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A David Biotech Making Goliath MovesHello! Take a seat, and please read through (and double-check) everything, I am not a salesman, I just want to give you a little run-down of this small Israeli Biotech making large global steps! Science My background is science, so that is what I am going to start with. I will try to explain the science in a digestible way, so you really understand the company's strengths. Cancer changes a cell in many ways, changes the environment in many ways, and these changes are bad. The immune system isn't just the thing that helps you fight the flu, or a cold, it protects your body against every change from normal, like a cell growing rapidly and changing the surrounding tissue (like a skin melanoma that causes death to the skin cells around it). In fact, your immune system is working right now to take care of every little possible bad cell right now, it is really really really good at it. Except when it isn't! The cancer cells find different ways of hiding themselves from the immune system, often getting the immune system to do the cancer cell's dirty work (think of Bugs bunny and Daffy Duck pushing Elmer Fudd's gun back and forth, except cancer is Bug bunny and healthy you is Daffy). This has been a goal for a while, and it is starting to come to fruition, except it happens to be a path that we need to hit in multiple ways. Think of it as a mechanical spider that wants to hurt us, if we knock out one leg, it has 7 more and will adapt. If we knock out a whole bunch at the same time, we can take it down. This company has been working for a while towards that goal, and found a leg different from the one many others have been working on! Background of the company and its leaders I don't give my investing money to the drunk on the corner, not because I don't want him to have booze, but because if he knew how to invest, he would be drunk at a much fancier corner. I believe a background into the company sets a stage, gives a glimpse of if the company has what it takes to make it. Started in 2010 as Kitov Pharmaceuticals (Hebrew for "It is Good"), from 2011-2015 focused on their first drug, which they likely thought was going to be more successful than it was, as they don't tout it, but rather their 2 upcoming cancer drugs. While Purple Biotech (PPBT) claims to have made their oncology switch in 2017 when they acquired a small biotech who had NT219 (see below), they filed a clinical trial with the FDA for CM24, which they claim they didn't have until 2019. While I doubt this is shady or illegal, most likely something clerical on the FDA clinical trials page from the last update in 2020, the trial is concerning as 27 patients were supposedly dosed with CM24+PD-L1 therapy, but never reported results and terminated it in 2017. But then they did a similar trial as their "first" just recently in 2019. Again, this might be clerical and not a real representation of the data, as I am no expert on this, but I thought it odd and wanted to share. Their current CEO is Isaac Israel. This guy is the Israeli version of the venture capitalists in Boston that are in every ground breaking company like moderna. He has had his fingers in a lot of pots for a while, this is the one he has set on now. While I cannot stand salesmen in a scientist's job, Bancel and Moderna have done really well this year (of course not having anything to do with Bancel). Just a warning, this guy was arrested in 2017 as part of an investigation into the consensei drug filing, he was released and everything was settled, it was a stupid error that a bonus independent commission to confirm consensei effectiveness got some paperwork late... but like really late. The end of the story is this, the guy looks like he is at least putting in the extra effort here. I don't know if he is smart or just rich, only time will tell for that. Their VP of Research, Dr. Reuveni, looks to be one of the major scientists from TyrNovo. She co-invented the tech for the NT219 drug, and was with the company since 2005. This fills me with confidence that someone who has been in the trenches for a long time has risen up and stayed, and that she got there. My theory, and only mine, Kitov (and now Purple) looks to be a really old shell company, just a name on a piece of paper being flung around for a while until it got used for Consensei, which was no blockbuster hit. But, here come 2 possible blockbusters all from the same place. I view Purple right now as a possible Pfizer/AZN, Takeda. Purple itself isn't a research company, its a hungry hippo Clinical stage that exists in Tel Aviv, and might possibly the best suited to keep acquiring promising smaller biotechs. If they keep making acquisitions through the next few years, especially as they continue to successfully raise funds, I will keep my eyes open for a long term buy and hold. For just right now, they just changed their name, they have positive catalysts coming, I view this as a good medium term investment with huge long term upside if you want to avoid massive capital gains taxes. Drug Pipeline/Development Let's start with Consensi, the first drug they made and came out with. I have a hypothesis on how they came to this drug (inflammation markers in cancer, they missed cancer ones but found great ones for vascular and arthritic stress). I would call it a failure in the right direction. While it is doubtful to be a money maker, it is something they can have to sustain/keep afloat. Getting through FDA for an approval period is no small feat, and they did it in ~7 years. CM24- Ceacam-1 therapy: Ceacam-1 is a protein that works in the immune system pathway, via stopping immune cells from killing it. Luckily for PPBT, CEACAM-1 is outside of the MHC class pathway, what that means is unimportant, but PD-L1 therapies work in