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Our initial work has been conducted in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, the Deputy Director. Dr. Miller is a recognized leader in the field of NK cell and IL-15 biology and their therapeutic potential. We have exclusive rights to the TriKE and TetraKE platforms® platform and are generating additional intellectual property aroundfor specific moieties.
Immuno-Oncology Platform
Tri-specific Killer Engagers (TriKEs) and Tetra-specific Killer Engagers (TetraKEs)
The generation of chimeric antigen receptor, or CAR, expressing T cells from monoclonal antibodies has represented an important step forward in cancer therapy. These therapies involve the genetic engineering of T cells to express either CARs, or T cell receptors, or TCRs, and are designed such that the modified T cells can recognize and destroy cancer cells. While a great deal of interest has recently been placed upon chimeric antigen receptor T, or CAR-T, therapy, it has certain limitations for broad potential applicability because it can require an individual approach that is expensive, and time consuming, and may be difficult to apply on a large scale. We believe there is an unmet need for targeted immuno-oncology therapies that have the potential to be dosed in a patient-friendly outpatient setting, can be used on a stand-alone basis, augment the current monoclonal antibody therapeutics and/or be used in conjunction with more traditional cancer therapy. We believe our TriKE and TetraKE constructs have this potential and therefore we have generated, and intend to continue to generate, a pipeline of product candidates to be advanced into the clinic on our own or through potential collaborations with larger companies.
We believe there is a continued unmet medical need for targeted immuno-oncology therapies that can have the potential to be dosed in a patient-friendly outpatient setting, can be used on a stand-alone basis, augment the current monoclonal antibody therapeutics, or be used in conjunction with more traditional cancer therapy. We believe our TriKE® constructs have this potential and therefore we have generated, and intend to continue to generate, a pipeline of product candidates to be advanced into the clinic on our own or through potential collaborations with larger companies.
GTB-3550 TriKE® and Phase 1 Acute Myeloid Leukemia/Myelodysplastic Syndrome (AML/MDS) Phase 1 Clinical Trial
GTB-3550 is the Company’s first-generation TriKE® product candidate which is a single-chain, tri-specific recombinant fusion protein construct 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 GTB-3550 Phase 1 clinical trial for treatment of patients with CD33-expressing, high risk myelodysplastic syndromes and refractory/relapsed acute myeloid leukemia opened for patient enrollment September 2019 and completed enrollment in September 2021. The clinical trial was conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota under the direction of Dr. Erica Warlick and Dr. Mark Juckett.
Background and Select Non-Clinical Data
In conjunction with our research agreement with the Masonic Cancer Center at the University of Minnesota, the exploration of targeting NK cells to a variety of tumors initially focused on novel bi-specific killer engagers, or BiKEs, composed of the variable portions of antibodies targeting the CD16 activating receptor on NK cells and CD33 (AML and MDS; see figure below), B7H3 (solid tumors – breast, lung, colon, prostate), PD-L1 (solid tumors), Her2 (Breast, Gastric), or CD19/CD22 (B cell lymphomas), or EpCAM (epithelial tumors (breast, colon, and lung)) on the tumor cells.
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Subsequently, a tri-specific (TriKE)(TriKE®) construct that replaced the linker molecule between the CD16 scFv and the CD33 scFv with a modified IL-15 molecule, containing flanking sequences, was generated, and tested. Data indicateindicates that the CD16 x IL-15 x CD33 and CD16 x IL-15 x EpCAM TriKEs potently induce proliferation of healthy donor NK cells, possibly greater than that induced by exogenous IL-15, which is absent in the BiKE platform. Targeted delivery of the IL-15 through the TriKE® also resulted in specific expansion of the NK cells without inducing T cell expansion on post-transplant patient samples.
When compared to the CD16 x CD33 BiKE, the CD16 x IL-15 x CD33 TriKE® is also capable of potently restoring killing capacity of post- transplantpost-transplant NK cells against CD33-expressing HL-60 Targetstargets and primary AML blasts. These results demonstrated the ability to functionally incorporate an IL-5IL-15 cytokine into the BiKE platform and also demonstrated the possibility of targeting a variety of cytokines directly to NK cells while reducing off-target effects and the amount of cytokines needed to obtain biologically relevant function.
The figure below is a schematic of a BiKE construct (top) and a TriKE® construct (bottom), which has the modified IL-15 linker between the CD16 scFv and the CD33 scFv components.
The TriKE® constructs were also tested against three separate human tumor cell lines: HL-60 (promyelocitic leukemia), Raji (Burkitt’s lymphoma), and HT29 (colorectal adenocarcinoma), in addition to a model for ovarian cancer. All cell lines contained the Luc reporter to allow for in vivo imaging of the tumors. These systems were used to show in vivo efficacy of BiKEsBiKE (1633) and TriKEs TriKE® (GTB-3550) against relevant human tumor targets (HL-60-luc) over an extended period of time. The system consisted of initial conditioning of mice using radiation (250-275 cGy), followed by injection of the tumor cells (I.V. for HL-60-luc and Raji-luc, intra-splenic for HT29-luc and IP for ovarian for MA-148-luc), a three-day growth phase, injection of human NK cells, and repeated injection of the drugs of interest, BiKE and TriKE® (three to five times a week). Imaging was carried out at dayDay 7, 14, and 21, and extended as needed.
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The figure below shows the results (tumor burden and mortality) when dosing NK cells alone (top panel), the BiKE version (lacking IL-15) of GTB-3550 (middle panel; called 1633), and the TriKE®, GTB-3550 (bottom panel; then called 161533) in the above described human tumor model, HL-60-luc. In the NK-cell-only arm, two out of the five mice were dead by dayDay 21 with two of the surviving mice having extensive tumor burden as depicted by the colored images. In contrast, all five mice in each of the BiKE and TriKE® arms survived. In addition, the tumor burden in the TriKE-treatedTriKE®-treated mice was significantly less than in the BiKE-treated mice, demonstrating the improved efficacy from NK cells in the TriKE-treatedTriKE®-treated mice.
Based on these results, and others, the IND for GTB-3550 was filed in June 2017 by the University of Minnesota. The FDA requested that additional preclinical toxicology, be conducted prior to initiating clinical trials. The FDA also requested some additional information and clarifications on the manufacturing, (CMC) and clinical packages.development plans. The requested additional information and clarifications were completed and incorporated by us into the IND in eCTD format. We filed the IND amendment in June 2018 and announced on November 1, 2018, that we had received notification from the FDA thatgranted approval of the IND was open and the Company was authorized to initiate a first-in-human Phase 1 study with GTB-3550 in AML, MDS, and severe mastocytosis. We expect to be in a position to begin theThe Phase 1 clinical trial was initiated in the first half of 2019.
Targeting Solid Tumors and Other Potentially Attractive Characteristics
Unlike full-length antibodies, TriKEs and TetraKEs are smallTriKE® is composed of a single-chain fusion proteinsprotein that bindbinds the CD16 receptor of NK cells directly producing a potentially more potent and lasting response as demonstrated by preclinical studies. An additional benefit that they may havedue to the smaller size of TriKE® is an attractiveenhanced biodistribution because of their smaller size, which we expect to be important in the treatment of solid tumors. In addition to these potential advantages, TriKEs and TetraKEs areTriKE® is designed to be non-immunogenic, have appropriate clearance properties and can be engineered quickly to target a variety of tumor antigens. We believe these attributes make them an ideal pharmaceutical platform for potentiated NK cell-based immunotherapies and have the potential to overcome some of the limitations of CAR-T therapy and other antibody therapies.
Examples of our earlier stage solid tumor targeting product candidates are focused on EpCAM,CD33, B7-H3, Her2, Mesothelin (mesothelioma and lung adenocarcinoma),PD-L1, CD19, CLEC12A, CD22, and CD133 alone and in combination. We believe certain of these constructs have the potential to target prostate, breast, colon, ovarian, liver, and head and neck cancers. Depending on the availability of drug supply, we hope to initiate human clinical testing for certain of our solid tumor product candidates in 2020.
Efficient Advancement of Potential Future Product Candidates --Production– Production and Scale Up
We are using our TriKE and TetraKE platforms® platform with the intent to bring to market multiple immuno-oncology products that can treat a range of hematologic malignancies sarcomas and solid tumors. The platforms are scalable, and we are currently working with several third partiesa third-party product manufacturer investigating the optimal GMP production expression system of the TriKEs and TetraKE constructs which we expect to be part of a process in which we are able to produce IND-ready moieties in approximately 90-120 days after the construct conceptual design.
We believe our TriKEs and TetraKEsTriKE®s will have the ability, if approved for marketing, to be used on a stand-alone basis, augment the current monoclonal antibody therapeutics, or be usedas both monotherapy and in conjunctioncombination with more traditional cancer therapy and potentially overcome certain limitations of current chimeric antigen receptor, or CAR-T, therapy.standard-of-care therapies.
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Immuno-Oncology Product Candidates
GTB-3550
GTB-3550 and GTB-C3550, are single-chain, tri-specific scFv recombinant fusion proteins composed of the variable regions of the heavy and light chains (or heavy chain only) of anti-CD16 antibodies, wild-type or a modified form of IL-15 and the variable regions of the heavy and light chains of an antibody designed to precisely target a specific
GTB-3550 IND will focus on AML, the most commonis being replaced by a more potent next-generation camelid nanobody TriKE®, GTB-3650, targeting CD33 positive relapsed/refractory Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).
About High-Risk Myelodysplastic Syndromes
Myelodysplastic Syndromes is a rare form of adult leukemiabone marrow-related cancer caused by irregular blood cell production within the bone marrow. As a result of this irregular production, MDS patients do not have sufficient normal red blood cells, white blood cells and/or platelets in circulation. High-risk MDS is associated with 21,000 newpoor prognosis, diminished quality of life, and a higher chance of transformation to acute myeloid leukemia. The goals of therapy are to reduce disease associated symptoms and the risk of disease progression and death, thereby improving both quality and quantity of life. United States incidence of MDS is estimated to be 10,000 cases expected in 2018 alone (American Cancer Society). These patients typically receive frontline therapy, usually chemotherapy, including cytarabine and an anthracycline, a therapy thatper year, although the condition is thought to be under diagnosed. The prevalence has not changed in over 40 years. About half will have relapses and require alternative therapies. In addition, MDS incidence rates have dramatically increasedbeen estimated to be from 60,000 to 170,000 in the population of the United States from 3.3 per 100,000 individuals from 2001-2004 to 70 per 100,000 annually, MDS is especially prevalent in elderly patients that have a median age of 76 years at diagnosis. The survivalStates. Approximately 40% of patients with High-Risk MDS transform to AML, another aggressive cancer with poor outcomes.
About Acute Myeloid Leukemia
Acute myeloid leukemia is poor duea type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. The median age at the time of diagnosis is 65–69 years. AML is an aggressive disease and is fatal without anti-leukemic treatment. Among patients treated with chemotherapy, 65% to decreased eligibility, as80% achieve complete remission. Despite a resultplethora of advancednovel agents that have been approved by the U.S. Food and Drug Administration since 2017 for treatment of AML, once complete remission (CR) is achieved, approximately 50% of patients age < 60 years of age and up to 90% of patients ≥ 60 years of age will relapse, despite consolidation strategies. Furthermore, while 10–40% of younger AML patients are primarily refractory to AML induction therapy, the number is considerably higher for allogeneicpatients above 60 years (40–60%). The vast majority of fit AML patients will undergo hematopoietic stem cell transplantation (Allo- HSCT)(HSCT) after achieving a CR. However, 40% of these patients relapse after HSCT. Thus, refractory or relapsed (r/r) AML is a very common scenario in AML and despite recent advances and new targeted therapies, the management of AML remains a challenge, particularly in older adults ineligible for intensive therapies. According to the National Cancer Institute (NCI), the only curative MDS treatment (Cogle CR. Incidencefive-year survival rate is about 35% in people under 60 years old, and Burden10% in people over 60 years old. Older people whose health is too poor for intensive chemotherapy have a typical survival of five to ten months. AML accounts for approximately 1.8% of cancer deaths in the Myelodysplastic Syndromes. Curr Hematol Malig Rep. 2015; 10(3):272-281). United States.
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About GTB-3550 TriKE® Clinical Trial
We believeopened our GTB-3550 could serve as a relatively safe, cost-effective, and easy-to-use therapy for resistant/relapsing AML and could also be combined with chemotherapy as frontline therapy thus targeting the larger market.
The Next Generation of solid tumors. It is a single-chain fusion protein composed of CD16-IL15-EpCAM-CD133. EpCAM is found on many solid tumor cells of epithelial origin and CD133 is a marker for cancer stem cells. This TetraKE is designed to target not only the heterogeneous population of cancer cells found in solid tumors but also the cancer stem cells that are typically responsible for recurrences. Depending on the availability of drug supply, we hope to initiate human clinical testing for certain of our solid tumor product candidates in 2020.
Our goal is to be a leader in immuno-oncology therapies targeting a broad range of indications including hematological malignancies sarcoma and solid tumors and to generate value from our CNS product candidates. Key elementstumors. A key element of our strategy includes introducing a next-generation camelid nanobody platform. Camelid antibodies (often referred as nanobodies) are to:
Generation of humanized single-domain antibody targeting CD16 for incorporation into the TriKE® platform
To develop second generation TriKE®s, we designed a broad rangenew humanized CD16 engager derived from a single-domain antibody. While scFvs consist of hematologic malignancies, sarcomasa heavy and solid tumors.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 NK cell degranulation (% CD107a+) and IFNg of 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). These data were published by Felices M et al (2020) in Cancer Immunol Res.
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CD33+ HL60 Targets
GTB-3650
GTB-3650 is a CD33 targeted TriKE® which targets CD33 on the surface of myeloid leukemias. We are preparing to study GTB-3550,advancing GTB-3650 through preclinical studies and anticipate filing an anti-CD16-IL-15-anti-CD33 TriKE in CD33 positive leukemias, a marker expressed on tumor cells in AML, MDS and other myeloid malignancies. We expect to beginInvestigational New Drug (IND) for a Phase 1 clinical trial in the firstsecond half of 2019 in2022. This study will target patients with relapsed/refractory AML. TheAML and high grade MDS.
GTB-5550
GTB-5550 is a B7-H3 targeted TriKE® which targets B7-H3 on the surface of advanced solid tumors. We are advancing GTB-5550 through preclinical studies and have initiated a GMP manufacturing campaign in anticipation of filing an IND and initiating a Phase 1 trial will be a dose finding study. We expect this will be closely followed by Phase 2 trials to determine the most efficacious dosing and cycles with the aim to maximize efficacy while minimizing on-target, off-disease adverse events.
Oncology Markets
Acute Myeloid Leukemia
AML is a heterogeneous hematologic stem cell malignancy in adults with 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 with an estimated 21,450 new cases in 2019 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 (MDS) 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 2019, it is estimated there will be approximately 1,762,450 new cases of cancer resulting in 606,880 deaths. Greater than 80% of these cancers will be classified as solid tumors. The most prevalent new cases of solid tumors being breast, lung, prostate, colorectal and bladder. (American Cancer Society, Cancer Facts & Figures 2019)
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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 a small number of third-party manufacturerscontract manufacturing operation 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 all of our future commercial needs. We do not have long-term agreementscommitments with any of these third parties.a third-party product manufacturer. We require in our manufacturing and processing agreements that all third-party contractproduct manufacturers and processors produce intermediates, active pharmaceutical ingredients, or API, and finished products in accordance with the FDA’s current Good Manufacturing Practices or cGMP,(cGMP), and all other applicable laws and regulations. We maintain confidentiality agreements with potential and existing manufacturers in order to protect our proprietary rights related to our drug candidates.
Patents and Trademarks
Immuno-oncology platform
TriKE® Patents
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 License Agreements
2016 Exclusive Patent License Agreement
We (through our wholly owned subsidiary Oxis Biotech, Inc.) are party to an exclusive worldwide license agreement with the Regents of the University of Minnesota, (“UofMN”) to further develop and commercialize cancer therapies using TriKE® technology developed by researchers at the universityUniversity to target NK cells to cancer. Under the terms of the 2016 agreement, we receivereceived 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. We shall beare 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 in the United States and the European Agency for the Evaluation of Medicinal Products in the European Union. Under the agreement, the University of Minnesota will receivereceived an upfront payment of $200,000, annual license maintenance fees of $100,000 beginning in 2021, 4% royalty fees (not to exceed 6% under subsequent license agreements or amendments to this agreement), upon sale of a licensed product or a minimum annual royalty payment ranging from $250,000 to $5.0 million. The agreement also includes certain milestone payments totaling $3.1 million, and one-time sales milestone payments of $1.0 million upon reaching $250 million in gross sales and $5.0 million upon reaching $500 million in cumulative gross sales of licensed products.
2021 Exclusive License Agreement
On March 26, 2021, we entered into an agreement with the UofMN specific to the B7H3 targeted TriKE®. Under the agreement, the UofMN received an upfront license fee of $20,000, and will receive annual license maintenance fees of $5,000 beginning in 2022, 2.5% to 5% royalty fees ranging from 4% to 6%,or minimum annual royalty payments of $250,000 beginning in 2022, $2,000,000the first year after the first commercial sale of licensed product, and $2.0 million beginning in 2025, and $5,000,000 in 2027 andthe fifth year after the first commercial sale of licensed product. The agreement also includes certain milestone payments totaling $3,100,000.
Employees
At the terms of the agreement, we receive exclusive rights to conduct research and to develop, make, use, sell, and import DT2219ARL worldwide for the treatment of any disease, state or condition in humans. We shall be 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 DT2219ARL, including without limitation the FDA in the United States and the European Agency for the Evaluation of Medicinal Products in the European Union. Under the agreement, Dr. Vallera will receive an upfront license fee, royalty fees ranging from 3% for net sales and 25% of net sublicensing revenues, and certain milestone payments totaling $1,500,000.
Form and Year of Organization
In 1965, the corporate predecessor of GT Biopharma, Diagnostic Data, Inc., was incorporated in the State of California. Diagnostic Data changed its incorporation to the State of Delaware in 1972;1972, and changed its name to DDI Pharmaceuticals, Inc. in 1985. In 1994, DDI Pharmaceuticals merged with International BioClinical, Inc. and Bioxytech S.A. and changed its name to OXIS International, Inc. On July 17, 2017, we amended our Certificate of Incorporation for the purpose of changing our name from Oxis International, Inc. to GT Biopharma, Inc.
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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 prospectusAnnual 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 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, 2021, the Company reported a net loss of $58.0 million and as of December 31, 2018,2021, we had an accumulated deficit of $528,685,000.$653.6 million. We have not generated any significant 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 at least four years.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 in order to develop our product candidates going forward and launch and commercialize any product candidates for which we receive regulatory approval.
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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 next 12 months.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 will depend on many factors, including:
| ● | the accuracy of the assumptions underlying our estimates for capital needs in 2022 and beyond; | |
| ● | scientific and clinical progress in our research and development programs; | |
| ● | the magnitude and scope of our research and development programs and our ability to establish, enforce and maintain strategic arrangements for research, development, clinical testing, manufacturing and marketing; | |
| ● | our progress with pre-clinical development and clinical trials; | |
| ● | the time and costs involved in obtaining regulatory approvals; | |
| ● | the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims; and | |
| ● | the number and type of product candidates that we pursue. |
Additional financing through strategic collaborations, public or private equity or debt financings or other financing sources may not be available on acceptable terms, or at all. Additional equity financing could result in significant dilution to our stockholders, and any debt financings will likely involve covenants restricting our business activities. Additional financing may not be available on acceptable terms, or at all. Further, if we obtain additional funds through arrangements with collaborative partners, these arrangements may require us to relinquish rights to some of our technologies, product candidates or products that we would otherwise seek to develop and commercialize on our own.
If sufficient capital is not available, we may be required to delay, reduce the scope of or eliminate one or more of our research or product development initiatives, any of which could have a material adverse effect on our financial condition or business prospects.
Our research and Development Investment
Our currently projected expenditures for 20192022 include approximately $12 million to $15$14 million for research and development. The actual cost of our programs could differ significantly from our current projections if we change our planned development process. In the event that actual costs of our clinical program, or any of our other ongoing research activities, are significantly higher than our current estimates, we may be required to significantly modify our planned level of operations.
The successful development of any product candidate is highly uncertain. It is difficult to reasonably estimate or know the nature, timing and costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from any product candidate, due to the numerous risks and uncertainties associated with developing drugs. Any failure to complete any stage of the development of products in a timely manner could have a material adverse effect on our operations, financial position and liquidity.
We have identified material weaknesses in our internal controls over financial reporting and have not yet remediedare working to remedy these weaknesses. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations. Ineffective internal control could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock.
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We have identified material weaknesses in our internal control over financial reporting as a company.company, which have resulted in unauthorized transactions involving our assets and common stock. As defined in Regulation 12b-2 under the Securities Exchange Act of 1934, or the Exchange Act, a “material weakness” is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented, or detected on a timely basis. Specifically, we determined that we had the following material weaknesses in our internal control over financial reporting: (i) inadequate segregation of duties; (ii) risks of executive override; and (iii) insufficient written policies and procedures for accounting and financial reporting with respect to the requirements and application of both generally accepted accounting principles in the United States of America, or GAAP, and the U.S. Securities and Exchange Commission, or the SEC, guidelines.
As of the date of this report,Annual Report, we have not remediated some of these material weaknesses. The company intends to takehas taken measures to mitigate the issues identified and implement a functional system of internal controls over financial reporting. Specifically, the Company has engaged a forensic accountant to review the Company’s bank records, transactions with affiliates and/or related parties, expense reimbursement practices and vendor payment practices. That review is ongoing. In addition, the Company’s Board of Directors previously designated a Special Committee in August 2021 charged with, among other duties, evaluating the current compliance, compensation, operations and personnel of the Company, and determining actions appropriate to address any deficiencies or inefficiencies identified through such evaluation. Such measures will include, but are not be limited to the hiring of additional employees in its finance and accounting department, although the timing of such hires is largely dependent on our securing additional financing to cover such costs;department; preparation of risk-control matrices to identify key risks and develop and document policies to mitigate those risks; and identification and documentation of standard operating procedures for key financial activities. The implementation of these initiatives may not fully address any material weakness or other deficiencies that we may have in our internal control over financial reporting.
Even if we develop effective internal control over financial reporting, such controls may become inadequate due to changes in conditions, or the degree of compliance with such policies or procedures may deteriorate, which could result in the discovery of additional material weaknesses and deficiencies. In any event, the process of determining whether our existing internal control over financial reporting is compliant with Section 404 of the Sarbanes-Oxley Act, or Section 404, and sufficiently effective requires the investment of substantial time and resources, including by certain members of our senior management. As a result, this process may divert internal resources and take a significant amount of time and effort to complete. In addition, we cannot predict the outcome of this process and whether we will need to implement remedial actions in order to establish effective controls over financial reporting. The determination of whether or not our internal controls are sufficient and any remedial actions required could result in us incurring additional costs that we did not anticipate, including the hiring of outside consultants. We may also fail to timely complete our evaluation, testing and any remediation required to comply with Section 404.
