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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Heats Up as DCVax®-L Proves Safe & Effective While Sawston Facility Applies for Commercial Manufacturing License for Cellular Therapies

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1 year ago

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has made a significant move northbound out of the trading channel where it was trading for the past few weeks since the stock was decimated due to a massive short attack helped along by Adam Feuerstein’s misleading article on Stat News. The move up comes after the Company reported its application for license of the manufacturing facility in Sawston, UK for commercial manufacturing of cellular therapies has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).  NWBO is targeting Glioblastoma multiforme (GBM) the deadliest, most treatment resistant cancers and the Company continue to see significant progress where all others have failed including many big names in biotech. 

NWBO is among the most exciting stocks in small caps. Recently the Company released the much-anticipated results of the Phase 3 clinical trial of DCVax®-L for GBM presented at NYAS on May 10 which showed significant improved overall survival. 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. The stock has a significant short position that could fuel a massive short squeeze as NWBO continues to make progress. 

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe.  The Company has a broad platform technology for DCVax® dendritic cell-based vaccines.  Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names recently who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. DCVax®-L has been featured by main stream press numerous times as many recovered patients have come forward crediting DCVax®-L for saving their lives. The stock represents easily among the highest risk-reward opportunities in the market today.  

NWBO lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM).  GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.”  This Phase III trial has been completed and the top line data was presented by a key investigator at a recent scientific meeting. The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers.  It has completed a 40-patient Phase I trial and plans to prepare for Phase II trials as resources permit. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.  

Northwest has an integrated strategy for protection of its technology through both patents and other mechanisms, such as Orphan Drug status. Currently the Company holds 204 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. Of these, 191 issued patents and 52 pending patent applications directly relate to its DCVax products. In the United States and Europe, some of its patents and applications relate to compositions and the use of products, while other patents and applications relate to other aspects such as manufacturing and quality control. Additionally, with the acquisition of Flaskworks, Northwest gained ownership of a portfolio of patents and patent applications which include those held by Flaskworks as well as patents and patent applications exclusively licensed by Flaskworks from Northeastern University. The portfolio includes a total of thirteen patent families, with issued patents and pending applications worldwide. Collectively these patents and patent applications cover key aspects of the design and function of automated cell culture systems.   In addition to its patent portfolio, Northwet has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.  

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On July 6 NWBO reported an application for license of the manufacturing facility in Sawston, UK for commercial manufacturing of cellular therapies has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).  The application builds upon the 3 licenses received for the Sawston facility in 2021. This application for a Manufacturer’s license (MIA) represents the culmination of an additional year of intensive work, beyond the preparations over more than 2 years that were required for the applications for the initial licenses last year.  The first license was received in September, 2021, from the Human Tissue Authority of the UK, and provided authorization for collection and storage of human tissues (such as the tumor tissue used to make the lysate for DCVax®-L products) and cells (such as the immune cells used to make DCVax-L).  The second and third licenses were received in December, 2021, from MHRA, and provided authorization for manufacturing cellular therapies for use in clinical trials and compassionate use (“Specials”) cases, respectively.   

As reported last year, a further license from MHRA is required specifically for commercial manufacturing of cellular products. Application for a commercial license requires meeting even higher standards. Preparations for this commercial license have included the creation of a further 50 standard operating procedures (SOPs) and policy and technical specification documents, validation of transport and shipping, and full validation and qualification of seven new pieces of equipment.  Each step in such validation and qualification processes incorporates user requirement specification, design qualification, installation/operational qualification and performance qualification.  This takes many months for each item of equipment.  Additional controlled rate freezers were also procured, validated and qualified to expand the cryostorage capacity at the Sawston facility. 

An automated system for the fill and finish of DCVax-L product has also been delivered, installed, validated and qualified.  “Fill and finish” is the final step of the process, after a batch of DCVax-L product has been manufactured, in which the batch is allocated into single doses in individual vials for cryopreservation and distribution. Preparations for this commercial license application have also included successful recruitment of additional highly experienced, senior-level GMP experts and scientists.  There is a significant shortage of such senior experts throughout the cell and gene therapy sector, and such personnel are in extreme demand.  These additions bring significant additional capacity and depth to the Sawston team. 

