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Started By
Message
Northwest Biotherapeutics (NWBO)
Posted on 5/14/21 at 12:06 pm
Posted on 5/14/21 at 12:06 pm
OTC: NWBO
I've posted about this company a few times in varying threads but wanted to start one for some chat amongst people who are invested, or to give a tip for others. It may not get much traffic, not sure how many people bought in with me, but I just want something specific to be able to bump when updates happen.
A small cap (just over $1B market cap) biotherapeutics company with a flagship drug "DCVAX-L" for the treatment of glioblastoma multiforme 'GBM' (brain cancer). The treatment uses a dendritic cell targeted vaccine which is created using harvested cells from the patient's own tumor. This product just wrapped up its Phase III trials (the data set was locked in October '20) and is awaiting readout of topline results.
Some DD:
- Their flagship drug, DCVax-L, had interim data readout in 2018 (still blinded) showing an overall survival rate of 23.1 months; that is 18% better than current standard of care which is enough to get approved on its own. However, this was blinded so included DCVax survival AND SOC survival. The DCVax patient pool alone would logically have a larger OS increase (easily 20%+)
- The DCVax-L P3 trial endpoints were originally PFS (progression free survival) as the primary and OS (overall survival) as the secondary. I won't get too much into the weeds here, but there is a phenomenon known as 'pseudo-progression' that can prematurely flag a patient's tumor as having progressed, thus confounding a PFS endpoint. It is believed that the company has buyin from regulatory agencies to change the primary endpoint to overall survival, which greatly increases the chance of the trial meeting it's primary endpoint. They have indeed updated their SAP to the new endpoint.
- NWBO is rapidly building out a manufacturing facility for DCVax-L in the UK; they have just applied for certification and upon getting it will immediately have capability to produce DCVax that would bring ~$100M/yr revenue under the compassionate use in the UK; related, the UK has just opened DCVax up to compassionate use for pre-approval distribution
- Short term GBM market is ~$2.5B and NWBO would have a strangle hold on that market if they are approved
- NWBio has another pipeline drug which is currently on hold known as DCVax-Direct. This drug is intended to be applicable for all solid tumors and, as such, has a market potential that dwarves the $2+billion of GBM alone. It works almost the same way and, if DCVax-L is approved, focus will quickly shift to getting Direct fired up again.
- Merck is currently running a combo trial with DCVax-L in tandem with their flagship drug 'Keytruda' at UCLA. The use of checkpoint inhibitors is believed to greatly increase the potency of the vaccine. Obviously any success with Merck would be great for the company.
- On this point, the rumors are swirling that Merck (and others) are interested in a buyout of NWBio. Read this bullet with caution, these are only internet message board rumors, which are present in all penny stocks. I will say, Etrade issued an "in play" alert for NWBO this week...not many penny stocks get that, FWIW
- Like most biotechs, the company has raised money by dilutive funding through sale of stock. They currently have a little over 1 billion authorized shares, just under 1 billion outstanding shares, and several hundred million warrants which have not yet been issued. In order to exercise those warrants (mostly held by execs) they would have to raise the AS (more dilution potential), perform a reverse split, or have the shares bought out/back
- Annual shareholder meeting is next week
- ASCO conference is early June, and NWBO was just confirmed to be presenting there; they have continuously said they want to release data in a journal and in tandem with a large conference. ASCO would be the gold standard conference at which to do such a release.
In summary, this is a SUPER HIGH RISK play. I can't stress that enough, any number of things could happen to send this thing to $0.10/share. But, if you are looking for a flier with a near term binary event that could triple your money, this is a fun one. We've been waiting an agonizing amount of time for TLD release, but I truly believe it's coming by mid-July at the latest.
Price is currently at $1.70. Posting this at a 'bad' time as it's running today, up almost 15%. I really meant to start this up earlier this week, stupid me. This run is in anticipation of news/updates during the ASM next week. I believe the ASM will not give any real update and the price will dwindle back to the $1.50's towards the end of next week. Unfortunately we're waiting on a binary so the top could pop off at any moment, hard to time an entry, and if there is a significant revelation at ASM who knows what happens.
Anyhow, I'll bump this every once in a while to update on progress. Full disclosure, I'm long in NWBO with a good chunk of change. Got in last June.
