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Northwest Biotherapeutics: An Analysis Of What We Know About DCVax Direct
- Immuno-oncology is one of the most exciting areas for cancer research and cancer vaccines should be considered as a promising research area within immuno-oncology.
- Cancer vaccines might have been expected to produce great investor interest, but a long string of clinical trial failures over the last decade has made investors cautious or skeptical.
- However, evidence is growing that strongly suggests that cancer vaccines have therapeutic effects that may lead to their having a meaningful role in cancer treatment.
- Investor caution on Northwest also has been the result of bears questioning clinical data that has led to a major short selling effort against the stock.
- Clinical data and actions taken by regulators in the UK and Germany to grant early access to DCVax-L are beginning to undermine important parts of the bear thesis.
Northwest Biotherapeutics' DCVax-L: A Reimbursement Perspective
- NWBO is currently in talks with regulators regarding reimbursement.
- DCVax-L reimbursement numbers vary significantly amongst sources.
- This article examines DCVax-L reimbursement from a value perspective putting a reasonable price at approximately $96,600 per patient.
Update: Northwest Bio Benefits From Two Financings, Woodford Makes Encouraging Investment
- Northwest Bio announced two financings on Wednesday. Woodford, a UK based equity income fund, agreed to make a $25 million investment in Northwest Bio at $5.79/share.
- I reiterate my "Hold" rating on Northwest Bio.
- Given Northwest Bio's dwindling cash position, the two financings should be received positively by shareholders. Woodford's significant investment also instills confidence regarding the potential of Northwest Bio's clinical pipeline.
Northwest Biotherapeutics: Capital Raise Of $35 Million Could Be A Positive Catalyst For The Stock
- Neil Woodford, a highly respected UK portfolio manager has just invested $25 million on very favorable terms and the Company has also received $10 million from a mortgage financing.
- This takes away the near term concern about financing that has been a lid on the stock.
- There is now a cash runway to see the Company through to the release of phase 3 results on DCVax-L in 2H, 2015 and completion of phase 1 DCVax Direct.
- I see this as a significant catalyst for the stock.
Northwest Biotherapeutics: DCVax-Direct Validation And Updated DCVax-L Ph III Modeling
- A recent abstract published in the JITC provides validation to Company PRs on DCVax-Direct efficacy.
- An examination of the only possible competitor to DCVax-L for ND-GBM finds its therapy lacking in key ways.
- A qualified biostatistician provides modeling expertise on the DCVax-L Ph III trial.
- After multiple sector wide sell-offs, many small biotechs indiscriminately lost much of their stock value.
- Market forecasts and the resultant public sentiment provoked these moves rather than specific company fundamentals.
- The end result is an opportunity: oversold stocks with high intrinsic value.
Northwest Bio's Latest Financing Abuses Its Shareholders: Is The Charade Over?
- NWBO had about $12.3 million in cash (including cash equivalents and cash in “custodial accounts” . . . whatever that means) as of June 30th,
- And raised $17.5 million in August through a convertible note.
- Investor expectation is that NWBO will start earning revenues in Germany by the end of 2014.
- Raising $11.5 million at this time and re-setting warrant terms is an abuse of shareholders, with no rationale for the financing provided by NWBO.
Update: Northwest Biotherapeutics Announces $11 Million Financing, Harms Shareholders Again
- Northwest Bio announces $11 million financing, causing the stock to drop 5%.
- Considering Northwest Bio completed a $17.5 million convertible debt offering back in August, I didn't anticipate its latest announcement of yet another financing.
- While shareholders may be unhappy with this announcement, Northwest Bio must fund its clinical programs one way or another.
- I reiterate my "Hold" rating on Northwest Bio given the important clinical designations for DCVax-L, and the company's "stronger" financial position.
Northwest Biotherapeutics Misrepresents Clinical Trial Data
- Survival benefit of DCVax-L shown in Phase I trials overstated by NWBO.
- Key findings from DCVax-L Phase I trials are ignored in company presentations.
- Ongoing DCVax-L Phase III trial does not incorporate key lessons from earlier trials.
- There have been a lot of strong words exchanged about Northwest Biotherapeutics.
- Small companies that have been unable to interest anyone else in their technologies have a difficult time of it, to be sure. But we don't need to go to conspiracy theories to explain this.
