NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Let's break down what's on the menu today

Manibiotech:
Lol instead of using real intelligence he uses artificial intelligence . So what do u expect

Well, seing how easy it is to counter, refute and dismantle your nonsense, just because I can handle feeding AI with the correct information and use AI's to corroborate their results, I can feel your pain. It really puts your drivel on exhibition.

And now pull up comments on why NWBO had to let go of Cognate and Cognate had to return the shares.And the related party transactions they were accused of , they got out of one to start a new one . Go figure where the interest of CEO lies .Looking at your posts , it is quite obvious that you are paid shill of NWBONow try harder

No, YOU DO THAT, and then I'll be back dismantling your bullshit tomorrow.

Come on, let's see REAL INTELLIGENCE get that information out there for all to see. You are just asking everyone else to do the job, you are just insinuating, because its "cheap" to do.

Accusations are "cheap". Try to actually put up some evidence to back it up, then we might be getting somewhere.

1) NONSENSE ABOUT COGNATE (Mani)
2) NONSENSE ABOUT BIOSIMILARITY VS. BIOEQUIVALENCE (HyGro)
3) NONSENSE ABOUT LINDA POWERS (DennisDave)


Let's start with the resurrection of a 10 years old FUD narrative.

1) NONSENSE ABOUT COGNATE (Mani)

If you can't dazzle them with brilliance, baffle them with bull.

Nothing to see here ... NEITHER!

🔍 Summary of What Happened with Cognate
✅ Background:
Cognate BioServices was NWBO’s contract manufacturer for DCVax products. It was owned by Toucan Capital Fund III, an investment fund controlled by NWBO’s CEO Linda Powers. This made it a related party until Q1–Q2 2018, at which point Cognate underwent institutional restructuring and was no longer under Toucan’s or Powers’ control?Annual Report 2019.

🔁 Transition to Advent:
As part of Cognate’s institutional financing, its ex-U.S. branches were spun off. The UK division became Advent BioServices, which remained under Toucan Capital Fund III and thus under Linda Powers’ influence. NWBO then contracted with Advent in May 2018 for European manufacturing operations?Annual Report 2019.

💸 Why the Relationship Changed
⚠️ Financial Breaches:
NWBO had repeated breaches of payment obligations to Cognate due to severe cash constraints. Previously, due to Powers’ control of both firms, Cognate tolerated non-payments. But after Cognate was sold to institutional investors in early 2018, they no longer tolerated delays. NWBO’s management explained that continued breaches could result in termination of contracts?Annual Report 2018.

🤝 Settlement Deal:
In 2017–2018, NWBO and Cognate reached a settlement:

$22M in obligations were cleared via preferred stock and warrants, not cash.

This included Series A and B convertible preferred shares and nearly 82 million warrants.

NWBO booked this as a research & development cost and capital contribution?Annual Report 2019.

🧾 SEC Filings on Cognate & Powers
SEC filings confirm:

Linda Powers had a material interest in Cognate via Toucan.

The relationships were disclosed and reviewed by a Conflicts Committee of independent directors.

All agreements had built-in restrictions, including lockups, vesting, and stock subject to most-favored-nation treatment, ensuring she couldn't just dump shares?Annual Report 2019?Annual Report 2018.

🧠 What FUD Misses: Context & Misrepresentation
Critics claim that Powers profited personally from Cognate while harming shareholders. But:

Cognate accepted shares instead of cash—effectively subsidizing NWBO operations.

Powers loaned NWBO $5.4M out of her own pocket in 2018 via convertible notes, helping the company avoid collapse. These notes had convertible preferred shares and warrants, disclosed in filings?Annual Report 2019.

Cognate forgave $3.75M in payables, which was booked as a capital contribution, not profit?Annual Report 2019.

In short, Cognate kept NWBO afloat through vendor financing, equity arrangements, and patience no institutional manufacturer would offer.

📚 Additional Third-Party Confirmation
Nancy Kim’s Shorting Innovation article (2024) confirms that:

“Cognate was willing to accept a substantial portion of its billings in NWBO stock to allow the company to reduce its cash burn…”

And further:

“Cognate provided favorable terms and manufacturing services over several years, converting $11.6M of accounts payable to stock.”

