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Company is blinded. The 9 responders might belong to the control arm...
Why the 12% drop?
Quote:
I haven’t taken the loss yet...maybe I should just get it over with...
Response:
I have sold my shares thinking that the share price had nowhere to go but down. However, at $1.80 the company would only be worth the cash held by the company which seems unreasonably low. At $2.0, I intend to buy back the shares I sold earlier.
Coming back to your case, it can go a little lower than the current price of $2.30 but not significantly lower. On the other hand, the shares might jump due to a buyout or before intermediary results are announced mid 2019.
Quote:
Seems like this is going nowhere unless A) someone buys them B) ovarian does well C) go broke...
Indeed, the events that can impact investors are 1) ovarian p3 is successful (mid 2019 for preliminary results) 2) or it does not, in which case the company will have very hard time surviving.
A buyout can happen at any time, especially when the share price is so low.
Disclaimer: I sold my shares at a loss.
Interesting point about data leakage not causing a price hike. This can be explained in several ways.
For one, most patients on VB-111 still end up dying. Moreover, for a caretaker who is also an investor, having a patient survive 16 months instead of 12, no definitive conclusions can be drawn regarding trial success. Most importantly in my opinion, those in the know cannot talk or act in a conspicuous way.
The article is quite informal and was published in the Modiin municipal journal. The author seems most interested in the choice of the city (Modiin) for establishing the company HQ and manufacturing facility.
I would summarize the article as "look we were able to attract this really cool company to our city". I really would not read too much into this piece.
I read the article in Hebrew without Google translate.
Regarding FDA approval, the sentence is: "We shall get approval early 2018 after the latest trial".
Any claim that the trial is over is highly speculative.
The article mentions that the assembly line for manufacturing VB-111 is still being put together. Their plan calls for the manufacturing plant to get FDA approval within 18 months.
I also learned that Nano Carrier is a bio-tech company in its own right. They will be responsible for getting the required approvals from the local authorities for the Japanese market.
I don't think most investors look at the actual number of months of OS to decide whether to invest or not. Moreover, no one is going to jail for having published OS values in units of weeks instead of months or vice versa.
Regarding VB-111, there is an ongoing phase 3 trial for rGBM under an SPA with the FDA. The p3 tiral is what makes investors take the plunge.
Regarding CEO credibility:
Prof. Harats has an illustrious career as a medical doctor, a researcher at Tel Hashomer, Israel's largest hospital, and as a faculty member at Tel-Aviv university.
He is also surrounded by high calibre people with years of experience in clinical trials and related fields.
I understand that the ability to prosecute and jail a CEO might be reassuring to some investors. However, we can assume that there exist guarantees put in place by the SEC so that US investors are not easily scammed. Admittedly, I do not know the actual guarantees involved.
Notwithstanding the above, it is entirely possible that VB-111 is a dud as many have claimed in the past. We will find out shortly.
Assuming an stock offering takes say 3 months, from inception to completion, that much time would be lost before required investments could be made. Lost time which would translate to lost revenue opportunities. A very similar line of reasoning was invoked by Dr. Harats regarding the mfg facility being built before p3 results.
Regarding the strength of the company, I reject the idea that after favorable p3 results the company would NOT be in a better negotiating position. After favorable p3 results, VBLT would be trading at $20 and not $7. It follows that 2.5 million shares would bring in three times as much cash. I am at a loss how anyone could argue otherwise.
To summarize this and my previous posts, the current offering:
1) hedges against bad p3 results
2) buys precious time in bringing VB-111 to market.
I am no expert but I now think that by the time the offering is announced publicly, private investors had already committed to purchase the offered shares at an agreed price.
The offering should be viewed as insurance for the rGBM trial failure, however unlikely that may be.
Stock offering will raise additional $18.75 million extending operations for an additional year. In case rGBM trial failed, this was the last moment to raise funds. A cautious management team should be expected to prepare for a worst case even if improbable and raising funds at this juncture does just that.
Today's precipitous drop in price reflects in my opinion another possibility, that is, management predicting failure of the upcoming rGBM trial, at least as perceived by outside investors. Management cannot make openly reassuring statements at this time. For instance, it cannot make optimistic statements about the trial outcome without exposing itself to judicial action in case of trial failure.