We are required, pursuant to Section 404, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. However, for as long as we are a “smaller reporting company,” our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404. While we could be a smaller reporting company for an indefinite amount of time, and thus relieved of the above-mentioned attestation requirement, an independent assessment of the effectiveness of our internal control over financial reporting could detect problems that our management'smanagement’s assessment might not. Such undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation.
Our intellectual property may be compromised.
Part of our value going forward depends on the intellectual property rights that we have been and are acquiring. There may have been many persons involved in the development of our intellectual property, and we may not be successful in obtaining the necessary rights from all of them. It is possible that in the future, third parties may challenge our intellectual property rights. We may not be successful in protecting our intellectual property rights. In either event, we may lose the value of our intellectual property, and if so, our business prospects may suffer.
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.
We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies. Any disclosure to or misappropriation by third parties of our trade secret or other confidential information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding any competitive advantage we may derive from this information.
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The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications we own or license may fail to result in issued patents in the United States or in foreign countries. Third parties may challenge the validity, enforceability or scope of any issued patents we own or license or any applications that may issuebe issued as patents in the future, which may result in those patents being narrowed, invalidated or held unenforceable. Even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from developing similar products that do not fall within the scope of our patents. If the breadth or strength of protection provided by the patents we hold or pursue is threatened, our ability to commercialize any product candidates with technology protected by those patents could be threatened. Further, if we encounter delays in our clinical trials, the period of time during which we would have patent protection for any covered product candidates that obtain regulatory approval would be reduced. Since patent applications in the United States and most other countries are confidential for a period of time after filing, we cannot be certain at the time of filing that we are the first to file any patent application related to our product candidates.
In addition to the protection afforded by patents, we seek to rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our discovery platform and drug development processes that involve proprietary know-how, information or technology that is not covered by patents or not amenable to patent protection. Although we require all of our employees and certain consultants and advisors to assign inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, our trade secrets and other proprietary information may be disclosed or competitors may otherwise gain access to such information or independently develop substantially equivalent information. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant difficulty in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent material disclosure of the trade secret intellectual property related to our technologies to third parties, we may not be able to establish or maintain the competitive advantage that we believe is provided by such intellectual property, which could materially adversely affect our market position and business and operational results.
Claims that we infringe the intellectual property rights of others may prevent or delay our drug discovery and development efforts.
Our research, development and commercialization activities, as well as any product candidates or products resulting from those activities, may infringe or be accused of infringing a patent or other form of intellectual property under which we do not hold a license or other rights. Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents of which we are currently unaware, with claims that cover the use or manufacture of our product candidates or the practice of our related methods. Because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes one or more claims of these patents. If our activities or product candidates infringe the patents or other intellectual property rights of third parties, the holders of such intellectual property rights may be able to block our ability to commercialize such product candidates or practice our methods unless we obtain a license under the intellectual property rights or until any applicable patents expire or are determined to be invalid or unenforceable.
Defense of any intellectual property infringement claims against us, regardless of their merit, would involve substantial litigation expense and would be a significant diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, obtain one or more licenses from third parties, limit our business to avoid the infringing activities, pay royalties and/or redesign our infringing product candidates or methods, any or all of which may be impossible or require substantial time and monetary expenditure. Further, if we were to seek a license from the third party holder of any applicable intellectual property rights, we may not be able to obtain the applicable license rights when needed or on commercially reasonable terms, or at all. The occurrence of any of the above events could prevent us from continuing to develop and commercialize one or more of our product candidates and our business could materially suffer.
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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.
A third party may hold intellectual property, including patent rights, that are important or necessary to the development of our product candidates, in which case we would need to obtain a license from that third party or develop a different formulation of the product that does not infringe upon the applicable intellectual property, which may not be possible. Additionally, we may identify product candidates that we believe are promising and whose development and other intellectual property rights are held by third parties. In such a case, we may desire to seek a license to pursue the development of those product candidates. Any license that we may desire to obtain or that we may be forced to pursue may not be available when needed on commercially reasonable terms or at all. Any inability to secure a license that we need or desire could have a material adverse effect on our business, financial condition and prospects.
The patent protection covering some of our product candidates may be dependent on third parties, who may not effectively maintain that protection.
While we expect that we will generally seek to gain the right to fully prosecute any patents covering product candidates we may in-license from third-party owners, there may be instances when platform technology patents that cover our product candidates remain controlled by our licensors. If any of our current or future licensing partners that retain the right to prosecute patents covering the product candidates we license from them fail to appropriately maintain that patent protection, we may not be able to prevent competitors from developing and selling competing products or practicing competing methods and our ability to generate revenue from any commercialization of the affected product candidates may suffer.
We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time- consumingtime-consuming and unsuccessful.
Competitors may infringe our patents or the patents of our current or potential licensors. To attempt to stop infringement or unauthorized use, we may need to enforce one or more of our patents, which can be expensive and time-consuming and distract management. If we pursue any litigation, a court may decide that a patent of ours or our licensor’s is not valid or is unenforceable, or may refuse to stop the other party from using the relevant technology on the grounds that our patents do not cover the technology in question. Further, the legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, which could reduce the likelihood of success of any infringement proceeding we pursue in any such jurisdiction. An adverse result in any infringement litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing, which could limit our ability to exclude competitors from directly competing with us in the applicable jurisdictions.
Interference proceedings provoked by third parties or brought by the U.S. PTO may be necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to use it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms, or at all. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.
If we are unsuccessful in obtaining or maintaining patent protection for intellectual property in development, our business and competitive position would be harmed.
We are seeking patent protection for some of our technology and product candidates. Patent prosecution is a challenging process and is not assured of success. If we are unable to secure patent protection for our technology and product candidates, our business may be adversely impacted.
In addition, issued patents and pending international applications require regular maintenance. Failure to maintain our portfolio may result in loss of rights that may adversely impact our intellectual property rights, for example by rendering issued patents unenforceable or by prematurely terminating pending international applications.
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If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patents for some of our technology and product candidates, we also rely on trade secrets, including unpatented know- how,know-how, technology and other proprietary information, to maintain our competitive position. We currently, and expect in the future to continue to, seek to protect these trade secrets, in part, by entering into confidentiality agreements with parties who have access to them, such as our employees, collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for any such disclosure. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time- consuming,time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they disclose the trade secrets, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our 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 business depends in part on licenses from third parties. These third-party license agreements impose obligations on us, such as payment obligations and obligations to diligently pursue development of commercial products under the licensed patents. If a licensor believes that we have failed to meet our obligations under a license agreement, the licensor could seek to limit or terminate our license rights, which could lead to costly and time-consuming litigation and, potentially, a loss of the licensed rights. During the period of any such litigation, our ability to carry out the development and commercialization of potential products could be significantly and negatively affected. If our license rights were restricted or ultimately lost, our ability to continue our business based on the affected technology platform could be severely adversely affected.
We will have to hire additional executive officers and employees to operatecarry on our business.business operations. If we are unable to hire qualified personnel, we may not be able to implement our business strategy.
We currently have only threeeight fulltime employees. The loss of the services of any of our employees could delay our product development programs and our research and development efforts. We do not maintain key person life insurance on any of our officers, employees or consultants. In order to develop our business in accordance with our business strategy, we will have to hire additional qualified personnel, including in the areas of manufacturing, clinical trials management, regulatory affairs, finance, discovery biology, and business development. We will need to raise sufficient funds to hire and retain the necessary employees and have commenced our search for additional key employees.
Moreover, there is intense competition for a limited number of qualified personnel among biopharmaceutical, biotechnology, pharmaceutical and other businesses. Many of the other pharmaceutical companies against which we compete for qualified personnel have greater financial and other resources, different risk profiles, longer histories in the industry and greater ability to provide valuable cash or stock incentives to potential recruits than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than what we are able to offer as an early- stageearly-stage company. If we are unable to continue to attract and retain high quality personnel, the rate and success at which we can develop and commercialize product candidates will be limited.
We depend on key personnel for our continued operations and future success, and a loss of certain key personnel could significantly hinder our ability to move forward with our business plan.
Because of the specialized nature of our business, we are highly dependent on our ability to identify, hire, train and retain highly qualified scientific and technical personnel for the research and development activities we conduct or sponsor. The loss of one or more key executive officers, scientific or scientific officers,operational team members would be significantly detrimental to us. In addition, recruiting and retaining qualified scientific personnel to perform research and development work is critical to our success. Our anticipated growth and expansion into areas and activities requiring additional expertise, such as discovery biology, clinical testing, regulatory compliance, manufacturing and marketing,compliance, will require the addition of new management personnel and the development of additional expertise by existing management personnel. There is intense competition for qualified personnel in the areas of our present and planned activities. Accordingly, we may not be able to continue to attract and retain the qualified personnel, which would adversely affect the development of our business.
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We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees do not use the proprietary information or know-how of others in their work for us, with contractual provisions and other procedures, we may be subject to claims that these employees or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employers. Litigation may be necessary to defend against any such claims.
In addition, while it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact contributes to the development of intellectual property that we regard as our own. Further, the terms of such assignment agreements may be breached and we may not be able to successfully enforce their terms, which may force us to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of intellectual property rights we may regard and treat as our own.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause our business to suffer.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with regulations of governmental authorities, such as the FDAU.S. Food and Drug Administration (FDA) or the European Medicines Agency, or EMA, to provide accurate information to the FDA or EMA, to comply with manufacturing standards we have established, to comply with federal, state and international healthcare fraud and abuse laws and regulations as they may become applicable to our operations, to report financial information or data accurately or to disclose unauthorized activities to us. Employee misconduct could also involve the improper use of information obtained in the course ofduring clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the precautions we currently take and the procedures we may establish in the future as our operations and employee base expand to detect and prevent this type of activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure by our employees to comply with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions.
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.
We rely extensively upon and have relationships with scientific consultants at academic and other institutions, some of whom conduct research at our request, and other consultants with expertise in clinical development strategy or other matters. These consultants are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. We have limited control over the activities of these consultants and, except as otherwise required by our collaboration and consulting agreements to the extent they exist, can expect only limited amounts of their time to be dedicated to our activities. These research facilities may have commitments to other commercial and non-commercial entities. We have limited control over the operations of these laboratories and can expect only limited amounts of time to be dedicated to our research goals.
It may take longer to complete our clinical trials than we project, or we may not be able to complete them at all.
For budgeting and planning purposes, we have projected the date for the commencement, continuation and completion of our various clinical trials. However, a number of factors, including scheduling conflicts with participating clinicians and clinical institutions, and difficulties in identifying and enrolling patients who meet trial eligibility criteria, may cause significant delays. We may not commence or complete clinical trials involving any of our products as projected or may not conduct them successfully.
We expect to rely on medical institutions, academic institutions or clinical research organizations to conduct, supervise or monitor some or all aspects of clinical trials involving our products. We will have less control over the timing and other aspects of these clinical trials than if we conducted them entirely on our own. If we fail to commence or complete, or experience delays in, any of our planned clinical trials, our stock price and our ability to conduct our business as currently planned could be harmed.
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Clinical drug development is costly, time-consuming and uncertain, and we may suffer setbacks in our clinical development program that could harm our business.
Clinical drug development for our product candidates is costly, time-consuming and uncertain. Our product candidates are in various stages of development and while we expect that clinical trials for these product candidates will continue for several years, such trials may take significantly longer than expected to complete. In addition, we, the FDA, an institutional review board, or IRB, or other regulatory authorities, including state and local agencies and counterpart agencies in foreign countries, may suspend, delay, require modifications to or terminate our clinical trials at any time, for various reasons, including:
| ● | discovery of safety or tolerability concerns, such as serious or unexpected toxicities or side effects or exposure to otherwise unacceptable health risks, with respect to study participants; | |
| ● | lack of effectiveness of any product candidate during clinical trials or the failure of our product candidates to meet specified endpoints; | |
| ● | delays in subject recruitment and enrollment in clinical trials or inability to enroll a sufficient number of patients in clinical trials to ensure adequate statistical ability to detect statistically significant treatment effects; | |
| ● | difficulty in retaining subjects and volunteers in clinical trials; | |
| ● | difficulty in obtaining the Institutional Review Board’s (“IRB”) approval for studies to be conducted at each clinical trial site; | |
| ● | inadequacy of or changes in our manufacturing process or the product formulation or method of delivery; | |
| ● | delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective contract research organizations, (“CROs”), clinical trial sites and other third-party contractors; | |
| ● | inability to add a sufficient number of clinical trial sites; | |
| ● | uncertainty regarding proper formulation and dosing; | |
| ● | failure by us, our employees, our CROs or their employees or other third-party contractors to comply with contractual and applicable regulatory requirements or to perform their services in a timely or acceptable manner; | |
| ● | scheduling conflicts with participating clinicians and clinical institutions; | |
| ● | failure to design appropriate clinical trial protocols; | |
| ● | inability or unwillingness of medical investigators to follow our clinical protocols; | |
| ● | difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data; or | |
| ● | changes in applicable laws, regulations and regulatory policies. |
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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.
We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by U.S. Food and Drug Administration, or the FDA, or similar regulatory authorities outside the United States. In particular, because we are focused on patients with molecularly defined cancers, our pool of suitable patients may be smaller and more selective and our ability to enroll a sufficient number of suitable patients may be limited or take longer than anticipated. In addition, some of our competitors have ongoing clinical trials for product candidates that treat the same indications as our product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.
Patient enrollment for any of our clinical trials may also be affected by other factors, including without limitation:
| ● | the severity of the disease under investigation; | |
| ● | the frequency of the molecular alteration we are seeking to target in the applicable trial; | |
| ● | the eligibility criteria for the study in question; | |
| ● | the perceived risks and benefits of the product candidate under study; | |
| ● | the extent of the efforts to facilitate timely enrollment in clinical trials; | |
| ● | the patient referral practices of physicians; | |
| ● | the ability to monitor patients adequately during and after treatment; and | |
| ● | the proximity and availability of clinical trial sites for prospective patients. |
Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, and we may not have or be able to obtain sufficient cash to fund such increased costs when needed, which could result in the further delay or termination of the trial.
Consistent with our general product development strategy, we intend to design future trials for our product candidates to include some patients with the applicable clinical characteristics, stage of therapy, molecular alterations, biomarkers, and/or cell surface antigens that determine therapeutic options, or are indicators of the disease, with a view to assessing possible early evidence of potential therapeutic effect. If we are unable to locate and include such patients in those trials, then our ability to make those early assessments and to seek participation in FDA expedited review and approval programs, including breakthrough therapy and fast track designation, or otherwise to seek to accelerate clinical development and regulatory timelines, could be compromised.
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We have limited clinical testing and regulatory capabilities, and human clinical trials are subject to extensive regulatory requirements, very expensive, time-consuming and difficult to design and implement. Our products may fail to achieve necessary safety and efficacy endpoints during clinical trials, which may limit our ability to generate revenues from therapeutic products.
We cannot assure you that we will be able to invest or develop resources for clinical trials successfully or as expediently as necessary. In particular, human clinical trials can be very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is time consuming. We estimate that clinical trials of our product candidates will take at least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. The commencement and completion of clinical trials may be affected by several factors, including:
| ● | unforeseen safety issues; | |
| ● | determination of dosing issues; | |
| ● | inability to demonstrate effectiveness during clinical trials; | |
| ● | slower than expected rates of patient recruitment; | |
| ● | inability to monitor patients adequately during or after treatment; and | |
| ● | inability or unwillingness of medical investigators to follow our clinical protocols. |
In addition, we or the FDA, may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our investigational new drug application, or IND, submissions or the conduct of these trials.
We are subject to extensive regulation, which can be costly and time consuming and can subject us to unanticipated delays. even if we obtain regulatory approval for some of our products, those products may still face regulatory difficulties.
All of our potential products, processing and manufacturing activities, are subject to comprehensive regulation by the FDA in the United States and by comparable authorities in other countries. The process of obtaining FDA and other required regulatory approvals, including foreign approvals, is expensive and often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved. In addition, regulatory agencies may lack experience with our technologies and products, which may lengthen the regulatory review process, increase our development costs and delay or prevent their commercialization.
If we violate regulatory requirements at any stage, whether before or after we obtain marketing approval, the FDA may take enforcement action(s) against us, which could include issuing a warning or untitled letter, placing a clinical hold on an ongoing clinical trial, product seizure, enjoining our operations, refusal to consider our applications for pre-market approval, refusal of an investigational new drug application, fines, or even civil or criminal liability, any of which could materially harm our reputation and financial results. Additionally, we may not be able to obtain the labeling claims necessary or desirable for the promotion of our products. We may also be required to undertake postmarketingpost marketing trials to provide additional evidence of safety and effectiveness. In addition, if we or others identify side effects after any of our adoptive therapies are on the market, or if manufacturing problems occur, regulators may withdraw their approval and reformulations, additional clinical trials, changes in labeling of our products, and additional marketing applications may be required.
Any of the following factors, among others, could cause regulatory approval for our product candidates to be delayed, limited or denied:
| ● | the product candidates require significant clinical testing to demonstrate safety and effectiveness before applications for marketing approval can be filed with the FDA and other regulatory authorities; | |
| ● | data obtained from pre-clinical and nonclinical animal testing and clinical trials can be interpreted in different ways, and regulatory authorities may not agree with our respective interpretations or may require us to conduct additional testing; | |
| ● | negative or inconclusive results or the occurrence of serious or unexpected adverse events during a clinical trial could cause us to delay or terminate development efforts for a product candidate; and/or | |
| ● | FDA and other regulatory authorities may require expansion of the size and scope of the clinical trials. |
Any difficulties or failures that we encounter in securing regulatory approval for our product candidates would likely have a substantial adverse impact on our ability to generate product sales, and could make anya search for a collaborative partner more difficult.
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Obtaining regulatory approval even after clinical trials that are believed to be successful is an uncertain process.
Even if we complete our planned clinical trials and believe the results were successful, obtaining regulatory approval is a lengthy, expensive and uncertain process, and the FDA or other regulatory agencies may delay, limit or deny approval of any of our applications for pre-market approval for many reasons, including:
| ● | we may not be able to demonstrate to the FDA’s satisfaction that our product candidates are safe and effective for any indication; | |
| ● | the results of clinical trials may not meet the level of statistical significance or clinical significance required by the FDA for approval; | |
| ● | the FDA may disagree with the number, design, size, conduct or implementation of our clinical trials; | |
| ● | the FDA may not find the data from pre-clinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of our product candidates outweigh their safety risks; | |
| ● | the FDA may disagree with our interpretation of data from pre-clinical studies or clinical trials, or may not accept data generated at our clinical trial sites; | |
| ● | the data collected from pre-clinical studies and clinical trials of our product candidates may not be sufficient to support the submission of applications for regulatory approval; | |
| ● | the FDA may have difficulties scheduling an advisory committee meeting in a timely manner, or the advisory committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling, or distribution and use restrictions; | |
| ● | the FDA may require development of a risk evaluation and mitigation strategy as a condition of approval; | |
| ● | the FDA may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies; | |
| ● | the FDA may change their approval policies or adopt new regulations that adversely affect our applications for pre-market approval; and | |
| ● | the FDA may require simultaneous approval for both adults and for children and adolescents delaying needed approvals, or we may have successful clinical trial results for adults but not children and adolescents, or vice versa. |
Before we can submit an application for regulatory approval in the United States, we must conduct a pivotal, Phase 3registrational trial. We will also need to agree on a protocol with the FDA for a clinical trial before commencing the trial. Phase 3Registrational clinical trials frequently produce unsatisfactory results even though prior clinical trials were successful. Therefore, even if the results of our Phase 2early phase trials are successful, the results of the additional trials that we conduct may or may not be successful. Further, our product candidates may not be approved even if they achieve their primary endpoints in Phase 3registrational clinical trials. The FDA or other foreign regulatory authorities may disagree with our trial design and our interpretation of data from preclinical studies and clinical trials. Any of these regulatory authorities may change requirements for the approval of a product candidate even after reviewing and providing comments or advice on a protocol for a clinical trial. The FDA or other regulatory agencies may require that we conduct additional clinical, nonclinical, manufacturing validation or drug product quality studies and submit those data before considering or reconsidering the application. Depending on the extent of these or any other studies, approval of any applications that we submit may be delayed by several years, or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA or other regulatory agencies.
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In addition, the FDA or other regulatory agencies may also approve a product candidate for fewer or more limited indications than we request, may impose significant limitations related to use restrictions for certain age groups, warnings, precautions or contraindications or may grant approval contingent on the performance of costly post-marketing clinical trials or risk mitigation requirements.
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.
Even if we are successful in obtaining regulatory approval of our product candidates, we will continue to be subject to the requirements of and review by, the FDA and comparable regulatory authorities in the areas of manufacturing processes, post-approval clinical data, adverse event reporting, labeling, advertising and promotional activities, among other things. In addition, any marketing approval we receive may be limited in terms of the approved product indication or require costly post-marketing testing and surveillance. Discovery after approval of previously unknown problems with a product, manufacturer or manufacturing process, or a failure to comply with regulatory requirements, may result in enforcement actions such as:
| ● | warning letters or other actions requiring changes in product manufacturing processes or restrictions on product marketing or distribution; | |
| ● | product recalls or seizures or the temporary or permanent withdrawal of a product from the market; | |
| ● | suspending any ongoing clinical trials; | |
| ● | temporary or permanent injunctions against our production operations; | |
| ● | refusal of our applications for pre-market approval or an investigational new drug application; and | |
| ● | fines, restitution or disgorgement of profits or revenue, the imposition of civil penalties or criminal prosecution. |
The occurrence of any of these actions would likely cause a material adverse effect on our business, financial condition and results of operations.
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.
