NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

bought additional 28k shares at $0.84. Btw, can vote those missing shares with brokers.
 
Northwest bio will announce the news tomorrow with more details. Yet today we had just one hour of trading after retail investors dug out this commercial manufacturing approval by UK MHRA. In a drug/biological approval process, my decades of experience in biotech tells me manufacturing approval is normally the last step before approval, but in the case of NWBO, no BLA has yet been announced. Once again, it seems NWBO is indeed not a normal biotech company, It follows its own rules to do business.

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It turned out the issuance is a renewal of the previous issued authorization, but inspections of the facility required for that were performed at the same time for both the renewal and the commercial MIA authorization.
 
I have shown examples that MIA(IMP) for investigational purpose and MIA for commercial manufacturing can be issued on the same day or day or days apart. So it's highly likely we may have MIA commercial manufacturing authorization issued within days!

More examples

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Short interests have steadily increased since "top line" data presentationon 5 October at NYSA, the day price crashed from $2 to as low as $0.30s. At least it goes with the general market trend but humans (investors to be exact) should exercise some independent thinking and have a solid base to do thing not just the base of the general market trend). It's fascinating there is always two distinct takings on the same thing. And I believe these short interests are just the tip of the iceberg if the naked short interests are considered.

It's dangerous for those who short a biotech stock with solid data as backing, and with upcoming material events. Nonetheless, if some of the shorts are associated with BigPs or competitors then let it be because they short the stock not for making profit from the stock.

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最后编辑:
For reference purpose, it's informative:

Bio99/BIO9999’s analysis of potential $NWBO partners​

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Much has been said about potential $NWBO partners or acquirers. I decided to determine for myself their likelihoods using data comparisons. I made a list of the largest public pharmaceutical companies in the world. I identified those with approved and clinical development-stage checkpoint inhibitors and related molecules like CSF1R inhibitors (sometimes through a partner; note that I count a total of 61 such molecules), as this is the class of treatments that will most likely have the strongest synergism with DCVax and therefore be the most attractive. The Big Pharma I decided to focus on based on this data are Merck (MRK), Johnson & Johnson (JNJ), AstraZeneca (AZN), Roche (RHHBY), Pfizer (PFE), Bristol-Myers Squibb (BMY), Novartis (NVS), AmGen (AMGN), Eli Lilly (LLY), Gilead (GILD), and Glaxo-Smithkline (GSK). I then counted only those companies that have annualized revenues from oncology treatments of > $4 billion (which I calculated using their latest quarterly earnings reports—sometimes requiring adding up their list of broken down oncology drug sales), as these are companies that are heavily vested in and vulnerable to changes in oncology income. This removed Gilead and Glaxo-Smithkline. I then looked at the degree to which these companies are digesting acquisitions in the past two years by dividing the cash they have currently on hand with the cost of acquisitions the companies have made in 2021 and 2022. My purpose here is to eliminate those that have recently bought too much for their size. I removed Amgen in this way. I next looked at their free cash levels relative to their market capitalization and eliminated the one without much cash on hand (Eli Lilly). Ultimately, I believe that the remaining eight companies are potentially in serious negotiations with $NWBO and are: MRK, JNJ, AZN, RHHBY, PFE, BMY, NVS, and GSK. I think that Pfizer and Merck are likely the strongest suitors. Interestingly, as seen in the below comments from Pfizer and Merck in their most recent earnings call transcripts relating to acquisitions, that Pfizer was specifically asked in its earnings call if they were or should be considering an oncology acquisition, with the area of personalized cancer vaccines recommended…. Even despite the $26 billion of acquisitions that they’ve made the past two years, Pfizer still has the most cash ($36 billion), which is a pile growing faster than the others too. It also has the most checkpoint inhibitors and related drugs in clinical trials, and so it’s very likely going to be one of the early partners.
Lastly, see the chart that I’ve made with some of the information I’ve collected from various sources. Note that the underlying data may not be 100% accurate and is always going to be a work in progress, but it has led to many recognitions on my part.

r/NWBO - Bio99/BIO9999’s analysis of potential $NWBO partners
Pfizer (Q3 2022 Pfizer Earnings Call):
Aamir Malik, Executive VP & Chief Business Innovation Officer: “The BD priorities remain consistent with what we've articulated before. And principally, we are most excited about scientific substrate that has the potential for patient breakthroughs. That's going to continue to be our north star. We're looking for deals that accelerate our top line growth in the back half of the decade. And importantly, we're focused on opportunities where we can add substantial value, and that can come in the form of either shaping the science or also accelerating our commercial momentum. And if you look at the deals that we announced and closed in 2022, including Arena, Biohaven, ReViral and GBT, they would all be very consistent with those priorities. We've said that we are agnostic to size of transaction. But you've also heard us be very clear about the fact that cost synergy-driven deals is not where our focus is going to be. We're going to be focused on driving growth through our BD.”
Evan David Seigerman, BMO: “On BD, I want to be brief here. But can you talk about what other therapeutic areas you might want to explore? I know you're in neurology with Biohaven, nonmalignant hematology with GBT and, of course, inflammation. Would you consider adding oncology? ... I mean this personalized cancer vaccine is an area that you would explore.”
Aamir Malik, Executive VP & Chief Business Innovation Officer: “As far as our therapeutic areas of focus, as I mentioned before in our priorities, our focus is on where we can make a difference and shape the science. And the good news is we actually have distinctive capabilities across many different therapeutic areas. So you've seen us active in internal medicine, anti-infectives, I&I and, certainly, oncology. And our focus is going to be on where we have breakthrough science and the potential to shape it. And we feel very good about the breadth of our scientific capabilities to give us lots of flexibility to work in different TAs.”
Merck (Q3 2022 Merck Earnings call):
Robert M. Davis, President and CEO: “But just for the BD landscape, we continue to, frankly, see a portfolio of opportunities we are interested in and are continuing to look at. So as we sit here today, our focus, our urgency on business development has not changed. We do see a list of potential places to play. Obviously, we got to bring them through to fruition which we’re working to do. That is our priority because we continue to believe the best thing we can do for long-term value creation is to invest in the sustainability of our business, which is investing in the pipeline of the future in both what we do internally and through BD. So that’s our priority. And I do see opportunities. But obviously, we remain committed also to not hold cash.”