Let us not forget that the underwriter of the offering is expected to sell the stock at a unit price of $7.50. Buyers will be few if the the stock price remains considerably below $7.50.
Since the offering is expected to close around November 21st, I am afraid it wont complete. It follows that the offering may be an ill-considered move and only positive trial results redressing the balance.
Anyway, we will soon discover how the offering went...
@staccani I share much of your sentiments. If all goes well, in 5 to 10 years $20B valuation for VBL is plausible imho.
However, I should add that with 3000 ongoing clinical trials in the US alone, the competition in the biotech sector is tremendous.
Given this competition, the pricing for cancer treatments will have to eventually go down. At present time, we are paying astronomic prices for drugs with microscopic benefits. This cannot continue indefinitely. In the future, the balance must change in favor of lower prices and higher benefits.
Agreed, combining with Avastin is/was the easiest and fastest path to approval. Indeed, many clinical trials struggle with finding patients ready to try an experimental drug. The Globe trial enrollment was finished ahead of schedule. I think this is mosltly due to combination with Avastin and less to word of mouth regarding VB-111 efficacy.
However, I still think it was a risky gamble as will be the ovarian p3 trial. This was stated almost verbatim by the CEO himself in one of his presentations in Hebrew. A bigger company with deeper pockets would have taken a different less risky route.
Anyway, if the gamble succeeds, then so much the better. However, if the gamble fails, it would be a waste of talent and years of development. The wait for the Globe trial feels like October 15th 1973 crossing of the Suez canal. It was the right move under the circumstances, but very risky as well. In hindsight, the crossing proved to be a tremendous success. I hope the Globe trial will be such a successful turning point for VBL.
If Globe trial is successful, will VB-111 approved as a standalone drug or only in combination with Avastin? Note that both arms of the Globe trial are with Avastin.
I am worried that Avastin can hurt VB-111 effectiveness as a treatment in addition to its potential in the market.
Quoting from "How Infection Can Prevent and Cure Cancer" by Andreas Moritz that Oren cited:
The polio vaccine has been the main reason behind polio
outbreaks in recent history.
Are you serious? The relationship between various illnesses and the immune system can be complex, but the above assertion is completely irresponsible.
As Dr. Harats stated in his latest conf presentation, VB-111 requires some vascularization of the cancerous tumor. I don't think you can inject VB-111 preemptively to healthy individuals like a vaccine.
Oren, it's good to have lots of ideas. However, you also need some sort of filter to weed out the bad ones.
The article entitled "Immunity over inability: The spontaneous regression of cancer" [1] was a good read. However, your latest proposal to inject healthy individuals with VB-111 in order to immunize them is pretty unhinged.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3312698/
In the Chardan Inaugural Gene Therapy Conference Dr. Harats stated top line data would become available 1Q18 or towards the end of 1Q18. He also stated that since the trial was under an SPA, the FDA required the trial to reach its term.
Adam Feurstein has discredited himself by his own admission that he does not consider the company because it's based in Israel.
Do you have a reference?
Jumpinjackas wrote:
It's the calling of the co/CEO scam by Isrealites with nothing to back it up. Just trying to see if there is a back story to it.
Interesting presentation:
http://tocagen.com/our-science/#platform_tech
There are strong similarities between Tocagen's TOCA-511+TOCA FC combination and VB-111. The latter is much easier to administer which I think will help its success.
You should not invest in biotech sums that you are not prepared to lose.
Even if VB-111 is approved by the FDA, it does not necessarily mean that it will be adopted by doctors as a treatment. Approved drugs fail in the market. Dr. Harats hinted that VBL was good in creating innovative drugs but not necessarily good in marketing.
Oren, you seem to focus on the elements that make VBL shine but seem to ignore the potential pitfalls ahead. The road for VBL is still long albeit VERY promising.
In light of the above caveats, I also think that current VBLT valuation is very low. I am already invested in VBLT to my limit.
Your optimismm, Oren, knows no bounds. I hope you are right.
As Dr. Harats stated in one of his presentations, the p3 is a big hurdle and once overcome, it will be a different ball game.
The easy administration of VB-111 will be a very significant advantage for the acceptance of the drug.
The stars are beginning to align for VB-111 but it's not over yet.
