Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Major Move Northbound as Sawston Facility is Licensed by (HTA) and (MHRA) & Biotech Awaits Imminent Phase III Top Line Data
Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is making a powerful run up the charts ever since reversing off $0.59 lows halfway through December. Volume has been increasing too with NWBO a staple among the top most traded stocks on the otc trading $3 million in dollar volume on a slow day as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that Northwest is on the cusp of major success so many others have failed including many of the biggest names in bio. DCVax®-L is proving itself as an effective treatment/cure for the deadliest, most treatment resistant cancers in the world. 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 continues to be featured regularly in main stream press as many recovered patients have come forward to credit DCVax®-L for saving their lives. NWBO is among the highest risk-reward opportunities in small caps today and if top line data is positive as many think it will be, there is no limit to how high NWBO can go.
NWBO is also making excellent progress on other fronts recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000 bringing the Company’s cash position to over $20 million. NWBO is pursuing an intensive program of manufacturing preparations and planning recently reporting development of the initial production capacity at its 88,345 square foot Sawston, UK advanced manufacturing facility has been completed. The initial production capacity at the Sawston facility comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually. The Sawston facility was recently licensed by the UK Human Tissue Authority (HTA) and was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products.
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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) 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 them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines. Their lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. This trial is currently underway at 69 locations throughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late-stage ovarian cancer together with the University of Pennsylvania. Their second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida. They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late-stage prostate cancer. NWBO owns a valuable intellectual property portfolio with 199 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. Northwest has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.
DCVax® is a platform technology that uses activated dendritic cells (the master cells of the immune system), and 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.
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. We believe the broad applicability of DCVax to many cancers provides multiple opportunities for commercialization and partnering. DCVax has an excellent safety profile and is on-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 – no “serious adverse events” – related to the treatment.
Northwest has been very successful raising money recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000 bringing the Company’s cash position to over $20 million. The Loan has a maturity of 22 months and no payments are due for the first 8 months of the Loan term. Upon announcement of the top line data from the Company’s Phase III clinical trial of DCVax®-L for glioblastoma brain cancer, the Lender has a then-springing right to exchange the outstanding balance of the loan for common shares priced at the price of the first private placement transaction following TLD less a 12% discount and to purchase another 50% of that number of shares at the same price. This then-springing right expires 14 days after the post-TLD private placement.
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 in a quiet period and hasn't released any negative news in the past year since locking the data from their phase 3 trial. The only news they've released is that they've been approved for manufacturing in the UK and the trial results are due any minute now, not day.
— 10 G's and a Trip (@litmpodcast) January 19, 2022
CVM announced datalock in 12/2020 and topline results in 6/2021. I think a primary endpoint failure necessitates immediate disclosure. $NWBO needed time to get manufacturing online and integrate a closed loop manufacturing system. Waiting to disclose TLD could be prudent.
— Justin Keister MS DABR (@justinkeister5) January 19, 2022
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DCVAX Survival Stories & Testimonials
Alice – Metastic Merkel Cell patient from Florida – ASCO 2018
Brad Silver – GBM patient from Huntington Beach, California – ASCO 2018
Sarah Rigby – GBM patient from Hong Kong – ASCO 2018
Kristyn Power – daughter of GBM patient from Canada – ASCO 2018
Kat Charles – GBM patients from UK – ASCO 2018 – as related by her husband Jason (Kat’s Cure)
Prospective patients may contact NW Bio at firstname.lastname@example.org
UCLA Jamil Newirth DCVax-Patient Video – 2015
Allan Butler Video – National Geographic Vice President – DCVax-Direct patient from Phase 1 Trial with Pancreatic Cancer
NWBO – Patients Sunday Dennis and Jami Newirth – Enrolled at UCLA – Vimeo, Uploaded approx. May 2015
NWBO – Vaccine Helps Keep Brain Cancer Patient Alive (Jennifer Sugioka) – NBC Channel 4, Southern California, February 24, 2015
NWBO – National Geographic’s Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
NWBO GBM Brain Cancer Suvivial Story of Brad Silver
NWBO, GBM Brain Cancer Survival Story of Mike Gregoire
UCLA – Real Stories Using DCVax
NWBO is pursuing an intensive program of manufacturing preparations and planning as the Company awaits top line data from its Phase III trial of DCVax®-L. Northwest recently announced development of the initial production capacity at its 88,345 square foot Sawston, UK advanced manufacturing facility has been completed. To date, the Company’s production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 – 6 patients per month. The initial production capacity at the Sawston facility comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually.
The Company has made significant headway recently getting licensed by the UK Human Tissue Authority (HTA) giving the Company the right to work with human tissues for medical products. More recently the Company was approved 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.
The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London. The license also permits the import and GMP manufacture of other cell therapy products under the UK’s supply of unlicensed medicinal products (‘Specials’) regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme.
