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A second 13G today, taking 7.8% ownership... in just a few days. It’s not like we have a massive float to contend with either. Greens, it seems others may finally be taking notice. We aren’t even to 5.00 yet... better... than expected.
Fellow Vikings, onward to Valhalla!!
I think the MDGL price is more a reflection of the companies that hold stakes in them and their motivation to maintain price points. Most investors have never heard of a SARM, it’s easy to confuse it with anabolics. Anabolics stocks have been hammered for a long time. I don’t think we share their levels of risk and I feel we may become drug of choice and eventually eat into their market, but it’s guilt by association, until others realize there is an alternative course available (us). Phase 2 data is easier to remain unknown. There are far fewer drugs making it to phase 3, and positive phase 3 data is generally a national story, when it represents a new class of molecule especially. Most nash investors put their money into the mega cap stocks, because there is no current consensus to what the path forward will be in that realm... so it’s a ‘safer’ bet in their mind to go with some massive company that has their eggs in many baskets. As more nash plays fizzle out, and our side effect profile is hopefully further solidified, this will become a no brainer to everyone. It’s also easy for people with no medical knowledge to fail to grasp that a thyroid hormone isn’t a thyroid targeted drug, or that a selective androgen receptor activator is being used in bone fractures, and to lose sight of the far reaching potential to expand that drug into a lot of other realms (especially with the known dangers of anabolics and the lack of safer alternatives). Dudes will always want steroids, people will claw for this alternative, middle age guys with healthy hips... if you get my drift. It’s just too soon for most people. Good for us (who are able to get in early and solidify positions), also bad for us (not much attention to our amazing progress in all realms of our pipeline). Time is our friend, as previously stated. When someone takes a bigger stake in us, or we have a huge upside day and make it on the movers boards, people will start to wonder what all this stuff is, and what it does, and it will snowball, imho. I also suspect someone is accumulating, and that march and April may treat us very very well, when people start wanting to gamble on upcoming results again, and the attention it shall bring. Most people and institutions hate betting on phase 2 results. The valuation cap with MDGL will become undeniably absurd when we have our upcoming data in hand.
Happy holidays buddy
13G filing just out. Sphera funds with 7.43% stake in VKTX (2,145,300 shares). Stars might be aligning for this to start catching up gents... ho ho ho!
Hey Greens, it would somewhat go against the lgnd model for them to partner with us, so I don’t think that would directly be the best option. I do think it becomes more reasonable for lgnd to increase stake or provide alternative capital raise options if needed down the road though, if things keep going well.
Yes... I think that if data continues to come in that is good, that the gap may close substantially. If we can maintain these levels at least for a few months, it leave the door open for the move up to 7-10 range at least. As you’ve previously mentioned, getting near 5 will bring in institutional investors, which will be a big turning point. We remain up big from recent, but still disproportionately undervalued compared to most nash companies, including mdgl, which has essentially the same tech and approval odds.
Happy Monday buddy
Hey Bull, hard to say. Generic Endocrine/nash/testosterone players or anyone looking to enter any of those spaces. You could make a decent list with that alone. Some tech is going to need validated first, by us or our competition, for a real deal, imho. Don’t think it makes sense to settle for phase 1 /2 type values if you are ligand, with so many irons in the fire. I don’t think anyone is yet willing to pay the premium it would take, esp with how derisked they are (ligand) to continue forward, available data considered. This may be bigger than I thought, if April/May treats us well. Have a good week, best of luck
Hey Bull, great questions. I didn’t proofread all this too much, I’m in the middle of a few things this weekend. Didn’t want to leave the question hanging though, going into what is likely to be a crazy trading week.
Even if MDGL is significantly overvalued (the topic of ‘are nash stocks overvalued’ — lol, not even going there), we still remain disproportionately undervalued, even when adjusting for much more modest valuations of MDGL’s supposed worth... which is giving me a bit of confidence holding our stock. Funny to say, but I actually think the offering may be unknown factor that we were missing, to mount a true, real run. I think that the large amount of VKTX owned by insiders and LGND has kept out bigger players and removed the usual pathways for people to secure stakes and then push the price to enrich themselves. I know that MDGL has a relatively more palatable management team for Wall Street, but I don’t think our mgmt is otherwise scaring everyone away. Giving some bigger players a chance to enter on the heels of MDGL news with the offering may end up being all that was missing to start a real run.
Hate to be overly simple, but... Barring anything unforeseen, I basically anticipate being higher in share price during the nash results run-up, than we are now. That’s all I am comfortable betting on at this point. I’ll continue to sell some small chunks as we march, and will continue reloading if we have any big dips, all the way up until mar/apr. If I have to wait a few months, that’s ok. That’s all I know for sure. This week will set the tone. We will either run out of the gates early or mid this week and possibly not look back until 300+ mil cap, or we will stall out for a few weeks (not much more than that tho, imho). I’d expect a sustained stall or dip If someone big decides to really buy in, and keeps the price down to secure a real entry. If we end up treading water at these levels, it will be a bullish indicator to me. We have been pretty methodical and transparent with trial timing updates (acknowledging that delays occurred lol)... almost too much so. I don’t know if we will stall out until they announce that enrollment is complete for nash. They keep giving a detailed roadmap. It’s smart to do when attracting investors, but it also tells bigger players exactly how much time they have to get what they need. A lot of people are sitting on big gains- no matter how undervalued we are, it may be too much to maintain this momentum at this moment, even if this momentum is long overdue.
I’m long and still holding a ton, and I like our chances of a big run up, I just don’t know how close it would come to March or April, if this week stalls us.