Oren1976' wrote:
"Corin statement is a bold clue to public big investors and doctors about what to expect to...the phase 3 is going to be a big success"
Indded, when the results are announced, this will move very fast. It will be very hard to chase after it (in case of up move) or sell it (in case of down move).
The risk/reward ratio for VBLT is very favorable. Nevertheless, one should not invest any sums that one is not prepared to lose.
Where everyone else has failed in rGBM, even a 10% improvement of OS over Avastin would be a remarkable achievement. Clinical trials are designed to detect and demonstrate such "small" improvements.
Making predictions about GLOBE results without actual enrolment data is quite futile imo.
Now, do I want GLOBE trial to succeed? Yes, I do. But my wishful thinking does not make it true.
As far as I know, there have been at least 10 studies involving Avastin. Thus, it is reasonable to assume that Avastin will behave similar to past in the GLOBE study as well. Note that there was some variation in OS results with Avastin between studies.
In any case, given that Kaplan-Meier curvers are all about precise data, without knowing the enrollment dates with relative precision all predictions about top-line result announcement date are moot.
We will know the results when they are announced and not before.
IR might have miunderstood the question or misspoken. Morever, anythig said over the phone is not really binding. Having said that, 105 not having occured by August seems highly unlikely but you never know.
If survival probability for the VB-111 arm is 50% at 12 months, 40% at 15 months, and 30% at 18 months, then 75% events won't be reached before 18 months have elapsed for patients in the VB-1111 arm of the trial.
Thus, I think the 189 events is a figure of speech. For argument sake, assume VB-111 show stellar results in Globe trial with 80% survival at *24* months for the VB-111 arm, then 189 events won't occur until 2019 or 2020. Under these hypothetical conditions, it would be irresponsible to delay approval for VB-111 until late 2019 (when 189 events occur). Several year would have been lost for no good reason.
The Globe trial is intended to show an improvement of VB-111+Avastin over just Avastin. Given Avastin's past OS results, the Kaplan-Meier survival curve should be able to show convincing results after 12 months (subsequent to trial enrollment completion).
The FDA knows that delaying approval in order to obtain more precise results needs to be counter-balanced with benefits of early approval when current results are already positive (but not as precise as they could be).
We cannot know for sure until the results are published.
Both rGBM and prOC are very aggressive cancers with abysmal survival numbers. P2 results show benefits of VB-111 in both indications. However, there is a risk that P3 results will disappoint. This risk is largely mitigated by the "all-comers" filter (or non-filter) of the two P2 trials.
From what understand, FDA meeting have a format whereby the sponsor of the trial, in this case VBL, is supposed to make reasonable recommendations to the FDA and the FDA approves or rejects them based on the data. Recommendations originate with the sponsor, not the FDA. For the sponsor to make recommendations, it needs to have the data prior to the meeting...
Given that the FDA meeting to discuss Globe trial data is scheduled for Q1 2018, the results must be made available to VBL several weeks before the meeting.
In any case, I am cautiously optimistic, but this is not a slam dunk.
Oren1976, you can't just average the trial enrollment dates. Indeed, events happen *after* a given number of months pass.
As an example to prove my point, assume half the patients were enrolled in March 2016 and the other half in March 2017, the average enrollment date is September 2016. However, most of the March 2017 cohort would be expected to be alive in both arms...
Without having a precise idea of the enrollment dates, one cannot make predictions about the date when 189 events will be reached. Only those privy to the actual enrollment dates can do such predictions.
We know that the official date for the meeting regarding p3 top-line results with the FDA is scheduled for early 2018. The rest is hearsay.
@staccani Do you have a reference for these numbers mentioned in your post #1213 (reproduced below)? I was unable to find these numbers with google. I thank you in advance.
Let me put it more simply. We know that:
1) ca 50 patients were enrolled before June 2016
2) ca 75 more patients were enrolled between June and Aug 206
3) ca 125 patients were enrolled between Sept and Nov 2016
4) ca 2 patients were enrolled in Dec 2016
Thank you for the pointer.
Slide 5 states Adenovirus "is internalized by endothelial cells in blood vessels". It does not say "internalized ONLY by endothelial cells".