While payment is not yet available from third-party payors (government or commercial) for our product, our goal is to obtain such coverage as soon as possible after product approval and commercial launch in the U.S. If this occurs, the availability of such payment would mean that many healthcare laws would place limitations and requirements on the manner in which we conduct our business (including our sales and promotional activities and interactions with healthcare professionals and facilities) and could result in liability and exposure to us. In some instances, our interactions with healthcare professionals and facilities that occurred prior to commercialization could have implications at a later date. The laws that may affect our ability to operate include, among others: (i) the federal healthcare programs Anti- KickbackAnti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as Medicare or Medicaid; (ii) federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, and which may apply to entities like us under theories of “implied certification” where the government and qui tam relators may allege that device companies are liable where a product that was paid for by the government in whole or in part was promoted “off-label,” lacked necessary approval, or failed to comply with good manufacturing practices or other laws; (iii) transparency laws and related reporting and/or disclosures such as the Sunshine Act; and/or (iv) state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, many of which differ from their federal counterparts in significant ways, thus complicating compliance efforts.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, exclusion from participation in government healthcare programs, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. The risk of our being found in violation of these laws is increased by the fact that their provisions are open to a variety of evolving interpretations and enforcement discretion. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
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Both federal and state government agencies have heightened civil and criminal enforcement efforts. There are numerous ongoing investigations of healthcare pharmaceutical companies and others in the healthcare space, as well as their executives and managers. In addition, amendments to the Federal False Claims Act, have made it easier for private parties to bring qui tam (whistleblower) lawsuits against companies under which the whistleblower may be entitled to receive a percentage of any money paid to the government. In addition, the Affordable Care Act amended the federal civil False Claims Act to provide that a claim that includes items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Penalties include substantial fines for each false claim, plus three times the amount of damages that the federal government sustained because of the act of that person or entity and/or exclusion from the Medicare program. In addition, a majority of states have adopted similar state whistleblower and false-claims provision. There can be no assurance that our activities will not come under the scrutiny of regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen "relators"“relators” under federal or state false claims laws. Any future investigations of our business or executives, or enforcement action or prosecution, could cause us to incur substantial costs, and result in significant liabilities or penalties, as well as damage to our reputation.
Laws impacting the U.S. healthcare system are subject to a great deal of uncertainty, which may result in adverse consequences to our business.
There have been a number of legislative and regulatory proposals to change the healthcare system, reduce the costs of healthcare and change medical reimbursement policies. Doctors, clinics, hospitals and other users of our products may decline to purchase our products to the extent there is uncertainty regarding coverage from government or commercial payors. Further proposed legislation, regulation and policy changes affecting third-party reimbursement are likely. Among other things, Congress has in the past proposed changes to and the repeal of the Patient Protection and Affordable Care and Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Affordable Care Act”), and lawsuits have been brought challenging aspects of the law at various points. There have been repeated recent attempts by Congress to repeal or replace the Affordable Care Act. At this time, it remains unclear whether there will be any changes made to or any repeal or replacement of the Affordable Care Act, with respect to certain of its provisions or in its entirety. We are unable to predict what legislation or regulation, if any, relating to the health care industry or third-party coverage and reimbursement may be enacted in the future at the state or federal level, or what effect such legislation or regulation may have on us. Denial of coverage and reimbursement of our products, or the revocation or changes to coverage and reimbursement policies, could have a material adverse effect on our business, results of operations and financial condition.
We may not be successful in our efforts to build a pipeline of product candidates.
A key element of our strategy is to use and expand our product platform to build a pipeline of product candidates and progress those product candidates through clinical development for the treatment of a variety of different types of cancer. Even if we are successful in building a product pipeline, the potential product candidates that we identify may not be suitable for clinical development for a number of reasons, including causing harmful side effects or demonstrating other characteristics that indicate a low likelihood of receiving marketing approval or achieving market acceptance. If our methods of identifying potential product candidates fail to produce a pipeline of potentially viable product candidates, then our success as a business will be dependent on the success of fewer potential product candidates, which introduces risks to our business model and potential limitations to any success we may achieve.
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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.
Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:
| ● | regulatory authorities may withdraw approvals of such product; | |
| ● | regulatory authorities may require additional warnings on the product’s label; | |
| ● | we may be required to create a medication guide for distribution to patients that outlines the risks of such side effects; | |
| ● | we could be sued and held liable for harm caused to patients; and | |
| ● | our reputation may suffer. |
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects.
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.
Because we have limited financial and managerial resources, we must focus our efforts on particular research programs and product candidates for specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Further, our resource allocation decisions may result in our use of funds for research and development programs and product candidates for specific indications that may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. Any such failure to improperly assess potential product candidates could result in missed opportunities and/or our focus on product candidates with low market potential, which would harm our business and financial condition.
Our products may be expensive to manufacture, and they may not be profitable if we are unable to control the costs to manufacture them.
Our products may be significantly more expensive to manufacture than we expect or than other therapeutic products currently on the market today. We hope to substantially reduce manufacturing costs through process improvements, development of new methods, increases in manufacturing scale and outsourcing to experienced manufacturers. If we are not able to make these, or other improvements, and depending on the pricing of the product, our profit margins may be significantly less than that of other therapeutic products on the market today. In addition, we may not be able to charge a high enough price for any product we develop, even if they are safe and effective, to make a profit. If we are unable to realize significant profits from our potential product candidates, our business would be materially harmed.
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We currently lack manufacturing capabilities to produce our therapeutic product candidates at commercial-scale quantities and do not have an alternate manufacturing supply, which could negatively impact our ability to meet any future demand for the product.
We expect that we would need to significantly expand our manufacturing capabilities to meet potential demand for our therapeutic product candidates, if approved. Such expansion would require additional regulatory approvals. Even if we increase our manufacturing capabilities, it is possible that we may still lack sufficient capacity to meet demand.
We do not currently have any alternate supply for our products. If the facilities where our products are currently being manufactured or equipment were significantly damaged or destroyed, or if there were other disruptions, delays or difficulties affecting manufacturing capacity or availability of drug supply, including, but not limited to, if such facilities are deemed not in compliance with current Good Manufacturing Practice, or GMP, requirements, future clinical studies and commercial production for our products would likely be significantly disrupted and delayed. It would be both time- consumingtime-consuming and expensive to replace this capacity with third parties, particularly since any new facility would need to comply with the regulatory requirements.
Ultimately, if we are unable to supply our products to meet commercial demand, whether because of processing constraints or other disruptions, delays or difficulties that we experience, our production costs could dramatically increase and sales of our products and their long-term commercial prospects could be significantly damaged.
To be successful, our proposed products must be accepted by the healthcare community, which can be very slow to adopt or unreceptive to new technologies and products.
Our proposed products and those developed by our collaborative partners, if approved for marketing, may not achieve market acceptance since hospitals, physicians, patients or the medical community in general may decide not to accept and use these products. The products that we are attempting to develop represent substantial departures from established treatment methods and will compete with a number of more conventional therapies manufactured and marketed by major pharmaceutical companies. The degree of market acceptance of any of our developed products will depend on a number of factors, including:
| ● | our establishment and demonstration to the medical community of the clinical efficacy and safety of our proposed products; | |
| ● | our ability to create products that are superior to alternatives currently on the market; | |
| ● | our ability to establish in the medical community the potential advantage of our treatments over alternative treatment methods; and | |
| ● | reimbursement policies of government and third-party payers. |
If the healthcare community does not accept our products for any of these reasons, or for any other reason, our business would be materially harmed.
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.
The clinical development, commercialization and marketing of immuno-oncology therapies are at an early-stage, substantially research- oriented,research-oriented, and financially speculative. To date, very few companies have been successful in their efforts to develop and commercialize an immuno-oncology therapeutic product. In general, such products may be susceptible to various risks, including undesirable and unintended side effects, unintended immune system responses, inadequate therapeutic efficacy, or other characteristics that may prevent or limit their approval or commercial use. Furthermore, the number of people who may use such therapies is difficult to forecast with accuracy. Our future success is dependent on the establishment of a significant market for such therapies and our ability to capture a share of this market with our product candidates.
Our development efforts with our therapeutic product candidates are susceptible to the same risks of failure inherent in the development and commercialization of therapeutic products based on new technologies. The novel nature of immuno-oncology therapeutics creates significant challenges in the areas of product development and optimization, manufacturing, government regulation, third-party reimbursement and market acceptance. For example, the FDA has relatively limited experience regulating such therapies, and there are few approved treatments using such therapy.
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Our competition includes fully integrated biotechnology and pharmaceutical companies that have significant advantages over us.
The market for therapeutic immuno-oncology products is highly competitive. We expect that our most significant competitors will be fully integrated and more established pharmaceutical and biotechnology companies or institutions, including major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions. These companies are developing similar products, and they have significantly greater capital resources and research and development, manufacturing, testing, regulatory compliance, and marketing capabilities. Many of these potential competitors may be further along in the process of product development and also operate large, company-funded research and development programs. As a result, our competitors may develop more competitive or affordable products, or achieve earlier patent protection or product commercialization than we are able to achieve. Competitive products may render any products or product candidates that we develop obsolete.
Many of our competitors have substantially greater financial, technical and other resources than we do, such as larger research and development staff and experienced marketing and manufacturing organizations. Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in certain of our competitors. As a result, these companies may be able to obtain regulatory approval more rapidly than we can and may be more effective in selling and marketing their products. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing drug products that are more effective or less costly to produce or purchase on the market than any product candidate we are currently developing or that we may seek to develop in the future. If approved, our product candidates will face competition from commercially available drugs as well as drugs that are in the development pipelines of our competitors.
Established pharmaceutical companies may invest heavily to accelerate discovery and development of or in-license novel compounds that could make our product candidates less competitive. In addition, any new product that competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be commercially successful. Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA, EMA or other regulatory approval, or discovering, developing and commercializing medicines before we do, which would have a material adverse impact on our business and ability to achieve profitability from future sales of our approved product candidates, if any.
If competitors develop and market products that are more effective, safer or less expensive than our product candidates or offer other advantages, our commercial prospects will be limited.
Our therapeutic immuno-oncology (IO) development programs face, and will continue to face, intense competition from pharmaceutical, biopharmaceutical and biotechnology companies, as well as numerous academic and research institutions and governmental agencies engaged in drug discovery activities or funding, both in the United States and abroad. Some of these competitors are pursuing the development of drugs and other therapies that target the same diseases and conditions that we are targeting with our product candidates. According to a recent analysis by InVentiv HealthGlobal Data, Thematic Research: Immuno-Oncology (March 2021), as of December 2020, there are over 800 companies developing approximately 1500 cancer immunotherapies via 4000 development projects across 535 targets. According to the Pharmaceutical Manufacturers Research Association Medicines in Development4,822 industry-sponsored clinical trials for Cancer 2018 Report, there were 135immuno-oncology with 422 drugs in development fordevelopment. Phase 2 trials constitute the treatmentmajority of lymphoma, including non-Hodgkin lymphoma, which accounts forthe IO pipeline, followed by early-stage molecules in Phase 1/2 and Phase 1. For late-stage pipeline products, 484 clinical trials are ongoing in Phase 3, and 51 are in Phase 2/3 development. There are currently 22 marketed immuno-oncology agents. Cancer vaccine products lead the category with 9 products followed by checkpoint modulators with 8 approved drugs. The indications with the most marketed IO agents in the United States are metastatic melanoma and non-small cell lung cancer, with 6 approved products each. The market value of bispecific antibodies, cancer vaccines, checkpoint modulators, cell therapies, and oncolytic viruses globally has increased sharply in the past 10 years with nearly five percent of all new cancer diagnoses.$29 billion in 2019 compared to $370 million in 2010.
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As a general matter, we also face competition from many companies that are researching and developing cell therapies. Many of these companies have financial and other resources substantially greater than ours. In addition, many of these competitors have significantly greater experience in testing pharmaceutical and other therapeutic products, obtaining FDA and other regulatory approvals, and marketing and selling. If we ultimately obtain regulatory approval for any of our product candidates, we also will be competing with respect to manufacturing efficiency and marketing capabilities, areas in which we have limited or no commercial-scale experience. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources’ being concentrated by our competitors. Competition may increase further as a result of advances made in the commercial applicability of our technologies and greater availability of capital for investment in these fields.
If we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably.
We are engaged in activities in the biotechnology field, which is characterized by extensive research efforts and rapid technological progress. If we fail to anticipate or respond adequately to technological developments, our ability to operate profitably could suffer. Research and discoveries by other biotechnology, agricultural, pharmaceutical or other companies may render our technologies or potential products or services uneconomical or result in products superior to those we develop. Similarly, any technologies, products or services we develop may not be preferred to any existing or newly developed technologies, products or services.
We may not be able to obtain third-party patient reimbursement or favorable product pricing, which would reduce our ability to operate profitably.
Our ability to successfully commercialize certain of our proposed products in the human therapeutic field may depend to a significant degree on patient reimbursement of the costs of such products and related treatments at acceptable levels from government authorities, private health insurers and other organizations, such as health maintenance organizations. Reimbursement in the United States or foreign countries may not be available for any products we may develop, and, if available, may be decreased in the future. Also, reimbursement amounts may reduce the demand for, or the price of, our products with a consequent harm to our business. We cannot predict what additional regulation or legislation relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future or what effect such regulation or legislation may have on our business. If additional regulations are overly onerous or expensive, or if healthcare-related legislation makes our business more expensive or burdensome than originally anticipated, we may be forced to significantly downsize our business plans or completely abandon our business model.
We may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome.
Our business may bring us into conflict with our licensees, licensors or others with whom we have contractual or other business relationships, or with our competitors or others whose interests differ from ours. If we are unable to resolve those conflicts on terms that are satisfactory to all parties, we may become involved in litigation brought by or against us. That litigation is likely to be expensive and may require a significant amount of management’s time and attention, at the expense of other aspects of our business. The outcome of litigation is always uncertain, and in some cases could include judgments against us that require us to pay damages, enjoin us from certain activities, or otherwise affect our legal or contractual rights, which could have a significant adverse effect on our business.
We are exposed to the risk of liability claims, for which we may not have adequate insurance.
Since we participate in the pharmaceutical industry, we may be subject to liability claims by employees, customers, end users and third parties. We intend to obtain proper insurance, however, there can be no assurance that any liability insurance we purchase will be adequate to cover claims asserted against us or that we will be able to maintain such insurance in the future. We intend to adopt prudent risk-management programs to reduce these risks and potential liabilities, however, we have not taken any steps to create these programs and have no estimate as to the cost or time required to do so and there can be no assurance that such programs, if and when adopted, will fully protect us. We may not be able to put risk management programs in place, or obtain insurance, if we are unable to retain the necessary expertise and/or are unsuccessful in raising necessary capital in the future. Our failure to obtain appropriate insurance, or to adopt and implement effective risk-management programs, as well as any adverse rulings in any legal matters, proceedings and other matters could have a material adverse effect on our business.
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Preclinical and clinical trials are conducted during the development of potential products and other treatments to determine their safety and efficacy for use by humans. Notwithstanding these efforts, when our treatments are introduced into the marketplace, unanticipated side effects may become evident. Manufacturing, marketing, selling and testing our product candidates under development or to be acquired or licensed, entails a risk of product liability claims. We could be subject to product liability claims in the event thatif our product candidates, processes, or products under development fail to perform as intended. Even unsuccessful claims could result in the expenditure of funds in litigation and the diversion of management time and resources, and could damage our reputation and impair the marketability of our product candidates and processes. While we plan to maintain liability insurance for product liability claims, we may not be able to obtain or maintain such insurance at a commercially reasonable cost. If a successful claim were made against us, and we lacked insurance or the amount of insurance were inadequate to cover the costs of defending against or paying such a claim or the damages payable by us, we would experience a material adverse effect on our business, financial condition and results of operations.
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 could be subject to product liability lawsuits if any product candidate we develop allegedly causes injury or is found to be otherwise unsuitable for human use during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates, if approved. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:
| ● | decreased demand for our product candidates; | |
| ● | withdrawal of clinical trial participants; | |
| ● | initiation of investigations by regulators; | |
| ● | costs to defend the related litigation; | |
| ● | a diversion of management’s time and our resources; | |
| ● | substantial monetary awards to trial participants or patients; | |
| ● | product recalls, withdrawals or labeling, marketing or promotional restrictions; | |
| ● | loss of revenues from product sales; and | |
| ● | the inability to commercialize our product candidates. |
Our inability to retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the clinical testing and commercialization of products we develop. We may wish to obtain additional such insurance covering studies or trials in other countries should we seek to expand those clinical trials or commence new clinical trials in other jurisdictions or increase the number of patients in any clinical trials we may pursue. We also may determine that additional types and amounts of coverage would be desirable at later stages of clinical development of our product candidates or upon commencing commercialization of any product candidate that obtains required approvals. However, we may not be able to obtain any such additional insurance coverage when needed on acceptable terms or at all. If we do not obtain or retain sufficient product liability insurance, we could be responsible for some or all of the financial costs associated with a product liability claim relating to our preclinical and clinical development activities, in the event that any such claim results in a court judgment or settlement in an amount or of a type that is not covered, in whole or in part, by any insurance policies we may have or that is in excess of the limits of our insurance coverage. We may not have, or be able to obtain, sufficient capital to pay any such amounts that may not be covered by our insurance policies.
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We rely on third parties 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 and our business could be substantially harmed.
We rely, and expect to continue to rely, upon third-party CROs to execute our preclinical and clinical trials and to monitor and manage data produced by and relating to those trials. However, we may not be able to establish arrangements with CROs when needed or on terms that are acceptable to us, or at all, which could negatively affect our development efforts with respect to our drug product candidates and materially harm our business, operations and prospects.
We will have only limited control over the activities of the CROclinical research organization (CRO) we will engage to conduct our clinical trials including the University of Minnesota for our phase 2 clinical trial for GTB-1550 and phase 1 clinical trial for GTB-3550.trials. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on any CRO does not relieve us of our regulatory responsibilities. Based on our present expectations, we, our CROs and our clinical trial sites are required to comply with good clinical practices or GCPs,(GCPs), for all of our product candidates in clinical development. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of our CROs fail to comply with applicable GCPs, the clinical data generated in the applicable trial may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving a product candidate for marketing, which we may not have sufficient cash or other resources to support and which would delay our ability to generate revenue from any sales of such product candidate. In addition, our clinical trials are required to be conducted with product produced in compliance with current good manufacturing practice requirements, or cGMPs. Our or our CROs’ failure to comply with those regulations may require us to repeat clinical trials, which would also require significant cash expenditures and delay the regulatory approval process.
Agreements governing relationships with CROs generally provide those CROs with certain rights to terminate a clinical trial under specified circumstances. If a CRO that we have engaged terminates its relationship with us during the performance of a clinical trial, we would be forced to seek an engagement with a substitute CRO, which we may not be able to do on a timely basis or on commercially reasonable terms, if at all, and the applicable trial would experience delays or may not be completed. In addition, our CROs are not our employees, and except for remedies available to us under any agreements we enter with them, we are unable to control whether or not they devote sufficient time and resources to our clinical, nonclinical and preclinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to a failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for, or successfully commercialize, the affected product candidates. As a result, our operations and the commercial prospects for the effected product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed.
We contract with third parties for the supply of product candidates for clinical testing and expect to contract with third parties for the manufacturing of our product candidates for large-scale testing and commercial supply. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
We anticipate continuing our engagement of third parties to provide our clinical supply as we advance our product candidates into and through clinical development, and we depend on third parties to produce and maintain sufficient quantities of material to supply our clinical trials. If these third parties do not produce and maintain adequate supplies of clinical material, our development efforts could be significantly delayed, or could incur substantially higher costs. We expect in the future to use third parties for the manufacture of our product candidates for clinical testing, as well as for commercial manufacture. We plan to enter into long-term supply agreements with several manufacturers for commercial supplies. We may be unable to reach agreement on satisfactory terms with contract manufacturers to manufacture our product candidates. Additionally, the facilities to manufacture our product candidates must be the subject of a satisfactory inspection before the FDA or other regulatory authorities approve a marketing authorization for the product candidate manufactured at that facility. We will depend on these third-party manufacturers for compliance with the FDA’s and international regulatory authority requirements for the manufacture of our finished products. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturers for compliance with cGMPs. If our manufacturers cannot successfully manufacture material that conforms to our specifications and the FDA and other regulatory authorities’ cGMP requirements, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved, and may subject us to recalls or enforcement action for products already on the market.
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If any of our product candidates are approved and contract manufacturers fail to deliver the required commercial quantities of finished product on a timely basis and at commercially reasonable prices, and we are unable to find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would likely be unable to meet demand for our products and could lose potential revenue. It may take several years to establish an alternative source of supply for our product candidates and to have any such new source approved by the FDA or any other relevant regulatory authorities.
We currently have no marketing and sales force. If we are unable to establish effective marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to effectively market and sell our product candidates, if approved, or generate product revenues.
We currently do not have a marketing or sales team for the marketing, sales and distribution of any of our product candidates that are able to obtain regulatory approval. In order toTo commercialize any product candidates, we must build on a territory-by-territory basis marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. If our product candidates receive regulatory approval, we intend to establish an internal sales and marketing team with technical expertise and supporting distribution capabilities to commercialize our product candidates, which will be expensive and time consuming and will require significant attention of our executive officers to manage. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of any of our products that we obtain approval to market. With respect to the commercialization of all or certain of our product candidates, we may choose to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into such arrangements when needed on acceptable terms or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval or any such commercialization may experience delays or limitations. If we are not successful in commercializing our product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incur significant additional losses.
Our business and operations would suffer in the event of system failures.
Despite the implementation of security measures, our internal computer systems and those of our contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any such system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and we may incur substantial costs to attempt to recover or reproduce the data. If any disruption or security breach resulted in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and/or the further development of our product candidates could be delayed.
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Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity and other events beyond our control, the occurrence of which could materially harm our business.
Businesses located in California have, in the past, been subject to electrical blackouts as a result of a shortage of available electrical power, and any future blackouts could disrupt our operations. We are vulnerable to a major earthquake, wildfire and other natural disasters, and we have not undertaken a systematic analysis of the potential consequences to our business as a result of any such natural disaster and do not have an applicable recovery plan in place. We do not carry any business interruption insurance that would compensate us for actual losses from interruption of our business that may occur, and any losses or damages incurred by us could cause our business to materially suffer.
Epidemic or pandemic outbreaks such as COVID-19 (coronavirus), natural disasters, whether or not held regular annual meetings in the past,caused by climate change, unusual weather conditions, terrorist acts and if we are required by the Delaware Court of Chancery to hold an annual meeting pursuant to Section 211(c) of the Delaware General Corporation Law, or the DGCL, itpolitical events, could disrupt business and result in the unanticipated expenditurehalting our clinical trials and otherwise adversely affect our financial performance.
The occurrence of funds, time and other Company resources.
Risks Related to 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 you 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.
Our common stock is listed for trading on the OTCQBNasdaq Capital Market under the trading symbol “GTBP”; historically, however, there has been a limited public market for our common stock. We cannot assure you that an active trading market for our common stock will develop or be sustained. The liquidity of any market for the shares of our common stock will depend on a number of factors, including:
| ● | the number of stockholders; | |
| ● | our operating performance and financial condition; | |
| ● | the market for similar securities; | |
| ● | the extent of coverage of us by securities or industry analysts; and | |
| ● | the interest of securities dealers in making a market in the shares of our common stock. |
Even if an active trading market develops, the market price for our common stock may be highly volatile and could be subject to wide fluctuations. In addition, the price of shares of our common stock could decline significantly if our future operating results fail to meet or exceed the expectations of market analysts and investors and actual or anticipated variations in our quarterly operating results could negatively affect our share price.
