Recent Surge in Biotech has Investors and Analysts Watching for a Big Breakout

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The biotech sector Is on a tear! Why?  The long-term trends that have made the sector such an outperformer in the market for the past five years remain in place.

Smart money Investors have begun to follow a biotech stock that has the right mix of seasoned management, track tested bio-therapy, and is on the brink of a major acquisition but the Street hasn’t caught wind of it…YET.

This could present A HUGE OPPORTUNITY for early investors!

What are these investors looking at RIGHT NOW? A little company called GT Biopharma (GTBP).  (GTBP) develops and commercializes innovative immunotherapeutics and has a robust intellectual property portfolio.

not only has (GTBP)‘ lead drug captured the attention of biotech investors, but the incredible opportunity ahead after announcing the acquisition of Georgetown Translational Pharmaceuticals, Inc.

An aging population, a larger amount of the healthcare spending going toward drugs and treatments (roughly 10% of overall healthcare spending), and new technologies being used to create new and more effective compounds are all key factors to stronger future growth potential.

“…Encouraging industry trends including a merger & acquisition frenzy, promising drug launches, cost-cutting efforts, an aging population, ever-increasing demand for new drugs, higher healthcare spending, expansion into emerging markets…will continue to fuel growth in the sector.” – Zacks Investment Research

Many biotech companies are undertaking clinical trials, have projects under development, and some have just begun to start capitalizing their action plans; meaning, biotechnology is usually a long road ahead.  Plus, the allure of under-followed companies has been a big focus as of late with the mergers and acquisitions climate becoming red hot.

(GTBP) has a portfolio of next-generation cancer initiatives and its lead drug candidate, 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.

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Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Cancer Center, helped develop OXS-1550. He said, “The initiation of Phase 2 patient treatment is a key opportunity to demonstrate the effectiveness of this promising cancer therapy. This brings us one step closer to an important alternative to invasive chemotherapies and costly cell therapies, Kite Pharma, Inc. (KITE), Juno Therapeutics (JUNO), for cancer patients.”

Inventors of OXS-1550 has also received a Notice of Allowance from the United States Patent and Trademark Office.  (GTBP) holds WORLDWIDE EXCLUSIVE RIGHTS to develop and commercialize OXS-1550. But what begs immediate attention is that OXS-1550 has demonstrated success in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia.

The (GTBP) pipeline could offer a more balanced risk/reward profile with potential for steady news flow! And OXS-1550 is just one piece of the (GTBP) pie! The U.S. Patent and Trademark Office has approved and issued Patent No. 9,580,382 for its drug candidate OXIS-4235 for the treatment of myeloma.

 

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The drug is a P62-ZZ chemical inhibitor intended for use as a treatment for multiple myeloma. According to the American Cancer Society, more than 30,000 people are expected to be diagnosed with the disease this year and more than 12,000 are expected to die from it.

And on top of this, the OXS-2175 addresses triple negative breast cancer.  According to the American Cancer Society there were over a quarter million new cases of invasive breast cancer in the US last year with over 40,000 deaths coming from breast cancer during that period. OXS-2175 is a small molecule therapeutic candidate that has shown “promise,” according to the company, in early stage preclinical in vitro and in vivo models of triple negative breast cancer. Due to the fact that there is no known or pending drug therapy for the treatment of Triple Negative Breast Cancer, this opens another opportunity for (GTBP) International to capitalize on.

With eyes everywhere, the Pfizer’s and Johnson & Johnsons of the world are targeting smaller companies during a time when the mergers and acquisitions climate is red hot.

According to a report from EY (formerly Ernst & Young) there are 17 biotech companies in the US that generate more than $500 million per year in revenue. And they’re increasingly focused on buying innovative new products through mergers and acquisitions, rather than developing them in house!

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The EY report describes the biotech industry overall as quite healthy. The regulatory environment in the US leans in favor of biotechnology, with the Food and Drug Administration offering fast-track approval for some breakthrough drugs, especially those targeting rare diseases. And the science is moving quickly, opening opportunities for drug development in the fields of gene editing, gene therapy, and cancer immunotherapy in particular.