✅ Conclusion
There is no evidence of wrongdoing by Linda Powers in the Cognate arrangement. In fact, she:

Used her fund (Toucan) to sustain NWBO during a critical period.

Disclosed all relationships and compensation structures.

Helped transition to Advent, which is still key to DCVax-L production.

The narrative of self-enrichment pushed by online “FUDders” misrepresents the nature of the transactions, omits critical context, and ignores the survival role Cognate and Toucan played in NWBO’s story.

GROKS ACCOUNT ON COGNATE

Verification and Analysis of ChatGPT’s Output on NWBO and Cognate, with Additional Insights

The ChatGPT output provides a summary of the relationship between Northwest Biotherapeutics (NWBO) and Cognate BioServices, the transition to Advent BioServices, the reasons for the change, SEC filings, and a rebuttal to allegations against Linda Powers. I’ll verify the output, add context, and address the "fudders" narrative, focusing on the period around a decade ago (circa 2015) as requested, while incorporating more recent developments where relevant.

Verification of ChatGPT’s Output

Background: Cognate BioServices and Linda Powers’ Connection
ChatGPT Claim: Cognate was NWBO’s contract manufacturer for DCVax products, owned by Toucan Capital Fund III (controlled by Linda Powers) until Q1–Q2 2018, when it underwent institutional restructuring.

Verification: This is accurate. SEC filings, such as NWBO’s 2014 10-K, confirm that Cognate BioServices was a related party, with Linda Powers having “voting and dispositive power” over Cognate’s shares in NWBO, as she was a principal of Toucan Capital Fund III, which founded Cognate in 2002. The 2018 management buyout of Cognate, announced on February 20, 2018, severed Powers’ and Toucan’s ownership, as NWBO’s press release stated: “Following this transaction, neither Linda Powers nor any Toucan Capital related entities have any ownership interest in Cognate or any role on Cognate’s Board.” This aligns with the timeline of Q1–Q2 2018.

Transition to Advent BioServices
ChatGPT Claim: Cognate’s UK division became Advent BioServices in May 2018, remaining under Toucan Capital Fund III and Linda Powers’ influence, and NWBO contracted with Advent for European manufacturing.

Verification: This is correct. NWBO’s 2019 Annual Report (10-K) confirms that as part of Cognate’s restructuring, its UK operations were spun off into Advent BioServices, which continued to be affiliated with Toucan Capital Fund III. Advent took over DCVax-L manufacturing for European operations, particularly at the Sawston facility in the UK, which later received MHRA GMP certification in February 2025 for commercial production. A May 2018 agreement with Advent is referenced in NWBO’s filings, aligning with the timeline.

Why the Relationship Changed: Financial Breaches and Settlement
ChatGPT Claim: NWBO breached payment obligations to Cognate due to cash constraints, which Cognate tolerated under Powers’ control. After the 2018 buyout, institutional investors were less tolerant, leading to a 2017–2018 settlement where $22M in obligations were cleared via preferred stock and warrants.

Verification: This is mostly accurate, with some clarification:
Financial Breaches: NWBO’s 2018 10-K confirms repeated breaches of payment obligations to Cognate due to cash constraints, a common issue for development-stage biotechs. While Powers controlled Cognate, it accepted delayed payments or equity in lieu of cash, as noted in the 2019 10-K: “Cognate billings to NW Bio for prior periods were reduced by approximately $10 million, with some amounts related to periods of inactivity being cancelled.”

Settlement Details: The 2019 10-K details a settlement with Cognate, announced on May 28, 2019, resolving past obligations. However, the $22M figure cited by ChatGPT appears to aggregate multiple transactions. The 2019 settlement reduced Cognate’s billings by $10M, with $1.1M deferred to 2020, and included a new manufacturing agreement for DCVax-Direct. Earlier, in 2013, Cognate converted $11.6M in notes payable into 2.9M shares of NWBO common stock at $4.00 per share (2014 10-K), totaling roughly $22M over time, but not in one 2017–2018 settlement. The use of preferred stock and warrants is accurate, as NWBO often compensated Cognate with equity, including Series A and B convertible preferred shares and warrants, per the 2019 10-K.

