious diseases. INKmune is being developed to treat NK sensitive hematologic malignancies and solid tumors.
We believe our DN-TNF platform can be used to reverse resistance in immunotherapy, to target glial activation to prevent progression of Alzheimer’s disease (“AD”), to target intestinal leak and inflammation to treat non-alcoholic steatohepatitis (“NASH”) and to treat complications of the cytokine storm associated with COVID-19 infection. The drug is named differently for each indication; INB03, XPro1595, LIVNate and Quellor, respectively, but it is the same drug product. In each case, we believe neutralizing sTNF is a cornerstone to the treatment of each of these diseases. As an immunotherapy for cancer, we are using INB03 to neutralize sTNF produced by HER2+ trastuzumab resistant breast cancers to reverse resistance to therapy. sTNF causes an up-regulation of MUC4 expression that causes steric hindrance of trastuzumab binding to the HER2/Neu receptor on HER2+ breast cancer cells. Without binding, trastuzumab is not effective. In addition, INB03 changes the immunobiology of the tumor microenvironment by decreasing the number of immunosuppressive myeloid cells, both myeloid derived suppressor cells and tumor active macrophages, and increasing the number of cytotoxic lymphocytes in the TME. We have completed an open label dose escalation trial in cancer patients with metastatic solid tumors that have failed multiple lines of therapy. The trial informs the design of the Phase II trial by demonstrating that INB03 was safe and well tolerated, defined the dose of INB03 to carry into Phase II trials, and demonstrated a pharmacodynamic end-point. A Phase II trial is planned in women with advanced HER2+ breast cancer with brain metastasis.
Likewise, we believe the DN-TNF platform can be used to treat selected neurodegenerative diseases. XPro1595 is being used to treat patients with Alzheimer’s disease in a Phase I trial partially funded by a Part-the-Clouds Award from the Alzheimer’s Association. XPro1595 targets activated microglia and astrocytes of the brain that produce sTNF that promotes nerve cell loss and synaptic dysfunction, the cornerstones of dementia. In animal models, elimination of sTNF prevents nerve cell dysfunction and reverses synaptic pruning. The Phase I trial in patients with biomarkers of inflammation with AD is enrolling patients. The open label, dose escalation trial is designed to demonstrate that XPro1595 decreases neuroinflammation in patients with AD. This end-points of the trial are measures of neuroinflammation and neurodegeneration in blood and cerebral spinal fluid, measures of neuroinflammation by MRI by measuring white matter free water and breath by measuring volatile organic compounds in exhaled breath and by monitoring neuropsychiatric symptoms known to be associated with neuroinflammation including depression, apathy, aggression, hallucinations and sleep disorders.
Likewise, we believe the DN-TNF platform can be used to treat selected metabolic diseases. LIVNate is being developed to treat NASH. NASH is a pleiotropic disease caused by a complex mix of metabolic, inflammatory and fibrotic pathophysiology. We believe targeting inflammation caused by intestinal leak, mesenteric and peripheral fat will prevent lipotoxicity, hepatic stellate cell activation and hepatocyte death that causes fibrosis and liver dysfunction associated with advanced disease. sTNF is elevated in obesity and is believed to cause intestinal leak. Intestinal leak combined with cytokines coming from mesenteric fat may dramatically increase the concentration of inflammatory cytokines in portal blood destined for the liver. The cytokine load contributes to the development of non-alcoholic fatty liver disease (“NAFLD”) and progression to NASH. LIVNate, by neutralizing sTNF improves insulin sensitivity, decreases the inflammation in peripheral and mesenteric fat and may also seal the intestinal leak. This combination prevents development of NAFLD or NASH in animal models. The Company is planning a Phase II open label randomized study using non-invasive measures to enroll patients with NASH in a study using a fixed dose of LIVNate delivered as a once a week sub-cutaneous injection.
Likewise, we believe the DN-TNF platform can be used to treat the complications associated with the cytokine storm caused by coronavirus disease 2019 (“COVID-19”). Three inflammatory cytokines make up the cytokine storm associated with COVID19 infection – sTNF, IL-6 and IL-1β. Targeting sTNF with Quellor may have advantages because IL-6 and IL-1 expression occur after sTNF expression; sTNF promotes endothelial activation causing expression of proteins that promote trafficking of immune cells from the blood vessel to the tissue and expression of Tissue Factor that stimulates the coagulopathy that is a prominent pathology of COVID-19 infection. The Company plans a Phase II trial in patients with symptomatic COVID-19 infection and hypoxia. The goal of the study is to prevent the catastrophic complications of advanced COVID-19 infection including one or more of admission to an intensive care unit, the need for mechanical ventilation, new onset of cardiovascular, neurologic or thromboembolic disease or death. The randomized trial will treat patients requiring hospitalization because of their disease.
