UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark One)
For the fiscal year ended: December 31, 2024 or
For
the transition period from _____________ to _____________
Commission
File Number: 001-40023
GT
BIOPHARMA, INC.
(Exact
name of Registrant as specified in its charter)
N/A1
(Address
of principal executive offices)
(415)919-4040
(Registrant’s
telephone number including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title of Securities Trading Symbol(s) Exchanges on which Registered
Common Stock, $0.001 Par Value GTBP Nasdaq Capital Market
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
aggregate market value of the registrant’s common stock, $0.001 par value per share, held by non-affiliates on June 30, 2024 was
approximately $5.1 million. As of February 19, 2025, there were 2,234,328 shares of the registrant’s common stock, $0.001 par value,
issued and outstanding.
GT
Biopharma, Inc.
FORM
10-K
TABLE
OF CONTENTS
PART I 1
Item 1. Business 1
Item 1A. Risk Factors 9
Item 1B. Unresolved Staff Comments 29
Item 1C. Cybersecurity 30
Item 2. Properties 30
Item 3. Legal Proceedings 30
Item 4. Mine Safety Disclosures 31
Item 6. [Reserved] 32
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 36
Item 8. Financial Statements and Supplementary Data 37
Item 9A. Controls and Procedures 57
Item 9B. Other Information 58
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 58
PART III 59
Item 10. Directors, Executive Officers and Corporate Governance 59
Item 11. Executive Compensation 61
Item 14. Principal Accounting Fees and Services 66
Item 15. Exhibits and Financial Statement Schedules 67
SUMMARY
RISK FACTORS
Our
business involves significant risks. Below is a summary of the material risks that our business faces, which makes an investment in our
securities speculative and risky. This summary does not address all these risks. These risks are more fully described below under the
heading “Risk Factors” in Part I, Item 1A of this annual report on Form 10-K. Before making investment decisions regarding
our securities, you should carefully consider these risks. The occurrence of any of the events or developments described below could
have a material adverse effect on our business, results of operations, financial condition, prospects and stock price. In such event,
the market price of our securities could decline, and you could lose all or part of your investment. In addition, there are also additional
risks not described below that are either not presently known to us or that we currently deem immaterial, and these additional risks
could also materially impair our business, operations, or market price of our common stock.
●
Our financial condition raises substantial doubt as to our ability to continue as a going concern.
●
Our business is at an early stage of development and we may not develop therapeutic products that can be commercialized.
●
We have a history of operating losses and we expect to continue to incur losses for the foreseeable future. We may never generate revenue
or achieve profitability.
●
We will need additional capital to conduct our operations and develop our products, and our ability to obtain the necessary funding is
uncertain.
●
Our current and future indebtedness may impose significant operating and financial restrictions on us and affect our ability to access
liquidity.
●
The cost of our research and development programs may be significantly higher than expected, and there is no assurance that they will
successful in a timely manner, or at all.
●
If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not
be able to compete effectively in our market and our business would be harmed.
●
Claims that we infringe the intellectual property rights of others may prevent or delay our drug discovery and development efforts.
●
We may desire, or be forced, to seek additional licenses to use intellectual property owned by third parties, and such licenses may not
be available on commercially reasonable terms, or at all.
●
If we are unsuccessful in obtaining or maintaining patent protection for intellectual property in development or licensed from third
parties, our business and competitive position would be harmed.
●
If we fail to meet our obligations under our license agreements, we may lose our rights to key technologies on which our business depends.
●
Our reliance on the activities of our non-employee consultants, research institutions and scientific contractors, whose activities are
not wholly within our control, may lead to delays in development of our proposed products.
●
Clinical drug development is costly, time-consuming and uncertain, and we may suffer setbacks in our clinical development program that
could harm our business.
●
If we experience delays or difficulties in the enrollment of patients in clinical trials, those clinical trials could take longer than
expected to complete and our receipt of necessary regulatory approvals could be delayed or prevented.
●
Obtaining regulatory approval, even after clinical trials that are believed to be successful, is an uncertain process.
●
We will continue to be subject to extensive FDA regulation following any product approvals, and if we fail to comply with these regulations,
we may suffer a significant setback in our business.
●
Many of our business practices are subject to scrutiny and potential investigation by regulatory and government enforcement authorities,
as well as to lawsuits brought by private citizens under federal and state laws. We could become subject to investigations, and our failure
to comply with applicable law or an adverse decision in lawsuits may result in adverse consequences to us. If we fail to comply with
U.S. healthcare laws, we could face substantial penalties and financial exposure, and our business, operations and financial condition
could be adversely affected.