PS: I should have included analysis of Abbvie (ABBV). It is a big pharma with significant oncology sales, a lot of cash and probably in need of a good cancer deal. I will include it if I decide to update this article completely.
 

In "20 of the best good news stories from 2022" from the Weekly, No: 17 is talking about NWBO's trial​

www.theweek.co.uk

20 of the best good news stories from 2022

From the development of GM soya beans to a surge in greenfinch sightings, there were plenty of things to smile about in 2022
www.theweek.co.uk www.theweek.co.uk

17
November
Close-up of a CT scan on the brain

Patients’ white blood cells can be taught to attack tumours
Zoonar GmbH/Alamy Stock Photo

A brain cancer breakthrough​

A brain cancer breakthrough
A vaccine to treat brain cancer tumours was found to have “astonishing” results in a phase-three trial. People with glioblastoma, the most common form of brain cancer, live on average only 12 to 18 months after diagnosis. But in the trial, 13% of the newly diagnosed patients who had the vaccine were still alive after five years and, on average, they lived for 19 months. By contrast, only 5.7% of the patients in a control group were alive five years after diagnosis; and on average, these patients lived for 16.5 months, according to the report in the Journal of the American Medical Association Oncology. A form of immunotherapy, the treatment works by teaching the patients’ white blood cells to recognise tumours and attack them – “almost like training a sniffer dog”, said trial investigator Professor Keyoumars Ashkan.
 
Annual shareholders meeting will take place this afternoon. So far no earth-shattering news have announced which is as expected while traders exited and corrupted MMs played fiddle. Below are two pieces of information noteworthy for today:


 
Courtesy of beartrap12


Friday, December 30, 2022 5:11:53 PM


Positives from ASM meeting:

1) “Our intention is to file as soon as we can” for product approval. Linda says completing an application for approval can take up to a year. “We have teams of specialized consultants for the different portions of the package…and they’ve been working on portions of it all year long…..we have come a long way already.” “We also plan to be strategic in filing in multiple places.”

2) They are working on scale up, including bottlenecks that might occur when they scale up. Flaskworks is prominent in Linda’s discussion of scale up.

About flaskworks: “we tested multiple versions of the system” (high flow profusion of the culture, low flow, static) to reach specifications about the yield ..to prove that the product that comes out is fundamentally equivalent to the same product that comes out of our manual manufacturing... There are teams working in tandem at Sawston and at Flaskworks in Boston.

3) they currently have cryostorage capacity for 3 million doses.

4) Uplisting is something they are continuing to examine, specifically an uplisting WITHOUT doing a reverse split.

5) about US publicity: “We are currently in discussions about some US media coverage , they are not finalized yet, but we think they are encouraging.. “. They’ve see. An uptick in interest.

6) commercial manufacturing license. Regulator conducted the inspection in October. “They’ve been going back and forth on the post inspection steps with regulator and we are hopeful that the commercial manufacturing license will be getting approved in the not too distant future. ….Post inspection steps are far along.”

7) company plans to pursue combo trials after submitting application for approval. As soon as we’ve got the application for approval submitted we’re very eager to proceed with these combos. We’ll be looking for the terms to be favorable for us. We did walk away from a combo trial that was not favorable…we received very little.” Besides brain tumors, Linda said they were “eager to be able to apply DCVax out to other tumors, as well. Talking about where we go from here, that’s where we go.”

8)They are talking to CRL about manufacturing I. US. Also Memphis and Sawston labs are being set up to back each other up. Sawston will be able to make product for US when it receives its commercial license.
 
Attended ASM yesterday. Courtesy of Sentiment_Stocks below you will find transcripts of the meeting. For those of you who are interested and have the patience of a year starting from today, i.e., about 1/7 of mine (I have invested more than 6 years as of today), it may be the time to start a position or accumulate to the numbers of shares you desire for substantial multiple-fold future gains.

Saturday, December 31, 2022 3:39:17 PM

2022 ASM Transcript : Northwest Biotherapeutics, Inc. - Shareholder/Analyst Call

12/30/2022 | 06:30pm

Transcript taken from the market screener link. I wanted to get in onto a post here that I can link to in the intro section in case the market screener link gets taken down at some point in the future.
Transcript : Northwest Biotherapeutics, Inc. - Shareholder/Analyst Call | MarketScreener

YouTube Link


Presenter Speech
Linda Powers (Executives)
So good afternoon, everybody. Thank you so much for coming to our Annual Meeting of Stockholders of Northwest Biotherapeutics. It's 1:30 p.m. East Coast Time, and the meeting is called to order, and the polls are now open. Our agenda for this year's annual meeting will be as follows. First, I'll introduce the company's directors and officers.

Our annual meeting -- then we'll introduce the 6 proposals that stockholders are being asked to vote on. Following that introduction, we'll discuss the proposals and open and close the polls. After the closing of the polls, we will provide the stockholders with a report of the election results.

Following the completion of the stockholder voting procedures, we will have an informal discussion of questions that have been submitted by shareholders. Following the Q&A discussion, we'll adjourn and close the annual meeting. At this time, I'll start the formal business of this meeting by introducing the directors and officers in attendance, along with several of our senior managers.

So I'm Linda Powers, the Chairman of the Board, the President and Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer, and it's my pleasure to welcome you here today. I will preside as Chair of today's meeting. Also joining me is Mr. Les Goldman on my right, who serves as our Senior Vice President and our General Counsel. I think everybody knows Les.

