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

[GlobeCitizen]

 

[GlobeCitizen]

The legal affairs in the US is so cumbersome and pricey that it is obviously favor the big money individuals and groups, which should meet in the midway with the PRC's which is innate flaw due to the one party system. Well here you go our lawyer's filing on behalf of Northwest Bio in its fight to dismiss Defendants MTD (wondering how long this process will still ensure as it's already long enough since the case began, and it's time for the judge to rule!)

Adobe Acrobat

acrobat.adobe.com

Below are partial excerpt of the doc:

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK
NORTHWEST BIOTHERAPEUTICS, INC., Plaintiff, - against- CANACCORD GENUITY LLC, CITADEL SECURITIES LLC, G1 EXECUTION SERVICES LLC, GTS SECURITIES LLC, INSTINET LLC, LIME TRADING CORP., and VIRTU AMERICAS LLC, Defendants.
Case No: 1:22-cv-10185-GHW-GS
PLAINTIFF’S RESPONSE TO DEFENDANTS’ OBJECTIONS TO MAGISTRATE JUDGE STEIN’S REPORT AND RECOMMENDATION
Case 1:22-cv-10185-GHW-GS Document 144 Filed 01/26/24 Page 1 of 25i

TABLE OF CONTENTS
I. INTRODUCTION ............................................................................................................................. 1
II. STANDARD OF REVIEW ............................................................................................................... 4
III. THE R&R CORRECTLY FOUND THAT PLAINTIFF ADEQUATELY ALLEGES MANIPULATIVE ACTS .................................................................................................................. 5
IV. THE R&R CORRECTLY FOUND THAT PLAINTIFF ADEQUATELY ALLEGES SCIENTER 9
A. The R&R Applied the Appropriate Pleading Standard and Considered Competing Inferences .................................................................................................................................... 9
B. The Complaint Adequately Alleges Conscious Misbehavior or Recklessness ......................... 12
C. The Complaint Adequately Alleges Motive and Opportunity .................................................. 14
V. THE R&R CORRECTLY FOUND THAT PLAINTIFF ADEQUATELY ALLEGES MARKET EFFECTS ........................................................................................................................................ 15
VI. THE R&R CORRECTLY FOUND THAT PLAINTIFF ADEQUATELY ALLEGES RELIANCE ..................................................................................................................................... 16 VII. THE R&R CORRECTLY FOUND THAT THE COMPLAINT PLED TEMPORAL PROXIMITY FOR CERTAIN OF PLAINTIFF’S SALES ................................................................................... 17
VIII. THE R&R CORRECTLY DECLINED TO TAKE JUDICIAL NOTICE OF DEFENDANTS’ PURPORTED TRADING RECORDS ........................................................................................... 18
IX. CONCLUSION ............................................................................................................................... 20
Case 1:22-cv-10185-GHW-GS Document 144 Filed 01/26/24 Page 2 of 25ii TABLE OF AUTHORITIES Page(s) Cases ATSI Commc’ns, Inc. v. Shaar Fund, Ltd., 493 F.3d 87 (2d Cir. 2007) ........................................................................................................4
Catania v. United Federation of Teachers, No. 21-cv-1257, 2022 WL 767107 (S.D.N.Y. Mar. 12, 2022) (Woods, J.) ..............................4
CFTC v. Shak, No. 2:22-cv-01258-GMN-NJK, 2023 WL 5717289 (D. Nev. Sept. 5, 2023) ..........................5
Chill v. Gen. Elect. Co., 101 F. 3d 236 (2d Cir. 1996)....................................................................................................20
CP Stone Fort Holdings, LLC v. Doe(s), No. 16-cv-4991, 2017 WL 1093166, at *4 (N.D. Ill. Mar. 22, 2017) ......................................5
Doe v. New York University, No. 20-cv-01343 (GHW), 2021 WL 1226384 (S.D.N.Y. Mar. 31, 2021) (Woods, J.) ...............................................................................................................................18
Harrington Global Opportunity Fund, Ltd. v. CIBC World Markets Corp., 585 F. Supp. 3d 405 (S.D.N.Y. 2022)..........................................................................11, 12, 15 Harrington Global Opportunity Fund, Ltd. v. CIBC World Markets Corp., No. 21-cv-761 (LGS), 2023 WL 6316252 (S.D.N.Y. Sept. 28, 2023) ............................ passim Kessev Tov, LLC v Doe(s), No. 20-cv-4947, 2022 WL 2356626 (N.D. Ill. 2022) ...............................................................5
Kessev Tov, LLC v. Doe(s), No. 20-cv-4947, 2023 WL 4825110 (N.D. Ill. July 27, 2023) ........................................ passim McIntire v. China MediaExpress Holdings, Inc., 38 F. Supp. 3d 415 (S.D.N.Y. 2014) .......................................................................................17
S.E.C. v. U.S. Environmental, Inc., 155 F.3d 107 (2d Cir. 1998)...............................................................................................11, 15
Set Capital LLC v. Credit Suisse Group AG, 996 F.3d 64 (2d Cir. 2021)...................................................................................................4, 10
Sharette v. Credit Suisse Int’l, 127 F. Supp. 3d 60 (S.D.N.Y. 2015)..............................................................................6, 13, 14
Case 1:22-cv-10185-GHW-GS Document 144 Filed 01/26/24 Page 3 of 25iii In re Tufin Software Technologies Ltd. Sec. Litig., No. 20-cv-5646, 2022 WL 596861 (S.D.N.Y. Feb. 25, 2022) (Woods, J.) .............................20
U.S. v. Coscia, 866 F.3d 782 (7th Cir. 2017) ................................................................................................... 5
Vega v. Artuz, No. 97-cv-3775, 2002 WL 31174466 (S.D.N.Y. Sept. 30, 2002) .............................................4
Xu v. Gridsum Holding, Inc., No. 18-cv-3655, 2020 WL 1508748 (S.D.N.Y. Mar. 30, 2020) ..............................................20


IX. CONCLUSION For the foregoing reasons, the Court should adopt Magistrate Judge Stein’s Report & Recommendation as to the elements of manipulative acts, scienter, market effects, and reliance, and should find Plaintiff has adequately pled loss causation for the reasons set forth in Plaintiff’s Limited Objection.8

7 Defendants’ arguments on this score are also incomplete. R&R p. 20 n.13 (“Defendants do not provide trading data from Global OTC, nor do they argue that Plaintiff’s conclusions drawn from the Global OTC trading data are refuted by any record extraneous to the FAC.”) 8 Should the Court dismiss the Complaint, Plaintiff respectfully requests leave to amend and is fully prepared to, inter alia, add the factual allegations Magistrate Judge Stein requested or any others that the Court finds necessary.