I will say something controversial here... regarding our drug vs MDGL. Imho, There is zero way to know which version is or will be ‘better,’ and for anyone to guess or postulate without having some incredible degree of advanced bio chem research knowledge specific to nash and outside of mainstream concrete medicine... it’s just too soon. They are exactly the same bet imho, right now at least. Our drug technically has shown equivalence in many categories, and is actually a more effective on at least one of the data subsets they measure. Who knows what the Optimal profile will be. (Just because you can do “X”, doesn’t always mean it will be the best thing for the patients disease). All of the long-term downstream effects of what this class of drugs does, is unknown- which really helps our cause, just as much as it limits us. Logic says that if you reduce the liver fat and can potentially stall or reverse the cascade of inflammation (at most any cost?) and prevent a few liver transplants etc, that most means would justify those ends. We have never been able to fix nash, so we don’t know which specific pathway targets will end up being the most important. It will likely be determined anecdotally, once we actually find something that really works... usually the way it goes. Find something that works, then figure out why exactly it did it. We solve a problem the other way around, usually when we exhaustively fail at finding something that works haha. Ie.. start trying to find ways to target specific subsets of things loosely involved and see what happens. So... my biggest questions... if this works... Would they give it at therapeutic doses to reduce liver fat burden as a temporizing measure when things get really bad... start it early in the nash course... give it to people with metabolic syndrome stuff who are at risk... or dose it long term to stave off smoldering damage with people who already demonstrate a propensity to develop the most legit manifestations of nash disease... there’s no way to know, until a lot of long term stuff and complex metabolic stuff gets sorted out. Nothing against our drug at all... it’s just a new molecule class in general, right now it’s all about immediate effects, short term safety, and big obvious limiting stuff, at this stage. It may be as simple as our drug works better overall if the data keeps coming in the way it has, or it may end up being too much, and they need to tone it down dose wise, or maybe our profile of action is the best fit with the pathways they eventually nail down as most pertinent and meaningful, maybe not. At this stage of the game, more effect seems better, but who knows. It may be something where there is a role for both of our drugs (VKTX and mdgl) in different settings, depending on the individual lab values of patients (a likely course). Personalized medicine with genetic profiling and increased reliance on lab parameters is the name of the game lately. It wouldn’t start that way, they would both likely hit market (given that there are no alternatives) and then it would get sorted out in the journals and with subsequent specialized subset trials, done by viking or mdgl or by outside folks. It’s simultaneously the best and worst place to be in, being a new molecule class. Thyroid agonists are a safer nash bet than many (Many) other nash plays that are currently out there, imho, because of the current side effect profiles and the similarity to a naturally occurring compound. And for many reasons, everyone is betting on nash lately. I would hope that it is a trend that will continue. There are a lot of ways that people are approaching nash, really really different approaches sometimes. Hard to know where the answer will be. We stand a much higher chance of remaining in the nash game of musical chairs though, because of our side effect profile and the characteristics of our molecule class. So looking from a nash play only perspective, betting on us and betting on MDGL... are basically the same nash bet, at this point at least. Which is why I loved throwing money at our stock... I can bet on thyroid beta agonists for dirt cheap, compared to buying MDGL. We will very likely suffer the same exact short term fate as MDGL, it will take awhile for all the long term data stuff to become meaningful and to knock one (or both) of us out of the running, such is life. The molecule class will be validated or it won’t. And both will go up big potentially if one of them hits it big in phase 3, regardless who gets there first. Right now... for example- is similar to trying to decide which statin could be better for high cholesterol, before they ever knew if statins would be tolerated, short or long term, and what the rate limiting factors would be with side effects.
That being said, if our drug shows a similar side effect profile in our upcoming data, to what MDGL showed, I think that both MDGL and VKTX will become much much (much) more attractive to the nash world. The longer the clock ticks without horrible side effects and weird metabolic downstream stuff being found, and the more consistently that tolerability and lipid benefits are shown from this class of molecules, the more intriguing this all becomes. I suspect that some other companies that are exploring nash will hit pitfalls in the next year or so, and we will remain in the running, and become a buy based on exclusion, if nothing else... I don’t know how long it will take for the market to realize we are here, but we are currently one of the few nash companies with time on our side. As a nash play only, a 100-200 market cap (without phase 2 data), based upon the currently available data from MDGL indicating that this class of molecule will be allowed to continue, seems prudent. It completely ignores our Sarm, and the rest of the pipeline, which really de-risk us... there are some one-trick ponies in the nash market. A disclaimer though- anything bad that comes up in either our (or MDGL’s) drug developments will equally impact us. You won’t be able to say that another thyroid beta agonist did X, but ours won’t. We’ll be forced to prove it, and stuff like that costs good money. We have been infinitely blessed, thus far, in this realm. If our side effect luck continues, others will no longer be able to ignore this. A drug that does Anything without serious side effects... is a unicorn in modern medicine. The FDA process works ‘best’ when forced along by statin pushing giants with massive financing lol. This is big competition. Statins have tolerability issues for a fair amount of patients, and they are very profitable. If this train keeps rolling, buyout is the only ending that makes sense. Because nobody is otherwise going to make a nash approval route an easy task.
MDGL is good company to share this bumpy road with though. They are on their game thus far. And so far, we have been able to piggyback and add on to their accomplishments. We are less likely to be dragging them behind us, trying to prove to the world that thyroid agonists are safe and reasonable to temporize the nash process. Ie... they are becoming less and less likely to inadvertently sabotage us by screwing up their trials and stalling the advancement of this molecule class.
You could take bad things from this, but in my mind, it’s all good. I’m really looking forward to holding this stock and waiting for the run up to nash results around apr-june. The orphan indications are a better bet with the FDA, but nash is the Wall st buzz word that will bring in huge money someday soon hopefully. The sarm and nash drugs are each blockbusters. The orphan indication drugs may end up getting approved, even if bad things came up in the nash race. Even bad side effects (still yet to be found) would be unlikely to hold us back from approval on the lucrative orphan indications, because of how severe the diseases are that they will address. Risks, benefits...
I hope this helps Bull. I’m a big ‘teach a man to fish’ type guy. I don’t have the answers, but I have been taught a lot of questions to ask. Take care brother.
I’ll be MIA for a few days, my second life is calling. Have a nice week all, and best of luck
Agreed Rolling.
Wow they raised enough money to start sending emails again lol. Warm up the share printing press.
People with money will still go to Vegas. People without money for vacation can get pot in their California home towns. Wherein lies the true demand for this ghost town?
As MDGL news disseminates in the nash community, others will show up to our party. Can’t believe they now have a 1 B cap...
Nice to see the modest size offering to buy time before this really starts heating up. This is the volume day we’ve been missing. Congrats all.
And in case I didn’t spell it out, the data was solid, this is obviously going to phase 3, barring something largely unforeseen to everyone at this point. And they have a decent size ATM available... it’s premature to think that they need cash in the short term. They have a great sense now of what it cost for the phase 2. Until they meet with the fda early next year and figure out how large and long the phase 3 will be, the company likely has little idea of what the cash requirement would be, and is unable to decide if capital raise to go alone or partnering (or further backing from Ligand- their default partner) will be necessary. While the money question is valid, it seems a bit premature imho.
