NorthWest Biotherapeutics Inc (NWBO)

[IkeEsq]

Northwest Biotherapeutics, Inc Annual Shareholder Meeting
Tuesday, May 18, 2021
16:30 EDT – Start meeting

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

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

Officers and Directors present: (16:33)
- Linda Powers
- Les Goldman
- Dr. Alton Boynton
- Jerry Jasinowski
- Dr. Navid Malik
- Ambassador Cofer Black
- Dr. Marnix Bosch
- Jean Davis
- David Innes
Also present, Lisa Porter from the transfer agent (Computer Share Trust).

There are 613,953,464 shares represented at the meeting of a total of 842,289,193 issued shares [for a total of 72.89%] and therefore a quorum of shares issued as of the close of business on March 26, 2021.

The three proposals:
1. To elect Jerry Jasinowski to our Board of Directors to serve as Class II Director for a term of three years. Proposal PASSED.
2. Advisory vote to approve executive compensation. Proposal PASSED.
3. Appointment of Cherry Bekaert LLP as independent registered accounting firm for the fiscal years ending December 31, 2021 and 2020. Proposal PASSED.

16:47 – Concluded business and meeting is adjourned.
_______________________________________________________________

The following may contain forward-looking statements.

Linda Powers: "We received a number of questions from various questions from shareholders. Not surprisingly they grouped into several main categories of subject matter about five subject matter categories and one question about ASCO.

"The subject matter categories were: The process for the Phase III trial results; Question about whether we’ll be presenting at ASCO; Questions about the DC-Vax Direct program; Question about a patents; Questions about Sawston; and about Flaskworks.

"We have bundled the questions into these subject-matter categories in order to make it feasible to walk through some informal discussion of them and I will walk through that discussion now. And we appreciate the shareholders sending in these questions."

1. Phase III trial Results

"So first of all is the process for Phase III trial results. We know everyone is very anxious to see the results of the trial. As I think everybody knows, back on October 5th [2020] we outlined the process that we would be going through to get to the stage where the results can be announced. And I want to assure everyone that the Phase III trial and the analysis of the data are the most important topic that everyone in this company is focusing on. It has the full focus and attention of our management and our Board as well. Every resource we have has been and is being brought to bear on it. As we say, ‘it is our number one, number two, and number three priority.’ There’s nothing more important to the company. I’d like to be able to go into the details that we know everybody is craving, and understandably so, but we are in a quiet period now, while the data are being reviewed and analyzed. We’ve explained the process that we’re going through, it’s six stages of various analyses and reviews by various parties. And I can assure everyone that we are committed to completing this full process that we outlined at the outset, back when we did data lock. And we are doing so with great care. To put this in context, this is a fourteen-year long, Phase III trial. It’s really important that the review process be of the highest quality. We really appreciate the patience of our long-term investors. We do understand how hard it is to be patient after all this time. But we do ask that you continue to be patient because we serve you best by moving carefully and thoroughly through all the stages of the process that we’ve outlined. So that’s what we have been doing and we will finish doing. That’s really all I can say at this moment about the Phase III trial process."

2. ASCO

"The next subject that came up relates to ASCO, the big ASCO conference, big annual conference. And I think everybody knows that the ASCO conference will be virtual this year. We plan to be a sponsor and exhibitor again this year, we have been for a good number of years now. Seven or eight or nine, something like that, anyway a good number of years. But it’s come to our attention that rumors and even some claims have been circulating that we would be presenting the Phase III results at ASCO. And that’s simply not the case. It’s not accurate and those rumors and claims are unfounded. And we think it’s very important to clarify this. We’re not presenting the Phase III trial results at ASCO."

3. DC-Vax Direct

"Third subject, DC-Vax Direct. We were quite pleased to receive several questions about our DC-Vax Direct technology. And about whether we plan to do anything further with that. The short answer is ‘Definitely, Absolutely, Yes.’ We certainly do plan to. At present, as I just explained a few minutes ago, our whole intense focus is on DC-Vax L and the Phase III trial results, as you would want it to be. But it’s worth remembering that the extended survival results that we saw in the Phase I trial with DC-Vax Direct, which if you remember was thirteen different types of advanced, solid-tumor, inoperable cancers in that trial. And those extended-survival results in that trial were quite encouraging. We reported those, that information at ASCO several years ago. So, we’ve been mentioning in our quarterly and annual reports, we do plan to proceed with Phase II trials with DC-Vax Direct after the Phase III results, the process of getting to the Phase III results is completed and as soon as time and resources permit. ‘Cause as I just said, first the focus is DC-Vax L. But there is a tremendous need for new treatments and approaches for inoperable metastatic cancers. There’s so many treatments in development for cancer but there’s so little for patients who are at that kind of a stage of advanced, inoperable cancer. Definitely ‘yes’ we will be reactivating the DC-Vax Direct program."

