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Expert Financial Analysis and Reporting

Northwest Biotherapeutics: Some Thoughts about the Upcoming Presentation by CEO Linda Powers on Monday, January 26th. (NWBO, Buy, $6.28)

  • Ms. Powers will present at 10:30 AM.
  • She will then participate in a discussion panel with representatives from Amgen, Roche Diagnostics, Adaptimmune and Biovest International.
  • Prior to her presentation representatives from Bristol-Myers Squibb, Merck and M.D. Anderson will speak.
  • I don’t know if there will be anything new that will be presented but inclusion of Northwest with this prestigious group of presenters is a significant enhancement of its credibility.

Investment Significance of this Presentation

Linda Powers will make a presentation on Monday January 26 at the Immunotherapy Forum 2015 in Washington D.C. at 10:30 AM. Northwest Biotherapeutics has been the subject of repeated criticisms from bears that no credible people take the Company’s technology seriously. I have printed later in this report the January 26th morning agenda for the conference that shows Northwest Biotherapeutics (NWBO) presenting alongside Bristol-Myers Squibb (BMY), Merck (MRK), Roche Diagnostics and M.D. Anderson among others; this is a prestigious and credible group to be a part of.

Northwest has had to battle an extensive prejudice by investors against cancer vaccines. And in the financial crisis of 2008, a delay in a clinical trial caused a financial crisis that reduced the Company to a penny stock with virtually no cash. Its struggle back from those dark, near bankruptcy, days to the current time when it is nearing completion of the phase 3 trial of DCVax-L in newly diagnosed glioblastoma multiforme and is preparing for phase 2 trials with DCVax-Direct in inoperable solid tumors that could be the basis for regulatory approval, if successful, has been a remarkable journey.

Still, the corporate path taken by Northwest has been highly unusual and not appreciated or supported by Wall Street analysts. This has enabled repeated bear attacks on the stock and indeed there are over 9 million shares sold short. Central to the bear argument is that Northwest and its technology are not credible. Approval  of DC-Vax-L by regulatory agencies in Germany and the UK that allow widespread patient access and in the case of Germany reimbursement, prior to completion of the pivotal phase 3 trial should have been taken as high validation of the Company’s technology, but bears were able to plant doubt about the meaning of these approvals.

I think that the inclusion of Northwest in this prominent conference speaking on a peer basis with some of the leading companies in immuno-oncology could be a watershed event for the company in helping it to gain investor credibility. It certainly diminishes the bear arguments which have been strident. One prominent bear has actually stated that DCVax-L and DCVax-Direct are no better than grapefruit juice.

Ultimately, the success or failure of Northwest will depend on the results of its clinical trials. Appearing at this conference has no effect on the potential outcomes in those trials. We will get some meaningful data on the phase 1 trial of DCVax Direct in the first half of 2015 and there will likely be an ASCO presentation in May 2015. Topline results on the phase 3 trial of DCVax-L and interim phase 2 results for DCVax Direct are probable 2016 events. That is the year of truth. The importance for current investors is that this increased credibility may cause new institutional investors to take a hard look at the stock and it may cause some bears to rethink or soften their position.

I don’t know what to expect of Ms. Powers presentation. It may just be comparable to and no more than her recent presentation at the Biotech Showcase on January 8th. I also don’t know if anything will come out of other presentations or panel discussions, but I will be listening carefully to see if there a few new nuggets of information that come out of this conference.

More Background on the Conference

Linda Powers will make her presentation Monday January 26 at the Immunotherapy Forum 2015 in Washington D.C. at 10:30 AM. There will be a live webcast of the presentation available at I am not sure if other parts of the conference will be webcast. Her topic is Personalized Approaches to Immune Therapy. She will then participate in a discussion panel with representatives from Amgen (AMGN), Roche Diagnostics, Adaptimmune and Biovest International. None of the other panel participants were selected to give an individual presentation.

