NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

hyperopia

Re: None

Thursday, January 05, 2023 11:26:22 AM

Post#
556751
of 556800
Thoughts on the Annual Shareholder Meeting:

While management was careful not to give away any specific information that could potentially be used against them, I think they still gave a candid, general idea of what they’ve been working on, where they are, and what are some of the next steps. There has been some important progress made this past year, but much remains, and I think 2023 will be a very pivotal year for the company, with many years of work finally culminating in the first regulatory approval of DCVax.

Preliminary
It’s clear that the company has the support of the majority of investors, with every item on the proxy passing. (this, despite all the negative postings by the supposed shareholders on this board voting no) By the way, while I voted yes on everything else, I do not support the excessive share grab (~20% of the company) by Linda Powers and others, but it never matters. I would like to reward them for their hard work with a reasonable amount of shares, (5-10% of the company) but we were not given that choice. I’ll be curious to see the actual vote totals.

Sawston
Now we know that Sawston was inspected in the beginning October and Advent is far along in their corrective actions, so I anticipate that the commercial manufacturing license will be granted this month, or possibly next. We also now know that construction on phase 1b (expanding Advent’s production development space, and adding more cleanrooms) has been on-going for months.

Marketing applications
Before the meeting, I posed the question: “has Northwest Bio requested or received any accelerated approval pathways from any regulator?” The Common Technical Documents of the marketing approval application (except parts of the first module) are the same for most jurisdictions, so Northwest Bio could request accelerated approval from each country’s regulator, and file separate applications in each country, or potentially they could have simultaneous review of the application by the different countries if they are participating in the FDA’s Project Orbis. Linda’s language that “we have teams of specialized consultants for the different portions of the application package” is consistent with a rolling review in the UK (which I think is highly likely), but it’s still unclear what route(s) Northwest Bio plans to take, only that they “plan to be strategic about filing in multiple places.”

The timing of the final submission of the marketing application is also uncertain, but it seems they are reasonably close (2-3 months?) per this language; “And so on this front, as on the overall picture that we still have more to do. There's still a ways to go on all the document work, but we have come a long way already.” and “It can take an entire year to put an application together . . . we’ve been working on portions of it, as I said, all year long.”

Flaskworks
I posed this question online, but also asked an acquaintance who was attending the meeting, if he could ask, “Is Flaskworks’ Eden system a part of the commercial license application?” He matter of factly said, “there’s no need to ask, it’s not.” I was a bit surprised, and asked how he “knew” this, and he replied that he has provided capital to the company before, and remains in contact. He didn’t have any specific knowledge exactly where Flaskworks is in the development process, or how long it would take for the comparability process.

The testing of multiple versions of the system with high-flow perfusion, slow-rate perfusion, and static culture, that Linda described, was simply part of the performance qualification process, so not really news to me. Knowing now that the inspection of Sawston didn’t occur in September when Advent was hiring for multiple computer validation, and software/firmware script writing positions, along with Flaskworks hiring of product development engineers whose responsibilities include “Identifying design improvements and integrating technology for monitoring cell culture to ensure reliability” could indicate that Flaskworks was still working on the biosensors, and in-process controls with Advent, and the software data integration with Autolomous’ Manufacturing Execution System that is deployed at Sawston, and required for the commercial process. The language used by Flaskworks, “to ensure reliability” sounds like additional commercial validation work was necessary.

Like everything else Northwest Bio is working on, the commercial development of the Flaskworks’ system has taken longer than I expected. As I’ve said previously, there is a relatively short regulatory process to get it approved for use in the commercial manufacturing process once it can repeatedly and reliably produce a highly similar product, so I’m still optimistic that it will be approved by the same time that DCVax is approved.

