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"All the while, I see NOTHING posted on NWBO'S corporate structure change. Everything about it screams set up for executing a CUSP registration change."
Some of us, me included, are not up to speed with what this phrase and the strategy behind it means. Could you explain what this means? Thanks.
Yes, the numbers are obvious. A penny a day keeps investors away. 5 years ago the share price was nearly the same as today and after the ASCO debacle several years ago the pps has continued to decline, and for months now at an approximate rate of a penny a day. Assuming the MHRA actually keeps to its 150 day + 60 day pause to conclude their review the pps could decline another 29 pennys. I voted to reject rewarding this management and their rubber stamping Board lackeys every time the issue arose. I’m waiting for Merck or Roche or another competent entity to take this otherwise good science and save some lives. Franchising is another delay tactic and smokescreen. LP and her crew will then take the options unjustly rewarded to them by “shareholders,” cash out millions and fade to black.
Shocked that you are parsing and trying to find any meaning in anything they say given their history of stretching the truth. They say what is needed to keep kicking the can down the road but also inspiring hope. So we continue to wait but unfortunately cancer patients cannot wait forever. Hopefully we submit FDA application in 2025[/I]
Correct, and a perfect summation. For those of us who are actual investors, and not acolytes, the facts are indisputable - this management crew continues to gaslight us with their milestone "achievements" and con the acolytes into giving them free options worth millions while simultaneously tanking shareholder value. The numbers don't lie, they do. The almost religious like fervor shown by the "shareholders" in praising and rewarding a CEO+CFO+++ team that utterly fails to increase shareholder value is like watching a pilgrimage to nowhere. Did you see how happy they were at the now bi-annual ASM when they realized the pilgrims once again rewarded them with "true up" options the pilgrims won't be getting? For those of you, like me, who had relatives die from GBM while waiting for this crew to actually accomplish a worthy goal and become a stellar investment don't be surprised when their new breadcrumbs blow away.
Thanks for the update and clarity. FWIW according to the CHM website their next meeting date(s) coincident with the 150 day approval process guide are May 30/31 and June 26/27.
CHM meeting dates:
2024
Jan Feb March April May June July Aug Sept Oct Nov Dec
25/26 22/23 21/22 25/26 30/31 27/28 25/26 29/30 26/27 24/25 21/22 19/20
2025
Jan Feb March April May June July Aug Sept Oct Nov Dec
23/24 27/28 27/28 24/25 29/30 26/27 24/25 28/29 25/26 30/31 27/28 18/19
https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership#chm-meeting-dates
"Yet you felt the need to give your worthless opinion. I can look in a mirror tonight, can the rest of the fudsters as they count their Judas coins?"
My rare comments and opinions are always directed at the quality of management decisions. I have been invested here for over 10 years. I was buying when the sp was $12 and when it was $.14. Unlike you, I don't denigrate the opinions of other board members, so again, piss off. Silver lining - I just discovered the Ignore button.
Didn’t ask for your opinion, keep it to yourself and piss off.
Yes, and you can bet the same management that just pulled the dog ate my homework routine once again will be giving us all another tongue bath in December just in time for their annual grease their palms meeting, aka Annual Meeting.
Merck recently filed a Prospectus on May 8, 2023 to raise a lot of funds to buy an immunotherapy company named Prometheus for $10.8 Billion. I am a bit out of my lane in reading these SEC filing’s but it looks like they raised a hell of a lot more than they needed to buy this company. What do you suppose they’re doing with the rest of it?
Spot on correct!! This went exactly as I believed it would. To those that voted for this mediocrity, once again, you’ll be getting exactly that. Why else do you think they put the ASM on the last business day of the year and had you vote for their pay raises and share increases before you heard from them, Sounds just like Popeye’s friend Wimpy asking for a hamburger today and you’ll be paid for it on Tuesday.
I will be starting my phased withdrawal from this mirage investment since I’m certain now I will never outlive it. I just hope there’s a buyout in the near future.