Bought back some of those warrants I sold a bit ago. — “Just when I think I’m out... they pull me back in”. Ha!
They didn’t power the study for the secondaries to be SS... the lack of SS means nothing due to that, as that is the way the study was designed. The secondaries that are showing trends will be used to guide the way the phase 3 is set up. We also do not yet have the full picture of the 12 week follow up period, due to timing of releasing top line. Much more still to come here, stay tuned. Exciting stuff, really good results thus far imho... can’t wait to get the full picture when the remainder of the data analysis is complete. The gradual release of remainder of data on the secondaries will also be decent catalysts imho, along with the upcoming MDGL data release catalyst, as we creep closer to lipid drug data around q1/q2. Also reassuring to see them execute an effective phase 2... all the ranting someone did about how they wouldn’t power it correctly and all that jazz was, as expected, a non-issue. A positive indicator that they hopefully designed and executed a decent phase 2 for their lipid drug. Happy Thursday all
I will address your LBM (lean-body mass endpoint) 'concern' - in the spirit of the holidays, better to let people make their own decisions. I will start by saying that you listed acceptable mortality data, but failed to explain why it is relevant to your LBM endpoint concern. As an open discussion, I will think out loud for ya on this one, and I welcome any plausible counterargument- there may be time yet for me to sell haha.
Here goes... I've previously stated that lean body mass is the easiest endpoint to choose, to get the study going. It is also the wisest endpoint to choose, imho, because it will be the easiest endpoint to piggyback additional studies onto one day, to address the multitude of other diseases that involve muscle wasting.
In the spirit of citations--- Here is a citation to introduce my counterargument-
Sarcopenia is the degenerative loss of skeletal muscle mass and strength associated with aging (50% loss between 20 and 80 years). Due to lessened physical activity and increased longevity of industrialized populations, sarcopenia is emerging as a major health concern. The global population affected is estimated to be over 50 million cases today and to reach more than 200 million in the next 40 years (Source: Neurotune).
Cachexia is characterized by unintended weight loss, muscle weakness and fatigue. It is not a disease by itself but rather a symptom for other affections such as cancer or aids. Cachexia is associated with increased morbidity and mortality independent of the underlying condition. Cachexia is responsible for the deaths of 20 to 40% of cancer patients (source US National Cancer Institute). The disease affects about 9 million people in North America, Europe and Japan only.
Currently, there are no widely accepted drugs to treat sarcopenia or cachexia.
Note the statement "Cachexia is associated with increased morbidity and mortality independent of the underlying condition."
I think what you were trying to imply, is that the hip fracture population is too far gone, and will do poorly no matter what is done for them, and that perhaps they have picked the wrong population, and that the hip fracture is not something that can be overcome, and will inevitably spiral into the same statistics we have always known. In reality, the hip fracture itself is just a symptom. Sure, some people slip on wet floor and break a hip (and generally do better than the next subset of people) - those people that get to advanced ages, and experience significant losses in muscle mass and activity level, becoming more and more unsteady on their feet, throw in a bunch of other medical conditions that can make people prone to being more off balance (history of stroke, blood sugar problems, you name it) - and they are a set up for breaking a hip. There are usually warnings before the hip fracture, falls where nothing is broke, falls where they catch themselves and break a wrist, increased difficulty walking, etc. Generally they are referred to physical therapy, but physical therapy alone can only do so much, especially when there is the current mindset we have in medicine - that nothing will help these people, nothing but grueling physical therapy, making it to appointments, forcing yourself out of bed, etc etc.
So here's what our study is actually about (in MY opinion). I agree that if we arbitrarily give everyone our SARM that breaks a hip, and they all sit there and do nothing, that the gains in muscle mass will be less impressive, and less clinically relevant. It's a false assumption that all of these individuals are giving up and dying though. They generally participate in physical therapy if able (it's hard physical work to do PT, you would be very surprised). Just imagine if all of these folks were told that there is an FDA approved drug used to boost muscle mass and improve recovery trajectory... talk about placebo effects! I think that positive results on this and eventual approval could have the potential to actually change the dynamic and expectations of hip fracture recovery. I won't even talk about the possible Acute fracture healing/bone remodeling benefits they were hinting at--- whole different topic... huge wildcard that could open this up to a lot of other fractures in huge populations.
IMHO all your stats on disability after hip fracture, are EXACTLY why they have chosen this patient population. 1. The expectations are low. 2. A big percentage of these patients have sarcopenia 3. There will be a higher risk tolerance for side effects (even though they haven't found any bad ones yet), because many many of these patients are expected to die. It's all about risks/benefits/alternatives/side effects in medicine. Most of their secondary endpoints are aimed at capturing significant areas of benefit - quality of life, ability to walk/function/perform daily activities, mortality rate (not just what percentage of patients pass away, but how long it takes them to pass away). If they are able to demonstrate any decrease in mortality, or significant improvements in quality of life and functionality, it would be a home run... because then, physicians would be likely to prescribe it, even if they find a few minor or moderate risks associated with it, as we know there are NO currently available alternatives.
The reason LBM WILL BE A PERFECTLY ACCEPTABLE ENDPOINT - is because of the ancillary data they are collecting. To get a drug approved, you have to be able to say what it does. And that is exactly what our drug is purported to do- supposedly improves lean body mass. As you have cleverly used to ?
maybe mislead people, you have said that improvement in lean body mass won't get us approved. Bravo on the way you say that--- in a vacuum--- if all our does is improve lean body mass, why would the FDA approve it? So when they dump all this data on the FDA, they will be seeking to show the FDA [WHY IMPROVEMENT IN LBM HELPS THESE PATIENTS SPECIFICALLY]. There are numerous ways to finish the statement, depending on what our secondaries show... but you only need to find one or two of those secondaries- (I'm not really using too much imagination here)- Imagine something like this... Patients with hip fracture that are treated with VK... show statistically significant improvements in lean body mass, WHICH IS ASSOCIATED WITH (?reduction in mortality?improved functionality or participation/completion of therapy?increased ability to live independently following fracture?quality of life metrics). That's how this works. You show them that your drug can do what you claim it can do (build muscle), and then show them why the patients in question benefit from getting that effect. That is why it is an approvable endpoint, in my opinion.
