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TG Therapeutics (NASDAQ: TGTX): Bullish Analysts & Breakthrough Treatment in Relapsing MS

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TG Therapeutics (NASDAQ:TGTX) concluded its most recent trading session with a closing price of $10.25, showcasing a remarkable 56.9% increase since the stock’s October low of $6.53. This stock was on quite a roll last week, surging by a staggering 65.6%. What’s fuelling this impressive growth? The company has seen triple-digit sales and earnings per share (EPS) growth after commercializing their lead asset in the US and expansion in Europe, marking multiple significant milestones.

This is the first time we’re looking at a small-cap biotech company with a market value over $1B in quite a while. That sets it apart from the clinical and preclinical stage biotech companies we typically discuss. Can TGTX continue their impressive run given the latest increase in valuation? According to several analysts, the answer is yes – let’s dig into the company to better understand where it might be headed.

Background:

TGTX focuses on addressing diseases associated with the abnormal behavior of B-cells. These diseases encompass B-cell non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and autoimmune disorders such as multiple sclerosis (MS).

B-cells belong to the family of white blood cells called lymphocytes and play a crucial role in the immune system by producing antibodies to combat infections. Diseases arising from the misbehavior of B-cells are quite prevalent and can be broadly classified into two main groups:

  1. Malignant lymphomas, including NHL and CLL, with over 80 types of NHL, many of which are attributed to rogue B-cells. Some grow slowly, while others exhibit rapid growth. Examples of these diseases include marginal zone lymphoma, follicular lymphoma, and small lymphocytic lymphoma (SLL).
  2. Autoimmune disorders occur when B-cells produce antibodies that mistakenly target healthy organs, resulting in conditions like multiple sclerosis and rheumatoid arthritis.

On December 12th, 2022, the FDA granted approval for their flagship product, Briumvi, designed to treat Relapsing MS. Additionally, the company boasts a clinical-stage pipeline that is currently undergoing phase 1 trials, with a focus on addressing B-cell disorders.

However, what holds greater significance is their already commercialized drug, Briumvi. Let’s delve deeper into that aspect to see the opportunity at hand.

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Lead Asset:

As mentioned, the company’s lead asset Briumvi, (Ublituximab monotherapy) was recently approved by the FDA on December 28th, 2022 to treat Relapsing MS, a market said to reach $26.1 billion by 2029.

Briumvi is the first and only anti-CD20 monoclonal antibody approved in the United States (US) and European Union (EU) for adult patients with relapsing forms of multiple sclerosis (RMS) that can be administered in a one-hour infusion, twice a year, following the starting dose.

Patients currently face two treatment options for managing RMS: daily pill intake or self-administered injections. Given the clinical evidence and ease of use, it’s clear that Briumvi offers a significant improvement in their quality of life, here’s more on the compelling clinical data.

Clinical data on Lead Asset:

In extensive clinical studies involving over 1,000 individuals with relapsing multiple sclerosis (RMS), Briumvi was evaluated in comparison to a treatment that requires daily oral pill consumption—specifically, Teriflunomide (Aubagio). These trials spanned over two separate two-year phases, facilitating a rigorous assessment of the drug’s efficacy.

The findings from these studies, which compared 543 individuals treated with Briumvi to 546 treated with Aubagio, demonstrated that Briumvi outperformed Aubagio in reducing relapses and significantly decreased brain lesions as observed in magnetic resonance imaging (MRI). Specifically:

  • Briumvi reduced relapses by an impressive 59% in Study 1 and 49% in Study 2.
  • In Study 1, 86% of individuals treated with Briumvi experienced zero relapses, compared to 74% for Aubagio. In Study 2, 87% of those taking Briumvi had zero relapses, compared to 72% for Aubagio.
  • Briumvi demonstrated near-complete suppression of lesions, with remarkable 97%  fewer T1 Gd+ lesions compared to Aubagio over two years, as shown in the MRI results.
  • On average per MRI over two years, Briumvi also exhibited up to 92% fewer T2 lesions compared to Aubagio. In Study 1, the reduction was 92%, and in Study 2, it was 90% fewer.

