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Biotech Sleeper (NWBO) Northwest Biotherapeutics Heats Up as Imminent DCVax-L Phase III Top Line Data Looms Large

Published

3 years ago

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has moved back into full beast mode and has been running higher in recent trading on heavy accumulation. NWBO is the darling of small caps and has proven itself as among the most resilient stocks in small caps with a huge following of investors. With a 52-week high of $2.51 and a newly established base over $1 NWBO is holdings its gains with ease and surging higher with power as Investors eagerly await top line data from the Phase III trial of DCVax®-L.  

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. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. 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 and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range.

NWBO (Northwest Biotherapeutics) 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. NWBO owns a valuable patent portfolio of 199 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. For a look at NWBO recent history go here. As per their latest quarterly report NWBO had $9.2 million in the treasury. Since then, according to a recent 8k, the company acquired a loan of around $11mn non-dilutive. 

The Company’s lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. This product is in a 331-patient Phase III trial for newly diagnosed Glioblastome multiforme (GBM). Recently the database for the Phase III trial of DCVax®-L for Gliobastoma was locked. On Oct. 5, NWBO issued a press release detailing many steps that would ensue, including the unblinding of the company’s management of the results of the statistical analysis of the data. “With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage. The Phase III trial went on for years as the Company waited for the 233rd death to occur out of 331 patients to calculate whether DCVax-L has any survival benefit. The fact that it took so long is another highly positive pointer here. 

NWBO is pursuing an intensive program of manufacturing preparations and planning as it approaches top line data from its Phase III trial of DCVax®-L. NWBO is currently building a manufacturing facility in Sawston, Uk. The buildout is the culmination of several years of design, development and preparatory activities, including clean room suites, quarantined storage, quality control testing suites, controlled cryostorage (freezing) facilities for the finished products, as well as specialized systems such as full air changes every 60 seconds in the clean room suites, and precise monitoring of particle counts in the clean room air. This accelerated effort is being supported by the Company’s recent financings and by a special purpose competitive loan of £1.35 (~$1.77) million from the Department for Business, Energy & Industrial Strategy which is administered locally in the Cambridge/Sawston region by the Cambridgeshire & Peterborough Combined Authority. The project cost is approximately $4.6 million. NWBO also recently aquired Flaskworks. 

Investor Sentiment in NWVO is very high:

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There have been indications that the top line date for DCVax®-L will be overwhelmingly positive; according to date published from 2018 at the Society for Neuro-Oncology Annual Meeting in New Orleans shows the following: Median overall survival (OS) from surgery in the intent-to-treat population at data cutoff was 23.1 months, the same OS benefit identified in 2017. The survival rate at year 2 was 46.4%, on par with 46.2% in 2017. In patients with methylated MGMT genes, median OS after surgery was 35.1 months, slightly better than 34.7 months observed in 2017. This represents a vast improvement over the median OS of only 14.6 months. “The survival rate is quite remarkable compared to what would be expected for glioblastoma,” said lead author Dr. Linda Liau, professor of neurosurgery at the David Geffen School of Medicine at UCLA and a member of the UCLA Jonsson Comprehensive Cancer Center. “The 20 to 30 percent of long-term survivors in immunotherapy clinical trials are the people in whom we think there may be a particularly strong immune response against their cancer that is protecting them from getting tumor reoccurrence.” 

Glioblastoma, also known as glioblastoma multiforme (GBM), is the most aggressive type of cancer that begins within the brain. There is no known method of preventing the cancer. Treatment usually involves surgery, after which chemotherapy and radiation therapy are used. The medication temozolomide is frequently used as part of chemotherapy. High-dose steroids may also be used to help reduce swelling and decrease symptoms. Despite maximum treatment, the cancer usually recurs. The typical duration of survival following diagnosis is 12 to 15 months, with fewer than 3 to 7% of people surviving longer than five years. Without treatment, survival is typically three months. Brain and other nervous system cancers are the 10th leading cause of death for men and women.  With the increasing prevalence of brain cancer, rising aging population, and growing incidences of cancer via chemical exposure, the demand of diagnosis and treatment of brain tumors is steadily increasing. The diagnosis, treatments, therapeutics and drug segments are all projected to continue to rise at a significant pace over the next several years. A report from Industry Research concerning the diagnostic and treatment markets projected that the global Brain Tumor Diagnosis and Treatments market size is projected to reach US$ 590 million by 2026, from US$ 444.8 million in 2020, at a CAGR of 4.8% during 2021-2026… while another report from ResearchAndMarkets, focusing on the drugs market added that the global brain tumor drugs market, which was valued at about $2.4 billion in 2018, is expected to grow to $3.41 billion at a CAGR of 9.2% through 2022. One player that has emerged in the space is NovoCure (NVCR), which now markets Optune and Optune Lua, a Tumor Treating Fields delivery system for use as a monotherapy treatment for adult patients with glioblastoma. This treatment has over 3400 active patients, and made $144mn in Q4 revenue this year. 

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has moved back into full beast mode and has been running higher in recent trading on heavy accumulation. NWBO is the darling of small caps and has proven itself as among the most resilient stocks in small caps with a huge following of investors. With a 52-week high of $2.51 and a newly established base over $1 NWBO is holdings its gains with ease and surging higher with power as Investors eagerly await top line data from the Phase III trial of DCVax®-L.  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. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. 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 and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range. Microcapdaily first reported on NWBO in 2018 and continues today. 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.

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Emerging Markets

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

Published

3 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

4 weeks ago

on

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

1 month 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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