<SEC-DOCUMENT>0001654954-19-011042.txt : 20190924
<SEC-HEADER>0001654954-19-011042.hdr.sgml : 20190924
<ACCEPTANCE-DATETIME>20190924080032
ACCESSION NUMBER:		0001654954-19-011042
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20190919
ITEM INFORMATION:		Entry into a Material Definitive Agreement
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20190924
DATE AS OF CHANGE:		20190924

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			GT Biopharma, Inc.
		CENTRAL INDEX KEY:			0000109657
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				941620407
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-08092
		FILM NUMBER:		191109200

	BUSINESS ADDRESS:	
		STREET 1:		310 N. WESTLAKE BLVD.
		STREET 2:		SUITE 206
		CITY:			WESTLAKE VILLAGE
		STATE:			CA
		ZIP:			91362
		BUSINESS PHONE:		(800) 304-9888

	MAIL ADDRESS:	
		STREET 1:		310 N. WESTLAKE BLVD.
		STREET 2:		SUITE 206
		CITY:			WESTLAKE VILLAGE
		STATE:			CA
		ZIP:			91362

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	OXIS INTERNATIONAL INC
		DATE OF NAME CHANGE:	19940916

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	DDI PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19920703

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	DIAGNOSTIC DATA INC /DE/
		DATE OF NAME CHANGE:	19850312
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>gtbp_8k.htm
<DESCRIPTION>CURRENT REPORT
<TEXT>
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UNITED STATES</font></div>
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SECURITIES AND EXCHANGE COMMISSION</font></div>
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FORM 8-K</font></div>
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CURRENT REPORT</font></div>
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Pursuant to Section 13 Or 15(d) of the</font></div>
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Securities Exchange Act of 1934</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date of
Report (Date of earliest event reported): September 19,
2019</font></div>
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GT Biopharma, Inc.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Exact
name of Registrant as specified in its charter)</font></div>
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Delaware</font></div>
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000-08092</font></div>
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94-1620407</font></div>
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Number)</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
9350 Wilshire Blvd. Suite 203</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Beverly Hills, CA 90212</font></div>
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Phone: (800) 304-9888</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Address,
including zip code, and telephone number, including area code,
of</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">registrant&#x2019;s
principal executive offices)</font></div>
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N/A</font></div>
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report)</font></div>
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below):</font></div>
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communications pursuant to Rule 13e-4(c) under the Exchange Act (17
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<div></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Item 1.01. Entry into a Material Definitive Agreement.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
On September 19, 2019, GT Biopharma, Inc. (the
&#x201C;Company&#x201D;) entered into an Asset Purchase Agreement
(the &#x201C;Agreement&#x201D;), pursuant to which the Company sold
its rights, titles and interests, including associated patents, to
the pharmaceutical product designated by the Company as GTB-004
(the &#x201C;Product&#x201D;). Under the Agreement, the Product was
purchased by DAS Therapeutics, Inc. who the Company believes is
well positioned to take over the clinical development of the
Product including obtaining timely approval by the
FDA.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
The Company received $200,000 at closing. The Company will also
participate in the future commercial value of the Product by
receiving $6,000,000 upon the achievement of certain sales
objectives. In addition, the Company will receive a royalty equal
to 1.5% of U.S. sales until such time as the last of the patents
associated with the Product expires.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><a name="T1"><!--anchor--></a>The Product has to do with the treatment
of myasthenia gravis.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Item 9.01 Financial Statements and Exhibits.</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">(d)
Exhibits</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">No.</font></div>
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<div><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Description</font></div>
</td>
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<div><a href="gtbp_ex991.htm"><font style="font-family: Times New Roman; font-size: 13px">99.1</font></a></div>
</td>
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<div><font style="font-family: Times New Roman; font-size: 13px">Press
Release</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
