LOS ANGELES, January 24, 2018 /PRNewswire/ --
GT Biopharma Inc. (OTCQB: GTBP)
(Euronext Paris: GTBP.PA) today announced that Executive Chairman
Anthony Cataldo has issued the
following 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.
Increasing our Profile on Wall Street and Preparing for a
NASDAQ Uplisting
Throughout 2017, and accelerating towards the end of last year,
we worked on putting the pieces in place to prepare for an
uplisting on NASDAQ and to increase our profile with the
institutional investor community. On December 18, 2017, we took the first step in the
uplisting process and announced our intention to apply for listing
on the Nasdaq Capital Markets exchange. In January 2018, we filed our application for that
listing.
We have also spent the past couple of months meeting with key
players on Wall Street to help increase our profile with the
institutional investor community. We were recently invited to
present at the 30th Annual ROTH Conference; which takes
place on March 11-13, 2018, at The
Ritz-Carlton in Orange County, CA.
We will provide a separate communication that provides more details
about our attendance at that investor conference. Our management
team will be attending several other scientific and investor events
throughout the year and we look forward to providing updates as
appropriate.
Going Forward
We expect 2018 to be a similarly productive year as compared to
2017 but with more of an emphasis on creating shareholder value by
hitting our clinical and pre-clinical milestones vs reducing debt
and recruiting management. We anticipate we will be listed on
NASDAQ and will appoint additional experienced employees and board
members. We will work hard to increase our presence amongst the
leading institutional investors on Wall Street and attract and
maintain a high-quality shareholder base. We will continue to have
our shareholders as our top priority and will be singularly focused
on working to create significant shareholder value over time.
As you know, we closed a financing of over $7 million this week which, along with the
progress we made in 2017, has put our company in a much stronger
position than one year ago and provided the capital we need to push
forward with our business plan. Thank you for your support. We will
continue to work hard and smart for you, our investors, to create a
company that will build in value and deliver on the goals we have
set forth for this year.
Sincerely,
Anthony J. Cataldo
Executive Chairman
About GT Biopharma, Inc.
GT Biopharma, Inc. is an immuno-oncology biotechnology company
focused on innovative treatments based on the company's proprietary
Tri and Tetra-specific Natural Killer Cell Engagers (TriKEs™ and
TetraKEs) and bispecific antibody-drug conjugate (ADC) platforms.
GT's most advanced oncology drug candidate, OXS-1550 (DT2219) is a
novel bispecific scFv recombinant fusion protein-drug conjugate
composed of the variable regions of the heavy and light chains of
anti-CD19 and anti-CD22 antibodies and a modified form of
diphtheria toxin as its cytotoxic drug payload. OXS-1550 has
demonstrated success in early human clinical trials in patients
with relapsed/refractory B-cell lymphoma or leukemia. In addition,
GT's TriKE platform will address a number of cancer types. GT's
nervous system platform is focused on acquiring or discovering and
patenting late-stage, de-risked, and close-to-market improved
treatments for nervous system diseases (Neurology and Pain) and
shepherding them through the approval process to the NDA. GT
Biopharma's neurology products currently include PainBrake, as well
as treatments for the symptoms of myasthenia gravis, and motion
sickness.
Except for historical information contained herein, the
statements in this release are forward-looking and made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are inherently
unreliable and actual results may differ materially. Examples of
forward-looking statements in this news release include statements
regarding the effectiveness of the Company's products, the
potential outcome of clinical studies, the future success of
development activities and the future growth and operating and
financial performance of the Company. Factors which could cause
actual results to differ materially from these forward-looking
statements include such factors as the Company's ability to
accomplish its business initiatives, obtain regulatory approval and
protect its intellectual property; significant fluctuations in
marketing expenses and ability to achieve or grow revenue, or
recognize net income, from the sale of its products and services,
as well as the introduction of competing products, or management's
ability to attract and maintain qualified personnel necessary for
the development and commercialization of its planned products, and
other information that may be detailed from time to time in the
Company's filings with the United States Securities and Exchange
Commission. The Company undertakes no obligation to publicly update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Contact:
Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com
SOURCE GT Biopharma Inc