OTLC 10-K
Oncotelic Therapeutics, Inc. (OTLC)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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DOCUMENTS INCORPORATED BY REFERENCE
TABLE OF CONTENTS
| I |
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K for the year ended December 31, 2025 (this “Annual Report” or “Report”) contains statements that are, or may be deemed to be, “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Any statements contained in or incorporated by reference into this Annual Report, that are not statements of historical fact are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “assumption” or the negative of these terms or other comparable terminology. Statements concerning: our expectations on the timing, success of the JV’s product approvals, commercialization of the JVs products and results of operations of the JV: our expectations on the timing, success, or valuation our JV’s planned initial public offering; the timing, success or continuing valuation of our equity interest in the JV; our ability to secure future debt or equity financing needed to meet operating costs; the timing, costs and other limitations involved in obtaining regulatory approval for any product candidate; the expected efficacy of our product candidates compared to competitive products; anticipated results of our research and development programs as well as preclinical and clinical trials; expected market size, market acceptance for our product candidates; our ability to enter into future partnerships, joint ventures or other corporate transactions, ability of us being able to obtain additional resources, including debt or equity funding, and the expected benefits to be derived from those transactions; the anticipated impact of regulatory and legislative changes in the United States and foreign countries on our product candidates and operations; anticipated trends in revenues, operating expenses or financial position and results of operations; and our estimates regarding anticipated operating income or losses, future performance, future revenues and projected expense; are all forward-looking statements.
Forward-looking statements reflect current views about future events and are based on our currently available financial, economic and competitive data and on current business plans. Forward-looking statements are not guarantees of future performance and our actual results may differ significantly from the results discussed or implied in the forward-looking statements. Factors that might cause such differences include, but are not limited to, the factors included in “Risk Factors,” in this Annual Report and the other registration statements and reports that we file with the Securities and Exchange Commission (“SEC”).
The forward-looking statements contained in this Annual Report are based on our current expectations and beliefs concerning future developments and their potential effects on us. We undertake no obligation to update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
You should consider the inherent limitations on, and risks associated with, forward-looking statements and not unduly rely on the accuracy of predictions contained in such forward-looking statements.
This Annual Report also contains market data related to our business and industry. These market data include projections that are based on a number of assumptions. While we believe these assumptions to be reasonable and sound as of the date of this Annual Report, if these assumptions turn out to be incorrect, actual results may materially differ from the projections based on these assumptions. As a result, the markets for our product candidates may not grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates may have a material adverse effect on our business, results of operations, financial condition and the market price of our common stock.
| II |
PART I
ITEM 1. BUSINESS
Company Background
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) (“Oncotelic”), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic conducts business activities through Oncotelic and its wholly-owned subsidiaries, Oncotelic, Inc., a Delaware corporation, PointR Data, Inc. (“PointR”), a Delaware corporation, Pet2DAO, Inc., a Delaware corporation; and EdgePoint AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic, Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the “Company” or “We”). The Company is currently developing OT-101, in addition to five additional compounds, for various cancers and COVID-19 through its joint venture (“JV”), GMP Biotechnology Limited (“GMP Bio”), with Dragon Overseas Capital, Limited (“Dragon”), Artemisinin for COVID-19 and AI technologies for clinical development and manufacturing. In addition, GMP Bio is developing 5 additional nanoparticle compounds in the JV, which has the potential of significant revenues and value. The Company also acquired apomorphine for Parkinson’s Disease, erectile dysfunction and female sexual dysfunction. In addition, the Company is evaluating the further development of its product candidates OXi4503, as a treatment for acute myeloid leukemia and myelodysplastic syndromes, and CA4P, in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma. The Company is also planning to address the animal health industry through Pet2DAO. Our principal corporate office is in the United States at 29397 Agoura Road, Suite 107, Agoura Hills, CA 91301 (telephone: 650-635-7000). Our internet address is www.oncotelic.com.
Overview
We are a clinical-stage biopharmaceutical company developing drugs for the treatment of orphan oncology indications, developing antisense and small molecule injectable drugs for the treatment of cancer. After the acquisition of Mateon Therapeutics, Inc. through a reverse merger in 2019, we realigned the company pipeline to focus on various cancers, including but not limited to rare pediatric cancers. The United States Food and Drug Administration (“FDA”) has granted us Rare Pediatric Designations (“RPD”) for pediatric Diffuse Intrinsic Pontine Glioma (“DIPG”) for OT-101, which was transferred to our joint venture as part of the joint venture agreement (see “JV” below), pediatric melanoma for CAP4 and acute myeloid leukemia (“AML”) for Oxi4503. In addition, the Company, through its JV, is developing 5 additional products for treatments of various cancers. Each of the products being developed by the JV has the potential of becoming very successful drugs. The JV is contemplating developing and obtaining regulatory approval for each of the 5 additional products via different regulatory pathways and in various countries and regions. Further, the Company aims to capitalize on a voucher program in the United States (“US”). By focusing on capitalizing on the RPD we anticipate: 1) reducing the cost of clinical development by way of a smaller and faster clinical trial, 2) acceleration of the approval process and final approval, 3) obtaining regulatory/ marketing exclusivity for up to 12 years as a biologic, and 4) obtaining vouchers worth a significantly large monetary value upon regulatory approval, which can be upwards of several million dollars. Approval in the US could allow for approval in the rest of the world (“ROW”) using the US dossier. Phase 3 clinical trials for approval in adult indications could be conducted following the positive interim read of the pediatric trials. This approach maximizes return on investment for the shareholders.