So many of us are left to speculate about what’s going on with the company, while others are apparently “in the know.” This can be frustrating, but I understand that it’s common that investment bank analysts have access to management, and have knowledge about the companies they cover, that retail investors don’t.

reality check
Northwest Bio’s technology, their associated scientific advisors, and medical doctors, have always been on par or better than anything from Big Pharma, but this shareholder meeting was another reminder that Northwest Bio is still a tiny company that is under resourced and almost, but not quite, ready for prime time. They are continually behind schedule of where I, and many others, think they should be. There are many examples of this but a couple highlighted during the meeting; the contractor that is now working on all the patient data files that Linda described, could have been tasked and finished with this work over a year ago, rather than still working on them over the past few months. Northwest Bio has a single supplier for a critical manufacturing component, and when that supplier is lost, they must vet another supplier which takes many months, while Big Pharma companies have many suppliers who have been properly vetted, and they can simply switch without causing delays.

Northwest Bio would benefit greatly from the resources that a strategic partner would provide, but are unwilling to make a deal that doesn’t properly value their technology, and they seem willing to wait until they’re better positioned to negotiate more favorable terms. This may not happen until they have received marketing approval, an uplisting on a major stock exchange, and have received the institutional investment support, as well as the proper media exposure, that their treatment warrants. The good news is that it appears that this is finally the year that those important milestones will be reached, and there is a plan to achieve these milestones, possibly without the help from Big Pharma. I know that Linda and Les have access to a significant amount of private capital, but may be waiting to access it until a marketing application has been submitted (and possibly approved) and Northwest Bio is finally ready for commercialization, which may be in conjunction with an uplist. This could gain the institutional support and analyst coverage that would bring the needed major media attention, which could propel Northwest Bio to the next level (and out of the control of the current market manipulators).

Shareholders are clearly not being told everything that the company is planning, and working on, so I do anticipate a few pleasant surprises this year.





ae kusterer

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ae kusterer

Re: None

Sunday, January 01, 2023 1:49:50 PM

Post#
555208
of 556803
SOME ASM SALIENT LP QUOTES , AND AVC INTERPRETATIONS :


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170833690

1) MIA IMMINENT ; NWBO'S FIRST APPROVAL TO BE IN COMMERCIAL BUSINESS.
( MIA implies tacit approval for the MAA , plus NICE reimbursement)

"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."


2) WAS THE SUPPLIER PROBLEM NEFARIOUS ? :

"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 ? "


3) IS THE MAA READY TO FILE ? JUST AWAITING THE MIA ?

"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."


4) HAS FLASKWORKS PASSED ALL COMPARABILITY TESTS ?


"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."

5) JAMA PROVES DC VAX L AS AN FDA APPROVABLE DRUG . DOES THAT MEAN COMBO TRIALS CAN START ?

" 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."


6) THE JAMA PAPER WILL LEAD TO FUNDING FOR 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."

7 ) MANUFACTURING STRATEGY : TWO INTERCHANGEABLE PLANTS . BOTH EMA APPROVED. " 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 ? "


8) LP BELIEVES DC VAX WILL WORK ON ALL SOLID TUMORS . DISPLACEMENT FOR THE $ 300 BILLION CHEMO INDUSTRY ?

"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."

BIBLIOGRAPHY:

Re: None

Saturday, December 31, 2022 3:25:48 PM

Post#
555011
of 555188
ASM(12/30/22) REFLECTIONS:

If NWBO had closed at $1.10 yesterday, the IHUB and Twitter fickled mongol hordes would have been nominating Linda Powers for " ' 22 biotech CEO Of The Year ." . With the stock under pressure , concurrent with the ASM , and down 3.7% on the day, the Bitch and Moan Club piled on with petty grievances , amongst flawed conclusions. What the naysayers and doubters are missing is that by the end of '23, NWBO will have the business assets for which BiG Biotech will be willing to hand over $ 5 to $30 billion in cold hard cash, or AAA rated stock.


What are those assets ? :

1) MHRA and FDA full commercial approval for DC VAX L , by the end of '23.

2) A settled lawsuit for $200-$500 million cash.


3) The commencement of several DC VAX L -checkpoint inhibitor phase 2-3 trials , that could have full commercial approval by the end of ' 25. These trials could validate the recently revealed (LL 12/5/22 and 10/26/22) 6x improvement in survival demonstrated in an early UCLA combo trial , with results showing SOC =10% alive at 2 years versus 60% alive at 2 years with Keytruda and DC VAX L .