I've posted about this company a few times in varying threads but wanted to start one for some chat amongst people who are invested, or to give a tip for others. It may not get much traffic, not sure how many people bought in with me, but I just want something specific to be able to bump when updates happen.
A small cap (just over $1B market cap) biotherapeutics company with a flagship drug "DCVAX-L" for the treatment of glioblastoma multiforme 'GBM' (brain cancer). The treatment uses a dendritic cell targeted vaccine which is created using harvested cells from the patient's own tumor. This product just wrapped up its Phase III trials (the data set was locked in October '20) and is awaiting readout of topline results.
Some DD:
- Their flagship drug, DCVax-L, had interim data readout in 2018 (still blinded) showing an overall survival rate of 23.1 months; that is 18% better than current standard of care which is enough to get approved on its own. However, this was blinded so included DCVax survival AND SOC survival. The DCVax patient pool alone would logically have a larger OS increase (easily 20%+)
- The DCVax-L P3 trial endpoints were originally PFS (progression free survival) as the primary and OS (overall survival) as the secondary. I won't get too much into the weeds here, but there is a phenomenon known as 'pseudo-progression' that can prematurely flag a patient's tumor as having progressed, thus confounding a PFS endpoint. It is believed that the company has buyin from regulatory agencies to change the primary endpoint to overall survival, which greatly increases the chance of the trial meeting it's primary endpoint. They have indeed updated their SAP to the new endpoint.
- NWBO is rapidly building out a manufacturing facility for DCVax-L in the UK; they have just applied for certification and upon getting it will immediately have capability to produce DCVax that would bring ~$100M/yr revenue under the compassionate use in the UK; related, the UK has just opened DCVax up to compassionate use for pre-approval distribution
- Short term GBM market is ~$2.5B and NWBO would have a strangle hold on that market if they are approved
- NWBio has another pipeline drug which is currently on hold known as DCVax-Direct. This drug is intended to be applicable for all solid tumors and, as such, has a market potential that dwarves the $2+billion of GBM alone. It works almost the same way and, if DCVax-L is approved, focus will quickly shift to getting Direct fired up again.
- Merck is currently running a combo trial with DCVax-L in tandem with their flagship drug 'Keytruda' at UCLA. The use of checkpoint inhibitors is believed to greatly increase the potency of the vaccine. Obviously any success with Merck would be great for the company.
- On this point, the rumors are swirling that Merck (and others) are interested in a buyout of NWBio. Read this bullet with caution, these are only internet message board rumors, which are present in all penny stocks. I will say, Etrade issued an "in play" alert for NWBO this week...not many penny stocks get that, FWIW
- Like most biotechs, the company has raised money by dilutive funding through sale of stock. They currently have a little over 1 billion authorized shares, just under 1 billion outstanding shares, and several hundred million warrants which have not yet been issued. In order to exercise those warrants (mostly held by execs) they would have to raise the AS (more dilution potential), perform a reverse split, or have the shares bought out/back
- Annual shareholder meeting is next week
- ASCO conference is early June, and NWBO was just confirmed to be presenting there; they have continuously said they want to release data in a journal and in tandem with a large conference. ASCO would be the gold standard conference at which to do such a release.
In summary, this is a SUPER HIGH RISK play. I can't stress that enough, any number of things could happen to send this thing to $0.10/share. But, if you are looking for a flier with a near term binary event that could triple your money, this is a fun one. We've been waiting an agonizing amount of time for TLD release, but I truly believe it's coming by mid-July at the latest.
Price is currently at $1.70. Posting this at a 'bad' time as it's running today, up almost 15%. I really meant to start this up earlier this week, stupid me. This run is in anticipation of news/updates during the ASM next week. I believe the ASM will not give any real update and the price will dwindle back to the $1.50's towards the end of next week. Unfortunately we're waiting on a binary so the top could pop off at any moment, hard to time an entry, and if there is a significant revelation at ASM who knows what happens.
Anyhow, I'll bump this every once in a while to update on progress. Full disclosure, I'm long in NWBO with a good chunk of change. Got in last June.