I have asked Dr. Al Boynton, the Chief Scientific Officer; and the Secretary of the company to serve as the Secretary of the meeting. So altogether, the directors, officers and senior managers present today include Dr. Boynton, who's on the electronic link, the audio link, the phone link. Mr. Jerry Jasinowski, to my right, at the end of the table there, who is one of our directors, Dr. Navid Malik, who is on the link as well from Europe.

And Ambassador Cofer Black, who's on my left. He's also a director. I've already introduced Les. We also have on the link Dr. Marnix Bosch, our Chief Technical Officer, who's also based in Europe. And we have Mr. Dave Ines, the Director of Investor Relations. I'm sure you all know Dave as well as all of you know Les.

So also joining us in the meeting today is Ms. [ Lisa Brenten ] of Computershare Trust Company, the company's transfer agent. So let's turn to our formal agenda. As set forth in the corporate governance documents, the only matters to be discussed and acted on by the shareholders and the formal voting portion of the meeting today are set forth in the proxy statement. This meeting is held pursuant to the Notice of Annual Meeting of Stockholders, which was mailed to you along with both a copy and a notice of Internet availability of the proxy statement.

And an annual report on Form 10-K for the fiscal year ended December 31, 2021. This mailing was sent on or about December 5, 2022 to the stockholders of record of the company at the close of business on October 31, 2022. Is there a motion to order the notice of meeting filed with the records of this meeting.

Presenter Speech
Unknown Executive (Executives)
I move that the notice of meeting be filed with the minutes of this meeting.

Presenter Speech
Jerome Jasinowski (Executives)
And I will second that motion.

Presenter Speech
Linda Powers (Executives)
There being no objection, the notice of meeting is ordered filed with the minutes of this meeting. Will the Secretary present the affidavit of mailing of the notice of the meeting.

Presenter Speech
Alton Boynton (Executives)
And these are the affidavits of mailing and they indicate that a copy of the notice was duly mailed to each stockholder of record on or about December 5, 2022.

Presenter Speech
Linda Powers (Executives)
Okay. The Secretary is directed to file the affidavits with the minutes of this meeting. Will the Secretary report on how many stockholders are present online or by proxy.

Presenter Speech
Alton Boynton (Executives)
There are now present the holders of 837,129,834 shares of the common stock and Series C preferred shares online and by proxy, out of a total of 1,076,901,470 shares of common and preferred stock issued and
outstanding as of the record date. This constitutes more than a majority of shares of the company's common and Series C preferred stock issued and outstanding and entitled to vote at this meeting and there is, therefore, a quorum present.

Presenter Speech
Linda Powers (Executives)
Dr. Boynton, will you please present a certified list of stockholders of the company?

I will now entertain a motion to dispense with the calling of the roll.

Presenter Speech
Jerome Jasinowski (Executives)
I move that the calling of the roll be dispensed with.

Presenter Speech
Alton Boynton (Executives)
I second that motion.

Presenter Speech
Linda Powers (Executives)
There being no objection, it is ordered that the calling of the roll be dispensed with. Under the power granted to me by the bylaws of the company, I hereby designate Ms. Brenton as Inspector of Election to count the votes presented to the meeting online or by proxy. I have requested the Inspector of Election to submit her oath as inspector, and I direct the Secretary to attach the same to the minutes of the meeting.

Copies of the 2021 annual report to stockholders have already been sent to all stockholders, and I therefore ask for a motion to dispense with the reading of the annual report and to order it accepted and filed.

Presenter Speech
Jerome Jasinowski (Executives)
I move that the reading of the annual part be dispensed with and that the annual report be accepted and filed with the minutes of this meeting.

Presenter Speech
Alton Boynton (Executives)
I second the motion.

Presenter Speech
Linda Powers (Executives)
There being no objection, it is ordered that the reading of the annual report be waived and that the annual report be accepted and filed with the minutes of this meeting. Ms. Brenton, on the behalf of Computershare
has been appointed as Inspector of Election and will ascertain the number of shares outstanding and the voting power of each will determine the shares represented at the meeting and the validity of the proxies and
ballots and will count all votes and determine the results of the voting.

Most stockholders have already voted by proxy, and your proxy votes have been tallied. Registered stockholders may vote during the meeting pursuant to the instructions provided by Computershare on the Annual Meeting website. Beneficial stockholders whose shares are held through an intermediary are not able to vote at the annual meeting.

They were required to vote pursuant to the 2 voting options provided in the notice of the annual meeting and in the proxy statement. The first voting option was to vote prior to the meeting through their bank, broker or proxy solicitor; the second voting option was to fill out the voter information form included in the proxy materials and submit the form to Broadridge, receive a legal proxy from Broadridge and submit the proxy to Computershare before 6:00 p.m. on December 27.

I have received Ms. Brenton's written oath of office as inspector of election. Secretary will file this with the minutes of the meeting. Ms. Brenton has a list of stockholders entitled to vote at this meeting. I have also been presented with evidence from Computershare and Broadridge Financial Solutions that Notice of this Meeting was properly given to all stockholders of record as of the close of business on October 31, 2022.

Ms. Benton, have you determined whether a quorum is present at the meeting.

Presenter Speech
Unknown Executive (Executives)
I have determined that there are stockholders represented at this meeting online or by proxy, holding shares representing at least the majority of the votes entitled to be cast at this meeting, which is sufficient for a quorum and for transacting the business of this meeting.

Presenter Speech
Linda Powers (Executives)
Thank you. I find that a quorum is present for the purpose of conducting this meeting. Only stockholders of record on our books at the close of business on October 31, 2022, are entitled to vote at this meeting, either
online or by proxy, on all business to come before this meeting. The first item of business today is the election of 2 members to our Board of Directors to serve as Class III directors for a term of 3 years that will last
until the third annual meeting after his or her election, which is expected to be held in 2025 or until his or her successor is elected and duly qualified.