See Chill v. Gen. Elect. Co., 101 F. 3d 236, 271 (2d Cir. 1996) (“In the securities litigation context, leave to amend is particularly appropriate[.]”); In re Tufin Software Technologies Ltd. Sec. Litig., No. 20-cv-5646, 2022 WL 596861, at *11 (S.D.N.Y. Feb. 25, 2022) (Woods, J.) (granting leave to amend for a second time); Xu v. Gridsum Holding, Inc., 2020 WL 1508748, at *9 (S.D.N.Y. Mar. 30, 2020) (same). In the Second Circuit, “t is the usual practice upon granting a motion to dismiss to allow leave to replead.” In re Tufin, at *11.

Case 1:22-cv-10185-GHW-GS Document 144 Filed 01/26/24 Page 24 of 2521 Dated: January 26, 2024 New York, New York Respectfully submitted, By: Laura H. Posner Laura H. Posner Michael B. Eisenkraft COHEN MILSTEIN SELLERS & TOLL PLLC 88 Pine Street, 14th Floor New York, New York 10005 Tel: (212) 838-7797 Fax: (212) 838-7745 lposner@cohenmilstein.com meisenkraft@cohenmilstein.com Raymond M. Sarola COHEN MILSTEIN SELLERS & TOLL PLLC 100-120 N. 18th Street, Suite 1820 Philadelphia, PA 19103 Tel: (267) 479-5700 Fax: (267) 479-5701 rsarola@cohenmilstein.com Counsel for Plaintiff

 

[GlobeCitizen]

@hoffmann6383
‍ $NWBO's Closing Arguments on the Motion to Dismiss‍

The Case: Northwest Biotherapeutics, Inc v. Canaccord Genuity LLC, 1:22-cv-10185, (S.D.N.Y.)

Plaintiff: Northwest Biotherapeutics, Inc. $NWBO

Defendants: Canaccord Genuity, LLC @CG_Driven
, Citadel Securities, LLC @citsecurities
, G1 Execution Services, LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp. @LimeTrading_
, and Virtu Americas, LLC @VirtuFinancial


Plaintiff's filing on the evening of January 26, 2024 was the last filing in a long line of filings related to Defendant's Motion to Dismiss ("MTD") in the above referenced case. Plaintiff's attorneys, led by Laura Posner, did not hold back. She went for the knockout blow.

In this post I'll go over Plaintiff's latest, and what should be their last, filing on Defendant's MTD, but first I'll give a quick recap of the MTD timeline.

MTD Timeline ️

4-10-23: Plaintiff filed the First Amended Complaint

7-12-23: Defendants filed their MTD and Joint Memorandum of Law in Support of Motion to Dismiss Amended Complaint

8-25-23: Plaintiff filed the Memorandum of Law in Opposition to Defendants' Motion to Dismiss the Amended Complaint

9-27-23: Defendants filed their Joint Reply Memorandum of Law in Support of Motion to Dismiss Amended Complaint and Defendants filed a letter requesting oral arguments

9-28-23: The Court scheduled oral arguments for Tuesday, November 14, 2023 at 10:30am

9-29-23: Plaintiff filed a Notice of Supplemental Authority in Support of Opposition to Defendants' Motion to Dismiss the Amended Complaint. Recall, this shed light on the new Harrington ruling

10-6-23: Defendants filed their Joint Response to Notice of Supplemental Authority

11-14-23: Oral Arguments on the MTD

11-20-23: Letter from Defendants providing caselaw on trading data discussed at the Oral Arguments.

11-22-23: Plaintiff's response to Defendants' 11-20-23 letter.

12-29-23: Magistrate Judge Stein's R&R

1-4-24: Defendants' letter requesting additional time to file objections to the R&R

1-5-24: Plaintiffs opposition to Defendants' request for an extension

1-5-24: Magistrate Judge Stein Denied Defendants' January 4th request for an extension of time to file objections to the R&R

1-12-24: Defendants filed their Objections to Report and Recommendation

1-12-24: Plaintiff filed their Limited Objection to Magistrate Stein's Report and Recommendation Regarding the Element of Loss Causation

1-26-24: Defendants filed their Response to Plaintiff's Objection to Report and Recommendation

1-26-24: Plaintiff filed their Response to Defendants' Objections to Magistrate Judge Stein's Report and Recommendation

Plaintiff's Closing Argument, aka Posner's Haymakers

General Haymakers :

"Defendants’ true objection is, thus, not with the R&R’s application of the law to the Complaint’s allegations, but rather with the law governing spoofing and market manipulation cases more generally. The same objections that Defendants now raise, and that they raised originally, have been presented and rejected in numerous spoofing cases that mirror the allegations in the Complaint. The R&R carefully considered Defendants’ arguments and rejected them in a manner consistent with these cases. As such, its conclusions regarding the elements of manipulative acts, scienter, market effect and reliance should be adopted by this Court."

"Nonetheless, Defendants submit pro forma objections to virtually every statement in the R&R, many with just a mere sentence stating their disagreement and the overwhelming majority without a single case citation. And while the R&R is replete with references to other spoofing and market manipulation cases, including cases from this District, that support each of those conclusions, Defendants cannot distinguish these cases or discredit their relevance, so instead they simply ignore them. For example, while the R&R references on point cases upholding spoofing complaints such as Kessev Tov eleven times and CP Stone five times, Defendants’ objections do not mention either case even once."

Manipulative Acts

"The R&R correctly found that the Complaint alleges the same five indicia of spoofing that courts, including Judge Schofield in the Harrington case, consistently find sufficient to plead manipulative acts."

Haymakers related to manipulative acts :

"In not one of their objections to the R&R’s conclusion on manipulative acts do Defendants cite to a single spoofing decision in support of their position, nor do they make any attempt to distinguish the many spoofing cases on which the R&R relied. As the R&R concluded, at best, Defendants’ arguments “merely raise[] a factual dispute inappropriate for resolution at the pleading stage.” R&R p. 37 (quoting Sharette v. Credit Suisse Int’l., 127 F.Supp.3d 60 at 84 (S.D.N.Y. 2015))."