SIGNATURE PAGE</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to the requirement of the Securities and Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div><font style="font-size: 13px; font-family: Times New Roman"></font></div>
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">GT
Biopharma, Inc.</font></td>
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<font style="font-family: Times New Roman; font-size: 13px">Dated:
September 24, 2019</font></td>
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Weldon</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-family: Times New Roman; font-size: 13px">Steven
Weldon</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Chief
Financial Officer</font></div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>gtbp_ex991.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
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<title>Blueprint</title>
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&#xA0; <font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold">Exhibit 99.1</font><br></font></div>
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<font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
GT BIOPHARMA ANNOUNCES THE SALE OF ITS FIXED DOSE COMBINATION
TABLET (GTB-004) FOR MYASTHENIA GRAVIS (CHRONIC AUTOIMMUNE DISEASE)
TO DAS THERAPEUTICS</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">TAMPA,
Florida, September 24, 2019 / PRNewswire / --&#xA0;GT Biopharma,
Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on
innovative treatments based on the Company's proprietary NK cell
engager (TriKE&#x2122;) platform and Multi-Target Directed
Bispecific Drug Conjugate platform, announced today that it sold
the rights to GTB-004 for the treatment of myasthenia gravis to DAS
Therapeutics, Inc.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Myasthenia
gravis is a chronic autoimmune disease of the neuromuscular
junction characterized by muscle weakness. The disease occurs in
all ethnic groups and both genders. The prevalence of the disease
in the United States is estimated at 14 to 20 per 100,000
population; approximately 36,000 to 60,000 cases in the U.S.
(Howard, 2015). Myasthenia gravis most commonly affects adult women
(onset between 20 to 40 years) and older men (onset over 60), but
it can occur at any age (Myasthenia Gravis Fact Sheet; National
Institute of Neurological Disorders and Stroke, 2016).</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">GTB-004
is a fixed-dose combination tablet for the treatment of the muscle
weakness associated with myasthenia gravis. GTB-004 combines
pyridostigmine with an antagonist helping to reduce
gastrointestinal side effects associated with pyridostigmine
therapy.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Under
the terms of the Asset Purchase Agreement, DAS Therapeutics
acquires all rights, title, clinical data, composition-of-matter
and use patents related to GTB-004. GT Biopharma will receive a
$200,000 up-front payment, annual royalties of 1.5% of Net Yearly
Sales, and a $6 million payment based on achievement of commercial
milestone.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Mr.
Anthony Cataldo, the Chairman and Chief Executive Officer of GT
Biopharma commented &#x201C;we are pleased that DAS Therapeutics
will continue to advance GTB-004 in a Phase II clinical trial and
toward product registration via the 505(b)(2) regulatory
path.&#x201D; Mr. Cataldo further stated &#x201C;we are gratified to
have been able to monetize part of our shareholders&#x2019;
investment from our earlier acquisition of Georgetown Translational
Pharmaceuticals, Inc. &#x2013; a developer of central nervous
systems (CNS) targeted therapeutics. We will continue to remain
focused on our high value oncology assets, two of which are now in
FDA clinical trials.&#x201D;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Myasthenia
gravis is a chronic autoimmune disease of the neuromuscular
junction characterized by muscle weakness. The disease occurs in
all ethnic groups and both genders. The prevalence of the disease
in the United States is estimated at 14 to 20 per 100,000
population; approximately 36,000 to 60,000 cases in the U.S.
(Howard, 2015). Myasthenia gravis most commonly affects adult women
(onset between 20 to 40 years) and older men (onset over 60), but
it can occur at any age (Myasthenia Gravis Fact Sheet; National
Institute of Neurological Disorders and Stroke, 2016).</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About GTB-3550 Trispecific NK cell Engager
(TriKE&#x2122;)</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">GTB-3550
(OXS-3550) is the Company's first Tri-specific NK cell Engager
(TriKE&#x2122;) product candidate being initially developed for the
treatment AML. GTB-3550 is a single-chain, tri-specific scFv
recombinant fusion protein conjugate composed of the variable
regions of the heavy and light chains of anti-CD16 and anti-CD33
antibodies and a modified form of IL-15. The natural killer (NK)
cell stimulating cytokine human IL-15 portion of the molecule
provides a self-sustaining signal that activates NK cells and
enhances their ability to kill. We intend to study GTB-3550 in CD33
positive leukemias such as acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS), and other CD33+ hematopoietic
malignancies.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About GTB-1550 Multi-Target Directed Bispecific Drug
Conjugate</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">GTB-1550
targets cancer cells expressing the CD19 receptor or CD22 receptor