The directors standing for election as nominated by the Board of Directors and as set forth in the proxy statement are myself, Linda Powers; and Dr. Navid Malik. The Board unanimously recommends a vote for the Class III director nominees. There were no director nominations by stockholders submitted prior to the meeting in accordance with the bylaws. Therefore, I declare the nominations closed.

The second item of business is to ratify the appointment of Cherry Bekaert as our independent registered public accounting firm for the fiscal year ending December 31, 2022. The Board unanimously recommends a vote for this proposal. The third proposal is to ratify the same stock option awards that were made to the company's executive officers in 2020 and for which the shareholders already voted in favor in an advisory vote by stockholders at last year's 2021 Annual Meeting.

The Board unanimously recommends a vote for this proposal. The fourth proposal is to approve on an advisory basis, the company's executive compensation. The Board unanimously recommends a vote for this proposal. The fifth proposal is to approve the previously reported option awards made in 2020 to the independent directors of the company's Board of Directors. The Board unanimously recommends a vote for this proposal. The sixth proposal is to approve an amendment to the amended and restated certificate of incorporation as amended to increase our authorized shares of common stock par value $0.001 per share by [ 500 million ] to raise from 1.2 billion to 1.7 billion, and the Board unanimously recommends a vote for this proposal.

This concludes the description of matters to be voted on at this meeting. We will close the polls on all matters shortly. Many stockholders have already submitted their proxies. If you are a registered stockholder and you have not voted or you wish to change your vote, please do so now by executing the voting instructions provided on the annual meeting website.

If you have already voted and do not wish to change your vote, you need not take any further action. We will now collect any votes cast by registered stockholders during the annual meeting. The polls are now closed.

That concludes our formal business and concludes the formal portion of the annual meeting. Ms. Brenton, will you please announce preliminary results of the vote.

Presenter Speech
Unknown Executive (Executives)
The motion for the election of Ms. Linda Powers and Dr. Navid Malik as Class III directors, majority of the votes cast at this meeting voted for the reelection of Ms. Linda Powers and Dr. Navid Malik as Class III directors. On the motion to ratify the appointment of Cherry Bekaert LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2022, majority of the votes cast at this meeting voted in favor of the ratification of Cherry Bekaert, LLP.

On the motion to ratify the same stock option awards that were made to the company's executive officers in 2020 and for which the stockholders already voted in favor and an advisory vote by stockholders at last year's 2021 Annual Meeting, a majority of the votes cast at this meeting voted in favor of this proposal. On the motion to approve on an advisory basis, the company's executive compensation, majority of the votes cast at this meeting voted in favor of the company's executive compensation.

On the motion to approve the previously reported option awards made in 2020 to the independent directors on the company's Board of Directors, majority of the votes cast at this meeting voted in favor of the option awards to independent directors on the company's Board of Directors. On the motion to approve an amendment to the amended and restated certificate of incorporation as amended to increase our authorized shares of common stock par value $0.001 per share by 500 million from 1.2 billion to 1.7 billion, a majority of all outstanding shares entitled to vote at the meeting voted in favor of this proposal and also a majority of the outstanding shares of the common stock at the annual meeting, voting as a separate class voted in favor of this proposal to increase our authorized shares by 500 million from 1.2 billion to 1.7 billion shares.

Presenter Speech
Linda Powers (Executives)
Thank you. I declare first that the proposed Class III directors have been duly elected. Second, that the appointment of Cherry Bekaert as the company's independent registered public accounting firm for the fiscal year ending at year-end 2022 has been duly ratified. Third, the proposal that the same stock option awards that were made to the company's executive officers in 2020 and for which the stockholders already voted in favor in an advisory vote by stockholders at last year's 2021 Annual Meeting has been duly ratified.

Fourthly, the proposal to approve on an advisory basis, the company's executive compensation has been duly approved. Fifth, the proposal to approve the previously reported option awards made in 2020 to the independent directors of the company of the Board of Directors has been duly approved. And sixth, the motion to approve an amendment to the amended and restated certificate of incorporation as amended to increase our authorized shares from -- of common stock par value $0.001 per share by 500 million shares from 1.2 billion to 1.7 billion has been duly ratified or approved.

I hereby direct the results of the voting to be incorporated into the minutes of this meeting. That concludes the technical requirements of our meeting. Having concluded the formal business of the meeting, we have no other business that was properly brought before the Annual Meeting of Stockholders. Within 4 business days, we will provide the final voting results on a Form 8-K filed with the Securities and Exchange Commission.

I would now like to take this opportunity for a informal discussion of questions submitted by stockholders in advance of our meeting.

I want to start by making clear that we may make forward-looking statements during this discussion, and our actual results may differ materially from these forward-looking statements. You should not rely upon forward-looking statements, and you should read Northwest Bio's periodic filings with the U.S. Securities and Exchange Commission, including for a non-exhaustive list of risk factors related to our business and operations that could cause actual results to differ materially from any forward-looking statements provided in the discussion during this meeting.

And so I will turn to that now.

Okay. I'll be a little more informal now. So the information that I'm about to share in this informal discussion is available publicly through the audio link that we provided. Questions were submitted to the company by various shareholders. The questions were reviewed, a list was compiled taking into account the limited time we have at this meeting to try to cover key topics.

Answer
Linda Powers (Executives)
So let me start with a few words about 2022. We believe this has been a really exciting year. We believe this has been our strongest year yet in operational terms. I think everybody is familiar with what we consider the 3 biggest achievements. First, we reported what we believe are really great results from our Phase III trial. Secondly, we had our manuscript published in JAMA Oncology, which is a top, highly respected, peer-reviewed scientific journal. And third, we commenced a major lawsuit to begin fighting back against what we believe has been manipulation of our stock. So [those] as our 3 biggest achievements this year.

I would also say that in addition to those things, we have had a very busy year on and made important progress on a number of other things. some of these other things we've made announcements about as the year has gone on. And as [sawston that i'll] touch on in a minute and others we're still working on and have not yet made announcements, and I'll touch on a little bit about the behind the scenes for that's going on as well in our discussion here.