I loved your final 'stat' - "The mortality rate within 1 year after hip fracture is as high as 36% despite aggressive management including surgery and rehabilitation; this rate has remained relatively stable over time." --- what percentage reduction in mortality rate would make this a blockbuster and make this not only the only available drug for these people, but also the standard of care. Even 5% would be blockbuster. Find me more than a handful of drugs (outside of antibiotics) that have been shown to prolong someone's life facing illness with a mortality rate that high. Good luck lol.
The goal in post-operative hip fracture treatment is Early Mobility. They do the surgery, put in the metal hardware, and get people up and on their feet within a couple days (at the most!). That 10% mortality rate in the first month of healing is directly related to immobility and post-op complications. If you languish in physical therapy, fail to rebuild muscle (or Maintain muscle), you end up sitting in bed, and get urinary infections, blood clots, pressure ulcers that get infected, etc etc etc. Keep in mind that many of these patients Lose decent amounts of muscle mass after this injury, because they are even more weak and frail after their recovery as usual.
They won't need to show much, to make this a formidable drug. I am truly not being crude- but many of the patients aren't expected to live more than 2 years. You really think that they are going to require post-marketing cardiovascular (and lipid LOL) studies, on patients that would otherwise be dead. This is a simple one. They are either still alive, or not. They are either walking, or not. They are either maintaining their muscle mass, or not. And if they then find that more of them are living more than two years, they can start looking at the people that are living longer (they gotta save them first), or explore restricting it to sarcopenic patients if they find long term issues in the patients that break a hip due to non-sarcopenic trauma situations.
So if they get that data, and it shows improvement in lean body mass... then they can finish what they started in phase 3, get it out there and on physician's minds, and then start exploring the heck out of this molecule, for a variety of conditions. And they will likely be telling all these doctors - that this drug is used to build muscle, and approved for hip fracture people 'currently.' It may or may not be a controlled substance, given that it is not a steroid molecule. Once they demonstrate that it can build muscle (the obligatory 'demonstrate the mechanism of action' step), they can start looking at all the muscle wasting diseases, and do other studies with secondaries to explain WHY building muscle would help various conditions.
So again, the bar is set low. Lean body mass (LBM) is just another way of saying, increased proportion of muscle mass, relative to the amount of fat we have. "Lean" gives it a funny connotation, likely the reason you have chosen it. Lean body mass (MUSCLE GROWTH OR PRESERVATION) will be a perfect endpoint, once they have all this amazing data available, to show the FDA why (building muscle helps weak and frail people). But hey, it's all a shot in the dark. Logic would dictate that if you take old, frail, and debilitated people, and then (build more muscle for them after fracture or keep them from losing as much muscle), that they probably will be able to participate more in therapy, stay on their feet longer, need less physical assistance overall, and maintain their independence longer. And the more time they are able to spend on their feet and out of bed, the less likely they are to die from the complications of IMMOBILITY- the stuff that gets these people- blood clots, urinary infections from sitting in wet diapers, etc etc.
Now start moving backwards, and consider that if things are good, why not start treating people earlier, like after their first fall, after their body mass index falls below a certain point, after they are noted to be frail and fail a physical therapy evaluation in the hospital when sick for other reasons, etc etc. That's the true potential here. That's where the post-marketing stuff will be used, to see just how many other people we could safely give this to. Post-marketing will be our friend here, imho, when it occurs. I am skeptical that the FDA would require lengthy follow-up cardio stuff etc. to push through a drug, if that drug is being used to treat a patient population that is expected to suffer huge mortality rates. The mortality data will be their post-marketing, at least initially, again my opinion.
In case you feel like re-inventing your fracture healing counter-argument- You were correct in saying that we don't usually see whole body bone density improvements after treating people with bisphosphonates etc for a few months. But they weren't talking about that (as you likely know), they are talking about Fracture Healing. Bones heal in months, you see big changes on xray. It is perfectly acceptable to compare fracture healing at endpoints in a few months, IMHO, and further out.
Finally, your assertion that this is a pump and dump. LOL. How many companies are capable and willing to run a pump and dump on a company that is majority owned by insiders, and defacto controlled by a 2.8 Billion dollar company (LGND). If results are good, I guess they could always "dump" those shares on Ligand. I understand the Ligand business model and respect it, and have serious doubts that Ligand will sit on the sidelines and maintain only their current ownership percentage if their Viking-child starts hitting home runs with their molecules. They can only buy shares at certain times, due to the rules that be. Separate convo.
Throw in the catalysts approaching with MDGL data coming up, and our looming lipid data, and it de-risks a bet on this trial's outcome, at least for me.
As you can see, I had to drag out my laptop to type all this. Now that you have heard what I have to say, by all means, explain to me where I have this wrong. I can throw stats out there all day long, but without clinical context and a real world discussion of potential implications, it doesn't mean much. Knowledge is power. I'm thankful for the 10 years I've spent at patient's bedsides, and the ability it has given me to make calculated bets in this crazy stock market world. Who knows if results will be good or bad, not I... Thankfully we will all know soon! Hopefully this helps to de-mystify what is going on here.
Happy Thanksgiving to all, Greens and Bull included.
Thanks greens, much appreciated. Have a good week buddy.
GLTA VKTX
You can’t build muscle from nothin. Body uses sugars, then fat. That’s why you see the cholesterol drop (gee whiz mr science). Body sending fat stored energy to muscle land. Nothin bad happens when your cholesterol gets used up to build muscle for awhile. Long term Hyperlipidemia is bad, long term hyperlipidemia is worse if you have low good cholesterol (HDL). I’m tired of dealing with you though, and I’m comfortable with waiting for news. I’ll come back around here after the news. Good luck getting a few shares. I do this stuff in my sleep. You want a few real points to consider that are relevant, I could drop some real knowledge on ya
Hey buddy. I knew I liked u for a reason haha. Agreed when it’s all said and done I would one day like to pick your brain on your other life.