4) Patent protection for DC VAX L and combos globally,

5) Two interchangeable plants ( Sawston and Memphis) (with EMA certification ) , each capable of generating $ 2.5 billion ($ 2 billion FCF) within 5 years. What's the value of $4 billion in FCF for Big Biotech? 20x ?

6) DC VAX L is a proprietary cancer immunotherapy platform for all solid tumors. How much of the $300 billion chemotherapy industry will DC VAX L displace in the next 10 years?

7) A pre full commercial approval DC VAX L , MHRA approved , Specials business at Sawston. NWBO has not confirmed production levels. A 12/21/21 NWBO PR indicated capacity at 50 doses per month . At assumed pricing of $200,000 per patient , is this NWBO division currently throwing off $ 80 million in cash flow annually ?


8) Perhaps the best cancer immunotherapy research lab in the world . Lock up patents feed the inventions of this facility to NWBO.


9) A scientific, peer reviewed, publication on the DC VAX L phase 3 trial in a world class medical journal , which in 1.5 months has generated global patient and clinician awareness . Advertising value ???

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847





BIBLIOGRAPHY:


ae kusterer
Re: None
Saturday, December 31, 2022 9:42:01 AM
Post# of 554946 Go
1)You must have been a on a different ASM than me.
First part of question and answers session Linda highlighted the major accomplishments/milestones for 2022
3 biggest achievements:
(1) Really Great results from phase-3.
(2) JAMA peer reviewed journal publishing.
(3) Commenced a major lawsuit to fight back against manipulation of our stock.
In addition to those had a very important year on other things. Some we have announced and some not yet.
* Got the first licenses for Swanson manufacturing.
* Submitted the package for commercial licensing in June. Inspection took place in October.
* Had on going development of Swanson. Completed Phase-1A construction. Phase-1B has been underway for months.
* Pediatric investigation plan submitted in Feb and Aug got final approval. Legally required in Europe.
We are acutely aware that a lot of the work going on behind the scenes that shareholders do not have visibility but can't do a press release until work is completed.
Second half was a deep dive into specific on many of the time consuming work items associated with their laser focus on completing the application and ramping up volume manufacture capabilities and approvals.
Not really sure what you wanted Linda to say about Stupp. She has no control over this sleazy unethical looser attacking NWBO and DCVAX with false accusations and failing to mention other competing companies/products he has association with. Bitching ha . . . you seem to be the one bitching not Linda.
Linda made it clear 2023 is the year.


2)ae kusterer

Re: None

Saturday, December 31, 2022 12:16:29 AM

Post#
554839
of 554921
HOW MANY DOSES BEING PRODUCED PER MONTH AT SAWSTON CURRENTLY ?
"About 10 of us sat around afterward: 1) one guy heard 30 patients per month about a month ago, 2) The presentation said the paper has put demand way up, 3) a week ago somebody said, "they have never been in better financial shape.”., 4) also, “they have a backlog”, 5) 50 per month is $120 million annually. $80 million cash flow? "



3)beartrap12

Re: None

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

Post#
554644
of 554922
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.
2)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.



4)https://www.scribd.com/document/611586726/Northwest-Bio-v-Canaccord-et-al-aka-The-MMs



5)ae kusterer
Re: None
Saturday, December 31, 2022 10:55:13 AM
Post# of 554942 Go
Re: spartex post# 554909

Saturday, December 31, 2022 10:21:42 AM

Post#
554934
of 554938
Great job, Doctors and $$$

Spartex, your assessment of doctors "that are corrupted by $$$ for their sunset cancer treatment protocols like chemo.?
Posted about this problem several months back.
Research indicted the average costs for breast cancer chemo averaged around $1.6 million depending on the cancer severity. Interviewed several Phamaceutical Reps that mentioned some cost factors like ($60,000) for just one shot of a particular chemo drug. So, a typical treatment every three weeks after sixteen treatments ($960,000).
Here was the sad part of the money corrupt issues.