So as you may remember, we got the first licenses for the manufacturing facility in Sawston in December of last year, and the actual manufacture of DCVax products began in February. So that was a major milestone that was very important in our view. As you know, I think we submitted the full -- the application for the commercial manufacturing license. That whole package was submitted in June of this year, and that was the culmination of several years of work.

And we've had already the inspection take place in October by MHRA, the U.K. regulator. Additionally, we've had ongoing development of the Sawston facility, which is a major asset of the company. We completed the Phase Ia construction and development, Phase Ib is well underway right now and has been for months.

As you know also that we announced, we developed over the course of many months, as these things always take, the so-called pediatric investigation plan, a PIP. This is a legally required prerequisite whenever a part of sponsor develops a medicine for adult patients. In Europe, you're required to develop a plan for clinical trials and potentially making the same product, same treatment available for pediatric patients.

And that were culminated in our submission in February. We interacted with the regulator over the ensuing months and final approval came in August of this year and on a favorable basis. So those are just some of the things that have been going on that we have made announcements about, and I think people are aware of and have made for a busy and very productive year.

But I want to emphasize that we are acutely aware that a lot of the work that we do goes on behind the scenes and that it's not visible to shareholders while we're doing it. And we realized that months go by, and we don't have necessarily visibility on everything we're working on, and we do understand that, that can be really frustrating, especially if folks are not as familiar with biotech time lines, which are always longer than one would like.

So thinking about the progress this year in addition to being aware that you guys don't always get to see what we're working on behind the scenes, we're also acutely aware that the stock price has not yet reflected all of the operational progress that we think has been so important and so substantial. We know that's a great frustration as well. We do believe that at least part of that has to do with the attacks and what we believe have been manipulation of our stock.

And we have, as I mentioned, we've begun taking steps to address that. We also believe that as we continue to make strong operational progress, and I'm going to describe a little bit about in the Q&A questions that follow, we think that will also help that. So that as background. Okay.

So the questions that we compiled hopefully will cover a lot of what everybody's questions are, we think they do. The first question, key question is, okay, we've had a really exciting, really strong 2022 Where do we go from here, what's next? What's the plan? What are the next steps, right? And are there any specific time lines?

In talking about the answer to that question, first and foremost, where we go is we continue working very intensively on preparing the applications for product approval. That is our top priority, our laser focus and we are working. Our aim is to file as soon as we can. I want to give you a little bit of a flavor, it's an enormous undertaking.

Putting together after a trial finishes, and even after data lock and even after analysis by the independent statistician after data lock, putting together the application package for an application for product approval is an enormous undertaking. It doesn't happen in a time frame of weeks, and it doesn't even necessarily happen in a time frame of months.

It can take an entire year to put an application together. And before everybody gets worried, we've been working on portions of it all year long. We have teams of specialized consultants for the different portions of the application package. Sometimes it feels like armies of consultants. And we're very fortunate to have really terrific consultants, and we've been working on portions of it, as I said, all year long.

In our case, putting the application package together has some special challenges by virtue of the fact that our product is a fully personalized product, as you all know. It's not a standardized product. That means, for example, the ingredients that go into it, each patient's immune cells, each patient's tumor tissue sample has a lot of variability. So we have to deal with those kind of aspects, which if we were making [big] batches of small molecule chemical drugs where the pills are all the same, we wouldn't have those aspects to deal with, okay?

So we have some special aspects to deal with in putting our application together. We also don't have a lot of precedents to follow. There's only been one other dendritic cell product that's reached approval. There are T cell products, and they have some similarities, but they have some meaningful differences. So a lot of what we're doing is pioneering and we're figuring out as we put it together, what will it take to make the case convincing to regulators.

As I said, we've been working on portions of this all year long. We still have a ways to go in putting the application package together but we have come a long way already. So what I think one of the things I wanted to do is give you guys a little bit of glimpse of what are some of the things when I described that we're working on this as we go along.

And I'm going to go into a bit of detail on these examples in this first question. just to try to give a bit of a sense of, again, what the work is going on behind the scenes. We won't have time to go into this kind of detail in all the answers to all the questions. But I think, hopefully, this will be useful for folks.

One example is just the sheer scale of documentation and data involved in putting one of these application packages together. This includes documents that go into the application package and also includes documents that have to be ready and available to support the application package and to be inspected by regulators or multiple regulators.

So there's a trial master file. And there are case report forms that contain the patient data. There are batch manufacturing records from each individual product that's been manufactured. Overall, the documents could be in the range of 1 million pages. And these pages have to be gone through by humans and they have to be checked and checked for any gaps, inconsistencies, anything so that this body of documents, some of which will go in the application package and some of which will be supportive and have to be inspection-ready, all have to be up to snuff and pass muster with inspection by regulators.

[It's] just a paper. That's just the documents, okay? I want to give another example also still on the document subject and then I will give the different, another example. So one of the portions of work that we've been working on has been getting the trial master file in shape. And we're working with the contract research organization, the CRO and the specialized consultants who are working with us on the application package.

And we have very strict procedures. No one from Northwest is able to touch anything. You remember that as we went through the clinical trial, all of the data was collected by the independent CRO and was held by an independent database party and was delivered directly to the independent statisticians who crunched the numbers [did the] survival curves, calculated the hazard ratios and all that and gave the results to us.

So all of these attacks that you're seeing about [indiscernible], we don't have the ability to do it. The data was never in our hands. [Similarly] with these documents with the trial master file. No one at Northwest has these we're involved in the process, we're overseeing, but we're scrupulous about all of it being only in the hands of the independent CRO and consultants.

And just the work that we did, for example, from mid-September to the first week of December this fall, while everything else was going on that you already know, we went through a process of scanning and processing close to 0.5 million pages of trial master file, 12,000 to 15,000 pages a day for months. right? That's the scale of what's involved in putting this together.