Microcapdaily first reported on NWBO on November 18, 2018 when the stock was $0.20 per share stating the time: “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. The company operates in the booming global cancer biologics market which is expected to reach USD $87.6 billion by 2024 and is projected to grow substantially over the forecast period from 2017 to 2024. Increasing prevalence of cancer and patent expiry of related drugs is anticipated to boost the oncology biologics market.
Incredible Value Delivered to Society! Watershed Event. $NWBO https://t.co/BoEHrw0jIj
— Michael Bigger (@biggercapital) January 13, 2022
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NWBO is making a powerful run up the charts ever since reversing off $0.59 lows halfway through December. Volume has been increasing too with NWBO a staple among the top most traded stocks on the otc trading $3 million in dollar volume on a slow day as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that Northwest is on the cusp of major success so many others have failed including many of the biggest names in bio. DCVax®-L is proving itself as an effective treatment/cure for the deadliest, most treatment resistant cancers in the world. 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 continues to be featured regularly in main stream press as many recovered patients have come forward to credit DCVax®-L for saving their lives. NWBO is among the highest risk-reward opportunities in small caps today and if top line data is positive as many think 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. NWBO is also making excellent progress on other fronts recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000 bringing the Company’s cash position to over $20 million. NWBO is pursuing an intensive program of manufacturing preparations and planning recently reporting development of the initial production capacity at its 88,345 square foot Sawston, UK advanced manufacturing facility has been completed. The initial production capacity at the Sawston facility comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually. The Sawston facility was recently licensed by the UK Human Tissue Authority (HTA) and was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products. 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.
Bioxytran (OTCMKTS: BIXT) Peer-Review Published Showing Functional Cure for COVID-19
On the cusp of a cure for COVID, one of the most promising yet under-the-radar biotech stocks on the OTC is generating much well-deserved buzz in the scientific community and is poised to go viral.
Bioxytran Inc. (OTCMKTS: BIXT) over the weekend had their phase 2 top-line results published in the peer-reviewed journal “Vaccines.” There is a not-so-subtle tinge of irony in that name because while their drug is nothing like a vaccine, there is no doubt about its efficacy– 100% PCR negative rate by day 7 versus 6% in placebo. The medical journal article was titled “An Oral Galectin Inhibitor in COVID-19 – A Phase 2 Randomized Controlled Trial.” This is a landmark journal article because – until now – only one other drug, Harvoni, had equaled a 100% responders rate in the past decade. Harvoni ultimately ended up being a cure for Hepatitis C Virus.
At this point in Bioxytran’s drug development pipeline, it essentially has a functional cure for COVID-19 that simply needs a pivotal phase 3 trial to show the true extent of their discovery. Their drug is a galectin antagonist, which neutralizes the now infamous spike proteins by placing a carbohydrate sheath over the spikes making attachment to the cell impossible. The carbohydrates binding grip is so tight on the virus that it carries it around in the blood until it is eventually filtered out by the liver and excreted.
If solving the pandemic wasn’t enough, the company recently reported that in vitro studies suggest the drug would be effective in Influenza and RSV. Yet despite the fact that this one drug could seemingly end upper respiratory infections, which most of us refer to as a “common cold,” it has a nominal market cap of just $50 million.
For the past three months, BIXT has been teasing this peer-reviewed article as a catalyst and a major value inflection point for the company. Despite that, investors haven’t gotten the hint, and have been steadily selling into this inflection point. Even though the company has yet to report it in a press release, the scientific community is understandably going crazy over it. Investors, however, are seemingly oblivious to the viral traffic and simply not paying attention to the sheer magnitude of the discovery–a functional cure for COVID and the methodology to seemingly combat any virus.
One of the reasons peer review is so important for a biotech is that major media outlets won’t touch the science without it. With its publication, this article means that BIXT now has an opportunity to tell its story on network media. The biggest risk that investors now face in BIXT is FOMO, driven by an unexpected media appearance that ushers unbridled buying into the name and leaves tepid investors chasing up.
If the article itself wasn’t enough, their peer-reviewed article was picked up by a major biotech influencer on Twitter, quickly garnering more than 100k hits. The influencer, Chris Turnbull, summarized the article highlighting key points like the rapid viral clearance in 3 days through entry inhibition and suggested the ideal use is when you know you were exposed. He hammered the point that ProLectin-M was for standard-risk patients and that Paxlovid was for high-risk groups with at least one medical condition.
This discovery changes the COVID landscape permanently. Multi-billion dollar antiviral drugs like Paxlovid and Lagevrio can’t hold a candle to the viral clearing power of BIXT’s galectin antagonist. Looking at the Twitter account of BIXT Chief Commercial Officer Michael Sheikh, it’s clear that there are some ongoing discussions with big pharma that have not yielded any fruit. But big pharma may not be their only option. BIXT has also said they are looking to partner with companies with large cash balance sheets. Both galectin antagonist companies Galectin Therapeutics (NASDAQ: GALT) and Galecto Bioscience (NASDAQ: GLTO) fit the profile and are the subject of a number of relatively supportive tweets by Sheikh. Sleuthing Sheikh’s LinkedIn profile reveals hardcore evidence of that sort of dealmaking with clusters of top executives in certain companies and networking, which suggests significant activity among their larger Galectin-focused peers. In an emerging growth interview, the CCO did say that he got a lot of business cards and was networking.