1) The hospitals received on average 30% kick back for the total costs of the chemo.
2) The Oncologist received on average 6% to 8% insensitive compensation for each chemo patient.
3) None of the Oncologist would consider having chemo themselves based on its negative side effects.

These are just a few of the sad issues regard the corruption issues with SOC chemo.
BTW, the standard feedback from these Oncologist regarding the negative side effect from chemo "well at least we cured the cancer", while the patients suffered many negative side effects. On the next cancer patient as the $$$$$ override the patient. No wonder the Oncologist and Phamaceutical people fear NWBO. Sad indeed!

People need to be proactive and do their own DD regarding the issues of chemo and all its so called pos and cons, IMPO.

1 Like


0





6)Sojourner55
Re: jfr1611 post# 554883
Saturday, December 31, 2022 10:06:16 AM
Post# of 554941 Go
I think the MIA licensing will likely be the first positive catalyst to start moving the stock followed by MAA submission. I see the price testing 1.27 high and then work its way to the long term multi-year resistance at 1-50 - 1.70. Breaking out of that is when things start get interesting and could accelerate quite rapidly from there JMO.




Multi-year downtrend at 1.50 - 1.70 with the cup and handle formation complete and also simultaneously breaking out of resistance. That would be a huge buy signal from a technical perspective.


Pedal to the Metal

Charts and comments are provided for interest and discussion for those who share a common passion for trading. This by no means constitute investment/trading advice.Scenarios created are for educational purposes only.



7)Transcript : Northwest Biotherapeutics, Inc. - Shareholder/Analyst Call
12/30/2022 | 01:30pm EST



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 Dr. 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.


© S&P Capital IQ 2022



8)Idunno
Re: spartex post# 554909
Saturday, December 31, 2022 11:31:13 AM
Post# of 554951 Go
Right. And others with financial agendas. It needs to stop. Unconscionable.

Their (docs with $$ agendas) words and actions against “promise and hope” will never disappear. Much like they tell their teenage children, once on-line, it is out there forever. …. They will be forever embarrassed, forever professionally disgraced. It will not go away, their actions.

The bought and paid for “journalist(s)” will be professionally destroyed… by their own actions. If not criminally charged, if. If, right? But, if, then.

The stock manipulators will, fingers crossed, be criminally indicted. Fingers crossed. Laws were broken, it appears. Laws. The law. Maybe they wiggle out with a terrific settlement. Maybe. Gonna be huge, if. They are caught, hands on cookie jar. People are tired of it. Maybe they pay off important people, in some form or fashion. But. People are sick of it. People are watching. We will see.

Their paid social media contacts will be charged, if. Sorry, friends. If you’re part of the criminality, you’re not exempt or immune. Don’t care what your bosses told you. So easily traceable today. What a can of worms, frankly. So many other equities where some are “saving” retail. Too look into…. Not that hard. To figure out. What’s really going on. And who is behind it. ..gov warrants, subpoenas, et al. Worth a look, imo.

The little engine that could is about to reach the top of the hill. Downhill is going to be a different ride. And many will get on the train, imo.

Not financial or legal advice. All, imo. It’s just a message board, coughwirericofraudcough cough fingers crossed right…?

Unconscionable. Enough is enough.





9)Bright Boy

Re: None
Friday, December 30, 2022 3:36:11 PM
Post# of 554954 Go
I thought the presentation was skillfully handled in every instance. LP emphasized the company's main focus of getting approvals, ASAP. She mentioned at great length, the Sawston success, even to the point of saying that "WE expect a manufacturing approval (MIA) very soon and she would never say that if she didn't know it was guaranteed !! And additionally after describing the MAA application as voluminous, close to a million pages, said that it would be filed upon receipt of the MIA. That tells us that it's completed!!! She discussed another "FIRST time ever " and that is an up-list very soon!! Again, for her to say that indicates that it will happen and we're almost there!!!! Further, she mentioned institutional investors following approvals at Sawston along with the up-listing!!! Again, loud and clear, it's a big deal for LP to suggest anything unless she has the license, the up-list and institutional investors "in hand and lined up"!!! So she must have a strong reason to believe that the company will have approvals and up-listing "in hand" very shortly!!!