As was the case before, the preparations for this license application have taken place in the context of ongoing supply chain problems, personnel shortages and other post-COVID obstacles.  For example, delivery of necessary equipment has been delayed months beyond the scheduled delivery dates.  Certain reagents that are required ingredients for DCVax-L have been subject to ongoing supply shortages, and there is an ongoing worldwide shortage of the special caps required for the cell culture flasks used to make DCVax-L.  The cumulative effects of these and other individual delays and shortages have been, and continue to be, substantial. 

The next step for this license application will be another on-site inspection of the Sawston facility by MHRA – this time, inspecting the facility, its procedures, personnel, regulatory documents, capacity and capabilities in accordance with the standards for commercial manufacturing.  Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA. 

Following completion of any post-inspection actions, the Company is hopeful that a manufacturing license for commercial production of cellular products in the Sawston facility may be approved by year-end. Such a manufacturing license is separate from any regulatory decision about approval of DCVax-L itself.  The Company has not to date submitted an application for commercial approval of DCVax-L. 

Dr. Mike Scott, President of Advent Bioservices commented “Our Team has put in an extraordinary effort to meet our self-imposed, end of Q2 deadline to submit the MIA application.  The standards set for the manufacturing of commercially licensed advanced medicinal therapies are understandably extremely stringent.  We now await scrutiny of the application and processes by the MHRA, and are ready to welcome their inspectors to the Sawston facility.” 

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Currently trading at a $750 million market valuation NWBO has over $15 million in the treasury and is fully funded moving forward. NWBO is among the most exciting stocks in small caps. Recently the Company released the much-anticipated results of the Phase 3 clinical trial of DCVax®-L for GBM presented at NYAS on May 10 which showed significant improved overall survival. 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. The stock has a significant short position that could fuel a massive short squeeze as NWBO continues to make progress moving forward. The stock recently broke northbound out of its trading range after the Company reported its application for license of the manufacturing facility in Sawston, UK for commercial manufacturing of cellular therapies has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).  NWBO is targeting Glioblastoma multiforme (GBM) the deadliest, most treatment resistant cancer and the Company continues to see significant progress where all others have failed including many of the biggest names in biotech. Microcapdaily first 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 as more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.

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Emerging Markets

Lucy Scientific Discovery’s (NASDAQ: LSDI) Game-Changing Move: A Closer Look at the High Times Acquisition

Published

2 weeks ago

on

September 8, 2023

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On August 8th, 2023, Lucy Scientific Discovery Inc. (NASDAQ: LSDI), a leading developer in the psychedelic drug industry, witnessed an impressive surge in its stock value, gaining approximately 25% in combined trading, including after-hours (AH) trading. The British Columbia-based company made headlines by announcing its strategic move to acquire intellectual property (IP) from the renowned cannabis publication, High Times Holding Corp. (HHC).

Additional Background:

Under this agreement, Lucy will exchange 20% of its shares and a series of payments for access to HHC’s valuable IP portfolio, which includes the rights to generate licensing and royalty income from renowned brands like High Times, 420.com, and Cannabis Cup, along with their associated domain names.

Lucy’s commitment involves making semi-annual payments to HHC over a five-year period, structured around earnings before income, taxes, depreciation, and amortization (EBITDA) generated through the acquired IP. The flexibility exists for Lucy to fulfill these payments either in cash or through stock issuance and the announcement is generating considerable interest.

Furthermore, post-acquisition, Lucy will grant High Times the opportunity to operate retail outlets and distribute THC products bearing these prestigious brands within the United States. This privilege comes in exchange for an annual license fee of $1 million, set to double to $2 million annually once federal legalization of cannabis occurs in the country.