Other factors may also contribute to volatility of the price of our common stock and could subject our common stock to wide fluctuations. These include, but are not limited to:
| ● | developments in the financial markets and worldwide or regional economies; | |
| ● | announcements of innovations or new products or services by us or our competitors; | |
| ● | announcements by the government relating to regulations that govern our industry; |
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| ● | significant sales of our common stock or other securities in the open market; | |
| ● | variations in interest rates; | |
| ● | changes in the market valuations of other comparable companies; and | |
| ● | changes in accounting principles. |
Our outstanding warrants may affect the market price of our common stock.
As of December 31, 2021, we had approximately 32.4 million shares of common stock issuable or issued and outstanding and warrants outstanding for the purchase of up to 221,000 additional shares of common stock at an exercise price of $3.40 per share, and warrants outstanding for the purchase of up to 2,116,000 additional shares of common stock at an exercise price of $5.50 per share, all of which are exercisable as of the date of this Annual Report (subject to certain beneficial ownership limitations). The amount of common stock reserved for issuance may have an adverse impact on our ability to raise capital and may affect the price and liquidity of our common stock or other securities in the open market;
Because our common stock may be deemed a low-priced “penny” stock, an investment in our common stock should be considered high- riskhigh-risk and subject to marketability restrictions.
Historically, the trading price of our common stock has been $5.00 per share or lower, and deemed a penny stock, as defined in Rule 3a51-1 under the Exchange Act, and subject to the penny stock rules of the Exchange Act specified in rules 15g-1 through 15g-10. Those rules require broker–dealers, before effecting transactions in any penny stock, to:
| ● | deliver to the customer, and obtain a written receipt for, a disclosure document; | |
| ● | disclose certain price information about the stock; | |
| ● | disclose the amount of compensation received by the broker–dealer or any associated person of the broker–dealer; | |
| ● | send monthly statements to customers with market and price information about the penny stock; and | |
| ● | in some circumstances, approve the purchaser’s account under certain standards and deliver written statements to the customer with information specified in the rules. |
Consequently, the penny stock rules may restrict the ability or willingness of broker–dealers to sell the common stock and may affect the ability of holders to sell their common stock in the secondary market and the price at which such holders can sell any such securities. These additional procedures could also limit our ability to raise additional capital
in the future.
Financial Industry Regulatory Authority (“FINRA”) sales practice requirements may also limit a stockholder’s ability to buy and sell our common stock, which could depress the price of our common stock.
In addition to the “penny stock” rules described above, FINRA has adopted rules that require a broker-dealer to have reasonable grounds for believing that the investment is suitable for that customer before recommending an investment to a customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. Thus, the FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our shares of common stock, have an adverse effect on the market for our shares of common stock, and thereby depress our price per share of common stock.
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If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
The trading market for our common stock may be influenced by the research and reports that industry or securities analysts publish about us or our business. We do not currently have research coverage by three securities analysts, and we may never obtain research coverage by securities and industryadditional analysts. If no or few securities or industry analysts commence coverage of us, the trading price for our common stock may be negatively affected. In the event that we receive additional securities or industry analyst coverage, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance, or if our operating results fail to meet the expectations of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
Anti-takeover provisions may limit the ability of another party to acquire us, which could cause our stock price to decline.
Delaware law and our charter, bylaws, and other governing documents contain provisions that could discourage, delay or prevent a third party from acquiring us, even if doing so may be beneficial to our stockholders, which could cause our stock price to decline. In addition, these provisions could limit the price investors would be willing to pay in the future for shares of our common stock.
We do not currently or for the foreseeable future intend to pay dividends on our common stock.
We have never declared or paid any cash dividends on our common stock. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. As a result, any return on your investment in our common stock will be limited to the appreciation in the price of our common stock, if any.
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ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 2. PROPERTIES
At the date of the issuance of this Annual Report, we sublease offices comprising of 4,500 rentable square feet at 8000 Marina Blvd, Suite 100, Brisbane, CA 94005 under a sublease that expires on June 30, 2024. We currently maintainpreviously leased offices at 310 N. Westlake Blvd.,9350 Wilshire Blvd, Suite 206, Westlake Village,203, Beverly Hills, CA 91362. We previously maintained offices at 1825 K Street NW, Suite 510, Washington, D.C. 20006 and in Tampa, Florida. The leases for the facilities in Washington, D.C. and Tampa, Florida have expired and were not renewed. Our total monthly rent expense is approximately $5,725.
ITEM 3. LEGAL PROCEEDINGS
On June 23, 2016, we were served withAugust 28, 2019, a complaint was filed in the CircuitSuperior Court of California, County of Los Angeles, West Judicial District, Santa Monica Courthouse, Unlimited Civil Division by Jeffrey Lion, an individual (“Lion”), and by Daniel Vallera, an individual (“Vallera”). Lion and Vallera are referred to jointly as the 13th Judicial Circuit in“Plaintiffs”. The complaint was filed against GT Biopharma, Inc. and for Hillsborough County, Florida, Case No. 16-CA-004791, by Lippert/Heilshornits subsidiary Oxis Biotech, Inc. (either of them or jointly, the “Company”). The Plaintiffs alleged breach of a license agreement between the Plaintiffs and Associates, Inc. Lippert/Heilshorn and Associates, Inc. alleged it was owed compensation for consulting services provided to us and was seeking payment of $73,898. On December 27, 2018, the Company signedentered into on or about September 3, 2015. Lion alleged breach of a Settlement Agreementconsulting agreement between Lion and Mutual Release of Claims whereby the Company agreed to issue 45,000entered into on or about September 1, 2015. Vallera alleged breach of a consulting agreement between Vallera and the Company entered into in or around October, 2018. The Complaint sought actual damages of $1.7 million, for the fair market value of the number of shares of unregistered, Rule 144 restricted Common Stock in fullcommon stock of GT Biopharma, Inc. that at the time of judgment represent 15,000,000 shares of such common stock as of September 1, 2015, and that GT Biopharma, Inc. issue Lion the number of shares of common stock of GT Biopharma, Inc. that at the time of judgment represent 15,000,000 such shares as of September 1, 2015. The Company filed an answer to the complaint denying many allegations and asserting affirmative defenses. A settlement of this matter.
On December 14, 2018,March 3, 2021 a finalcomplaint was filed by Sheffield Properties in the superior Court of California. County of Ventura. The litigation arose from a commercial lease entered into by GT Biopharma for office space in Westlake Village. In July, 2021 we entered into settlement agreement with Sheffield Properties in the amount of $100,000 that was reached between the Company and Multicell whereby the Company paid Multicell $100,000 in cash and agreed to issue 200,000 shares of unregistered, Rule 144 restricted Common Stock in full settlement of this matter.
ITEM 4. MINE SAFETY DISCLOSURES
None.
PART II
ITEM 5.
Our common stock is traded on the Nasdaq Capital market under the trading symbol “GTBP.” Until May 2009, our common stock was traded on the OTC Bulletin Board (“OTCBB”) under the symbol “OXIS.” From May 20, 2009 until March 11, 2010, our common stock was traded on Pink OTC Markets Inc. trading platform under the symbol “OXIS.” From January 2015 to August 2017, our common stock iswas quoted on the OTCQB under the “OXIS” trading symbol. SinceFrom August 2017 to February 11, 2021, our common stock has beenwas quoted on the OTCQB under the “GTBP” trading symbol.
| YEAR | PERIOD | HIGH | LOW | |||
| Fiscal Year 2017 | First Quarter | 69.00 | 3.81 | |||
| Second Quarter | 9.90 | 3.36 | ||||
| Third Quarter | 29.55 | 4.66 | ||||
| Fourth Quarter | 6.99 | 4.25 | ||||
| Fiscal Year 2018 | First Quarter | 5.06 | 1.60 | |||
| Second Quarter | 2.52 | 1.25 | ||||
| Third Quarter | 2.75 | 1.42 | ||||
| Fourth Quarter | 2.16 | 0.62 |
Our common stock is also quoted on several European based exchanges including Berlin (GTBP.BE), Frankfurt (GTBP.DE), the Euronext (GTBP.NX) and Paris, (GTBP.PA). The foregoing trading prices exclude trading on these foreign stock markets.
Stockholders
As of December 31, 2018,March 28, 2022 there were 2350 stockholders of record, which total does not include stockholders who hold their shares in “street name.” The transfer agent for our common stock is ComputerShare, whose address is 8742 Lucent Blvd., Suite 225, Highland Ranch, CO 80129.
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Dividends
We have not paid any dividends on our common stock to date and do not anticipate that we will pay dividends in the foreseeable future. Any payment of cash dividends on our common stock in the future will be dependent upon the amount of funds legally available, our earnings, if any, our financial condition, our anticipated capital requirements and other factors that the Board of Directors may think are relevant. However, we currently intend for the foreseeable future to follow a policy of retaining all of our earnings, if any, to finance the development and expansion of our business and, therefore, do not expect to pay any dividends on our common stock in the foreseeable future.
Equity Compensation Plan Information
In accordance with General Instruction G(3) to Form 10-K, the Company intends to file with the SEC the information included underrequired by this item not later than 120 days after the heading “Equity Compensation Plan Information” in Item 12end of Part III ofthe fiscal year covered by this report, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.” is hereby incorporated by reference into this Item 5 of this report.
Recent Issuances of Unregistered Securities
The Company made the following issuances of its unregistered securities pursuant exemptions contained in the Circuit CourtSection 4(a)(2) or 3(a)(9) of the 13th Judicial Circuit in and for Hillsborough County, Florida, Case No. 16-CA-004791, by Lippert/Heilshorn and Associates, Inc. Lippert/Heilshorn and Associates, Inc. alleged it was owed compensation for consulting services provided to us and was seeking paymentSecurities Act and/or Rule 506 of $73,898. On December 27, 2018, the Company signed a Settlement Agreement and Mutual Release of Claims and issued 45,000 shares of unregistered, Rule 144 restricted Common Stock in full settlement of this matter.
| ● | The Company issued 1,737,861 shares of common stock to consultants as compensatory bonuses after completion of the successful listing on the Nasdaq Capital Market on February 11, 2021; | |
| ● | The Company issued 1,060,853 shares of common stock in accordance with various consulting agreements. | |
| ● | The Company issued 708,144 shares of common stock in accordance with a research and development agreement. | |
| ● | The Company issued 1,125,752 shares of common stock upon exercise of warrants for cash. | |
| ● | The Company issued 50,000 shares of common stock in accordance with the terms of the employment agreement of an employee. |
Repurchase of Shares
We did not repurchase any shares during the fourth quarter of the fiscal year covered by this report.
ITEM 6. SELECTED FINANCIAL DATA
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
We are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based off our proprietary Tri-specific Killer Engager (TriKE), Tetra-specific Killer Engager (TetraKE) and bi-specific Antibody Drug Conjugate (ADC)(TriKE®) technology platforms.platform. Our TriKE and TetraKE platforms generate® platform generates proprietary moietiestherapeutics 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 enhance the NK cell, and precisely direct it to one or more specifically-targeted proteins (tumor antigens) expressed on a specific type of cancer cell or virus infected cell, ultimately resulting in the cancertargeted cell’s death. TriKEs and TetraKEs are made upTriKE® is composed of recombinant fusion proteins and interleukin 15 (IL-15), can be designed to target any number of tumor antigens on hematologic malignancies, sarcomas or solid tumors and do not require patient-specific customization. They are designed to be dosed in a common outpatient setting similar to modern antibody therapeutics and are expected to have reasonably low cost of goods. Our ADC platform generates product candidates that are bi-specific, ligand-directed single-chain fusion proteins that, we believe, represent the next generation of ADCs.
As shown in the accompanying consolidated financial statements, the Company has incurred an accumulated deficit of $528,685,000$653.6 million through December 31, 2018.2021. On a consolidated basis, the Company had cash and cash equivalents of $60,000$9.0 million and short-term investments of $23.0 million at December 31, 2018. Because our lack of funds,2021. We anticipate we will have to raise additional capital in order to fund our selling, general and administrative, and research and development expenses.expenses until we have a marketable product. There are no assurances that we will be able to raise the funds necessary to maintain our operations or to implement our business plan. The consolidated financial statements included in this Annual Report on Form 10-K do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classification of liabilities that might be necessary in the event we cannot continue our operations.
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COVID-19
In March 2020, the World Health Organization declared coronavirus COVID-19 a global pandemic. This contagious disease outbreak, which has continued to Certificatespread, has adversely affected workforces, customers, economies, and financial markets globally. It has also disrupted the normal operations of Incorporation
During the year ended December 31, 2021, the Company believes the COVID-19 pandemic did impact its operating results. However, the Company has not observed any impairments of its assets or a significant change in the fair value of its assets due to GT Biopharma, Inc.
The Company has been following the recommendations of health authorities to minimize exposure risk for its team members, including the temporary closure of its corporate office and having team members work remotely. Most vendors have transitioned to electronic submission of invoices and payments.
Corporate Developments
On February 16, 2021, as a result of the completion of the public offering and the successful listing of our shares of common stock on the Nasdaq Capital Market, 2,353,548 shares of GTP. GTP isSeries J-1 Preferred Stock mandatorily converted at a biotechnology company focused on acquiring or discoveringconversion rate of $3.40 per share into 692,220 shares of our common stock. (See Note 8 of our Financial Statements)
As part of employment agreements with Anthony Cataldo, our former Chief Executive Officer (former CEO) and patenting what it believesMichael Handelman, our former Chief Financial Officer (former CFO), these officers received a fully vested stock grant of shares of common stock equal to be close-to-market improved treatments for CNS disease (neurologyaggregate of 10% and pain) and shepherding1.5% of the products through the FDA approval process potentially to NDA. GTP products currently include a treatment for neuropathic pain, the symptoms of myasthenia gravis, and motion sickness. In exchange for the ownership of GTP, we issued a total of 16,927,878fully diluted shares of our common stock (calculated with the inclusion of the current stock holdings of Mr. Cataldo, and Mr. Handelman, upon conversion of options, warrants and convertible notes in association with a national markets qualified financing as consideration for entering into the Agreement (with such stock to vest and be delivered within 30 days after the national markets qualified financing). In addition, we also granted similar equity compensation to members of our Board of Directors wherein these directors received stock grants equal to 1% and 1.25% of the fully diluted shares of our common stock. Pursuant to these agreements, the common stock issued vested over a period of two years. On February 16, 2021, we completed a qualified equity offering and listing. As a result, we granted these two employees 3,197,662 shares and an additional 1,181,745 shares to directors for a total of 4,379,407 shares of common stock.
On April 23, 2021, our Compensation Committee approved amendments to the three prior ownerscompensation terms of GTP, which represented 33%Anthony Cataldo, our former CEO and Michael Handelman, our former CFO to increase their base salary and bonus compensation.
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On April 23, 2021, Dr. Gregory Berk resigned as a director and accepted employment as our Chief Medical Officer. In connection with his appointment as Chief Medical Officer, the Compensation Committee approved a four-year employment agreement for Dr. Berk.
On August 23, 2021, Dr. Gregory Berk was promoted to the position of our issuedPresident of Research & Development and outstanding capital stock on a fully diluted basis atChief Medical Officer. Dr. Berk assumed additional responsibilities including discovery, non-clinical development, clinical development, and manufacturing.
On November 5, 2021 the timeCompany terminated the employment of closing.
On November 8, 2021, the Board also appointed Michael Breen as Executive Chairman of the acquisition,Board.
On November 8, 2021, the Board appointed Dr. Gavin Choy as Acting Chief Financial Officer.
On December 15, 2021, Anthony J. Cataldo resigned as our chief executive officer and was simultaneously elected as executive chairman of the board of directors. Kathleen Clarence-Smith, M.D., Ph.D., the founder of GTP, was then elected as our chief executive officer and a member of the boardCompany’s Board of directors.Directors.
On February 14, 2022, the Company appointed Manu Ohri as the Chief Financial Officer and Dr. Gavin Choy ceased serving as the Acting Chief Financial Officer.
Effective March 2, 2022, the Company appointed Michael Breen as Interim Chief Executive Officer. Dr. Berk ceased serving as the Company’s Interim Chief Executive Officer, but continues to serve as its President of Research & Development and Chief Medical Officer.
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Issuance of Common Stock in public offering
On February 16, 2021, the acquisitionCompany completed a public offering of GTP, (i) we raised $4,540,000 upon the sale of debentures which were subsequently converted into 3,575,109 shares of restricted common stock and 208,224 shares of Series J Preferred Stock to a total of nine persons or entities; (ii) canceled debt in the amount $17,295,352 upon the issuance of 13,712,5164,945,000 shares of common stock for net proceeds of $24.7 million, after deducting underwriting discounts, commissions and 700,278other direct offering expenses. As part of the offering, the Company also granted the investors, warrants to purchase 5,192,250 shares of Series J Preferred Stock tocommon stock. The warrants are fully vested, exercisable at $5.50 per share and have a totalterm of 26 persons or entities; (iii) issued 494,911five years .(see Note 8 of our Consolidated Financial Statements).
As a result of the completion of the public offering and the listing of its shares of common stock on the Nasdaq Capital Market, convertible notes payable and 5,046 sharesaccrued interest with an aggregate amount of Series J Preferred Stock upon the cashless exercise$38.8 million were mandatorily converted at its stated conversion rate of warrants to a total of 22 persons or entities; and (iv) converted 25,000 shares of Series H Preferred Stock and 1,666,667 Series I Preferred Stock$3.40 per share into 5,327,734 shares of common stock held by a total of three persons or entities. All stock issuances were exempt from the registration requirements of Section 5 of the Act of 1933, as amended, or the Act, pursuant to Section 4(a)(2) of the Act because the issuances did not involve any public offering.
Issuance of Common Stock for services - consultants
As part of consulting agreements with certain consultants, the Company agreed to grant these consultants common stock equal to 1% and 3% of the fully diluted shares of common stock of the Company upon conversion of options, warrants and Convertible Notes in association with a national markets qualified financing as consideration for entering into the agreement (with such stock to vest and be delivered within 30 days after the national markets qualified financing).
On February 16, 2021, we completed a qualified equity offering and listing. As a result, we granted these consultants 2,850,090 shares of common stock with a fair market value of $10,701,394, of which 1,934,817 shares of common stock fully vested immediately while the remaining 915,273 shares of common stock vest over two years. During the year ended December 31, 2021, pursuant to the vesting terms of the consulting agreements, we recorded the corresponding stock compensation expense of $8,981,869. We also issued 1,060,853 shares of common stock with a fair value of $6,836,400 to other consultants for services rendered that will vest over a period of 24 months. In addition, on December 31, 2021, the Company cancelled 278,058 shares of common stock granted to a consultant in February 2021.
At December 31, 2021, there were 550,479 unvested shares of common stock with a grant date fair value of $2,203,126, which will be recognized as stock compensation in future periods based upon the remaining vesting term of the applicable grants.
Issuance of Common Stock for research and development agreement
During the year ended December 31, 2021, the Company issued 189,753 shares of common stock for a research and development agreement valued at $1.3 million. The common shares were valued at the market price at the date of grant.
Issuance of Common Stock upon exercise of warrants
During the Agreement. Theyear ended December 31, 2021, the Company issued 3,076,017 shares of common stock option grant would vest according toupon the following schedule: (i) 1,250,000 fully vested shares upon signingexercise of the agreement, (ii) 1,250,000 shares on January 1, 2019, and (iii) 471,102 shares on January 1, 2020. On March 15, 2019, Dr, Urbanski resigned his position as Chief Executive Officer, President and Chairmanwarrants resulting in cash proceeds of the Board.
Significant Agreements
TriKE Agreements
In June 2017, we entered into a co-development partnership agreement with Altor BioScience Corporation in which the we will collaborate exclusively in the clinical development of a novel 161533 (GTB-3550) TriKE® fusion protein for cancer therapies using our TriKE® technology.
University of Minnesota Scientific Research Agreement
We are a party to a patent licensescientific research agreement with the ID4, datedRegents of the University of Minnesota, effective June 16, 2021. This scientific research agreement aims to 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 here 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 us under current UMN/GTB licensing terms. The term of this agreement shall expire on June 30, 2023.
The University of Minnesota shall use reasonable efforts to complete the project for a fixed sum of $2.1 million. We paid an initial payment of $541,527 on December 2, 2021, which is to be followed by seven quarterly equal payments of $191,527, the first of which was paid on December 29, 2021. The second quarterly payment was recorded in accounts payable at December 31, 2014, we received a non-exclusive, worldwide license to certain intellectual property, including intellectual property related to treating a p62-mediated disease (e.g., multiple myeloma).
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Subcontract Manufacturing Agreement
On October 5, 2020, GT Biopharma entered into a Master Services Agreement with a third-party product candidates which contain GTBP’s lead drug candidates OXS-2175manufacturer to perform biologic development and OXS-4235.
Clinical Trial Agreement
In July 2016,September 2019, we executed an exclusive worldwide licenseclinical trial agreement with the Regents of the University of Minnesota, to further develop and commercialize cancer therapies usingcommence enrollment in its first-in-human GTB-3550 TriKE technology developed by researchers at the university to target NK cells to cancer. Under the terms of the agreement, we received exclusive rights to conduct research and to develop, make, use, sell, and import TriKe technology worldwide® (CD16/IL-15/CD33) Phase 1, open-label, dose escalation clinical trial for the treatment of any disease, stateCD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or condition in humans. We shall own 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. Under the agreement,advanced systemic mastocytosis. The clinical trial was conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota will receive an upfront license fee, royalty fees,under the direction of Dr. Erica Warlick and certain milestone payments.
License Agreements
See discussion of Patents and Licenses above under Item 1: Business
Results of Operations
Comparison of the three (3) lowest intra-day trading prices of the Common Stock during the 20 Trading Days immediately prior to the date on which the Notice of Conversion is delivered to the Company, with an initial principal balance of $633,593Years Ended December 31, 2021 and warrants to acquire up to 42,239 shares of the Company's common stock at an exercise price of $15.00 per share.
Research and Development Expenses
During the years ended December 31, 20182021 and 2017,2020, we incurred $9.1$9.6 million and $1.1 million$485,000 of research and development expenses, respectively. 2018 researchResearch and development costsexpenses increased due primarily to $1.3 million in stock compensation to consultants, and the additioninitiation of new employees, increased regulatory and preclinical consultant costs to support the GTB-3550 IND, higher costs to advance the CNS portfolio and position the assets for licensing efforts, and higher preclinical and clinical expenses incurred at the University of Minnesota to continue development of our immune-oncology assets. 2018 expenses also include non-cash compensation of $6.8 million. We anticipate our direct clinical and preclinical costs to continue to increase throughout 2019, totaling approximately $12 to $15 million, as we initiate a Phase 1 clinical trial of our most advanced TriKeTriKE® product candidate, GTB-3550 along with progression on other promising product candidates. We anticipate our direct clinical and preclinical expenses to increase significantly in 2022, totaling approximately $12 million to $14 million, as we have completed the first halfPhase 1 clinical trial of 2019,our most advanced TriKE® product candidate GTB-3550, and initiate IND-enabling activities for GTB-C3550, and GTB-1615.have plans to advance the next generation camelid nanobody into the clinic.
