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!

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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Shares of T2 Biosystems (NASDAQ:TTOO) are soaring up over 20% today on the heels of receiving a 510(k) clearance for its T2Biothreat from the FDA. This unique test directly detects six biothreat pathogens from a blood sample.

Spotting Biothreats Faster:

T2Biothreat Panel is a game-changer, being the first and only FDA-approved product that can spot these critical biothreat pathogens simultaneously. T2 Biosystems proudly stands as the first U.S. company to achieve this milestone, reshaping the field of biothreat detection.

Big Investor Sells:

Interestingly while celebrating this achievement, a significant investor, CR Group (CRG), decided to sell off a substantial chunk of shares. This sell-off, totaling 24.81 million shares, took place between Sept. 20 and Sept. 26. The timing of this sell-off alongside the FDA clearance raises some eyebrows.

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New CDC Guidelines:

Regardless of CR Group selling, there still appears to be a massive opportunity according to many retail investors. Following new CDC guidelines, the U.S. government now mandates that all hospitals in the country must adopt rapid testing protocols to combat the sepsis pandemic by 2026, or risk losing Medicare funding.

Buying opportunity of the year!!! Update
byu/den1183 inTTOOstock

T2 Biosystems stands as the exclusive FDA-cleared product capable of achieving 100% accurate sepsis detection within 3 to 5 hours. Anticipating widespread adoption of T2 instruments in hospitals, the CEO foresees significant revenue generation, potentially reaching $1.3 billion annually, given the mandate.

This development drastically alters the landscape, potentially influencing the stock’s trajectory positively. With the ongoing surge in manufacturing hires and likely acceleration in orders, coupled with potential government contracts or international sales, many beleive T2 Biosystems presents an undervalued opportunity for investors.

What Borrowing Costs Tell Us:

Another interesting indicator to look at is the cost to borrow (CTB) fee. In terms of TTOO’s case, the stock has seen a massive surge in CTB fees, indicating a high demand from short sellers. When compared to the average CTB fee for other stocks, it’s pretty drastic. While this is typically not a very positive sign, retail investors seem to be buzzing with interest, given there also could be a potential short squeeze if enough buying comes in to trap the shorts.

Better News for Patients:

But let’s not forget the real impact and that’s what TTOO can do for patients. @ChengKeki a user from Twitter also shared an article about Butler Memorial Hospital and their approach to Sepsis. The hospital came up with a 2 step approach to expedite patient care.  They’re utilizing the Beckman Coulter automation line to identify changes in a person’s blood cells that might indicate the development of sepsis. Which apparently has only been used in Europe and they’re the first in the US with the technology. Then shortly after, they use T2 Biosystems panels that as you know, quicken the process from 36 hours, to just 3-5 hours.

Catching sepsis quickly is crucial because it’s a life-threatening condition that rapidly progresses throughout your body and can lead to death if not promptly diagnosed and treated. Sepsis occurs when the body responds improperly to an infection, causing widespread inflammation and potentially damages multiple organ systems. Early detection allows for immediate medical intervention.

Conclusion:

T2 Biosystems is hitting major milestones, not only in the market but in improving critical healthcare processes. The company is also a major hit with retail investors and continues to trade an astronomical amount of shares daily, the current average is ~115M shares. The FDA approval and its implications, along with the positive shift in sepsis diagnosis, showcase T2 Biosystems’ growing role in healthcare. Keep an eye on how this progresses—it’s exciting for both investors and patients alike.

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

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• Solowin Holdings (NASDAQ: SWIN) has been making headlines this week, with its stock price soaring by an impressive 94% since Monday, September 18th, 2023. This surge follows the company’s announcement of their IPO on September 6th, 2023. Despite the lack of recent filings or news updates, the stock continues to experience significant gains, and the trading frenzy shows no signs of slowing down. It’s a puzzling situation, and if you’re following this, you might be feeling a bit bewildered. Interestingly, this kind of rapid and exaggerated performance is not necessarily unusual. We’ve seen similar behaviour with others last summer, AMTD Digital (NYSE: HDK) and Top Ships (NASDAQ: TOPS) to name a couple.

About Solowin Holdings:

Before we get into what’s happening and why, here’s a little background on the company based on the prospectus and “About” section in their latest press releases.

Solowin Holdings is a Hong Kong-based brokerage firm focused on Chinese investors. They offer a wide range of financial products and services through a secure and user-friendly online platform. They are licensed by the Hong Kong Securities and Futures Commission for various services. Their platform provides access to over 10,000 securities and their derivatives on major exchanges like HKSE, NYSE, Nasdaq, Shanghai Stock Exchange, and Shenzhen Stock Exchange. The company is known for its financial strength and technical expertise, serving both individual and institutional investors in Hong Kong and earning recognition from users and industry experts.