The GTBP Proposed Acquisition of Georgetown Translational Pharmaceuticals, Inc Presents More Than Just New Pipelines!

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On June 26, (GTBP) announced that it had executed a binding LOI agreement to acquire Georgetown Translational Pharmaceuticals Inc., a move that, when closed, will deliver new management and a class of close-to-market Central Nervous Systems products to (GTBP). Georgetown’s Pain Brake, a pain-relief drug expected to be submitted to the FDA as a New Drug Application in 15 to 18 months, is their lead drug candidate.

 

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A new management team will also come on-board (GTBP). The Georgetown Translational Pharmaceuticals co-founder Dr. Kathleen Clarence-Smith, is a respected and experienced leader in the pharmaceutical industry. Now only will she become CEO of the combined companies but according to company reports, there will also be a Chief Medical Officer coming on who formerly served as CMO with Pfizer.

A History of Successes

There’s no question about it, this proposed acquisition could turn up the heat with (GTBP).  But as many seasoned investors know, biotechnology is heavily viewed from a management perspective as many companies need that leading force to see things like phase trials and patent submissions through to completion.

Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC in 2016 in a deal that, with milestones, could reach $1 billion!

She’s also held executive management positions with Sanofi, Roche, and Otsuka Pharmaceutical. Dr. Clarence-Smith was the founder and CEO of Prestwick Pharmaceuticals, which was acquired by Biovail for $100MM in 2008!

She is co-founder and a managing member of KM Pharmaceutical Consulting in Washington, D. C.

Are you starting to get the picture?

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This isn’t just some new CEO but someone who has intimate experience with taking biotech’s from development stage and building them into viable acquisition targets for some of the BIGGEST NAMES IN BIOTECH!

In addition to this, Executive Chairman and former CEO Anthony Cataldo is no stranger to emerging biotech and has been credited with taking companies “to the next level”.  In fact, Mr. Cataldo served as Founder and Chairman/CEO of Genesis Biopharma, Inc., now known as Lovance Biotherapeutics (IOVA)

Mr. Cataldo created the highly successful Lion/Genesis with the inclusion of assets acquired from the National Cancer Institute for the treatment of stage four melanoma. Cataldo managed to grow IOVAmarket – cap to over $360 million through a simple process: acquiring strong IP, having a strong research team, and attracting the right group of inside ownership to build a REAL biotechnology enterprise.

Mr. Cataldo has extensive experience in the biotechnology sector having served as Chairman/CEO of several biotech companies including: MultiCell Technologies, Inc., Calypte Biomedical Corporation, and Senetek, PLC.

UPDATE: (GTBP) Adds New Key Management With Strong Background At Pfizer!

Through this latest acquisition of Georgetown Translational, (GTBP) is filling its roster with top talent. In addition to the new CEO, Dr. Kathleen Clarence-Smith, (OXIS) has now brought on a new Chief Medical Officer. This wasn’t just someone with a little experience with medical therapies, it is Dr. Raymond Urbanski.

Now, if you hadn’t heard of him before today, you may want to start reading up on him. He’s the former business unit Chief Medical Officer and senior director of oncology research and development with Pfizer Inc. (PFE).Dr. Urbanski spent eight years with Pfizer and held several positions with the company, including Vice President/CMO of the Established Products Business Unit, senior medical director of oncology clinical R&D, senior medical director of breast cancer products and medical director of diversified products. In addition to his role with Pfizer, Dr. Urbanski served as Chief Medical Officer of Mylan Inc., Chief Medical Officer of Metabolex Inc., and Senior Director of US Medical Affairs for Aventis.

He will now oversee development of key products in (GTBP)’s product pipeline, including its platform targeted immunotherapy BiKE and TriKE technologies as well as its newly acquired Central Nervous System pipeline.

“We announced on Tuesday the completion of our acquisition/merger of Georgetown Translational Pharmaceuticals, Inc., the elimination of all debt and a suite of neurological products that are late stage and close to market. Along with this, we have retained a world class CEO in Dr. Kathleen Clarence-Smith in the process. Her resume speaks for itself.” – GT Biopharma Executive Chairman Anthony J. Cataldo .