Concurrently we also explore opportunities to create value for shareholders by forming strategic alliances and/or licensing our product portfolio. In this connection, in March 2022, the Company entered into a joint venture (“JV”) with Dragon, affiliates of Golden Mountain Partners, LLC, to form GMP Biotechnology, Limited (“GMP Bio”). GMP Bio and the Company are also looking to take the JV into an initial public offering (“IPO”) of the JV and which is anticipated to be a liquidity event for Company, especially if the IPO is successful. While we believe that the IPO can be completed and would be successful, we cannot provide assurance for either of the events to occur; or if they occur, and then whether the IPO would be successful.
We believe we are well positioned as a biotech company with our drug candidate OT-101, through our JV, targeting high value TGF-β2, and the new product portfolio being developed by the JV, for various cancers and COVID-19, PointR artificial intelligence (“AI”) for clinical trials, research and development, Edgepoint for developing technologies for manufacturing and for developing technologies for supporting our COVID-19 programs, our vascular disruptor proven safe in more than 500 patients capable of causing massive antigen release which would stimulate immune response against the cancerous tumor and apomorphine, which we in-licensed in 2021, for developing against Parkinson’s Disease (“PD”), erectile disfunction (“ED”) and female sexual disfunction (“FSD”).
| 1 |
We may also plan to continue to develop OT-101, through our JV, an antisense against TGF-β2 – for the treatment of various viruses, which would include the severe acute respiratory syndrome (“SARS”) and the coronavirus (“COVID-19”), on its own and in conjunction with other compounds. Viral replication cannot occur without TGF-β; and TGF-β surge and a cytokine storm cannot occur without TGF-β. A Phase 2 trial was completed for OT-101 in South America. This was a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of OT- 101 in adult patients hospitalized with positive COVID-19 and pneumonia. Based on the final results of the trial, the trial was planned to be expanded into a Phase 3 trial; however, with the impact of COVID-19 reducing in the past few years, the Company will be re-evaluating this treatment for further development upon the occurrence or recurrence of the COVID-19 or any similar virus. We were conducting an observational study in conjunction with the Biomedical Advanced Research and Development Authority (“BARDA”. For more information on BARDA, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024. At this time, since the impact of COVID-19 has significantly reduced, the development of OT-101 for COVID-19 is not a top priority. In addition, during 2020 and 2021, the Company was developing Artemisinin as a potential therapy for the virus causing COVID-19. Again, with the impact of COVID-19 reducing over the past year or so, we have put on hold any further development of Artemisinin, till we have another severe virus situation. We will focus on any future development on Artemisinin against other respiratory viruses with unmet needs when the circumstances arise. For more information on Artemisinin, refer to our 2022 Annual Report on Form 10-K filed with the SEC on April 14, 2023.
In September 2021, Oncotelic entered into an exclusive License Agreement (the “Agreement”) with Autotelic, Inc. (“Autotelic”), pursuant to which Autotelic granted Oncotelic the exclusive right and license to certain Autotelic Patents for AL-101 - an intranasal apomorphine asset with clear 505(b)2 pathway to approval for PD as well unique mechanism of action for treatment of ED and FSD. For more information on AL-101, refer to our 2022 Annual Report on Form 10-K filed with the SEC on April 14, 2023.
We currently have 6 drugs through our JV, three primary drugs of our own, and AI technology programs we are seeking to advance, presently or in the future:
| ● | OT-101 - an antisense against TGF-β2 –for the treatment of various cancers and for the treatment of various viruses, including COVID-19, on its own and in conjunction with other compounds. This is being advanced through our JV. | |
| ● | Five additional nanoparticle products - for the treatment of various cancers, using various regulatory pathways and for various regions/countries. This is being advanced through our JV. | |
| ● | Artemisinin – a natural derivative from an Asian herb Artemisia Annua - Artemisinin has shown to be highly potent at inhibiting the ability of various viruses to multiply. This will be advanced through our JV at an appropriate time. | |
| ● | AL-101 - Intranasal drug and delivery system for intra-nasal Apomorphine for the treatment of PD, ED and FSD. | |
| ● | CA4P- a vascular disrupting agent (“VDA”) - in combination with Ipilimumab for the treatment of solid tumors with focus on melanoma in adult and pediatric melanoma. An RPD has been granted to the Company by the FDA for pediatric melanoma. | |
| ● | Oxi4503- a second generation VDA - for the treatment of liquid tumors with focus on childhood leukemia. A RPD has been granted to the Company by the FDA for AML. | |
| ● | Developing newer AI based technologies to enhance the development and commercialization of support technologies. The JV has acquired a non-exclusive license for the AI platform developed by PointR / EdgePoint for implementation in a planned CDMO. |
In November 2022, the Company formed a Decentralized autonomous organization (“DAO”) entity, Pet2DAO, Inc. (“Pet2DAO”), as a wholly owned subsidiary. For more information on Pet2DAO, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
Our products under development, including those through our JV
Developments through our JV:
The Company entered into a JV with Dragon Overseas Capital Limited (“Dragon Overseas”) to form GMP Biotechnology Limited (“GMP Bio”) on March 31, 2022. GMP Bio and the Company will focus to further expand the development of OT-101 for various oncology indications like pancreatic cancer, melanomas, gliomas etc. as also for viral infections like COVID-19. This path is being evaluated as a monotherapy, as well as combination therapies in conjunction with other drugs like checkpoint inhibitors. The pharmaceutical development of OT-101, our nano-particle platform and other artificial intelligence (“AI”) development is being advanced through our JV. This is being reported here for informational purposes only.