Scienter

The R&R correctly concluded that the Complaint adequately alleges scienter both because it pleads “conscious misbehavior” and “motive and opportunity.”

Haymakers related to Scienter :

“…each of the objections that Defendants now present were carefully considered and analyzed in the R&R, and again Defendants cite to no spoofing case to support their position.”

"They also assert that the R&R failed to consider competing inferences, but what they really mean is that the R&R failed to adopt their version of the facts instead of presuming the well-pled allegations in the Complaint to be true, as the Court must on a motion to dismiss."

"…Defendants offer irrelevant musings about things a plaintiff might plead on information and belief, and argue that a spoofing complaint must identify corporate employees by name – something not required by any spoofing case and which would make little sense given that trading by algorithm, not a person, is generally at issue."

"Defendants assert that Magistrate Judge Stein applied the wrong standard in finding the Complaint’s allegations of scienter sufficient, but the only basis for their assertion is that the Magistrate Judge Stein rejected their arguments."

Reliance

"Defendants still are unable to point to a single factual allegation in the Complaint that is insufficient on this score or even suggest any additional factual allegations that they believe would be necessary."

Haymaker related to Reliance :

"Defendants ignore Plaintiff’s allegations of actual reliance and do not indicate in their Objections which of the Complaint’s Cammer allegations are insufficient or what more a plaintiff would need to allege under Rule 8, nor can they since “[t]he Cammer factors ‘are not a rigid checklist’ and not ‘every factor needs to be established.’” R&R p. 84 (quoting McIntire v. China MediaExpress Holdings, Inc., 38 F. Supp. 3d 415, 432 (S.D.N.Y. 2014))."

Loss Causation

"All of the allegations in the Complaint are properly considered for all elements of its claims, including the element of loss causation."

Market Effects

"The R&R thoroughly considered Defendant’s arguments that the Complaint failed to allege a negative market effect and found each of them “unpersuasive.” R&R p. 46."

Defendant's Purported Trading Records

"...Magistrate Judge Stein engaged in a thorough and persuasive analysis, stretching over 10 pages of the R&R, ultimately concluding that the exhibits of purported trading records that Defendants submitted with their motion to dismiss (Exhs. 11-28) should not properly be considered."

What is next?

We now await Judge Woods' ruling on the MTD. I'd suspect that the MTD will ultimately be denied. The only question is what steps are required in the interim. Will we have to file a second amended complaint? Clarity to those steps should be provided with Judge Woods' ruling.

Judge Woods has a lot of work in front of him. He will be reading through hundreds of pages of briefings, an 85 page R&R, citations to dozens of cases and a docket with over a hundred entries, some of which might be relevant to the MTD. I'd speculate that we will see his ruling within 1-4 months.

https://twitter.com/hoffmann6383

 

[GlobeCitizen]

Northwest Biotherapeutics Moves From Optimization of Flaskworks Prototype to Fabrication of GMP-Compliant Units For Installation, Validation and Final Testing Prior to Regulatory Certification

/PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor...

www.prnewswire.com

Northwest Biotherapeutics Moves From Optimization of Flaskworks Prototype to Fabrication of GMP-Compliant Units For Installation, Validation and Final Testing Prior to Regulatory Certification
​

​

---

News provided by
Northwest Biotherapeutics
06 Feb, 2024, 09:30 ET

Accompanied by Broad Patent Coverage ​

BETHESDA, Md., Feb. 6, 2024 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that the key development work for the Flaskworks manufacturing system has been completed and an external vendor has been engaged to produce GMP-grade units of the system. In addition, the patent coverage of the Flaskworks system has been expanded: the foundational patent has been issued in the U.S. (and elsewhere) and an additional new patent application has been filed. The Company believes that this broad patent coverage will help it build a strong franchise.
The Company believes that the Flaskworks system will play a central role in enabling the efficient and timely scale-up of manufacturing to make DCVax-L products for large numbers of patients, and in reducing the manufacturing facility costs. The Company further believes that these efficiencies will be pivotal for enabling the DCVax-L platform to be affordable and potentially suitable for widespread use as a frontline therapy.
As the Company has previously reported, including at its Annual Meeting in December 2022, the Flaskworks system has been under intensive development for a number of years. Several fundamentally differing approaches and system designs were developed, tested, modified and re-tested until the best one was determined.
These efforts have required a combination of engineering, physics and biology expertise. This included both big-picture conceptual design work, and highly detailed work on factors such as the specific flow rates of liquids and materials through the system, shear forces and pressure on the cells in each part of each of multiple cell culture vessels on the machine at each time point, cell expression profiles, surface markers and functional characteristics, and countless other metrics.
Development Work That Has Been Completed
This work has now been completed and has included:

• Determining the fundamental type of mechanized approach to most closely mirror the existing manual process of manufacturing DCVax-L;
• Designing and creating a new machine to implement this approach;
• Making numerous prototype units and progressively optimizing the system;
• "Closing" the manufacturing process so that it does not involve any "open" steps (i.e., open to the air in the manufacturing lab) and therefore does not need to be conducted in the most sterile and most burdensome and expensive type of manufacturing lab;
• Automating key steps in the manufacturing process involving isolation of the desired immune cells, feeding and culturing those cells, and extracting them from the culture vessel (which involved special difficulty, as described below);
• Producing finished DCVax-L products with substantially the same composition and percentage purity of dendritic cells, the same biologic profile and functional characteristics of the cells, and the same yield in number of doses as with the existing manual process.