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Selling, general and administrative expenses
During the yearsyear ended December 31, 20182021 and 2017,2020, we incurred $12.5$47.9 million and $134.5$6.3 million of selling, general and administrative expenses, respectively. Selling, general and administrative expensesThe increase in 2017 were driven by stock compensation related to the acquisition of Georgetown Translational Pharmaceuticals on September 1, 2017. Stock compensation expenses totaled $2.3 million and $129.1 million for in 2018 and 2017, respectively. Additional selling, general and administrative expenses in 2018 were dueis primarily attributable to increased spending on investor relations campaigns to broaden awareness of the Company, and increased legal costs primarily associated with financing efforts. We anticipate selling, general and administrative expenses, excluding stock compensation to range between $1 and $2expenses of $32.6 million in the coming quarters.
Interest Expense
Interest expense was $9.1$0.7 million and $8.6$3.0 million for the years ended December 31, 20182021 and 2017,2020 respectively. The increasedecrease is primarily due to the conversion of all outstanding interest on convertible notes on February 16, 2021. No promissory notes were outstanding as of December 31, 2021.
Change in fair value of derivative liability
Change in fair value of derivative liability resulted in a gain of $0.21 million for the year ended December 31, 2021 compared to a loss of $0.23 million for the year ended December 31, 2020.
Loss on legal settlements
No loss from legal settlements was recorded for the year ended December 31, 2021 while a $5.4 million loss from legal settlements was recorded for the year ended December 31, 2020. Loss from legal settlements resulted due to the Company settling legal claims during the year ended December 31, 2020.
Loss on forbearance agreement
Loss on forbearance settlement were $0 and $12.6 million for the years ended December 31, 2021 and 2020 respectively. Loss on extinguishment resulting from the change in fair value of debt and equity instruments modified due to the forbearance settlement the Company entered into during the year ended December 31, 2020.
Amortization of debt discount
Amortization of debt discount was $0 and $0.32 million for the years ended December 31, 2021 and 2020 respectively. The decrease is due to an increasethe adoption of ASU 2020-06 on January 1, 2021 which extinguished the debt discount recorded in non-cash amortization2020 of debt issuance costs associated with convertible debentures and warrants issued in January 2018.
Liquidity and Capital Resources
The Company’s current operations have focused on business planning, raising capital, establishing an intellectual property portfolio, hiring, and conducting preclinical studies and clinical trials. The Company does not have any product candidates approved for sale and has not generated any revenue from product sales. The Company has sustained operating losses since inception and expects such losses to continue over the foreseeable future. During the year ended December 31, 2018,2021, the Company raised $15$24.7 million through issuance of common stock, raised $16.4 million through the exercise of warrants and raised $1.2 million from a series of issuances of convertible notes, as compared to $12.5 million raised in the year ended December 31, 2020 through a series of issuances of convertible debentures in January, August, and September. $4.4 million of the proceeds raised in August were used to repay a portion of the January convertible debentures. The remaining proceeds were used primarily to aid in raising capital, increasing investor awareness, establishing an intellectual property portfolio, and to ensure continued progression of the Company’s development programs.notes. We anticipate that cash utilized for selling, general and administrative expenses will range between $1$2 and $2$4 million in the coming quarters, while research and development expenses will vary depending on clinical activities. OnThe Company reported $32.0 million of cash and short-term investments at December 31, 2018, we had a working capital deficit2021 and anticipates that will be sufficient to fund operations for the following 12 months, and anticipates raising additional funds during the fiscal year 2022.
The consolidated financial statements of $13,939,000. On February 4, 2019, we entered into a Securities Purchase Agreement with the purchasers identified on the signature pages thereto, pursuant to which the Company issued tohave been prepared on a going-concern basis, which contemplates the Purchasers, on February 4, 2019, Secured Convertible Notesrealization of assets and the satisfaction of liabilities in an aggregate principal amountthe normal course of $1,352,224, consisting of gross proceeds of $1,052,224 and settlement of existing debt of $300,000, which Notes shall be convertible atbusiness. Accordingly, the financial statements do not include any time after issuance into shares of the Company’s common stock, par value $0.001 per share, at a conversion price of $0.60 per share. After closing of this financing, it will stilladjustments that might be necessary should the Company be unable to raisecontinue in existence.
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The Company has incurred substantial losses as of December 31, 2021. The Company anticipates incurring additional capitallosses until such time, it can generate significant sales or revenue from out-licensing of its products currently in development. Substantial additional financing will be needed by the end of the second quarter in order to continueCompany to fund currentits operations and to commercially develop its product candidates.
Management is currently evaluating different strategies to obtain the required funding for future operations. The Company is pursuing several alternatives to address this situation, including the raisingThese strategies may include but are not limited to: public offerings of additional funding through equity and/or debt financings. In order to finance existing operationssecurities; and pay current liabilities over the next twelve months, the Company will need to raise an additional $15 million of capital in 2019.
Critical Accounting Policies
We consider the following accounting policies to be critical given they involve estimates and judgments made by management and are important for our investors’ understanding of our operating results and financial condition.
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. The consolidated financial statements contained in this report include the accounts of GT Biopharma,the Company and its wholly owned subsidiaries, Oxis Biotech, Inc. and its subsidiaries. All intercompany balances and transactions have been eliminated.
Accounting Estimates
The preparation of consolidated financial statements in conformity with Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets associated with IPR&D projects are not amortized until approval byand liabilities and disclosure of contingent assets and liabilities at the Food and Drug Administration (FDA) is obtained in a major market subject to certain specified conditions and management judgment. The useful life of an amortizing asset generally is determined by identifying the period in which substantially alldate of the cash flows are expected to be generated.
Stock-Based Compensation
The Company accounts for income taxesshare-based awards to employees and nonemployees and consultants in accordance with the provisions of Accounting Standards Codification (“ASC”) 718, Compensation-Stock Compensation. Stock-based compensation cost is measured at fair value on the grant date and that fair value is recognized as expense over the requisite service, or vesting period.
The Company values its equity awards using the assetBlack-Scholes option pricing model, and liability approach, whereby deferred income tax assets and liabilities are recognizedaccounts for the estimated future tax effects, based on current enacted tax laws, of temporary differences between financial and tax reporting for current and prior periods. Deferred tax assets are reduced, if necessary, by a valuation allowance if the corresponding future tax benefits may not be realized.
December 31, | ||
2018 | 2017 | |
| Exercise of common stock warrants | 1,813,053 | - |
| Conversion of preferred stock into common stock | 1,163,659 | 1,163,659 |
| Conversion of convertible debentures into common stock | 5,704,543 | - |
| Exercise of common stock options | 1,113 | 1,246 |
8,682,368 | 1,164,905 | |
Inflation
We believe that inflation has not had a material adverse impact on our business or operating results during the periods presented.
Off-balance Sheet Arrangements
We have no off-balance sheet arrangements as of December 31, 2018.2021.
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ITEM 7A7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
This company qualifies as a smaller reporting company, as defined in 17 C.F.R. §229.10(f) (1) and is not required to provide information by this Item.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Please see the consolidated financial statements beginning on page F-1 located in Part IV of this Annual Report on Form 10-K.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our principal executive officer, principal financial officer and principal accounting officer evaluated the effectiveness of our “disclosure controls and procedures” (as such term is defined in Rules 13a-15(e) and 15d-15(e) of the United States Securities Exchange Act of 1934, as amended), as of December 31, 2018.2021. Based on that evaluation, we have concluded that because a material weakness in the Company’s internal control over financial reporting existed as of December 31, 2018, that our disclosure controls and procedures were not effective as of the endDecember 31, 2021 as a result of material weaknesses in internal control over financial reporting, and for the period covered by this Annual Report on Form 10-K. The material weaknessweaknesses in the Company’s internal control over financial reporting and the Company’s remediation efforts are described below.
Management’s Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, a company’s principal executive and principal accounting officers and effected by a company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
| ● | Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company; | |
| ● | Provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and | |
| ● | Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the consolidated financial statements. |
| 40 |
All internal control systems, no matter how well designed, have inherent limitations and can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
As of December 31, 2018,2021, management of the company conducted an assessment of the effectiveness of the company’s internal control over financial reporting. In making this assessment, it used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control—Integrated Framework. In the course of the assessment, material weaknesses were identified in the company’s internal control over financial reporting.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis.
Management determined that fundamental elements of an effective control environment were missing or inadequate as of December 31, 2018.2021. The most significant issues identified were:
1) lack of segregation of duties due to very small staff and significant reliance on outside consultants, and consultants;
2) risks of executive override also due to lack of established policies, and smalllimited employee staff. staff; and
3) insufficient written policies and procedures for accounting and financial reporting for the requirements and application of GAAP and SEC Guidelines.
Management also determined that inadequate and/or ineffective internal controls over financial reporting resulted in unauthorized transactions involving the Company’s assets and common stock. Following the termination of Anthony Cataldo, the Company’s former Chief Executive Officer, and Michael Handelman, the Company’s former Chief Financial Officer, management determined that in July 2021, Mr. Cataldo obtained a short-term advance from the Company in the amount of approximately $2.6 million. Mr. Cataldo’s advance was not memorialized pursuant to customary documentation and was not approved by the Company’s Board of Directors. Mr. Cataldo repaid the full amount of the advance through installment payments in October, November and December 2021. Management has also determined that the Company may have issued up to 187,500 shares of its common stock to various parties without documentation supporting the consideration received by the Company in exchange for the issuance of such shares, or the approval of the Company’s Board of Directors.
Based on the material weaknesses identified above, management has concluded that internal control over financial reporting was not effective as of December 31, 2018. As the company’s operations increase, the company intends2021. The Company has begun to take measures to mitigate the issues identified and implement a functional system of internal controls over financial reporting. Specifically, the Company has engaged a forensic accountant to review the Company’s bank records, transactions with affiliates and/or related parties, expense reimbursement practices and vendor payment practices. That review is ongoing. In addition, the Company’s Board of Directors previously designated a Special Committee in August 2021 charged with, among other duties, evaluating the current compliance, compensation, operations and personnel of the Company, and determining actions appropriate to address any deficiencies or inefficiencies identified through such evaluation. Such measures have included and/or will include, but not be limited to, hiring of additional employees in itsthe Company’s finance and accounting department; preparation of risk-control matrices to identify key risks and develop and document policies to mitigate those risks; and identification and documentation of standard operating procedures for key financial activities.
Attestation Report on Internal Control over Financial Reporting.
This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm, due to the deferral allowed under the Jobs Act for small reporting companies.
Changes in Internal Control over Financial Reporting
Other than as describedwith respect to the remediation efforts discussed above, there was no changeschange in our internal control over financial reporting were madethat occurred during our most recent fiscal quarterthe period covered by this Annual Report on Form 10-K that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
None.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
In accordance with General Instruction G(3) to Form 10-K, the name, age and position heldCompany intends to file with the SEC the information required by eachthis item not later than 120 days after the end of our executive officers and directors as of February 28, 2019. Directors are elected for a period of onethe fiscal year and thereafter serve until the next annual meeting at which their successors are duly electedcovered by the stockholders.
ITEM 11. EXECUTIVE COMPENSATION
In accordance with General Instruction G(3) to Form 10-K, the Company intends to file with the SEC the information concerningrequired by this item not later than 120 days after the annual and long-term compensation for services rendered to us in all capacities for the fiscal years ended December 31, 2018 and 2017end of all persons who served as our principal executive officers and as our principal financial officer during the fiscal year ended December 31, 2018. No other executive officers received total annual compensation during the fiscal year ended December 31, 2018 in excess of $100,000. The principal executive officer and the other named officers are collectively referred to as the “Named Executive Officers.”
| Name and Principal Position | Year | Salary ($) | Bonus ($) | Stock Awards ($) (1) | Option Awards ($) (2) | Non-Equity Incentive Plan Compensation ($) | Nonqualified Deferred Compensation Earnings ($) | All Other Compensation ($) (3) | Total ($) | |
Anthony J. Cataldo (7) | 2018 | $- | $- | $- | $- | $- | $- | $404,151 | $404,151 | |
| Chief Executive Officer | 2017 | $310,667 | $90,000 | $77,275,253 | $- | $- | $- | $77,675,920 | ||
| 2016 | $216,000 | $- | $4,417,026 | $20,707 | $- | $- | $- | $4,653,733 | ||
Steven Weldon (6) | 2018 | $230,000 | $- | $- | $- | $- | $- | $- | $230,000 | |
| Chief Financial Officer | 2017 | $245,333 | $- | $38,472,797 | $- | $- | $- | $- | $38,718,130 | |
| 2016 | $168,000 | $- | $752,852 | $- | $- | $- | $- | $920,852 | ||
Raymond Urbanski, M.D., Ph.D. (4) | 2018 | $321,154 | $- | $7,644,490 | $- | $- | $- | $- | $7,965,644 | |
| Former Chief Executive Officer | 2017 | $133,333 | $- | $7,644,490 | $- | $- | $- | $- | $7,777,823 | |
Shawn Cross (5) | 2018 | $233,942 | $20,000 | $- | $- | $- | $- | $- | $253,942 | |
| Former Chief Executive Officer | 2017 | $104,165 | $- | $- | $- | $- | $- | $- | $104,165 | |
Kathleen Clarence-Smith (8) | 2018 | $278,846 | $- | $- | $- | $- | $- | $- | $278,846 | |
| Former Chief Executive Officer | 2017 | $166,667 | $- | $- | $- | $- | $- | $- | $166,667 |
Option Awards | |||||
| Name | Number of Securities Underlying Unexercised Options (#) Exercisable | Number of Securities Underlying Unexercised Options (#) Unexercisable | Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#) | Option Exercise Price ($) | Option Expiration Date |
| Steven Weldon | - | - | - | $- | |
| Anthony Cataldo | 358 | - | - | $750 | 7/1/19 |
| Anthony Cataldo | 358 | - | - | $1,500 | 7/1/19 |
| Anthony Cataldo | 358 | - | - | $2,250 | 7/1/19 |
| Name | Fees Earned or Paid in Cash ($) | Option Awards ($) | Stock Awards ($) | Total ($) |
| Dr. John Bonfiglio (1) | $- | $- | $- | $- |
| Dr. Peter Kiener (1) | $8,173 | $- | $- | $8,173 |
| Geoffrey Davis (1) | $26,250 | $- | $- | $26,250 |
| Anthony Cataldo | $- | $- | $- | $- |
| Federica O'Brien (2) | $8,173 | $- | $- | $8,173 |
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
In accordance with General Instruction G(3) to own beneficially 5% or more of any class of our common stock, (b) by each of our named executive officers, (c) by each of our directors and (d) by all our current executive officers and directors as a group. As of February 22, 2019, there were 51,291,083 shares of our common stock issued and outstanding. Shares of common stock subjectForm 10-K, the Company intends to stock options and preferred stock that are currently exercisable or exercisable within 60 days of February 22, 2019 are deemed to be outstanding for purposes of computing the percentage ownership of that person but are not treated as outstanding for computing the percentage ownership of any other person. Unless indicated below, the persons and entities named in the table have sole voting and sole investment power with respect to all shares beneficially owned, subject to community property laws where applicable. Except as otherwise indicated, the address of each stockholder is c/o GT Biopharma, Inc. at 310 N. Westlake Blvd., Suite 206, Westlake Village, CA 91362.
Number of Shares of Common Stock Beneficially | Percent of Shares of Outstanding Common | |
| Name and Address of Beneficial Owner | Owned | Stock |
| Security Ownership of Certain Beneficial Owners: | ||
| Kathleen Clarence-Smith, M.D., Ph.D. (7) | 7,521,051 | 14.66% |
| Mark Silverman (7) | 7,226,108 | 14.09% |
| William Heavener (1) | 4,674,749 | 9.11% |
| Bristol Investment Fund, Ltd. (2) | 4,534,795 | 8.84% |
| Adam Kasower (3) | 3,645,620 | 7.11% |
| Theorem Group, LLC (4) | 3,540,130 | 6.90% |
| Alpha Capital Anstalt (5) | 2,966,667 | 5.78% |
| The Rosalinde and Arthur Gilbert Foundation (6) | 2,739,267 | 5.34% |
| Security Ownership of Management and Directors: | ||
| Anthony J. Cataldo (7) | 3,734,320 | 7.28% |
| Steven Weldon (7) | 2,269,707 | 4.43% |
| Executive officers and directors as a group — 2 people | 6,004,027 | 11.71% |
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants, and Rights | Weighted-Average Exercise Price of Outstanding Options, Warrants, and Rights | Number of Securities Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) | |
| Plan Category | (a) | (b) | (c) |
| Equity compensation plans approved by security holders (1) | 1,113 | $1,320 | - |
| Equity compensation plans not approved by security holders | - | $- | - |
| Total | 1,113 | $1,320 | - |
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
In accordance with General Instruction G(3) to useForm 10-K, the definition for “director independence” under the Nasdaq Stock Market’s listing standards, which defines an “independent director” as “a person other than an officer or employee of us or its subsidiaries or any other individual having a relationship, which in the opinion of our Board of Directors, would interfereCompany intends to file with the exercise of independent judgment in carrying outSEC the responsibilities of a director.” The definition further provides that, among others, employment of a directorinformation required by us (or any parent or subsidiary of ours) at any time duringthis item not later than 120 days after the past three years is considered a bar to independence regardlessend of the determination of our Board of Directors.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
In accordance with General Instruction G(3) to Form 10-K, the Company intends to file with the SEC the information required by this item not later than 120 days after the end of the fiscal years ending December 31, 2018 and 2017. The following table shows the fees that were paid or accruedyear covered by us for audit and other services provided by Seligson & Giannattasio, LLP for the 2018 and 2017 fiscal years.this Form 10-K.
| 42 |
2018 | 2017 | |
| Audit Fees (1) | $69,000 | $64,000 |
| Audit-Related Fees (2) | $- | $- |
| Tax Fees (3) | $4,000 | $4,000 |
| All Other Fees | $- | $- |
| Total | $73,000 | $68,000 |
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
The Company’s consolidated financial statements and related notes thereto are listed and included in this Annual Report beginning on page F-1. The following documents are furnished as exhibits to this Annual Report on Form 10-K.
EXHIBIT INDEX
| 43 |
| 44 |
| Incorporated by Reference | ||||||||||
| Exhibit Number | Exhibit Description | Form | Date | Number | Filed Herewith | |||||
| Agreement and Plan of Merger | 10-Q | 11/14/17 | 2.1 | |||||||
Restated Certificate of Incorporation as filed in Delaware September 10, 1996 and as thereafter amended through March 1, 2002 | 10-KSB | 04/01/02 | 3.A | |||||||
Certificate of Amendment to Amended and Restated Certificate of Incorporation of GT Biopharma, Inc. | 10-K | 03/31/11 | 3.2 | |||||||
Certificate of Designation of Preferences, Rights and Limitations of Series H Convertible Preferred Stock of GT Biopharma, Inc., dated February 5, 2010 | 8-K | 02/16/10 | 3.1 | |||||||
Certificate of Designation of Preferences, Rights and Limitations of Series I Convertible Preferred Stock of GT Biopharma, Inc., dated March 18, 2011. | 10-K | 03/31/11 | 3.4 | |||||||
Bylaws, as restated effective September 7, 1994 and as amended through April 29, 2003 | 10-QSB | 08/13/03 | 3 | |||||||
| Certificate of Amendment to the Certificate of Incorporation of the Registrant, effective as of July 19, 2017. | 8-K | 3/15/18 | ||||||||
| License Agreement with ID4 Pharma LLC | 10-Q | 08/11/17 | 10.1 | |||||||
| License Agreement with MultiCell Immunotherapeutics, Inc. | 10-Q | 08/11/17 | 10.2 | |||||||
| License Agreement with the University of Minnesota | 10-Q | 08/11/17 | 10.3 | |||||||
| License Agreement with Daniel A. Vallera, Ph.D. | 10-Q | 08/11/17 | 10.4 | |||||||
| Warrant Conversion Agreement | 10-Q | 11/14/17 | 10.6 | |||||||
| Preferred Conversion Agreement | 10-Q | 11/14/17 | 10.7 | |||||||
| Amended Note Conversion Agreement | 10-Q | 11/14/17 | 10.8 | |||||||
| Amended Warrant Conversion Agreement | 10-Q | 11/14/17 | 10.9 | |||||||
| Amended Preferred Conversion Agreement | 10-Q | 11/14/17 | 10.10 | |||||||
| Securities Purchase Agreement | 8-K | 01/13/17 | 10.1 | |||||||
| 10% Senior Convertible Debenture | 8-K | 01/13/17 | 10.2 | |||||||
| Common Stock Purchase Warrant | 8-K | 01/13/17 | 10.3 | |||||||
| Securities Purchase Agreement by and among the Company and the Buyers, dated January 22, 2018. | 8-K | 1/23/18 | 10.1 | |||||||
| Form of Registration Rights Agreement by and among the Company and the Buyers, dated January 22, 2018. | 8-K | 1/23/18 | 10.2 | |||||||
| Form of Note. | 8-K | 1/23/18 | 10.3 | |||||||
| Form of Warrant. | 8-K | 1/23/18 | 10.4 | |||||||
| First Amendment to the Employment Agreement, dated as of February 14, 2018, between the Company and Dr. Clarence-Smith. | 8-K | 2/21/18 | 10.2 | |||||||
| Consultant Agreement, dated as of February 14, 2018, between the Company and Mr. Cataldo. | 8-K | 2/21/18 | 10.3 | |||||||
| Form of 10% Senior Convertible Debenture | 8-K | 08/03/18 | 4.1 | |||||||
| Security Purchase Agreement | 8-K | 08/03/18 | 10.1 | |||||||
| Form of 10% Senior Convertible Debenture | 8-K | 09/07/18 | 4.1 | |||||||
| Security Purchase Agreement | 8-K | 09/07/18 | 10.1 | |||||||
| Form of 10% Senior Convertible Debenture | 8-K | 09/24/18 | 4.1 | |||||||
| Security Purchase Agreement | 8-K | 09/24/18 | 10.1 | |||||||
| Separation Agreement between the Company and Dr. Clarence-Smith | 8-K | 10/12/18 | 10.1 | |||||||
| Resignation of Steven Weldon | 8-K | 10/16/18 | ||||||||
| Stock Pledge Agreement | 10-Q | 08/14/18 | 10.10 | |||||||
| Executive Employment Agreement with Dr. Urbanski | 10-Q | 11/14/18 | 10.17 | |||||||
| Code of Ethics | 10-K | 03/31/16 | 14.1 | |||||||
| Subsidiaries of GT Biopharma, Inc. | 10-K | 03/31/16 | 21.1 | |||||||
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | X | |||||||||
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | X | |||||||||
Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | X | |||||||||
Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | X | |||||||||
| 101 | Interactive Data File | X | ||||||||
| 45 |
++ Indicates management contract or compensatory plan.