●
Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval,
limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
●
We may expend our limited resources to pursue a particular product candidate or indication that does not produce any commercially viable
products and may fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater
likelihood of success.
●
Our products may be expensive to manufacture, and they may not be profitable if we are unable to control the costs to manufacture them.
●
We currently lack manufacturing capabilities to produce our therapeutic product candidates at commercial-scale quantities and do not
have an alternate manufacturing supply, which would negatively impact our ability to meet any demand for the product.
●
Our business is based on novel technologies that are inherently expensive and risky and may not be understood by or accepted in the marketplace,
which could adversely affect our future value.
●
We could be subject to product liability lawsuits based on the use of our product candidates in clinical testing or, if obtained, following
marketing approval and commercialization. If product liability lawsuits are brought against us, we may incur substantial liabilities
and may be required to cease clinical testing or limit commercialization of our product candidates.
●
We rely on third parties to supply candidates for clinical testing and to conduct preclinical and clinical trials of our product candidates.
If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain
regulatory approval for or commercialize our product candidates. As a result, our business could be substantially harmed.
●
Our failure to maintain compliance with the Nasdaq Capital Market’s (“Nasdaq”) continued listing requirements could
result in the delisting of our common stock.
●
There has been a limited public market for our common stock, and we do not know whether one will develop to provide adequate liquidity.
Furthermore, the trading price for our common stock, should an active trading market develop, may be volatile and could be subject to
wide fluctuations in per-share price.
●
Because our common stock may be deemed a “penny” stock, an investment in our common stock should be considered high-risk
and subject to marketability restrictions.
PART
I
CAUTIONARY
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This
Annual Report on Form 10-K, including any documents which may be incorporated by reference into this Annual Report, contains “Forward-Looking
Statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. All statements other than statements of historical fact are “Forward-Looking Statements” for purposes
of these provisions, including our plans of operation, any projections of revenues or other financial items, any statements of the plans
and objectives of management for future operations, any statements concerning proposed new products or services, any statements regarding
future economic conditions or performance, and any statements of assumptions underlying any of the foregoing. All Forward-Looking Statements
included in this document are made as of the date hereof and are based on information available to us as of such date. We assume no obligation
to update any Forward-Looking Statement. In some cases, Forward-Looking Statements can be identified by the use of terminology such as
“may,” “will,” “expects,” “plans,” “anticipates,” “intends,”
“believes,” “estimates,” “potential,” or “continue,” or the negative thereof or other
comparable terminology. Although we believe that the expectations reflected in the Forward-Looking Statements contained herein are reasonable,
there can be no assurance that such expectations or any of the Forward-Looking Statements will prove to be correct, and actual results
could differ materially from those projected or assumed in the Forward-Looking Statements. Future financial condition and results of
operations, as well as any Forward-Looking Statements are subject to inherent risks and uncertainties, including any other factors referred
to in our press releases and reports filed with the Securities and Exchange Commission. All subsequent Forward-Looking Statements attributable
to the company or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Additional factors
that may have a direct bearing on our operating results are described under “Risk Factors” and elsewhere in this Annual Report
on Form 10-K.
Introductory
Comment
Throughout
this Annual Report on Form 10-K, the terms “GT Biopharma,” “GTBP,” “we,” “us,” “our,”
“the company” and “our company” refer to GT Biopharma, Inc., a Delaware corporation formerly known as DDI Pharmaceuticals,
Inc., Diagnostic Data, Inc. and OXIS International, Inc., together with our former wholly-owned subsidiaries, Oxis Biotech, Inc. and
Georgetown Translational Pharmaceuticals, Inc., which were both dissolved on October 22, 2024.
ITEM
1. BUSINESS
We
are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based
on our proprietary Tri-specific Killer Engager (TriKE®), and Tetra-specific Killer Engager (Dual Targeting TriKE®)
fusion protein immune cell engager technology platforms. Our TriKE® and Dual Targeting TriKE® platforms generate proprietary
therapeutics designed to harness and enhance the cancer killing abilities of a patient’s own natural killer cells, or NK cells.
Once bound to an NK cell, our moieties are designed to activate the NK cell to direct it to one or more specifically targeted proteins
expressed on a specific type of cancer cell or virus infected cell, resulting in the targeted cell’s death. TriKE®s
can be designed to target any number of tumor antigens, including B7-H3, HER2, CD33 and PDL1, on hematologic malignancies or solid tumors
and do not require patient-specific customization. We believe our TriKE® and Dual Targeting TriKE® platforms that activate endogenous
NK cells are potentially safer than T-cell immunotherapy because there is less cytokine release syndrome (CRS) and fewer neurological
complications. Our preclinical data suggests that this is explained by the TriKE® dependent CD16 directed IL-15 proliferation of
NK cells but little effect endogenous T cells.
