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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is Heating Up as Biotech Begins Production of Dendritic Cell Cancer Vaccine at Sawston Facility & Phase III Top Line Data Looms

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is one exciting biotech that has given up some gains since hitting highs of $2.50 per share but not that much and is now making another strong move on $1 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 in pharma 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 is also making rapid progress on other fronts recently reporting commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK. This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility for compassionate use cases, and approval by the Human Tissue Authority (HTA) of a license for collection and processing of human cells and tissues for medical purposes. Under this regulatory program in the UK, the vaccine is identified as ADCV (“Autologous Dendritic Cell Vaccine”).  The Sawston facility contains a total of 88,345 square feet on two floors.  The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. Now that the facility is ready for the manufacture of cell therapy products for clinical use, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility. The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year.  

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a biotech 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. The Company’s 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 reached data lock and the Company is actively continuing to move toward announcement of top line data. Northwest has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. 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 199 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 US 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. In addition to its patent portfolio, Northwet has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.  

DCVax® is designed to reinvigorate and educate the immune system to attack cancers. Unlike conventional cancer drugs, which use one active agent to hit one target on the cancer, DCVax uses many active agents to hit many targets on the cancer. Northwest believes that at least three key aspects of the DCVax technology contribute to the positive results seen in clinical trials to date: (1) DCVax is designed to mobilize the entire immune system, not just one among the many different categories of immune agents in that overall system. 2) DCVax is designed to target not just one but the full set of biomarkers on the patient’s tumor. And 3) DCVax is personalized, and targets the particular biomarkers expressed on that patient’s tumor.  

NWBO has a strong management team behind it, led by CEO Linda F. Powers, a high-powered executive who served on the MD Stem Cell Research Commission, and was the Commission Chair for the first two years of the state’s stem cell funding program. Ms. Powers served for more than 6 years on the Board of the Trudeau Institute, as well as several years on the Steering Committee of the National Academy of Sciences, evaluating government research funding, and has been appointed to three Governors’ commissions created to determine how to build the respective states’ biotech and other high-tech industries. Ms. Powers also serves on the boards of a number of private biotech companies. The Company’s CSO, Alton L. Boynton used to be head of the Molecular Oncology research lab at the Pacific Northwest Research Foundation (the original foundation of Bill Hutchinson, from which the Fred Hutchinson Cancer Center was spun off). NWBO’s CTO, Marnix L. Bosch Ph.D. has led the processes for numerous regulatory submissions in both the U.S. and abroad and used to work at the Dutch National Institutes of Health (RIVM) as head of the Department of Molecular Biology, as well as in academia as a professor of Pathobiology. He has authored more than 40 peer-reviewed research publications in immunology and virology, and is an inventor on several patent applications on dendritic cell product manufacturing. 

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The DCVax technology is expected to be applicable to most cancers, and is embodied in several distinct product lines. One of the product lines (DCVax®-L) is designed to cover all solid tumor cancers in which the tumors can be surgically removed. Another product line (DCVax®-Direct) is designed for all solid tumor cancers which are considered inoperable and cannot be surgically removed. Management believes the broad applicability of DCVax to many cancers provides multiple opportunities for commercialization and partnering. Importantly, DCVax has an excellent safety profile and is non-toxic. In clinical trials to date, stretching over a decade and including over 1,000 treatment cycles, there have been no toxicities such as chemotherapies involve – and not a single “serious adverse event” – related to the treatment.  

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.”   

NWBO is pursuing an intensive program of manufacturing preparations and planning in preparation of the top line data from its Phase III trial of DCVax®-L; development of the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and certified by the UK Medicines and Health Products Regulatory Authority (“MHRA”). The Sawston facility contains a total of 88,345 square feet on two floors.  The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. 

NWBO Sawston, UK advanced manufacturing facility

 

The last press release from NWBO came on February 17 when the Company reported commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK. This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility for compassionate use cases, and approval by the Human Tissue Authority (HTA) of a license for collection and processing of human cells and tissues for medical purposes. Under this regulatory program in the UK, the vaccine is identified as ADCV (“Autologous Dendritic Cell Vaccine”). 

As previously reported, the MHRA license was received in December of 2021, following nearly two years of preparations. This included hiring and training of technical staff, preparation of approximately 1,000 regulatory documents (including Standard Operating Procedure documents and others), validation of facilities, equipment and protocols, and practice manufacturing cycles. This was followed by a review and detailed inspection by the MHRA. 

Since the issuance of the MHRA license, Advent Bioservices, NW Bio’s contract manufacturer in the UK, has been conducting the required post-approval re-validations and testing so that the facility is now ready for the manufacture of cell therapy products for clinical use. Accordingly, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility. The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year. The Company plans to continue developing the Sawston facility in phases, both to calibrate the capital expenditures with the capacity needed and to leave room for implementation of new technologies such as the Flaskworks system. 