* This certification shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that Section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act.
ITEM 16. FORM 10-K SUMMARY
None.
| 46 |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| GT Biopharma, Inc. | |||
| Dated: March | By: | /s/ | Manu Ohri |
| Manu Ohri, Chief | |||
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Michael Breen and Manu Ohri, and each of them, as his true and lawful attorneys-in-fact and agents, with full power of substitution for him, and in his name in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, and any of them or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Name | Date | |||
| /s/ Michael Breen | Executive Chairman of the Board and | March 28, 2022 | ||
| Michael Breen | Interim Chief Executive Officer (Principal Executive Officer) | |||
| /s/ Manu Ohri | Chief Financial Officer (Principal Financial and Accounting Officer) | March 28, 2022 | ||
| Manu Ohri | ||||
| /s/ Bruce Wendel | Vice Chairman of the Board | March 28, 2022 | ||
| Bruce Wendel | ||||
/s/ Rajesh Shrotriya | March | |||
| 47 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Stockholders and Board of Directors and Stockholders of
GT Biopharma, Inc.
Brisbane, California
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of GT Biopharma, Inc. and subsidiaries ,(the "Company"(the “Company”) as of December 31, 20182021 and 2017,2020 and the related consolidated statements of operations, changes in stockholders’ equity (deficit), and cash flows for each of the years in the two-year periodthen ended, December 31, 2018, and the related notes (collectively referred to as the financial statements)“financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company and subsidiaries as of December 31, 20182021 and 20172020, and the consolidated results of its operations and its consolidated cash flows for each of the years in the two-year periodthen ended, December 31, 2018, in conformity with accounting principles generally accepted in the United States of America.
Basis offor Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our auditsaudit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter Description
The accompanyingcritical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, have been prepared assuming the Company will continuetaken as a going concern. whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
As discussed in Note 18 to the consolidated financial statements, the Company has incurredissues equity awards to certain officers, employees and consultants as compensation (the “Equity Awards”). The fair values of these Equity Awards were determined as of the grant date using a Black-Scholes option-pricing model (the “Black-Scholes Model”). The selection of the valuation methodology and assumptions utilized in the Black-Scholes Model are based, in part, upon assumptions for which management is required to use judgment, particularly the risk-free interest rate, volatility, and dividend yield.
We identified the valuation of the Equity Awards as a critical audit matter because of the significant recurring losses. The realizationjudgments made by management to determine the grant date fair values. This required a high degree of a major portionauditor judgment and an increased expenditure of its assets is dependent upon its abilityeffort when performing audit procedures to meet its future financing needsevaluate the reasonableness of management’s valuation methodology and related assumptions, including the risk-free interest rate, volatility, and dividend yield.
Our audit procedures related to the determination of the fair values of the Equity Awards, including the valuation methodology and related assumptions such as the risk-free interest rate, volatility, and dividend yield, consisted of the following, among others:
●We obtained an understanding of management’s process over the valuation of the Equity Awards, including those over the determination of the valuation methodology and related assumptions, including the risk-free interest rate, volatility, and dividend yield.
●We obtained and read the Equity Award agreements and management’s valuation analyses, including supporting schedules and related narrative information.
●We evaluated management’s valuation methodology, including the selection of the model to determine the fair values of the Equity Awards.
●We evaluated the reasonableness of management’s valuation assumptions and the successunderlying source information of significant valuation assumptions, including the risk-free interest rate, volatility, and dividend yield.
●We assessed whether management’s calculations of the fair values were applied in accordance with the selected methodology, including testing the mathematical accuracy of the valuation analyses.
●We developed independent estimates for the fair values of the Equity Awards based on assumptions utilized by the Company in its future operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from this uncertainty.
We have served as the Company’s auditor since 2008.December 2020.
Weinberg & Company, P.A.
Los Angeles, California
March 28, 2022
PCAOB ID: 572
| F-1 |
GT Biopharma, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except shares and par value and share data)
December 31, 2018 | December 31, 2017 | |
| ASSETS | ||
| Current Assets: | ||
| Cash and cash equivalents | $60 | $576 |
| Prepaid expenses | 30 | - |
| Total Current Assets | 90 | 576 |
| Intangible assets | 25,262 | 253,777 |
| Deposits | 12 | 9 |
| Fixed assets, net | 35 | 6 |
| Total Other Assets | 25,309 | 253,792 |
| TOTAL ASSETS | $25,399 | $254,368 |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
| Current Liabilities: | ||
| Accounts payable | $1,762 | $2,546 |
| Accrued expenses | 1,455 | 102 |
| Line of credit | 31 | 31 |
| Note Payable to Related Party | 100 | - |
| Deferred Rent | 8 | - |
| Convertible debentures | 10,673 | - |
| Total Current Liabilities | 14,029 | 2,679 |
| Total liabilities | 14,029 | 2,679 |
| Stockholders’ Equity: | ||
| Convertible preferred stock - $0.001 par value; 15,000,000 shares authorized: | ||
| Series C - 96,230 and 96,230 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 1 | 1 |
| Series J – 1,163,548 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 1 | 1 |
| Common stock - $0.001 par value; 750,000,000 shares authorized; and 50,650,478 and 50,117,977 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 51 | 50 |
| Additional paid-in capital | 540,171 | 521,305 |
| Accumulated deficit | (528,685) | (269,499) |
| Noncontrolling interest | (169) | (169) |
| Total Stockholders’ Equity | 11,370 | 251,689 |
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $25,399 | $254,368 |
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 8,968 | $ | 5,297 | ||||
| Short-term investments | 23,011 | - | ||||||
| Prepaid expenses and other current assets | 190 | 364 | ||||||
| Total current assets | $ | 32,169 | $ | 5,661 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 8,189 | $ | 2,243 | ||||
| Accrued expenses | 1,901 | 1,296 | ||||||
| Accrued interest | - | 4,838 | ||||||
| Convertible notes payable (net of discount of $4,519 at December 31, 2020) | - | 26,303 | ||||||
| Line of credit | 31 | 31 | ||||||
| Derivative liability | 138 | 383 | ||||||
| Total current liabilities | 10,259 | 35,094 | ||||||
| Stockholders’ equity (deficit) | ||||||||
| Convertible Preferred stock, par value $, shares authorized | ||||||||
| Series C - shares issued and outstanding at December 31, 2021 and 2020, respectively | 1 | 1 | ||||||
| Series J - and shares issued and outstanding at December 31, 2021 and 2020, respectively | - | 2 | ||||||
| Convertible Preferred stock | ||||||||
| Common stock, par value $, shares authorized, shares and shares issued and outstanding as of December 31, 2021 and 2020, respectively | 32 | 5 | ||||||
| Common stock issuable shares at December 31, 2021 | 1,113 | |||||||
| Additional paid in capital | 674,348 | 566,356 | ||||||
| Accumulated deficit | (653,584 | ) | (595,797 | ) | ||||
| Total stockholders’ equity (deficit) | 21,910 | (29,433 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 32,169 | $ | 5,661 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-2 |
GT Biopharma, Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands except per share data)
December 31 | ||
2018 | 2017 | |
| Operating expenses: | ||
| Research and development | $9,067 | $1,068 |
| Selling, general and administrative expenses | 12,487 | 134,502 |
| Loss on impairment | 228,515 | - |
| Total operating expenses | 250,069 | 135,570 |
| Loss from operations | (250,069) | (135,570) |
| Other income (expense): | ||
| Interest expense | (9,117) | (8,602) |
| Total other income (expense) | (9,117) | (8,602) |
| Loss before provision for income taxes | (259,186) | (144,172) |
| Provision for income tax | - | - |
| Net loss | $(259,186) | $(144,172) |
| Net loss per common share – basic and diluted | $(5.16) | $(8.60) |
| Weighted average common shares outstanding – basic and diluted | 50,240 | 16,769 |
| 2021 | 2020 | |||||||
| For the Year Ended | ||||||||
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| Revenues | $ | - | $ | - | ||||
| Operating Expenses: | ||||||||
| Research and development | 9,591 | 485 | ||||||
| Selling, general and administrative (including $of stock compensation to officers, directors and employees during the year ended December 31, 2021) | 47,924 | 6,279 | ||||||
| Loss from Operations | 57,515 | 6,764 | ||||||
| Other (Income) Expense | ||||||||
| Interest income | (38 | ) | - | |||||
| Interest expense | 718 | 3,003 | ||||||
| Change in fair value of derivative liability | (211 | ) | 230 | |||||
| Unrealized loss on marketable securities | 29 | - | ||||||
| Loss on forbearance agreement | - | 12,598 | ||||||
| Loss on legal settlements | - | 5,384 | ||||||
| Amortization of debt discount | - | 317 | ||||||
| Total Other (Income) Expense | 498 | 21,532 | ||||||
| Net Loss | $ | (58,013 | ) | $ | (28,296 | ) | ||
| Net loss per share - basic and diluted | $ | (2.06 | ) | $ | (6.45 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 28,155,624 | 4,385,222 | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-3 |
GT Biopharma, Inc. and Subsidiaries
Consolidated StatementStatementS of Stockholders'Stockholders’ Equity
(in thousands)
Additional | ||||||
Preferred Shares | Common Shares | Paid-in | Accumulated | |||
Shares | Amount | Shares | Amount | Capital | Deficit | |
| Balance at December 31, 2016 | 1,788 | $2 | 104 | $0 | $105,891 | $(124,649) |
| Issuance of common stock for acquisition | 16,928 | 17 | 253,901 | |||
| Issuance of common and preferred stock for convertible notes and interest | 909 | 1 | 17,678 | 18 | 25,254 | |
| Issuance of common and preferred stock for warrants | 5 | 0 | 497 | 0 | 5,819 | |
| Issuance of common for preferred stock | (2,042) | (2) | 5,678 | 6 | (4) | |
| Issuance of common and preferred stock for compensation | 600 | 1 | 9,233 | 9 | 129,766 | |
| Change in accounting method for debt and warrants | 678 | (678) | ||||
| Net loss | (144,172) | |||||
| Balance at December 31, 2017 | 1,260 | $2 | 50,118 | $50 | $521,305 | $(269,499) |
| Issuance of warrants | 8,304 | |||||
| Issuance of common stock for convertible notes | 162 | 0 | 325 | |||
| Beneficial conversion feature on convertible notes | 544 | |||||
| Issuance of common stock for compensation | 370 | 1 | 9,693 | |||
| Net loss | (259,186) | |||||
| Balance at December 31, 2018 | 1,260 | $2 | 50,650 | $51 | $540,171 | $(528,685) |
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||
| Preferred Shares | Common Shares | Common Shares Issuable | Additional Paid in | Accumulated | ||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||
| Balance, December 31, 2019 | 2,450 | $ | 3 | 4,105 | $ | 4 | - | $ | - | $ | 548,184 | $ | (567,501 | ) | $ | (19,310 | ) | |||||||||||||||||||
| Fair value of amended convertible notes and warrants | - | - | - | - | - | - | 8,643 | - | 8,643 | |||||||||||||||||||||||||||
| Issuance of common and warrants for settlement of litigation | - | - | 262 | - | - | - | 2,246 | - | 2,246 | |||||||||||||||||||||||||||
| Beneficial conversion feature on convertible notes payable | - | - | - | - | - | - | 5,274 | - | 5,274 | |||||||||||||||||||||||||||
| Common shares issued upon conversion of notes payable | - | - | 512 | 1 | - | - | 1,740 | - | 1,741 | |||||||||||||||||||||||||||
| Extinguishment of debt discount upon adoption of ASU 2020-06 | ||||||||||||||||||||||||||||||||||||
| Conversion of Preferred Series J-1 to common stock | ||||||||||||||||||||||||||||||||||||
| Conversion of Preferred Series J-1 to common stock, shares | ||||||||||||||||||||||||||||||||||||
| Common shares issued upon mandatory conversion of notes payable and accrued interest | ||||||||||||||||||||||||||||||||||||
| Common shares issued upon mandatory conversion of notes payable and accrued interest, shares | ||||||||||||||||||||||||||||||||||||
| Common shares issued upon exercise of warrants | - | - | 240 | - | - | - | - | - | - | |||||||||||||||||||||||||||
| Issuance of common stock for compensation | - | - | 99 | - | - | - | 269 | - | 269 | |||||||||||||||||||||||||||
| Issuance of common stock in public offering, net of cost | ||||||||||||||||||||||||||||||||||||
| Issuance of common stock in public offering, net of cost, shares | ||||||||||||||||||||||||||||||||||||
| Issuance of common stock for research and development agreement | ||||||||||||||||||||||||||||||||||||
| Issuance of common stock for research and development agreement, shares | ||||||||||||||||||||||||||||||||||||
| Issuance of common stock for services | ||||||||||||||||||||||||||||||||||||
| Issuance of common stock for services, shares | ||||||||||||||||||||||||||||||||||||
| Equity compensation to officers and board of directors | ||||||||||||||||||||||||||||||||||||
| Equity compensation to officers and board of directors, shares | ||||||||||||||||||||||||||||||||||||
| Extinguishment of derivative liability | ||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | (28,296 | ) | (28,296 | ) | |||||||||||||||||||||||||
| Balance, December 31, 2020 | 2,450 | 3 | 5,218 | 5 | - | - | 566,356 | (595,797 | ) | (29,433 | ) | |||||||||||||||||||||||||
| Extinguishment of debt discount upon adoption of ASU 2020-06 | - | - | - | - | - | - | (4,745 | ) | 226 | (4,519 | ) | |||||||||||||||||||||||||
| Conversion of Preferred Series J-1 to common stock | (2,354 | ) | (2 | ) | 692 | 1 | - | - | 1 | - | - | |||||||||||||||||||||||||
| Common shares issued upon mandatory conversion of notes payable and accrued interest | - | - | 11,086 | 11 | 327 | 1,113 | 37,675 | - | 38,799 | |||||||||||||||||||||||||||
| Common shares issued upon exercise of warrants | - | - | 3,074 | 3 | - | - | 16,430 | - | 16,433 | |||||||||||||||||||||||||||
| Issuance of common stock in public offering, net of cost | - | - | 4,945 | 5 | - | - | 24,674 | - | 24,679 | |||||||||||||||||||||||||||
| Issuance of common stock for research and development agreement | - | - | 190 | - | - | - | 1,355 | - | 1,355 | |||||||||||||||||||||||||||
| Issuance of common stock for services | - | - | 3,082 | 3 | - | - | 15,337 | - | 15,340 | |||||||||||||||||||||||||||
| Equity compensation to officers, board of directors and employees | - | - | 3,775 | 4 | - | - | 17,230 | - | 17,234 | |||||||||||||||||||||||||||
| Extinguishment of derivative liability | - | - | - | - | - | - | 35 | - | 35 | |||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | (58,013 | ) | (58,013 | ) | |||||||||||||||||||||||||
| Balance, December 31, 2021 | 96 | $ | 1 | 32,062 | $ | 32 | 327 | $ | 1,113 | $ | 674,348 | $ | (653,584 | ) | $ | 21,910 | ||||||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-4 |
GT Biopharma, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
Twelve Months Ended December 31, | ||
2018 | 2017 | |
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||
| Net loss | $(259,186) | $(144,172) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation | 7 | 2 |
| Loss on impairment of long-lived assets | 228,515 | - |
| Stock compensation expense for options and warrants issued to employees and non-employees | 9,696 | 130,124 |
| Amortization of debt discounts | 8,663 | 4,914 |
| Note Allonge | - | 100 |
| Non-cash interest expense | 441 | 2,197 |
| Amortization of loan costs | 1,076 | - |
| Changes in operating assets and liabilities: | ||
| Prepaid Expenses | (30) | - |
| Other assets | (3) | (7) |
| Other liabilities | 8 | |
| Accounts payable and accrued liabilities | 136 | 1,412 |
| Net cash used in operating activities | (10,677) | (5,430) |
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||
| Acquisition of fixed assets | (36) | (4) |
| Net cash used by investing activities | (36) | (4) |
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||
| Proceeds from notes payable | 15,145 | 5,991 |
| Loan costs | (533) | - |
| Repayment of note payable | (4,415) | - |
| Net cash provided by financing activities | 10,197 | 5,991 |
| NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (516) | 557 |
| CASH AND CASH EQUIVALENTS - Beginning of period | 576 | 19 |
| CASH AND CASH EQUIVALENTS - End of period | $60 | $576 |
| Supplemental cash flow disclosures: | ||
| Issuance of common stock upon conversion of convertible notes | $325 | $- |
| Acquisition of intangibles through issuance of common stock | $- | $253,777 |
| Issuance of common stock for interest expense | $- | $5,179 |
| Issuance of common stock for debt | $- | $19,166 |
| 2021 | 2020 | |||||||
| For the Year Ended | ||||||||
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (58,013 | ) | $ | (28,296 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock based compensation - consultants and research and development | 16,695 | - | ||||||
| Stock based compensation - officers, directors and employees | 17,234 | 269 | ||||||
| Convertible notes payable issued for consulting services | 720 | - | ||||||
| Amortization of debt discount | - | 317 | ||||||
| Convertible notes payable issued and fair value of amended convertible notes payable and warrants as part of forbearance agreements | - | 12,598 | ||||||
| Convertible notes payable issued and fair value of common shares and warrants issued as part of legal settlements | - | 5,003 | ||||||
| Loss on abandonment of lease | - | 60 | ||||||
| Change in fair value of derivative liability | (211 | ) | 230 | |||||
| Unrealized loss on marketable securities | 29 | - | ||||||
| Issuance of warrants accounted as derivative liability | - | 153 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| (Increase) decrease in prepaid expenses | 174 | 242 | ||||||
| Increase (decrease) in accounts payable and accrued expenses | 7,077 | (838 | ) | |||||
| Increase in accrued interest | 689 | 3,000 | ||||||
| Net Cash Used in Operating Activities | (15,606 | ) | (7,262 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Purchases of investments | (23,040 | ) | - | |||||
| Net Cash Used in Investing Activities | (23,040 | ) | - | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from exercise of warrants | 16,433 | - | ||||||
| Proceeds from issuance of common stock | 24,679 | - | ||||||
| Proceeds from issuance of convertible notes payable | 1,205 | 12,531 | ||||||
| Net Cash Provided by Financing Activities | 42,317 | 12,531 | ||||||
| Net Increase in Cash | 3,671 | 5,269 | ||||||
| Cash at Beginning of Period | 5,297 | 28 | ||||||
| Cash at End of Period | $ | 8,968 | $ | 5,297 | ||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
| Cash paid during the year for: | ||||||||
| Interest | $ | - | $ | - | ||||
| Income taxes paid | $ | - | $ | - | ||||
| SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES | ||||||||
| Extinguishment of unamortized debt discount and adjustment to accumulated deficit upon adoption of ASU 2020-06 | $ | 4,745 | $ | - | ||||
| Beneficial conversion feature of notes payable issued for cash | $ | - | $ | 4,745 | ||||
| Common stock issued upon conversion of notes payable and accrued interest | $ | 38,799 | $ | 1,741 | ||||
| Accounts payable reclassified to convertible notes | $ | 525 | $ | - | ||||
| Extinguishment of derivative liability | $ | 35 | $ | - | ||||
| Conversion of Series J Preferred Stock to Common Stock | $ | 2 | $ | - | ||||
| Convertible notes payable issued for consulting services | $ | - | $ | 360 | ||||
| Reclassification of lease liability to accrued expenses | $ | - | $ | 58 | ||||
The accompanying condensed notes are an integral part of these consolidated financial statements.
| F-5 |
GT Biopharma, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
For the Years Ended December 31, 2021 and 2020
Note 1 – Organization and Operations
In 1965, the corporate predecessor of GT Biopharma Inc. (the Company), Diagnostic Data, Inc., was incorporated in the State of California. Diagnostic Data changed its incorporation to the State of Delaware in 1972;1972 and changed its name to DDI Pharmaceuticals, Inc. in 1985. In 1994, DDI Pharmaceuticals merged with International BioClinical, Inc. and Bioxytech S.A. and changed its name to OXIS International, Inc. In July 2017, the Company changed its name to GT Biopharma, Inc.
The Company is a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based off our proprietary Natural Killer (NK) cell engager (Tri-specificTri-specific Killer Engager (TriKE) &(TriKE®), and Tetra-specific Killer Engager (TetraKE)(Dual Targeting TriKE®Dual Targeting TriKE®) platforms. The Company’s TriKE® and bi-specific Antibody Drug Conjugate (bispecific-ADC) technology platforms. OurDual Targeting TriKE and TetraKE® platforms generate proprietary moietiestherapeutics designed to harness and enhance the cancer killing abilities of a patient’s own natural killer or NK, cells. Once bound to an NK cell, our moieties are designed to stimulate the NK cell and precisely direct it to one or more specifically-targeted proteins (tumor antigens) expressed on a specific typecells (NK cells).
Note 2 – Summary of cancer, ultimately resulting in the cancer cell’s death. TriKEs and TetraKEs are made up of recombinant fusion proteins, can be designed to target tumor antigens on hematologic malignancies, sarcomas or solid tumors and do not require patient-specific customization. They are designed to be dosed in an outpatient setting and are expected to have reasonably low cost of goods. Our bispecific-ADC platform can generate product candidates that are ligand-directed single-chain fusion proteins that simultaneously target two tumor antigens. We believe our bispecific-ADC moieties represents the next generation of ADCs.
Basis of ConsolidationPresentation and Comprehensive Income
The accompanying consolidated financial statements include the accounts of GT Biopharma, Inc. and its subsidiaries. All intercompany balances and transactions have been eliminated. The Company's financial statements are prepared using the accrual method of accounting.
Liquidity
The accompanying consolidated financial statements have been prepared under the assumption that the Company will continue as a going concern. Such assumption contemplates the realization of assets and satisfaction of liabilities in the preparationnormal course of business. For the year ended December 31, 2021, the Company recorded a net loss of $58.0 million of which $ million resulted from non-cash stock compensation, and used cash in operations of $15.6 million. As of December 31, 2021, the Company had a cash and short-term investments balance of $32.0 million, and working capital and stockholders’ equity of $22.9 million. Management anticipates that the $32.0 million of cash and cash equivalents, and short-term investments are adequate to satisfy the liquidity needs of the Company for at least one year from the date the Company’s 2021 consolidated financial statements. statements are issued.