"We have been waiting for a progress update from the company for over 2 years. The entire 'quiet period', shareholders were assured (via back channels, not from official company PR's, that would be asking too much) that once the TLD and journal were released there would be a flurry of PRs ready to roll.
We finally got the journal, and the only PR has been an unexpected lawsuit. One that, if successful, will not even benefit shareholders."
Agree completely. I first heard of NWBO years ago when Goldman appeared on Fox Business to schill for new shareholders. Where is he now? My brother-in-law had just been diagnosed with GBM and I hoped NWBO would deliver their treatment. Death came right on schedule at 16 months even after wearing the NVCR helmet. Still nothing but "we anticipate" from LP regularly. That was also when outstanding shares were at 66 million. Nearly a 20x dilution since then to 1.7 billion expected after the ASM.
I will be voting no on everthing if the silence continues to Wednesday. I anicipate we will once again hear "we anticipate" at the ASM. We will also likely hear something similar to Popeye's pal Wimpy when he famously said "I will gladly pay you Tuesday for a hambuger today." Pay management now for a promise tomorrow - again...
Agree 100%, thank you. This is an investment, not a cause. Time for management to produce for the shareholders or pass it to an entity that will.
Correct. This move should properly be viewed as a defensive counter- strike to force them to stop the “spoofing”practice as we all assume something big is coming and management wants to keep another May 10 debacle from occurring. I have justifiably been very critical of managements’ lack of shareholder support and apparent self dealing, but in this case they’ve made the right move.
Agree completely. Very likely they will be forced by way of threatened or actual litigation to hold the ASM. If I hear the word "anticipate" from the CEO/COO/CFO, etc, LP once again I'm out. No more goalposts getting moved, hiding behind nefarious forces allegedly after them, unprofessional barroom interviews, hiding behind a "silent period" for 2 years without explaining to the shareholders why, and on and on and on. It never ends. May 10 was a neutron bomb lighting up their incompetence and lack of transparency. Yet management still gets paid and gets "milestone" bonuses. For what, a 95% loss in shareholder value since the heady days of 66 million authorized shares and a $12 share price?
With regard to voting rights, excellent points OpennyS, thank you.
If a yes vote guaranteed the current management would inflate their ever present golden parachutes and depart in favor of a Merck or BMY or other competent team I will vote with you.
I have been Intrigued by the timing and real purpose of the New York presentation so close to ASCO. Spreading pheromones looking for a BP mate? Having watched over half million $ of my equity dissipate on May 10th I’m out of patience with management’s delay and duck and cover tactics.
I also agree with you PM. My 475,000 shares will likely vote no to dilution if proposed. In the 8+ years as a shareholder I’ve lost track of how many phrases like “we anticipate” management has gaslighted us with yet here we are again well under $1 a share with even more fresh breadcrumbs to follow. Put up or shut up and sell.
Your position - "Rank and file shareholders should reject any request for an increase in the number of authorized shares unless reasonable concessions to us like a clear time frame for completion of whatever is pending with the statistical analysis plan, unblinding, and the public release of top line data are given." Absolutely correct! No more vague assurances like "pedal to the metal" which any half-assed lawyer could defend to mean anything they wanted. Put up or get out, or at least LP should donate her time if they are so close to the finish line. Remember the vague pronouncements they made at last year's ASM at how close they were to finishing? Some of the bears prior arguments now appear rational to me given the continual secrecy and failure to produce anything by the Board and management. If it hadn't been for Woodford I would not be invested here. Remember, LP is a fund manager first and she and the compliant, Burisma-like Board indirectly and adroitly used NWBO shareholder money to build up Cognate but then LP was forced by the SEC to disgorge it for conflict of interest reasons. Who got paid? Not the NWBO shareholders. Shareholder money was also used to buy and build up Sawston and then sell off pieces of it to continue to do what again? Now that management and LP have gotten their millions of shares, options and warrants at our expense (read dilution) they appear to be making the moves to sell out and make LP a billionaire and the toast of the town in DC. I would happy at this point to get my original investment returned. Damn that Woodford, and why is Smith now pumping a competitor to NWBO?