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Leveraging the brand rights secured from HHC, Lucy aims to bolster its revenue streams by expanding and enhancing its existing 18 licensing agreements, both domestically and internationally. These arrangements encompass a wide array of consumer products and merchandise, promising to further establish Lucy’s presence in the global market. The acquisition is expected to be finalized within the coming two weeks, marking a significant strategic move for Lucy Scientific Discovery Inc.

As a result of the acquisition, High Times is now a publicly-traded entity. Lucy anticipates that this agreement will contribute over $10 million in revenue to its financial results in the upcoming year, along with $5 million in EBITDA.

Adam Levin, the Executive Chairman of HHC, expressed optimism about the deal, noting, “This transaction will create exciting new growth opportunities for the High Times brand, under the leadership of Richard Nanula, a seasoned executive with extensive experience in major consumer brands and global corporations.”

Levin also emphasized High Times’ enthusiasm in becoming a significant shareholder of Lucy Scientific Discovery. Notably, Lucy completed its initial public offering and Nasdaq listing in February, offering 1,875,000 shares at $4.00 each.

Richard Nanula, CEO of the British Columbia-based company, shared his outlook on the acquisition, stating, “Lucy expects this acquisition to rapidly generate high-margin revenue within the global cannabis sector.”

In recent developments, Lucy introduced the sleep aid product “Twilight,” which includes amanita muscaria and reishi mushrooms. Additionally, the company joined forces with Wesana Health Holdings Inc. (OTCQB: WSNAF) in March to collaborate on the development of the CBD and psilocybin-based drug SANA-013, targeting conditions such as migraines, cluster headaches, and major depressive disorder.

High Times, founded in 1974, has a rich history, featuring works by renowned writers like Truman Capote and Hunter S. Thompson. Since 1988, its Cannabis Cup has stood as the most prestigious cannabis competition globally, with notable judges including Snoop Dogg, Joe Rogan, Tommy Chong, and other prominent figures in the cannabis industry.

While Lucy’s shares showed a nearly 16% increase to reach $0.68 on the Nasdaq exchange on Friday, it is worth noting that they have experienced a decline of over 77% over the past year.

Macro Trend:

In recent times, our articles have prominently featured cannabis-related topics, reflecting the growing popularity of stocks in this sector. LSDI’s acquisition aligns perfectly with the current climate, as the cannabis industry experiences a significant surge, coinciding with the Health and Human Services (HHS) exploring the possibility of reclassifying cannabis from Schedule I to Schedule III of the Controlled Substances Act.

While many countries around the world have already moved towards decriminalization and legalization, the United States has been relatively cautious in its approach. However, the consideration of such a reclassification represents a potential historic turning point. If such a change were to materialize, it would mark a substantial shift in the regulatory landscape, potentially revitalizing cannabis as an attractive investment opportunity. The industry is already showing signs of reestablishing its market presence and could once again become a noteworthy investment option.

We will update you on LSDI when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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WM Technology’s (NASDAQ: MAPS) Stock Surges 91% in Mysterious Rally: What’s Behind the Boom?

Published

3 weeks ago

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September 5, 2023

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WM Technology’s (NASDAQ: MAPS) stock has exhibited remarkable growth, surging by an impressive 91% since August 16th, 2023. Intriguingly, this surge occurred in the absence of any substantial news or filings from the company, with their most recent release dating back to August 23rd, 2023. This limited information raises the question: What is driving this impressive rally? We will delve into the details below to shed light on the matter.

Cannabis Industry:

If you’ve been following our newsletter, you may have noticed our recent article spotlighting Flora Growth Corp. (NASDAQ: FLGC), along with larger players like Cronos Group Inc. (NASDAQ: CRON), and Canopy Growth Corporation (NASDAQ: CGC).

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In case you haven’t had a chance to read it, you can find the article here, featuring a dedicated section on the broader trends shaping the cannabis industry.

For those seeking a quick summary, a significant development has emerged in the cannabis landscape. A high-ranking official at the Department of Health and Human Services (HHS) has proposed moving cannabis from Schedule I to Schedule III of the Controlled Substances Act. This shift marks a historic moment and comes after a comprehensive yearlong investigation requested by President Biden.