Post-Buyout Dynamics: After the 2018 buyout, Cognate’s new institutional owners (later acquired by Charles River Laboratories in 2021 for $825M) were less flexible, as ChatGPT notes. This is supported by NWBO’s 2018 10-K, which highlights the need to settle past obligations to continue manufacturing relationships.

SEC Filings on Cognate and Powers
ChatGPT Claim: SEC filings confirm Powers’ material interest in Cognate via Toucan, relationships were disclosed, reviewed by a Conflicts Committee, and included restrictions like lockups and most-favored-nation treatment.

Verification: This is accurate:
Disclosure of Interest: The 2014 10-K explicitly states: “Ms. Powers has voting and dispositive power over the securities owned by… Cognate BioServices, Inc.,” confirming her material interest via Toucan Capital Fund III.

Conflicts Committee: NWBO’s 2014 10-K notes that related-party transactions, including those with Cognate, were reviewed by the Board for potential conflicts, with independent directors involved. The 2019 10-K further confirms that agreements with Cognate and Advent were subject to oversight, including lockups (e.g., 18-month lockup on converted

2) NONSENSE ABOUT BIOSIMILARITY VS. BIOEQUIVALENCE (HyGro)

We've been here before HyGro, but sometimes I get this strange notion, that you are not interested in "knowing what you hold"? Perhaps it's because you don't hold anything?!

🧬 Understanding Biosimilarity, Bioequivalence, and Comparability Studies
… and What It Means for NWBO’s Regulatory Pathway
🔬 Key Differences Explained
Many people confuse biosimilarity, bioequivalence, and comparability when discussing regulatory approval pathways.

✅ Biosimilarity – Used for biologic drugs to show they are highly similar to an already-approved biologic (the reference product) in structure, function, and efficacy.

Requires clinical trials to confirm similarity in safety and effectiveness.
Not relevant to NWBO, because DCVax-L (Murcidencel) is not a biosimilar—it is an Advanced Therapy Medicinal Product (ATMP).

✅ Bioequivalence – Used for small-molecule drugs (like generics) to show they release the same amount of active ingredient in the bloodstream at the same rate as the reference drug.

Requires pharmacokinetic studies (drug levels in blood) but not always clinical trials.
Not relevant to NWBO, because DCVax-L is a biologic vaccine, not a small-molecule drug.

✅ Comparability Studies – Used when making changes to the manufacturing process of biologic drugs or cell therapies. The goal is to show that the product made with a new method (Flaskworks’ EDEN system) is the same as the original product made with the manual process.

Relies on laboratory (in vitro) testing, NOT clinical trials.
This is what NWBO and Advent Bio are doing.

📌 Why NWBO/Advent Bio Are Doing a Comparability Study (NOT a Trial)
The switch to the Flaskworks EDEN system is not a new drug, it is a manufacturing process change. Regulatory guidance (MHRA, EMA, FDA) states that when switching manufacturing processes:

📍 Comparability is required, not a clinical trial – Studies must show the product is the same biologically and functionally through lab testing.

📍 Commercially available leukapheresis samples can be used – NWBO does NOT need patients for the study. Healthy donor material can be used for the comparability assessment.

📍 Assays already exist to confirm DCVax-L is unchanged – The company has developed characterization assays (e.g., measuring IL-6, IL-8, IL-12, TNF-a) to scientifically prove the final product is the same.

📍 The latest MHRA guidance supports this – The MHRA has confirmed that comparability studies are acceptable in place of trials for ATMPs if data shows no meaningful differences.

🧠 Updated Flaskworks Regulatory Timeline
Assumption: Flaskworks-produced DCVax-L was included in the MAA prior to validation (March 7, 2024), supported by comparability and “substantially comparable” data per NWBO’s February 6 press release.

✅ 2023: Flaskworks EDEN Final Optimization & SOPs
Throughout 2023: Flaskworks EDEN system is adapted for GMP use at Advent’s Sawston facility.

SOPs and automation workflows are finalized.

Advent and NWBO collaborate to ensure assay alignment for comparability (likely involving Flaskworks-run material).