Microcapdaily first reported on NWBO on November 11, 2018 when NWBO was trading at $0.20 stating at the time: “Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has been sitting at around $0.20 as Investors wait out a news vacuum since the end of August. Northwest is an exciting Company with a recent history of explosive moves up. The stock used to trade at much higher levels. Currently trading at a $105 million market valuation NWBO has $1.6 million in the treasury, some revenues reporting $410,000 in revenues for the 6 months ended June 30, 2018 and significant debt on the books. Northwest is a really exciting company; their lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. This product in an ongoing Phase III trial for newly diagnosed Glioblastome multiforme (GBM).” 

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Currently trading at a $904 million market valuation NWBO has 981,374,858 shares outstanding out of 1.2 billion authorized. The Company is an SEC filer and fully reporting OTCQB. While the Company has $15.2 million in the treasury and over $40 million in assets, they also have significant debt on the books. NWBO is pre revenue but some have started to trickle in topping $1 million in sales in 2021. Northwest has been very successful raising money recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000. Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names in pharma 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 on November 11, 2018 when NWBO was trading at $0.20 per share. 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.

BioPharma

BioXyTran Inc (OTCMKTS: BIXT) Crushes Primary Endpoint, Expected to Achieve Unicorn Status in New Year

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Last month, BioXyTran Inc (OTCMKTS: BIXT) achieved a once-in-a-decade type event with their announcement of a perfect phase 2 clinical trial outcome with a 100% response rate by day 7.  Only when Gilead (NASDAQ: GILD) announced results of their Hepatitis C treatment in May 2013, which became a cure for HCV, did a trial last achieve a perfect response rate status and then increased the company’s market value by $80 billion in the process. Most investors familiar with BioXyTran know the company for its oxygenation drug, BXT-025, which has massive potential across many medical indications, including ischemic stroke. However, fewer investors are just as familiar with the company’s prowess in infectious diseases, specifically with antivirals.  The question on investors’ minds is how an obscure oxygen carrier company turned into a potential pandemic-ending therapeutic company. The answer is that the therapy wasn’t a repurposed drug; it was developed from scratch.

During the pandemic’s start, the company made a hard pivot into COVID-19, where a predominant number of biotechs shifted toward COVID-19 treatments. Clinical trials in chronic diseases slowed to a halt while healthcare facilities focused solely on the pandemic. The company’s deep expertise in carbohydrate chemistry presented a unique opportunity to do what nobody else was doing—design a carbohydrate-based antiviral for COVID-19 that might act as an entry inhibitor instead of blocking viral replication from the inside. The idea’s genesis started in March 2020, when the focus of the world’s researchers was on getting a compromised immune system to respond better and faster to clear the viral infection. The oral version of the antiviral they developed, ProLectin-M, is an unconventional antiviral since it doesn’t interfere at the intracellular level; instead, it blocks viral docking of the virus to the target cell by binding to galectins and a conserved site on the spike protein. Most antivirals work inside the cell, but this works outside the cell as an entry inhibitor.

Overcoming Adversity – David vs. Goliath Struggle

The company successfully jumped through hurdles that other companies did not have placed in their path. They were one of 38 companies suspended by the SEC in a blanket of COVID-19 enforcement action that temporarily suspended the company and effectively forced them to reregister the company in order to achieve trading status via a 15c211 filing. To survive, the company had to raise money as essentially a private company and negotiate with debtors they were in default to. They found the backing of a private equity firm and high-net-worth individuals and went through an almost 2-year process in order to regain trading status while cleaning up all their toxic debt. They were the only company to return to trading status as an OTCQB-listed stock from the SEC COVID trading halts. If the SEC was using the premise of “survival of the fittest” during the COVID halts then BioXyTan might have emerged as a new life form because as you will see their drug not only works but has pandemic-changing potential.

Helping drive the need for new therapeutics is the fall off of vaccine effectiveness, along with COVID-19 becoming an endemic problem. However, it doesn’t seem quite endemic yet as deaths in the United States are still averaging over 2000 weekly. Ongoing infections and hospitalizations as well as antivirals proving effective are going to help validate the long-term stability of a market for antivirals. Thus, this story has become pretty compelling.

BioXyTran’s Value Inflection

Last month, BioXyTran released topline results from its lead asset, ProLectin-M, an orally administered COVID-19 antiviral candidate, in patients with mild-to-moderate COVID-19. The drug exceeded all expectations with:

“-Complete elimination of viral load in 100% of patients at day 7 vs 6% in placebo (p=.001)

-Complete elimination of viral load in 88% of patients at day 3 vs 0% in placebo (p=.001)

-Treated population experienced no viral rebounds within the 14-day observation period”

When looking at these results, investors have to keep in mind that BioXyTran achieved these pristine-looking results despite enrolling patients 1) with high viral load (Ct<25), 2) regardless of vaccination status (unvaccinated and vaccinated), and 3) with any medical conditions—no limits. This is noteworthy because current COVID antivirals aren’t technically indicated for patients who are otherwise considered healthy and vaccinated—Merck (NYSE: MRK) and Pfizer (NYSE: PFE) excluded vaccinated individuals in their phase 3 studies to help them achieve their endpoints. In the case of Paxlovid, there are many contraindications for Paxlovid, which limits its market, which is enormous anyway; Pfizer expects $22 billion in 2022 Paxlovid sales.