The special difficulty involved in developing the Flaskworks machine was that, unlike other cell types, the dendritic cells tightly adhere to the surface of the culture vessel (similar to barnacles). Extracting them from inside the culture vessel without damaging the cells or reducing the yield of doses was extremely challenging. Other cells (including T cells) are generally cultured suspended in liquid in a bag, which makes it much easier to move them through processes. Many companies have developed or are developing machines to handle such other cell types - but not adherent cells.
The tight adherence of dendritic cells is essential for 3 main reasons: (a) to isolate the specific desired cell population and remove others, (b) to assess the health of the patient's immune cells (if the cells do not adhere tightly, they are likely not healthy) and (c) to start the activation of the dendritic cells (the adherence triggers the start of activation).
Anticipated Benefits of the Flaskworks System
The Company believes that implementing the Flaskworks system will deliver multiple benefits:

• Manufacturing using the "closed" Flaskworks system can be done in lower grade clean rooms (grade C labs) that are substantially less expensive to build out and to operate than the higher grade clean rooms (grade B labs) required for the existing "open" process. As the Company has previously reported, it has purposefully built out its Sawston facility in stages, both to manage capital expenditure and in anticipation of being able to transition away from the more expensive labs as manufacturing technology advanced.
• Manufacturing using the "closed" Flaskworks system will also enable products for multiple patients (potentially up to a dozen or so) to be produced in a single (larger) manufacturing lab at the same time. Under the present "open" process (as with most cell therapy production processes to date), only 1 patient's product can be made at a time in each manufacturing lab, and the lab must go through special cleaning in between each product.
• With the Flaskworks machine performing the manufacturing process steps, the manufacturing personnel will only need to operate and oversee the machine and transfer culture vessels onto and off of the machine for these manufacturing steps rather than performing the steps by hand. This will be crucial for scale up to producing DCVax-L for very large numbers of patients, because the personnel can be drawn from a much wider pool and not just the very limited number of technicians able to perform the process steps by hand in an essentially artisan process.

Next Steps
The next step is to have GMP-compliant (i.e., clinical grade) versions of the prototype Flaskworks machine made with GMP grade materials. A specialized contractor has been engaged to do so. This process is expected to take several months, in part due to ongoing supply chain issues. As soon as the GMP-grade units are delivered, Advent BioServices will undertake final qualification and validation of the GMP units and use engineering runs with the system to collect data in order to submit an application to regulators to approve the use of the system for production of DCVax-L for patients.
The Company is optimistic about this approach because the Flaskworks system now closely mirrors the existing manufacturing process, and the DCVax-L products manufactured through the Flaskworks system are substantially comparable to the DCVax-L products made through the existing manual process.
Patent Coverage
The Company and Flaskworks have worked to develop strong patent coverage on the Flaskworks system. The foundational patent, with broad claims covering this closed manufacturing system, has issued in the US and elsewhere. In addition, a new patent application has been filed in regard to the new and optimized system and features.
Linda Powers, the CEO of Northwest Biotherapeutics, parent company of Flaskworks, commented: "We are extremely proud of the Flaskworks team's successful development efforts. They combined a lot of creativity with meticulous and rigorous measurements, analyses and testing. We are also proud of the efforts and expertise contributed by the NW Bio team and the Advent BioServices team. The many skill sets brought to bear together were key to the successful development."
Ms. Powers continued: "We are also very pleased to have expanded the scope of our patent coverage on the Flaskworks system. We believe this is a valuable asset that will help Northwest Bio build a strong franchise."
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company's lead program involves DCVax®-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of primary brain cancer, and is an "orphan disease." The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will be viewed as demonstrating safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Northwest Biotherapeutics
Dave Innes
804-513-6758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
SOURCE Northwest Biotherapeutics

 

[GlobeCitizen]

A well-explained post on the Flaskworks manufacturing system development news announced yesterday:

hyperopia 9:15 AM
Post #670,701
Re: #670,345: @Pattyloco - What does todays pr mean

I’ll break it down. The Flaskworks’ news is a VERY BIG DEAL, so don’t let the muted stock reaction fool you. The stock price is being suppressed by entities that are against Northwest Bio in order to create uncertainty and doubt about any positive news, with the idea being, that the news can’t be that important if the share price hardly increased. Nothing could be further from the truth.

In a nutshell, this Flaskworks news means that when Northwest Bio receives marketing approval, they will soon after, be able to produce their DCVax product to meet very strict commercial quality standards, in large quantities, at a low cost, and they will have patent protection from all the other competition that will come along and attempt to copycat Northwest Bio’s cell therapy. The biggest takeaway is that Northwest Bio has now industrialized the production process of a cell therapy, and they will be capable of producing tens of thousands of treatments annually, and eventually ramp up to hundreds of thousands as other solid-tumor indications are approved, and demand increases.

Due to the lack of any updates about the Flaskworks’ system for over a year, the haters have recently suggested that Flaskworks’ development has stalled, and that Northwest Bio is still years away from regulatory approval for an automated manufacturing system. They say that if and when Northwest Bio does receive marketing approval from regulators this year, they will have to produce the product using the very expensive, inferior manual process, which means they will only be able to produce hundreds of treatments annually, and they may not get insurance reimbursement because it will be too expensive to produce, or they won’t be able to earn much of a profit even if they do. This PR put all those ridiculous lies to death.

Since the Flaskworks acquisition in 2020, Northwest Bio (actually Flaskworks and Advent) has in fact, been very busy developing the original Flaskworks MicroDEN system, which was designed as a bench-top device intended for clinical trial production, which has lower regulatory requirements, and turning it into a commercial system with biosensors that are capable of providing real-time feedback on culturing conditions, and the ability to adjust those conditions as needed. This is necessary for commercial production, which has much higher regulatory requirements. The prototype culturing system was first revealed during a presentation entitled, Manufacturing of DCVax-L Past, Present and Future by Dr. Marnix Bosch, Chief Technical Officer of NW Bio, at ASCO on June 4, 2022. (better pictures here )

Yesterday’s Flaskworks press release revealed that in the time period since that ASCO presentation, Northwest Bio (Flaskworks and Advent) have actually further developed that commercial system, which was capable of producing one patient’s treatment (10-12 doses) at a time, into an industrial commercial system that is capable of producing 10-12 patient’s treatments (100-120 doses) at a time. This is A VERY BIG DEAL. With this Flaskworks automated process, Northwest Bio will be able to produce tens of thousands of treatments a year. All of the current companies with CAR-T cell therapy treatments are capable of producing a single patient’s treatment at a time, and are only able to produce a few thousand treatments a year. They are currently unable to meet patient demand, with long backlogs, and rationing care, which obviously limits the revenue they can earn.

So this Flaskworks news means that when the Flaskworks automated production process is approved, Northwest Bio will have the only commercial cell therapy treatment in the world that can produce enough treatments to meet a very high patient demand, which means this company will become much more valuable because the potential available revenue just skyrocketed. What this also means is that ten times the number of treatments can be manufactured from the same cleanroom footprint of that first iteration. As I said in another post a couple years ago, I think this may be what Michael Bigger was referring to as “cleanroom disruption.”