We
are using our TriKE® platform with the intent to bring to market immuno-oncology products that can treat a range of hematologic
malignancies, solid tumors, and potentially autoimmune disorders. The platform is scalable, and we are implementing processes to produce
investigational new drug (IND) ready moieties in a timely manner after a specific TriKE® conceptual design. Specific drug
candidates can then be advanced into the clinic on our own or through potential collaborations with partnering companies. We believe
our TriKE®s may have the ability, if approved for marketing, to be used as both monotherapy and in combination with other standard-of-care
therapies.
Our
initial work was conducted in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr.
Jeffrey Miller, Professor of Medicine, and the Interim Director at the Center. Dr. Miller, who also serves as our Consulting Senior Medical
Director, is a recognized key opinion leader in the field of NK cell and IL-15 biology and their therapeutic potential. We have exclusive
rights to the TriKE® platform and are generating additional intellectual property for specific moieties.
Product
Pipeline
Our
current product candidate pipeline is summarized in the table below:
GTB-3550
GTB-3550
was our first TriKE® product candidate and its clinical development was suspended so that we could focus resources on second-generation
TriKEs®. GTB-3550 is a tri-specific killer engager (TriKE) comprised of two single-chain variable fragments (“scFv”)
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. We
studied this anti-CD16-IL-15-anti-CD33 TriKE® in CD33 positive leukemias, a marker expressed on tumor cells in acute myelogenous
leukemia, or AML, and myelodysplastic syndrome, or MDS. The anti-CD33 antibody fragment in GTB-3550 was derived from the M195 humanized
anti-CD33 scFv We believe the approval of the antibody-drug conjugate gemtuzumab validates the targeting of CD33.
We
previously announced the interim clinical trial results for GTB-3550, which showed significantly reduced CD 33+ bone marrow blast levels
by 33.3%, 61.7%, 63.6%, 50% in Patient 5 (25 μg/kg/day), Patient 7 (50 μg/kg/day), Patient 9 (100 μg/kg/day), and Patient
11 (150 μg/kg/day), respectively. After the end of infusion, GTB-3550 and IL-15 concentrations declined rapidly with overall geometric
mean terminal phase elimination half-life (T1/2) of 2.2 and 2.52 hours, respectively. There was minimal CRS resulting from hyperactivation
of patient’s T-cell population at doses 5–150 μg/kg/day.
Despite
the positive interim clinical trial results, GTB-3550 was replaced by a more potent next-generation camelid nanobody TriKE®, GTB-3650,
that similarly targets CD33 on relapsed/refractory AML and high-risk MDS. A key difference between GTB-3550 and GTB-3650 is the incorporation
of camelid antibody technology instead of a scFv; our preclinical experience showed markedly enhanced potency of TriKEs® comprised
of camelid components. This is illustrated below by better tumor control of AML bearing animals with GTB-3650 (purple dots) compared
to GTB-3550 (blue dots). This provided the rationale for pausing further development of GTB-3550 and moving over to solely develop the
second-generation, camelid-based TriKE® platform.
Second
Generation TriKE®s Utilize Camelid Nanobody Technology
Our
goal is to be a leader in immuno-oncology therapies targeting a broad range of indications including hematological malignancies and solid
tumors. A key element of our strategy includes introducing a next-generation camelid nanobody platform. Camelid antibodies (often referred
as nanobodies) are smaller than human immunoglobulin, consisting of two heavy chains instead of two heavy and two light chains. These
nanobodies have the potential to have greater affinity to target antigens, potentially resulting in greater potency. We are utilizing
this camelid antibody structure for all of our new TriKE® product candidates.
To
develop second generation TriKE®s, we designed a new humanized CD16 engager derived from a single-domain antibody. While scFvs consist
of a heavy and a light variable chain joined by a linker, single-domain antibodies consist of a single variable heavy chain capable of
engaging without the need of a light chain counterpart (see figure below).
These
single-domain antibodies are thought to have certain attractive features for antibody engineering, including physical stability, ability
to bind deep grooves, and increased production yields, amongst others. Pre-clinical studies demonstrated increased NK cell activation
against CD33+ targets including enhanced NK cell degranulation (% CD107a+) and IFNγ with the single-domain CD16 TriKE® (cam
16-wt15-33; GTB-3650) compared to the original TriKE® (scFv16-m 15-33; GTB-3550) (see figure below). This data was published by Dr.
Felices M et al (2020) in Cancer Immunol Res.
