GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) has developed a new technology that “supercharges” the body’s NK cells (in blue) to keep attacking cancer tumors far longer than they normally could…
And with virtually no side effects.
The Covid-19 pandemic may turn out to be a blessing in disguise for biotech investors.
The lockdowns contributed to many small immunotherapy stocks losing up to 90%1 of their value — right when the companies were releasing breakthrough new cancer treatments.
Yet for investors, this may turn out to be an enormous opportunity. If the shares of these companies return to their recent highs, investors could potentially pocket gains as high as 900% or more.
From $2 to $19 Per Share
One example is GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP), a Bay Area company pioneering breakthrough immunotherapy treatments for tumors.
In a Phase 1 clinical trial right before the Covid pandemic, the company’s innovative approach demonstrated reductions in cancer cells as high as 63%. And more recent pre-clinical tests with second-generation therapies have seen even better results.1
Yet investors can now pick up shares of GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) for less than $1 per share – a fraction of their recent high of $18.962 per share.
In other words: If the company’s shares just return in value to their recent highs, that’s a potential gain of 936%.3
Another reason why GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) is attracting the attention of biotech investors is its rapidly expanding product line.
The company used the two years of Covid lockdowns to perfect its technology for “supercharging” the body’s natural immunity to attack cancerous cells, incorporating advanced nanobody and Camelid antibody technologies for greater effectiveness.4
It then created an entire series of new and improved immunotherapies for many types of cancer, including solid tumors, leukemia, B-cell malignancies and solid and hematological malignancies.5
Why Gilead Sciences was Willing to Pay $300 Million to License a Single Molecule
Best of all, small immuno-oncology companies such as GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) are often prime candidates for buyouts by Big Pharma.
In May 2022, pharmaceutical giant Gilead Sciences paid $300 million, a 20% royalty and undisclosed milestone payments for a single pre-clinical molecule license from the small immuno-oncology company Dragonfly.6
A year earlier, Sanofi paid $1 billion to acquire the upstart immuno-oncology company Amunix Pharmaceuticals and its portfolio of T-cell engagers using its XTEN technology.7
The point is: new immunotherapy treatments for cancer is where much of the M&A action may be headed… and both Big Pharma and shrewd investors are aware of this new trajectory.
That means, a small company that can produce a viable anti-cancer treatment for a reasonable price – such as GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP), could potentially see sales grow exponentially.
A Burgeoning Immuno-Oncology Industry
Cancer stocks are popular with investors for a reason. Cancer is a devastating and ongoing scourge that affects approximately 39.5% of the global population at some point in their lifetimes.8
According to the National Cancer Institute, approximately 18 million people are diagnosed with cancer in the U.S. every year – and 9.5 million die from the disease annually.9
Yet despite this, the main therapies used to treat cancer are now more than 80 years old, with chemotherapy first becoming widely used in the 1940s,10 and radiation dating as far back as 189511.
However, in recent years, immuno-oncology companies like GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) have been looking to harness the body’s own natural defense system, unleashing so-called Natural Killer (NK) cells to destroy tumors without the side effects of chemotherapy or radiation.
Most biotech companies working in the field are trying to harness the power of the NK cells to fight cancer rather than the more common T-cells. The problem is, there aren’t as many NK cells in the body as T-cells – and once their primary target is destroyed, they’re exhausted and cease fighting.
As a result, many biotech companies developing immunotherapy treatments for cancer try to create new NK cells in a lab.
But this is a time-consuming, customized process that is hugely expensive – sometimes costing millions of dollars per individual– and often very hard on patients.
Radically New Approach To Cancer Treatment
That’s why the approach of GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) and a tiny handful of other “NK engager” companies is so exciting – and could be the breakthrough doctors have been in search of for decades.
Instead of trying to create new NK cells in a lab, GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) is “supercharging” the cells already in the body so they can keep on fighting and destroying cancer.
It does this with a proprietary protein technology known as Trispecific Killer Engagers, trademarked TriKE®.