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Post by JHam on Jul 16, 2020 5:58:44 GMT
Corporate presentation: www.inmunebio.com/images/pdf/Presentation/FINAL_INMB_-_May_Corp_Presentation.pdfUpcoming Milestones:*Report results of Phase 1 XPro1595 in Alzheimer’s Disease, expected to complete 2H 2020. Submit IND for Quellor™ for the prevention of complications of COVID-19 infection, expected in May 2020. Enroll first patient in Phase II Quellor program, targeting COVID-19 patients with complications from COVID19 as soon as possible. The following milestone timelines have been updated due to the ongoing COVID-19 pandemic.Enroll first patient in Phase II INB03™ program, targeting trastuzumab resistant HER2+ breast cancer using INB03™ as part of combination therapy, expected mid-2021. Enroll first patient in Phase II LIVNate™ for NASH, expected mid-2021. Enroll first patient in Phase I INKmune™ in High Risk MDS cancer, expected 2H20. Enroll first patient in Phase I INKmune™ in Ovarian cancer, expected mid-2021. *They plan to release the full data in October. Interim data release was not planned, so obviously they felt compelled to do so.
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Post by magnus123 on Jul 16, 2020 8:55:09 GMT
Interesting company, but not a long term holding for me. Speculation for the full data readout in october could be interesting. There were so many alzheimer fails in the last years in late stage studies that the risk would be to big for me in the long term.
The propability of a fail in Phase 2 or 3 is very high.
GLTA here!
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Post by magnus123 on Jul 16, 2020 11:41:21 GMT
Interesting company, but not a long term holding for me. Speculation for the full data readout in october could be interesting. There were so many alzheimer fails in the last years in late stage studies that the risk would be to big for me in the long term. The propability of a fail in Phase 2 or 3 is very high. GLTA here! I will buy today or tomorrow a position for the october data readout. AC Immune, another Alzheimer company, is skyrocketing today on news. Market seems to like these companies actually. INMB could be a really nice trade.
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Post by JHam on Jul 16, 2020 11:43:44 GMT
Interesting company, but not a long term holding for me. Speculation for the full data readout in october could be interesting. There were so many alzheimer fails in the last years in late stage studies that the risk would be to big for me in the long term. The propability of a fail in Phase 2 or 3 is very high. GLTA here! That’s probably wise. AD is a tough nut to crack. I felt the same way until I listened to that call. I’ve listened to dozens of calls on AD/ALS/MS/Autism, and never heard KOLs sounds so positive about this data. It’s is early data and only on 6 patients though, so I agree. A looooong way from the finish line.
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Post by JHam on Jul 16, 2020 11:46:42 GMT
Interesting company, but not a long term holding for me. Speculation for the full data readout in october could be interesting. There were so many alzheimer fails in the last years in late stage studies that the risk would be to big for me in the long term. The propability of a fail in Phase 2 or 3 is very high. GLTA here! I will buy today or tomorrow a position for the october data readout. AC Immune, another Alzheimer company, is skyrocketing today on news. Market seems to like these companies actually. INMB could be a really nice trade. Yeah I’d be slow and careful with this one so you don’t get caught holding the bag.
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Post by selluwud on Jul 16, 2020 13:25:29 GMT
Once the raise price is announced, most pps fall below the mark before recovering. I'm going to sit on the sidelines and watch for a while. Good Luck.
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Post by JHam on Jul 16, 2020 13:47:27 GMT
Once the raise price is announced, most pps fall below the mark before recovering. I'm going to sit on the sidelines and watch for a while. Good Luck. It’s announced, 2.17M shares @ $10, for $21.7M. That’s exactly what I guessed actually. Maybe they were reading my posts? Anyway, the pps so far is trying to stay above $11. I averaged down a bit and may do so again if it dips down in the $10s again. finance.yahoo.com/news/inmune-bio-inc-prices-public-131510451.html
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Post by JHam on Jul 16, 2020 13:56:14 GMT
No warrants, over-allotment option of 326K shares:
INmune Bio, Inc. Prices Public Offering of Common Stock
GlobeNewswire GlobeNewswire•July 16, 2020 LA JOLLA, Calif, July 16, 2020 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company” or “INmune”), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, today announced today the pricing of its underwritten public offering of an aggregate of 2,173,914 shares of its common stock at a public offering price of $10.00 per share. In addition, INmune has granted the underwriters an over-allotment option, exercisable for 45 days from today to purchase up to an additional 326,086 shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about July 20, 2020, subject to customary closing conditions.
The gross proceeds to INmune from this offering are expected to be approximately $21.7 million, before deducting underwriting discounts and commissions and other offering expenses payable by INmune but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. Net proceeds are estimated to be $20 million. INmune intends to use the net proceeds from the offering for general corporate purposes, including to support research and development, including clinical trials.
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Post by JHam on Jul 16, 2020 14:31:27 GMT
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Post by JHam on Jul 16, 2020 15:02:07 GMT
Here’s a link to the clinicaltrials.gov page for their COVID-19 trial. It’s estimated to start this month so we should hear something soon.
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Post by selluwud on Jul 16, 2020 15:04:17 GMT
I bought 1/2 of what I'll risk at 11.00 and will go in again if it goes under 10.
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Post by JHam on Jul 16, 2020 15:11:47 GMT
I bought 1/2 of what I'll risk at 11.00 and will go in again if it goes under 10. Welcome to the party! I just averaged down again.
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