⚗️ Late 2023 – Early 2024: Comparability Studies
Flaskworks-produced batches are run in engineering comparability runs (not “after” the MAA — but before and in parallel with MAA assembly).

Assays show Flaskworks output is “substantially comparable” to manual DCVax-L per Feb 6, 2024 press release.

This implies analytical characterization was completed by Jan–Feb 2024.

📤 February 6, 2024: NWBO Publicly Confirms Flaskworks Is Ready
NWBO states:

“Initial production runs using the Flaskworks system have yielded DCVax-L products that are substantially comparable to products made by the existing manual manufacturing process.”

This is a clear signal that comparability data was already available at the time of MAA submission.

🏛️ March 7, 2024: MHRA Accepts MAA for Review
Validation of the MAA begins.

This effectively confirms that Flaskworks EDEN comparability was included or cross-referenced in the application package — because no major process changes are allowed after validation without withdrawing or resetting the clock.

🧪 Q1 2024 – Present (Q1 2025): Ongoing Flaskworks Data Collection?
Additional real-world Flaskworks batches may continue to be produced (e.g. Specials/compassionate use or stockpiling).

If necessary, MHRA could request supplementary data, but Flaskworks is already on the table.

🧾 February 21, 2025: Advent’s Updated MHRA GMP License
Adds Flaskworks-enabled production area.

Strong confirmation that MHRA has already assessed Flaskworks for GMP suitability, reinforcing inclusion in the ongoing MAA.

✅ Summary: 🎯 Why This Matters for Approval
Flaskworks is already in scope. The phrase “substantially comparable” signals inclusion of Flaskworks comparability data in the original MAA.

The MAA clock would not have started if Flaskworks was a post-submission change — MHRA guidance prohibits this unless comparability is pre-established.

The February 21 GMP update and February 6 PR are consistent with Flaskworks inclusion from the outset.

✔️ Regulatory Compliance: The latest GMP certificate confirms Advent can produce DCVax-L for commercial use, a key requirement for final MAA approval.
✔️ No Additional Trials Needed: NWBO has followed MHRA’s pathway for manufacturing changes without requiring a clinical trial.
✔️ Submission Likely Done: If all data was ready before the MHRA inspection, the comparability package could already be with regulators.

🔍 Fact-Checking the Ihub Conversation

🔴 Claim: “They need patients to provide the leuko and lysate.”
✅ False. MHRA allows the use of commercial leukapheresis material from healthy donors?. No trial participants are required.

🔴 Claim: “And that means they will need a formal trial.”
✅ False. MHRA guidance confirms that comparability studies for ATMPs do not require a formal clinical trial?.

🟢 Claim: “The comparability study will test potency and purity using chemical, physical, and bio assays.”
✅ True. Comparability is assessed through assays measuring biological and functional characteristics?.

🔴 Claim: “There is no way to say DCs are the same.”
✅ False. NWBO has co-developed assays that confirm the final DCVax product meets all biological criteria?.

🔴 Claim: “That is tech we do not have.”
✅ False. NWBO announced a year ago that Flaskworks successfully produces DCVax-L meeting all criteria?.

🔴 Claim: “There will be no comparability study complete this year.”
✅ False. Given the rapid MIA/GMP approval, it is likely already completed and possibly submitted?.

🔴 Claim: “Eden is not in the MAA.”
✅ Unclear. If the comparability study was already submitted, then Eden could be included in the MAA. MHRA may provide final clarity soon.

🚀 Conclusion: NWBO is on Track for Approval
NWBO/Advent are doing a comparability study, NOT a trial.
Clinical trials are NOT required for the manufacturing switch (per MHRA guidelines).
The comparability study likely started in late 2024 and could already be completed.
The recent MIA/GMP certification strongly suggests that data has already been submitted to MHRA.
This means DCVax-L's final approval is now in the hands of regulators. If accepted, this could lead to the final MAA approval for commercialization. 🚀🎉

3. NONSENSE ABOUT LINDA POWERS (Dennis Dave)

Let's tear down the claims from this:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175994842

one by one.