It’s a bit of an apples-and-oranges comparison to try to compare these results to Paxlovid because of methods and materials differences and data availability. But by all available measures, it sure looks like ProLectin-M is overthrowing Pfizer’s Paxlovid as the superior COVID-19 antiviral.

The company released data a while ago in a small phase 1 study which suggested that the drug would work fairly well, but issues in gathering data on placebo patients made it really difficult to draw solid conclusions confidently.

However, the new data BioXyTran released arguably puts it in the lead in the COVID-19 antiviral field with respect to viral load data. It seems that no other company could compete to this degree if they wanted to use their antiviral as a prophylactic, which could be especially useful in, for instance, travel or healthcare situations since the viral load can have a great effect on transmissibility.  These two clinical trials denote what looks to be an unstoppable trend that could culminate with regulatory approval.

ProLectin-M Likely Eliminates SARS-CoV-2 More Effectively

This is where the red-apple-to-green-apple comparison sets in. ProLectin is much more effective at quickly bringing the viral load down since it prevents viral entry while helping mop up the existing viral load. However, the only way to really compare the rate of viral elimination (by time-to-Ct≥30) is through two different studies with two different PCR tests, and heterogeneous populations. Despite that, the drastic difference between time-to-undetectable viral burden is so different between the groups that it paints a pretty clear picture of which antiviral likely works better:

A real-world study of Paxlovid and Lagevrio was done in a hospitalized group of patients, where key endpoints measured were time to achieving low viral burden, or Ct≥30. The real-world study showed that the antivirals were highly effective in getting patients’ viral loads down, with cycle threshold values increasing over placebo by ~3 by days 5-7. However, the antivirals failed to cause a large portion of patients to have a low viral burden by days 5-7; if one looks at the excerpted charts below, ~4-5% of patients on those two antivirals had low viral burdens vs ~1-2% in the match controls. Compare this to BioXyTran’s 100% of treated patients reaching Ct≥30 vs 6% of the placebo group reaching Ct≥30.

Adapted from https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00507-2/fulltext

BioXyTran’s treated patient data outperforms the real-world Paxlovid/Lagevrio data to the extent that when it is superimposed on the journal’s graph of the antivirals’ performances, the Prolectin curve doesn’t even fit on the chart, which is cut off at 50%. Note that in BioXyTran’s trial, the placebo arm reached a mere 6% Ct≥30, so the placebo line would basically look flat up until day 7. Does it even matter that the compared populations are heterogenous when Prolectin-M outperforms by such a large margin?

We can do a further comparison with Paxlovid and see that after day 7, Paxlovid mustered a mere ~-1log10 change in viral load over placebo (about 1/10th the viral load). This is good but when compared to Prolectin-M it falls short. Prolectin-M, which is showing about an average Ct value of ~+8 versus placebo on day 7 (which translates to over 1/100th the viral load in my estimation). The picture starts becoming clearer; Prolectin clears the virus really quickly.

https://www.nejm.org/doi/full/10.1056/nejmoa2118542

The last drug to achieve such a high responders rate for viral load was Gilead’s drug Harvoni which is a cure for Hepatitis C.  This drug supplemented Gilead’s HIV business and helped bolster its market capitalization by $80 billion of dollars in the course of 1.5 years.

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Hepatitis C was indeed an incurable chronic condition that isn’t the same as an acute infectious disease like COVID. But they both have enormous economic burdens. And COVID-19 can lead to Long-COVID.

Long-COVID, however, is also a chronic condition with an immense burden to the person and the overall economy. It is likely that with a lack of viral rebound seen in BioXyTran’s COVID-19 phase 2 and some symptom measurement in the anticipated phase 3 trial, they would be making a great case for Long-COVID. And in terms of economic burden, Long-COVID is estimated to be much greater ($3.7 trillion) than Hepatitis-C, especially when one considers the fact that every time COVID mutates and reinfects patients, it has the chance of causing Long-COVID again. Hepatitis C doesn’t pose the same issue since it’s not airborne.