This post was edited on 5/17/21 at 10:20 pm
5
Posted on 5/14/21 at 1:23 pm to Fe_Mike
Kige the risk and kige the potential.
Posted on 5/14/21 at 1:32 pm to Fe_Mike
I’m the dd baw around here
Posted on 5/16/21 at 2:56 pm to Fe_Mike
Love a good pharma play. Thanks 
Posted on 5/17/21 at 10:57 pm to Fe_Mike
Quick update, the 10-Q was released on time today.
NWBO 10-Q
Honestly, not much of interest in it. Probably the most significant detail is that it was actually released on time, again. That's 2 reports running. NWBO hasn't released fins on time pretty much their entire career (15+ years), and they've hired a new accounting firm and are back to back on time. Such things are required for a company with uplisting aspirations. Coincidence??? Probably. But definitely not a bad sign.
Otherwise, they still have a few million cash remaining from their most recent loan (burn rate of about $2M/month) and have again suspended the executive warrants. There is a financial pinch point coming in that is a significant risk portion to this investment. Something really needs to materialize in the next 6-8 weeks.
ASM is tomorrow after hours. I expect it will be very bland, and the price will drop Wednesday. Probably another decently green day tomorrow (there is still speculation that TLD will be dropped tomorrow, pre-ASM...I think there is next to no chance of that) so if you're teetering on getting in, tomorrow is a risky day for swing trading. Maybe buy a bit so you have some skin in the game, but plan on averaging down the rest of the week. But if they do something crazy like say they're going to present TLD at ASCO, price won't be getting any cheaper.
IMO I think a fair value for this company pre-TLD is ~$3. Probably about the highest I'd buy at. I put it at ~33% chance of success, and I think with positive data it can hit $9-10 pre-approval. That spread is based on the nearing zero level of safety concern for the drug. If the P3 trial meets more than the primary endpoint (mainly looking at r-GBM), the chances of approval are significantly higher than a typical drug hitting P3 PE. DCVax is quite literally no more risky than Ibuprofen. Perhaps even less so. The worst side effects were inflammation at the injection site.
Tomorrow will be interesting. If you're on the sidelines, I'd probably wait until Thursday/Friday to get in at this point. You could miss the wave, but I don't see it as likely.
NWBO 10-Q
Honestly, not much of interest in it. Probably the most significant detail is that it was actually released on time, again. That's 2 reports running. NWBO hasn't released fins on time pretty much their entire career (15+ years), and they've hired a new accounting firm and are back to back on time. Such things are required for a company with uplisting aspirations. Coincidence??? Probably. But definitely not a bad sign.
Otherwise, they still have a few million cash remaining from their most recent loan (burn rate of about $2M/month) and have again suspended the executive warrants. There is a financial pinch point coming in that is a significant risk portion to this investment. Something really needs to materialize in the next 6-8 weeks.
ASM is tomorrow after hours. I expect it will be very bland, and the price will drop Wednesday. Probably another decently green day tomorrow (there is still speculation that TLD will be dropped tomorrow, pre-ASM...I think there is next to no chance of that) so if you're teetering on getting in, tomorrow is a risky day for swing trading. Maybe buy a bit so you have some skin in the game, but plan on averaging down the rest of the week. But if they do something crazy like say they're going to present TLD at ASCO, price won't be getting any cheaper.
IMO I think a fair value for this company pre-TLD is ~$3. Probably about the highest I'd buy at. I put it at ~33% chance of success, and I think with positive data it can hit $9-10 pre-approval. That spread is based on the nearing zero level of safety concern for the drug. If the P3 trial meets more than the primary endpoint (mainly looking at r-GBM), the chances of approval are significantly higher than a typical drug hitting P3 PE. DCVax is quite literally no more risky than Ibuprofen. Perhaps even less so. The worst side effects were inflammation at the injection site.
Tomorrow will be interesting. If you're on the sidelines, I'd probably wait until Thursday/Friday to get in at this point. You could miss the wave, but I don't see it as likely.
Posted on 5/18/21 at 7:19 pm to Fe_Mike
As predicted, the ASM was absolutely nothing. They pretty much just read through their last three PRs. The most significant revelation was that they for some reason denied internet claims that they would be releasing data at ASCO. Unfortunately all that does is push out the binary event and, therefore, the short term price support will be gone.