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OT-101: An Antisense Against TGF-β2
Trabedersen (AP12009, OT-101) is a novel antisense oligodeoxynucleotide (“ODN”) developed by Oncotelic Inc. for the treatment of patients with pancreatic carcinoma, malignant melanoma, colorectal carcinoma, high-grade glioma (“HGG”), and other transforming growth factor beta 2 (“TGF-β2”) overexpressing malignancies (e.g., prostate carcinoma, renal cell carcinoma, etc.). Trabedersen is a synthetic 18-mer phosphorothioate oligodeoxynucleotide (“S- ODN”) complementary to the messenger ribonucleic acid (“mRNA”) of the human TGF-β2 gene.
TGF-β is a multifunctional cytokine with a key role in promoting tumor growth and progression including cell proliferation, cell migration, and angiogenesis. Above all, TGF-β is a highly potent immunosuppressive molecule. Inhibition of TGF-β overexpression in tumor tissue represents a novel multimodal treatment principle leading to the reduction of tumor growth, inhibition of metastasis, and restoration of host antitumor immune responses. Despite its recognized pivotal role in cancer, therapeutics targeting TGF-β have not been successful and many have failed due to toxicity issues possibly due to inhibition of TGF-β1 essential functions. The high level of homology between the various TGF-β isoforms is making it impossible to create mAb or small molecule inhibitor without TGF-β1 cross- inhibition. Therefore, Oncotelic Inc. chose to target TGF-β2 only using OT-101 antisense approach. The sequence of OT-101 can only target TGF-β2 and does not have any impact on other TGF-β isotypes. However, suppression of TGF-β2 directly by OT-101 would also result in suppression of TGF-β2 indirectly, but not TGF-β3.
Trabedersen is believed to reverse TGF-β’s immunosuppressive effects, rendering the tumor visible to a patient’s immune system and resulting in priming and specific activation of the patient’s anti-tumor immune response. OT-101 has completed multiple clinical trials with promising outcomes. OT-101, is being developed as a broad- spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers. Oncotelic plans to initiate phase 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer. During phase 2 clinical trials in pancreatic cancer, melanoma, and colorectal cancers (Study “P001”) and in high-grade gliomas (Study “G004”), meaningful single agent activity with meaningful tumor reduction was observed, and OT-101 exhibited a favorable safety profile. Both partial and complete responses have been observed in the G004 Phase 2 clinical trial of OT-101 as a single agent in patients with aggressive brain tumors.
OT-101s self-immunization protocol (SIP©) is based on the novel and proprietary sequential treatment of cancers with OT-101 (antisense against TGF-β2) and chemotherapies. Additionally, the Company believes that a rational combination of the Oncotelic Inc. SIP platform with immune-modulatory drugs like interleukin 2 (IL-2) and/or immune checkpoint inhibitors has the potential to help achieve sustained and robust immune responses in patients with the most difficult-to-treat forms of cancer. The combinations with IL-2 and NK are already partnered with external corporate partners. For more information on OT-101 against TGF-β2, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
In addition, OT-101 is being developed for various other oncology indications, described below.
Pancreatic Cancer
Pancreatic cancer is associated with the poorest prognosis of gastrointestinal cancers and is expected to become the second leading cause of cancer-related mortality in the USA by 2030. Pancreatic cancer is traditionally considered to be an immune-resistant disease. There is a lack of effector T cells, an abundance of myeloid-derived suppressor T cells, and a dearth of key immune effector and regulatory cells. This may be part of the reason why single-agent checkpoint inhibitors are not as effective in comparison to other diseases. Here is where breaking immune tolerance by inhibiting TGF-β with OT-101 could have a significant impact.