So it’s all ongoing, so people have been getting dosed and completing the trial all along. I’m trying not to summon our friend on here who loves saying that ‘the company is blinded!’ —- so I’ll tread lightly here. One may argue that in a world of black and white, a company would have no idea what on earth is going on with their massively expensive trial until the fat lady sings and it’s all done with. But it just doesn’t happen like that, generally. So a company is going to employ someone to be a sight director and oversee the clinical sites, it may or may not be the same person for multiple sites. Essentially that person or people is making sure that all is progressing. It’s also their job to make sure that their data collection makes sense... ie they aren’t getting really weird data. Interim data analysis is the name of the game. Whoever is running the show with the trial, they are going to keep an eye on what’s coming in, data wise, and make sure that they don’t have a problem. They are also going to keep an eye on what’s going on medically, ie... what is the frequency of adverse events any serious bad outcomes, anything negative enough to consider halting it. So to illustrate... we got the enrollment criteria stuff adjusted for lipid drug. In order to make a case for that to the FDA, you need to show the FDA what’s going on, why you are failing to secure patients, and you need to make darn sure that you are making that calculated risk in the right setting. They would have to decide if they feel that individuals with lower LDLs for example will still be able to benefit enough points wise in improvement still, to where you will still get statistically sig results. You generally won’t know that answer unless you have massive quantities of phase I data to rely on, or more likely, you have done an interim analysis of available data and are seeing enough of what you need to see in the population you are about to adjust things to. So imho, when they got the FDA nod to alter enrollment criteria, somebody probably saw what they needed to see, to de-risk the proposed new population. Otherwise, they probably would have let the trial trickle along with enrollment. Much Easier to enroll for a long time and answer questions on a delay, very hard to design a whole new trial to do what you meant to do the first time, and to tackle the enrollment question all over again.
So ‘someone’ has had a lot of data for a long time now, as people have been finishing for awhile. Some trials are really tiny and easy to enroll, so it still happens where some trials do it all at once and get stuff back quick and see what they got. Large multi center trials are a pain to organize and execute. All this jazz about ‘we need to transfer the images’ —- well... yeah. You need to physically own all that data, and be able to prove your trial claims if someone questions you, so they need to physically possess it all. But in reality, someone reads those studies, and there is a tech who does the leg work of getting the patient where they need to be. Every time they get images, someone is responsible to make sure that the images/data, technique, is acceptable. Kinda like getting an MRI done... they have someone there or remotely who looks at your films to make sure they were done correctly, and will be able to be interpreted. It would be a massive failure if you just put everyone through a DXA, and then send the data, and realize that your machine screwed up/you obtained the images incorrectly or differently than another site/or that you are somehow getting totally different findings on those from a single site, like a huge outlier. These studies cost a fortune, and whatever they are calling our company... you can bet that someone from ligand is helping them to make sure they aren’t screwing this up. And these are all legal things and totally fine... don’t even get me started about the way that some trials are run. So yeah, in a perfect world, nobody knows nothin forever, but in reality, not the case. Let alone, everyone is on the payroll in most trials, site directors and quality control guys are answering to someone... someone is asking ‘what is the progress with x and y and z...’ it’s not a ‘what did this weeks numbers look like convo’... but every now and then it gets close to that. It’s also why our company was able to give guidance that they anticipated 2-4 weeks to clean up the data. If nobody had seen anything, how would they know how much work is going to be involved to integrate and clean up data from so many independently running sites. I’m not too worried that we haven’t heard anything. I’m getting the ‘master plan’ vibe lately, with the ligand conference, the bread crumbs we got not too long ago on the early trials... they can’t ethically delay results, once in hand, but you can hold out your hand really slowly when you have a hold on what your overall progress has been, and you just need to put a few more values into the charts as people finish up their dosing and trickle in. The closer these results are released to the upcoming lipid results, the richer we all might be. It’s a welcome prospect to think that we could announce news very late this year, and have a 3 month gap for lipid data... as ya know, big gains are easily lost, when future catalysts are far off. I’m liking where this is headed, but it’s all still just a shot in the dark. So the entire company doesn’t hadn’t gotten the ‘things went good’ memo yet... but somebody has been sitting on a pile of something for awhile now, and is actively working to shade their argument with data as we speak. Charts and graphs can make anything look like anything, in the right hands, that’s the game... and of course, meeting that primary endpoint. Loved their explanation for why they picked lean muscle mass btw... because it showed great data on that the first time, and seemed like the surest bet. They may find a few gems in this trough of info that may change future directions, but for now, they picked the easiest thing that was likely to be ok, to justify all the other data they wanted to get.
Hope all that helps!
Enjoy the weekend all, cheers
Right there with ya brother. Gave me ample time and means to re-ponder my portfolio and some kind of end game. holding about 65% of my original warrant position. I’ll probably stop watching this as much once the data is known... whether it be good or bad, the no brainer trading will be a needed relief. 6 months to glory or ruin. Been a bumpy ride. They gave a respectable presentation at Ligand. Day trading my common shares on the ups and downs some and put a big bet down on the Cali and Canada ‘green’ stocks, hoping for a repeat of 2014 around Dec/Jan, and then maybe I can take a nice long vacation. Don’t think I could feel much stronger about Viking than I do right now, so for now I’m still sleeping at night haha. Take care buddy
Academic/clinical. Lol. The ihub stock message board, the think tank of academias brightest scientific minds. We are all on here for the same thing buddy, just different angles is all. Advice noted. I'm comfortable holding. They are casting a wide net with all the data they are collecting, though the secondaries aren't powered, they will likely guide a phase 3 approach. This is still a phase 2... they needed to list a prelim reason to get the data flowing, it's a moving barometer of sorts. Anyways, please list scientific reason why it will fail, not your resume
Hey buddy, Im a bit pessimistic in my old age. I'd like to think 60/40. Agreed the KOL and the timelines recently of news and events would suggest higher, but one never knows in this world. Hoping for some bread crumbs this afternoon at the quarterly. On the bright side, it seems that the regulatory environment with drug approvals will hopefully continue to improve and effects may trickle down to the prices of some similar lower cap biotechs, and then us as well. So in a few ways time is on our side here. Writing up the results of a study this large (both in site number and endpoint variables) is quite a task, I really can't understate that... so I am still thinking we are well within the timeframe of waiting for results. This drug is their baby. They essentially created an entire company around it, and have only been taking cash to further their pipeline. Ligand watched it sold on the black market for years, big bucks, I think they have the best idea of what this drugs true monetiziation value is, and that's likely why they chose to as of now, not partner. If they had a just ok or borderline ok drug, or one that would make them some money but not rich, I think they would have partnered long ago. Or, that they are savvy enough to lead on that they are and convince someone to bankroll us on favorable terms before the end of the road and phase 3's. 10 years in the making and now just a few days from results. It's known as ligandrol for a reason, and ligand has put in a ton of work to get this thing here, and in multiple ways has its name sake attached to this. I think they are going to play this very careful and be detail oriented, they will only get one chance to get the narrative right, people love to criticize not only drug trials themselves, but also the ways in which the data is analyzed and interpreted, so there is just a lot at play here for these guys. I also think this will make waves in the press eventually, if data good. I can picture it now, foxnews special, showing grandma next to some bodybuilder, explaining how they are both on the same drug, really doing it up, explaining why this drug represents a paradigm shift and has broad reaching potential ;) Ligand has held for 10 years, i think I can hold another 10 days haha. 70/30 may be close brother. Either way, gonna be interesting. Take care
Are you saying they won't see whole body bone changes that soon, or that they won't see fracture healing differences/changes (the bone remodeling and resorption stuff that guy was talking about on that phone call thing they had), since this is a fracture trial. Are you grouping this with osteoporosis trials?
