Replies to post #417721 on NorthWest Biotherapeutics Inc (NWBO)

[Nick119]

I did not catch this the first time around @ATL - good find and call out.

Have you yet gone back to see if this language was included in any of the previous 10-Q updates? If not, then this is the most meaningful update in this 10-Q and great news, IMO.

[vator]

Nice blurb to post.

[ae kusterer]

ATLnsider,NICK:from the June Q:"Our operating costs also include the costs of preparations for new or expanded clinical trial programs, such as our planned Phase II clinical trials. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other. Additional substantial costs relate to the maintenance and substantial expansion of manufacturing capacity, in both the U.S. and Europe."

[Gus McCrae]

This statement has been substantially the same in all of the 10-Qs going back at least 1 year.

[abc1212]

Thanks ATL, good attention to detail as always.

[biosectinvestor]

Not surprising and very interesting ATL. Excellent post.

[ae kusterer]

ATLnsider:Good find on the U.S. manufacturing spend.I missed that.

"Additional substantial costs relate to the maintenance and substantial expansion of manufacturing capacity, in both the U.S. and Europe"(see below)

Results of Operations

Operating costs:

Operating costs and expenses consist primarily of research and development expenses, including clinical trial expenses, which increase when we are actively participating in clinical trials and especially when we are in a large ongoing international phase III trial or we are completing such a large international trial, and undertaking substantial one-time expenses such as for final site visits, query resolutions, statistical work for the Statistical Analysis Plan (SAP) and analyses pursuant to the SAP, preparations for data analyses and other activities related to completion and assessment of the trial and its results. The operating costs also include administrative expenses associated with trials and increase as such operating activities grow.

In addition to clinical trial related costs, our operating costs may include ongoing work relating to our DCVax products, including R&D, product characterization, and related matters.

Following our acquisition of Flaskworks, our operating costs now include the costs for its ongoing operations and its intellectual property filings.

Our operating costs also include the costs of preparations for new or expanded clinical trial programs, such as our planned Phase II clinical trials. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other. Additional substantial costs relate to the maintenance and substantial expansion of manufacturing capacity, in both the U.S. and Europe.

Our operating costs also include significant legal and accounting costs in operating the Company.



ATLnsider Monday, 11/15/21 06:02:16 PM
Re: None 0
Post #
417721
of 417878
These statements are very encouraging, forward-looking, and tells us some of the things NWBio has been spending money on recently:

Quote:
Our operating costs also include the costs of preparations for new or expanded clinical trial programs, such as our planned Phase II clinical trials. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other. Additional substantial costs relate to the maintenance and substantial expansion of manufacturing capacity, in both the U.S. and Europe.


Also, please note that the words clinical trials are plural, in this sentence:

Quote:
such as our planned Phase II clinical trials


And, alsn note that NWBio is expanding manufacturing capacity in the "U.S. and Europe"



ae kusterer Tuesday, 11/16/21 12:08:01 AM
Re: None 0
Post #
417844
of 417881
So far in looking at the Q , I see no mention of expansion with Cognate . Please point out what I am missing.






https://www.sec.gov/ix?doc=/Archives/edgar/data/0001072379/000110465921106389/nwbo-20210630x10q.htm



Manufacturing Services Agreements

Advent BioServices

On May 14, 2018, the Company entered into a DCVax®-L Manufacturing and Services Agreement (“MSA”) with Advent BioServices, a related party which was formerly part of Cognate BioServices and was spun off separately as part of an institutional financing of Cognate. The Advent Agreement provides for manufacturing of DCVax-L products at an existing facility in London. The Agreement is structured in the same manner as the Company’s prior agreements with Cognate BioServices. The Advent Agreement provides for certain payments for achievement of milestones and, as was the case under the prior agreement with Cognate BioServices, the Company is required to pay certain fees for dedicated production capacity for DCVax production, and pay for manufacturing of DCVax-L products for a certain minimum number of patients, whether or not the Company fully utilizes the dedicated capacity and number of patients. Either party may terminate the MSA on 12 months’ notice, to allow for transition arrangements by both parties.


ae kusterer Monday, 11/15/21 11:51:28 PM
Re: None 0
Post #
417837
of 417844
reachjo Member Level Monday, 11/15/21 09:50:19 PM
Re: None 0
Post #
417797
of 417797
The 4 important points I took from the 10Q:

1. Substantial expansion of manufacturing capacity in U.S. and Europe.
( can someone post the details of U.S. expansion.I do not see that.I assume the expansion in only with Cognate.)


2. Expanded clinical trial programs. Planned Phase II clinical trials.


(Please post the announced details of these trials.I do not see that.)
3. Inspection done! Waiting for official MHRA inspection report and perform any corrective actions that may be required. Should be completed before year-end.

(yes, Linda Powers stated as much in the most recent nwbo PR)





4. Preparation for publication in a scientific journal and public announcement is under way. Public announcement will follow these processes.( crickets because such silence is mandated by the journal)

Everything on track in my book!

[muee88]

This isn’t new? The line about expansions in US and Europe has been in at least the five past 10Qs.

[john1045]

I saw that as well ATLnsider and caught my attention. Agree with you 100%!

Message in reply to:

These statements are very encouraging, forward-looking, and tells us some of the things NWBio has been spending money on recently:

Quote:
Our operating costs also include the costs of preparations for new or expanded clinical trial programs, such as our planned Phase II clinical trials. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other. Additional substantial costs relate to the maintenance and substantial expansion of manufacturing capacity, in both the U.S. and Europe.


Also, please note that the words clinical trials are plural, in this sentence:

Quote:
such as our planned Phase II clinical trials


And, alsn note that NWBio is expanding manufacturing capacity in the "U.S. and Europe"