4. Patents

"Next question was about patents. We received a question and we are pleased to report that ‘yes we did receive a new patent’ relating to our DC-Vax Direct process that’s recently been approved in the US. What’s very nice is the US was the first country to approve it. So we’re excited about that. That patent covers certain aspects of optimizing DC-Vax Direct, the DC-Vax Direct product for enhanced potency. That’s what that’s about. So the answer is ‘yes we did receive that patent, it was approved in the US.’"

5. Sawston

"The next category of subject matter that was asked about was the Sawston, UK facility. I think probably a number of the questions came before our announcement, our press release last week which was on this subject. And I hope everybody had a chance to see our press release last week. Because it was announcing that a quite important milestone was reached. The milestone was the completion and the submission to the UK regulatory authority, the FDA of the UK, of the whole application package for the initial licensing of the Sawston facility. I think everyone knows, but just to provide the background, all facilities that produce medical products for human patients are required to be licensed by the regulator in that country. Every facility has to go through this. And the application that was submitted and that we announced last week as we said in the announcement, was the culmination of more than two years of work by a large team and a whole lot of expert consultants. So that was a quite important step, a quite important milestone. Looking ahead, looking forward, we are hopeful that the process, the next steps are for the regulatory authority to make an on-site inspection, in person of the facility. There’s some lead-time for scheduling that, there’s some time involved in the regulatory authority writing up the results after the inspection and if there is anything to address then having that be addressed. So we are hopeful that that process those steps will proceed quickly over the coming months. And we hope to have the initial license for the Sawston facility by around the end of the third quarter this year. Something in that time frame. Once we have the initial license, then we expect to begin producing vaccine products for our existing programs as we’ve been doing at the small facility in London that we’ve been using up ‘til now. So that’s the update on the Sawston facility and the discussion related to the questions we got on that."

6. Flaskworks

"Our last subject for discussion today relates to questions we received about Flaskworks. As we have described in various announcements and filings, we believe the Flaskworks system has the potential to significantly enhance our product economics and our production capacity. So at present, DC-Vax products, like other immune cell therapies, CAR-Ts, cell therapies, and others, NK, CAR-NKs, all these immune cell therapies, they’re made in extremely costly, specialized facilities that are called GMP facilities, which stands for Good Manufacturing Practice, and they’re made by hand by specialized technicians. The GMP facilities require all sorts of specialized infrastructure, all of the air has to be sterile, goes through so many air changes per minute, per hour the technicians who work there have to wear space suits. It’s very expensive to develop these facilities in the first place and to operate them on an ongoing basis. The Flaskworks system is designed to make two fundamental improvements. First of all, it closes the manufacturing process, which means that the steps of the process take place inside machines and since they’re not exposed to the air, there’s not a need for sterile air, the space suits, and all that special infrastructure. So that takes a whole lot of cost, a huge cost out of the equation for the product cost of the DC-Vax products, or it is anticipated that it will, it should. Second, the Flaskworks system automates the steps so that the machines are doing it so it is not being done by hand by specialized technicians. This is really important to enable scale-up to large production quantities for large numbers of patients. So that’s a little recap of, you know we’ve had some questions about what the Flaskworks system will do, how will it benefit us and I think those are very significant benefits. So in terms of progress or status, the Flaskworks teams has been working intensively toward some key milestones, which we built into the acquisition agreement last year when we acquired Flaskworks. And the initial focus of the milestones is on applying the Flaskworks system to the production of DC-Vax L products. So, once again, that’s a reflection of that’s and a part of our company-wide priority focus on the DC-Vax L program for the time being. As we announced last week, we anticipate that the initial practice runs with the Flaskworks system for the DC-Vax L product may begin at the Sawston facility during this summer. And what’ll happen after that is that after sufficient practice runs have been done and any optimization work has been completed, then the Flaskworks system will go through a similar validation process and regulatory process as what our existing manufacturing is currently going through. So it will be the same type of process, that was another question that we got."

Conclusion

"That brings me in conclusion to the end of our subject grouping categories for informal discussion today. I hope this discussion has been interesting and helpful. I will say on behalf of the whole Northwest Bio team, we’d really like to express again our appreciation for everyone’s patience and understanding and I’ll just conclude by assuring everyone again that we will continue to press forward to complete the six-stage process of . . . or multi-stage process that we originally outlined that the Phase III trial results need to go through to be reviewed and analyzed in a high-quality process. So I’d like to thank everyone for attending and wish everyone a nice day and that brings our meeting to an end."

End of meeting: 17:04

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