You are stating that participants will develop metabolic syndrome after 12 weeks? I think I saw somewhere that they could someday look at muscle wasting disorders as well and wasting diseases. Metabolic syndrome changes in that population, weight gain and packing on pounds, could that be viewed as a positive. I think some hip fracture patients might be frail and skinny older folks, that could also be another interesting population. I am sure curious to see these results. Could you cite a source please that states there is short term risks associated with short changes in HDL, or that HDL is used as more than a long term risk factor. Thank you, that would be helpful. I wonder if hypogonadism and fatigue of stopping a steroid will be seen to the extents of other steroids. I also wonder if they lose some of the muscle gains, if they will have changes in mortality rate still, if they had short term gains in muscle mass and become more active quicker and maybe reduce some of the short term risks of hip fracture associated with mortality. Who knows what the data will show though, it sure is hard waiting. I wonder if they would consider longer courses of tteatment or repeat treatment at intervals, if they could show muscle gains but the drop off, or if they would end up having to taper people off these medications slowly. Your articles raise a lot of exciting possibilities and directions, please keep them coming :)
And agreed, good news on a Monday or tues would be a great set up to lead off next week. I hope Christmas comes a lil early this year ;)
Did they have dxa scans in '77? Leading off with a study from 1977 is usually how a lot of my classes started... usually the slide from 1977 is followed by a frowny face or a cartoon, then some slide about the marvels of modern medicine. Welcome to the VKTX carnival folks, Step right up folks, they call it a dxa scanner! I imagine you at this carnival as the man in the front row yelling 'make it guess my age!'
Imho the question has never been 'good as steroid' - the question seems to be, just my opinion btw... does it have a more tolerable side effect profile via its selective pathway activation, to open it up bigger populations, and to better study (our version's) pathway activation, and resultant effects on a lot of the typical hormone regulation pathways that give steroids lots of side effects and the mostly unusable rep for mainstream rehabilitation in the cachectic and elderly... % goals on some typical steroid outcomes as secondaries, with modest muscle/lean mass gains as a benchmark to qualify its mechanism of action.
Lol dude. Lol. We'll find out soon ;)
Doing physical therapy after a hip fracture is no walk in the park from what I'm told lol. I agree they won't be snackin on 90 pound dumbbells in the gym and slammin whey protein so we won't get the big results like in the lifting world. But these patients generally are told in the real world that they need to take PT and recovery seriously and the mortality risks after this injury and ways to improve it. Healthy eating exercise that is tolerable etc etc etc. Less likely they would desire to test it on a purely sedentary population, hence the time needed to enroll something like this. consider the likelihood that the addition of our drug be compared to 'treatment as usual' which means everyone is getting close to the same things over all, so you can compare apples to apples. Anyways, physical therapy is hard. Muscle buildin hard. Happy Tuesday all.
Most of their stuff has been early morning premarket, seems to have worked well enough thus far, probably the same. Seems like time is standing still lol, almost there.
Def know what you mean. Finally feels like we're at that point, the roller coaster is pretty near the top of that first hill. None of my sentiments have changed, nor do I reasonably think they should, and I bought a few shares back yesterday. If no news by mid next week I will look to add more back, as share price will likely be affected. I have mentally given them two weeks from now to update progress or release, before I buy a front row seat to the paranoia game lol. Based upon all timelines they have given or hinted at in the calls. Best case would be news on (this) mon or tues so we have time to run. Either way it's been a long ride. The longer we wait for this, the closer our lipid data gets, so I'm getting a little more comfortable adding back when opportunities arise. I also am hoping they give us more clues about their remaining molecules in development, as clearly they have their hands full with two actively concluding big phase 2's. The steady flow of good news we have had lately will become infinitely more meaningful to share price imo if we get even slightly positive data. There may be a lag to our true reaction to good news, I won't be quick to sell. The sarm, my favorite of their drugs btw, is holding us down more than propping us up right now, imho. Hopefully that changes soon. Great example being DRRX. Decent pipeline, but their most advanced molecule dictates the share price, no matter how much you got going on behind that. So many potential catalysts including MDGL relevant news that could keep us moving sequentially up if positive news of any sort with this sarm trial, it's nerve wracking but this is the kind of bet I've been waiting for, sucks to wait and be playin this game again, but I'm hopeful this is one of the last times I gotta do this. All just my 2 cents... everyone can make their own choices. GLTA. Glad you are here sharing the ride, always good to hear your opinions. A relaxing weekend to all!
Lol. So it's not actually a steroid. You could generalize and state that it produces steroid like effects due to mech of action, but again, not actually a steroid. I fail to see why HDL or testosterone like endocrine suppression stuff (generally correlated with strength of steroid, and few have alleged this is as strong as testosterone) - likely to be present but extent is unlikely to put a halt, just like HDL... to a drug intended for end of life patients with huge mortality rate. Post market cardiac monitoring?!? Or Lipid monitoring? Sure. Ive heard that ? cardiac death is a sizeable portion of patient mortality in our patient population. Keep in mind they are looking at mortality rate I'm sure in this trial. Your exclamation that FDA will never approve a nonsteroid molecule that is being evaluated with secondaries like mortality rate reductions and quality of life endpoints? Glad you're not my broker! That's why I'm my own broker haha. So in summary, I respectfully disagree with every point you made.