Gosh, the very mentioned of the current successes in the areas of combo trials should blow the roof off the party!! We already know the clinical trial results from many of the CI's combing with DCVax-L.Merck's Keytruda with DCVax-L resulted in over 50% 8 year survival !!!! Every CI company will want to combine with Northwest!!! Just think of the potential from all those combinations!! AND again, for LP to even mention that, she would have to be convinced that DCVax-L alone and in combination with other treatments will replace SOC becoming the PROMISE and HOPE for all large tumor cancers and others AND IS THE FUTURE OF THE NEW AGE OF HEALTHCARE!!

The lawsuit and the potentials from discovery are virtually limitless, but more importantly, it signals that "Market Oversight" is about to change in support of honest, balanced and fair trading practices protecting the hard working American's IRA's and their investments in general from those unscrupulous trading strategies deployed by the defendants in the lawsuit and many others!!!

Bravo to Linda Powers and Team Northwest for accomplishing the impossible in creating a new world order in treating cancers, patient healthcare, patient advocacy and stamping out those that are driven by greed to deny all those accomplishments in the pursuit of money and privilege!!!

Cheers,

BB

jon_k84
Re: None
Saturday, December 31, 2022 1:59:28 PM
Post# of 554988 Go
Perhaps the best ASM we've ever had:

A lot of the newer guys may not be able to appreciate this, but as a long of 10 years, I remember the days when nothing but "please be patient with us" was said. That was not the case at this ASM. A lot of good info was provided, and I'd encourage everyone to read the transcript.

What I liked most was that the company more or less outlined their game-plan for moving towards commercialization that is independent of a Big Pharma BO or JV. This is absolutely vital to NWBO's success as a company. We cannot simply stick our hand out to big Pharma while crying "please save us." This is a business, and if BP can acquire this technology for 1/10th of our current market cap, they absolutely will. Moving forward with a compelling strategy to bring the drug to market sends the message "make us a real offer because our value / price is going up more by the day."

It's all about the milestones. Everything else (including the day-to-day flux in share price) is background noise. Milestones will drive the price up, and I expect we will hit several in 2023 Q1. There is no way to predict exactly when things will happen, but this is what I expect for 2023:

-MIA approval - Q1
-Regulatory submission - end of Q1 / start of Q2
-Uplisting to NASDAQ late Q2
-Regulatory decisions - late Q2 / early Q3
-Sustainable revenue streams - Q4

A BO, JV, or institutional investment could happen at any time, but after hearing LP at the ASM, I would expect it to be after MIA approval or regulatory submission. Our timeline becomes a lot clearer after those milestones, and I'd expect big Pharma will want to act before the price starts to go out of control.

I think an uplisting will come at a time when the stock price makes sense for them to do so - so probably after one of the above milestones pushes the price higher. I do not see it requiring a RS.

BULLISH

0



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Northwest Biotherapeutics Inc (QB)
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Additional Proxy Soliciting Materials (definitive) (defa14a) • Edgar (US Regulatory) • 12/23/2022 10:24:51 PM
Additional Proxy Soliciting Materials (definitive) (defa14a) • Edgar (US Regulatory) • 12/16/2022 06:40:40 PM
Proxy Statement (definitive) (def 14a) • Edgar (US Regulatory) • 12/05/2022 12:01:37 PM
Northwest Bio Accuses Market Makers of Share Price Manipulation • TipRanks • 12/01/2022 03:29:04 PM
Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) • Edgar (US Regulatory) • 11/25/2022 10:30:31 PM
Quarterly Report (10-q) • Edgar (US Regulatory) • 11/09/2022 09:31:44 PM
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Amended Annual Report (10-k/a) • Edgar (US Regulatory) • 06/30/2022 09:09:33 PM
Quarterly Report (10-q) • Edgar (US Regulatory) • 05/10/2022 10:02:07 AM
Amended Annual Report (10-k/a) • Edgar (US Regulatory) • 05/02/2022 09:05:06 PM
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ae kusterer