or both receptors thereby maximizing cancer cell recognition by
binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550
binds to cancer cells, the cancer cells internalize GTB-1550, and
are killed due to the action of drug's cytotoxic diphtheria toxin
payload.</font></div>
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<div><font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About GT Biopharma, Inc.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">GT
Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immuno-oncology
products based off our proprietary Tri-specific Killer Engager
(TriKE&#x2122;) and Multi-Target Directed Bispecific Drug Conjugate
technology platforms. Our TriKE platform is designed to harness and
enhance the cancer killing abilities of a patient's immune system
natural killer cells (NK cells). GT Biopharma has an exclusive
worldwide license agreement with the University of Minnesota to
further develop and commercialize cancer therapies using
proprietary TriKE technology developed by researchers at the
university to target NK cells to cancer. Our Multi-Target Directed
Bispecific Drug Conjugate platform can generate product candidates
that are bi-specific, ligand-directed single-chain fusion proteins
that, we believe, represent the next generation of targeted
therapy.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Forward-Looking Statements</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">This
press release contains certain forward-looking statements that
involve risks, uncertainties and assumptions that are difficult to
predict, including statements regarding the potential acquisition,
the likelihood of closing the potential transaction, our clinical
focus, and our current and proposed trials. Words and expressions
reflecting optimism, satisfaction or disappointment with current
prospects, as well as words such as &#x201C;believes&#x201D;,
&#x201C;hopes&#x201D;, &#x201C;intends&#x201D;,
&#x201C;estimates&#x201D;, &#x201C;expects&#x201D;,
&#x201C;projects&#x201D;, &#x201C;plans&#x201D;,
&#x201C;anticipates&#x201D; and variations thereof, or the use of
future tense, identify forward-looking statements, but their
absence does not mean that a statement is not forward-looking. Our
forward-looking statements are not guarantees of performance and
actual results could differ materially from those contained in or
expressed by such statements. In evaluating all such statements, we
urge you to specifically consider the various risk factors
identified in our Form 10-K for the fiscal year ended
December&#xA0;31, 2018 in the section titled &#x201C;Risk
Factors&#x201D; in Part I, Item 1A and in our subsequent filings
with the Securities and Exchange Commission, any of which could
cause actual results to differ materially from those indicated by
our forward-looking statements.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Our
forward-looking statements reflect our current views with respect
to future events and are based on currently available financial,
economic, scientific, and competitive data and information on
current business plans. You should not place undue reliance on our
forward-looking statements, which are subject to risks and
uncertainties relating to, among other things: (i)&#xA0;the
sufficiency of our cash position and our ongoing ability to raise
additional capital to fund our operations, (ii)&#xA0;our ability to
complete our contemplated clinical trials for GTB-3550 or GTB-1550,
or to meet the FDA's requirements with respect to safety and
efficacy, (iii) our ability to identify patients to enroll in our
clinical trials in a timely fashion, (iv)&#xA0;our ability to
achieve approval of a marketable product, (v)&#xA0;design,
implementation and conduct of clinical trials, (vii)&#xA0;the
results of our clinical trials, including the possibility of
unfavorable clinical trial results, (vii)&#xA0;the market for, and
marketability of, any product that is approved, (viii)&#xA0;the
existence or development of treatments that are viewed by medical
professionals or patients as superior to our products,
(ix)&#xA0;regulatory initiatives, compliance with governmental
regulations and the regulatory approval process, and social
conditions, and (x)&#xA0;various other matters, many of which are
beyond our control. Should one or more of these risks or
uncertainties develop, or should underlying assumptions prove to be
incorrect, actual results may vary materially and adversely from
those anticipated, believed, estimated, or otherwise indicated by
our forward-looking statements.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">We
intend that all forward-looking statements made in this press
release will be subject to the safe harbor protection of the
federal securities laws pursuant to Section&#xA0;27A of the
Securities Act, to the extent applicable. Except as required by
law, we do not undertake any responsibility to update these
forward-looking statements to take into account events or
circumstances that occur after the date of this press release.
Additionally, we do not undertake any responsibility to update you
on the occurrence of any unanticipated events which may cause
actual results to differ from those expressed or implied by these
forward-looking statements.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">For
more information, please visit <font style="text-decoration: underline; color: #0000FF">www.gtbiopharma.com</font>.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
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