Two of the leading theories for Long-COVID include viral persistence and the persistence of the spike protein S1 subunit in monocytes. Prolectin-M targets this part of the spike and therefore could theoretically address Long-COVID from either perspective. In fact, when looking at viral rebound after therapy, Prolectin-M exhibited no patients with viral rebound whereas it is documented that “Paxlovid has significant rebound issues: 3.53% and 5.40% for COVID-19 infection, 2.31% and 5.87% for COVID-19 symptoms, and 0.44% and 0.77% for hospitalizations.” So when considering these facts it isn’t a stretch to expect BioXyTran to measure viral rebound in its upcoming phase 3 and potentially even start to pursue Long-COVID.

Financials

BioXyTran has maintained about a $2 million cash burn for the past 2 years, but only has about $0.37 million of cash in the bank. The company will need an estimated $2.7 million outlined in its latest presentation for running its pivotal acute COVID-19 trial. If it wants to pay off its convertible notes, it will need an additional $2.2 million. While this picture, makes it seem like BioXyTran is insolvent and unable to finance a phase 3 trial, its cost structure is extremely lean with officers forfeiting accrued salaries and benefits. The biggest risk with BIXT is their ability to attract capital because the risk of the medicine failing is just not realistic and it may seem too good to be true.  This assumes that the peer review goes off without a hitch and doesn’t turn into a Theranos scandal. While a risk, it is important to characterize it as a very low risk since their journal article included the Mechanisms of Action (MOA) deduced from Nuclear Magnetic Resonance (NMR) imaging. The NMR tests show binding to the spike and arguing against that conclusion is equivalent to saying 1+1 is not equal to 2.

There is also the traditional regulatory risk, but the company is going after approval in the United States and India, so its dual track offers investors a plan B should any barriers present themselves.  The Indian regulatory climate makes it very tough to get a drug into trials because unlike the US FDA all the manufacturing needs to be done beforehand.  However, it’s a dual-edged sword because if the study meets its endpoints in India approval happens swiftly whereas in the United States there is a lot of back and forth on the safety and manufacturing of the drug.

The risk of dilution is very high given that they filed an S-1 on April 12, 2022, but it has not gone effective.  It’s reasonable to assume that BioXyTran got a “no comment” S-1, meaning all they have to do is mark in a price and resubmit it for effectiveness.  The fact that they didn’t complete a raise in light of these phase 2 trial results suggests that the valuation levels might not be high enough or that they might have another plan.

Valuation

The quickest way to figure out what kind of value these homerun phase 2 results brings to BioXyTran is to compare the market potential to existing antivirals on the market and in development. From a sales perspective, Pfizer’s antiviral Paxlovid pulled in sales of $7.5 billion just this last quarter, which met the company’s expectations for $22 billion in the full year. There is a significant market opportunity for new market entrants with differentiated products; a Fierce Pharma article stated that:

“More needs to be done to convince doctors that Paxlovid is a good option for patients, said Angela Hwang, chief commercial officer and president of Pfizer’s global biopharmaceutical business.

‘The one area of education that we need to emphasize is: Who are the eligible people for Paxlovid,” Hwang said. “There are 22 risk factors for who should be eligible and those include those who are over 65—age-related risks—but equal risks like mental health illness, inactive lifestyle, risks you may not be aware of. I think that’s where we want to focus now.’”

BioXyTran probably doesn’t expect to sell its drug with a large sales force. What is more likely is that the company pursues a licensing deal with pharma or sells directly to governments, like when Pfizer sold 10 million courses of Paxlovid to the U.S. government for $5.3 billion.

With respect to stock market value, we can compare to a company that lost billions in market capitalization when its phase 2 results for a COVID-19 antiviral flopped. BioXyTran isn’t the first company to design a phase 2 trial to measure viral load. Well-backed Atea Pharmaceuticals (NASDAQ: AVIR) released topline results from its Phase 2 trial of its own COVID-19 antiviral about a year ago. Atea Pharmaceuticals lost over $2 billion in market capitalization the day it announced that its oral RdRp inhibitor called AT-527, intended to be an improved version of Gilead’s remdesivir, failed to meet its primary endpoint, and the company cited that in a subset of patients, the viral load went down (a little bit): “In high-risk patients with underlying health conditions, a reduction of viral load of approximately 0.5 log10 at Day 7 was observed at 550 mg (prespecified subgroup analysis) and 1,100 mg BID (exploratory subgroup analysis) compared with placebo”.

The drug failed to meet its primary endpoint in patients with mild-to-moderate COVID-19, where BioXyTran passed with flying colors. Compare Atea’s subgroup 0.5log10 reduction in viral load vs placebo at day 7 to my estimate of BioXyTran’s reduction: 2log10 reduction at day 7 for ProLectin vs placebo. Prolectin even compares favorably to Paxlovid’s ~1log10 change vs placebo). So we can speculate that BioXyTran’s results, in the heat of COVID-19, might have been worth $2 billion. While the pandemic fear has subsided, these results are still highly valuable and it’s likely safe to say that an antiviral with robust viral clearance such as Prolectin-M should be worth at least a few hundred million.