CD33+
HL60 Targets in Killing Assays
The
purple line represents the GTB-3650 and the blue line represents GTB-3550.
GTB-3650
GTB-3650
is a TriKE® which targets CD33 on the surface of myeloid leukemias and an agonistic camelid engager to the potent activating receptor
on NK cells, CD16. Use of this engager enhances the activity of wild type IL-15 included in GTB-3650. The TriKE® approach provides
a novel way to specifically target these tumors by leveraging NK cells, which have been shown to mediate relapse protection in this setting,
in an anti-CD33-targeted fashion. We are advancing GTB-3650 to clinical studies based on pre-clinical data showing a marked increase
in potency compared to GTB-3550, which we anticipate could lead to an enhanced efficacy signal in AML and MDS. We advanced GTB-3650 through
requisite preclinical studies and filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA)
in December 2023. In late June 2024, the FDA cleared our IND Application for GTB-3650. We started study enrollment targeting patients
with relapsed/refractory AML and high grade MDS on January 21, 2025. This initial study is testing GTB-3650 as monotherapy testing administration
2 weeks on and two weeks off (to prevent NK cell exhaustion) for at least 2 cycles of therapy, as agreed on with the FDA.
GTB-5550
GTB-5550
is a B7-H3 targeted TriKE® which targets B7-H3 on the surface of advanced solid tumors (figure above). GTB-5550 is our first dual
camelid TriKE®. B7-H3 is expressed on a broad spectrum of solid tumor malignancies, allowing our team to target these malignancies
through GTB-5550. Pre-clinical work has shown that this molecule has NK-cell targeted activity against a variety of solid tumors, including
head and neck cancer squamous cell carcinoma (figure below), prostate cancer, breast cancer, ovarian cancer, glioblastoma, and lung cancer
(amongst others). We are advancing GTB-5550 through preclinical studies and initiated a GMP manufacturing campaign in anticipation of
filing an IND. A pre-IND packet was submitted to the FDA in October 2023 with a written response from the FDA
in December 2023. The main question from the FDA was regarding pre-clinical toxicology and a pivot to subcutaneous dosing. The initial
trial is designed as a basket trial for patients with B7-H3+ solid tumors using Monday through Friday dosing (2 weeks
on and 2 weeks off to prevent immune exhaustion), and is dependent on manufacturing of clinical materials.
GTB-7550
GTB-7550
TriKE® is a product candidate in development for the treatment of lupus and other autoimmune disorders. GTB-7550 TriKE® is a
tri-specific molecule composed of a camelid nanobody that binds the CD16 receptor on NK cells, a scFv engager against CD19 on malignant
and normal B cells, and a human IL-15 sequence between them.
Published
data shows that GTB-7550 effectively targets CD19+ malignant cell lines and primary chronic lymphocytic leukemia (CLL). Preliminary data
shows that GTB-7550 can target and eliminate normal B cells, which we are continuing to test in mice. We are currently exploring and
assessing potential manufacturers of GTB-7550.
Oncology
Markets
Acute
Myeloid Leukemia and Myelodysplastic Syndromes
AML
is a heterogeneous hematologic stem cell malignancy in adults with an incidence rate of 4.3% per 100,000 populations. The median age
at the time of diagnosis is 68 years. AML is an aggressive disease and is fatal without anti-leukemic treatment. AML is the most common
form of adult leukemia in the U.S. These patients will require frontline therapy, usually chemotherapy including cytarabine and an anthracycline,
a therapy that has not changed in over 40 years. Myelodysplastic syndromes are a heterogeneous group of myeloid neoplasms characterized
by dysplastic features of erythroid/myeloid/megakaryocytic lineages, progressive bone marrow failure, a varying percentage of blast cells,
and enhanced risk to evolve into acute myeloid leukemia. It is estimated that over 10,000 new cases of MDS are diagnosed each year and
there are minimal treatment options; other estimates have put this number higher. In addition, the incidence of MDS is rising for unknown
reasons.
B7-H3
Positive Solid Tumors
The
B7-H3 protein, which functions as a checkpoint inhibitor, has been identified in many of the most common solid tumor cancers, including
but not limited to bladder, breast, cervical, colorectal, endometrial, esophageal, gastric, glioma, kidney, liver, lung, pancreatic,
prostate, head and neck cancer, and melanoma. In recent studies, B7-H3 has been identified as a critical promoter of tumor cell proliferation,
migration, invasion, epithelial-to-mesenchymal transition, cancer stemness and drug resistance. Because this protein does not seem to
be expressed in normal cells, this makes it an attractive target for therapeutic intervention.