Briumvi not only offers enhanced convenience of a one-hour infusion, twice a year. It also exhibits remarkable effectiveness in reducing relapses and suppressing T1 Gd+ and T2 lesions when compared to Aubagio .

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Agreement with Neuraxpharm:

In August this year, the TGTX announced a landmark agreement, with a total deal size of approximately $650 million, featuring an upfront payment of $140 million and potential milestone-based payments of up to $492.5 million based on certain launch and commercial milestones. Here’s the highlights:

  • TGTX retains strategic flexibility with an option to repurchase all rights under this agreement if TGTX is acquired.
  • Neuraxpharm’s dedicated focus on neurology and established European presence in over 20 countries positions them as an attractive partner for Briumvi’s European launch, set to take place within the next six months.
  • The agreement allows TGTX to benefit from attractive economic terms and meaningful participation in the success of Briumvi in Europe
  • Neuraxpharm envisions Briumvi as a potential leading treatment for RMS patients and is intensifying its commitment by expanding its CNS commercial team with 100+ new MS specialists, scaling is their top priority.

Latest Earnings:

In Q3 2023, TGTX reported robust financials with total net revenue hitting $165.8 million. This was driven by $25.1 million in BRIUMVI® net sales in the United States and a substantial $140.0 million in license revenue from an upfront payment received from Neuraxpharm. Notably, Briumvi garnered around 2,200 prescriptions since its launch, involving over 500 healthcare providers at roughly 350 centers across the U.S. Moreover, payor coverage has been secured for nearly 95% of individuals covered by insurance plans for Briumvi.

Overall highlights:

  • Total net quarterly revenue of $165.8 million and a cash position of $229.2 million.
  • Presentation of data from the ENHANCE Phase 3b trial, evaluating Briumvi for patients switching from an IV anti-CD20 therapy for relapsing forms of multiple sclerosis.
  • In the U.S., Briumvi net sales generated $25.1 million during Q3 2023, accumulating to approximately $48.9 million since its launch.
  • Over 900 Briumvi prescriptions were issued in Q3 2023, totaling around 2,200 prescriptions from over 500 healthcare providers at more than 250 centers.
  • The company secured a permanent J-Code (J2329) for Briumvi from the U.S. Centers for Medicare & Medicaid Services (CMS), effective from July 1, 2023.
  • Briumvi received approval from the European Commission (EC) for the treatment of adult patients with relapsing forms of multiple sclerosis.
  • An agreement was reached with Neuraxpharm for the ex-U.S. commercialization of Briumvi in RMS.

Highlights by numbers:

  • Product revenue, net reached approximately $25.1 million and $48.9 million for the three and nine months ended September 30, 2023, primarily from Briumvi net product sales.
  • License revenue was about $140.0 million and $140.1 million for the three and nine months ended September 30, 2023, primarily related to a one-time payment from Neuraxpharm.
  • R&D expenses decreased to $14.8 million and $58.7 million for the three and nine months ended September 30, 2023.
  • SG&A expenses increased to $32.8 million and $91.6 million for the three and nine months ended September 30, 2023.
  • Net income amounted to $113.9 million and $27.1 million for the three and nine months ended September 30, 2023.
  • The company’s cash, cash equivalents, and investment securities stood at $229.2 million as of September 30, 2023, with expectations of covering planned operations into cash flow positivity based on the current plan.

Analyst Ratings:

TGTX has a number of analyst ratings with substantial price targets (PT). Out of the 9 that have researched the company, the average PT is $26.83 – with a high of $41. From the last closing price of $10.25, that’s a 161.7% and 300% gain respectively. It’s important to note that analysts are often incorrect in their valuations and projections, but it’s hard to ignore the aggressive PT’s from multiple analysts who believe there’s a substantial opportunity through TGTX’s commercialized drug, Briumvi.