'gr8db8' wrote:
@mantoo, take a look at slides 5 and 6 in the company's presentation.
http://ir.vblrx.com/static-files/9b1c10ac-65b5-4867-9100-0c25ab7a1a9c
Using your enrolment schedule (reproduced below) and assuming:
- 0.25 survival probability at 18+ weeks for both the Avastin-only and Avastin+VB--111 groups
- 0.25 survival probability at 15+ weeks for the Avastin-only group
- 0.5 survival probability at 15 weeks for the Avastin+VB-111 group
then, according to my calculations, only 172 events are expected by January 2018 and 189 events expected to be reached 3 months later, i.e. April 2018
Nevertheless, given past OS with Avastin at 20% or 25%, December 2018 is sufficient to compare Avastin to Avastin+VB-111.
In post #1213 staccani wrote:
Company is expecting final results in Q1 2018, let us say the 189 are reached in Jan 2018.
1) the first 50 patients would have 24 on average until Jan 2018
2) the 75 patients , 21 months on avg until Jan 2018
3) the 125 patients , 15 months until Jan 2018
4) the last 2 patients 13 months until Jan 2018
The weighted avg trial duration is 18,75 months. This means that if all the patients were alive, they would have been on trial for an avg of 18,55 months or ca 87 weeks
If we look at the survival curves in slide 22 of June 2017 company presentation we will see the avg survival between the vb111 curve in ph2 ansd the historical curve in BEV at week 87 is probably around 15%.
Whereas the ph3 trial will be stopped at 25% survival. That is why I believe VB111 is doing better than ph2 (possibly due to BEV addition for the whole trial), assuming that BEV cohort is behaving like in historical trials
staccani:
How do we know that at present date the average treatement period is 14 months? Moreover, how do we know 189 events have not yet occured?
From listening to Dr. Harats, it seems that VB-111 shows therapeutic results after a delay of a few months. Some patients die before they have a chance to react. As I understand it, the Ovarian P2 trials initial results (after the first 3-6 months) were quite disappointing. Nevertheless, I think the people at the FDA are far from stupid and will be able to identify the therapeutic benefits of VB-111 if there is any.
The fact that the Or Yehuda facility is being built for $20 million dollars shows the conviction VBL management has in their product. It's a calculated risk which will pay off very nicely if and when VB-111 is approved.
In addition, the people managing VBL give the impression of being very experienced and know how to navigate around difficulties of their field.
On another register, I understand that the adenovirus contained in VB-111 induces cell death in angiogenic endothelial cells in the tumor milieu. However, does this adenovirus infect ALL cells in the body or only angiogenic endothelial cells?
We know that the patients that enrolled in the VB-11 arm were in worse share than those enrolled in the control arm, both in the rGBM and Ovarian p2 trials. For rGBM this was made explicit in LifeSci OSCO report. I heard Dr. Harats make this claim for Ovarian in a presentation he gave in Hebrew.
Moreover, we also know that FDA granted VB-111 for rGBM a special status (orphan and/or fast track?) whereby if the P3 trials succeed, then the company will be quickly/automatically approved to market VB-111.
gr8db8 wrote:
The failure of VB-201 in psoriasis and ulcerative colitis in phase 2 is now a positive factor for the company, imo. It shows that if a treatment is not working, the company will stop it early. This can be grouped in the positive factors bucket (like facilities, Thai Lee, upcoming OVAL study, etc). They are positive signs that the company is doing the right things but they don't impact the phase 3 GLOBE results.
Great post. I share your sentiments.
While there are several hints pointing at VB-111 trial success, they are all worthless unless VB-111 obtains FDA approval.
Thank you for the presentation link.
The "SCO 2017 – Highlighted Company Presentations #2" by LifeSci Capital [1] which you mentioned earlier is noteworthy, in particular the sentence:
Notably, patients in the continuous exposure group had an overall lower Karnofsky performance status (KPS), a less successful initial resection, and had a higher rate of second recurrence than the limited exposure group at baseline, increasing our confidence in the prior survival results with VB-111. Patient baseline characteristics are depicted in Figure 1.
VB-111 seems to be fighting with one hand tied behind its back and still bringing in better results.
[1] http://www.lifescicapital.com/wp-content/uploads/LSC-ASCO2017%E2%80%93Highlighted-Company-Presentations2.pdf