I am. I voted against the re-election of LP and the current Board last year and will do so again. I still can not fathom why shareholders should continue to pay the salaries of employees who do virtually nothing and obfuscate what little they actually do. They run this company like a secret private equity fund, repeatedly move the goalposts and then run for cover by claiming they can't discuss anything more. UFO sightings have more credibility. If it comes to lawsuit time, I'm in.
Agreed, I voted my 400K+ shares to remove her, the other do nothing board member and deny any more stock compensation to Board members who have proven to be of no value to shareholders other than themselves. Enough is enough, no more patience with preparing-to-prepare to maybe, possibly, think about unblinding after their self-imposed double top secret probation ends sometime in the future. Any wagers on who gets their "dumpster fire" put out with the proceeds from Sawston? My money is on LP, literally. Believing in the science had two purposes for me, 1)my brother in law died last summer from GBM and 2)NWBO is an investment, not a charity research project. I was astounded to see what the $$ the officers of NWBO get paid, and for what, slick self-dealing in promoting a never ending trial and the paychecks that went with it? If by some miracle the pps gets back to my break even point, I'm out asap.
Make that 1.2 Million, I'm in.
Thanks for your reply, that was helpful to a non-science type like me.
Thanks, that also got my attention.
Is CD47 an issue for DCVax? I could not find any reference to it in any of the NWBO literature I have and I'm wondering if the article I ran across today has implications for -L or Direct. Here are a few excerpts from the article:
"Forty Seven Inc. Completes $75M Series A Financing and Licenses Technology from Stanford University to Advance Next Generation Immuno-Oncology Programs
Lead program stimulating ingestion of cancer cells by the immune system is in two Phase 1 clinical trials for solid tumors and acute myeloid leukemia (AML)
PALO ALTO, Calif., Feb. 24, 2016 /PRNewswire/ -- Forty Seven Inc., a clinical-stage immuno-oncology company, announced today that it has completed the first half of a committed $75 million Series A financing round and has licensed the rights to multiple immuno-oncology programs from Stanford University.
The Series A financing was led by Lightspeed Venture Partners and Sutter Hill Ventures with participation from Clarus Ventures and GV (formerly Google Ventures). The license includes rights to over 100 issued or pending U.S. or foreign patents that cover the antibody Hu5F9-G4 and several other novel immune checkpoint inhibitors and cancer-specific antibodies.
Forty Seven is committed to the advancement of immuno-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity. The financing will allow Forty Seven to continue the clinical development of its lead molecule, Hu5F9-G4, a humanized monoclonal antibody against human CD47 that potentially has broad applications spanning multiple tumor types and treatment modalities.
CD47 is a molecule that is overexpressed on the surface of the majority of tumors and transmits a "don't eat me" signal, enabling cancer cells to evade phagocytosis by macrophages. The molecule was originally identified as a cancer target by researchers at Stanford. In preclinical models, Hu5F9-G4 facilitated phagocytosis and elimination of cancer cells from multiple human tumor types as a monotherapy. Additionally, when used in combination therapy, it engaged macrophages as effector cells to enhance the efficacy of cancer-specific antibodies via Antibody-Dependent Cellular Phagocytosis (ADCP). Importantly, Hu5F9-G4 also could prime an effective antitumor T-cell response through cross-presentation of cancer cell antigens by macrophages, preventing engraftment of tumors expressing a cross-presented antigen into animals."
Here is a link to the article: http://www.fiercebiotech.com/story/google-backs-75m-round-stanfords-immuno-oncology-spinout-forty-seven/2016-02-24
Jack2479, et al,
I ran across this building guide when I was trying to figure out what the Cognate expansion might be. I have zero background in this field and my eyes glossed over while reading it until I got to Part III and what followed. It covers room sizing, electrical, etc. for "clean rooms" for Pharm. It may be of some use next time you do your drive by. Thanks for the updates on Sawston.