In a hypothetical situation where BioXyTran completes its phase 3 trial successfully and secures an order to a government organization in 2024 for 1/5th of what Pfizer did, we can discount that value to the present using a modest P/S multiple of 2.5x and a WACC of 30%, as well as a risk factor of 50%. The resulting value is $784 million. Accounting for some additional dilution, using 150 million shares outstanding, we arrive at $5.23/share. This valuation is well below the $2.2 billion AVIR lost when posting negative phase 2 results, and it is significantly less than the total revenue Pfizer posted for Paxlovid in this latest quarter. From about $0.50 for BIXT shares, this would be a 10-bagger, hypothetically.

Risks

Primary risks at this point include funding; the company needs money to run its phase 3. The company may also have to compete with big pharma to sell their antiviral, though at this point the patient populations do not necessarily overlap much. Lastly, the endpoints currently set in its planned phase 3 trial are primarily seropositivity and secondarily, symptoms, time to discharge, duration of hospitalization, and mortality. Other key antivirals have been approved based on time to resolution of disease/alleviation of symptoms (Tamiflu – Roche (OTCMKTS: RHHBY)) and reduction in hospitalization and death (Paxlovid – Pfizer, and Lagevrio – Merck), all of which are clinical endpoints rather than biomarker endpoints (serum positivity). However, BioXyTran is still measuring clinical endpoints; they’re just listed as secondary endpoints at this time.

As with all clinical-stage biotechnology companies, there are management, funding, and clinical trial outcome risks that in general put biotech companies like this in a very high-risk category, which balances against the high reward. BIXT also trades on the OTC, where volumes are lower and investments can be more speculative.

Conclusion

Bioxtytran is fighting the mindset that COVID is over and that there is no way a small pharma can produce a pandemic-ending therapeutic. The prevailing thought is that the world has entered the endemic phase and that we all must find ways to live with the virus.  The facts tell a different story. Although there are no head-to-head comparisons of ProLectin-M to Paxlovid, BioXyTran’s phase 2 results appear superior in every metric.  There is no known toxicity or drug-to-drug interactions compared to the 40+ known drugs that Paxlovid interferes with. The efficacy results are unprecedented because BIXT had almost a 90% response rate by day 3 and no viral rebounds within 14 days like those that are reported with Paxlovid use. The company also proved their MOA that their drug attaches to the spike protein and galectins to prevent viral entry—these results are not expected to be a fluke. Their journal article BIXT published harps on the idea of reducing infectivity and introduces the idea that by treating the disease early we can potentially prevent Long-COVID.  ProLectin-M is a drug designed for the masses and would likely have broad appeal given its currently-observed tolerability profile.

BIXT has about a $50 million market cap despite its completion of a phase 2, and the price attempted a readjustment on the day of the release but it appears that profit takers had other plans, and the stock isn’t quite well-known yet.  Given the high insider ownership of 75% and the low float of 12 million shares, it takes some time to get the word circulated.  Some may speculate that this could be a cure for COVID because two clinical trials denote a very favorable trend, but what’s arguably more important is counteracting the increased infectivity as the variants have mutated to become more transmissible or evade existing anti-spike antibodies from mass vaccination.  The time spent quarantining and the productivity lost before returning to work or feeling better is all calculus in the future pricing of the drug.  In all likelihood, with governments buying bulky contracts, the governments will set the pricing and consider these factors.  ProLectin-M has the potential to be one of the biggest hits of all time, like Pfizer’s $22 billion Paxlovid, though this claim might seem ridiculous in light of BioXyTran’s market capitalization.  Having a small amount in a portfolio could dramatically improve its performance as word of the clinical breakthrough starts to spread.

Disclosure: MicroCapDaily has not been compensated for this article. This post was written by a guest contributor and posted on our website for free. The owners of MicroCapDaily have no position in any of the securities mentioned.

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BioPharma

Cosmos Holdings Inc (NASDAQ: COSM) Huge Short Position Panicks as COSM Rockets Up the Charts

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Cosmos Holdings Inc (NASDAQ: COSM) is rocketing up the charts northbound since reversing off $0.0675 lows earlier this month where we first gave the heads up on COSM at around a dime in our article here. Since than COSM has rocketed northbound recently surpassing $0.60 per share with speculators pointing at $1 as the next stop. In our previous article on COSM on November 13 when COSM was $0.10 we stated: “COSM was trading well over $3 at the beginning of this year but has been heavily shorted since than with current estimates of well over 5 million shares sold short and almost the entire public float sold short. 

While COSM has been heavily shorted into oblivion, the Company is actually doing quite well recently reporting revenues for the 3 months ended September 30 were $12 million. The Company is successfully developing their business recently closing a deal with Iberica, a European Airline, for in flight distribution of their products. The CEO has bought millions of shares at current levels and COSM is beginning to go viral on social media trending on the sub reddit Short Squeeze, Number #1 on Stocktwits and multiple videos being made on YouTube about a massive short squeeze taking place in small caps. 