- Wonderful drugs don't get buried by short-sellers. Drugs get buried by data.
Update: Northwest Biotherapeutics Stock In Turmoil, But Not For Long
- Medicines and Healthcare Products Regulatory Agency designates DCVax as a Promising Innovative Medicine.
- Despite this achievement, Northwest Biotherapeutics stock has faltered. This follows as the company completed a $17.5 million convertible debt offering back in August.
- At this time, I amend my bear thesis on Northwest Biotherapeutics to hold, since I believe the latest drop in stock price is unwarranted.
Northwest Biotherapeutics: U.K. May Grant Early Patient Access For DCVax-L Prior To Formal Approval
- UK designates DCVax-L as first drug to be considered for early access approval under recently enacted EAMS program.
- Earlier this year, Germany granted approval to DCVax-L under its early access program.
- Early access means that DCVax-L can be prescribed prior to formal approval that might come in 2016. I expect revenues from German sales in 2014.
- These actions by regulatory agencies are unsurpassed validation for the potential of the DCVax-L technology, in my opinion.
- On another positive note, the phase 2 trial of DCVax Direct should begin in 4Q, 2014.
Northwest Bio: The Data Monitoring Committee Addresses The Status Of The DCVax-L Trial
- Chairman of DMC says that there has not yet been an interim analysis performed for efficacy in the phase 3 trial of DCVax-L.
- He says that NWBO is totally blinded to the data and has no idea of how results are trending.
- This is a serious blow to the bear thesis that maintains that the interim analysis had been performed, the results were bad and that NWBO hid the results from investors.
Northwest Bio - You Can See This Data, But Not That Data
- Northwest Bio has a history of showing data too soon.
- Now it's refusing to release data when it's appropriate to show it.
- Failing to release data now means that DC-Vax likely failed and the company is struggling to find something positive by adding "enhancements" to its studies.
- Now is the perfect timing to short NWBO, as all but the most die hard longs must be getting skeptical.
- The company is likely broke right now, and needs to do another equity raise.
Northwest Bio And The Curious Relationship With Cognate BioServices
- NWBO granted $20-$70 million in equity to a contractor controlled by its CEO in Q1 2014.
- The contractor appears to be wildly overinflating service fees to NWBO.
- NWBO does not segregate financial duties to assure internal controls.
Northwest Biotherapeutics: Responding To Richard Pearson's Article Alleging A Promotion Scheme
- I categorically deny all charges that Pearson has raised in his article that I engaged in the promotion of NWBO or any other company.
- I categorically deny that I received any compensation to write about NWBO, or any other company.
- Pearson presents only circumstantial arguments to support his case. I have asked Pearson for objective evidence that I have been paid to write on companies.
- Northwest Bio has been the subject of a massive promotional campaign which has seen the stock price soar.
- Many of the authors involved have close hidden ties to promotional firm MDM Worldwide and / or Redfish Creative.
- In some cases, authors have used fictitious identities and fake credentials within healthcare or finance. In fact they are simply paid writers.
- Redfish Creative reveals its use of bulk pricing for writing undisclosed promo articles and mass message board postings on Yahoo.
- Much of the promotional information written on Northwest has been either misleading or downright wrong.
Placing Northwest Biotherapeutics In The Figure-4 Deadfall Trap
- The Figure-4 Deadfall Trap metaphor is useful in examining the flimsy sticks we use to prop up our investment thesis in any biotechnology stock, but especially those engulfed in controversy.
- There was a hidden sales message in the cascade of recent DCVax-Direct press releases, and investors bought it hook, line and sinker.
- Northwest Biotherapeutics has postponed DCVax-L trial completion dates, expanded and contracted estimated enrollment numbers, avoided updating actual patient participation statistics, and hinted at trial expansion.
- Instead of fighting progression-free survival (PFS) as a primary endpoint in the DCVax-L trial, I'll get you to see how it's an investment advantage, at least up until approval.
Northwest Biotherapeutics Gets Called Out: Should Investors Worry?
- Northwest Biotherapeutics plummets more than 17% for touting positive interim results.
- Is the market responding appropriately?.
- To answer this question, here are several important things investors need to know.
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Northwest Biotherapeutics Inc is a development stage biotechnology company engaged in the development of immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies.
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