RR
Here is the link to the guide, you can download it as a pdf also:
http://www.pdhonline.org/courses/m143/m143content.pdf
Good research, well done. Thank you.
Financing Source Build Out for Sawston?
The mayor of London has been floating the idea, for over a year now, of creating a superfund to finance biotech development in the UK "Golden Triangle" between Oxford, Cambridge and London. Looks like the proposal is getting more traction. Several stories today talking it up. NWBO's site in Sawston, as we all know, is in the Golden Triangle and could be a candidate if this superfund becomes reality. The mayor is in his last year in office, has aspirations to the Parliament and seems to be motivated to make it happen. Here is the text to a story today in Fiercebiotech:
Published on FierceBiotech (http://www.fiercebiotech.com)
"London's mayor suggests quick $15B fix for financially ailing biotech sector
June 25, 2015 | By John Carroll
The general consensus about the U.K.'s place in the biotech world can be summed up in a few words: Great science, world-class academic centers and way too little cash to finance promising new companies. But London Mayor Boris Johnson has come up with a radical idea to fix the funding gap virtually overnight, suggesting that the country leverage its place as a leading global financial center to create a $15.7 billion (£10 billion) megafund that could finance a fast biotech revolution.
That proposal--not the first of its kind--puts a bright spotlight on the mayor's meetings today to highlight the role of the new MedCity to act as a catalyst for the Golden Triangle, knitting together an R&D infrastructure that spreads from London and connects to Oxford and Cambridge.
"If we want to develop another GSK or AstraZeneca, if we want to get a full return on the investment we put into our research base, and if we want better therapies more quickly, this is an issue we have to address," says Eliot Forster, executive chair of MedCity, according to a report from the Financial Times' Andrew Ward.
How would it work? The fund would patiently invest in drugs at various stages of development in exchange for a royalty stream from any money generated by new treatments. And by spreading its bets it would attract cautious investors like pension funds.
The proposal highlights an awkward phase of development for the country's biotech industry. A few years ago a string of high-profile R&D failures chilled the U.K.'s investment community. As a result, the U.S. biotech boom over the last two years made Wall Street a more likely place for Europeans to find the kind of money needed to grow a company--a lesson that wasn't lost on up-and-coming companies like Oxford-based Adaptimmune, which completed its IPO on Nasdaq.
In the meantime, Invesco vet Neil Woodford has set up his own new publicly-traded trust to invest in a blend of biopharma companies, while some venture groups--such as New Enterprise Associates--have been more willing to make the transatlantic trek to connect with a few of the more promising companies in the region.
The MedCity initiative and today's radical plan, though, underscores the considerable frustration that biotech centers in Boston/Cambridge and the Bay Area around San Francisco are booming while the Golden Triangle still languishes far behind."
I'm wondering about the curious use of the phrase (bolded by me above) "patiently invest" and how that may relate to Woodford's Patient Capital Trust and/or Woodford's influence on the formation of this superfund. Also of interest, at least to me, is another recent story discussing how Woodford loaded up the Patient Capital Trust Board with veterans of the "Golden Triangle." Could there be a confluence of events forming up here?
Here are some links to several of the stories -
insert-text-here
insert-text-here
Fraunhofer IZI - Anyone have an accurate estimate of their manufacturing capacity for -L in Germany? I think it was Pyrr who made the recent statement they could only produce vaccine for 200 patients per year under the Hospital Exemption program. Well before that statement was made I researched everything I could find on that issue with documents from Fraunhofer and the only related data I could find was they now have 2 "clean rooms" in their new facility in Leipzig for cell therapy production comprising 750 square meters (8072 square feet). While that is certainly larger than the 5000 square feet Cognate has available for NWBO in the U.S., I couldn't find anything stating Fraunhofer would be dedicating these two clean rooms for NWBO's -L vaccines or their capacity. It's unlikely they would be dedicating those two clean rooms for NWBO given their many other projects and clients needs. That statement about manufacturing for only 200 patients per year still bugs me, where did that come from? Can anyone support it, debunk it or have another credible estimation? Thanks.