This brings up another interesting feature that was discussed in the press release; that the updated system now incorporates another previously separate process, in addition to cell culturing. As I’ve said in other posts, the manufacturing process has three main stages; the separation of the monocytes from the other white blood cells in the leukapheresis material, the culturing of those cells, and then filling the final product into individual dosage vials and cryopreserving. This new system now combines the first two steps in one system so that it not only requires less manufacturing systems, but it also allows those steps to be enclosed in one system so that it’s not necessary to transfer the cells from one machine to another, which saves time, reduces potential contamination, saves critical cleanroom space, and cuts down on expensive manpower.

Some have have speculated or at least hoped that the automated Flaskworks production process is a part of the marketing application, and it will also be approved when the DCVax product is approved. Linda Powers threw cold water on this idea at the shareholder meeting a year ago, but because the marketing application took so long to finish, some still thought that in that extra time, the development work on the Flaskworks system might also be finished. This PR dispelled this speculation, because it said that final installation, validation, and testing of the system will still need to be accomplished before it can be approved by the regulators, and the marketing application has already been submitted.

So the question that many may be asking is: “How long until it is approved by the regulators?”

First, I think it’s important to note that some of the development work that has already been completed was, “producing finished DCVax-L products with substantially the same composition and percentage purity of dendritic cells, the same biologic profile and functional characteristics of the cells, and the same yield in number of doses as with the existing manual process.” So Advent has already demonstrated to their own satisfaction that the Flaskworks’ system can produce an equivalent product as the current approved method. Now they just have to demonstrate it to the satisfaction of the regulators. They have also already engaged a contract manufacturer to make the systems that will be installed and validated at Sawston which may take a few months to receive. Then the validation - the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), will take a few months. Then, a few side-by-side runs for the comparability study, and gather and assess the data, and submit the Comparability Protocol to the MHRA which could take a couple more months. The MHRA should be able to review the CP within a couple months, but possibly longer if there are still staffing issues. (the EMA has a 60-day response time for this type of filing, but I’m unsure about the MHRA) If all goes well, it may be possible to receive regulatory approval, and begin automated commercial production with Flaskworks by the end of the year.

So, in summation, THIS IS A VERY BIG DEAL!

 

[GlobeCitizen]

I am 100% sure the ultimate purpose of NWBio's lawsuit against 7 market makers for spoofing is to seek maximal compensation and justice not only from MMs spoofing but more from their illegal short selling (mostly naked short selling which is difficult to approve without discovery), and the optimal timing of the judge's denial of Defendants MTD would be after DCVax-L approval in the UK. Now it seems it is heading this way, hence maximizing the power of NWBio in seeking maximal compensation and justice. So the below news is a welcome news IMO:

hoffmann6383
@hoffmann6383
‍Judge Woods Motion to Dismiss Ruling‍

$NWBO

The Case: Northwest Biotherapeutics, Inc v. Canaccord Genuity LLC, 1:22-cv-10185, (S.D.N.Y.)

On February 14, 2024 Judge Woods granted Defendants’ Motion to Dismiss (“MTD”), with leave to amend. The Order can be found here:

https://storage.courtlistener.com/recap/gov.uscourts.nysd.590344/gov.uscourts.nysd.590344.148.0.pdf

In relevant part, it states:

“On December 29, 2023, Magistrate Judge Gary Stein issued a thoughtful and well-reasoned Report and Recommendation in this matter. In it, Judge Stein recommended that the Court grant Defendants’ motion to dismiss Plaintiff’s First Amended Complaint, while granting leave to amend. Because the Report and Recommendation is sound, the Court adopts it in full and grants Defendants’ motion to dismiss with leave to amend.”

What does this mean?

I’ve always believed $NWBO was going to be able to proceed past the MTD stage to discovery. This was going to happen one of two ways:

1⃣ Judge Woods was going to adopt the Report and Recommendation (“R&R”) in full and require $NWBO to file a Second Amended Complaint. This was always the likely scenario, but it added a little extra time to the case.

2⃣ Judge Woods rejected the findings of the R&R as related to loss causation and denied the MTD. This would have immediately led to the case moving to discovery. This was the optimistic, yet, less likely scenario.

As expected, the case proceeded along path one.

What does this mean moving forward?

Timeline

It will go something like this:

$NWBO will file a Second Amended Complaint on, or before, March 15, 2024.

Defendant’s will request to file a MTD.

Defendants will be given 45 days to file their MTD and Joint Memorandum of Law in Support of Motion to Dismiss the Second Amended Complaint

NWBO will be given 45 days to file their Memorandum of Law in Opposition to Defendants’ Motion to Dismiss the Second Amended Complaint

Defendants will be given 30 days to file their Joint Reply Memorandum of Law in Support of Motion to Second Amended Complaint

30 (to file new complaint) + 45 (to file MTD) + 45 (to file MTD Opposition) + 30 (to file D’s Reply) = 150 days or 5 months

Plus another month for the Judge to rule. I don’t expect there to be another oral argument although Defendant’s might try to request such.

Call it ~6 months

Then you add another month to agree on and obtain a discovery scheduling order.

Remember my comment on the day the R&R was released?

“I’d guess this results in a ~7 month delay.”

I’m wrong on most of my timelines, but I believe this one will be very close to accurate!

Will NWBO Survive the MTD?

Yes, I believe so. As I’ve stated prior, Magistrate Judge Stein gave $NWBO a roadmap to survive the MTD. NWBO will file a Second Amended Complaint, we will go through another round of MTD filings/briefings and then I believe the Judge will deny said MTD and the case will proceed to discovery.

Side Note: Keep an eye on this case. This is Cohen's other spoofing lawsuit and the parties are awaiting the Judge's decision on the MTD. This case is a mirror of $NWBO's case. Lets see if the Judge rules the same way. The case - Phunware, Inc. v. UBS Sec. LLC, No. 1:23-cv-06426 (S.D.N.Y.)

What is this Judge doing issuing an Order this late on Valentine's Day?! Also, what am I doing writing this tweet while my wife is giving me sideways looks?!

Happy V day everyone! I'm out for the evening. Time for Fargo Season 5 with the wifo.

