GT Biopharma (GTBP) Could Have Investors Looking At A Billion-Dollar Opportunity

43715 had the opportunity to interview the new CEO of GT Biopharma (GTBP), Dr. Kathleen Clarence-Smith to get insight into the new company following the recent acquisition, and to explain the opportunity ahead. The recent $12 billion acquisition of Kite Pharma, Inc. by big-pharma giant, Gilead Sciences has biotech investors hungry for the next big buyout target. Does GT Biopharma (GTBP) have what it takes to be a billion dollar opportunity?

Dr. Clarence-Smith started by explaining the potential market value of three in house therapies (GTBP) is already developing.

(GTBP) expects to enter the pain management therapies market, expected to be $83 billion by 2024 in just 12-18 months with their pain relief drug, Pain Brake. Dr. Clarence-Smith estimates ANNUAL sales of Pain Brake to be $250 -$300 million. That’s $250 – $300 MILLION PER YEAR!

GTP-004 is a novel treatment for myasthenia gravis, a muscular disease caused by antibodies that attack certain components of muscles leading to weakness and fatigue. (GTBP) hopes to treat approximately 13,000 patients per year generating $280 MILLION PER YEAR.

GTP-011 is a motion sickness treatment that could produce as much as $300 million in annual sales. Some studies indicate motion sickness impacts as much as 38% of the US population. GTP-011 is a repurposed existing drug designed to be as effective as the scopolamine patch with fewer side effects. As much as $300 MILLION ANNUAL SALES.

Annual sales potential of over $800 million and Dr. Clarence-Smith says the therapies brought to the merger by Oxis are higher value therapies than the three described above. While Georgetown has focused on Central Nervous System therapies, Oxis Biotech has been developing its oncology portfolio.

Unprecedented clinical success has recently been achieved in cancer immunotherapy using cytotoxic T cells armed with activating tumor-specific Chimeric Antigen Receptors (CARs). To be more specific, Natural killer (NK) cells also hold potential to be effectively harnessed for immunotherapy but have been limited by a lack of antigen specificity and the poor persistence of NK cells in vivo. Novel Trispecific Killer cell Engagers (TriKEs) have been found to address this issue.

Let’s explain a bit further. CAR-T therapy involves extracting a patient’s T-cells, reprogramming them and reintroducing them into the patient’s body. A single treatment could cost as much as $1 million, by some estimates. Further, CAR – T is only for liquid tumors, which only represents less the 20% of the cancer market.

TriKEs provide a versatile and cost-effective platform onto which novel targeting ligands can be incorporated and hold the potential to stimulate endogenous NK cells in order to circumvent the need for cell transfers altogether, heralding a new generation of immunotherapeutics.

With this next generation of therapy, investors may be better positioned to target companies working on these new therapy options that are high in efficacy and lower in the cost of treatment. GT Biopharma (GTBP), has a specific focus on TRiKE therapies. Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Cancer Center, and his team helped develop this specific treatment and is leading the group developing (GTBP)’s OXS-1550.

OXS-1550 is in FDA Phase 2 clinical trials right now. In fact, the first patient has begun treatment in a Food and Drug Administration-approved Phase 2 clinical trial of its promising cancer therapy. OXS-1550 has already demonstrated success in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia.

GT Biopharma

The low cost of OXS-1550, roughly $12,000.00 per patient, is a significant difference compared to CAR-T’s price per patient of around $500,000. It’s also important to recognize that this is a drug and not a “per person engineered therapy like CAR-T.” This allows OXS -1550 to be sold to hundreds of thousands of patients per year compared to the???? 4 to l????? patients that companies like Kite and Juno can service per year…remember, Kite was just acquired for almost $12 billion and has a higher cost/less impactful therapy based on applicable audience for a similar target

With eyes everywhere, the Pfizer’s (PFE) and Johnson & Johnson’s (JNJ) of the world are targeting smaller companies during a time when the merger and acquisition climate is red hot.

“There is a revolution taking place in the practice of medicine, particularly cancer therapy, and most of that innovation is taking place in the biotech companies,” said Chris Sassouni, health care specialist and co-portfolio manager of the mid-cap growth investment team at Eagle Asset Management. The overall cancer death rate in the U.S. fell 13 percent from 2004 to 2013, according to the SEER Cancer Statistics Review from September 2016.

It has been estimated that 1.7 million people were diagnosed with cancer in the U.S. in 2016, according to the National Cancer Institute. Almost 600,000 people died from the disease.

Unlike most other drugs, cancer drugs typically are more immune to increased political pressure for lower prices. When you’re talking about saving lives with these kinds of therapies, it’s hard for payers to argue the cost.

But again, when you look at CAR-T therapies from companies like Novartis, who’s recent FDA approved cell therapy costs $475,000 for a one-time treatment, alternative options are aimed at higher efficacy and lower costs. Those companies focused on TriKE therapies, for example could be the ones to focus on especially in a climate of high value M&A and during a time where public opinion is advocating lower drug costs.

GT Biopharma also has other TriKe therapies in addition to its OXS-1550. The company’s OXS–3550 can be used on solid tumors (80% of the cancer market) as well as liquid tumors. When you see the outlook for this therapy, it isn’t years away from FDA trials. In fact, it is scheduled to begin FDA clinical trials early next year in a single center phase I/II clinical trial of CD16/IL-15/CD33 (161533) TriKE for the treatment of high risk myelodysplastic syndromes or refractory/relapsed acute myeloid leukemia.

Both OXS – 1550 and OXS – 3550 are platform technologies that will likely generate pharma partnerships due to their ability to enhance other drugs capabilities. Which could add significant value to GT Biopharmal’s market cap and at less than $10 per share, now could be the time to start taking a look at this company.

Assuming that from the 1.7 million people diagnosed with cancer in the National Cancer Institutes 2016 study, if the OXS-1550 treatment was applied to just 1% (17,000) of that group and GT Biopharma charges $12,000 per treatment per person, that equates to over $200,000,000. Now throw in the potential from the three other therapies from Georgetown that come with this acquisition as well as whatever opportunity there is for OXS-3550, and the numbers suggest that GT Biopharma could be a company with over $1 billion in potential.

Not only does the company hold a drug therapy pipeline that could be worth over $1 billion, but why else would the likes of Dr. Clarence-Smith or Dr. Urbanski choose to come on board a company like this if there wasn’t a very near term opportunity to capitalize? These are the questions that have investors curious about GT Biopharma and could be the catalyst to the groundswell that has begun with this company in the market

BIOTECHSTOCKS,.com is owned by MIDAM VENTURES LLC., a Florida Corporation that has been compensated $550,000.00 by a GT Biopharma Inc. for a period beginning August 1, 2017 and ending Oct. 1, 2017 now extended to October 1, 2017 to publicly disseminate information about (OXISD). We own zero shares.


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