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It’s important to note that Solowin is not an operating company, but a Cayman Islands holding company with operations solely conducted by its subsidiary, Solomon JFZ (Asia) Holdings Limited, a limited liability corporation incorporated in Hong Kong.

Does it sound kind of fishy? Maybe… But is that enough to stop you from making a trade based off the intense retail hype we’re seeing during after hours trading on September 21, 2023? We’ll let you decide, but as per usual, always do your own due diligence. Stocks like these could cost you, and come with a significant amount of risk.

Thoughts from Retail:

Upon our initial research, the first thing we noticed was a notable user off Twitter, “MayaTrades” who started talking about the company’s potential earlier this week.

The user has since spoken on multiple occasions about the potential short squeeze the stock offers and suggests that it could continue to trade parabolically tomorrow on September 22nd, 2023. So it could be worth keeping an eye on to track the technicals.

We stumbled upon another user’s testimonial praising Maya’s day trading approach, claiming they’ve made over $15,000 using it. However, it’s essential to keep in mind that such testimonials endorsing various trading strategies are abundant on Twitter. It’s wise to approach these claims cautiously and form your own conclusions based on thorough research and analysis.

The general idea is that the shorts on SWIN are quite substantial, according to one user off Twitter, it’s 150% of the entire float and the stock hasn’t even seen the start of the squeeze yet. If it’s already gained over 90% in four days, I’m sure you can do the math on what this user is suggesting could happen next.

“Spec play that I have a lotto sized position in. It’s China. Cashed up for 5 years, allegedly. 2M float / 14M OS. I believe insiders will run it at some point, so whether it’s weeks or months, I’m holding a small position as it mirrors the other crazy China IPO runners. Currently $2.65” stated MayaTrades on September 14th, 2023.

We’re continuing to see the narrative of “No reason to close position with the strength SWIN is seeing into close” and that it’s seen “Unbelievable strength in a bloody market”. If you look at the technicals, you can see that it flagged into close yesterday and continued with the same pattern today.

Many also believe that the company has not only overcome previous resistance levels, but also surged beyond expectations in after hours trading September 21st, 2023. The stock just recently surpassed the $5 mark, leaving the future trajectory in the upcoming trading days quite unpredictable. This rapid movement follows a trend of consistently breaking through crucial resistance levels.

Once again, it’s important to acknowledge the speculative nature of these trades, with the possibility of a complete loss of investment. However, given the heightened retail interest surrounding the stock this week, we found it relevant to take note, delving into the factors and conversations driving this wave of excitement.

Short Squeeze:

By now, it’s safe to assume that most people are familiar with the concept of a short squeeze. We’ve covered it in several previous articles. However, if you’re new to the market or unfamiliar with our daily articles, here’s a brief explanation below:

A short squeeze is a market phenomenon where the price of a stock or other asset increases rapidly and significantly. This can be triggered by a surge in demand for the asset, often caused by a large number of investors who had bet against the asset (short sellers) rushing to buy it to cover their positions and limit their losses.

Short Selling: Short selling is a trading strategy where an investor borrows shares of a stock from a broker and sells them on the market, anticipating that the stock’s price will decline.

Betting Against the Stock: Short sellers profit when the stock price falls. They aim to buy back the shares at a lower price later to return them to the lender (broker), pocketing the difference.

Potential Losses and Squeeze: However, if the stock price starts to rise instead of fall, short sellers face potential losses. As the price climbs, they may feel pressured to buy the shares back to cut their losses, adding to the buying pressure in the market.

Buying to Cover: To exit their short positions, short sellers buy shares (covering their shorts) on the open market. This buying activity further drives up the stock price, as demand increases.

Feedback Loop: As the stock price rises due to increased buying from short sellers trying to cover their positions, it can trigger more short sellers to cover, creating a feedback loop of buying and price escalation.

Rapid Price Increase: The sudden increase in demand can lead to a sharp and swift rise in the stock price, catching short sellers off guard and forcing them to buy at higher prices to close their positions.

Magnitude and Duration: The extent and duration of a short squeeze can vary. It could be a short-lived spike or a more prolonged increase in the stock price, depending on the level of short interest, overall market conditions, and the availability of shares for shorting.

Short squeezes often attract significant attention and can result in substantial gains for those holding long positions, while causing substantial losses to short sellers, further fueling the market dynamics.

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

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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