The P001 trial was an open-label, multicenter dose-escalation study to evaluate the safety and tolerability of OT-101 (TGF-β2-specific Phosphorothioate Antisense Oligodeoxynucleotide) in adult patients with advanced tumors known to overproduce TGF- β2, which are not or no longer amenable to established therapies. The primary objective of the study was to determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of two cycles of trabedersen administered intravenously (i.v.) on a 7-days-on/7-days-off or 4-days-on/10-days-off schedule.
OT-101 treatment more than doubled the ratio of patients being able to go onto subsequent chemotherapy versus not being able, and consistent with the expected immunization boost coming from Xenogenization with subsequent chemotherapies (taxanes and 5FU/Cisplatin) as discussed for SIP, those with subsequent chemotherapy exhibited increased mOS and more than doubled their 1-year survival. Patients treated with the non-SIP agent did not exhibit these properties.
The JV initiated a Phase 2/3 clinical trial for pancreatic cancer and is actively seeking participants to enroll into the study. While enrollment has been slow, due to a smaller patient population and the protocol, the JV is working hard to enroll patients and to complete the trial.
For more information on OT-101 against Pancreatic Cancer, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
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Gliomas
Brain tumors in the United States are rare and only accounted for 2% of all adult cancers. However, the rate of brain tumors has been on the rise for the last 30 years. The more common and most malignant form of brain tumors – glioblastoma (“GBM”) has more than doubled from 2.4 to 5.0 per 100,000. In the face of this increase, treatment remained essentially unchanged during the last decade. And despite aggressive surgery followed by radiation and/or chemotherapy, GBM has the worst five–year survival rates among all human cancers, with an average survival from diagnosis of only about 1 year and less than 5% of the patient survived after 5 years. On top of it all, GBM will recur or regrow in most patients. Treatment of recurring a high-grade GBM that has recurred does not always improve survival compared with hospice care alone and deciding when to stop treating the cancer and entering into hospice care is frequently recommended when the patient is unlikely to live longer than six months.
GBM resilience and persistence is in stark contrast with the recent excitement in oncology where Immuno Oncology (“IO”) agents have shown promise to be curative by driving the immune cells to attack the tumors. Though extraordinarily effective against the growing number of tumors, IOs have been ineffective against GBM. GBM is generally considered immunologically “cold” with few immune effector cells needed for successful immunotherapy. The overexpression of TGF-β2 is associated with poor prognosis of tumors and plays a key role in malignant progression of various tumors including GBM by inducing proliferation, metastasis, angiogenesis, and immunosuppression. Our JV is developing a novel TGF-β2 antisense agent OT-101 as immunotherapy against GBM.
For more information on OT-101 against Gliomas, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
OT-101: Pediatric DIPG
DIPG, the second most common malignant pediatric brain tumor, has a dismal outcome with available standard treatment modalities. No significant therapeutic advances have been accomplished in the treatment of this poor prognosis brain tumor and the average overall survival has remained <1 year with a 2-year survival rate of <10%. In solid tumors, the expression level of the TGFβ has been identified as a significant contributor to disease progression and poor prognosis as well as resistance to standard therapy and metastasis. In particular, TGFβ has been implicated in treatment resistance to targeted therapeutics, chemotherapy as well as immune-oncology drugs. Importantly, TGFβ restrains anti-tumor immunity by restricting cytotoxic T-cell infiltration, recruiting regulatory T-cells, and inhibiting the maturation as well as function of natural killer (“NK”) cells. Amplified activity of the TGFβ-Smad signaling pathway enhances tumor growth, invasion, as well as angiogenesis and has been implicated in the malignant phenotype and poor prognosis of high-grade gliomas in adults. Therefore, TGF-β has emerged as an attractive target for the therapeutic intervention of high-grade gliomas.
The US FDA granted the Company a RPD for pediatric DIPG, which was transferred to the JV as part of the JV Agreement. The Company is likely to receive 50% of the value of the RPD, upto a maximum of $50 million, upon the RPD being sold to a third party should the JV decide to do so.
For more information on OT-101 against DIPG, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
OT-101 for Treatment of Advanced or Metastatic Cancers
In March 2025, the Company announced successfully completing a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors, on behalf of the JV. These results set the stage for new studies that combine OT-101, an antisense therapeutic targeting Transforming Growth Factor Beta 2 (TGFβ2), with checkpoint inhibitors (“CKIs”) and recombinant IL-2 (aldesleukin) (“IL-2”). The Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety and tolerability of OT-101 in combination with recombinant IL-2 in patients with advanced or metastatic solid tumors. The combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected safety signals identified. Based on the favorable safety data, the JV, through the Company, plans to advance OT-101 plus IL-2 into further clinical studies, exploring synergies with CKIs such as PD-1 blockers.
OT-101 for Treatments of Corona Viruses
A Phase 2 study for COVID-19 was completed for OT-101 in South America, that can expand into a Phase 3 trial in the event there is a resurgence in COVID-19. Based on the final results of the trial, the trial was planned to be expanded into a Phase 3 trial; however, with the impact of COVID-19 reducing in the past year, the Company will be re-evaluating this treatment for further development upon the occurrence or recurrence of the COVID-19 or any similar virus. We were conducting an observational study, looking at OT-101 and long COVID-19, in conjunction with the BARDA For more information on OT-101 for the treatment of Corona Viruses, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.