Manufacturing
We
do not currently own or operate manufacturing facilities for the production of clinical or commercial quantities of any of our product
candidates. We rely on third-party contract manufacturing operations, including Cytovance Biologics, Inc. (“Cytovance”),
a related party, to produce and/or test our compounds and expect to continue to do so to meet the preclinical and clinical requirements
of our potential product candidates as well as for our future commercial needs. We require in our manufacturing and processing agreements
that third-party product manufacturers produce intermediates, active pharmaceutical ingredients, or API, and finished products in accordance
with the FDA’s current Good Manufacturing Practices (cGMP), and all other applicable laws and regulations. We maintain confidentiality
agreements with potential and existing manufacturers to protect our proprietary rights related to our drug candidates.
Cytovance
Biologics, Inc., a Related Party
In
October 2020, the Company entered into a Master Services Agreement with Cytovance Biologics, Inc. (“Cytovance”), to perform
biologic development and manufacturing services, and to produce and test compounds used in the Company’s potential product candidates.
The Company subsequently executed numerous Statements of Work (“SOWs”) for the research and development of products for use
in clinical trials.
On
August 24, 2022, the Company entered into a Settlement and Investment Agreement with Cytovance that amended existing SOWs and allowed
for future invoices to be settled in in a combination of cash and issuance of the Company’s common stock. The Agreement also set
Cytovance’s beneficial ownership limitation at 4.9% of the issued and outstanding shares of the Company’s common stock.
On
April 25, 2024, the Company entered into an Amendment to the Settlement and Investment Agreement with Cytovance that increased Cytovance’s
beneficial ownership limitation to 9.9% of the issued and outstanding shares of the Company’s common stock.
During
the years ended December 31, 2024 and 2023, the Company recognized research and development expenses of $2,335,000 and $4,584,000, respectively
and made cash payments amounting to $3,857,000 and $2,213,000, respectively to Cytovance. In addition, the Company issued 127,597 and
57,437 shares of common stock to Cytovance to settle accounts payable valued at approximately $810,000 and $1,120,000, respectively.
On
June 30, 2024, Cytovance became a related party as their beneficial ownership exceeded 5% of the issued and outstanding shares of the
Company’s common stock.
As
of December 31, 2024 the Company’s commitments in relation to unbilled and unaccrued SOWs and any related Change Orders from Cytovance
for services that have not yet been rendered as of December 31, 2024, amounted to approximately $1.1 million.
TriKE®
Patents and Trademarks
On
August 24, 2021, two patents were issued by the US Patent Office covering our pipeline of clinical and non-clinical product candidates
consisting of tri-specific killer engagers, or TriKE®s, designed to target natural killer, or NK, cells and tumor or virus
infected cells forming an immune synapse between the NK cell and the tumor cell thereby inducing NK cell activation at that site. The
patents broadly include TriKE®s that target the CD16 receptor, which includes the more potent camelid nanobody sequence,
an IL-15 activating domain, and any targeting domain.
University
of Minnesota
2021
Scientific Research Agreement
Effective
June 16, 2021, the Company entered into a scientific research agreement with the Regents of the University of Minnesota, expiring on
June 30, 2023. Payments totaling approximately $2.1 million are due over the life of the agreement. The purpose of the agreement is for
the Regents of the University of Minnesota to continue work with the Company with three major goals in mind: (1) support the Company’s
TriKE® product development and GMP manufacturing efforts; (2) TriKE® pharmacokinetics optimization in humans;
and (3) investigation of the patient’s native NK cell population based on insights obtained from the analysis of the human data
generated during our GTB-3550 clinical trial. The major deliverables proposed are: (1) creation of IND enabling data for TriKE®
constructs in support of our product development and GMP manufacturing efforts; (2) TriKE® platform drug delivery
changes to allow transition to alternative drug delivery means and extended PK in humans; and (3) gain an increased understanding of
changes in the patient’s native NK cell population as a result of TriKE® therapy. Most studies will use TriKE®
DNA/amino acid sequences created by the Company under existing licensing terms.
The
Company recorded an expense classified as research and development of approximately $0 and $192,000, pursuant to the 2021 Scientific
Research Agreement, for the years ended December 31, 2024 and 2023, respectively.
As
of December 31, 2024 the Company’s commitments in relation to unbilled and unaccrued amounts from the University of Minnesota pursuant
to the 2021 Scientific Research Agreement for services that have not yet been rendered as of December 31, 2024, amounted to $0.