🔍 Claim #1: “Linda Powers funded her private company Advent with shareholder money”
🛑 False.
Advent BioServices is not a "privately held company funded by NWBO." It is a contract manufacturer (CDMO) that NWBO uses for GMP production of DCVax-L in the UK. Like Cognate before it, Advent operates under arms-length service agreements. NWBO did not purchase equity in Advent or inject shareholder capital into it.

📄 “We contract out the manufacturing of our DCVax products to… Advent BioServices (formerly Cognate U.K.) for Europe.”
— NWBO 2019 10-K?Annual Report 2019

There is no indication of Advent equity funding, capital injection, or ownership stake disclosed in NWBO’s filings — because none exists.

🔍 Claim #2: “No disclosure under SEC Regulation S-K, Item 404”
✅ Disclosed.
All related-party transactions with entities associated with Linda Powers (e.g., Cognate BioServices and Advent) were repeatedly and transparently disclosed in SEC filings under Item 13 and Item 7 of NWBO's Form 10-Ks.

📄 "Ms. Powers had a material interest in Cognate and Advent. The Company has addressed this conflict by using a Conflicts Committee composed of independent directors."
— NWBO 2019 10-K?Annual Report 2019

📄 “The Company incurred approximately $3.4 million in manufacturing costs to Advent BioServices… Advent is controlled by Ms. Powers through Toucan Capital.”
— NWBO 2018 10-K?Annual Report 2018

So, disclosure did occur — not only in 10-Ks, but in multiple years, with full amounts and control relationships documented.

🔍 Claim #3: “Violation of Rule 10b-5, SOX, and misuse of funds”
🛑 No violation. No misappropriation.
All payments to Advent were:

for legitimate manufacturing services

at negotiated rates, with independent board oversight

disclosed in financial reports

There is no personal loan, no diversion of funds, and no concealment.

Also:

Section 402 of SOX applies to personal loans to executives — not payments to third-party vendors, even if controlled by insiders. That’s why Conflicts Committees exist.

Payments to Advent were booked as R&D expenses, not hidden transfers.

📄 “A substantial portion of our manufacturing expenses were with Advent BioServices... Advent is a related party controlled by Ms. Powers, and this relationship was disclosed and managed by independent directors.”
— NWBO 10-K?Annual Report 2019

🔍 Claim #4: “Lack of independent board oversight”
❌ Incorrect.
SEC proxy rules require disclosure of material related-party transactions. NWBO explicitly states in 10-Ks and proxies that:

A Conflicts Committee of independent directors reviews all transactions with entities affiliated with Linda Powers.

All major related-party transactions were reviewed, negotiated, and approved by this committee.

📄 [bi]“A Conflicts Committee of independent Board members has reviewed and negotiated all related-party arrangements.”
— NWBO 10-K?Annual Report 2019

NWBO is not currently listed on Nasdaq or NYSE, so exchange rules don’t apply. However, it voluntarily follows many governance best practices, including conflict reviews.

✅ In Summary: The Factual Rebuttal

GROKS TAKE

Claim 1: Linda Powers Funded Advent with Shareholder Money
ChatGPT Rebuttal: Advent is a contract manufacturer (CDMO) for NWBO, not a company funded with shareholder money. NWBO paid Advent for DCVax-L manufacturing services, not for equity or ownership.

Verification: This is correct. NWBO’s 2019 10-K states: “We contract out the manufacturing of our DCVax products to… Advent BioServices (formerly Cognate U.K.) for Europe.” Payments to Advent were for services, not investments. The 2024 Q3 10-Q details $2.4 million in cash and 22.5 million shares (valued at ~$4.95 million) paid to Advent for manufacturing, not for funding or ownership. No SEC filings show NWBO taking an equity stake in Advent.

Simplified Explanation: Advent is like a hired factory making NWBO’s product. NWBO paid them for work, not to own the factory. No shareholder money was used to “fund” Advent.

Claim 2: No Disclosure Under SEC Regulation S-K, Item 404
ChatGPT Rebuttal: NWBO disclosed all related-party transactions with Advent in SEC filings, as required by Item 404, including Powers’ control via Toucan Capital.