Conclusion:

Between investor and analyst optimism, the market appears to be very bullish on TGTX’s future prospects. Their recent agreement with Neuraxpharm and their commercialized drug, Briumvi offer a particularly interesting opportunity. An opportunity that comes without the constant dilution we’re accustomed to in clinical stage biotechs. Briumvi has clear prospects to be a leading treatment option  globally for patients with relapsing forms of multiple sclerosis. The company exceeded expectations on earnings, showing very strong financial performance with clinical data that outperforms the current standard of care and is much more convenient for consumers. The current slump in the biopharma offers a number of opportunities, TGTX might be one worth considering.

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

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

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Clean Vision Corp (OTC: CLNV): Overcoming the Plastic Waste Crisis

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Clean Vision Corporation (OTC: CLNV) has experienced several interesting developments recently, but it hasn’t noticeably influenced the market with any substantial gains. Nonetheless, we believe it’s worth providing an update on the company given it’s been a few months since our last mention. In today’s discussion, we’ll explore a variety of updates and their significance, with aim of providing insight on what to expect for 2024.

Background:

Clean Vision is led by Dan Bates, and their goal is to tackle the global plastic waste crisis head-on. Their wholly owned subsidiary, Clean Seas, has developed the Plastic Conversion Network (PCN), a groundbreaking technology aimed at diverting millions of tons of waste plastic from landfills, incineration, and oceans. The PCN converts this plastic feedstock into clean fuels and green hydrogen, significantly reducing reliance on fossil fuels and lowering the carbon footprint.

For a brief 2 minute overview on the company, feel free to reference the video CLNV’s subsidiary put together on YouTube. Here’s the link.

Clean Seas utilizes proven pyrolysis technology to produce environmentally friendly products, which are sold to multinational petrochemical companies, driving the circular plastic economy. Operational PCN facilities are already in place in Morocco and India, with additional conversion facilities in development across West Virginia, Arizona, and Southeast Asia. Long-term feedstock supply agreements exceeding one million tons of waste plastic annually have been secured at no cost.

Their recently trademarked brand, AquaH®, is produced in their PCN. According to the release, it offers a differentiated green hydrogen product from carbon-neutral sources. Currently, hydrogen is predominantly produced through methods that involve fossil fuels, which of course contributes to global carbon emissions. Furthermore according to Deloitte’s 2023 global green hydrogen outlook, this could be a $1.4T annual market by 2050.

$65 Million Plastic Conversion Facility:

CLNV is making big moves in West Virginia and according to the release on October 24th, 2023, they’ve brought in some serious players—CDI Engineering Solutions and ERM—to help out with their Clean-Seas West Virginia project.

CDI has over 70 years of experience integrating engineering, design, project support, procurement and construction management services to the energy, chemicals and electrical infrastructure markets.

ERM is the world’s largest advisory firm focused solely on sustainability, offering environmental, health, safety, risk and social expertise for more than 50 years with more than 8,500 dedicated professionals operating across 40 countries.

The plan is to kick things off in 2024, turning 100 tons of plastic every day into recycled plastics and clean fuels. It’s a hefty project with a $65 million investment, creating over 200 jobs initially. And they’re not stopping there—they want to scale up to 500 tons of plastic per day over time.

West Virginia Governor Jim Justice is also on board, throwing over $12 million in state incentives to support the project.

Governor Jim Justice made a reference to Clean Seas in his state of the union address. If you want to catch the mention, go to 34:15 in the video. The three minutes leading up to it are also worth reviewing.

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Launches Global Operations:

CLNV made another significant advancement, planning to launch waste plastic conversion facilities in the European Union, Eastern Europe, and Southeast Asia. This will be accomplished through their new subsidiary, Clean-Seas Partners UK Limited (CS-UK), who of course shares the same vision of creating sustainable solutions to the global plastic pollution crisis.