There exists a huge chasm between the current market cap and what it ought to be given that it successfully completed a phase 2 and nailed the endpoint with a perfect score. The CCO described in an Emerging Growth video how valuations work and a number of comparables in the $500 million range for a number of disease indications that BIXT is developing. The stock has a very tiny float of 19 million with an OS of 123 million. This represents a float of 15% and insiders own over 60%. There is no dilution from the convertible notes as they have company-friendly terms that allow up to 5% conversion into restricted common stock. In an Emerging Growth interview a couple of months ago, the CCO acknowledged the stock’s current challenge, indicating a legacy seller was responsible for half the daily volume and was almost gone. In early March after a ZeroHedge article was published, the stock went on a record run to $1.05 in a matter of minutes before short forces brought it back down. On March 7th it looks like the seller ran out of inventory for the day and the demand just lifted the stock price allowing it to go through a short period of natural price discovery. The long-term legacy seller seems to be at the end of his block, which means any news announcement could push the stock higher.
Low-Risk Explosive Reward Profile
There is no doubt that BIXT has incredible potential yet the stock continues to languish. With the anemic volume, it’s very difficult to diagnose what the root cause is for the disconnect from the comparable valuations established by big pharma in the $500 million region and BIXT’s current $50M cap. If one article that generated a little bit of buying pushed it to the brink of explosiveness, perhaps there is more stock from this legacy seller that is still controlling the narrative.
For the investor with a longer-term view, BIXT represents a safe place to park funds for explosive returns. The upcoming catalysts are a dosing of patients in India for the dose optimization trial, a potential IND from the FDA, and of course, the announcement of the peer-reviewed journal article. While it’s uncertain which catalyst will send the stock into overdrive it’s abundantly clear this is one of the most undervalued stocks in OTC.
Pound-for-Pound Comparison of Paxlovid and PLM
Paxlovid also helped lower the length of time people with underlying medical conditions were infectious. However, Paxlovid is not a very effective drug and is walking a tightrope with respect to its approval as more and more real-world data reveals their toxicity.
Here is a chart capture from the company’s latest scientific webinar that shows a side-by-side comparison for illustrative purposes. The charts show that Paxlovid can barely turn 30% of the patients PCR negative by day 20 whereas a majority of the PLM patients were PCR negative on day 3. This is an absolute game-changer in controlling the pandemic. The other thing that this peer-reviewed journal highlighted is that the symptoms were eliminated and without those symptoms, people were unlikely to develop Long COVID. It’s very reasonable to believe that PLM stops Long COVID due to its mechanism of action as well as the fact that it appeared to eliminate symptoms in this trial, as seen in the picture below. While it’s nice that Paxlovid stops hospitalization and death, PLM takes it to a new level by making you feel better faster and eliminating the risk of Long COVID.
Bioxytran is not only sitting on a solution for COVID and a possible end to the pandemic, but it appears they can also treat Long COVID and a number of viruses. All this information is out there in the public domain and investors seem to be sitting on their hands waiting for something more to happen. It’s unclear what that trigger will be. Will it be a video interview on major media? Will it be the IND announcement from the FDA? Or will it be an explosion of XBB1.16 cases in India whereby they fast-track the PLM development in the country? Whatever the catalyst, the risk/ reward scenario on BIXT is one of the best in all of the OTC. The small float coupled with the lack of an S-1 on file eliminating the risk of immediate dilution bodes well for either a long-term or medium-term investor.
Investors need to ask themselves if they could have invested in penicillin knowing the impact it was going to have last century would they have dived in? Investors are facing a similar scenario with PLM. This is perhaps the biggest antiviral discovery of the century which amounts to a functional cure for COVID and possibly other viruses. Will investors stay on the sideline because some grumpy shareholder is selling not allowing immediate price discovery or will they step up to secure their place in history? Time will tell, but what is certain is that PLM will save an immeasurable amount of lives and take away untold suffering if it can navigate its way to regulatory approval. But while BIXT may be curing Covid, there is still only one cure for FOMO. Investors would do well to stop waiting on the sidelines to enter or affirm their positions before this game-changing anti-viral goes viral.
Disclosure: MicroCap Daily and its owners do not have a position in the stocks posted and have posted this article for free without editorial input. This article was written by a guest contributor and solely reflects his opinions.
BioXyTran Inc (OTCMKTS: BIXT) Crushes Primary Endpoint, Expected to Achieve Unicorn Status in New Year
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.
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.
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.
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.
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.
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.
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.
Cosmos Holdings Inc (NASDAQ: COSM) Huge Short Position Panicks as COSM Rockets Up the Charts
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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Cosmos 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:
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.
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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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