NWBO 2017 Annual Shareholder Meeting wrap up.
The following are the notes I took at the ASM, questions in bold, replies in normal typeface, my thoughts in italics. Questions and answers often paraphrased.
First, there are 481,525,114 voting shares, of which 310,202,663 (64.42%) were 'present.'
Status of SEC investigation? - On going. As reported in filings. NWBO is cooperating and hopes to resolve them this year.
Previous meetings have been followed by bad events, will this year be any different? NWBO continues to make good progress, continues to be able to get funding, even if management and shareholders are not always pleased with the terms. Managed to pay off the $12MM in bonds, which most people did not expect. Per Les, things are better than they were a year ago, NWBO keeps moving forward toward completion of Phase III and unblinding of manuscript.
Publication of an article was promised in June 2017, status? The process began in June 2017 and they worked all summer. There are 65 Doctors who wanted to be co-authors and it will be featured in a major publication but they cannot say which. It was submitted in the Fall. The process for publishing in a major publication is generally around 6-9 months. It sounded like it was submitted about two months ago and they expect it to be published next month although they have no control over that.
What can you say about results? They have the interim blinded data but that only shows aggregate data from all participants. Patients with tumor progression were put on DC-Vax so 90% of patients received DC Vax at some point during the trial. They cannot release interim blinded data because no journal will publish an article if the data has been released. The article is based on the blinded data. This suggests that the blinded data alone is very significant based on the number of doctors interested in being co-authors and a major journal publishing the blinded data.
What are we waiting for once 233 OS events have occurred? The number of OS events is not an automatic trigger to cut off the trial, it is a floor. Until you reach 233 OS events you cannot stop but you do not have to stop when that threshold has been reached. They can only see the blinded data. In immunotherapy, there is a big focus on the long tail. A long tail in a survival curve is a home run. (The following might be slightly muddled) In checkpoint inhibitors, 20-25% of patients who responded are in a long tail of two years. Even in melanoma cases only 20% of that 25% or 5% of the total are in the long tail. They want to get as much data as possible about how large and how long the tail is. Once they stop the trial, data collection stops and they won't be able to learn anymore. My understanding is that 20-25% of patients respond to a drug and about 20% are represented in a long tail in Melanoma cases, so only 5% of the total population of the trial have the long-life expectancy.
When do you cutoff the trial? They do periodic data collection but it is expensive and time-consuming. It takes ~12 weeks/3 months. The independent operator running the trial has to send a physical body to each hospital (there are 80 in 4 countries) and compare the physical results to the electronic ones. This generates thousands of queries (irregularities between observation and records), each of which must be reconciled. NWBO then reviews this data and weighs the results against waiting for more data. They have done these collections each Spring for the last three years. So there is precedent for them doing it this Spring. The results of the last collection are what they reported at ASCO in June 2017. They will be doing another collection this Spring and probably ending the trial and announcing at ASCO. Letting this go another year is dangerous given the forces working against NWBO and the stock and raising large quantities of cash to keep operations running for another year would be equally risky. There is also the matter of the shares that are available for sale/conversion in June.
Would NWBO consider a buyout at this stage? This area of immunotherapy is a whole new category of treatment. Biologics are the past. There is no dominant company yet in this field and the landscape is still wide open. NWBO is a serious candidate for leadership in this field across different stages and types of cancers. They have a universal partner product. The field is moving in this direction. Unlike normal T-cell inhibitors, which can only target a single area, DC Vax has a whole set of targets on the tumor. Les: They have never been so determined and never been so enthusiastic. They have made very painful progress against a very powerful foe.
What is the status of NWBO's IP, lots of filings recently? NWBO's IP portfolio is very large with more than 150 patents worldwide. One of the patents they recently received is for harvesting the cells for DC Vax and allows them to do so very precisely. Dendrion failed because of a poor % of dendric cells harvested which them caused pollution in their vaccine. NWBO has Orphan Drug certifications in the US, Britain, Germany, and Switzerland which give exclusivity outside of patents for 7 years in the US and 10 years in Europe. The exclusivity timer does not even start until they are in production. IP is not holding up the trial.
What is the relationship between NWBO and Cognate and its impact on investors? Per Les: NWBO has been the recipient of vendor financing from Cognate and a willingness by Cognate to take equity rather than cash, and a willingness to continue working even when they are not paid for months. A lot of the equity is not even saleable. No other vendor has been willing to be so accommodating. Cognate is a world-class vendor and NWBO has been the beneficiary of its increasing diversity.
What can be said about the nefarious actions being taken against NWBO? Per Cofer, enemies are noteworthy, he is appalled that people would attack a company trying to prolong peoples' lives. There is nothing currently in it for NWBO and shareholders to release anything now. They want the information they have gathered to benefit the company. He is pleased with where they are. Nothing to say.
What is going on with combo trials? NWBO has not said anything about them because everyone is waiting for the Phase III results and any talk of the combo trials would just be seen as an attempt to distract from the Phase III results. FDA approved trials with Optivo. Merck approved trials with Keytruda. Thre are several planned with DC VAX L that have not been publicly discussed, so they can't talk about them. NWBO is ready to go on these combo trials.
Final thoughts by Jerry: Unlike other companies, NWBO has multiple vaccines that cover all solid tumors. They've raised capital despite attacks where other companies have gone under. THey have resolved three major lawsuits without giving a penny and hope to resolve the final one soon.
