NorthWest Biotherapeutics Inc (NWBO)

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This is something I put together about DCVax and NWBO for family members who are investing in NWBO and for our kids whom we just gifted some shares.

Northwest Biotherapeautics. (NWBO)

Northwest Biotherapeutics, Inc is a clinical stage biotechnology company focused on the development of personalized cancer vaccines designed to treat a broad range of solid tumor cancers.
NW Bio is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs. NW Bio’s proprietary manufacturing technology enables the Company to produce its personalized vaccine in an efficient, cost-effective manner. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company’s lead product, DCVax-L, recently completed a 331-patient Phase III trial for patients with newly diagnosed/recurring Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer.
The Company’s second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers. DCVax-Direct trial has survivors who today live normal lives. Direct not only attacked the primary tumor, but also went after distant tumors that had metastasized elsewhere in the body.
The Company has also conducted a Phase I/II trial with DCVax for late stage ovarian cancer together with the University of Pennsylvania, which showed similar positive results as the GBM trial.
The Company previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.
DCVax is a vaccine used to prevent/inhibit the return of cancer. It is not given to healthy people.

Results of DCVax_L trial
* NWBO met its endpoints. Both median survival and the “long tail” of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L.
* The trial more than doubled the median survival, from 5% to 11% in new GBM cases
* Long term Survival for the first time ever in recurrent GBM: from 0% to 13%.
* The trial results were reported in the highly acclaimed, peer reviewed cancer journal JAMA Oncology, co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany. The article is titled “Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma”.  https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847. It is one of the most viewed article ever in JAMA, which is a top-tier publication in the US.
* A second Phase I clinical trial with Poly-ICLC shows that DCVax-L with Poly-ICLC extends survival in GBM patients to 50% with many surviving 8 years and counting. Poly-ICLC had no effect on GBM without DCVax.

* A third Phase I clinical trial with DCVax-L, Poly-ICLC, and Merck’s Keytruda shows survival after 2 years at 65% and the median has not been reached. Previously, Keytruda failed in its GBM trial without DCVax.

Where is NWBO Now?

* NWBO is currently preparing documents for application for a commercial license to sell DCVax-L in four countries: U.S., U.K., Germany, and Canada. We expect them to submit that application any day now.

* In April, NWBO’s manufacturing plant in Sawston, U.K, received all of the manufacturing certifications required to manufacture DCVax-L on a commercial level, including the commercial license to make the vaccine. It also has an international license to import/export biological products so they can handle patients from around the world. This manufacturing license was the last requirement for a commercial license application.

* DCVax-L is applicable to all solid tumors that are operable. It is a “tumor agnostic” treatment, meaning that it doesn’t care where the tumor is in the body. It uses the tumor antigens from the patient’s own tumor to create the vaccine.
* DCVax-Direct, VWBO’s second product, is applicable to all inoperable solid tumors, including tumors too close to organs to safely operate and too many tumors to successfully remove.
* NWBO holds hundreds of patents in many countries across 5 continents for DCVax-L and DCVax-Direct, and is working on a combo trial patent for dendritic cells combined with other immunotherapies. Our CEO is an expert in patent writing and helped Europe create patent laws before working with NWBO.

Will DCVax-L receive approval?

Most experts say ‘Yes’ because of these facts:

* DCVax has little to no side-effects, mainly a slight fever. People can live a normal life while receiving treatment and beyond.
* Treatments for GBM are called orphan drugs, which receive special priority with the FDA and other regulatory bodies. Orphan drugs are drugs that target small populations of patients, and have little treatment options available, which is the case with GBM.

* 400+ clinical trials by other companies have failed in GBM to find a treatment that changes survival beyond 5 and most of these surviving patients die or see GBM return and die.

* Currently, if GBM returns, it is a death sentence. Patients live less than a year.

* The 13% survival in recurrent GBM and 50% survival when combined with Poly-ICLC means GBM (and other cancers) could become a manageable disease with DCVax-L.

* The U.K. is already pricing DCVax for payment to providers, and is expected to be the first regulatory body to approve it. They also allow patients to pay for their own DCVax-L treatments, called “compassionate care”. NWBO is already treating patients at its U.K. facility. In addition, the U.K. recently set up a program to re-pay U.K. patients who use compassionate care and pay for it themselves, if the treatment is approved.

* The FDA has recently passed policies that make it easier for drugs like DCVax to be approved using the type of clinical trial design that NWBO used.

* The FDA has also very recently created policy for “tumor agnostic” drugs, like DCVax-L, making it more likely that it will allow NWBO to get quick approvals as it applies for drug approval for other cancer types. It is conceivable that DCVax-Direct, NWBO’s second treatment for inoperable tumors, will also fall under this category and could receive quick approvals, since it is basically the same as DCVax-L, with differences only in how it is administered.

* DCVax-L is already being used as the “placebo” in current trials underway on combination treatments with Poly-ICLC and Keytruda. This is quite unusual for a treatment that hasn’t been approved yet to be used like a placebo in a U.S. clinical trial.

* The success of DCVax has been touted by top neuro-oncologists around the world. Dr. Linda Liau, inventor of DCVax-L and head of the trial for NWBO is an acclaimed neuro-oncologist at UCLA in California who was named top neurologist in the US for several years before becoming head of the neurology department at UCLA. Dr. Askhan at King’s University Hospital in the U.K. has been begging to have DCVax for all his patients. He is the top neuro-oncologist in the U.K. Organizations for brain conditions have also backed DCVax and called for the treatment to be approved. It has a strong backing in the science and medicine world.