COSM Friday December 2, 4PM Close Update: COSM had a wild trading day on Friday dropping to $0.42 in the morning before rocketing up to $0.61 highs. This was followed by another drop to the $0.47 range before COSM rocketed up in late afternoon trading, closing at $0.53 on 205 million shares traded. COSM was up 33% on the day on around $110 million in dollar volume. COSM is setup for an enormous week ahead, looking to overtake the $0.845 from Monday and embark on a blue-sky breakout with $1 as the first stop. We gave the heads up on COSM when the stock was below $0.10 per share at the beginning of November. We will be updating on COSM as soon as anything new happens so make sure you are subscribed to Microcapdaily by entering your email in the box below.  

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No alternative text description for this imageCosmos Holdings Inc (NASDAQ: COSM) is a global healthcare group that was incorporated in 2009 and is headquartered in Chicago, Illinois. Cosmos Health is engaged in the nutraceuticals sector through its own proprietary lines of products “Sky Premium Life” and “Mediterranation.” Additionally, the Company is operating in the pharmaceutical sector through the provision of a broad line of branded generics and OTC medications and is involved in the healthcare distribution sector through its subsidiaries in Greece and UK serving retail pharmacies and wholesale distributors. Cosmos Health is strategically focused on the R&D of novel patented nutraceuticals (IP) and specialized root extracts as well as on the R&D of proprietary complex generics and innovative OTC products. Cosmos has developed a global distribution platform and is currently expanding throughout Europe, Asia and North America. Cosmos Health has offices and distribution centers in Thessaloniki and Athens, Greece and Harlow, UK. 

The Number #2 post on the subreddit ShortSqueeze currently is titled: COSM about to test resistance. A pump through $0.66 and lift off to over $1.00 is possible now. 

In another post on COSM in the subreddit ShortSqueeze rubio2430 states: “$COSM you cant make this stuff up. this baby is ready for space. the shorts are burying themselves on the daily. constant pr’s, growing fundamentals, no plans on dilutions, dual listing on upstream soon—the list goes on! 

nimble_broccoli replied: Why this is a good play: 

1.) Extremely tiny Marketcap 2.) CEO buying 15’000’000 shares 3.) Good fundamentals, unlike other plays, they actually sell products valued around 10x the valuation. Q1/22 was profitable. 4.) Getting momentum on social media (Reddit Twitter, YT) 

Next catalysts: -Info that they will not be delisted from NASDAQ -Degen and Retail FOMO kicking in -Shorts starting to cover their asses 

In addition, consider this: The stock was somewhere between USD 2 and USD 12 the past ~8 years. Most Hodlers bought back then, do you think they will sell now? Do your own thinking but if one of my stocks dropped 80+ % i d not sell, i d just hope for a miracle or ride it out. Thus, not many regular buy&hold holders of the stock are expected to sell. 

Cosmos operates in the business of full-line pharmaceutical wholesale distribution and serves approximately 1,500 independent retail pharmacies and 40 pharmaceutical wholesalers in Greece region by providing brand-name and generic pharmaceuticals, over-the-counter medicines, vitamins and nutraceuticals. Cosmos invests in technology to enhance safety, distribution and warehousing efficiency and reliability. Specifically, the Company operates a fully automated warehouse system with three robotic systems, two ROWA™ types and one A-frame type, that ensure 0% error selection rate, accelerate order fulfillment, and yield higher cost-efficiency in our distribution center. Cosmos has 3 operating subsidiaries including:

SkyPharm
Sky Pharm SA is headquartered in Thessaloniki, Greece. Sky Pharm trades the excess amounts of about 500 medicines that can be exported within the EU countries. We buy from Greek wholesale pharmaceutical companies and multinational pharmaceutical manufacturers, and export to European markets where demand and prices are substantially higher.
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DHN
Decahedron Ltd. is a pharmaceutical wholesaler incorporated in the UK in August 2011. It is audited by the MHRA under European GDP (Good Distribution Practices). They are also a full member of the EAEPC and have been audited by TÜV on their behalf.
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Cosmofarm
Founded in 1994, Cosmofarm is a fully licensed pharmaceutical wholesale company operating in the greater Athens area. The company is approved and authorized by the National Organization for Medicines under Good Distribution Practices to distribute a comprehensive range of pharmaceutical products. Cosmofarm’s core activity is sourcing, procuring, and distributing branded.
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COSM business is strong and Q3 highlights include closing a $7.5M capital raise via public offering and signing an exclusive agreement to market and distribute Nickelodeon’s SpongeBob and PAW Patrol kids’ vitamins in Greece and Cyprus, aiming to reach out 11,000 pharmacies and 120 wholesalers in Greece and 780 pharmacies in Cyprus. They also executed a letter of intent for a strategic co-venture agreement with Smart for Life (SMLF) to cross market products and services in their reciprocal markets. COSM also entered into an LOI to acquire ZipDoctor Inc., and entered into an agreement with Virax Biolabs (VRAX), to become the distributor of Monkeypox Virus Real-Time PCR Detection Kits, having the exclusive distribution rights for Greece and Cyprus, with the opportunity to distribute the test kits across Europe on a non-exclusive basis. SkyPharm officially launched its first Sky Premium Life products on Amazon in the United States. Cosmos targets having all 85 SKUs listed on Amazon by year end. COSM entered into an LOI to acquire Pharmaceutical Laboratories CANA S.A., and another LOI to acquire LIFE NLB, Ltd.’s product portfolio, including Bone-Vio® and Bone-X, related to bone health targeting the human gastrointestinal microbiome. 