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Additional Nanoparticle Platform for Treatment of Various Cancers as Sapu Nano
In late 2023, the JV initiated a plan to start evaluating various nanoparticles that could treat various cancers. In this regard, the JV identified a total of 4 compounds, in addition to OT-101, which had the potential of significant revenue generation for the JV. In the same year, the JV signed a lease agreement to set up a GMP manufacturing facility in San Diego, California. The main purpose of this facility was to initially commence an aggressive formulation development of newly planned nanoparticle platform (“Nano Platform”). The GMP manufacturing facility was initiated in January 2024. Upon the initiation of this facility by the JV, the JV commenced the development work on two of the four identified compounds, as well as other activities, in tandem with the development of OT-101.
The JV has since completed the formulation development of one of the products and is moving to complete the formulation development for the three additional products. The JV is also working on improved formulations for OT-101 with new nanoparticle sizes. The JV also has started clinical development for OT-101 for pancreatic cancer. Significant progress has been made in the development of the products and the JV anticipates to complete the formulation development work in 2025 and pushing to initiate clinical trials for the various compounds.
In late 2024, the GMP facility in San Diego (“SD”), California was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. Further, in late 2024, the JV identified a sixth candidate as a compound for development for the JV and has already started to work on the formulation development of that compound as well. The Company had indicated that the SD facility is intended to support manufacturing of clinical trial materials, including Phase 1 supply, for multiple pipeline programs. Concurrently, the JV expanded its nanoparticle portfolio to six development candidates, including OT-101 and additional reformulated oncology assets. Building upon these milestones, throughout 2025 and into early 2026, Oncotelic Therapeutics continued to expand the strategic and technological scope of the JV, positioning it as a fully integrated oncology platform spanning drug discovery, formulation science, clinical development, and early commercialization readiness. As part of this evolution, the Company formalized and advanced Sapu Nano as the dedicated nanomedicine development and commercialization arm of the JV. Sapu Nano has been positioned as the primary vehicle for advancing the Deciparticle™ platform into clinical-stage assets and external partnerships, including scientific presentations, clinical development programs, and strategic business development initiatives.
Consistent with prior announcements by the Company, the JV’s development strategy is centered on the convergence of three core capabilities: (i) proprietary biomarker-driven oncology insights, particularly those related to TGFβ-2 signaling and tumor microenvironment modulation; (ii) advanced nanomedicine delivery platforms, including the Deciparticle™ technology designed to enhance solubility, tissue distribution, and therapeutic index of oncology agents; and (iii) the integration of artificial intelligence–enabled discovery and decision-support tools through the Company’s PDAOAI platform.
During 2025, the JV advanced formulation development activities across its pipeline, including continued optimization of intravenous formulations for oncology therapeutics that have historically been limited by oral bioavailability, solubility constraints, or dose-limiting toxicities. These efforts culminated in the advancement of Sapu-003, an intravenous Deciparticle™ formulation of everolimus, into human clinical testing following regulatory clearance from Australia’s Human Research Ethics Committee. Sapu-003 is designed to address the pharmacokinetic limitations of oral everolimus, which exhibits approximately 10% bioavailability, by enabling intravenous delivery and full systemic exposure. The Company has stated that this approach may allow improved tumor penetration and more consistent drug exposure, potentially translating into enhanced therapeutic activity. Data presented at scientific forums, including the San Antonio Breast Cancer Symposium (“SABCS”) and related symposia, highlighted the pharmacokinetic advantages of Sapu-003 relative to oral everolimus. The Company reported that intravenous Deciparticle™ delivery reduced gastrointestinal accumulation of everolimus by up to 67-fold while enhancing systemic exposure, supporting the rationale for improved tolerability and therapeutic index. The Company further expanded the scientific and clinical positioning of Sapu-003 through multiple conference presentations, including the SABCS. These presentations highlighted a comprehensive translational framework integrating biomarker discovery, pharmacokinetic modeling, and clinical trial design. In particular, the Company reported the identification of a novel biomarker signature (High RICTOR / Low RPTOR) predictive of sensitivity to intravenous everolimus, based on analysis of over 9,000 tumor samples across multiple cancer types. This biomarker framework is intended to enable, for the first time, patient selection strategies for mTOR-targeted therapy, thereby aligning with the Company’s broader precision oncology strategy. Further reinforcing the platform’s breadth, Sapu Nano disclosed at scientific congresses (including SACS-related presentations) that the Deciparticle™ platform demonstrates broad applicability across hydrophobic small-molecule drugs, with the ability to transform traditionally cytostatic agents into potentially cytotoxic therapies through improved delivery and exposure control.