During the year ended December 31, 2021 the Company raised $24.7 million through issuance of common stock, raised $16.4 million through the exercise of warrants and raised $1.2 million from a series of issuances of convertible notes (see Note 8).
Historically, the Company has financed our operations through public and private sales of common stock, issuance of preferred and common stock, issuance of convertible debt instruments, and strategic collaborations.
Reclassification of Prior Year Presentation
Certain prior year amounts due to the resolution of non-controlling interest in net loss have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations.
COVID-19
In March 2020, the World Health Organization declared coronavirus COVID-19 a global pandemic. This contagious disease outbreak, which has continued to spread, has adversely affected workforces, customers, economies, and financial markets globally. It has also disrupted the normal operations of many businesses. This outbreak could decrease spending, adversely affect demand for the Company’s products, and harm the Company’s business and results of operations.
During the year ended December 31, 2021, the Company believes the COVID-19 pandemic did impact its operating results. However, the Company has not observed any impairments of its assets or a significant change in the fair value of its assets due to the COVID-19 pandemic. At this time, it is not possible for the Company to predict the duration or magnitude of the adverse results of the outbreak and its effects on the Company’s business or results of operations, financial condition or liquidity.
The Company has been following the recommendations of health authorities to minimize exposure risk for its team members, including a temporary closure of its corporate office and having team members work remotely. Most vendors have transitioned to electronic submission of invoices and payments.
| F-6 |
Accounting Estimates
The preparation of consolidated financial statements in conformity with Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities revenues and expenses and disclosuresdisclosure of contingent assets and liabilities at the date of the consolidated financial statements.statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Stock-Based Compensation
The Company accounts for share-based awards to employees and nonemployees and consultants in accordance with the provisions of Accounting Standards Codification (“ASC”) 718, Compensation-Stock Compensation. Stock-based compensation cost is measured at fair value on the grant date and that fair value is recognized as expense over the requisite service, or vesting period.
The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur. Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using a its own historical stock price volatility. The expected term of the instrument is estimated by using the simplified method to estimate expected term. The risk-free interest rate is estimated using comparable published federal funds rates.
Fair Value of Financial Instruments
Financial Accounting Standards Board (“FASB”) ASC 820-10 requires entities to disclose the fair value of financial instruments, both assets and liabilities recognized and not recognized on the balance sheet for which it is practicable to estimate fair value. ASC 820-10 defines the fair value of a financial instrument as the amount at which the instrument could be exchanged in a current transaction between willing parties.
The three levels of the fair value hierarchy are identified as componentsfollows:
Level 1 Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the entity has the ability to access.
Level 2 Valuations based on quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable data for substantially the full term of an enterprise about which separate discretethe assets or liabilities.
Level 3 Valuations based on inputs that are unobservable, supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying amount of the Company’s derivative liability of $0.1 million as of December 31, 2021 was based on Level 2 measurements.
The carrying amounts of the Company’s other financial informationassets and liabilities, such as cash, prepaid expense, accounts payable and accrued expenses, and notes payable, approximate their fair values because of the short maturity of these instruments.
Derivative Financial Instruments
The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocationinitially recorded at its fair value and assessing performance. Tois then re-valued at each reporting date, the Company has viewed its operations and manages its business as one segment operatingwith changes in the United States of America.
| F-7 |
Cash Equivalents
The Company considers all highly liquid investments with original maturitiesa maturity of three months or less when purchased to be cash equivalents.
Research and Development Costs
Costs incurred for research and development are expensed as incurred. The salaries, benefits, and overhead costs of Credit Risk
Leases
The Company maintains substantially all leases our corporate office space under a lease agreement with monthly payments over a period of its cash balances12 months. Pursuant to ASC 842, Leases, lease assets are presented as operating lease right-of-use assets and the related liabilities are presented as lease liabilities in our consolidated balance sheets. At December 31, 2021 and 2020, we have no leases with an initial term greater than 12 months. However, on November 19, 2021 we entered into a limited numbersublease with Aimmune Therapeutics, Inc. for 4,500 square feet of financial institutions. The balances are each insured byoffice space located in Brisbane, CA having a commencement date of January 1, 2022 and maturing on June 30, 2024. As the Federal Deposit Insurance Corporation up to $250,000. The Companylease had not yet commenced as of December 31, 2021, no balancesrelated rent expense was recorded in excess of this limit2021 and no right-of-use asset with a related liability was recorded at December 31, 2018.
Basic net incomeearnings (loss) per share is computed by dividingusing the net loss for the period by the weighted averageweighted-average number of common shares outstanding during the period. Diluted net incomeearnings (loss) per share is computed by dividingusing the net loss for the period by the weighted averageweighted-average number of common shares and the dilutive effect of contingent shares outstanding during the period, plusperiod. Potentially dilutive contingent shares, which primarily consist of convertible notes, stock issuable to the potential dilutive effectexercise of common shares issuable upon exercise or conversion of outstanding stock options and warrants duringhave been excluded from the period.
Schedule of Anti-dilutive Securities
| 2021 | 2020 | |||||||
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| A. Warrants to purchase common stock | 2,337,274 | 221,041 | ||||||
| B. Convertible notes payable | - | 9,065,262 | ||||||
| C. Convertible Series J Preferred stock | - | 692,220 | ||||||
| D. Convertible Series C Preferred stock | - | 7 | ||||||
| E. Options to purchase common stock | 302,500 | - | ||||||
| Total anti-dilutive securities | 2,639,774 | 9,978,530 | ||||||
Concentration
Cash is deposited in one financial institution. The balances held at this financial institution at times may be anti-dilutive:in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits of up to $250,000.
The Company has a significant concentration of expenses incurred and accounts payable from a single vendor. Please see Note 4 for further information.
| F-8 |
December 31, | ||
2018 | 2017 | |
| Exercise of common stock warrants | 1,813,053 | - |
| Conversion of preferred stock into common stock | 1,163,659 | 1,163,659 |
| Conversion of convertible debentures into common stock | 5,704,543 | - |
| Exercise of common stock options | 1,113 | 1,246 |
8,682,368 | 1,164,905 | |
Segments
The legal costs, patent registration fees and models and drawings required for filing patent applications are capitalized if they relate to commercially viable technologies. Commercially viable technologies are those technologies that are projected to generate future positive cash flows in the near term. Legal costs associated with patent applications that are notCompany determined to be commercially viable are expensed as incurred. All research and development costs incurred in developing the patentable idea are expensed as incurred. Legal fees from the costs incurred in successful defense to the extent of an evident increase in the value of the patents are capitalized.
Management has determined that the Company has one consolidated operating segment. The Company’s reporting segment reflects the manner in which its chief operating decision maker reviews results and allocates resources. The Company’s reporting segment meets the definition of a similar maturity. There were no such liabilities at December 31, 2018.
Recently Issued Accounting Standards
In FebruaryJune 2016, the FASB issued ASU No. 2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). ASU 2016-13 requires entities to use a forward-looking approach based on current expected credit losses (“CECL”) to estimate credit losses on certain types of financial instruments, including trade receivables. This may result in the earlier recognition of allowances for losses. ASU 2016-13 is effective for the Company beginning July 1, 2023, and early adoption is permitted. The Company does not believe the potential impact of the new guidance and related codification improvements will be material to its financial position, results of operations and cash flows.
In August 2020, the FASB issued Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-02, “Leases.” This2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. Under ASU requires all lessees2020-06, the embedded conversion features are no longer separated from the host contract for convertible instruments with conversion features that are not required to be recognized onaccounted for as derivatives under Topic 815, or that do not result in substantial premiums accounted for as paid-in capital. Consequently, a convertible debt instrument will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. The new guidance also requires the balance sheet as rightif-converted method to use assets and lease liabilitiesbe applied for the rights and obligations created by lease arrangements with terms greater than 12 months. The amendments in thisall convertible instruments. ASU are2020-06 is effective for fiscal years beginning after December 15, 2018 and for interim periods therein. The2021, with early adoption permitted. Adoption of the standard requires using either a modified retrospective or a full retrospective approach. Effective January 1, 2021, the Company isearly adopted ASU 2020-06 using the modified retrospective approach. Adoption of the new standard resulted in the processa decrease to additional paid-in capital of assessing the impact the adoption this ASU will have on its consolidated financial position, results of operations and cash flows. At a minimum, total assets and total liabilities will increase in the period the ASU is adopted. Early adoption of this ASU is permitted. At December 31, 2018, the Company’s undiscounted future minimum payments outstanding for lease obligations (including those currently included as capital lease obligations) were approximately $200,878.
In May 2014,2021, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers: Topic 606.” This2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. ASU replaces nearly2021-04 provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. An issuer measures the effect of a modification or exchange as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange. ASU 2021-04 introduces a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for all existing U.S. GAAP guidance on revenue recognition. The standard prescribes a five-step model for recognizing revenue, the application of which will require significant judgment. The amendments in this ASU are effectiveentities for fiscal years beginning after December 15, 2017, and for2021, including interim periods therein. The provisions of thiswithin those fiscal years. An entity should apply the guidance provided in ASU may2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early adoption is permitted for all entities, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied retroactively or on a modified retrospective (cumulative effect) basis.as of the beginning of the fiscal year that includes that interim period. The Company adopted the standard using the modified retrospective approach beginning January 1, 2018. Adoptionadoption of this ASU did2021-04 is not expected to have a significantmaterial impact on the Company’s consolidated financial position, resultsstatements or disclosures.
Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of operationsCertified Public Accountants, and the Securities and Exchange Commission (the “SEC”) did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements.
| F-9 |
Note 3 - Fair Value of Financial Instruments
The estimated fair values of financial instruments outstanding were (in thousands):
Schedule of Estimated Fair Value of Financial Instrument
| December 31, 2021 | ||||||||||||||||
| Unrealized | Unrealized | Fair | ||||||||||||||
| Cost | Gains | Losses | Value | |||||||||||||
| Cash and cash equivalents | $ | 8,968 | (8,189) | $ | — | $ | — | $ | 8,968 | |||||||
| Short-term investments | 23,040 | — | (29 | ) | 23,011 | |||||||||||
| $ | 32,008 | $ | — | $ | (29 | ) | $ | 31,979 | ||||||||
| December 31, 2020 | ||||||||||||||||
| Unrealized | Unrealized | Fair | ||||||||||||||
| Cost | Gains | Losses | Value | |||||||||||||
| Cash and cash equivalents | $ | 5,297 | $ | — | $ | — | $ | 5,297 | ||||||||
| Short-term investments | — | — | — | — | ||||||||||||
| $ | 5,297 | $ | — | $ | — | $ | 5,297 | |||||||||
The following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and investments, in thousands):
Schedule of Fair Value Hierarchy Financial Assets
| Fair Value | Level 1 | Level 2 | Level 3 | |||||||||||||
| December 31, 2021 | ||||||||||||||||
| Fair Value | Level 1 | Level 2 | Level 3 | |||||||||||||
| Money market funds | $ | 5,484 | $ | 5,484 | $ | — | $ | — | ||||||||
| Corporate notes and commercial paper | 23,011 | — | 23,011 | — | ||||||||||||
| Total financial assets | $ | 28,495 | $ | 5,484 | $ | 23,011 | $ | — | ||||||||
Note 4 – Accounts Payable
Accounts payable consisted of the following (in thousands):
Schedule of Accounts Payable
December 31, 2021 | December 31, 2020 | |||||||
| Accounts payable to a third-party manufacturer | $ | 6,335 | $ | - | ||||
| Other accounts payable | 1,854 | 2,243 | ||||||
| Total accounts payable | $ | 8,189 | $ | 2,243 | ||||
The Company relies on a third-party contract manufacturing operation to produce and/or test our compounds used in our potential product candidates. As of December 31, 2021 the Company was indebted $6.3 million of accounts payable to this vendor.
Note 5 – Convertible Notes Payable
Convertible notes payable consisted of the following (in thousands):
Schedule of Convertible Notes Payable
December 31, 2021 | December 31, 2020 | |||||||
| A. Notes payable issued for cash | $ | - | $ | 24,085 | ||||
| B. Notes payable issued for settlement agreements | - | 2,528 | ||||||
| C. Notes payable issued for forbearance agreements | - | 3,849 | ||||||
| D. Notes payable issued for consulting services | - | 360 | ||||||
| - | 30,822 | |||||||
| Less unamortized debt discount | - | (4,519 | ) | |||||
| Convertible notes, net of discount | $ | - | $ | 26,303 | ||||
| F-10 |
| A. | Notes Payable Issued for Cash |
As part of the Company’s financing activities, the Company issued convertible notes payable in exchange for cash. These notes payable were unsecured, bearing interest at a rate of 10% per annum, matured from nine months up to one year from the date of issuance, and were convertible to common stock at an average conversion rate of $3.40 per share, subject to certain beneficial ownership limitations (with a maximum ownership limit of 4.99%) and standard anti-dilution provisions. As of December 31, 2020, the outstanding balance of these notes amounted to $24.1 million.
In January 2021, the Company issued similar notes payable in exchange for cash flows.
| B. | Notes Payable Issued for Settlement Agreements |
In fiscal 2019 and 2020, the Company issued its convertible notes payable to resolve claims and disputes pertaining to certain debt and equity instruments issued by the Company in prior years. The notes were unsecured, bearing interest at a rate of 10%, matured from nine months up to one year from the date of issuance, and were convertible to common stock at a conversion rate of $3.40 per share, as adjusted, subject to certain beneficial ownership limitations (with a maximum ownership limit of 4.99%) and standard anti-dilution provisions. As of December 31, 2020, outstanding balance of these notes payable for settlement agreements amounted to $2.5 million.
On February 16, 2021 in accordance with the note agreements upon completion of the equity offering discussed in Note 8, these notes were mandatorily converted at a conversion rate of $3.40 per share into shares of the Company’s common stock.
| C. | Notes Payable Issued for Forbearance Agreements |
On June 23, 2020, the Company entered into an AgreementStandstill and PlanForbearance Agreements (collectively, the “Forbearance Agreements”) with the holders of Merger whereby it acquired 100%$13.2 million aggregate principal amount of the Convertible Notes (the “Default Notes”), which were in default. Pursuant to the Forbearance Agreements, the holders of the Default Notes agreed to forbear from exercising their rights and remedies under the Default Notes (including declaring such Default Notes (together with any default amounts and accrued and unpaid interest) immediately due and payable) until the earlier of (i) the date that the Company completes a future financing in the amount of $15 million and, in connection therewith, commences listing on NASDAQ (collectively, the “New Financing”) or (ii) January 31, 2021 (the “Termination Date”). As of December 31, 2020, outstanding balance of the notes payable amounted to $3.8 million.
On February 16, 2021 in accordance with the note agreements upon completion of the equity offering discussed in Note 8, these notes were mandatorily converted at a conversion rate of $3.40 per share into shares of the Company’s common stock.
| D. | Notes Payable issued for Consulting Agreements |
In prior years, the Company issued its convertible notes payable in exchange for consulting services. These notes payable were unsecured, bearing interest at a rate of 10% per annum, matured from nine months up to one year from the date of issuance, and were convertible to common stock at an average conversion rate of $3.40 per share, subject to certain beneficial ownership limitations (with a maximum ownership limit of 4.99%) and standard anti-dilution provisions. As of December 31, 2020, outstanding capital stockbalance of Georgetown Translational Pharmaceuticals, Inc. (GTP). these notes payable amounted to $0.4 million.
In January 2021, the Company issued similar notes payable of $0.7 millionin exchange for consulting services. In addition, the Company also issued a note payable of $0.5 millionin exchange for the ownershipcancellation of GTP,an unpaid consulting fee that was recorded as part of accrued expenses as of December 31, 2020.
On February 16, 2021 in accordance with the note agreements upon completion of the equity offering discussed in Note 8, these notes in the aggregate amount of $1.6 million were mandatorily converted at a conversion rate of $3.40 per share into shares of the Company’s common stock.
| F-11 |
As of December 31, 2020, the Company issuedaccrued interest of $4.8 million related to these convertible notes payable. During the period ended December 31, 2021, the Company accrued interest of $0.7 million. As a result of the mandatory conversion of the Company’s notes payable, on February 16, 2021, total accrued interest amounting to $5.5 million was converted to shares of common stock.
As a result, total notes payable of $33.3 million and accrued interest of $5.5 million for a total of 16,927,878 $38.8 million were mandatorily converted to shares of its common stock havingof which shares were unissued as of December 31, 2021 (see Note 8).
Adoption of ASU 2020-06
In fiscal 2020, the Company recorded a share pricenote/debt discount of $15.00$4.7 millionto account for the beneficial conversion feature that existed on the date of issuance for the transaction,above convertible notes payable. The debt discount is being amortized to interest expense over the term of the corresponding convertible notes payable. At December 31, 2020, the Company had recorded an unamortized note/debt discount of $4.5 million.
On January 1, 2021 the Company chose to adopt Accounting Standards Update (“ASU”) 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. Under ASU 2020-06, the embedded conversion features are no longer required to be separated from the host contract for convertible instruments with conversion features that are not required to be accounted for as derivatives under Topic 815, or that do not result in substantial premiums accounted for as paid-in capital.
As a result of the adoption of ASU 2020-06, the Company extinguished the previously recorded debt discount of $4.7 millionby charging the opening additional paid in capital at January 1, 2021. In addition, the Company also adjusted accumulated deficit to account for the derecognition of the $0.2 millioninterest expense due to the three prior owners of GTP which represented 33%amortization of the issued and outstanding capital stockdebt discount that was recorded in fiscal 2020. As a result of these adjustments, the Company on a fully diluted basis. $253.8unamortized debt discount of $4.5 million of the value of shares issued was allocated to intangible assets consisting of a portfolio of three CNS development candidates, which are classified as IPR&D.
Note 6 – Line of $228.5 million related to the portfolio of CNS IPR&D assets within Operating Expenses, which represents the excess carrying value compared to fair value. The impairment charge was the result of both internal and external factors. In the 3rd quarter of 2018, the Company experienced changes in key senior management, led by the appointment of a new CEO with extensive experience in oncology drug development. These changes resulted in the prioritization of immuno-oncology development candidates relative to CNS development candidates. In conjunction with these strategic changes, limited internal resources have delayed the development of the CNS IPR&D assets. The limited resources, changes in senior leadership, and favorable market conditions for immuno-oncology development candidates have resulted in the Company choosing to focus on development of its immuno-oncology portfolio. In light of this shift in market strategy, the Company performed a commercial assessment and a valuation of the CNS IPR&D assets, both to assess fair value and support potential future licensing efforts. The valuation indicated an excess carrying value over the fair value of these assets, resulting in the impairment charge noted above.
On November 8, 2010, the Company entered into a financing arrangement with Gemini Pharmaceuticals, Inc., a product development and manufacturing partner of the Company, pursuant to which Gemini Pharmaceuticals made a $250,000 $0.3 millionstrategic equity investment in the Company and agreed to make a $750,000 $0.8 millionpurchase order line of credit facility available to the Company. The outstanding principal of all Advancesbalance outstanding under the Lineline of Credit will bearcredit, which bears interest at the rate of interest of prime plus 2 percent% per annum. There is $31,000 due on this credit line atannum, amounted to $31,000as of December 31, 2018.2021 and 2020, respectively.
Note 7 – Derivative Liability
Under authoritative guidance used by the FASB on determining whether an instrument (or embedded feature) is indexed to an entity’s own stock, instruments that do not have fixed settlement provisions are deemed to be derivative instruments. The Company has issued certain warrants that included a fundamental transaction provision that could give rise to an obligation to pay cash to the warrant holder.
As a result, the warrants are classified as liabilities and are bifurcated from the debt host and accounted for as a derivative liability in accordance with ASC 815 and will be re-measured at the end of every reporting period with the change in value reported in the statement of operations.
The derivative liabilities were valued using a Binomial pricing model with the following average assumptions:
Schedule of Derivative Liabilities Assumptions
December 31, 2021 | December 31, 2020 | |||||||
| Risk-free interest rate | 1.26 | % | 0.36 | % | ||||
| Expected volatility | 129 | % | 135 | % | ||||
| Expected life (in years) | 3.6 years | 4.60 years | ||||||
| Expected dividend yield | 0 | 0 | ||||||
| Fair Value | ||||||||
| Warrants | $ | 138,000 | $ | 383,000 | ||||
| F-12 |
December 31, | ||
2018 | 2017 | |
| Research & Development | 585,000 | - |
| Accrued Interest | 432,000 | - |
| Professional Fees | 162,000 | 62,000 |
| Consulting and Advisory Services | 161,000 | - |
| Board of Directors Service Costs | 94,000 | - |
| Payroll and Benefits | 21,000 | 39,000 |
| Accrued Expenses | 1,455,000 | 101,000 |
The loan matured on January 20, 2019 and carries anrisk-free interest rate of 5%.was based on rates established by the Federal Reserve Bank. The loan was repaid in January, 2019.
During 2021, warrants were exercised which resulted in an extinguishment of derivative liability charge of $0.03 million. The Company recognized a net gain of $0.21 million and a loss of $0.23 million for the years ended December 31, 2021 and 2020, respectively, to account for the change in fair value of the derivative liability.
Note 8 – Stockholders’ Equity (Deficit)
At December 31, 2021, the Company had an authorized capital of shares of common stock, par value $, and shares of preferred stock par value $.
On February 10, 2021, the Company effectuated a 1:17 reverse stock split of the Company’s issued and outstanding capitalshares of common stock and all fractional shares were rounded up. All share and per share amounts in the accompanying consolidated financial statements have been adjusted retroactively to reflect the reverse stock split as if it had occurred at the beginning of the Company.
Common Stock
Common Stock Issuable
As a result of the six months ended June 30, 2017mandatory conversion of the Registrant has issuednotes payable and accrued interest in the aggregate of $38.8 millionon February 16, 2021, the Company was obligated to issue a total of 390,279 shares of common stock to a totalthe respective noteholders.
As of eleven entities or individuals in exchange for the cancellation of debt in the total amount of $2,025,000 and interest in the total amount of $486,000.
For financial reporting purposes, the Company reported $1.1 million as common stock issuable in the totalaccompanying statements of stockholders’ equity to account for the estimated balance of the converted notes payable and accrued interest that the Company has not yet issued the corresponding common stock.
Issuance of Common Stock in public offering
On February 16, 2021, the Company completed a public offering of shares of common stock for net proceeds of $24.7 million, after deducting underwriting discounts, commissions and other direct offering expenses. As part of the offering, the Company also granted these investors, warrants to purchase 5,192,250 shares of common stock. The warrants are fully vested, exercisable at $5.50 per share and will expire in five years.