Last week COSM announced its Sky Premium Life luxury food supplement brand will be sold on Ronda, the official inflight magazine of the airline company Iberia of BRITISH AIRWAYS group. Ronda is available free of charge to the over 10 million passengers who fly Iberian Airlines annually. Iberia Airlines, majority owned by British Airways, has a fleet of 147 aircrafts and engages in over 600 daily flights. 

https://twitter.com/nxtplse/status/1597365583934545920

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Currently trading at a $36 million market valuation COSM os is 92,008,281 the Company recently reported Q3 Revenues of $12 million down a bit from the same time last year due to a high variation in FX differences between EUR and GBP to USD. COSM was trading over $4 this time last year however OS has increased substantially since then.  COSM is an exciting opportunity in small caps; the stock was shorted into oblivion and currently there are minimum 5.8 million shares short and was way oversold to pennies and it looked as if it would definitely get delisted by the Nasdaq however, led by able CEO Grigorios Siokas, Cosmos is fighting back. Mr. Siokas continues to buy more COSM at current price levels, putting his money where his mouth is as COSM rockets towards $1 which is now just a day and half away if the stock continues up at the same trend.  We will be updating on COSM when more details emerge so make sure you are subscribed to Microcapdaily.

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

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BioPharma

CytoDyn Inc (OTCMKTS: CYDY) On Watch as Company Hires Ambitious New CEO Who Charts Path Forward (Update on leronlimab)

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CytoDyn Inc (OTCMKTS: CYDY) has formed a solid base over $0.30 and is beginning to move northbound again. The stock recently made a solid bounce from new 52-week lows of $0.231 to a high of $1.26 per share. CytoDyn was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share before the Citron short attack took the wind out of the stocks sails and the long downward trend began.  CyyoDyn lows earlier this year came as the FDA placed a partial clinical hold on the Company’s HIV program and a full clinical hold on its COVID-19 program in the US. This was followed by the CEO and registered public accounting firm, Warren Averett LLC, both resigning and the Company electing to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting. All of this has culminated in CYDY being offered at a cheap discount to prices from just a few months ago and the opportunity to buy in to Cytodyn for under $0.40 per share.    

CYDY is a highly volatile stock that ran to $10 per share in 2020 with a similar share structure. The underlying science of Leronmilab has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, and HIV and leronlimab with zero side effects. leronlimab (PRO 140), is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastasis, and immune signaling. leronlimab also has a lot of big believers including many well-respected scientists. Cytodyn recently raised $21.8 million in a stock offering and signed on a new President; Cyrus Arman, Ph.D. who said upon his hiring: “I look forward to uniting our teams and individuals in the pursuit of CytoDyn’s success through a renewed focus on the entrepreneurial spirit. Leronlimab is a unique molecule with the potential to help many individuals, particularly with unmet medical needs. We will focus on enhancing shareholder value through focused execution and refining of the path forward for leronlimab.” 

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CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of Leronlimab, a monoclonal antibody CCR5 receptor antagonist, to be used as a platform drug for a variety of indications. The target of leronlimab (PRO 140) is the important immunologic receptor CCR5. The CCR5 receptor is a protein located on the surface of a variety of cells including white blood cells and cancer cells. On white blood cells, it serves as a receptor for chemical attractants called chemokines. The CCR5 receptor is also the coreceptor needed for HIV to infect healthy T-cells. Recent research has identified the CCR5 receptor as an important target for many disease processes including cancer metastasis and certain immunological conditions. 

Leronlimab is a unique humanized monoclonal antibody. Leronlimab prevents HIV from using the CCR5 receptor as an entry gateway for healthy cells; preclinical research has also shown that leronlimab blocks calcium channel signaling of the CCR5 receptor when present on the cancer cell surface. It is believed that calcium channel signaling of the CCR5 receptor is a crucial component to the spread of metastatic cancer. The CCR5 receptor has been identified as a target in HIV, GvHD, NASH, oncology, transplantation medicine, multiple sclerosis, traumatic brain injury, stroke recovery, and a variety of inflammatory conditions. As we progress in evaluating leronlimab (PRO 140) via a pathways approach, we are encouraged by the opportunity to build a broad pipeline of indications. 