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In parallel, the collaboration with Shanghai Medicilon, Inc. has enabled the JV to leverage an accelerated IND-enabling infrastructure, including preclinical pharmacology, toxicology, and regulatory support. The Company has indicated that this platform may support up to 20 IND programs, with the initial focus on the six identified oncology candidates currently under development. This approach is intended to compress development timelines and enable parallel advancement of multiple IND-ready assets. The identification and advancement of multiple candidates, including the sixth program, further reflects the scalability of the JV’s platform. The Company continues to evaluate additional compounds that may benefit from reformulation, nanoparticle delivery, or biomarker-driven repositioning, particularly those with known clinical activity but suboptimal pharmacokinetic or safety profiles.
The Deciparticle™ platform, as presented at BIO-Europe Spring 2026, represents a next-generation nanomedicine approach designed to overcome key limitations of conventional oncology drug delivery systems. The platform utilizes ultra-small amphiphilic constructs, typically below approximately 20 nanometers in size, enabling these particles to behave more like molecular entities than traditional colloidal nanoparticles. This size range facilitates enhanced tissue penetration, cellular uptake, and distribution within tumor microenvironments, while potentially avoiding some of the clearance and immunogenicity challenges associated with larger nanoparticle systems. The Company has indicated that, with limited exceptions, the platform has successfully enabled the formulation of a broad range of hydrophobic small-molecule compounds that are otherwise difficult or impossible to formulate using conventional approaches. The Company believes that the Deciparticle™ platform builds upon prior generations of oncology drug delivery technologies, including solvent-based formulations, albumin-bound nanoparticles, and polymeric micelles, and represents a fourth-generation evolution characterized by non-biologic composition, simplified manufacturing, and enhanced biological performance. This positioning is informed in part by the development history of earlier nanoparticle-based oncology drugs, including Abraxane® and subsequent polymeric micelle formulations, and reflects the Company’s strategy of leveraging prior regulatory and clinical precedents to accelerate development timelines.
Within this platform, the JV is advancing multiple pipeline candidates, including Sapu-001 and Sapu-006, which were recently highlighted as part of the BIO-Europe Spring 2026 presentation.
In addition to the development of OT-101 (also referred to as Sapu-002), the JV is advancing the development of five additional therapies:
| a. | Sapu-001 – A paclitaxel-based taxane therapy, which can address cancers like breast cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer | |
| b. | Sapu-003 – An evorolimus formulation, which can address renal cell cancer, neuroendocrine tumors and tuberous sclerosis complex (renal angiomyolipoma and subependymal giant cell astrocytoma) | |
| c. | Sapu-004 – A carboplatin formulation, which can address small cell lung cancer, head and neck cancer and testicular cancer | |
| d. | Sapu-005 – A palbociclib formulation, which would address HR+, HER2- breast cancer | |
| e. | Sapu-006 – A docetaxel formulation, which can address prostate cancer and gastric cancer. |
Each of these therapies, and the various cancers the address, have shown they are increasing in terms of incidences and that opens up the avenue to be able to generate revenues ranging from several millions of dollars to several hundreds of millions of dollars, if successfully developed and commercialized.
Below is information on each of the various therapies:
Sapu-001 is a paclitaxel-based Deciparticle™ formulation designed as a next-generation taxane therapy. The program is intended to improve upon existing paclitaxel formulations by leveraging ultra-small particle size and amphiphilic design to enhance tumor delivery and therapeutic index. Preclinical data presented by the Company indicate that Sapu-001 may achieve improved tumor penetration through mechanisms including caveolae-mediated transcytosis and vascular fenestration within tumor tissues, resulting in enhanced intratumoral drug accumulation. In nonclinical models, Sapu-001 demonstrated improved antitumor activity at equivalent doses and superior efficacy at higher doses relative to comparator formulations, while maintaining a favorable tolerability profile as evidenced by minimal systemic toxicity signals such as weight loss. The Company has indicated that Sapu-001 is being developed under a regulatory strategy intended to leverage existing clinical and regulatory data for paclitaxel-based products, including a potential 505(b)(2) pathway, with anticipated progression through early-phase clinical development followed by a pivotal bioequivalence study and subsequent regulatory submission.
As described above, Sapu-003, an evorolimus formulation, is designed to address the pharmacokinetic limitations of oral everolimus, which exhibits approximately 10% bioavailability, by enabling intravenous delivery and full systemic exposure. The Company has stated that this approach may allow improved tumor penetration and more consistent drug exposure, potentially translating into enhanced therapeutic activity. SAPU-003 is an intravenous injection of everolimus deciparticles, which can form better accumulation effects in tumor cells than oral Everolimus tablet, thereby improving clinical efficacy profile and safety profile. In the future, the company will rapidly advance the research and development of SAPU-003 based on Fyarro’s research and development experience.
SAPU-004 is a carboplatin deciparticles formulation, which produces carboplatin nanoparticles, having the following advantages over conventional carboplatin injection. Firstly, the structure is more stable and it has better targeting ability. Secondly, Carboplatin deciparticles can be metabolized via renal instead of via liver, greatly reducing renal toxicity. Thirdly, the transport of carboplatin nanoparticles through the vascular endothelium into the underlying tissue can be achieved, making the AUC of Carboplatin deciparticles far exceed that of conventional carboplatin injection, with higher bioavailability and better efficacy.