As a result of the completion of the public offering and the successful listing of its shares of common stock on the Nasdaq Capital Market, convertible notes with an aggregate principal amount of $17,141,000$33.3 million and accrued interest of $5.5 million mandatorily converted at its stated conversion rate of $3.40 per share into shares of the Company’s common stock (see Note 5).
| F-13 |
Issuance of Common Stock for services - consultants
As part of consulting agreements with certain consultants, the Company agreed to grant these consultants common stock equal to 1% and 3% of the fully diluted shares of common stock of the Company upon conversion of options, warrants and Convertible Notes in association with a national markets qualified financing as consideration for entering into the total amountAgreement (with such stock to vest and be delivered within 30 days after the national markets qualified financing).
On February 16, 2021, the Company completed its equity offering and listed its shares of $4,693,000.
During the period ended December 31, 2021, pursuant to the vesting terms of the agreements, the Company recorded stock compensation expense of $million related to these consultants. In August 2017,addition, the Company also issued shares of common stock with a grant date fair value of $6.8 million to other consultants for service rendered that will vest over a period of months. In addition, on December 31, 2021, the Company cancelled shares granted to a consultant in February 2021. As a result, the Company recognized an aggregate of $million in stock compensation expense based upon the vesting of common stock granted to consultants.
At December 31, 2021, there are unvested shares of common stock with a grant date fair value of $ millionwhich will be recognized as stock compensation in future periods.
Issuance of Common Stock for research and development agreement
During the year ended December 31, 2021, the Company issued 496,855 shares of common stock for a research and development agreement valued at $1.4 million. The common shares were valued on the market price at the date of grant.
Issuance of Common Stock upon exercise of warrants
During the year ended December 31, 2021, the Company issued 3,076,017 shares of common stock upon the exercise of warrants on a cashless basis.
During the year ended December 31, 2020, the Company converted 25,000 Series H and 1,666,667 Series I shares of preferred stock into 5,327,734issued shares of common stock.
Issuance of common stock.
During the quarteryear ended September 30, 2018,December 31, 2020, the Company issued 110,000 shares of common stock upon conversion of $220,000$1.7 million in principal and interest on convertible notes payable.
Issuance of senior convertible notes.
During the quarteryear ended December 31, 2018,2020, the Company issued 52,500 shares of common stock upon conversionpursuant to Settlement Agreements with a fair value of $105,000$2.2 million. The common shares were valued on the market price at the date of senior convertible notes.
As a result of all common stock issuances, the quarter endedCompany had shares and shares of common stock issued and outstanding at December 31, 2018, the Company issued a total of 245,0002021 and December 31, 2020, respectively.
Preferred Stock
| A. | Series J Preferred Stock |
At December 31, 2021 and December 31, 2020, respectively, there were and shares of Rule 144 restricted common stock in full settlement of outstanding legal matters, and 125,000 shares of Rule 144 restricted common stock in connection with consulting services.
Shares of the Company's common stockSeries J-1 Preferred Stock were convertible at any time, at the option of the holders, into shares of the Company’s common stock at any time. Thean effective conversion ratio is based on the average closing bid price of $3.40 per share, subject to adjustment for, among other things, stock dividends, stock splits, combinations, reclassifications of our capital stock and mergers or consolidations, and subject to a beneficial ownership limitation which prohibits conversion if such conversion would result in the holder (together with its affiliates) being the beneficial owner of in excess of 9.99% of the Company’s common stock. Shares of the Series J-1 Preferred Stock had the same voting rights as shares of the Company’s common stock, forwith the fifteen consecutive trading days ending on the date immediately preceding the date noticeholders of conversion is given, but cannot be less than .20 or more than .2889 common shares for each Series C preferred share. The conversion ratio may be adjusted under certain circumstances such as stock splits or stock dividends. The Company has the right to automatically convert the Series C preferredJ-1 Preferred Stock entitled to vote on an as-converted-to-common stock intobasis, subject to the beneficial ownership limitation described above, together with the holders of the Company’s common stock ifon all matters presented to the Company lists itsCompany’s stockholders. The Series J-1 Preferred Stock are not entitled to any dividends (unless specifically declared by the Board), but would participate on an as-converted-to-common-stock basis in any dividends to the holders of the Company’s common stock. In the event of the Company’s dissolution, liquidation or winding up, the holders of the Series J-1 Preferred Stock would be on parity with the holders of the Company’s common stock and would participate, on a on an as-converted-to-common stock basis, in any distribution to holders of the Company’s common stock.
As a result of the completion of the public offering and the successful listing of the Company’s shares of common stock on the Nasdaq NationalCapital Market, andin February 2021, all outstanding Series J shares were mandatorily converted to shares of common stock pursuant to the average closing bid priceterms of the Company's common stock on the Nasdaq National Market for 15 consecutive trading days exceeds $3,000.00. Each shareconversion agreement.
| F-14 |
| B. | Series C Preferred Stock |
At both December 31, 2021 and December 31, 2020, there were shares of Seriesseries C preferred stock, is entitled to the numberpar value $ per share (the “Series C Preferred Stock”) issued and outstanding.
As a result of votes equal to .26 divided by the average closing bid price of the Company's common stock during the fifteen consecutive trading days immediately prior to the date such splits in previous years, shares of Series C preferred stock were purchased. InPreferred Stock are not convertible. Shares of Series C Preferred Stock have no voting rights. Similarly, as there are no conversion rights, in the event of liquidation, the holders of the Series C preferred stockPreferred Stock shall not participate on an equal basis with the holders of the common stock (as if the Series C preferred stock had converted into common stock) in any distribution of any of the assets or surplus funds of the Company. The holders of Series C preferred stockPreferred Stock also are not entitled to noncumulativeany dividends if and when declared by the Company'sCompany’s board of directors.directors (the “Board”). No dividends to holders of the Series C preferred stockholdersPreferred Stock were issued or unpaid through December 31, 2018.
| C. | Series K Preferred Stock |
On December 4, 2008,February 16, 2021, the Company entered into and closed an Agreement (the “Bristol Agreement”) with Bristol Investment Fund, Ltd. pursuant to which Bristol agreed to cancel the debt payable by the Company to Bristol in the amount of approximately $20,000 in consideration of the Company issuing Bristol 25,000Board designated shares of Series G ConvertibleK preferred stock, par value $. (the “Series K Preferred Stock”).
Shares of the Series K Preferred Stock which such shares carry a stated value equal to $1.00 per share (the “Series G Stock”).
As of December 31, 2021, there were Series K Preferred stock issued and outstanding.
| F-15 |
Warrants and Options
Common Stock Warrants
Stock warrant transactions for the years ended December 31, 20182021 and 2017 are2020 were as follows:
Number of Warrants | Weighted-Average Exercise Price | |
| Outstanding, December 31, 2016 | 15,550 | 135.00 |
| Granted | 486,351 | 15.00 |
| Exercised | (501,901) | 15.00 |
| Expired | - | - |
| Outstanding, December 31, 2017 | - | - |
| Granted | 1,813,053 | 2.00 |
| Exercised | - | |
| Expired | - | |
| Outstanding, December 31, 2018 | 1,813,053 | 2.00 |
| Exercisable Warrants: | ||
| December 31, 2018 | 1,813,053 | 2.00 |
| December 31, 2017 | - | - |
Schedule of Warrant activity
| Number of Warrants | Weighted-Average Exercise Price | |||||||
| Warrants outstanding at December 31, 2019 | 106,650 | $ | 3.40 | |||||
| Granted | 382,353 | 3.40 | ||||||
| Forfeited/canceled | (28,256 | ) | 3.40 | |||||
| Exercised | (239,706 | ) | - | |||||
| Warrants outstanding at December 31, 2020 | 221,041 | 3.40 | ||||||
| Granted | 5,192,250 | 5.50 | ||||||
| Forfeited/canceled | - | - | ||||||
| Exercised | (3,076,017 | ) | 5.50 | |||||
| Warrants outstanding at December 31, 2021 | 2,337,274 | $ | 5.30 | |||||
| Warrants exercisable at December 31, 2021 | 2,337,274 | $ | 5.30 | |||||
On February 16, 2021, as part of the Company’s public offering, the Company reserved 1,333issued warrants to investors to purchase up to an aggregate of 5,192,250 shares of its common stock atstock. The warrants have an exercise price of $5.50 per share, subject to adjustment in certain circumstances and has a term of five years from the date of issuance.
During the year ended December 31, 2014 for issuance under the 2014 Stock Incentive Plan (the “2014 Plan”). The 2014 Plan, approval by stockholders in May 2015, permits2021, the Company to grant stock options to acquire shares of the Company's common stock, award stock bonuses of the Company's common stock, and grant stock appreciation rights. At December 31, 2018, 87issued 3,076,017 shares of common stock were available for grant and optionsupon exercise of warrants which also resulted cash proceeds of $16.4 million.
On July 28, 2020, the Company issued a warrant to purchase 1,246 up to an aggregate of 58,824 shares of common stock at an exercise price of $3.40 per share, subject to adjustment in certain circumstances with a fair value of $0.2 million.
The warrant expires on July 28, 2025. The warrant was issued as compensation for certain services provided to the Company.
In July 2020, pursuant to the Settlement Agreement, the Company issued pre-funded warrants to purchase up to an aggregate of 323,529 shares of common stock (the “Settlement Warrants”) at an exercise price of $3.40 per share, subject to adjustment in certain circumstances and will expire on June 19, 2025.
As of December 31, 2021, all issued and outstanding warrants are fully vested and the intrinsic value of these warrants was $.
Common Stock Options
Schedule of Options Activity
| Number of Options | Weighted-Average Exercise Price | |||||||
| Options outstanding at December 31, 2020 | - | - | ||||||
| Granted | 302,500 | 3.05 | ||||||
| Forfeited/canceled | - | - | ||||||
| Exercised | - | - | ||||||
| Options outstanding at December 31, 2021 | 302,500 | $ | 3.05 | |||||
| Options exercisable at December 31, 2021 | 93,825 | $ | 3.05 | |||||
On December 31, 2021, the Company granted two employees a total of stock options. The stock options are exercisable at $ per share and will expire in . A portion of the options vested immediately, with the remaining portion vesting over a two year period from the date of grant. The fair value of the options amounted to $ or an average of $ per share and were calculated using a Black-Scholes option pricing model. Assumptions used in the model were: expected term – years; expected volatility – ; risk free interest rate – and dividend yield of . Pursuant to the vesting term of the stock options, the Company recorded stock compensation expense of $ for the year ended December 31, 2021.
There was intrinsic value of the outstanding options as of December 31, 2021, as the exercise price of these options equals the market price.
Note 9 – Commitments and Contingencies
1. Litigation
The Company is involved in certain legal proceedings that arise from time to time in the ordinary course of our business. Except for income tax contingencies, the Company records accruals for contingencies to the extent that our management concludes that the occurrence is probable and that the related amounts of loss can be reasonably estimated. Legal expenses associated with the contingency are expensed as incurred. There is no current or pending litigation of any significance with the exception of the matters that have arisen under, and are being handled in, the normal course of business.
| F-16 |
a. On August 28, 2019, a complaint was filed in the Superior Court of California, County of Los Angeles, West Judicial District, Santa Monica Courthouse, Unlimited Civil Division by Jeffrey Lion and by Daniel Vallera, as individuals. The complaint was filed against GT Biopharma, Inc. and its subsidiary Oxis Biotech, Inc. The Plaintiffs allege breach of a license agreement between the Plaintiffs and the Company entered into on or about September 3, 2015. The Company filed an answer to the complaint denying many allegations and asserting affirmative defenses. The Company reached a settlement of the case and paid on March 4, 2022, $425,000 in full and final settlement of the claims (see Note 14). This amount was fully accrued at December 31, 2021 and 2020, respectively.
b. On March 3, 2021, a complaint was filed by Sheffield Properties in the superior Court of California, County of Ventura. The litigation arose from a commercial lease entered into by GT Biopharma, Inc. for office space in Westlake Village in California. In July, 2021 the Company entered into settlement agreement with Sheffield Properties and the payment in the settlement amount of $0.1 million was made on August 6, 2021.
2. Significant Agreements:
Research and Development Agreements
The Company is a party to a Scientific Research Agreement with the Regents of the University of Minnesota, effective June 16, 2021. This scientific research agreement has three major goals: (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 here 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 us under current UMN/GTB licensing terms. The term of this agreement shall expire on June 30, 2023.
The University of Minnesota shall use reasonable efforts to complete the project for a fixed sum of $2.1 million. An initial payment of $541,527 was paid on December 2, 2021, followed by a payment of $191,527 on December 29, 2021 for the quarterly period ending September 30, 2021. The second quarterly payment for the quarter ending December 31, 2021 was recorded in accounts payable at December 31, 2021. Five quarterly payments of $191,527 remain, and a final payment of $192,470 will be payable within thirty (30) days of receipt of the final report.
On October 5, 2020, GT Biopharma entered into a Master Services Agreement with a third-party product manufacturer to perform biologic development and manufacturing services on behalf of the Company. Associated with this, the Company has subsequently signed five Statements of Work for the research and development of products for use in clinical trials. At December 31, 2021, the Company’s commitments in relation to these Statements of Work and any related Change Orders totaled approximately $13.0 million, of which $7.5 million was incurred at that date and an additional $5.5 million is in process during fiscal year 2022.
Patent and License Agreements
2016 Exclusive Patent License Agreement
The Company is party to an exclusive worldwide license agreement with the Regents of the University of Minnesota, (“UofMN”), to further develop and commercialize cancer therapies using TriKE® technology developed by researchers at the UofMN to target NK cells to cancer. Under the terms of the 2016 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. Under the agreement, the UofMN received an upfront payment of $0.2 million, and an annual License Maintenance fee of $0.1 million beginning in 2021. The agreement also includes 4% royalty fees, (not to exceed 6% under subsequence license agreements or amendments to this agreement or minimum annual royalty payments ranging from $0.25 million to $5.0 million. The agreement also includes certain performance milestone payments totaling $3.1 million, and one-time sales milestone payments of $1.0 million upon reaching $250 million in gross sales, and $5.0 million upon reaching $500 million dollars in cumulative gross sales of Licensed Products.
2021 Patent License Agreement
On March 26, 2021, the Company signed an agreement specific to the B7H3 targeted TriKE®. Under the agreement, the UofMN received an upfront license fee of $20,000 and will receive an annual License Maintenance fee of $5,000 beginning in 2022, 2.5% to 5% royalty fees, or minimum annual royalty payments of $0.25 million beginning in the year after the first commercial sales of Licensed Product, and $2.0 million beginning in the fifth year after the first commercial sale of such Licensed Product. The agreement also includes certain performance milestone payments totaling $3.1 million, and one time sales milestone payments of $1.0 million upon reaching $250 million in gross sales, and $5.0 million upon reaching $500 million dollars in cumulative gross sales of Licensed Products. There is no double payment intended; if one of the milestone payments has been paid under the 2014 Plan.
Office Lease Agreement
On November 19, 2021 the Company entered into a sublease with Aimmune Therapeutics, Inc. for 4,500 square feet of office space located in Brisbane, CA having a commencement date of January 1, 2022 and maturing on June 30, 2024. The following table summarizes stock option transactionsthe Company’s future minimum lease payments related to this lease (in thousands):
Schedule Of Future Minimum Lease Payments
| Year ending | Amount | |||
| 2022 | $ | 113 | ||
| 2023 | 117 | |||
| 2026 and thereafter | 60 | |||
| Total | $ | 290 | ||
3. Employee Compensation
The following table summarizes the Company’s future financial commitment to certain employees pursuant to their respective employment agreements (in thousands):
Schedule of Company’s Future Financial Commitment
| Year ending | Amount | |||
| 2022 | $ | 1,756 | ||
| 2023 | 1,293 | |||
| 2024 | 1,012 | |||
| 2025 | 377 | |||
| 2026 and thereafter | - | |||
| Total | $ | 4,438 | ||
Note 10 – Income Tax
The Company did not record any income tax provision for the years ended December 31, 20182021 and 2017:
Number of Options | Weighted-Average Exercise Price | |
| Outstanding, December 31, 2016 | 1,246 | ��1,320.00 |
| Granted | - | - |
| Exercised | - | - |
| Expired | - | - |
| Outstanding, December 31, 2017 | 1,246 | 1,320.00 |
| Granted | - | - |
| Exercised | - | - |
| Expired | (133) | 1,020.00 |
| Outstanding, December 31, 2018 | 1,113 | 1,320.00 |
| Exercisable Options: | ||
| December 31, 2018 | 1,113 | 1,320.00 |
| December 31, 2017 | 1,246 | 1,428.00 |
| F-17 |
Outstanding Options | Exercisable Options | ||||
Range of Exercise Prices | Number of Options | Weighted-Average Remaining Contractual Life | Weighted-Average Exercise Price | Number of Options | Weighted-Average Exercise Price |
| $750.00 to $2,225.00 | 1,113 | 0.49 | $1,320.00 | 1,113 | $1,320.00 |
At December 31, 2021 and 2020, based on the weight of available evidence, including cumulative losses in recent years and expectations of future taxable income, the Company determined that it was more likely than not that its deferred tax assets would not be realized. Accordingly, the Company has recorded a valuation allowance for 100% of its cumulative deferred tax assets. The components of our deferred tax assets are as follows.
Deferred taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and operating losses and tax credit carryforwards. The significant components of net deferred income tax assets for the Company are (in thousands):
December 31, | ||
2018 | 2017 | |
| Deferred tax assets: | ||
| Federal net operating loss carryforward | 25,306,000 | 15,949,000 |
| Intellectual Property | 61,787,000 | |
| Accrued Interest | 129,000 | - |
| Patent amortization | 5,000 | 6,000 |
| Deferred tax asseets before valuation | 87,227,000 | 15,955,000 |
| Valuation allowance | (87,227,000) | (15,955,000) |
| Net deferred income tax assets | - | - |
Schedule of Net Deferred Income Tax Assets
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| Deferred tax assets: | ||||||||
| Federal net operating loss carryforward | $ | 58,167 | $ | 39,340 | ||||
| Stock based compensation and other items | 7,622 | 4,779 | ||||||
| Intellectual property | 62,055 | 58,504 | ||||||
| Patent amortization | 4 | 4 | ||||||
| Deferred tax assets before valuation | 127,848 | 102,627 | ||||||
| Valuation allowance | (127,848 | ) | (102,627 | ) | ||||
| Net deferred income tax assets | $ | - | $ | - | ||||
Generally accepted accounting principles requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company'sCompany’s ability to generate sufficient taxable income within the carryforward period. Because of the Company'sCompany’s history of operating losses, management has provided a valuation allowance equal to its net deferred tax assets. The valuation allowance increased by approximately $71,270,000 during
A reconciliation of the federal statutory income tax rate and the effective income tax rate as a percentage of income before income tax provision is as follows for the year ended:
Schedule of Income Tax Provision
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| Federal statutory income tax rate | 21 | % | 21 | % | ||||
| State tax, net of federal benefit | 9 | % | 7 | % | ||||
| Change in valuation allowance on net operating loss carryforwards | (30 | )% | (28 | )% | ||||
| Effective income tax rate | 0 | % | 0 | % | ||||
Note 11 – Related Party Transaction
During the year ended December 31, 2018.
| F-18 |
As part of employment agreements with its former CEO and its former CFO (“Officers”), the next twelve months.
On February 16, 2021, the Company has agreed that upon shareholder approvalcompleted its equity offering and listed its shares of common stock on the Nasdaq Capital Market (see Note 8). As such, shares of its common stock were granted to these Officers and directors which had a Stock Option Plan, it will recommendfair value of $18.6 million. Since the grant of the common stock is subject to the Board thatmilestone or performance conditions, the Company grant Dr. Urbanski a Non-Qualified stock option to purchase 2,971,102 shares ofmeasured the Company’s common stock having an exercise equal to the fair market value of the sharescommon stock on the respective date of the Agreement. agreement, and such awards were recorded as compensation expense as the milestone or performance condition is met and in accordance with its vesting terms.
The Company recognized stock option grant would vest according to the following schedule: (i) 1,250,000 fully vested shares upon signingcompensation expense of million which is comprised of the agreement, (ii) 1,250,000 shares on January 1, 2019, and (iii) 471,102 shares on January 1, 2020. On March 15, 2019, Dr, Urbanski resigned his position as Chief Executive Officer, President and Chairmanissuance of the Board.
| Year ending December 31: | |
| 2019 | 69,000 |
| 2020 | 71,000 |
| 2021 | 61,000 |
| Total minimum lease payments | 201,000 |
Consolidated Balance Sheet | |||
December 31, 2017 | |||
Previously Reported | Revisions | Revised Report | |
| Additional Paid-in Capital | $519,702,000 | $1,603,000 | $521,305,000 |
| Accumulated Deficit | $(267,896,000) | $(1,603,000) | $(269,499,000) |
Consolidated Statement of Operations | |||
For the Year Ended December 31, 2017 | |||
Previously Reported | Revisions | Revised Report | |
| Change in Warrant Liability | $925,000 | $(925,000) | $- |
| Earnings per Share | $(8.54) | $(0.06) | $(8.60) |
Note 13 – Internal Control Considerations
Management has determined that dateinadequate and/or ineffective internal controls over financial reporting resulted in unauthorized transactions involving the Company’s assets and common stock. Following the termination of Anthony Cataldo, the Company’s former Chief Executive Officer, and Michael Handelman, the Company’s former Chief Financial Officer, management determined there to be no additional cost to be reported.
The Company is considering its course of action and potential recourse it may have against these former officers. The Company has taken measures to mitigate the issues identified and implement a conversion pricefunctional system of $0.60 per share (the “Conversion Price”).
Note 14 – Subsequent Events
On March 3, 2022, the Company until the date on which less than 10% of the Notes are outstanding, shall not effect any Variable Rate Transaction (as definedsettled a case filed by Jeffrey Lions and Daniel Vallera and paid $0.4 million in the Purchase Agreement)full and that, for as long as a Purchaser holds any Notes or Conversion Shares, thefinal settlement (see Note 9).
The Company shall amend the terms and conditions of the Purchase Agreement and the transactions contemplated thereby with respect to such Purchaser to give such Purchaser the benefit of any terms or conditions under which the Company agrees to issue or sell any Common Stock or Common Stock equivalents that are more favorable to an investor than the terms and conditions granted to such Purchaser under the Purchase Agreement and the transactions contemplated thereby.
On February 4, 2019, one or more registration statements on Form S-3 (or, if Form S-3 is not then available to the Company, such form11, 2022, shares of registration that is then available to effect a registration for resaleissuable common stock were converted into an equal number of the subject securities) covering the resale of all Conversion Shares, subject to certain penalties set forth in the Registration Rights Agreement. The Form S-3 was filed by the Company on February 14, 2019.
stock.
| F-19 |