And so on this front, as on the overall picture that we still have more to do. There's still ways to go on all the document work, but we have come a long way already. Okay, let me switch to a different example of the kind of thing that we're dealing with behind the scenes and that doesn't get embodied in announcement.

We deal more frequently than we like with unexpected issues, unexpected developments. For example, we had a situation earlier this year which we've already been addressing, where one of the key ingredients in making our product, the source, the supplier that we used for that ingredient stopped producing clinical grade [ front ] of that product. It's a supplier who's always been there, was rock solid, served as our suppliers throughout the entire long clinical trial.

So that was an unexpected issue. And just to kind of give a little bit of understanding, when things like that happen, it's not simple and it's not fast to solve it. The ingredients that we use in making our product include things like cytokines, human AB serum and other materials which are themselves considered complex biologic products by regulators. That means that the "same" product supplied by 1 supplier is not necessarily considered equivalent or substitutable by a regulator, if you get that "same product" from another supplier.

So when you have a situation where you lose a supplier unexpectedly, a long-standing one, you have to find a new supplier that is GMP compliant, meaning clinical grade regulatory requirements compliant and you have to obtain samples of their product. You have to test it for its characteristics and capture the data and show that the characteristics of that ingredient are fundamentally the same as the characteristics of the “same ingredient" from the supplier you previously had.

And then even then, you can't just start buying it and using it, then you have to go and conduct an audit of the supplier to audit. They can't just say we're GMP compliant and you can rely on that. You're required to conduct your own audit and make your own assessment that, yes, they are GMP compliant. And you can't just show up on the doorstep of the supplier because every one of their customers has to do this, and they’re constantly scheduling audits and the lead time for getting an audit slot isn't tomorrow.

So the whole process of simply changing from 1 supplier to the next supplier for the same ingredient takes months. okay? And these are -- this is just to give you -- and they're solvable, we do them. We dealt with it.

We found another supplier, although it was challenging because that particular ingredient also had a market situation of worldwide shortage. We're still dealing with supply chain issues on even ordinary things let alone complex biologic products, right?

So these -- I hope that gives you kind of a bit of a flavor of what are we working on when we -- it's been a few months, and we haven't made an announcement. And that's in addition to the fact that when we do make announcements for things, and we mentioned usually in our announcement this is the culmination of a year of work, 2 years of work, 5 months of work. Those are real -- those are important points. That means that all during those 5 months or that year or those multiyears, it wasn't visible what we were working on because it wasn't done yet, and we didn't have something to announce.

And I hope people pay attention to those mentions when we do make announcements of how long it's a culmination of. So that, I think, gives you a bit of flavor of what are we working on as we put the application together. And as I said at the outset, where do we go from here, top priority, laser focused, getting the applications prepared and submitted as soon as we can do.

Now secondly, there's a whole another picture going on while we're working on all of that. And this is work that I would describe as kind of process development and infrastructure development. These are things that we're doing to be ready for scale-up to solve bottlenecks that will otherwise be encountered when we try to scale up. And I'll just give you 3 examples of this.

One is, you're all familiar that we acquired Flaskworks, a couple of years ago in 2020. And the purpose of that acquisition was to acquire the technology, the system that they had developed to close and to ultimately automate most of the steps of the manufacturing process. And we haven't made announcements recently about this, but the entire team is working intensively on that.

I'm happy to say we feel that we've made considerable progress. Again, just to give you a flavor of it, we've tested multiple versions of the system. We've tested versions that had high rate, high flow perfusion of the culture and media. We've tested low flow or slow rate of perfusion. We've tested static cultures, all of which is to reach specifications about the yield of these products made through the automated system.

And because when we're ready, to ask for approval of this manufacturing system from regulators who are going to have to approve to their satisfaction that the product that comes out is fundamentally equivalent to the product that comes out from our manual manufacturing process today. So we've tested a number of versions of the system. We have a test system established at the Sawston facility. So there are teams working in tandem at Sawston and at Flaskworks facilities in Boston, and that is progressing.

So that is one area that is continuing to be worked upon. Another area that we haven't talked about publicly before. We haven't discussed is another aspect of producing these products. It's not just that you manufacture them. You -- after you finish manufacturing, which, as you know, our process is very efficient. It takes 8 days. It's a really good process.

Then you have to do quality control tests and you have to do -- go through a process called product release, product has to be -- only if a product successfully passes all of the quality control tests is it able to be released for use in human patients. The product release step is one thing when you're doing a release on a huge batch of millions of pills that are all the same. But this is a fully personalized product, each patient’s product has to be released individually separately.

Well, if you think about it, that could be a bottleneck for scale up. And not only does the product have to go through the quality control test, the person who's conducting the evaluation for the product release, which is a person who has to have a special certification in order to do it. In the U.K., this person is called a QP, a qualified person [indiscernible]. And it has to be a very specialized certified person to do it. They have to not only review the results of all of the quality control tests, the composition of the product, the purity, the potency, the sterility.

They have to not only do all that, they even have to review things like the readouts from the environmental monitoring centers that were in the clean room suite for the entire 8-day process that the product was made to make sure that the particles in the air, and the air goes through 60 air changes per hour, an entire air change per minute in these clean room suites have to check that the particle count didn't exceed the tolerance limits and that all the GMP requirements were met.

Well, that's a big thing. And it can take as much as 30 hours of a qualified person to release a product. So we started more than 3 years ago, okay, not weeks, not months, we started more than 3 years ago with [Advent ] and working on arrangement to develop ways that the product release process could be automated or at least partially automated. So as to not have a bottleneck on this and be ready for scale up.

And we're not ready to make an announcement yet, but suffice it to say that's been an area of a big amount of work and a big amount of focus. And we haven't talked about it because we weren't at the stage yet to have something completed. But there's a lot of things that we work on behind the scenes that are forward looking of what do we have to be ready for a year from now, 2 years from now, 3 years from now, because with the time lines involved, if we need something 2 years from now, we have to start today.