Earlier this year the FDA placed a full clinical hold on CytoDyn’s COVID-19 program and a partial clinical hold on its HIV program in the United States. As the stock price was collapsing Nader Pourhassan resigned and the collapse intensified after the Company’s registered public accounting firm, Warren Averett, LLC resigned. Since than Dr. Cyrus Arman has been appointed as new President of the Company and they are looking at potential strategies including:

  • Strengthening CytoDyn’s pharmacovigilance program enabling it to remove the FDA clinical holds placed on its HIV and COVID-19 programs to allow it to conduct future clinical studies.
  • Advancing CytoDyn’s NASH program to a Phase 2b or Phase 2b/3 trial for steatosis and liver fibrosis associated with NASH.
  • Exploring a study for patients with HIV and NASH as well as review the Company’s strategy for its COVID-19 program.
  • Continuing CytoDyn’s Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
  • Continuing CytoDyn’s work to evaluate the feasibility and timelines for the HIV BLA resubmission and explore other cancer and immunologic indications for leronlimab, continue its work on developing a long-acting version of leronlimab, and pursue proof of concept studies for HIV cure using leronlimab and AAV vectors.

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Cytodyn has been beefing up its BOD recently appointing Mr. Stephen Simes, a career public company biotech CEO and Mr. Ryan Dunlap, a current CFO with public company biotech experience to its board of directors. They join Tanya Durkee Urbach, Karen J. Brunke, Ph.D. and Lishomwa C. Ndhlovu, M.D., Ph.D. The Company’s corporate website looks more like a big boards. Check out their management team here. As we have reported, on July 9 of this year Dr. Cyrus Arman was appointed President of CytoDyn. 

On October 28 CytoDyn announced it has voluntarily withdrawn its pending BLA for leronlimab as a combination therapy in persons living with HIV with resistance to highly active antiretroviral therapy (HAART) in the HIV multi-drug resistant population (HIV-MDR). The decision to voluntarily withdraw was based on various factors, including systemic issues related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization (CRO) contracted to manage the trials, resulting in significant concerns with achieving a successful U.S. Food and Drug Administration (FDA) BLA approval. The Company is of the opinion that FDA approval for the HIV-MDR indication is not feasible without significant additional investment to remedy the issues. CytoDyn plans to publish soon the safety and efficacy data in which it met its primary endpoint, in its Phase 2b/3 randomized, double-blinded, placebo-controlled trial for the HIV-MDR population, in a peer-reviewed journal. 

The Company believes the data it currently possesses is sufficient to complete and submit its responses to the FDA to seek the removal of the clinical hold placed on the Company’s HIV program. Further, the Company will continue to leverage the performance of leronlimab in these and other studies to advance leronlimab in other HIV-related, non-alcoholic steatohepatitis (NASH), and oncology indications – where compelling data has been generated – that may benefit a greater number of patients and result in significant shareholder value creation. For example, the Company plans to continue to pursue other underserved HIV-related indications, where it can potentially be first to market. 

Cyrus Arman, Ph.D., President of CytoDyn, stated, “We have decided to voluntarily withdraw our BLA for the HIV-MDR population at this time only after extensive review and deliberation, including audits from three external independent regulatory quality firms. While the Company met its primary endpoints in these pivotal trials, which we think is a clear indication that leronlimab performs well in the clinic, we believe the issues identified in each of the three independent audits related to the quality of the data collection and oversight by the CRO make it difficult to support a successful BLA regulatory submission. Further, we have filed a claim against the CRO seeking damages resulting from its breach of the Master Services Agreement and related agreements and reimbursement of our attorney fees and costs associated with the action. As previously discussed, we are focusing on continued development in other HIV indications, NASH, and oncology, where we have Fast Track designation for metastatic triple-negative breast cancer. We plan to reenter the clinic in those indications and believe these steps will allow us to further build on the strong signals we have seen in these indications. I am very excited and quite optimistic about these opportunities, which are what ultimately attracted me to leronlimab and CytoDyn. I believe we have a unique opportunity to impact a significant number of patient lives while creating long-term value for our shareholders.”

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Currently trading at a $310 million market valuation CYDY is fully reporting OTCQB and while they are pre-revenue the Company has close to $100 million in assets and about the same in debt. At current levels CYDY is worth a close look; The stock was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share. Now trading for under $0.40, the underlying science has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, HIV and coronavirus with zero side effects. leronlimab (PRO 140), is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor  metastasis, and immune signaling. Now that Cytodyn has completed a stock offering and brough on new CEO Cyrus Arman, Ph.D. things could be on the up and up here. With a recent low of $0.231, a high of $10 CYDY at $0.38 should be at the top of speculators watch lists. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily.

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

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