Originally developed by renowned immunologist Dr. Jeffrey Miller of the University of Minnesota Medical School, TriKE® works by enhancing NK cells, helping them to identify and eliminate any deadly tumor cells in the body.
Like Microscopic, Laser-Guided Cruise Missiles Targeting Tumors
Delivered to a patient 12 by infusion the TriKE proteins are designed to trigger a “marker” on a patient’s tumor cells that then alerts the “natural killer” (NK) cells to attack the marked cells – and only the marked cells.
Unlike some conventional chemotherapy treatments, which often attack both healthy cells along with cancer cells, GT Biopharma’s TriKE agents are designed for precision.
They program NK cells to attack only tumor cells and to leave healthy cells intact.
In essence, GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) proprietary protein technology does four very important things:
- Activates or awakens the body’s own NK cells;
- Helps the NK cells precisely target tumor cells and only tumor cells;
- Helps the NK cells to continue attacking tumor cells, one after the other, for months instead of days; and
- Encourages the NK cells to proliferate or reproduce
Putting the Body’s Defenders on Steroids
GT Biopharma’s “secret sauce” is the unique way it embeds a compound known as interleukin 15 (IL-15) within its TriKE® protein at 16 times13 the normal dose –and yet without significant side effects!
This potent blast of interleukin acts like a kind of cellular steroid, greatly prolonging the cancer-destroying ability of the NK cells and helping them to proliferate.
Data from recent clinical trials are encouraging. Stage 4 cancer patients saw virtually no side effects yet experienced significant reductions in the amount of cancer cells in their bodies.
Plus, the cost is relatively low: As little as $100,000 per patient (covered by many insurance policies) instead of the $2 to $3 million per patient that other NK cell immunotherapies can charge.
A Rapidly Growing Market
The bottom line is that this is potentially a revolutionary breakthrough in the treatment of many types of cancer – and the size of the market is enormous.
According to Zion Market Research, the market for immuno-oncology drugs and therapies is expected to grow from $62.2 billion before the Covid pandemic to $194 billion by 2028, growing at a rate of 15% per year.14
The largest share of the market is North America, with much of the focus (72%) on treating cancer with monoclonal antibodies that attach themselves to lymphocytes such as NK cells.15
New “First in Class” Approach With Virtually No Side Effects
The TriKE® protein is a genuinely new “first in class” approach that makes GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) stand out from its competitors, even those with market caps in the billions.
Unlike companies such as Nkarta Therapeutics, GT Biopharma’s approach is not a cellular therapy but a simple drug. That means patients don’t have to pay for, and endure, highly customized lab-created treatments.
What’s more, GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP)’s immunotherapy has virtually no side effects – and that, too sets it apart. For patients suffering from end-stage cancer, the ability to tolerate treatments is an important consideration.
In addition, the TriKE® protein appears to naturally increase the number of NK cells within patient’s own bodies, potentially prolonging life.
A Small, Undiscovered Company with a Breakthrough Technology
Most important for investors, the market cap of other NK cell immunotherapy companies are in the billions – for example, Fate Therapeutics, which markets a therapy based on Dr. Miller’s earlier research, has a market cap of $619 million. In other words: If the company’s shares just return in value to their recent highs, that’s a potential gain of over 2,600%.
In contrast, GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP) is a smaller company that has licensed and is developing Dr. Miller’s latest, most advanced immunotherapy – and so its market cap is only $50 million and growing fast.
That means early investors can acquire significant share positions at very low costs.
In addition, the company currently has not one, but FIVE publicly disclosed TriKE® products in the pipeline.
One, GTB-3550, the company’s first TriKE® product being evaluated for the treatment of leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies, has finished Phase 1 clinical trials.
Another, GTB-3650, is a second-generation protein biologic for treating AML and MDS, has completed pre-clinical testing and is now in the GMP manufacturing phase.