Under the leadership of Managing Director Shaun Wootton, CS-UK will play a crucial role in strategic project development and investment facilitation, leveraging established relationships in the Middle East, Southeast Asia, and Europe.

To fortify effective governance and strategic direction, CS-UK is assembling a distinguished board with internationally recognized figures in banking, sustainability, and energy. This approach aims to have a diverse and experienced board guiding CS-UK in realizing its vision of promoting sustainability and environmental stewardship across diverse regions.

$340 Million Bond Offering:

CLNV even announced they partnered with a global advisory firm, Grant Thornton, to issue up to $340 million in Green Bonds. This is the world’s sixth-largest network of independent accounting and consulting firms, employing 62,000 people in more than 130 countries and had revenues of $6.6 billion in 2021. These bonds will fund the expansion of Clean Vision’s Plastic Conversion Network (PCN) under the “Clean-Seas” initiative worldwide, aimed at combatting plastic pollution on a global scale.

With the Green Bond’s net proceeds, CLNV plans to deploy at least six plastic waste conversion lines globally, with strategic locations in West Virginia, Arizona, Southeast Asia, and expansion in Morocco. The Green Bond is also expected to attract environmentally conscious investors, setting a new standard for corporate responsibility.

$15M Government Loan:

Lastly, under the capable management of Huntington Bank, CLNV has recently secured a $15 million government loan. What sets this apart is that the loan is FORGIVABLE.

A forgivable loan is a type of loan where the borrower is not required to repay the borrowed amount under certain conditions. Typically, these conditions are related to the borrower meeting specific criteria, such as using the funds for approved purposes, maintaining certain employment levels, or achieving predetermined goals. If the borrower fulfills these conditions, the loan is forgiven, and they are not obligated to repay the borrowed amount. Forgivable loans are often used as an incentive or support for specific activities, such as job creation, small business development, or other initiatives that contribute to economic growth or community welfare.

Not to mention it won’t result in any dilution for shareholders. This is an unexpected and uncommon accomplishment for an OTC company. Securing a government loan of this size without any dilution is truly impressive.

Conclusion:

CLNV has made impressive strides tackling the global plastic waste crisis, especially given their valuation of merely $22.65 million. The team has swiftly achieved key objectives, including a $65 million plastic conversion facility in West Virginia, global expansion through Clean-Seas Partners UK Limited, a $340 million Green Bond Offering, and a remarkable $15 million forgivable government loan. The vast $1.4 trillion market they’re tapping into offers an interesting opportunity with current indicators looking positive. Nevertheless, it’s crucial to acknowledge that there is still significant work ahead, and the team needs to maintain consistent execution to turn this potential into a reality.

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

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

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Meta Materials (NASDAQ: MMAT): More Due Diligence and Exploring Latest Developments

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Meta Materials (NASDAQ: MMAT) witnessed a significant uptick in trading activity on January 16th, 2024, resulting in a notable 20% increase in its stock value by market close. Intrigued by this surge, we explored various sources, including press releases, SEC filings, and social media, to identify the catalyst behind this sudden gain.

Unexpectedly our research revealed no recent material releases. Instead, the surge seems tied to an announcement from a few days ago that didn’t grab much attention at first. As time passed, it started generating more buzz but there’s still a lot more to dig into and a number of ideas to consider for today’s rally.

If you haven’t caught up on our previous analyses of MMAT, you can find the overview here. In this report, we aim to explore the cause-and-effect dynamics of recent events, offering insights that might illuminate expectations for Meta Materials in the near future.

Background:

If you’re new to MMAT or haven’t been a long-time follower, let’s kick things off with a quick intro to the company.

Meta Materials stands at the forefront of advanced materials and nanotechnology. Their focus is on pioneering novel products and technologies utilizing sustainable and innovative scientific approaches. The interesting part is their advanced materials have the transformative power to enhance a variety of common products, infusing them with heightened intelligence and sustainability.

Leveraging its technology platforms, they’re capable of empowering global brands in creating cutting-edge products that elevate overall performance.