It’s worth noting the potential implications of this change for U.S.-based, plant-touching marijuana companies. Currently, these companies are restricted from trading on major exchanges like the NYSE or NASDAQ and are relegated to smaller markets such as the OTC, or smaller Canadian markets like the TSX, CSE, or NEO.

The CEO of Trulieve Cannabis Corp. (OTC: TCNNF), Kim Rivers delves into these implications in a podcast conversation with a Twitter user known as @stock_mj. She also recommends keeping a close eye on the AdvisorShares Pure US Cannabis ETF (MSOS) as the cannabis sector garners increasing attention from investors.

Weedmap’s Earnings:

To evaluate the potential of MAPS, it’s essential to examine their recent earnings and assess the fundamentals. Here’s a brief overview of the news release.

Revenue: Amounted to $50.9 million, representing a decline compared to the same period in the prior year when it reached $58.3 million.

Net Income: Recorded at $2.0 million for the second quarter of 2023, marking a significant decrease from the previous year’s figure of $19.8 million.

Adjusted EBITDA: Showed substantial improvement, totaling $10.2 million in the second quarter of 2023, as opposed to a negative figure of $(0.6) million in the same period of the prior year.

Cash: As of June 30, 2023, the company held $24.6 million in cash, noteworthy for being entirely debt-free.

WM Technology’s Executive Chair, Doug Francis, underscored the company’s dedication to reinforcing its financial position and delivering sustained growth.

Guidance for the third quarter of 2023:

Revenue: An estimated $47 million.

Non-GAAP Adjusted EBITDA: Approximately $4 million.

It’s important to note that these projections are subject to potential variations based on various factors and developments.

Furthermore, WM Technology announced the transition to Moss Adams LLP as its new independent registered public accounting firm, effective upon the filing of the Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, following the resignation of Baker Tilly US, LLP due to staffing constraints.

Although the company maintains a debt-free status, it’s crucial to recognize that there has been a substantial decline in both revenue and net income. Consequently, it is advisable to exercise caution when considering investment, as the current trajectory of their top-line figures does not exhibit a positive trend.

https://twitter.com/5teelersfan/status/1699102436672299134?s=20

Weedmap’s Strategic Partnership:

Furthermore, the company made another recent announcement regarding its strategic partnership with the producer of “The Freak Brothers,” a celebrated stoner comic series that has captivated audiences for over five decades.

The series follows the adventures of three stoner characters and their cat, who awaken from a 50-year slumber induced by a magical strain of weed in 1969, now navigating life in contemporary San Francisco.

Key highlights of this partnership include in-episode Weedmaps integrations in the upcoming second half of “Freak Brothers” season two, commencing on September 24th. Additionally, exclusive “Smoke & Screen” events will be held across the U.S., bringing together influential figures from both the cannabis and entertainment industries.

“The Freak Brothers” series, based on Gilbert Shelton’s cult classic comic, celebrates its 55th anniversary with a star-studded voice cast for Season 2, featuring Woody Harrelson, John Goodman, Pete Davidson, Tiffany Haddish, Adam Devine, Blake Anderson, Andrea Savage, La La Anthony, ScHoolboy Q, and a special guest appearance by Joe Sikora.

To watch Season 2 of “The Freak Brothers,” visit Tubitv.com, and for cannabis-related information, explore Weedmaps.com. For more on “The Freak Brothers,” visit the official website at www.thefreakbrothers.com.

We will update you on MAPS when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Emerging Markets

Cannabis Industry Surges: Flora Growth Corp. (NASDAQ: FLGC) Leads the Way with 77% Intraday Jump

Published

3 weeks ago

on

August 31, 2023

By

Flora Growth Corp. (NASDAQ: FLGC) experienced a remarkable intraday surge of over 77%. While the company has made significant announcements recently, today’s surge occurred without any specific filings or press releases to explain it. There seems to be something substantial driving this trading frenzy, a broader force impacting the entire asset class.