that pathway. This has been a promising therapy, and was supposed to revolutionize the world of cancer therapeutics, but it turns out cancer cells have more tricks up their sleeves. Want to learn more about Ceacam-1: Please note that I am not an immunologist, if there is recent work that suggests CEACAM-1 and PD-L1 PD1 therapies are in the same pathway, this is my source. This is extremely promising. I value this at an extremely high price, not just because of the potential to be combined with EVERY OTHER CANCER THERAPY IN THE WORLD but because this could save freaking lives! They are planning Phase 1 trials for this in a bunch of different cancers, but as a combination therapy, which is amazing. They did a monotherapy phase 1 in solid tumours, it sucked but showed a real dose response , which I am extremely impressed with. Market value of this is unimaginable, same as PD-L1 therapies. Clinicians don't give a shit about monotherapies, they don't care how many drugs they have to slam down their patients throat, if it works it works. If PD-L1 & CEACAM-1 therapies work at all together in their NSCLC or solid tumour trials, without a triple therapy, then this would go blockbuster. HOWEVER there is no proof it works yet. While the biological concept of PD-L1 and CEACAM-1 working perfectly together is promising and sensical, the truth is that we thought just one would get the job done before. It is one thing doing an experiment in a controlled setting, in cell culture and preclinical animal experiments we don't get to work with the beautiful chaos that is cancer. That is why we need to temper our expectations, but keep funding science so we can push forward and find the combination that works. I am torn between, if everyone thought this would work, than someone would have done it by now. But as I grow in the science sector, I realize that logic isn't sound. I am not betting on CEACAM-1 curing all cancer, I am betting that CEACAM-1 therapeutics offer a better chance of prolonging survival and working as a combinatorial therapy, and if not, oops. NT219 - IRS1/2 & STAT3 small molecule inhibitor To put this very simply, IRS1 IRS2 STAT3 are all proteins that work in growth pathways, they control the growth and life of cells. In cancer, these are commonly dysregulated and abused. By inhibiting both, it puts a significant halting pressure on the cancer cell, while also stopping some of the ways it prevents itself from blowing itself up. Yeah, cancer cells are walking time bombs, in fact all of our cells are! There are as many ways +1 our cells are programmed to die than to live, if something goes wrong. A cancer cell has gone quite wrong, and it knows that. It doesn't want to do what its doing, but its kind of just Mr. Beaning its way through the body. If we can provide a way to halt the cancer cell from growing constantly, then it might give other pathways time to start the self-destruct sequence. Of course these pathways are very big and very confusing and very mysterious, so the true mechanism of action, especially if this 1 drug is hitting both, is going to be quite unknown. Which means it could absolutely not work in any way at all. Plenty of attractive therapies look just like this, but flunk out of Phase 2 trials because, while it certainly isnt killing the patient faster than the cancer, it isnt helping stop the cancer. So my excitation for this has to be limited to the degree that I think the company can take a loss, but also knowingly move forward spending more time in pre-clinical trials to make sure there is a winner. Seeing as this drug was brought to PPBT via acquiring TyrNovo in 2017, and likely being the source of the "oncology pivot", I venture to say they feel confident about their Phase 1 and Phase 2 chances, especially as they are doing them in the same one: Given full results expected in second half of this year, and they dosed first patient last september, I bet we hear either really bad or really good news soon. As insider ownership has increased, I favour good news. Fundamentals: Institutional ownership: ~14.5% Insider ownership: ~1% Market cap of 100M at current price of 4.5/share Float of 15million shares with 10 day avg volume of only 500k. Definitely not day trade paradise, but this does suggest moves will be big. As of 12/31/20 it was a massive buy-in by a lot of big funds, SUSQ, Morgan Stanley, UBS, Goldman Sachs, you know the drill. We learn more at the end of this month on updates of institutional ownership, but I am hopeful given the action we have seen so far this year. Financials wise, they don't spend much per year, this will ramp up with their clinical trials, but they also have the money to. With 85 mil in the bank as of the end of the year, and extremely low debt, with an extremely undiluted stock value, this company doesn't have to look for outside sources for funding, which will take profitability away in the long term. These things make me happy. Upcoming positive catalyst: "American Association of Cancer Research (AACR) 2021 Annual Meeting, taking place in virtual format, on April 10-15 and May 17-21, 2021" <--- presenting data on NT219 in front of everyone, expect massive price action around these dates, depending on which they end up presenting on. My brain is fried, I can't think of anything else. Please let me know if you want to see anything else added, or your general feelings on the format. I am not a financial analyst, not an anything analyst, this is all just purely speculative and in no way should be the basis for any decision, financial or otherwise. Please double check everything you read, and if you disagree with anything I wrote, please let me know so we can discuss. Peace out. EDIT: SORRY CANNOT HAVE LINKS YET, WILL INCLUDE AS SOON AS I AM ABLE
NASDAQ:PPBTLong
by DoctorFaustus
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