Their technology has application across multiple industries including aerospace and defense, consumer electronics, 5G communications, batteries, authentication, automotive, and clean energy. Their agreement with Panasonic is certainly a great start to empowering their growth in one of many verticals. Overall the TAM is ~$32B and with current growth rates, it’ll increase to a whopping ~$61B by 2026.

MMAT’s goal is to shape a smarter and more sustainable world. If you look through their presentation, you can continue to evaluate the many ways their technology transforms everyday lives. We highly suggest you take a look.

Additional Resources:

  1. @LauraLoomer’s video on MMAT
  2. @metaheadj’s post on X, displaying Rob Stone‘s response update for an investor

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What Happened:

So, MMAT issued a press release on January  11th, 2024, announcing a proposed settlement with the Securities and Exchange Commission (SEC) concerning an investigation related to the Torchlight Energy Resources, Inc. and Metamaterial Inc. merger.

According to the release, The company has extended a settlement offer (Proposed SEC Settlement) to the SEC’s Division of Enforcement. This proposed settlement aims to address concerns regarding antifraud, reporting, books and records, and internal accounting control provisions of securities laws. It is important to note that the Proposed SEC Settlement is contingent on approval by the SEC Commissioners, and the company cannot predict the approval timeline.

If accepted, the Proposed SEC Settlement would involve the SEC entering a cease-and-desist order and the company paying a civil money penalty of $1 million over a one-year period in four installments. Notably, the company would neither admit nor deny the findings outlined in the Order.

The company’s board of directors and management team view the Proposed SEC Settlement as beneficial for shareholders. If approved, it is expected to remove uncertainty surrounding the investigation, enabling the company to focus on advancing its business objectives.

So What:

If you’ve just read through the announcement and are confused, you’re not alone. It appears that many investors may have mis-read the press release, thinking that the SEC was being punished and MMAT was reaching a settlement agreement, but it appears to be the other way around.

In the event of approval, the company is obligated to pay a civil money penalty of $1 million. This penalty would be paid in four installments over the course of one year, following an agreed-upon payment plan. However, the PR also notes that the company cannot predict with certainty whether or when the Proposed SEC Settlement will even be approved by the SEC Commissioners.

According to another user on X, @AShortSqueeze, MMAT’s initial analysis has potentially revealed the motherload of counterfeit shares.

But if you scroll through the comments, you’ll see other users pointing out that this information is actually old news. This is just one of many widely circulated posts that might have been misunderstood.

Significant Coverage:

Another theory suggests that a notable influencer in the financial space, @MoonMarket_, has set their sights on the company and is conducting additional due diligence. With a substantial following of almost 75K users, the influencer’s involvement could have contributed to a significant fluctuation in today’s trading session. It’s important to recognize that X is packed with plenty of financial influencers, and blindly following their moves can be risky. Many are involved in day trades, momentum trading, or at least contemplating such strategies.

Conclusion:

The buzz around MMAT today seems fuelled by a mix of misrepresented themes and recycled news, creating the illusion of fresh, imminent developments.

As per usual, the magnitude of MMAT’s technology and potential integrations across various verticals continues to create a roar of excitement. On another front, we’re also continuing to see speculation about a short squeeze due to substantial amounts of counterfeit shares.

For now, patience is key and we suggest closely monitoring developments. MMAT especially tends to be quite volatile.

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

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Integrated Cannabis Solutions’ (OTC: IGPK) 633% Surge: Exploring Catalysts, Company Overview, and Growth Potential in 2024

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Integrated Cannabis Solutions (OTC: IGPK) has undergone a remarkable uptrend, surging an impressive 633% since December 11th, 2023, with 166% of that surge taking place across yesterday’s trading session and today, January 11th, 2023. Both days have been marked by unprecedented volume – Yahoo Finance reported an almost 30x increase, with 115,867,027 shares traded by close yesterday. We’re already seeing 90,092,317 shares traded this morning and it’s just barely noon. Today we’ll explore the catalysts behind the surge, offer a comprehensive overview of the company, and evaluate IGPK’s potential for sustained growth throughout 2024.