 

[GlobeCitizen]

This approval coming combinations patent of checkpoint inhibitors and Therapeutics (DCVax-L and D) is hugely significant in treating cancers (improving OS or even cure cancers). This patent alone should be worthy of multiple billion dollars today even without an approved DCVax yet, but again the market may not react as it should be usually when it comes to NWBio. We got it but We don't care. Truth and justice will prevail. It's just a matter of when.

WIPO - Search International and National Patent Collections

Under Documents:

Under National Biblio. Data:

1. EP3065772 - COMBINATIONS OF CHECKPOINT INHIBITORS AND THERAPEUTICS TO TREAT CANCER

​

 

[GlobeCitizen]

Continued with the above post: The Claims of soon to be approved combinations patent:

 

[GlobeCitizen]

hyperopia 1:32 PM
Post #673113 on NorthWest Biotherapeutics Inc (NWBO)

Bidding war? Yes, I think that’s certainly possible, maybe even likely . . . Gilead just announced more setbacks, this time for magrolimab in solid tumors. While some cell therapy treatments have shown limited success in blood cancers (lymphomas, myelomas, and leukemia) solid tumors are proving to be far more difficult to overcome. This really demonstrates just how impressive Northwest Bio’s accomplishment in Glioblastoma really is, and why they are likely to be highly sought after.


"Gilead reviewing drug acquired in $5B buyout after latest setback
The FDA issued a partial hold on four tests of magrolimab in solid tumors, as Gilead evaluates the program’s future.
Published Feb. 16, 2024
Ben Fidler

Gilead Sciences is evaluating the future of a cancer drug acquired in a multibillion-dollar deal following a new setback the company reported late Thursday.

In a statement, Gilead said it paused enrollment in four mid-stage trials of the drug, known as magrolimab, in different types of solid tumors. The Food and Drug Administration subsequently ordered a partial hold on these trials. The suspension also applies to investigator-run tests of magrolimab, the company said.

Gilead didn’t specify why it stopped recruiting study participants. However, one week ago, the company disclosed a regimen involving magrolimab was associated with an increased risk of death in a late-stage trial in leukemia. Gilead ended that study, and the agency halted all other tests of magrolimab in blood cancers.

Gilead said it is “reviewing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this assessment as soon as possible.”

The announcement is yet another disappointment for magrolimab, which Gilead acquired when it paid $5 billion for biotechnology company Forty Seven in 2020.

Gilead bought Forty Seven to bolster its oncology business amid a surge of industry interest in drugs like magrolimab, which block a mechanism cancer cells use to evade the immune system. Gilead viewed these drugs as a cornerstone for cancer drug combinations and pushed magrolimab into mid- and late-stage trials in leukemia and myelodysplastic syndrome as well as solid tumors.

Magrolimab has since faced myriad delays and trial stoppages over safety concerns. It failed Phase 3 trials in myelodysplastic syndrome and leukemia, proving ineffective in both cases.

Meanwhile, some pharmaceutical companies have backed away from the drug class, which are known as CD47 inhibitors. Pfizer still has one in Phase 2 testing that was acquired via its buyout of Trillium Therapeutics. Biotech ALX Oncology is also testing a CD47 drug in mid-stage studies.

Gilead’s struggles come as Wall Street scrutinizes the company’s business development strategy under CEO Daniel O’Day.

Partnerships with biotechs Galapagos and Arcus Biosciences haven’t paid dividends, and a drug acquired in its $21 billion buyout of Immunomedics hasn’t performed as well as expected.

Earlier this week, the company paid $4.3 billion to acquire liver drug developer Cymabay Therapeutics.

The four studies Gilead paused are evaluating magrolimab in colorectal, breast, and head and neck cancers, as well as in solid tumors more broadly. Patients who benefit from treatment can continue to receive the drug after again given their consent, the company said.

Gilead reviewing drug acquired in $5B buyout after latest setback "

When considering potential partners for Northwest Bio, most would agree that Merck does have a distinct advantage due to the combination trial at UCLA; however, I’ve also thought that Gilead could be one of the many companies that will be interested in partnering with, or acquiring Northwest Bio when the time comes, and they certainly bring more than a checkbook to the table. Recently, Gilead’s CEO said, “the company will continue to be opportunistic about pursuing business development within its three focus areas of virology, oncology, and inflammation, and it will look at later-stage deals.”

Although Gilead does not have a checkpoint inhibitor, like Merck or Bristol Myers, to combine with DCVax, Gilead has demonstrated a willingness to acquire immuno-oncology companies, most notably, Kite Pharma for $12B, Forty Seven for $5B, and Immunomedics for $21B. They obviously recognized the promise of cell therapy very early on, and were willing to take the risk to pioneer the commercialization of one of the first CAR-T cell treatments (Yescarta) with their Kite acquisition, and have proven the commercial viability of cell therapy.

Gilead allows its Kite subsidiary to stand alone, and it has become a leader, with two approved cell therapies (Yescarta and Tecartus) in over 20 countries, and has developed significant expertise and resources. They know better than most other Bio Pharma companies what it takes to successfully commercialize a cell therapy, and they’ve built multiple state-of-the-art manufacturing facilities designed specifically for cell therapy production, negotiated extremely expensive ($400k plus) insurance reimbursements, established international cold-chain distribution networks, developed relationships with hospitals and over 400 authorized treatment centers, and have an international personalized customer care network.

Gilead has been battling its CAR-T competitors ever since their $12B Kite acquisition in 2017, fighting for market share in each new indication, in a relatively small, 2nd and 3rd-line setting in every market around the world, for a treatment that requires patient hospitalization, has serious potential safety issues, and uses a very complex, expensive, and lengthy manual manufacturing process; in other words, it has been a continual struggle to get to where they are (around $1.5B in sales) after six years. And on top of that, in the past few years, they’ve shelled out almost $30B for other oncology acquisitions that haven’t really paid off.

So what must Gilead’s CEO think when he evaluates Northwest Bio in comparison? A company with a (soon-to-be) approved cell therapy, with no safety issues, that not only treats Glioblastoma, the most difficult to treat solid-tumor cancer in the world, but is also applicable to other solid tumors, and will be added to the standard of care (front-line), with orphan status, so it will own the entire brain-tumor market around the world, can be administered in an out-patient setting, and oh, it also has its own patented, completely automated manufacturing process, that can be scaled to meet mass-market demand, that is less than half the cost of CAR-T cell therapy treatments. Think about what that might be worth to him.