Another product, GTB-5550 TriKE®, designed to treat B7H3+ solid tumors, will also begin clinical trials next after GTB3650. Plus, GTB 4550 and GTB-6550, for the treatment of solid tumors and gastric and breast cancers, are currently undergoing pre-clinical testing.16
In addition, the company recently announced that it had won two U.S. patents for its products, specifically a patent for broad coverage for TriKE® proteins targeting any antigen and another for broad coverage for TriKE® proteins targeting HIV antigens.17 The company plans to advance these TriKEs into the clinic.
If clinical trials of GT Biopharma’s TriKE® therapies show further promise, then all bets are off. Investors could potentially see substantial growth.
Of course, it goes without saying that there are no guarantees in biotech investing. Past performance is no guarantee of future results, and you should only speculate with money you can afford to lose.
Yet for investors who like stocks with a substantial risk/ reward ratio, then GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP), currently selling for less than $1 per share, may well be worth a close look.
For more information about GT Biopharma (NASDAQ:GTBPNASDAQ:GTBP), visit the company’s website or download its free investor presentation here.
1 See GT_Biopharma_Corporate_Presentation_NOV_2022_GTB_Website, Slide 25: “Cam16 IL15 camB7H3 TriKE ® Enables NK Cell Therapies More Effective.”
2 Closing price on June 2, 2021, per Yahoo Finance: https://finance.yahoo.com/quote/GTBP/history
3 From $1.83 per share on November 25, 2022 to the old high of $18.96 per share on Jun 02, 2021, a gain of 936% per https://percentagecalculator.net/
4 See GT_Biopharma_Corporate_Presentation_NOV_2022_GTB_Website, Slide 20.
5 Ibid., Slide 8.
6 GT_Biopharma_Corporate_Presentation_NOV_2022_GTB_Website, Slide 29.
7 Ibid.
8 https://www.cancer.gov/about-cancer/understanding/statistics
9 https://www.cancer.gov/about-cancer/understanding/statistics
10 https://www.yalecancercenter.org/Answers_July_6_08_89594_5_v1.pdf
11 https://cancerres.aacrjournals.org/content/69/2/383
12 Verify Verified
13 Webinar video, Minute 12:00 ff.
14 https://www.zionmarketresearch.com/report/immuno-oncology-therapy-market
15 Ibid.
16 https://d1io3yog0oux5.cloudfront.net/_8422eae4a2802c98c45379aa35dd9978/gtbiopharma/db/184/625/pdf/GT+Biopharma+Corporate+Presentation+September+09-20-2021.pdf
17 https://www.gtbiopharma.com/news-media/press-releases/detail/234/gt-biopharma-announces-issuance-of-two-new-patents-covering
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This document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect expectations regarding GT Biopharma future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. Wherever possible, words such as “predicts”, “projects”, “targets”, “plans”, “expects”, “does not expect”, “budget”, “scheduled”, “estimates”, “forecasts”, “anticipate” or “does not anticipate”, “believe”, “intend” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative or grammatical variation thereof or other variations thereof, or comparable terminology have been used to identify forward-looking statements. These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to GT Biopharma industry; (b) market opportunity; (c) GT Biopharma business plans and strategies; (d) services that GT Biopharma intends to offer; (e) GT Biopharma milestone projections and targets; (f) GT Biopharma expectations regarding receipt of approval for regulatory applications; (g) GT Biopharma intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) GT Biopharma expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute GT Biopharma business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) GT Biopharma ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) GT Biopharma ability to enter into contractual arrangements; (e) the accuracy of budgeted costs and expenditures; (f) GT Biopharma ability to attract and retain skilled personnel; (g) political and regulatory stability; (h) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (i) changes in applicable legislation; (j) stability in financial and capital markets; and (k) expectations regarding the level of disruption as a result of COVID-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of GT Biopharma to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) GT Biopharma operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises such as the COVID-19 pandemic may adversely impact GT Biopharma business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing GT Biopharma business operations (e) GT Biopharma may be unable to implement its growth strategy; and (f) increased competition. Except as required by law, the Website Host undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise.
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