Negatives for NWBO going forward:

* NWBO is a “disruptive” technology, like the car was to horse-drawn carriages. This makes them a target for short sellers, hedge funds, and companies who stand to lose money when DCVax makes their products obsolete. While DCVax may continue to use chemo and radiation to soften the tumor before treatment, these painful and debilitating methods for treating cancer will likely be used much less, partly because more patients will survive in healthy condition. Temador, a form of chemo, is already being considered an obstacle to successful DCVax treatments, and I believe has been eliminated in current clinical trials.
* The only other current treatment for GBM is a helmet device that has to be worn 90% of the time in order to be considered part of their trial. It has little proof of extending survival, partly because most patients took the device off. It was created by Novacure. Several of their doctors have publicly attacked DCVax and many believe this company pays for bashers on public forums.

* Shorts have heavily attacked NWBO stock since 2015 when DCVax-Direct preliminary results showed astounding results in cancers where patients were told by their doctors to prepare for hospice. A number of these patients are still alive and living normal lives.
* Besides the short attacks, Market Makers for NWBO have been charged by the company with “spoofing” the stock for at least 5 years. The civil suit against 7 MMs by NWBO states hundreds of cases where the MMs offered bids or asks of large numbers of shares, but pulled their bids and asks before they could be filled. This is called spoofing and it causes real buyers and sellers to adjust their prices to sell and buy the stocks. It’s a form of stock price manipulation.

* NWBO stock is listed on the OTC market, which is a market for penny stocks and puts it out of the range for analysts and funds to discuss or buy. NWBO’s price is only 60 cents. Because of the manipulation and the being on the OTC it is unlikely the price will move until the company either gets approval for DCVax or declares large earning from its compassionate care program. That program’s income was $880,000 last quarter, which was double the quarter before.
* NWBO could be hit with a major issue that brings down the stock, like running out of money and being forced to sell cheap. This is an unlikely scenario because it has dedicated angel investors. It could also fail to get approval, which I believe is highly unlikely given the facts I listed above.
* NWBO has been a target of shorts who have already crashed the price at least twice, scaring retail share holders. While the price pops up again, this tactic causes many retailers to sell and take their money elsewhere.


Future catalysts

1. The company expects to complete an application for approval in 4 countries and submit it soon. When this is announced it may or may not move the stock price.
2. Commercial approval by U.K. is expected first and should come within 45 days after the U.K. announces they have received our application.
3. Other countries should follow quickly, including the FDA approval by early next year. NWBO may be making application under the Orbis program that allows them to apply to multiple countries at once. We don’t know how they are handling the applications. In addition, seven countries across 4 continents and the European Union have recently agreed to share drug approvals . This means a drug approved in one country can be quickly approved in another.
4. NWBO may already be in talks to sell the company to another Big Pharma. If this happens I believe it is highly likely the price tag will be $20 per share or more. I expect more like $35 per share. That’s based on what Merck was willing to offer for another independent company a few months ago.
5. More likely, NWBO may decide to partner with other BPs (big pharma’s). Remember that DCVax appears to have synergy with Merck’s Keytruda in one on-going trial. I hope this is what happens and there are lots of clues that it will. No big Pharma alone is able to pay us what DCVax technology is worth for the treatment of all cancers. I am hoping NWBO choses to take on multiple partners, each in different cancer areas perhaps, or different geological regions (such as US, Europe, Asia). Partners will bring funds, which will move clinical trials along quicker, which increases our value per share.
6. NWBO is hoping to get approval for a patent for combination of DC cells with other immunotherapies. If they are able to get this patent, Big Parma would be motivated to partner with us since we’ll hold the patent for combination treatments with DCs. (Which is the cell type DCVax is based on).
7. NWBO bought Flaskworks a few years ago. This company is automating the procedure for making individualized vaccines from each patient’s tumor. They are currently running tests with Flaskworks to refine its ability to consistently produce the same product. It is expected that Flaskworks is likely to increase the efficacy of DCVax as it also increases productivity by ten-fold over manual creation of the vaccine.

Advise for how to handle your shares

8. If NWBO sells, I expect the price to be at least $30 per share. This could happen this year.
9. If NWBO remains independent, I expect the share price to go up to $50 over the next 10 years, and to $100 or more over time.
10. And here’s the wild card: When NWBO makes a significant announcement, we could see a “short squeeze”, where the price runs up to crazy amounts, as we saw recently with GameStop. A short squeeze happens when there are too many players holding the stock “short” - they’ve sold the stock without first buying it or even borrowing it from an actual owner - and now they need to buy it back fast, like in 3 days.
11. Another way to trigger a short squeeze would be for NWBO to announce an unexpected uplifting to a major stock market. When companies uplift, their stock needs to be counted and accounted for, which means hedge funds, etc., need to come clean with any naked shares they’ve “failing to fill”. We know of a few hedge funds that have failed to follow regulations and their naked short positions are on on their books.
12. NWBO could merge with another company and uplift to a major exchange almost overnight.
13. Finally, I recommend you 7NOT selling this stock under $20 per share, preferably not under $35 per share. Best, wait until it is approved as standard of care in multiple major cancers. That will put it in the $100s per share, I believe.
14. When you decide to sell, you will have to pay taxes on your earnings. Since this is a gift, taxes will be paid from the price of when I bought the shares, not the price when we gifted them.
15. When you go to sell, DO use price limits. Place the price you want to buy at or above the “ask” …that’s what shareholders are currently offering for sale. Prices always move up and down.
16. DO NOT use price stop-loss order or trailing stop-loss orders when you sell. Lots of retailer shareholders use stop limits to prevent more loss of value when a stop price is falling, but price manipulators use this tool to take shares away from you. They will manipulate the price down and take out as many stop limits as they can. Then let the price jump up and continue to move up. Currently shorts are trying to accumulate shares to pay off their exposed shorts and are desperate. But they do it in normal trading days as well to get shares cheap as the price is rising.