Here is their website: Fraunhofer
Koman,
This might help. Back in the day before Pyrr's motives and/or investment thesis became a recent topic of discussion he published a compelling article on Seeking Alpha entitled "The Time Is Now For Northwest Biotherapeutics" published on October 29, 2014. It is much too long to post here in it's entirety but Steve went thru a series of calculations, which you can follow by reading the article, and estimated the 1st interim would occur by the "summer of 2015." I haven't seen a retraction or revision of that estimate since then.
Best,
RR
Thanks!! I'm so used to skimming right to the posts I completely missed those updates.
Thanks!!
Conference(s) in March?
Can anyone confirm that NWBO will be making presentations at conferences in March? I've seen references to this in some postings on this board by nothing from the company.
Woodford's New Fund Board
Top story in todays FierceBiotech/EuroTech Report highlights the heavy biotech backgrounds of the new board members of his new fund and hints at its focus on UK biotech in "southern England." NWBO's Sawston facility is near Cambridge in that area. Interesting, here is the link and story fwiw:
"Neil Woodford revealed the board of his new fund this week and hinted at his strategy in the process. With three-quarters of the board having biotech credentials and the same proportion being intrinsically linked to "golden triangle" commercialization business Imperial Innovations (AIM:IVO), Woodford looks set to go all in on south east England's academic hotspots. The U.K. government is set to further bolster the credentials of the region by setting up an international dementia institute within 5 years and lending its support to a dementia R&D investment fund." Also, "If anyone had doubts about exactly where Neil Woodford was going to aim the brunt of his new £200 million ($300 million) fund, details of the board that will oversee the venture will have washed away the uncertainty. The board is heavily tilted toward biopharma, the "golden triangle" and academic commercialization know-how." "Former Imperial Innovations (AIM:IVO) CEO Susan Searle will chair the board, which features leaders from two of the companies in which she invested during her stint in charge of the business. Circassia (LON:CIR) CEO Steve Harris and Nexeon CEO Scott Brown both pulled in serious cash during Searle's reign--in 2011 Imperial Innovations led rounds worth £100 million in the companies--and will now work alongside her on Woodford's board.
Louise Makin, CEO of specialty pharma company BTG (LON:BTG), has taken the fourth seat on the board, Citywire Wealth Manager reports. As such, three-quarters of the board have strong biotech credentials--Brown is developing lithium-ion battery technology at Nexeon--and the same proportion are part of Imperial Innovation's ecosystem. Woodford took a big stake in Imperial Innovations while at Invesco Perpetual and put the company near the top of the wish list when he went solo.
Stacking the board with people embedded in the academic ecosystems in south-east England gives the fund access to the sort of connections that have enabled Imperial Innovations to prosper. The board members won't have a direct say in investment decisions, but will support the fund by challenging its thinking and providing access to their networks of contacts in industry and academia."
Also interesting is a recent story on FierceBioTech stating Pfizer is looking to play catch up in oncology and is sitting on $33 billion in cash. LP has changed her presentations slightly to tout DCVax working with checkpoint inhibitors and -L for "all" solid tumors, not just brain tumors. Hmmm...
http://www.fiercebiotech.com/story/pfizer-takes-cuts-big-pharmas-immuno-oncology-line/2015-01-16
Thanks for taking the time and effort to keep us in the loop. Merry Christmas from the Left Coast!
Thanks for the update. Any idea what "catalyst" they are talking about (Note #3) since -L apparently will not see the light of day until 2016 and H.E. revenues are now being discounted? Sounds like another "stay tuned" kiss-off, especially since the company itself pumped up the importance of the Germany H.E. approval.