SAPU-005 is a palbociclib deciparticle formulation administered intravenously. Compared with oral palbociclib, the change in dosage form improves the drug accumulation in tumors with better safety and efficacy profile. Ibrance, the brand for palbociclib, reached peak sales in 2021, with global sales revenue of approximately US $5.4 billion. Given the clinical advantages of palbociclib deciparticle, its market potential is expected to be substantial.
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Sapu-006 is a docetaxel-based Deciparticle™ formulation designed to address known limitations of conventional docetaxel products, including excipient-related toxicities and pharmacokinetic variability associated with formulations such as Taxotere. The Company has developed Sapu-006 as a surfactant-free formulation, eliminating the need for polysorbate 80 (Tween 80), which has been associated with hypersensitivity reactions and other adverse effects. The Company believes that the Deciparticle™ formulation may enable receptor-mediated transport mechanisms, including gp60 and caveolae-mediated pathways, thereby enhancing tumor delivery and increasing intratumoral drug concentrations. Additionally, the Company has reported that Sapu-006 may demonstrate improved pharmacokinetic characteristics, including dose proportionality and reduced variability, which may support higher dosing and improved therapeutic outcomes. According to the Company’s disclosures, Sapu-006 has entered Phase 1 clinical development and is expected to follow a development pathway that includes a pivotal bioequivalence study and potential regulatory submission within a shortened timeline relative to traditional de novo drug development programs.
The JV has emphasized that both Sapu-001 and Sapu-006 are representative of a broader platform strategy focused on reformulating established oncology agents to improve delivery, safety, and efficacy. This approach is intended to reduce development risk by leveraging known mechanisms of action and existing clinical experience, while creating differentiated products through enhanced pharmacokinetics, tissue distribution, and biomarker-driven targeting.
A key component of the Company’s strategy is its integrated manufacturing capability. The San Diego GMP facility has been designed to support Deciparticle™ production from early formulation through clinical manufacturing. The Company has described a streamlined “one-pot” manufacturing process that enables bulk drug production followed by sterile filtration, filling, and lyophilization to generate finished drug product. The facility includes capabilities for both nonclinical and clinical manufacturing, including Phase 1 clinical trial material production, and is supported by quality systems incorporating data management and automation technologies. The Company believes that this integrated manufacturing infrastructure provides a competitive advantage by enabling rapid scale-up and parallel development of multiple pipeline candidates.
The Company’s overall nanomedicine strategy, as articulated through Sapu Nano and the Deciparticle™ platform, is to establish a scalable pipeline of oncology therapeutics that can be advanced through accelerated regulatory pathways and supported by integrated manufacturing and development capabilities. The Company believes that this approach, combined with its biomarker-driven oncology programs and artificial intelligence–enabled platforms, positions the JV to generate multiple clinical-stage assets and potential commercialization opportunities.
Looking forward, the Company expects that key development milestones for its nanomedicine platform will include continued clinical advancement of Sapu-006, initiation of clinical studies for Sapu-001, and further expansion of the Deciparticle™ pipeline. The Company believes that successful execution of this strategy could enable the JV to establish a differentiated position in oncology drug delivery and contribute to long-term shareholder value.
From a JV valuation standpoint, the Company announced in November 2025 that the JV obtained a preliminary independent third-party valuation of approximately $2.3 billion for its therapeutic pipeline, assuming and implying an illustrative value of approximately $1 billion based on the Company’s 45% ownership interest in the JV. The Company had previously stated that this valuation was non-binding, forward-looking, and not determinative of fair value under U.S. GAAP, and that a separate ASC-compliant valuation process would be done. The Company conducted an ASC-compliant valuation, including and through an independent valuation expert, for the JV, based on the same parameters and conditions envisioned in the valuation conducted by the JV. Based on the valuation, the Company proceeded to record a change in the value of the Company’s interest in the JV of approximately $365.4 million. The Company relied on the inputs by the JV valuation, however, certain parameters like lack of marketability discounts, lack of control discounts and other standard discounts, specific to the Company, have been applied to the independent valuation done by the Company, to derive the ASC-compliant valuation. The Company will also appropriately adjust the fair value of the interest of the Company’s interest in the JV at the end of reporting periods and when key value inflection points are met.
Looking forward, the Company expects that key value inflection points for the JV will include: (i) IND submissions for multiple pipeline candidates; (ii) continued progression of Phase 1 clinical trials for Sapu003 and initiation of clinical studies for Sapu006; (iii) validation of biomarker-driven patient selection strategies; (iv) generation of clinical pharmacokinetic and safety data; and (v) potential strategic collaborations, or licensing or IPO transactions are done by the JV. The Company believes that successful execution across these milestones could position the JV—and Sapu Nano in particular—as a significant contributor to long-term shareholder value and a central pillar of its integrated oncology platform strategy.