It’s worth noting that established industry leaders like Canopy Growth Corporation (NASDAQ: CGC) and Cronos Group Inc. (NASDAQ: CRON) have faced significant downtrends in past years. However, today’s market activity also lifted their stocks along with others. To understand this trend, let’s take a closer look at the larger market dynamics at play.

 

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What Happened:

A top official at the Department of Health and Human Services (HHS) has recommended moving cannabis from Schedule I to Schedule III of the Controlled Substances Act, marking a historic shift. This move follows a comprehensive yearlong investigation requested by President Biden.

https://twitter.com/NotFinancialRep/status/1697189406665245149?s=20

In the short term, this won’t significantly impact the cannabis industry, as the Drug Enforcement Agency (DEA) needs to conduct its own review and the federal prohibition on marijuana remains. However, the HHS recommendation, if followed by the DEA, could happen within a year, possibly before the 2024 presidential election.

Long-term implications for the cannabis industry are uncertain, but a key immediate effect would be the elimination of Section 280e of the IRS tax code for cannabis businesses. This provision currently prevents them from claiming standard business deductions, a major financial burden.

While rescheduling won’t directly open up access to institutional banking, it may attract new capital sources due to reduced risk perception among investors. Smaller banks and lenders might become more willing to engage.

Eliminating 280e could also stimulate lending in an industry with high borrowing costs, as companies would have improved cash flow. This might lead to lower interest rates and greater access to operating and expansion capital.

Rescheduling could benefit publicly traded cannabis companies, potentially enticing more exchanges, like the Toronto Stock Exchange, to accept U.S.-based cannabis businesses. It could also encourage Congress to take further action, such as passing the SAFE Banking Act and broader reforms.

Overall, while the exact implications of rescheduling are uncertain, the HHS announcement signals progress toward a post-prohibition reality for the cannabis industry, which is a significant development.

https://twitter.com/S_Andreoni/status/1697289527180562880?s=20

Having set the stage with the broader cannabis industry context, let’s delve into Flora Growth’s recent developments and their implications for the company’s future. Is Flora Growth strategically positioned to leverage the potential easing of restrictions in the cannabis sector?

European Expansion:

Flora Growth just formed a partnership with TruHC Pharma GmbH, a leading medical cannabis expert based in Hamburg, Germany. TruHC holds key certifications for importing, distributing, and manufacturing medical cannabis and is awaiting an EU-GMP license for its cutting-edge cannabis laboratory.

Hendrik Knopp, a respected legal professional and entrepreneur, and his team from TruHC are joining Flora, bringing their extensive expertise in pioneering medical cannabis in Germany. This partnership is seen as very valuable, especially as Germany and the European Union move towards making medical cannabis more accessible to patients.

Clifford Starke, CEO of Flora, expressed excitement about the collaboration, recognizing the potential to contribute to the growth of the medical cannabis industry as regulations evolve. The partnership aims to capture a significant market share in Germany.

Hulk Hogan Partnership:

Flora Growth also just recently entered an exclusive worldwide partnership with WWE legend Hulk Hogan to launch a range of consumer products through Just Brands. These products will include CBD-infused items like pre-rolls, topicals, edibles, and more, which Flora will produce and sell globally. The partnership aims to capitalize on Hulk Hogan’s iconic status and Flora’s global distribution network. The initial agreement is for three years, with potential renewals, targeting $20 million in sales over the first 24 months. Flora will pay royalties and license fees for Hulk Hogan-branded products.

Conclusion:

In summary, the cannabis industry appears ready for a resurgence, buoyed by renewed investor optimism and shifting market dynamics. Our focus today was Flora Growth Corp. (NASDAQ: FLGC) but larger names like Canopy Growth Corporation (NASDAQ: CGC) and Cronos Group Inc. (NASDAQ: CRON) are among the many companies benefitting from this positive trend.

We will update you on FLGC when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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