Some interesting insights from the Q4 call:
> "the point that we were recruiting very well in a trial which is a control randomized by open trial, which means that the doctors and the physicians know what they are getting, we are the only blinded party in this trial, is in my mind might be a meaningful thing that at least the patients and the doctors felt that there is a good chance that this will be a great drug, and that’s why they’re recruiting"
He has brought up this point before, and it is interesting that he is consistently delivering this message. He is right: recruiting was successful because doctors and to a degree patients (who do research on their own) were excited about the drug's potential.
> Regarding his comments on checkpoint inhibitors, he talked about combining it with VB-111 since one won't affect the other. Many patients are taking this multi-prong (cocktail) approach since each drug has different mechanism of attacking the cancer cell. Cancer cells mutate. They have need for blood (nutrients), they have different cell surface receptors, they use different pathways .. and more ... so it seems appropriate to use different mechanisms to attack it.
> Regarding dropouts, he was clear that this issue happened early on and it has been addressed; it is not happening anymore. It sounds like it happened on the avastin arm from patients that wanted to be on the VB-111 arm and didn't get selected for it.
> Regarding the interim report, he said, "It’s going to be quite close to the endpoint of the study or to the top line results, and therefore it was agreed with the FDA that no matter what the results are for the point, this is a single study that they are going to allow or need to put the drug on the market, and they need the safety data. .. The only thing that we will have in this interim analysis is the green light to go forward, but because at that point a trial will already be at the position that half of the patients will have at least one year follow-up, if we will get the green light to go on with the trial, then we believe that that will be a great signal."
It sounds like what he's saying is that the FDA will review the data and will give the "green light" to proceed if VB-111 is found safe (which it has been for multiple indications). *fingers crossed* I hope no serious AE gets reported. So far, patients are not reporting any serious AE so that is a good sign. I have seen drugs with worse (much worse) safety profile and they still get approved.
> For ovarian: "most current therapies fail to prolong patient survival ... There was also an overall survival benefit signal with a tell of more than 40% at 3.7 years for the therapeutic dose cohort, despite the fact that most patients in the VB-111 study had tumors that previously had progressed on several lines of therapy, including kinase inhibitors."
Phase 2 had a small population but this speaks to its (huge) potential impact to help ovarian cancer patients. It also is a good indicator for phase 3 since they did not hand-pick patients that would (falsely) give positive results in phase 2. (phase 2 rGBM recruiting was also done this way so there's a better chance that ph3 would have similar outcome)
Overall, I was please with the presentation. However, they did not address why the last funding was needed (was it for facilities? was it for ovarian phase 3?)
So I looked in the 20-F and found some helpful info.
NOTE 9—COMMITMENTS:
> "In October 2016, the Company entered into a long-term lease contract for approximately $2.0 million over 7 years for a new facility in Modiin, Israel with the option to extend for an additional two periods of three years each ... The expected future minimum lease payment is $182 thousand for the year ending December 31, 2017, $312 thousand on an annual basis for the years ending December 31, 2018 through December 31, 2023, and $130 thousand for the year ending December 31, 2024.
... The leases will expire in 2019. The expected lease payments for the years ending December 31, 2017, 2018 and 2019 are approximately $126 thousand, $50 thousand and $17 thousand, respectively."
These amounts are minimal and I agree that they won't significantly impact the company's cash position for operations.
> " In January 2015, the Company entered into an agreement with a Contact Research Organization (“CRO”) according to which it will receive project management, clinical development and other related services from the CRO for the execution of the Phase 3 rGBM clinical trial study in consideration for up to $18.7 million. Through December 31, 2016, expenses in the total amount of $9.2 million were incurred."
This item is pretty significant but I would think it has been factored in during the initial financing. ?
> "As of December 31, 2016, the total royalty amount payable by the Company, before the additional Libor interest, is approximately $19.0 million ($23.3 million including interest)."
Payment to the Gov't of Israel is also significant. This is from grants received. May be a reason why the company received favorable terms for their new facilities.
Risk factors
> "For instance, in order to complete our Phase 3 trial of VB-111 in ovarian cancer, we will need to obtain additional funding."
Really? I thought ovarian phase 3 has been funded but I guess we should expect another funding in the near future.