Background:

Let’s get straight to it. IGPK is the result of a recent reverse merger with Integrated Cannabis Solutions and JFH Digital E-Commerce Corp. The first thing you’ll notice is finding the website isn’t a walk in the park, we’re fairly certain there isn’t one yet, at least one that will help in any way related to more investment information. Your best bet for more any information is to check out IGPK’s OTC Market page for details, but even the company description on there is not accurate. We’ve mainly found the following information through filings, IGPK’s Twitter, and other online users.

Keep in mind this breakdown might not be flawless given we’re piecing it together mostly from what folks on X are saying. But we’ll try our absolute best to lay it all out for you.

IGPK appears to have been a shell for little while until JFH stepped in. A user on X, @stockplayer30, broke it down fairly simply, stating that the shell’s slate was wiped clean, cancelling all notes payable and any debt. Whether it’s a promissory note, convertible note, or convertible debenture, the main point is they ditched all debt. JFH has an opportunity to start fresh, and it certainly makes this deal a lot more interesting.

Just a heads up, it’s a Chinese merger. If the idea of a Chinese leadership team makes you a bit wary, you might want to pause here. However if you were in the trading game during the summer of ’23, you probably remember those crazy spikes in some Chinese Nasdaq deals. And get this – no big press releases or SEC filings to explain those sudden jumps either.

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Company Description:

Onto what the company actually does. According to @SuperRobotOTC on X, this is a digital e-commerce company based in China, here’s a link to their e-commerce website. This user also put together a great overview of the company on YouTube, if you’d like to watch something informative in video format, click here.

Another user, @igal_n, found a blurb on the company that states, “Junfenghuang (JFH) is a digital asset. It is a token issued by Uplus Future Company with the help of blockchain technology. It has no direct relationship with the original equity”.

The Potential:

What makes this story extremely interesting is the sheer magnitude of how large JFH is, the intrinsic value does not appear to be valued accurately in the market, given it’s only freshly merged into IGPK’s tiny shell company on the OTC.

Their Gross Merchandise Value (GMV) is heading north of 50 billion yuan, and post-merger profits from service outlets are looking at a hefty 10 billion yuan – yes, billion with a B.

Steering the ship is a leadership team featuring President Wang Dejun, Treasurer Xie Weiji, and Director Yang Lanfang. With a whopping 750 subsidiaries, 250,000 merchants, and 30 million registered users. We’ve also heard from other sources that the registered users could be nearly double that, coming in at 50 million registered users.

These numbers are substantial for a company with a $7 million market cap. Looking ahead, it won’t be shocking if IGPK sets its sights on moving up to a bigger exchange like NASDAQ. It’s no secret they’re already in the big leagues – or it at least appears so. If that were the case, they’d of course have enhanced credibility, more visibility, and increased access to capital with institutional funding.

The App:

Now, you might be wondering, “Sounds cool, but it’s a Chinese merger with a whole setup on the other side of the planet. Can we trust this info?” @SuperRobotOTC has also gone the extra mile by downloading the app, and gave us the lowdown in video format. On top of the SEC filings, this is an added layer of trust & credibility we can attribute to this new venture. Here’s the link to the video.

Conclusion:

Fortunately it appears IGPK is still for the most part flying under the radar. There’s not even a proper website or accurate update on IGPK’s OTC Market overview to tell us what the company even entails. But here’s the silver lining – that might mean you’re still early. The intrinsic value of IGPK appears strongly disproportionate to its current value in the market.

Our advice? Keep a close eye on IGPK’s journey as it takes on this exciting phase of growth and exploration. It’s likely this story will catch wind quickly and it could be a great time to take advantage. As @SuperRobotOTC eluded to in his video, this could be the OTC’s largest merger, with a potential $70B valuation.

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

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

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