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Northwest Biotherapeutics, Inc Annual Shareholder Meeting

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IkeEsq   Saturday, 04/18/20 03:19:31 PM
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Northwest Biotherapeutics, Inc Annual Shareholder Meeting
Saturday, April 18, 2020
13:01 – Start meeting

- Introduction of Directors and Officers
- Meeting Call to Order
- Explanation of three proposals
- Open/Close polls
- Announce Results
- Adjourn meeting

Following the meeting, a discussion of questions submitted by shareholders.

13:04 – Officers and Directors present:
- Linda Powers
- Les Goldman
- Dr. Alton Boynton
- Jerry Jasinowski
- Dr. Navid Malik
- Ambassador Cofer Black
Also present, Lisa Porter from the transfer agent (Computer Share Trust)

There are 405,885,961 shares represented at the meeting of a total of 640,486,199 issued shares for a total of 63.37% and therefore a quorum.

The three proposals:
1. Election of two Directors for a three-year term, Dr. Alton Boynton and Ambassador Cofer Black. Proposal PASSED.
2. Appointment of Markham LLP as independent registered accounting firm, in FAVOR.
3. Advisory frequency of future advisory votes to approve executive compensation, 1 year.

13:17 – Concluded business and meeting is adjourned.

13:19 – Discussion of shareholder questions

The following may contain forward-looking statements.

Linda Powers: “OK that brings us to the end of the formal meeting and now just some informal discussion on subjects that we know are of importance to stockholders near and dear to our stockholders’ hearts. It’s a little unusual doing this meeting virtually and we’re sorry to miss having a chance to see everybody in person. We really appreciate the people travel to come to our meeting, and we really appreciate everybody who has dialed in today. The main focus what I’m going to address is what we can see is the subject of greatest interest and greatest focus in shareholder inquiries that we’ve received. And that is the subject of what we anticipate to be the steps from here to the reporting of topline data from our lead program the Phase III clinical trial.

“We are excited by the progress that we’ve been making in finalizing the data and moving toward data lock, unblinding, and topline data. I will mention as a bit of context, when we set the date for this annual meeting back in mid-February---it seems like a lifetime ago---at the time we were in the late stages of the final data collection and confirmation. And as we all know all too well the world was very different. Hard to believe that was just two months ago. But the pandemic situation had not taken hold, even Italy only had a few cases, nobody was under any lockdowns and our contract research organization the CRO and our various service provider firms that we work with on this process of data collection and confirmation were working steadily with the hospitals that have been the clinical trial sites. Not long after setting the meeting date the whole world changed in a very big way as we all know. By early-March the hospitals had stopped by actually the beginning of March the hospitals stopped allowing the in-person monitoring visits that are necessary to check and confirm the data and they themselves became so overwhelmed that they really couldn’t help with the final data checking and confirmation, things like looking up pathology reports in the archives, when their emergency room and all of their wards at the hospital were flooded with patients.

“I’m happy to report that we have managed to continue moving the process forward, collecting the data. We developed some workarounds, like everybody. We’ve used Zoom, we’ve used email, we’ve used other information sources. We’ve gotten creative. And one of the reasons, we know that a lot of firms, companies who have scheduled their meetings for April have cancelled them and made plans to reschedule but we wanted to go ahead with our meeting because we’re proud of the progress and excited about the progress that we had already made and have managed to continue to make during what has pretty much been a shutdown for two months in March and April.

“And so, I wanted to just go through with you now where do we stand today and what do we believe will be the timelines to the remaining steps for announcing the data. Based on where we stand today, with the remaining queries, the remaining confirmations to be done with the hospitals, which we are assuming we will be able to do at least some work with during May, we anticipate that we will reach datalock by approximately the end of May.

“Additionally during this time, we’ve been working on making the data collection as comprehensive as we can. For example, in regard to certain genetic analyses, one that folks have asked us a lot about, I mean everybody knows we’ve been gathering the data on MGMT methylation status. Another genetic measure that folks have asked us quite a bit whether we will be including is IDH mutation status. There have been challenges because of a lot of the bio samples that we’ve collected we collected years ago in the trial. However, I’m happy to say that we have identified a method that we believe will enable us to include the IDH mutation status that effort is underway at present it looks like it will be doable even on bio samples from years ago. And it looks like it will be doable in the same timeframe as the anticipated datalock. So, we’re very happy about that and I’m happy to answer that question that a lot of people have had. The IDH mutation status was a completely unknown factor when our trial started and throughout much of the trial period. But in recent years has come to be recognized as very important in Glioblastoma. So we are continuing with the data collection and anticipate that the datalock will be approximately at the end of May.

“The steps that happen after that, there’s been a bit of confusion, folks have asked questions about how does the process work? What will happen at datalock, as soon as we have datalock the independent statisticians, we are not doing any of the calculations or analyses. They’re all being done by independent statisticians. They will gain access to the clinical trial database. Meaning they will have then access to all of the raw data and they will start doing all the calculations that everybody wants to see. They’ll calculate the median survival and the percent of survival at various time points and all of those various calculations. They will also do a lot of statistical calculations, t-values, hazard ratios, confidence intervals, etc. They will develop graphs and tables, all of the work that will take the raw data points and present them in a way that tells us the results. The clinical outcomes from this trial. That work will take several weeks. We anticipate that work will be taking place in June and as soon as the work by the statisticians is done and delivered to the company, that’s when we the company will become unblinded.

“We will not become unblinded at the time of datalock when the statisticians gain access to the database full of raw datapoints. We will become unblinded when the results of the statisticians, all their calculations and arithmetic gets delivered to us. Then as a final step we will, of course, consult with all of our medical experts. The steering committee of the Phase III trial, the Scientific Advisory Board, etc. And gather any questions or comments that those experts may have and make sure that those are addressed in preparing the information for public presentation. And as soon as that process with the medical experts is done, we will be announcing the results.

“I know the process has gone longer than many would like. We believe that having the process go longer and allowing the dataset to mature more has allowed a stronger and fuller and clearer picture of the capabilities of the DCVAX treatment to become visible, to become clear. Similarly, we think that the careful process that we’ve gone through, which was lengthy, last year developing the statistical analysis plan, and now the data collection and confirmation and cross-checking will give us the most solid basis for looking at the results. This is a very important trial. It’s one of the most important trials in the Glioblastoma space. One of the largest and one of the last Phase III ones to read out. So we felt that was very much in the best interests of the patients, the shareholders, and the company. But, I can assure you, management and the board are every bit as anxious and excited to get to the stage of unblinding and see those results. And we’re really happy to be able to give you this timeline today, this guidance, this visibility. Of course, nothing involving the future is certain. Things, we could hit unexpected bumps in the road. As I said, in mid-February we had no idea what would happen just weeks later and hopefully not some kind of change like that will happen, but we think the finish line is in sight now and we’re excited to be able to lay out this guidance for you. If the guidance changes significantly, we will find a way to announce that or update the guidance. And that’s basically what we wanted to convey and we hope that everyone’s as excited as we are. “

End meeting 13:31

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