Hey Lynx, essentially 1 share Of VKTXW = warrant to purchase 1 share of VKTX for $1.50, anytime before 4/13/2021.
So a warrant in this case is just like an call option with a 1.50 strike price that doesn't expire until 4/13/21. If you know options, that's really all you would need to know.
So the stock VKTX closed at 3.00 Friday. So my one share of VKTXW allows me to buy one share of VKTX at 1.50. So if I wanted, I could notify my broker, and broker could request 1 share of VKTX in exchange for (1 share VKTXW + pay $1.50 for the share). My broker told me it generally takes up to 2 weeks to get the shares from Viking if I request any. Who knows how long it takes in reality, but that's my current barometer. If anyone has more info on that please do tell.
Instead of requesting the share and paying the 1.50, you can buy and sell the warrant just like a share.
VKTXW is worth whatever someone wants to pay just like other stocks, but in reality, it's essentially worth the price of VKTX - 1.50, + whatever someone is willing to pay as a value for time. The time premium is why it is trading for more than what it is inherently worth.
So the simplest thing is in just selling the VKTXW when u would normally think of selling your VKTX. I would say that a fair price to get for it is currently is VKTX price minus - 1.50, + around .30-.40.
For every penny that VKTX goes up above 1.50, the warrant VKTXW will inherently be worth .01 more (if you had to request the share). So even if nobody wants to buy your warrant, it keeps become more valuable the higher VKTX goes, penny for penny actually, and you could always just request the share of VKTX, and then just sell the share of VKTX for whatever it's worth, and keep the difference. The higher the price of VKTXW gets, the less people will usually want to pay extra as a value for time, just the way it goes, but we are nowhere near that point yet.
If you got your warrants for cheap enough, you stand to make a lot of money (more money) if the share price goes up higher from this point. But if the stock price drops your warrant will drop in price quite a bit... so big risk big reward in this setting. A fair price for the warrants VKTXW is around 2.00, I wouldn't currently sell them for less than 1.90 if I were you, regardless of the 1000 shares that traded hands in the 1.60's to lower the price symbolically on Friday at close.
Hope that helps! Congrats on that investment btw!
FDA site still stated oct for the results expected when I checked a week back last updated august. Earliest date I felt based on call was oct 16. They stated 2-4 weeks to clean up data takes us all the way up oct 31. I'm hoping for early next week but realistically feel we should see something within next two weeks. Have a good one buddy
Thanks buddy. Home stretch...!
GLTA!VKTX
MDGL here we come haha
They would be to add extra data collection or testing within their target population (hip fracture), that could further explore that area of interest. They have chosen their patient population well imho, and seems like the quickest way to market because of the high mortality rate. The process of getting drugs approved for additional indications is quite complex and requires a lot of FDA involvement. Their big endpoints were short term musculoskeletal stuff, looking into long term bone stuff, or at least suggesting it might be helpful, is a new direction of sorts, and them bringing it up now at KOL is very very interesting.
Good SA article just put out, highlights things well and very favorable coverage. Hit the mark well with discussion of expanded indications and exploring secondary endpoint stuff with bone turnover stuff - was not previously on my radar but it merits saying that if they are ever able to show results that give a superior bone longer term bone changes and remodeling to existing therapies (there are very few examples), it could really send this in a really big direction. It was an unexpected twist in their KOL event, and may be the entire reason why they had the KOL- since it seems like an excellent angle to lend credibility to exploring other labeling indications and expanding the scope of what they could accomplish with a well designed phase 3. Exciting stuff, but still a big question mark.
Without having the benefit of hearing your convo and the way you presented the context 'the company is blinded' could mean numerous things in this setting, but it's not worth discussing. I will simple this down for ya. "Somebody" decided 108 patients is enough. So maybe Viking gave someone the authority to independently stop their study under certain conditions. Ok, maybe. Could interpret that many ways.
New line of thought. How'd they make that determination? Did they then flip some switch and a red light started blinking in the batcave (Viking headquarters). And since then, all Viking knew is that their study got triggered for early patient pool closure, which probably could only occur under really good or bad circumstances. So then they wait for months, and decide to pass the time by scheduling a KOL to talk about how much they love researching bone demineralization.
Anyways, outside of your one word answer- 'blinded' !!! that the clever chap in IR gave to another guy calling and asking about if they knew the results yet, which I commend you for picking up the phone, a lost art, what other information are you actually giving us here? And why'd ya buy stock recently if you feel that their sarm trial will result in catastrophic miscalculations in enrollment (avg phase II trial size = 100-500 pt). You could buy it way cheaper in a few weeks when the statistical significance monster emerges from its mountainside den, if you are so in love with the lipid drug and their selective ability to perform that trial well with 'statty sig'.
Exactly right. What usually happens is they perform an interim data analysis (to feel our where they are at with data and enrollment and see if the data collection is occurring correctly) - they see the results thus far, and then they decide if they have powered the study correctly to get results with statistic significance. So sometimes companies extend the trial or increase enrollment if they have borderline positive results but are way below magnitude of effect size needed for statistical significance with that volume of patients, and sometimes they see what the expect to see (or even better), and decide that data will likely continue as such and that statistical significance can be obtained with less than full enroll. Sometimes companies just can't find enough patients or run into problems with enrollment processes and cut trials early. If that were the case, they've made no mention of such being a cause. And if it was a wash and the trial is being scrapped and enroll cut early, why would they schedule the KOL and go through all the trouble... it likely is isn't to bump the price to do an offering, they have had No trouble raising money on favorable terms and have only done modest capital raises compared to what their peers generally do. Doubtful that ligand or mgmt is gonna be quick to dilute themselves out of their huge ownership of this company.
I think Greens understands this statistical significance issue much better than others on here.
Showing up and saying that Viking has had 10 years to plan all this and is backed by Ligand and Succeeded in correctly powering and executing ALL studies to date, and now magically stopped the trial early "just because" and that will cause them to lose statistical significance... wow. Ok, anythings possible... but honestly? Why would you (claim) to be invested in a company that you suspect is unable to correctly enroll enough people to get statistically significant data?! The effect sizes were large in phase I's just like the effect sizes claimed by bodybuilders and avg joes who have been using this drug for Years. I have yet to encounter people alleging that this product is analogous to a weak steroid.