One more thought, something else that a company with expertise in T-cell therapy may be interested in, is that other patented automated manufacturing system that Northwest Bio also owns, courtesy of the Flaskworks acquisition; the simple but brilliant, BATON system. That’s the automated system that co-cultures a patient’s own dendritic cells with the patient’s own T-cells, so it uses a natural process (rather than engineered) to present all of the antigen targets, specific to each patient’s own tumor, to the T-cells. That system was designed to make a personalized T-cell therapy for solid tumors, however, with Northwest Bio’s dendritic cell knowledge, it could be adapted to make both a dendritic cell therapy, and a T-cell therapy, so both could be administered to the patient.

And by the way, almost everything that was said about Gilead’s expertise in cell therapy and manufacturing . . . the same could be said about Bristol Myers. So yes, I definitely think there may be more than one company interested in partnering with, or acquiring Northwest Bio.

 

[GlobeCitizen]

Top my holding today with the buy of small trenches of shares at about $0.574.

there may still be a month or two ahead when price may become even more attractive, but don't want to miss out in case something really substantial occurs...

As said before the recent revelation about the combinations patent upcoming approval in and of itself should be worthy of multiple billions today, and will be worthy much more after dcvax-L approval.

The rugged and sleepy market when everything it comes to NWBO has always made my appetite bigger. Go figure!

 

[GlobeCitizen]

Again bought some today. Below is an order got filled:

 

[GlobeCitizen]

NT 10-K out, which means the company has 15 days to file 10-k.

https://www.sec.gov/Archives/edgar/data/1072379/000110465924030043/tm241019d2_nt10k.htm

PART III - NARRATIVE

State below in reasonable detail why Forms 10-K, 20-F, 11-K, 10-Q, 10-D, N-CEN, N-CSR, or the transition report or portion thereof, could not be filed within the prescribed time period.

The Company has determined that it is unable, without unreasonable effort or expense, to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “2023 Annual Report”) within the time period prescribed. This is solely because the Company has identified a potential valuation method error in valuing a convertible financial instrument sold in the third quarter by using the market price at which the instrument was sold, rather than a Monte Carlo valuation formula. The Company expects to report one material weakness in its internal control over financial reporting due to this valuation method error. The Company's remediation plan for changing such valuation method is expected to be described in the 2023 Annual Report.

The Company is working to file the 2023 Annual Report as soon as is reasonably practicable.

Cautionary Note Regarding Forward-Looking Statements

This Form 12b-25 contains forward-looking statements, which are statements that relate to the future and are, by their nature, uncertain. Words such as “expect,” “will,” and variations of such words and similar future or conditional expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the beliefs and expectations of the Company’s management relating to the timing of the filing of the 2023 Annual Report and the results of the Company’s ongoing assessment of the effectiveness of its internal controls. These forward-looking statements are not guarantees of future results or outcomes and are subject to a number of risks and uncertainties, many of which are difficult to predict and beyond the Company’s control. Important factors that may cause actual results or outcomes to differ materially from those in the forward-looking statements include the time and effort required to complete its assessment of the effectiveness of its internal controls; the timing and completion of the necessary interim review and audits by the Company’s independent registered public accounting firm. We disclaim and do not undertake any obligation to update or revise any forward-looking statement in this report, except as required by applicable law or regulation.

PART IV - OTHER INFORMATION

(1) Name and telephone number of person to contact in regard to this notification.


Les Goldman 240 497-9024
(Name) (Area Code) (Telephone Number)


(2) Have all other periodic reports required under Section 13 or 15(d) of the Securities Exchange Act of 1934 or Section 30 of the Investment Company Act of 1940 during the preceding 12 months or for such shorter period that the registrant was required to file such report(s) been filed? If answer is no, identify report(s).

Yes x No ¨

(3) Is it anticipated that any significant change in results of operations from the corresponding period for the last fiscal year will be reflected by the earnings statements to be included in the subject report or portion thereof?

Yes x No ¨

If so, attach an explanation of the anticipated change, both narratively and quantitatively, and, if appropriate, state the reasons why a reasonable estimate of the results cannot be made.

The Company currently expects to report a net loss of approximately $14.0 million for the quarter ended December 31, 2023, compared to a net loss of $28.3 million for the quarter ended December 31, 2022; a net loss of approximately $62.6 million for the year ended December 31, 2023, compared to a net loss of $105.0 million for the year ended December 31, 2022.

Northwest Biotherapeutics, Inc.
(Name of Registrant as Specified in Charter)

has caused this notification to be signed on its behalf by the undersigned hereunto duly authorized.

 

[GlobeCitizen]

A critical factor impacting the valuation of nwbo, besides corrupted MMs' manipulation of spoofing and naked shorting, is lack of or void of major news coverage despite substantial progress of the clinical trials, publication of the trial results in prestigious journal with hugely upbeat conclusions, marketing application, manufacturing leaps and bound achievement, etc. Now instead of a total embargo, a sign of cracks appears, NWBio mentioned in influential Financial Times.

‘Spoofing’ case might draw back curtain on high-speed trading firms

Seven broker-dealers including Citadel Securities face a challenge from a cancer vaccine company

www.ft.com

Joe Miller

File under huge if true. Agroup of Wall Street traders maliciously drove down the share price of a Maryland biotech with a promising new brain cancer vaccine-in pursuit of the marginal profits to be made by buying the stock cheaply and selling it backto the market.

That, at least, was the allegation made by Northwest Biotherapeutics in a suit filed against seven broker-dealers including Virtu and Ken Griffin's Citadel Securities in late 2022.

It accused the firms of "repeated spoofing by using their trading platforms to place tens of millions of orderstosellNWBO that they had no intention of fulfilling. These orders were visible to the rest of the market, the complaint alleged, which led other investors to dump shares, hammering NWBO'svaluation even as a key clinical trial yielded impressive results.

Predictably, the claims sent conspiracy-minded Redditors- including some of those who previously pumped meme stocks such as Gamestop -into afrenzy.

Their refrain for months has been that hedge funds "want to bury this company" while largely avoiding mention of factors that might have dissuaded investors from buying into NWBO, such as a study questioning the design of its cancer trialand a negative news report on its results. Northwest had also been mired in governance problems, settling with the SECover failures in financial reportingoversight. Earlier last month, NWBO and its

Reddit fans were rebuffed by a Manhattan court, which granted Citadel etal's motion to dismiss the case.

