GT Biopharma Inc. (GTBP) Issues Letter to Shareholders


GT Biopharma, Inc. Issues Letter to Shareholders

Fellow Shareholders,

I wanted to take the time to thank you for being a shareholder and for your continuing support as we strive to build GT Biopharma into a leading player in the biotechnology industry. We started 2017 with lofty goals and ended up having, what we believe to be, a great year that was full of accomplishments.

As we are well into our first month of 2018, the management team and I wanted to summarize some key achievements from 2017 and provide some insight into certain of our goals for 2018. Our top priority is our shareholders and to be singularly focused on creating significant shareholder value for you over time.

During 2017, and continuing today, we have spent, and are spending, a considerable amount of time: 1) better capitalizing our balance sheet, 2) enhancing and advancing our pipeline of potentially groundbreaking drug candidates, 3) building a top-notch management team and board of directors, and 4) increasing our profile to Wall Street and preparing for a listing on NASDAQ.

Balance Sheet Capitalization 

In January 2017, we had over $15,000,000 in senior secured debt while our market capitalization was approximately $22,000,000.

Fast forward to today, we have reduced the debt to $7,100,000 and our market capitalization is approximately $160,000,000. The makeup of our current debt is also structured more favorably than it was in 2017, as it is a convertible structure and provides us with the flexibility and capital to continue to build our business and advance our pipeline.

Pipeline Progress

Early last year, we had one FDA Phase 1 trial underway (for OXS-1550), our bispecific scFv recombinant fusion protein-drug conjugate, and a pipeline of potentially groundbreaking yet pre-clinical TriKE and TetraKE immune-oncology candidates.

On September 1, 2017, we closed on the acquisition of Georgetown Translational Pharmaceuticals, Inc. which brought a portfolio of Central Nervous System drug candidates including: GTP-004 for the symptoms of myasthenia gravis, PainBrake, a Non-Opioid for neuropathic pain, and GTP-011 targeting certain vestibular disorders.

In 2018, we have already made meaningful progress. OXS-1550 is in a FDA Phase 2 trial, in patients with ALL/NHL, which we expect to be completed later this year. Earlier this month, we completed dosing in our Phase 1 clinical trial for GTP-004 and, based on these results and feedback from key opinion leaders, we expect to be in a position to initiate a Phase 2 clinical trial in patients in the second half of 2018. We are working diligently to advance the first two of our potentially groundbreaking TriKE immune-oncology product candidates into FDA clinical trials in the second half of 2018 (OXS-3550 and OXS-C3550). Finally, we are progressing PainBrake and GTP-011, as well as a solid-tumor targeted TetraKE immune-oncology product candidate, in their pre and clinical development plans. We look forward to providing updates on these developments throughout the year.

Management and Board Enhancement 

2017 was a critical year in enhancing our management team and we made considerable progress in this regard.

On September 1, 2017, our Chief Executive Officer, Dr. Kathleen Clarence-Smith M.D., P.H.D. joined the company and brought substantial clinical development and intellectual property expertise (co-founder Chase Pharmaceuticals; formerly with Sanofi and Roche). We were also able to attract and hire Dr. Raymond Urbanski M.D., P.H.D. as Chief Medical Officer (a clinical oncologist formerly with Pfizer and Mylan). In November of 2017, Shawn Cross (formerly of Deutsche Bank) joined as President and Chief Operating Officer to help drive our strategy, interact with potential large pharmaceutical partners, and enhance our visibility with Wall Street. Finally, we announced Geoff Davis joined our board on January 16, 2018. Geoff is a former partner at Ropes & Gray where he played a significant role in establishing the firm’s internationally-recognized Life Sciences Group. His over 25 years of work includes numerous partnering and licensing transactions for major pharmaceutical companies, as well as for public and private biotechnology companies. Each is a welcome addition to our team.



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