Re: None

Saturday, December 31, 2022 3:25:48 PM

Post#
555011
of 556804
ASM(12/30/22) REFLECTIONS:

If NWBO had closed at $1.10 yesterday, the IHUB and Twitter fickled mongol hordes would have been nominating Linda Powers for " ' 22 biotech CEO Of The Year ." . With the stock under pressure , concurrent with the ASM , and down 3.7% on the day, the Bitch and Moan Club piled on with petty grievances , amongst flawed conclusions. What the naysayers and doubters are missing is that by the end of '23, NWBO will have the business assets for which BiG Biotech will be willing to hand over $ 5 to $30 billion in cold hard cash, or AAA rated stock.


What are those assets ? :

1) MHRA and FDA full commercial approval for DC VAX L , by the end of '23.

2) A settled lawsuit for $200-$500 million cash.


3) The commencement of several DC VAX L -checkpoint inhibitor phase 2-3 trials , that could have full commercial approval by the end of ' 25. These trials could validate the recently revealed (LL 12/5/22 and 10/26/22) 6x improvement in survival demonstrated in an early UCLA combo trial , with results showing SOC =10% alive at 2 years versus 60% alive at 2 years with Keytruda and DC VAX L .

4) Patent protection for DC VAX L and combos globally,

5) Two interchangeable plants ( Sawston and Memphis) (with EMA certification ) , each capable of generating $ 2.5 billion ($ 2 billion FCF) within 5 years. What's the value of $4 billion in FCF for Big Biotech? 20x ?

6) DC VAX L is a proprietary cancer immunotherapy platform for all solid tumors. How much of the $300 billion chemotherapy industry will DC VAX L displace in the next 10 years?

7) A pre full commercial approval DC VAX L , MHRA approved , Specials business at Sawston. NWBO has not confirmed production levels. A 12/21/21 NWBO PR indicated capacity at 50 doses per month . At assumed pricing of $200,000 per patient , is this NWBO division currently throwing off $ 80 million in cash flow annually ?


8) Perhaps the best cancer immunotherapy research lab in the world . Lock up patents feed the inventions of this facility to NWBO.


9) A scientific, peer reviewed, publication on the DC VAX L phase 3 trial in a world class medical journal , which in 1.5 months has generated global patient and clinician awareness . Advertising value ???

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847





BIBLIOGRAPHY:


ae kusterer
Re: None
Saturday, December 31, 2022 9:42:01 AM
Post# of 554946 Go
1)You must have been a on a different ASM than me.
First part of question and answers session Linda highlighted the major accomplishments/milestones for 2022
3 biggest achievements:
(1) Really Great results from phase-3.
(2) JAMA peer reviewed journal publishing.
(3) Commenced a major lawsuit to fight back against manipulation of our stock.
In addition to those had a very important year on other things. Some we have announced and some not yet.
* Got the first licenses for Swanson manufacturing.
* Submitted the package for commercial licensing in June. Inspection took place in October.
* Had on going development of Swanson. Completed Phase-1A construction. Phase-1B has been underway for months.
* Pediatric investigation plan submitted in Feb and Aug got final approval. Legally required in Europe.
We are acutely aware that a lot of the work going on behind the scenes that shareholders do not have visibility but can't do a press release until work is completed.
Second half was a deep dive into specific on many of the time consuming work items associated with their laser focus on completing the application and ramping up volume manufacture capabilities and approvals.
Not really sure what you wanted Linda to say about Stupp. She has no control over this sleazy unethical looser attacking NWBO and DCVAX with false accusations and failing to mention other competing companies/products he has association with. Bitching ha . . . you seem to be the one bitching not Linda.
Linda made it clear 2023 is the year.


2)ae kusterer

Re: None

Saturday, December 31, 2022 12:16:29 AM

Post#
554839
of 554921
HOW MANY DOSES BEING PRODUCED PER MONTH AT SAWSTON CURRENTLY ?
"About 10 of us sat around afterward: 1) one guy heard 30 patients per month about a month ago, 2) The presentation said the paper has put demand way up, 3) a week ago somebody said, "they have never been in better financial shape.”., 4) also, “they have a backlog”, 5) 50 per month is $120 million annually. $80 million cash flow? "



3)beartrap12

Re: None

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

Post#
554644
of 554922
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.
2)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.