Verification: This is correct. Item 404 requires disclosure of transactions over $120,000 involving related parties. NWBO’s 2018 10-K notes: “The Company incurred approximately $3.4 million in manufacturing costs to Advent BioServices… Advent is controlled by Ms. Powers through Toucan Capital.” The 2019 10-K and 2023 DEF 14A proxy statement also disclose these transactions, including amounts and Powers’ interest. Disclosures were consistent across years.

Simplified Explanation: NWBO told everyone in its public reports that it paid Advent, which is linked to Powers, for manufacturing. They followed the rules by sharing this info.

Claim 3: Violation of SEC Rule 10b-5, SOX, and Misuse of Funds
ChatGPT Rebuttal: Payments to Advent were for legitimate services, disclosed, and overseen by independent directors. There’s no fraud (Rule 10b-5), no personal loans (SOX Section 402), and no misappropriation.

Verification: This is correct, with added context:
Rule 10b-5 (Fraud/Misrepresentation): Rule 10b-5 requires intent to deceive. Payments to Advent were for DCVax-L production, disclosed in filings (e.g., 2019 10-K), and no SEC or DOJ actions allege fraud as of March 31, 2025.

SOX Section 402 (Executive Loans): This prohibits personal loans to executives. Advent payments were for manufacturing services, not loans to Powers. The 2019 10-K confirms these were R&D expenses, not personal benefits.

SOX Sections 302/404/906 (Certifications and Controls): Powers certified financial reports, and the 2023 10-K states internal controls were effective, with no material weaknesses. A 2019 SEC settlement fined NWBO $250,000 for past control weaknesses (2007–2018), but these were remediated, and no issues persist.

Misappropriation: No evidence exists of embezzlement or wire fraud. Advent’s role in producing DCVax-L benefits NWBO’s regulatory goals, not Powers personally.

Simplified Explanation: NWBO paid Advent to make its cancer treatment, not to give Powers money. Everything was reported, and no laws were broken. The government hasn’t said Powers stole anything.

Claim 4: Lack of Independent Board Oversight
ChatGPT Rebuttal: NWBO had a Conflicts Committee of independent directors to review related-party transactions, disclosed in filings. SEC proxy rules were followed, and NWBO isn’t subject to NYSE/NASDAQ listing standards.

Verification: This is correct, with clarification:
Independent Oversight: The 2019 10-K confirms: “A Conflicts Committee of independent Board members has reviewed and negotiated all related-party arrangements.” Powers was excluded from votes on these transactions, per the 2023 10-K.

SEC Proxy Rules (Schedule 14A, Rule 14a-9): The 2023 DEF 14A proxy statement discloses related-party transactions and the audit committee’s role, complying with rules against misleading statements. No lawsuits allege proxy violations.

Listing Standards: NWBO trades on OTCQB, not NYSE/NASDAQ, so those exchange rules don’t apply. Still, NWBO voluntarily uses a Conflicts Committee, showing good governance.

Simplified Explanation: NWBO has a group of independent people on its board who check deals with Advent to make sure they’re fair. They told shareholders about it, and NWBO isn’t on a big stock exchange, so some rules don’t apply.



Additional Context: Addressing the “Fudders” Narrative
The “fudders” claim Powers used Advent to enrich herself, but this ignores context:
Advent’s Role: Advent (formerly Cognate UK) has been key to DCVax-L production, achieving MHRA GMP certification in February 2025 for commercial manufacturing, per NWBO’s press releases. This benefits NWBO’s regulatory goals, not Powers personally.

Historical Payments: A 2014 Seeking Alpha article criticized NWBO’s $25.4 million R&D expense to Cognate, but this was for clinical trial manufacturing, not personal gain. Cognate often accepted stock over cash, helping NWBO survive cash shortages, as Nancy Kim’s 2024 article notes: “Cognate was willing to accept a substantial portion of its billings in NWBO stock to reduce its cash burn.”

Powers’ Support: Powers loaned NWBO $5.4 million in 2018 via convertible notes (2019 10-K), showing she supported the company during financial strain, not drained it.

Conclusion: The claims are baseless. Payments to Advent were for legitimate services, fully disclosed, independently reviewed, and compliant with SEC and SOX rules. The narrative of self-enrichment misrepresents NWBO’s operations and Powers’ role in keeping the company afloat.