But there was a stingin the tail. In his report recommending dismissal, magistrate Gary Stein concluded that, while the company had not yet done enough to tie the trading in question to losses sustained by selling shares at the artificially low prices on specific dates, almost all of NWBO's other claims were prima facir plausible enough to be allowed to proceed.

An attempted distinction by Citadel Securities and others between orders that were cancelledor merely reduced in volume was "unconvincing", Stein wrote. He also concluded that, at thisstage

If Citadel and its ilk are to beat this case, they will have to give us more of a peek behind the curtain

in the litigation, it mattered not whether they were executing orders on behalf of clients as they exerted "control over the high-speed trading algorithms"behind the trades. He further found that, when "viewed in the light most favourable to the plaintiff, the "allegations amply support the inference that defendants conduct affected the market price for NWBOstock".

In a line that seemed destined to make its way on to thet/wallstreetbets message boards on Reddit, Steinfurther called the claims "cogent and at least as compelling as the inference that defendants were simply engaged in legitimate trading activity".

The report came hot on the heels of another spoofing decision in the same New York courthouse, in a civil case brought by Bermudian hedge fund Harrington against Bank of America Merrill Lynch, CIBC and TD Securities.

That suit-which was referenced by Stein-survived a motion to dismiss and is currently scheduled to goto trialas earlyasthis year.

NWBO intends to refile its complaint within days. This time around, if a judge finds the deficiencies in the biotech's case have been fiurd, it could pave the way for the so-called discovery process In which Citadel Securities and its co- defendants would be compelled to hand over internal records and relevant communications. Critics of high- frequency trading firms, who claim they have an outsized and malign influence on global markets, will be watching,

Citadel Securities labelled the case a "malicious lawsuit [that] blatantly misrepresents how the market functions In an attempt to shake down the world's leading liquidity providers" and neither Northwest nor Harrington is necessarily

any closer to proving their claims. Todate, no spoofing case outside those brought by the US prosecutors or regulators has prevailed.

But the default stance adopted by market-makers-who claim allegations of market manipulation are implausible while declining to divulge the commercially sensitive intricacies of their high-tech platforms-has now been effectively knocked back.

Stein wrote the fact that NWBO did not specify what algorithmictrading programmes were used by defendantsto execute their schemes or how they were used was not an impediment to its case.

"It is hard to imagine howany spoofing case would survive the motion to dismiss stage if... 'facts solely within the defendant's knowledge' were required to be set forth in the complaint", he added.

In other words, if Citadel Securities and itsilkareto beat this case and prevent a string of copycat suits, they will probably have to give the rest of us more of a peek behind the curtain.

joe.millen@ft.com

 

[GlobeCitizen]

Project information | DCVax-L for treating glioblastoma [ID836] | Guidance | NICE

www.nice.org.uk

"A meeting was held between NICE and the company in early-February regarding next steps for the appraisal of DCVax-L for treating glioblastoma, and more information will be available in due course. NICE will continue liaising with the company and monitoring timelines. "

 

[GlobeCitizen]

NT 10-K out, which means the company has 15 days to file 10-k.

https://www.sec.gov/Archives/edgar/data/1072379/000110465924030043/tm241019d2_nt10k.htm

PART III - NARRATIVE

State below in reasonable detail why Forms 10-K, 20-F, 11-K, 10-Q, 10-D, N-CEN, N-CSR, or the transition report or portion thereof, could not be filed within the prescribed time period.

The Company has determined that it is unable, without unreasonable effort or expense, to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “2023 Annual Report”) within the time period prescribed. This is solely because the Company has identified a potential valuation method error in valuing a convertible financial instrument sold in the third quarter by using the market price at which the instrument was sold, rather than a Monte Carlo valuation formula. The Company expects to report one material weakness in its internal control over financial reporting due to this valuation method error. The Company's remediation plan for changing such valuation method is expected to be described in the 2023 Annual Report.

The Company is working to file the 2023 Annual Report as soon as is reasonably practicable.

Cautionary Note Regarding Forward-Looking Statements

This Form 12b-25 contains forward-looking statements, which are statements that relate to the future and are, by their nature, uncertain. Words such as “expect,” “will,” and variations of such words and similar future or conditional expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the beliefs and expectations of the Company’s management relating to the timing of the filing of the 2023 Annual Report and the results of the Company’s ongoing assessment of the effectiveness of its internal controls. These forward-looking statements are not guarantees of future results or outcomes and are subject to a number of risks and uncertainties, many of which are difficult to predict and beyond the Company’s control. Important factors that may cause actual results or outcomes to differ materially from those in the forward-looking statements include the time and effort required to complete its assessment of the effectiveness of its internal controls; the timing and completion of the necessary interim review and audits by the Company’s independent registered public accounting firm. We disclaim and do not undertake any obligation to update or revise any forward-looking statement in this report, except as required by applicable law or regulation.

PART IV - OTHER INFORMATION

(1) Name and telephone number of person to contact in regard to this notification.


Les Goldman 240 497-9024
(Name) (Area Code) (Telephone Number)


(2) Have all other periodic reports required under Section 13 or 15(d) of the Securities Exchange Act of 1934 or Section 30 of the Investment Company Act of 1940 during the preceding 12 months or for such shorter period that the registrant was required to file such report(s) been filed? If answer is no, identify report(s).

Yes x No ¨

(3) Is it anticipated that any significant change in results of operations from the corresponding period for the last fiscal year will be reflected by the earnings statements to be included in the subject report or portion thereof?

Yes x No ¨

If so, attach an explanation of the anticipated change, both narratively and quantitatively, and, if appropriate, state the reasons why a reasonable estimate of the results cannot be made.

The Company currently expects to report a net loss of approximately $14.0 million for the quarter ended December 31, 2023, compared to a net loss of $28.3 million for the quarter ended December 31, 2022; a net loss of approximately $62.6 million for the year ended December 31, 2023, compared to a net loss of $105.0 million for the year ended December 31, 2022.

Northwest Biotherapeutics, Inc.
(Name of Registrant as Specified in Charter)

has caused this notification to be signed on its behalf by the undersigned hereunto duly authorized.

10-k out today:

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