Letsgo45,
Here are some issues I would like addressed, if possible:
1)With regard to H.E. in Germany - when can we expect a definitive answer on the completion of the pricing negotiations? How many people are currently on the "waiting list?" How many hospitals have actually signed on? When can we expect earnings guidance from management for 2015? Since H.E. pricing and subsequent expected earnings from the waiting list will likely be the next catalyst for pps movement, how much longer are we expected to "stay tuned?"
2)With regard to Direct - why haven't we had any updates on the remaining patients referred to in the June 11th PR, they should have completed their treatment plan by now--"All 9 Out Of 9 Patients Who Have Reached 4 Injections Are Showing Tumor Cell Death, Tumor Shrinkage And/Or Stabilization Of Disease." Is there some "cone of silence" covering any more updates/PR's from the company and MDA? If so, why? The SITC presentation in November was positive, but it also failed to impress the market and now, without any more followup, risks looking to be more like case study cherry-picking Adam F-stein would love to rip apart. Personally, I believe A.F. amounts to nothing more than a fart in church, but its still bad press we don't need if he resurfaces soon.
3)What is the status of the PIM designation with MHRA? Has the company completed the next step for the MHRA to render its "scientific evaluation?" This evaluation, we expect, will be positive and should be trumpeted from the electronic rooftops. Where are we on this?
4) What steps has the company taken to get analysts to cover NWBO? There are well meaning members of this iHub board who appear to have taken more effort to get NWBO good press and coverage than the company's own PR department. Why?
Thanks for your offer letsgo45, I live on the Left Coast so this is not a good time to travel east for this meeting. Besides, I've already been burned three times this year buying call options on NWBO, including tomorrow, so I'm in no mood to hear "stay tuned" and "in the coming months" one more time.
Will do, glad to help.
Best,
RR
Hi Staccani,
No mention of Direct in this report. Sorry for the delay, I was on a self-imposed exile from the internet most of yesterday (aka Happy Hour). This report doesn't discuss how they reached their findings or the data they used, but I do like the rankings for whatever thats worth. I provided a link to the report (its a .pdf) from my Dropbox account in case anyone wants to see it, let me know if it doesn't work. Just click on the link and select download. I get these types of reports periodically from this outfit at no cost, I just had to sign up and provide my email address. Here is the link to the report:
https://www.dropbox.com/s/6w1geushr1e8hu2/2014OD.pdf?dl=0
Best,
RR
Evaluate Pharma 2014 Orphan Drug Report lists DCVAX-L as #3 of the Top 20 R&D Orphan Drugs based on NPV. Their report data is as of Oct. 27, 2014. Quote from page 14 of the report - WW NPV of DCVAX-L is $5.67 Billion with 2020 projected sales of $2.046 B
This may be helpful to add to the "sticky" list. I couldn't convert their graphs into a readable format for this board, so here is a text quote from page 14 list of "Top 20":
Worldwide Top 20 Orphan R&D Products based on NPV (Sales, NPV, PIII Cost & Expected Return)
Rank Product Company Phase (Current) Pharma Class Sales $m 2020 NPV R&D Cost $m Trial Size Strategy
3 DCVax-L*Northwest Biotherapeutics Phase III Cancer vaccine 2,046 5,672 87 300 65 Organic
Pyrr and/or Flip,
In reviewing the SITC seminar schedule a series of "Hot Topics" breakout sessions on 11/19 look interesting to me for DCVax implications. Being a layperson on this science I wonder if you could enlighten with your expertise if this one has Roche looking in our direction:
"511 – Hot Topic Symposium I: Accelerating Tumor Immunity with Agonist Antibodies
Anti-CD40 Agonist Antibody - The Ideal Combination Partner for Cancer Immunotherapy
calendar11/9/2014clock11:20 AM - 11:45 AMclockRoom: Woodrow Wilson A
Hy Levitsky, MD
Global Head, Cancer Immunology Experimental Medicine, Roche Pharma Research and Early Development, Schlieren 8952, Switzerland"
Thanks in advance.