And this product release system has been more than 3 years already so far. So that's just another example. The last example that I'll just give is infrastructure. As I think you know, the operational model that we plan to use going forward is the same as what we have used during the clinical trial, which is when the product gets manufactured.

And as I think everybody knows, a whole set of doses for a patient gets manufactured in 1 batch, right? That's part of the efficiency. We store those doses on a centralized basis. That's a risk management choice on our part right now. We send the doses when it's time for them to be administered because these are precious, individualized, irreplaceable doses. It's not just like if we send it to a hospital pharmacy and a hospital pharmacy doesn't handle it properly,oh well, we'll send another batch of pills, no.

So we do centralized storage. We have a lot of experience with this now. We did it during the clinical trial. That also means we need to be ready with large-scale capacity. And just as 1 aspect of that, we have to have controlled cryo storage. So we have to have controlled resource capacity for all these doses. Well, we already have existing physically in place now, controlled cryo storage capacity for up to 3 million doses, okay?

So this is, again, something that we've been working on for quite some time. Okay. That was a long discussion of kind of where are we, what are we working on behind the scenes, where do we go next is these applications for approval and not some of kind of what's involved. We don't have massive amounts of time left. So I'm going to go through the other questions more quickly.

But I hope that information has been helpful for you. A closely related question. Question number two, that folks asked us, where are we in regard to the commercial manufacturing license. So we received last year the license from the human tissue authority, which is needed in order to handle human immune cells and human tumor tissue samples. And we received the manufacturing license that allows manufacturing for specials patients compassionate use and clinical trials.

And we've been working ever since or we have been working ever since towards getting the commercial license. As we announced in the press release at the time, the whole big application package was submitted in June of this year, and the regulator reviewed of that documentation and scheduled inspection and conducted the inspection in the first half of October.

We're really grateful that is a very fast time line. The regulators have enormous backlogs. That is a very fast time line, and we're really grateful to the regulator for that. Subsequent to the October inspection and an inspection is quite an experience. It's a couple of inspectors for an entire week checking into everything, all the documents. They shadow the personnel, the technicians as they go through a manufacturing process.

They extended their elbow. They check everything they do. They check every record for every product that has been produced in the last year since we began operations and whether everything has been documented properly.

And so that has all been done. And that has been going back and forth on the post inspection steps with the regulator. And we are hopeful that, and I say hopeful that we -- the commercial license would be getting approved in the not-too-distant future. So that's something you can be looking towards, and we'll certainly make an announcement that will not be behind the scenes. That will be a very happy announcement.

So that's where we are on the commercial manufacturing license, inspection done and post-inspection steps far along. Question number three, kind of more to answer this. What's the approximate timing for filing an application for product approval and what kind of timing might regulators have. We, of course, can't predict it or there's certainly not control the timing of regulators. But as I've said, an application for product approval is our top priority and laser-focused.

We plan to file -- we have to get the commercial license first when I was just talking about. That is a prerequisite before being able to submit the application like the PIP, the pediatric investigation plan was a prerequisite. We had to get that done. So we have to have that. But our time line is to file as soon as we can. And we also plan to be strategic about filing in multiple places.

Question number four, shifting to kind of a little bit different subject matter. There are concerns about minimal press coverage in the U.S. We had a lot of press coverage outside the U.S., minimal press coverage in the U.S. about our trial results and our publication. We certainly share your view that we think we deserve more media and press attention and coverage.

In part, we think that the results need to have a little chance to sink in, as Les would say, a bit of soak time. We also think that the fact that we are on the OTC is a bit of a hindrance. A lot of U.S. media are -- don’t really want to report on things relating to companies that are on the OTC rather than on the exchanges. There's concern about volatility, and there's maybe some general skepticism. So I think that element is a bit of a hindrance.

But I will say that we've already had an uptick in interest that we've received since our publication came out in JAMA Oncology as well as we should, we believe. So we have seen an uptick in interest. We are currently in discussions about some U.S. media coverage and we don't have that definite or finalized yet, but we are in discussions that we think are encouraging.

We also believe that a regulatory approval of our product could dramatically increase the interest in our product. So there's various factors why we think and we share your frustration, and we think that the circumstances already are improving and should continue to improve, we think.

Question #5, any plans to up list the stock to a better exchange? And what would it take to get though? So right now, we -- our plan is to continue reviewing our situation and the market circumstances on an ongoing basis to evaluate when an uplisting could potentially be appropriate and on what choice of market and want methods to meet the market’s requirements.

Some of the factors that we think about in this ongoing analysis include, as I said, market conditions, the status of where we are in our process of seeking a product approval, the potential for institutional coverage after we would -- that could result from an uplisting. Also, of course, the individual market requirements and whether we would be able to do an uplisting without having to do a reverse split.

So we -- this is an ongoing evaluation. We're not there yet, but we are certainly -- we think we're getting closer, and it's something that's very much on our mind. Question #6. Do we anticipate additional trials, which could include combination studies in 2023, especially given the recent release of some early data about the combos, for example, at UCLA and others.

So we've been expressing enthusiasm about combo trials for years, and we are very eager to get underway with combos. One of the things that regulators still require and maybe this will change in the future. But regulators still require before they'll let you develop a combination treatment regimen you have to demonstrate that each element of the combo regimen has value in and of itself, is a reasonable treatment to administer to the patient in and of itself, right?

So this Phase III trial that we've just completed is very important because we believe it's shown great results in terms of both the efficacy and the safety of the product as a monotherapy and now is eminently suitable to build on for combinations. And we said this in our JAMA Oncology paper, if you read the discussion section, we said right in there. We think DCVax-L is suitable for combination with a wide range of treatment agents, types of treatments. You can combine it with checkpoint inhibitors. That's the type that the UCLA folks are doing.

