Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is looking to break north over $0.74 out its current trading channel after recently being decimated due to Adam Feuerstein’s article on Stat News that contained numerous demonstrably false claims that the trial had failed. On the contrary, the much-anticipated results of the Phase 3 clinical trial of DCVax®-L for GBM presented at NYAS on May 10 showed significantly improved overall survival and a favorable safety profile. Patients treated with DCVax-L showed a clinically meaningful and statistically significant extension of survival, in both newly diagnosed and recurrent GBM. Primary endpoint was met (mOS in nGBM) with statistical significance, secondary endpoint met (mOS in rGBM) with statistical significance. The safety profile was excellent, with no autoimmune reactions and noteworthy long tails of survival. While the data was revealed in the NYAS presentation, this does not represent a statement from the company. Currently shareholders are waiting for the actual TLD publication from Northwest which could come at any day now as management would not go into the ASM and ASCO 2022 with no TLD publication. Judging by what we have seen so far, if all goes right, a significant run leading into ASCO, 2022 where NWBO has 1/2-million-dollar booth lined up could take the stock back to its previous trading range.
Northwest Bio shares plunged 70% on Tuesday once the DCVax presentation concluded. After a brief rise to around $2 per share in the run-up to Tuesday’s event, the stock is now trading again well below a buck. The principal investigator of the study was Dr. Linda Liau, and due to a covid sickness she could not make the presentation at the Frontiers of Cancer Immunotherapy Conference of the New York Academy of Sciences and Dr. Paul Mulholland gave the presentation instead. While he did a fine job, the shorts used the confusion to decimate the share price. On May 10, the day of the short raid there were 77 million shares traded and market makers increased from 6 to 13. Speculators are looking for NWBO to get back on track here, and a breakout over $0.74 would be a good start.
Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is an American pharmaceutical company founded in 1996. The current CEO, Linda Powers, graduated magna cum laude from Princeton and Harvard. Their board also has a lawyer who graduated from Michigan and two PhD’s, one of whom holds several patents on dendritic cell product manufacturing. Their current emphasis is on cancer vaccines that incorporate the patient’s own immune cells which are trained to attack the malignancy in lieu of chemo or radiation. NWBO has amassed a valuable intellectual property portfolio; as of December 31, 2021, the Company had 204 issued patents and 59 pending patent applications worldwide, grouped into 11 patent families. Of these, 200 issued patents and 47 pending patent applications directly relate to the Company’s DCVax products. Taken straight from their website:
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, is currently in a 348-patient Phase III trial for patients with newly diagnosed 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. The Company has also conducted a Phase I/II trial with DCVax for late-stage ovarian cancer together with the University of Pennsylvania. 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.
1/3 $NWBO #DCVax I encourage anyone who wants to understand why I believe the FDA is working toward, not against, the P3 trial to watch and read all the following and think both clinically and politically, not just in a financial vacuum regarding approval: https://t.co/zIs69uJval
— Gregory Zivic, MD (@metacollectiveG) May 25, 2022
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The much-anticipated results of the Phase 3 clinical trial of DCVax®-L for GBM were announced on May 10 showing significantly improved overall survival and favorable safety profile.
The principal investigator (PI) of the study was Dr. Linda Liau, Chair of the Department of Neurosurgery at UCLA. Dr. Linda Liau was set to announced the TLD at a presentation entitled “Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma” on May 10 at the Frontiers of Cancer Immunotherapy Conference of the New York Academy of Sciences. However, due to a covid sickness she could not attend and Dr. Paul Mulholland gave the presentation instead. While he did a fine job, the shorts used the confusion to capitalize and decimated the share price in a massive bear raid to lows of $0.3862 per share.
Glioblastoma multiforme (GBM) is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” It’s also the cancer that killed Beau Biden son of President, Joe Biden. Most patients with GM only survice about a year with only 5% making it to five years. According to a recent report from Grand View Research, the market for Glioblastoma multiforme is enormous and is growing rapidly:
The global glioblastoma multiforme treatment market size was valued at USD 2.14 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.8% to 3.72 Billion by 2028. The growing prevalence of glioblastoma multiforme, increasing R&D, and favorable regulatory scenarios are among the factors anticipated to fuel the market growth. The presence of a strong pipeline is expected to act as a major driver for the glioblastoma multiforme (GBM) treatment market during the forecast period. The increasing incidence of brain tumors is expected to boost the growth of the market over the forecast period. According to Global Cancer Observatory, in 2020, the incidence of brain and CNS cancers was 308,102 globally and the number of deaths was 251,329 worldwide. Glioblastoma multiforme is the most common form of malignant tumor, accounting for up to 54% of gliomas and 16% of all primary brain cancers. The increasing approval for novel therapy and combination therapy is expected to drive the market in the coming years.
Much-anticipated, noteworthy results of the Phase 3 clinical trial of DCVax®-L for GBM are here https://t.co/DRFB76yXLH. Data shows improved Overall Survival and favourable safety profile #BTSM #BTAM pic.twitter.com/4zk5ISBvRM
— IBTA (@theIBTA) May 23, 2022
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Currently trading at a $700 million market valuation according to OTCMarkets Northwest Bio has $6.9 million in the treasury and $2.3 million in prepaid expenses. Things are heating up here as investors await the TLD results from NWBO which would come any day now following the NYAS presentation which showed significantly improved overall survival and a very favorable safety profile. Speculators are looking for NWBO to get back on track here, and a breakout over $0.74 would be a good start. The next few weeks are key with ASCO coming on June 3. Microcapdaily gave the heads up on NWBO on February 3, 2020 when the stock was $0.18 per share in our article: The Exciting Story of Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) We will be updating on NWBO when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with NWBO.
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Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.