4)https://www.scribd.com/document/611586726/Northwest-Bio-v-Canaccord-et-al-aka-The-MMs



5)ae kusterer
Re: None
Saturday, December 31, 2022 10:55:13 AM
Post# of 554942 Go
Re: spartex post# 554909

Saturday, December 31, 2022 10:21:42 AM

Post#
554934
of 554938
Great job, Doctors and $$$

Spartex, your assessment of doctors "that are corrupted by $$$ for their sunset cancer treatment protocols like chemo.?
Posted about this problem several months back.
Research indicted the average costs for breast cancer chemo averaged around $1.6 million depending on the cancer severity. Interviewed several Phamaceutical Reps that mentioned some cost factors like ($60,000) for just one shot of a particular chemo drug. So, a typical treatment every three weeks after sixteen treatments ($960,000).
Here was the sad part of the money corrupt issues.

1) The hospitals received on average 30% kick back for the total costs of the chemo.
2) The Oncologist received on average 6% to 8% insensitive compensation for each chemo patient.
3) None of the Oncologist would consider having chemo themselves based on its negative side effects.

These are just a few of the sad issues regard the corruption issues with SOC chemo.
BTW, the standard feedback from these Oncologist regarding the negative side effect from chemo "well at least we cured the cancer", while the patients suffered many negative side effects. On the next cancer patient as the $$$$$ override the patient. No wonder the Oncologist and Phamaceutical people fear NWBO. Sad indeed!

People need to be proactive and do their own DD regarding the issues of chemo and all its so called pos and cons, IMPO.

1 Like


0





6)Sojourner55
Re: jfr1611 post# 554883
Saturday, December 31, 2022 10:06:16 AM
Post# of 554941 Go
I think the MIA licensing will likely be the first positive catalyst to start moving the stock followed by MAA submission. I see the price testing 1.27 high and then work its way to the long term multi-year resistance at 1-50 - 1.70. Breaking out of that is when things start get interesting and could accelerate quite rapidly from there JMO.




Multi-year downtrend at 1.50 - 1.70 with the cup and handle formation complete and also simultaneously breaking out of resistance. That would be a huge buy signal from a technical perspective.


Pedal to the Metal

Charts and comments are provided for interest and discussion for those who share a common passion for trading. This by no means constitute investment/trading advice.Scenarios created are for educational purposes only.



7)Transcript : Northwest Biotherapeutics, Inc. - Shareholder/Analyst Call
12/30/2022 | 01:30pm EST



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 Dr. 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.


© S&P Capital IQ 2022



8)Idunno
Re: spartex post# 554909
Saturday, December 31, 2022 11:31:13 AM
Post# of 554951 Go
Right. And others with financial agendas. It needs to stop. Unconscionable.

Their (docs with $$ agendas) words and actions against “promise and hope” will never disappear. Much like they tell their teenage children, once on-line, it is out there forever. …. They will be forever embarrassed, forever professionally disgraced. It will not go away, their actions.

The bought and paid for “journalist(s)” will be professionally destroyed… by their own actions. If not criminally charged, if. If, right? But, if, then.

The stock manipulators will, fingers crossed, be criminally indicted. Fingers crossed. Laws were broken, it appears. Laws. The law. Maybe they wiggle out with a terrific settlement. Maybe. Gonna be huge, if. They are caught, hands on cookie jar. People are tired of it. Maybe they pay off important people, in some form or fashion. But. People are sick of it. People are watching. We will see.

Their paid social media contacts will be charged, if. Sorry, friends. If you’re part of the criminality, you’re not exempt or immune. Don’t care what your bosses told you. So easily traceable today. What a can of worms, frankly. So many other equities where some are “saving” retail. Too look into…. Not that hard. To figure out. What’s really going on. And who is behind it. ..gov warrants, subpoenas, et al. Worth a look, imo.

The little engine that could is about to reach the top of the hill. Downhill is going to be a different ride. And many will get on the train, imo.