2023
Sponsored Research Agreement
On
May 20, 2024, the Company entered into a sponsored research agreement with the Regents of the University of Minnesota (the “2023
Sponsored Research Agreement”), effective July 1, 2023, and expiring on July 1, 2025. Payments totaling approximately $1.7
million are due over the life of the agreement. The purpose of the agreement is for the Regents of the University of Minnesota to continue
work with the Company with three major goals in mind: (1) support the Company’s TriKE® product development and commercial
GMP manufacturing efforts; (2) TriKE® pharmacokinetics optimization in humans and investigation of effects of altering
the route of administration; and (3) research and development of TriKE® platform. The major deliverables proposed are:
(1) creation of IND enabling data for TriKE® constructs in support of the Company’s product development and commercial
GMP manufacturing efforts outside of the University of Minnesota; (2) TriKE® platform drug delivery changes to allow transition
from intravenous (IV) continuous infusion to alternative drug delivery administration (IV bolus, intraperitoneal [IP], subcutaneous [SQ])
and extended PK in humans and gain an increased understanding of changes in the patient’s native NK cell population as a result
of alteration of TriKE® administration; and (3) research and development of TriKE® platform combination
with other FDA approved (or soon to be approved) therapeutics and alterations to TriKE® platform through formation of
immune complexes. Most studies will use TriKE® DNA/amino acid sequences created by the Company under existing licensing
terms.
The
Company recorded an expense classified as research and development of approximately $1,078,000 and $0, pursuant to the 2023 Sponsored
Research Agreement, for the years ended December 31, 2024 and 2023, respectively.
As
of December 31, 2024 the Company’s commitments in relation to unbilled and unaccrued amounts from the University of Minnesota pursuant
to the 2023 Sponsored Research Agreement for services that have not yet been rendered as of December 31, 2024, amounted to approximately
$647,000.
2016
Exclusive Patent License Agreement
Effective
July 18, 2016, the Company entered into an exclusive patent license agreement with the Regents of the University of Minnesota (as amended,
the “2016 Exclusive Patent License Agreement”), to further develop and commercialize cancer therapies using TriKE®
technology developed by researchers at the University of Minnesota to target NK cells to cancer. Under the terms of the agreement,
the Company receives exclusive rights to conduct research and to develop, make, use, sell, and import TriKE® technology
worldwide for the treatment of any disease, state, or condition in humans. The Company is responsible for obtaining all permits, licenses,
authorizations, registrations, and regulatory approvals required or granted by any governmental authority anywhere in the world that
is responsible for the regulation of products such as the TriKE® technology, including without limitation the FDA and
the European Agency for the Evaluation of Medicinal Products in the European Union. The agreement requires an upfront payment of $200,000,
and license maintenance fees of $200,000 for years 2017 through 2020, and $100,000 per year beginning in year 2021 and each year thereafter.
The agreement also includes 4% royalty fees on the net sales of licensed products, not to exceed 6% under subsequent license agreements
or amendments to this agreement, and minimum royalty payments due upon the commencement of commercial sales of licensed product is $250,000
beginning in 2022, $2 million beginning in 2025, and $5 million beginning in 2027 throughout the remainder of the term. The agreement
also includes numerous performance milestone payments including clinical development milestone payments totaling $3.1 million, and one-time
sales milestone payments of $1 million upon reaching $250 million in cumulative gross sales, and $5 million upon reaching $500 million
in cumulative gross sales of licensed products.
Effective
May 13, 2024, the Company entered into an amended and restated exclusive patent license agreement with the Regents of the University
of Minnesota. The amendment requires an upfront payment of $145,000 and amends the license maintenance fees to $50,000 in 2025, and $100,000
per year beginning in year 2026 and each year thereafter. The amendment also includes 1% to 5% royalty fees on the net sales of licensed
products, not to exceed 6% under subsequent license agreements or amendments, and minimum royalty payments due upon the commencement
of commercial sales of licensed product is $250,000 in year one, $2 million in years two through five, and $5 million in year six throughout
the remainder of the term. The amendment also includes numerous performance milestone payments including clinical development milestone
payments totaling $3.1 million, and one-time sales milestone, and one-time sales milestone payments of $1 million upon reaching $250
million in cumulative gross sales, and $5 million upon reaching $500 million in cumulative gross sales of licensed products.
The
Company recorded an expense classified as research and development of $145,000 and $0, pursuant to the 2016 Exclusive Patent License
Agreement, for the years ended December 31, 2024 and 2023, respectively.
2021
Exclusive License Agreement
Effective
March 26, 2021, the Company entered into an exclusive license agreement with the Regents of the University of Minnesota (the “2021
Exclusive Patent License Agreement”), specific to the B7H3 targeted TriKE®. The agreement requires an upfront payment
of $20,000, and license maintenance fees of $5,000 per year beginning in year 2022 and each year thereafter. The agreement also includes
2.5% to 5% royalty fees on the net sales of licensed products, and minimum royalty payments due upon the commencement of commercial sales
of licensed product is $250,000 in year one though four, and $2 million beginning in year five and throughout the remainder of the term.
