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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.
There are no Transcripts on NWBO.
Tue, Sep. 30, 11:00 AM
- TheStreet's Editor-In-Chief Janet Guyon writes an extensive rebuttal to an article published on September 27 by the Washington Post's Steven Pearlstein where he accuses Adam Feuerstein of being in bed with short sellers regarding Northwest Biotherapeutics (NWBO -1.9%). In short, he accuses AF of securities fraud.
- TheStreet, unsurprisingly, takes exception to the piece saying Mr. Feuerstein does not own shares in NWBO, is not in cahoots with any hedge funds and supports his articles with facts. Ms. Guyon requests a retraction.
- Many observers will undoubtedly find the situation humorous considering AF's confrontational style. Mr. Pearlstein, however, questions his integrity which is out of bounds without the facts to back it up.
Tue, Sep. 16, 9:20 AM
Tue, Sep. 16, 8:53 AM
- Northwest Biotherapeutics (NASDAQ:NWBO) is up 10% premarket on good volume in response to its announcement that U.K. authorities have designated DCVax-L as a Promising Innovative Medicine (PIM) under its new Early Access to Medicines Scheme. The program, launched in April of this year, provides for accelerated approval for promising new therapies that address a serious disease or condition with high unmet medical need. It is akin to the U.S. FDA's Breakthrough Therapy Designation (BTD).
- PIM approval is a two-step process. Step one is an evaluation by the Medicines and Healthcare Products Regulatory Agency (MHRA) to determine if the product meets three criteria: 1. it addresses the aforementioned serious disease or condition with high unmet medical need; 2. the product is likely to offer a major advantage of available treatments; 3. the potential benefits outweigh the potential adverse effects. Step two is an evaluation of the clinical data to assess the product's benefits and risks. If MHRA's opinion is positive, the product may then be prescribed by physicians before it is formally licensed and while it is still in clinical development.
Mon, Aug. 25, 4:41 PM
- Northwest Biotherapeutics (NWBO -2.1%) closes a $17.5M convertible note paying 5% interest for a term of three years. The notes are convertible into common stock at $7.50 per share. Investors also have three-month option to buy an additional 30% of the notes.
- Proceeds will be used to fund increased manufacturing capacity and ongoing clinical trials.
- NWBO shares closed today at $5.98.
Tue, Jul. 8, 6:22 PM
- Northwest Bio (NWBO) CEO Linda Powers denies charges contained in yesterday's Seeking Alpha article by Richard Pearson that the driving force behind gains in the stock price is a string of promotional pieces, asserting that the author didn't mention "the real reason, that the company has made tremendous operational progress."
- Pearson contended that "many of the authors who have written on Northwest are using fake identities and fake credentials. They pretend to be biologists, other scientists, or fund managers. In fact, they are just paid writers."
- Powers says NWBO has a business relationship with an outside investor relations firm that promotes the company on social media sites, but that writers are not commissioned to write puff pieces, as Pearson alleges.
- NWBO has dropped nearly 7% since Pearson's story was posted Monday morning.
Fri, Jun. 20, 9:18 AM
- Northwest Biotherapeutics (NWBO) asserts that Mr. Feuerstein's June 19 article is misleading and inaccurate. For starters, it says that has not received a "rebuke" from any clinical trial site nor is there a basis to receive one. It claims that it has consistently stated that it would release interim data on an ongoing basis regarding the DCVax-Direct Phase 1/2 clinical trial. It confirms that the disclosed data originated from medical files sent to the company from the trial sites and a CRO, but it claims that reporting interim results is not unusual for an unblinded open-label study like DCVax.
- CEO Linda Powers says, "...Feuerstein seeks ever more sensationalized ways to try to smear the Company. This is not even the semblance of professional analysis. We condemn this attack campaign and appreciate the strong support we are receiving from shareholders, patients and other commentators. We intend to continue our progress undeterred."
Thu, Jun. 19, 12:45 PM
Thu, Jun. 19, 10:37 AM
- MD Anderson VP of Clinical Research Aman Buzdar, M.D., takes issue with Northwest Biotherapeutics' (NWBO -10.4%) trigger-happy behavior regarding disclosing preliminary and unconfirmed results from the ongoing DCVax clinical trial. The company has issued five press releases and conducted one conference call disclosing the results from individual cancer patients who have had single inoperable tumors injected with DCVax-Direct. This is problematic due to two issues: 1) the investigators have not reviewed or analyzed the data because patients are still being enrolled and treated and 2) NWBO's published "results" come from patient case report forms which the trial sites are obligated to send to the trial sponsor.
- Dr. Buzdar says, "I have read the information that the company has put in the public domain. It is extremely unusual and inappropriate." He terms the company's disclosures inappropriate because injecting a tumor with any substance can cause regression due to necrosis-causing inflammation. He says, "..it is a tremendous leap to say that this is a real response."
Thu, Jun. 19, 9:11 AM
Mon, Jun. 16, 12:45 PM
Wed, Jun. 11, 12:47 PM
Wed, Jun. 11, 10:17 AM
- Inovio Pharmaceuticals (INO +1.6%) takes umbrage over yesterday's bearish article published by TheStreet's Adam Feuerstein. In today's press release, the company says it intends to report VGX-3100's Phase 2 data at the end of July. At present, it remains blinded.
- Pertaining to efficacy, the study measures regression of disease from late-stage cervical pre-cancer (CIN 2/3) to early stage pre-cancer (CIN 1) or elimination of disease. The study is 80% powered to achieve a 52% response rate in vaccinated subjects compared to a hypothetical 25% in the control group. The 25% figure is based on natural regression response rates that have ranged from 4% - 40% in other studies.
- CEO Joseph Kim will undoubtedly join Northwest Biotherapeutics (NWBO +5.8%) Chief Linda Powers in declining a dinner invitation with Mr. Feuerstein.
Wed, Jun. 11, 9:13 AM
Tue, Jun. 10, 9:09 AM
- Northwest Biotherapeutics (NWBO) initiates a DCVax Phase 3 clinical trial at a medical center in Dresden, Germany. Three more sites will come on line in June followed by four more in July. The Dresden site has begun screening patients for enrollment. The initiation process will take ~six months per site according to the company.
Thu, May. 29, 10:04 AM
- Northwest Biotherapeutics (NWBO -0.2%) takes umbrage with TheStreet's Adam Feuerstein in response to his May 27 article asserting that the company's DCVax isn't working. He says the company's stated maximum tumor shrinkage of 28% in some Phase 1 trial patients falls short of the globally-accepted RECIST standard of at least a 30% reduction to qualify as a valid partial response.
- Northwest retorts in a press release today that there are numerous established measures of patient responses to therapies. It makes no claims regarding the RECIST criteria, but acknowledges the 30% partial response metric. It also cites the standard of "Stable Disease" for tumor shrinkage up to 28%. CEO Linda Powers says, "Feuerstein's so-called analyses consist of false statements, serious misrepresentations and personal attacks and smears."
- The rhubarb began in March.
Tue, May. 27, 9:11 AM
NWBO vs. ETF Alternatives
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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