  • Adaptimmune has a partnership in engineered T-cell space with Glaxo and is highly regarded. It is the still privately held UK counterpart to Kite (KITE) and Juno (JUNO).
  • The lead product of Biovest International is BiovaxID which is a patient specific cancer vaccine that was developed in partnership with the National Cancer Institute.  It has completed a phase 3 trial in follicular non-Hodgkin’s lymphoma, mantle cell lymphoma, and potentially other B-cell cancers.
  • Amgen is anticipating phase 3 results in malignant melanoma for its cancer vaccine T-Vac (talimogene laherparepvec) in 2015. This technology is based on an engineering of the herpes virus that causes cold sores. The virus is attenuated so that it can no longer cause infections, is made more selective for cancer cells and is also engineered to secrete GM-CSF which stimulates an immune response. This dual mechanism of action directly attacks cancer cells as well as generating a broad immune response. It is an off the shelf product unlike the autologous products of Northwest and Biovest International; it is injected directly into the cancer.

Earlier in the morning, speakers from Bristol-Myers Squibb and Merck will undoubtedly discuss their checkpoint modulators, Opdivo and Keytruda. Also earlier, than Ms. Powers ‘presentation, Dr. Laurence J.N. Cooper, Director, Immunology Laboratory of Physician Scientists, Department of Immunology at The University of Texas MD Anderson Cancer Center will speak. M.D. Anderson has run the phase 1 trial of DCVax Direct. However, I have not seen Dr. Cooper’s name mentioned in regard to this trial so that he may or may not have something to say about DCVax Direct. The complete morning agenda is as follows:


Conference Day One: January 26th 2015

Registration & buffet breakfast in the Exhibition / 1-2-1 Meeting Area
07:30 - 09:00
Breakfast Briefing sponsored by Marken
07:45 - 09:00
Marken and GlobalCare Clinical Trials present an interactive workshop:
Andrew Billimore
Senior Director, Global Key Accounts
Andrew Billimore, Senior Director, Global Key Accounts, Marken Andrew has 15 years experience in logistics, transport and distribution of temperature sensitive lifesaving pharmaceuticals,...

Reframing expectations for immunotherapy - what are the highlights and cautionary messages from 2014?

Chair's introduction and opening keynote
09:00 - 09:20
Reassessing the scope, promise and limitations of the field: Industry,...
Michael Giordano, M.D.
Bristol-Myers Squibb
Senior Vice President, Head of Oncology Development
Michael Giordano, M.D., is Senior Vice President, Head of Oncology Development at Bristol-Myers Squibb (BMS). Michael is accountable to the Chief Scientific Officer.  ...
Industry keynote
09:20 - 09:40
Roy D. Baynes, M.D., Ph.D.
Merck Research Laboratories
Senior Vice President Global Clinical Development
Roy Baynes is Senior Vice President Global Clinical Development at Merck Research Laboratories in Rahway, New Jersey. He was previously Senior Vice President of Oncology,...
Question & discussion
09:40 - 09:45
Investor view
09:45 - 10:05
Dr Howard Liang, Ph.D.
Leerink Partners, LLC
Managing Director, Biotechnology Equity Research
Key opinion leader view
10:05 - 10:25
Dr Laurence J.N. Cooper
The University of Texas MD Anderson Cancer Center
Director, Immunology Laboratory of Physician Scientists, Department of Immunology
Dr. Laurence J.N. Cooper obtained his M.D. and Ph.D. degrees at Case Western Reserve University in Cleveland and then training in Pediatric Oncology and Bone...
Questions & discussion
10:25 - 10:30
Personalized approaches to immune therapy
10:30 - 10:50
Linda F. Powers
Northwest Biotherapeutics, Inc.
CEO, Chairman of the Board
Ms. Powers has served as the Chairman of Northwest Bio’s Board of Directors since her appointment on May 17, 2007 and Chief Executive Officer since...
Panel discussion: How might immunotherapy complement or displace current treatment regimens?
10:50 - 11:30
How might immunotherapy complement or displace current treatment regimens?