Big drop tomorrow in price, so good buying opportunity if you’re looking to get in. I’d probably be looking for 1.40’s.
Not sure what the next catalyst could be but it’s looking like post ASCO (June 9) at the earliest.
Big drop tomorrow in price, so good buying opportunity if you’re looking to get in. I’d probably be looking for 1.40’s.
Not sure what the next catalyst could be but it’s looking like post ASCO (June 9) at the earliest.
Posted on 5/18/21 at 7:52 pm to Fe_Mike
It sounds like their data will be released through a peer reviewed journal. If that were true I am more optimistic. There are relatively few studies published when the results are negative.
I almost posted earlier just to compliment your earlier post. This thing probably will get shorted down into the mid to low 1.50 to 1.30 range and then rebound again in a few weeks. I might buy a few hundred shares as idle speculation.
I almost posted earlier just to compliment your earlier post. This thing probably will get shorted down into the mid to low 1.50 to 1.30 range and then rebound again in a few weeks. I might buy a few hundred shares as idle speculation.
Posted on 7/13/21 at 1:36 pm to Fe_Mike
If people are willing to risk a loss for a potentially big payout...
Then today's NWBO price gives you that option. 1.35 is a relative bargain compared to recent prices.
Then today's NWBO price gives you that option. 1.35 is a relative bargain compared to recent prices.
Posted on 8/3/21 at 9:30 pm to Fe_Mike
Figured I'd drop an update on this one for those that bought in or have it on a watch list.
Company has been completely radio silent for the past 3 months now. They maintain that they are in a 'quiet period' but it is unclear whether it is still self imposed or if it has become 'real', for lack of a better term.
That makes it almost 10 months since data lock and we still haven't seen TLD. This doesn't make me warm and fuzzy inside, but in reality the fundamentals still haven't changed.
The price has been tanking recently, pretty confident it is a combination of investors spooked by the huge delay in PRs, and warrant holders converting/selling. Nobody knows what is going on. I'm already fully leveraged here so won't be buying anymore, but if you're looking to get in or average down I believe it's a pretty good time.
Company has been good recently about filing their reports on time, and the next quarterly should be coming out within two weeks. That may spur some buying and price support. More importantly, the certification of their manufacturing facility in the UK is due out any time now; though it is at risk of delay because of the Covid spike. Lastly, one of the biggest cancer conferences in the world (ESMO) takes place in September. There will be buying in anticipation of that as NWBO has said on multiple occasions that they want to release data in a journal and time that with a large conference at which to present/discuss the results.
With a few catalysts potentially in the next 6 weeks, and a financed backstop for the price around $0.85, I think it'd be a pretty comfortable entry point here at $1.10's. But there is room to get back down to that $0.85 level so be wary of that and maybe ready to average down.
Otherwise...we're still just waiting impatiently.
Company has been completely radio silent for the past 3 months now. They maintain that they are in a 'quiet period' but it is unclear whether it is still self imposed or if it has become 'real', for lack of a better term.
That makes it almost 10 months since data lock and we still haven't seen TLD. This doesn't make me warm and fuzzy inside, but in reality the fundamentals still haven't changed.
The price has been tanking recently, pretty confident it is a combination of investors spooked by the huge delay in PRs, and warrant holders converting/selling. Nobody knows what is going on. I'm already fully leveraged here so won't be buying anymore, but if you're looking to get in or average down I believe it's a pretty good time.
Company has been good recently about filing their reports on time, and the next quarterly should be coming out within two weeks. That may spur some buying and price support. More importantly, the certification of their manufacturing facility in the UK is due out any time now; though it is at risk of delay because of the Covid spike. Lastly, one of the biggest cancer conferences in the world (ESMO) takes place in September. There will be buying in anticipation of that as NWBO has said on multiple occasions that they want to release data in a journal and time that with a large conference at which to present/discuss the results.
With a few catalysts potentially in the next 6 weeks, and a financed backstop for the price around $0.85, I think it'd be a pretty comfortable entry point here at $1.10's. But there is room to get back down to that $0.85 level so be wary of that and maybe ready to average down.
Otherwise...we're still just waiting impatiently.
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