The agreement also includes numerous performance milestone payments including clinical development milestone payments totaling $3.1 million,
and one-time sales milestone payments of $1 million upon reaching $250 million in cumulative gross sales, and $5 million upon reaching
$500 million in cumulative gross sales of licensed products. There is no double payment intended; if one of the milestone payments has
been paid under the 2016 restated exclusive patent license agreement no further payment is due for the corresponding milestone.
The
Company did not incur any expenses pursuant to the 2021 Exclusive License Agreement, for years ended December 31, 2024 and 2023, respectively.
Corporate
History and Structure
The
corporate predecessor of GT Biopharma, Inc, Diagnostic Data, Inc., was incorporated in the state of California in 1965. Diagnostic Data,
Inc. changed its incorporation to the state of Delaware on December 21, 1972 and changed its name to DDI Pharmaceuticals, Inc. on March
11, 1985. On September 7, 1994, DDI Pharmaceuticals, Inc. merged with International BioClinical, Inc. and Bioxytech S.A. and changed
its name to OXIS International, Inc. On July 17, 2017, OXIS International, Inc. changed its name to GT Biopharma, Inc.
Throughout
this Annual Report on Form 10-K, the terms “GTBP,” “we,” “us,” “our,” “the Company”
and “our Company” refer to GT Biopharma, Inc.
The
GT Biopharma logo, TriKE®, and other trademarks or service marks of GT Biopharma, Inc. appearing in this quarterly report are the
property of the Company. This Annual Report on Form 10-K also contains registered marks, trademarks and trade names of other companies.
All other trademarks, registered marks and trade names appearing herein are the property of their respective holders.
The
Company is a clinical stage biopharmaceutical company focused on the development and commercialization of novel immune-oncology products
based on our proprietary Tri-specific Killer Engager (TriKE®), and Tetra-specific Killer Engager (Dual Targeting TriKE®) platforms.
The Company’s TriKE® and Dual Targeting TriKE® platforms generate proprietary therapeutics designed to harness and enhance
the cancer killing abilities of a patient’s own natural killer cells (NK cells).
Common
Stock (February 2024 Reverse Stock-Split)
On
February 2, 2024, the Company effectuated a reverse stock-split of its common stock, par value $0.001 per share, at a ratio of 1 for
30. The Company’s common stock began trading on a reverse stock-split-adjusted basis on The Nasdaq Capital Market on February 5,
2024 under the existing trading symbol “GTBP.”
As
a result of the reverse stock-split, every thirty (30) shares of issued and outstanding common stock were automatically combined into
one issued and outstanding share of common stock, without any change in the par value per share. No fractional shares will be issued
in connection with the reverse stock-split. Stockholders who otherwise would be entitled to receive fractional shares of common stock
will be entitled to receive their pro-rata portion of the net proceeds obtained from the aggregation and sale by the exchange agent of
the fractional shares resulting from the reverse stock-split (reduced by any customary brokerage fees, commission and other expenses).
The reverse stock-split reduced the number of shares of common stock outstanding on the effective date of the reverse stock-split from
41,419,000 shares to 1,380,633 shares, subject to minor adjustments due to the treatment of fractional shares. The number of authorized
shares of common stock remains unchanged at 250,000,000 shares.
Proportionate
adjustments have been made to the per share exercise price and the number of shares of common stock that may be purchased upon exercise
of outstanding stock options and warrants for the Company’s common stock, and to the number of shares of common stock reserved
for future issuance pursuant to the Company’s 2022 Omnibus Incentive Plan.
All
share and per share information within this report have been adjusted to retroactively reflect the reverse stock-split as of the earliest
period presented.
Employees
and Human Capital Resources
At
the date of this Annual Report, we have 1 full-time employee and numerous consultants to carry on our operations. Many of our activities
are outsourced to consultants who provide services to us on a project basis. As business activities require and capital resources permit,
we will hire additional employees and consultants to fulfill our Company’s needs.
Available
Information
We
post our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports
filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, free of charge, on the Investors section of our public website
(www.gtbiopharma.com) as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC .
In addition, you can read our SEC filings over the Internet at the SEC’s website at www.sec.gov. The contents of these websites
are not incorporated into this annual report on Form 10-K. Further, our references to the URLs for these websites are intended to be
inactive textual references only.
ITEM
1A. RISK FACTORS
Investing
in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below in addition
to the other information contained in this Annual Report on Form 10-K before deciding whether to invest in shares of our common stock.