  • What...
Dr Carlos Santos
Biovest International
On July 8, 2013, Dr. Carlos Santos was appointed as our Chief Executive Officer. Since 2009, Dr. Santos has managed all key aspects of our...
David J. States, M.D., PhD
Biovest International
Chief Medical Officer,
Dr Gregory Friberg
Executive Medical Director, Global Program Area Lead & US Medical Organisation TA Head
Greg received his A.B. degree in biochemistry from Middlebury College and M.D. from New York Medical College.  He completed his residency training in Internal Medicine...
James Noble
James has been involved with Adaptimmune’s adoptive T cell therapy technology since 1999, when Avidex Limited (the predecessor company to Adaptimmune) was founded. He has...
Dr Klaus Bosslet
Roche Diagnostics GmbH
Site Head Discovery Oncology, Pharmaceutical Research & Early Development (pRED), Roche Innovation Center Penzberg
Klaus Bosslet earned his PhD from the University of Heidelberg (1980) in the field of Tumor-Immunology and Virology. After a PostDoc at the German Cancer...
Linda F. Powers
Northwest Biotherapeutics, Inc.
CEO, Chairman of the Board
Ms. Powers has served as the Chairman of Northwest Bio’s Board of Directors since her appointment on May 17, 2007 and Chief Executive Officer since...

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  1. Thank you Larry…..If you hear anything more on how I might tune in earlier and also after Linda’s presentation, please leave a note here, as I will check back on Mon. AM….I realize the “bashers” will say she brought herself in and it means nothing, but IMHO, that since she is accepted and on the same panel as those prestigious Dr.’s are, it is huge for me…..I think, again, IMHO, that she will have to be more specific than at the Jan. 8th presentation because this is to scientists, not Wall Street analists…Therefore, I do expect to hear new or clarified information that is more analyitical than in previous presentations…..Last year, I think, the CMO gave a presentation at the same conference, so we do have a history of attending, but the organization must be giving some credit and weight to what NWBO is doing to invite it back and ask, not only for a 20 minute overview on progress, but also to join the discussion group which will be fielding some tough questions and trying to deepen the understanding of what progress is being currently made in Immune Therapy….Should be great listening, and again, I hope we can listen to all the presentations, if possible….Again, thank you Larry for summarizing what is happening and what might be happening at NWBO…As Linda always says, “Keep Tuned”…..Cheers

  2. Lawrence Braverman says:

    From a stock perspective:

    Perhaps the January rise in the NWBO stock price has something to do with the anticipation over this conference… if so, I’d expect that a lack of significant news (along with the expected Feuerstein putdown) might cause the price to stumble in the near term; I mean, look what happened to AGEN yesterday after his latest slap: down 5.5%.

  3. What are your thoughts on this possibly being a stage for a partnership with 1 of the 2 approved PD-1 drugs to test in combination with DCVax? Honestly, I’m not expecting much, if anything new at all. But it is curious that Northwest will be side by side with the makers of Keytruda and Opdiva, don’t you think?

  4. There is a very high probability of the drugs being combined in a phase 1 trial.

  5. Good article Larry,

    I believe when NWBO announces complete enrollment on on it’s DCVax-L Phase 3 trial than the company will get it’s “watershed” moment. Hopefully Linda is not letting off the gas on enrollment while German negotiations are continuing.

  6. Linda’s presentation sounded good to me, just MHO…..Good news about the # of Compassionate Care patients that are still alive….Wish I could have heard the entire presentations, but of course, I would have to attend the conference, LOL….Can’t wait to hear your opinion on the presentation….

  7. Sorry for the question….Did Linda present “new” information on the 55 compassionate care patients on Monday??? I thought she did, but because no one, including yourself, has made that point, then I guess I am wrong and no new information has been forthcoming from NWBO….If you could at some point, clear this up for me, I would appreciate it….Cheers and dig out

  8. Yes. I will have a report out tomorrow or the day after. The data is encouraging but not indisputably conclusive of a meaningful therapeutic effect.

Trackbacks & Pingbacks

  1. The Potentially Key Role of Northwest Biotherapeutics in the Emerging Immuno-Oncology Landscape (NWBO, Buy, $6.19) | Expert Financial Analysis and Reporting | Smith on Stocks

    […] of personalized immunotherapy drugs in the treatment of cancer. She was prominently featured in the agenda as a speaker in which she explained Northwest’s business strategy and as a participant on a panel […]


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