Not financial or legal advice. All, imo. It’s just a message board, coughwirericofraudcough cough fingers crossed right…?

Unconscionable. Enough is enough.





9)Bright Boy

Re: None
Friday, December 30, 2022 3:36:11 PM
Post# of 554954 Go
I thought the presentation was skillfully handled in every instance. LP emphasized the company's main focus of getting approvals, ASAP. She mentioned at great length, the Sawston success, even to the point of saying that "WE expect a manufacturing approval (MIA) very soon and she would never say that if she didn't know it was guaranteed !! And additionally after describing the MAA application as voluminous, close to a million pages, said that it would be filed upon receipt of the MIA. That tells us that it's completed!!! She discussed another "FIRST time ever " and that is an up-list very soon!! Again, for her to say that indicates that it will happen and we're almost there!!!! Further, she mentioned institutional investors following approvals at Sawston along with the up-listing!!! Again, loud and clear, it's a big deal for LP to suggest anything unless she has the license, the up-list and institutional investors "in hand and lined up"!!! So she must have a strong reason to believe that the company will have approvals and up-listing "in hand" very shortly!!!

Gosh, the very mentioned of the current successes in the areas of combo trials should blow the roof off the party!! We already know the clinical trial results from many of the CI's combing with DCVax-L.Merck's Keytruda with DCVax-L resulted in over 50% 8 year survival !!!! Every CI company will want to combine with Northwest!!! Just think of the potential from all those combinations!! AND again, for LP to even mention that, she would have to be convinced that DCVax-L alone and in combination with other treatments will replace SOC becoming the PROMISE and HOPE for all large tumor cancers and others AND IS THE FUTURE OF THE NEW AGE OF HEALTHCARE!!

The lawsuit and the potentials from discovery are virtually limitless, but more importantly, it signals that "Market Oversight" is about to change in support of honest, balanced and fair trading practices protecting the hard working American's IRA's and their investments in general from those unscrupulous trading strategies deployed by the defendants in the lawsuit and many others!!!

Bravo to Linda Powers and Team Northwest for accomplishing the impossible in creating a new world order in treating cancers, patient healthcare, patient advocacy and stamping out those that are driven by greed to deny all those accomplishments in the pursuit of money and privilege!!!

Cheers,

BB

jon_k84
Re: None
Saturday, December 31, 2022 1:59:28 PM
Post# of 554988 Go
Perhaps the best ASM we've ever had:

A lot of the newer guys may not be able to appreciate this, but as a long of 10 years, I remember the days when nothing but "please be patient with us" was said. That was not the case at this ASM. A lot of good info was provided, and I'd encourage everyone to read the transcript.

What I liked most was that the company more or less outlined their game-plan for moving towards commercialization that is independent of a Big Pharma BO or JV. This is absolutely vital to NWBO's success as a company. We cannot simply stick our hand out to big Pharma while crying "please save us." This is a business, and if BP can acquire this technology for 1/10th of our current market cap, they absolutely will. Moving forward with a compelling strategy to bring the drug to market sends the message "make us a real offer because our value / price is going up more by the day."

It's all about the milestones. Everything else (including the day-to-day flux in share price) is background noise. Milestones will drive the price up, and I expect we will hit several in 2023 Q1. There is no way to predict exactly when things will happen, but this is what I expect for 2023:

-MIA approval - Q1
-Regulatory submission - end of Q1 / start of Q2
-Uplisting to NASDAQ late Q2
-Regulatory decisions - late Q2 / early Q3
-Sustainable revenue streams - Q4

A BO, JV, or institutional investment could happen at any time, but after hearing LP at the ASM, I would expect it to be after MIA approval or regulatory submission. Our timeline becomes a lot clearer after those milestones, and I'd expect big Pharma will want to act before the price starts to go out of control.

I think an uplisting will come at a time when the stock price makes sense for them to do so - so probably after one of the above milestones pushes the price higher. I do not see it requiring a RS.

BULLISH

3 Likes



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Northwest Biotherapeutics Inc (QB)
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