If any of the following risks actually occur, our business, financial condition or operating results could be harmed. In that case, the
trading price of our common stock could decline and you may lose part or all of your investment. In the opinion of management, the risks
discussed below represent the material risks known to the company. Additional risks and uncertainties not currently known to us or that
we currently deem immaterial may also impair our business, financial condition and operating results and adversely affect the market
price of our common stock.
Risks
Related to Our Business
Our
financial condition raises substantial doubt as to our ability to continue as a going concern.
As
of December 31, 2024, we had approximately $4.0 million in cash and cash equivalents and restricted cash, and a working capital deficit
of $1.7 million, and we have incurred and expect to continue to incur significant costs in pursuit of our drug candidates. For
the year ended December 31, 2024, we recorded a net loss of approximately $13.2 million and used cash in operations of approximately
$12.9 million. Our financial statements for the year ended December 31, 2024 have been prepared assuming that we will continue
to operate as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course
of business. To date, we have not generated substantial product revenues from our activities and have incurred substantial operating
losses. We expect that we will continue to generate substantial operating losses for the foreseeable future until we complete development
and approval of our product candidates. We will continue to fund our operations primarily through utilization of our current financial
resources and additional raises of capital.
These
conditions raise substantial doubt about our ability to continue as a going concern. The Company has evaluated the significance of the
uncertainty regarding the Company’s financial condition in relation to its ability to meet its obligations, which has raised substantial
doubt about the Company’s ability to continue as a going concern. While it is very difficult to estimate the Company’s future
liquidity requirements, the Company believes if it is unable to obtain additional financing, existing cash resources will not be sufficient
to enable it to fund the anticipated level of operations through one year from the date the accompanying financial statements are issued.
There can be no assurances that the Company will be able to secure additional financing on acceptable terms. In the event the Company
does not secure additional financing, the Company will be forced to delay, reduce, or eliminate some or all of its discretionary spending,
which could adversely affect the Company’s business prospects, ability to meet long-term liquidity needs and the ability to continue
operations.
Our
business is at an early stage of development and we may not develop therapeutic products that can be commercialized.
Our
business is at an early stage of development. We do not have immune-oncology products in late-stage clinical trials. We are still in
the early stages of identifying and conducting research on potential therapeutic products. Our potential therapeutic products will require
significant research and development and pre-clinical and clinical testing prior to regulatory approval in the United States and other
countries. We may not be able to obtain regulatory approvals, enter clinical trials for any of our product candidates, or commercialize
any products. Our product candidates may prove to have undesirable and unintended side effects or other characteristics adversely affecting
their safety, efficacy or cost effectiveness that could prevent or limit their use. Any product using any of our technology may fail
to provide the intended therapeutic benefits or achieve therapeutic benefits equal to or better than the standard of treatment at the
time of testing or production.
We
have a history of operating losses and we expect to continue to incur losses for the foreseeable future and we may never generate revenue
or achieve profitability.
During
the year ended December 31, 2024, the Company reported a net loss of $13.2 million and as of December 31, 2024 and had an accumulated
deficit of approximately $695 million. We have not generated any revenue to date and are not profitable, and have incurred losses in
each year since our inception. We do not expect to generate any product sales or royalty revenues for the foreseeable future. We expect
to incur significant additional operating losses for the foreseeable future as we expand research and development and clinical trial
efforts.
Our
ability to achieve long-term profitability is dependent upon obtaining regulatory approvals for our products and successfully commercializing
our products alone or with third parties. However, our operations may not be profitable even if any of our products under development
are successfully developed and produced and thereafter commercialized. Even if we achieve profitability in the future, we may not be
able to sustain profitability in subsequent periods.
Even
if we succeed in commercializing one or more of our product candidates, we expect to continue to incur substantial research and development
and other expenditures to develop and market additional product candidates. The size of our future net losses will depend, in part, on
the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and
will continue to have an adverse effect on our stockholders’ equity and working capital.
We
will need additional capital to conduct our operations and develop our products, and our ability to obtain the necessary funding is uncertain.
We
have used a significant amount of cash since inception to finance the continued development and testing of our product candidates, and
we expect to need substantial additional capital resources to develop our product candidates going forward and launch and commercialize
any product candidates for which we receive regulatory approval.
We
may not be successful in generating and/or maintaining operating cash flow, and the timing of our capital expenditures and other expenditures
may not result in cash sufficient to sustain our operations through the commercialization of our product candidates. If financing is
not sufficient and additional financing is not available or available only on terms that are detrimental to our long-term survival, it
could have a material adverse effect on our ability to continue to function. The timing and degree of any future capital requirements