The Numbers Are SHOCKING!

Though (GTBP) is still in its infancy compared to industry giants, the potential for acquisitions or even better yet, a real market driver may not be any greater than RIGHT NOW.  It doesn’t take long to look at the numbers of industry comps to show a true opportunity could be presenting itself in a BIG WAY:

Multiple Myeloma Presenting Multi-BILLION Dollar Opportunity?

According to FiercePharma, Celgene’s cancer drug Revlimid® for the treatment of multiple myeloma generated nearly $5 billion in revenue for the company in 2014.

Analysts believe sales of Revlimid could double within 5 years as a result of FDA’s recent approval of expanded labeling concerning the use of Revlimid in combination with dexamethasone for patients newly diagnosed with multiple myeloma.

About 93,600 patients are living with multiple myeloma in Europe and about 88,499 patients are living with it in the United States, Celgene said.

Limited Breast Cancer Treatments Roll Out the Carpet for New Therapies…

PDL BioPharma, Inc. stated its licensee Genentech, Inc. reported sales of Herceptin® which is used to treat HER2 breast cancer totaled $7.3 billion in 2014.  Of the 280,000 patients in the USA diagnosed annually with breast cancer, about 20% are diagnosed with triple-negative breast cancer.

Treatment options for triple-negative breast cancer patients are limited because the three most common types of receptors known to fuel most breast cancer growth – estrogen, progesterone, and the HER-2/neu gene – are not present in the triple-negative breast cancer cells, hence patients are ineligible for treatment with either hormonal or HER2-targeted agents such as Herceptin.  Treatment typically involves non-targeted cytotoxic chemo-therapies.

Potential of Antibody-Drug Conjugate (ADC) & Antibody Directed Cell-Mediated Cytotoxic (ADCC)

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ADCETRIS® (brentuximab vedotin) from Seattle Genetics is a first-in-class FDA approved antibody-drug conjugate (ADC) targeting CD30+ cancer cells.  Adcetris is approved for the treatment of certain lymphomas.

7Blincyto® (blinatumomab) from Amgen is a first-in-class FDA approved bispecific CD19-directed CD3 T-cell engager antibody directed cell-mediated cytotoxic therapeutic (ADCC).  Blinctyo is approved for the treatment of childhood acute lymphoblastic leukemia.

OXS-1550 is an ADC drug. ADCs, such as ADCETRIS® (brentuximab vedotin) from Seattle Genetics, a first-in-class FDA approved antibody-drug conjugate, have paved the way for this type of next generation platform drug.

Why Small Cap Biotech Stocks?

If you’re asking yourself why (GTBP), a stock trading under $0.10 right now, has such strong potential right now, just look at some of the other small cap biotech stocks that started out quiet and then exploded this year!

AVEO Oncology Up Over 400% THIS YEAR!

This biopharmaceutical company started the year UNDER $1 and is now trading OVER $1 with highs in the last 8 months of $3.19!

Infinity Pharmaceuticals Hits Highs of 180%

Another biotechnology company, Infinity managed a run of epic proportions after running from UNDER $1.40 to NEARLY $4!

Pieres Pharmaceuticals Moves From $1.38 to $6.20!

A biologics company that once again is another example of a breakout small cap biotech stock that exploded this year.

And with biotech indexes hitting new highs of 2017, there’s no doubt that we may soon see the next big biotech stock breakout!

Will You Let Another Biotech “Unicorn” Fly By?

The bottom line is that biotechnology stocks have been incredibly volatile and have been known in 2017 to deliver some of the most aggressive and highest percentage gains.

With sound leadership, an active pipeline, novel lead therapies, and its latest acquisition strategy, (GTBP) could be one of the hottest public biotech companies the Street has yet to see for themselves.

Early investors could be set to take advantage of one of the biggest cash grabs the industry could see in 2017!

Will you be the one to take advantage?

 


 

Disclosure: 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.  Full Disclaimer

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