NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

https://www.reddit.com/r/NWBO/comments/1cr272z/big_news_week_in_review_nwbo/

There has been a lot of new information in the last two weeks. There have been three SEC filings and a publication of the UCLA ran Phase II trial on Nature.com.

Lets start with the Phase II study. https://www.nature.com/articles/s41467-024-48073-y

“TLR agonists polarize interferon responses in conjunction with dendritic cell vaccination in malignant glioma: a randomized phase II Trial”


This study was performed by the UCLA team (Linda Liau and Robert Prinz et al) from September 2010 to August 2024. I will post the abstract here, and emphasis is mine.

“In this randomized phase II clinical trial, we evaluated the effectiveness of adding the TLR agonists, poly-ICLC or resiquimod, to autologous tumor lysate-pulsed dendritic cell (ATL-DC) vaccination in patients with newly-diagnosed or recurrent WHO Grade III-IV malignant gliomas. ~The primary endpoints were to assess the most effective combination of vaccine and adjuvant in order to enhance the immune potency, along with safety.~ The combination of ATL-DC vaccination and TLR agonist was safe and found to enhance systemic immune responses, as indicated by increased interferon gene expression and changes in immune cell activation. Specifically, PD-1 expression increases on CD4+?T-cells, while CD38 and CD39 expression are reduced on CD8+?T cells, alongside an increase in monocytes. Poly-ICLC treatment amplifies the induction of interferon-induced genes in monocytes and T lymphocytes. Patients that exhibit higher interferon response gene expression demonstrate prolonged survival and delayed disease progression. These findings suggest that combining ATL-DC with poly-ICLC can induce a polarized interferon response in circulating monocytes and CD8+?T cells, which may represent an important blood biomarker for immunotherapy in this patient population.”



The purpose of the study was to measure if combinations worked AND if they were safe. There was however an added bonus.

“Median follow-up of patients treated on this clinical trial was 2.2 years after surgery, although the long-term survivors have now been followed for over 10 years. Median progression-free survival (PFS) was 8.1 months; and median overall survival (OS) was 26.6 months~. Although this clinical trial was not designed or powered to detect effects of these treatments on survival between the treatment groups, there were noticeable differences in median survival between the treatments groups for both OS (placebo: 7.7 months, poly-ICLC: 52.5 months, and resiquimod: 16.7 months; log-rank~ ~P~?~=?0.017) and PFS (placebo: 5.5 months, poly-ICLC: 31.4 months and resiquimod: 8.1 months; log-rank~ ~P~?~=?0.0012)”~



To put it bluntly, this stuff in combination is working really well and provides significant overall survival to GBM sufferers. There were 23 patients in this trial (very small sample size) and 4 WERE STILL ALIVE AT THE END OF THIS STUDY in 2023!! (Supplementary Data 1A) There also may be an error in box N22 fwiw.



The article has been peer reviewed before being published.



~April 29 Amended 10K form for year end 2023.~

There was not a whole lot of new information but I did take a dive on Exhibit 10.90 Which is the loan agreement with Streeterville Capital from November 2023. As one of the debt covenants (If you take my money you agree to my rules) it reads, “(ii) the Common Stock shall be listed or quoted for trading on any of (a) NYSE, (b) NASDAQ, (c) OTCQX, (d) OTCQB, or (e) OTC Pink Current Information; and (iii) trading in Borrower’s Common Stock will not be suspended, halted, chilled, frozen, reach zero bid or otherwise cease on Borrower’s principal trading market.”

~May 2 SEC 8K Form~



NWBO Raised $11 Million from Steeterville Capital (again). Payments begin in December. This money will be used to build out the Sawston facility (in anticipation of MHRA approval) which lead us to the main event!



~May 10~****~th~ ~SEC 10Q Form~



Long story short, the company is burning through cash but is fortunate enough to pay creditors with stock in lieu of cash.



Spending on the Sawston facility has almost doubled. (Page 17)



There are several takeaways on page 23. A 40-Patient Phase I trial was completed using the DCVax-Direct. This was tested on “OVER A DOZEN TYPES OF CANCERS.” This foundation is being set to build an extensive pipeline.



~MAA APPLICATION UPDATE~

MAA was submitted on Dec 20, 2023. On Jan 24, 2024 the company was notified by MHRA that MAA passed validation. On March 7, 2024 the company was notified by MHRA that the validation was confirmed. There were no requested updates for clarification in that time period. (Page 23) This is where the confusion begins however as to where the clock started ticking.



I made a post 2 months ago “MHRA Timeline/Phase I completed”.



The company statements appear to align with my own projections. I feel the clock started upon the submission date. It sounds like the March 7th communication was to inform them that Phase I was completed, and that NO RFI WAS NECESSARY.



I may be wrong, but I expect MAA approval this week.

The company has stated that they will be going media silent until a decision has been made.



The Company also continued discussions and negotiations during the first quarter of 2024 relating to collaborations which the Company believes will help it build a ~broad franchise in dendritic cell-based immunotherapies.~ (Page 24)



“Annual Shareholder Meeting**. The Company plans to conduct its Annual Shareholder Meeting before the end of June 2024.”** To my knowledge they have never had a shareholder meeting.







~Lawsuit Updates~



There is a lawsuit against the board members over a dispute about their compensation. The board members motion to dismiss was denied and that lawsuit is now in the discovery phase.



~Manipulation lawsuit~

So basically the court told NWBO that they pleaded their case effectively, however, their calculations for losses was improper. They granted the motion to dismiss WITHOUT prejudice (They can refile with proper calculations AND THEY DID).

On May 1, the Market Manipulators (alleged) filed a new Motion to Dismiss. NWBO has 30 days to file a response (and is working on that now).









~Tl;DR~



MAA decision is imminent.

Groundwork is being laid for an extensive pipeline.

Lawsuits are going well (for investors at least).





As always, my sources:

~https://www.sec.gov/edgar/browse/?CIK=1072379&owner=exclude~



https://www.nature.com/articles/s41467-024-48073-y



~https://www.reddit.com/r/NWBO/comments/1bot5hz/mhra_timeline_phase_i_completed_nwbo/~

I added 20K shares to my position today. I am very bullish.

Thanks for your insights. But my thinking re the MAA approval date is late June: the timing confusion stems from whether or not to count every calendar day vs. work days (also when the clock started, which seems to be more clear now). Not sure it's valid to count every calendar day since the board isn't likely working on weekends. Secondly, expectations - especially w/MHRA approval hanging in the balance - often disappoint.

Having said that, I wouldn't mind being wrong.