You can combine it with oncolytic viruses, you can combine it with targeted therapies, you target with chemotherapies, you can really both because of what the mechanism of action is of our product and because of the wonderful safety profile. So even if you've looked even in the clinical trials where [ pharma ] has combined 2 checkpoint inhibitors. You got dropout rates, patients dropping out of the trial in the mid-40% due to intolerable toxicity.

One of the great things about DCVax is in terms of adding up the toxicity, DCVax is not going to be problematic in that regard. In fact, it should be very good. So just a little -- a few comments about combo trials.

Some years ago, some of you may remember, we had hoped to embark upon combo trials years ago, and we actually have reached conceptual agreement with several other parties, and we announced this to do -- to proceed with combo trials.

Unfortunately, from a resource standpoint just couldn't do it from a resource standpoint, and we had to just stay focused on getting our lead program to the finish line, right? But now that the Phase III trial is done and as soon as we've got the application for approval cemented, we're very eager to proceed with these combos. I will say we -- again [indiscernible] about the past, we will be looking for the terms to be favorable for Northwest than its shareholders.

We have actually -- we actually walked away from a combo trial that we could have proceeded with before. The terms were quite unfavorable with us supposed to supply everything and receive very little. So we're not going to do that. So anyway, that's our perspective on combo trials. One other thing that wasn't in this question, but just to remind, and we said this in our JAMA Oncology publication also, it's in the discussion section, that we believe from everything that we have seen about the DCVax and how it operates, we believe DCVax can potentially be applicable to a wide range of solid tumors, possibly even virtually all the different types of solid tumors.

We have some experience in compassionate use cases, and we have -- believe that this will be the case. And we're certainly eager to not only do combo trials in regard to the brain cancer that we're already in, we are eager to be able to apply DCVax-L to other cancers as well. So as you think about where do we go from here, that's where do we go in addition to going with the combos.

We are nearly -- we're supposed to be finishing about now 2 more quick final questions of the ones that we're submitted. Please describe manufacturing capabilities in the U.S., what type of lead time is needed for ramp-up in Memphis, et cetera. So we're in current discussions for the resumption of manufacturing in Memphis. Like everything, it's partly an expenditure issue and a timing issue, right? We're in the midst right now of discussions for new contract arrangements for that.

So we have that in our focus. But let me remind you that the facility in the U.K. is expected to provide product for North America as well as Europe. And likewise, when we resume manufacturing in the U.S., the same we anticipate the same would be the case. So there will be redundancies for each other. But each one will have the ability to supply both of the major markets, North America and Europe, okay?

So again, it's a question of the expenditure and the time lines. Last question. Since manuscript publication, attacks on the company have increased several fold. Are there any plans to at least refute some of these and et cetera? Let me tell you, we are acutely aware of all of the attacks. The attacks are just incessant, they're relentless. But we'll say that we find it quite shocking that even doctors associated with companies and that have competing technologies have indulged in attacks that have used fault information, false claims about our trial, how it was conducted, et cetera.

It's pretty shocking that -- I mean, the other companies in this space of each attacked us -- I mean, -- we kind of view the attacks as an indicator that people think we've got something important. If we don't have anything important, why bother, why bother, why try to attack us. But we do find it quite shocking that these parties just want to stop another treatment from getting to patients. These brain cancer patients need another treatment option. They need a lot of more treatment options, the more the better.

And anyway, yes, we're acutely aware of the attacks. We've already taken the first step on dealing with the attacks that we think have come from financial parties with the lawsuit that we filed and the attacks in what we believe to be manipulation there. We are, I would just say, exploring other steps to take to fight back against some of these attacks.

The one thing I would say is, and I know you guys want to see us standing up for ourselves and fighting back, the challenge is every hour that we spend doing that is an hour, we don't spend on all those other works that I just spent a long time describing to you. And it's a real balancing act because the attacks come in from all sides, you guys -- a lot of you guys have done wonderful jobs of outing some of these folks outing attacks by -- even by doctors who have undisclosed connections with competing technologies.

You guys as shareholders have done a wonderful job. It's amazing what you guys find and how fast you [indiscernible]. I have said that I think the [indiscernible] should lay off all their employees and just contact with you guys because you find everything faster than anybody. But in all seriousness, is serious. We try to strike a balance between taking action, but not diverting too many of those precious hours from working on the applications for approval because that's what the attackers want. They want our time, attention and resources to be diverted and taken away from making progress.

So one of the things we are thinking about [indiscernible] how much we may very well ask you guys to. So stay tuned on this space, and we are working on some additional steps is what I'll say. So we're a little past the 2/3 mark. And I hope that, that covered a lot of ground, some broad, some detail. I hope that covered most of the questions folks have. We really appreciate, as I said before we started the meeting, we really appreciate you guys coming to the meeting. I'm so appreciative that you actually went through the airport nightmare to get here and/or drove 18 hours to get here.

And I'll just close by saying, we know you guys have been just tremendously patient. You've been such a strong shareholder base. We wouldn't be here without you. I mean, this company exists because of the retail shareholders. This company is not here because institutional investors -- support from them. The company is here because of you guys, and we're so grateful for your patience. I know it really gets maddening, sometimes it gets frustrating, What are those people working on, at least now you have a little bit of a sense of what are we working on.

And with that, I guess we could move to adjourn. Is there a motion.

Answer
Jerome Jasinowski (Executives)
Madam Chairman, Alton Boynton was to make a motion to adjourn [indiscernible].

Answer
Linda Powers (Executives)
Dr. Boynton, are you still there?
Answer
Alton Boynton (Executives)
I'm here.

Answer
Linda Powers (Executives)
Did you have a motion?

Answer
Alton Boynton (Executives)
I move that the meeting be adjourned.

Answer
Linda Powers (Executives)
is there seconder?

Answer
Jerome Jasinowski (Executives)
Terrific. All right. We are adjourned for 2022. Thank you all so much very.

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最后编辑:
Added 30K more shares today at cost per share of about $0.729. Will buy more tomorrow if price is still this low.

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