I get it, people are here to bash. Claiming to own a bunch of shares and then saying that the results will be ok but not statistically significant... implies that you are betting on something that you think will fail based on data analysis metrics. Makes no sense. Bash on though!
Lol Greens, well said! Really happy to be going into news with these recent levels and volumes traded. I wonder if ligand would ever increase their stake if data looked good. Partnership opps shouldn't really be impacted if they did. They already have quite a stake in the drug anyways by virtue of their holdings.
Hey buddy I'm here, patiently waiting in the wings. I liked the presentation as well. A little dry and clearly more scientific based than what most Wall st types want to hear, but the science seemed solid, they are really looking to hit a home run here, the level of microbiology and bone resorption analysis they have been willing to address, acknowledge, and pursue is unheard of. Feel they did well to avoid it being a purely PR/hype based conference. Those guys on the panel were legit, as boring as any I've ever listened to at high level conferences lol.
I think it would've been a large error to pay for the conference/PR without having prelim data analyses at least (which is fairly typical to have), I don't find it reasonable or believable to believe that mgmt has no concept of data, given the overall picture and timeline, and companies will usually acknowledge freely that their field researchers don't have data, as a component of running double blind, which is usually all they are required or willing to say. I also found it funny that they made no generalizations or vague links to pending data, ominously absent, and thankfully offered no hints about future directions or problem spots in the science, which seems very relevant on the brink of news. So I sit and wait lol. Hearing the sheer volume of studies and research they have accumulated in this field was eye opening. I was thoroughly impressed to see the level of knowledge they have in this area, and the working knowledge they have of FDA tracks and approvals avenues- a piece that is classically missing from discussions led by new companies... so it was surprising to see the level of thought they are using to approach. So I was a bit surprised and enthusiastic to hear their thoughts on potentials for our compound to (potentially) favorably impact bone remodeling and fracture healing, independent of the muscle growth. As an analogy, Instead of just throwing gasoline into an engine and boosting mood and offering short term gains that fade, they hint at the potential for our compound to change the mechanics of the car, to modify the rubber on the torn tires... this is a huge angle they are looking at as proof of concept... truly cannot be understated. If they are able to link the data and get in depth analyses of the long term bone effects, our drug could then be used off label in a number of pathological fracture scenarios with other fracture sites... making it an unlimited market. I still find it a stretch, and more of a dream, at this stage. That being said, if they can create a scenario where our drug shows independently favorable bone health and repair benefits, this has the potential to be a panacea for fracture care in elderly populations. Using it on people with less to lose (end of life, high mortality fractures) is a great place to get the data they would need, that would open this up to less terminal participants. It also makes their bone/muscle more generalized approach seemingly much better thought out than the niche indication that GTXI is exploring, that will likely restrict GTXI from entering our areas as competition, without a lot of additional trials on their end.
I have finalized my position for trial results, and hold about 3/4 of my original warrant position, along with about 1/4 of my common position. Very excited for the weeks ahead. If data looks good, I will probably abandon another 25% of my warrants, and close my common position. Wish I had the patience to hold it all through both trials, but for whatever reason my sleep is less restful with unspeakable sums of money tied into one stock ;)
Hope you're enjoying the ride buddy, the waiting game continues, take care
Thanks buddy, hope all is well
Hey... so double blind means that the patient doesn't know if they are getting the drug, nor does the researcher/doc In The Field physically evaluating that person, removing the bias that the person doing the testing and data Collection. That does not mean that the Company is blinded to the results or to the ongoing data collection results (generally, nor could I imagine a situation where they would want to be. An exception would be if a company was partnered with a major health researcher that was given the opp to do their own thing with their drug trial, and there was a disconnect or unsmooth operating procedure). A common sense illustration of companies having their ongoing data would be the fact that some drug trials are terminated early due to side effects, deaths, failures. There is not some independent company that is given authority to collect data, and sense for problems, and notify a company with problems. The responsibility falls on the company to assess the ongoing safety and tolerability of their drug trial, and to act to halt the trial or intervene if safety problems resolve. So again, the physician or tech who is performing the dxa scans of these patients, and the physician reading the results, both blinded. If they are contracting with an independent data collection firm to collect the data (which is less relevant here), than they are likely not blinded (and companies like that are usually used for company convenience or sometimes ethical angles). But again, the company is not blinded. Another illustration relevant to our own company. The lipid trial they are running- they asked to lower the threshold of the ?LDL to recruit better. This would have been done in conjunction with reviewing the ongoing data, seeing the results of the patients who were screened and declined, etc. Interim data analyses are the name of the game. Companies alter dosing regimens (with FDA approval, keep in mind) sometimes, enroll more patients than anticipated originally to change the powering of the study, etc, based on ongoing evaluation of the numbers. A rhetorical question that will illustrate my answer and clear up confusion. How did Viking know that they were able to stop with only ?108 patients. Stopping the study prior to full enrollment essentially proves (in my mind at least, beyond a reasonable doubt (my opinion, not science fact)) that data analyses were completed, more than just my knowing how this works. I would encourage you to read more in detail on how clinical trials work and are overseen. Companies spend millions on these, they would rarely ever consent to just receive some envelope with a data analysis at the end of their trial, and give some team of paid researchers, typically working on their dime, the liberty of unrestricted time at the wheel juggling the fate of their baby. I respect your investment, 33K shares is no joke, so I felt it reasonable to give you an honest answer. I'm some sort of medical something or other (in case you can't guess), so I gamble on what I know best, medical stuff, and I stick to mainly that, with few exceptions. Having 33K+ to spend on this stuff, I think you made a decent bet on this company. A lot of this is luck, even with higher levels of knowledge, but I would strongly urge you to read up on how these wacky trials are run... it's a big game, and understanding the game will help you to reduce the risk inherent to this line of investing. Having 33K+ to put into this company, you clearly are good at something. You know many things much better than I ever will. Exploit those strengths. These trials scare the crap out of me, and they are my bread and butter. I am here because it's all I know, that's all. And I like Viking (clearly) lol. Best of luck friend