Artemisinin for Treatment of COVID-19
Artemisinin derived from Chinese herb Artemisia annua L. (Sweet wormwood) has been used medicinally to treat fevers for centuries in China. Like other potential COVID-19 therapeutic agents such as Hydrochloroquine and Remdesivir, the efficacy of Artemisinin remains to be tested in well controlled and sufficiently powered clinical trials. With the impact of COVID-19 reducing in the past year, the Company will be re-evaluating this treatment for further development upon the occurrence or recurrence of the COVID-19 or any similar virus. For more information on Artemisinin for the treatment of COVID-19, refer to our Annual Report on Form 10-K filed with the SEC on April 14, 2023.
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AI/Blockchain: PointR/EdgePoint
PointR, an acquisition made in November of 2019, develops, and deploys high performance cluster computers and artificial intelligence (“AI”) technologies for inference processing of a camera-grid that are interconnected to create 360-degree vision-grid to track men and materials indoors. The scope was expanded to include the entire life cycle of a drug: discovery, clinical trials, and manufacturing. In addition, AI is being targeted to provide support for clinical trials and pre-clinical research. The deployment of AI technology for data capture and insight extraction in real time in blocks which are chained into blockchain ledger records serving as immutable transactions for stakeholders such as regulatory agencies, caretakers, insurers, payers, and manufacturers. For more information on AI/Blockchain, refer to our 2002 Annual Report on Form 10-K filed with the SEC on April 14, 2023. Leveraging its partnerships with industry leaders, the AI team plans to combine its own AI technology with industry standard Blockchain to transform drug manufacturing. This will be advanced through our JV at an appropriate time, as our JV has acquired non-exclusive rights to the technology.
Human labor costs represent the most expensive element in drug manufacturing. In the $70.0 billion CDMO (contract development manufacturing operations) industry, personnel costs of $30 billion are ripe for computer automation. Until now, computer technologies like MRP and ERP created more problems than resolved. The labor problem is compounded by the cost of personnel onboarding and turnover. It takes 6-9 months to train a quality control employee only to lose them to a competitor. At this time, this technology is being evaluated for being upgraded for future uses. This will be advanced through our JV at an appropriate time, as our JV has acquired non-exclusive rights to the technology. For more information on AI/Blockchain, refer to our 2002 Annual Report on Form 10-K filed with the SEC on April 14, 2023.
The Company’s go-to-market plan is to execute a proof-of-concept project, possibly through a planned CDMO by the JV. As part of the JV Agreement, the JV has acquired a non-exclusive license for the AI platform developed by PointR/EdgePoint for implementation in a planned CDMO. At this time, this technology is being evaluated for being upgraded for future uses. For more information on AI/Blockchain, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
AL-101: PD/ ED/FSD
The Company acquired AL-101 for the intranasal delivery of apomorphine for the treatment of PD, ED and FSD. The Company plans to pursue the development of AL-101 for the various indications upon being successful in raising additional resources required for the development of the product.
For more information on AL-101, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
CA4P as an Immuno-Oncology Agent
CA4P causes rapid and widespread tumor cell necrosis. A number of laboratories have shown that the type of tumor cell death induced by ischemic necrosis not only controls the presence or absence of specific tumor antigens, but also can result in immunological responses ranging from immunosuppression to anti-tumor immunity. The terms “immunogenicity of cell death” or “immunogenic cell death” is often used by scientists to describe the ability of dead/dying cells (especially of tumor cells) to mount antigen-specific and particularly CD8 + T-cell- mediated adaptive immune responses and not simply lead to innate inflammation. Preclinical studies in which CA4P was combined with an anti-CTLA4 antibody using an EMT-6 mammary tumor model showed that 7 out of 8 mice receiving a combination of CA4P and an anti-CTLA4 antibody experienced complete remission of their tumors, compared to only 1 of 8 in the CA4P monotherapy arm and 2 of 8 in the anti- CTLA4 antibody monotherapy.
For more information on CA4P as an immune-oncology agent, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
CA4P: Pediatric Melanoma
It is expected that combination of CA4P with Ipilimumab or other immune-oncology drugs would result in improved tumor control for these patients above the 2 PR out of 17 patients treated with ipilimumab.
The FDA has granted an RPD for CA4P/ Fosbretabulin tromethamine for the treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients as a drug. For more information on CA4P for pediatric melanoma, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
OXi4503 for Acute Myeloid Leukemia
OXi4503 (combretastatin A1-diphsphate; CA1P) is a novel investigational VDA that has been shown to have a significant in vitro cytotoxic as well as chemo-sensitizing activity against human AML cells. OXi4503 also exhibited in vivo anti-leukemic activity in xenografted mice with human AML.
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OXi4503 has received orphan designation for AML in both the United States (Designation No. 12-3824) and the European Union (Designation No. EU/3/15/1587 - EMA/OD/144/15). In 2017, the FDA granted fast-track designation to OXi4503 for the treatment of relapsed/refractory AML. Oxi4503 met the qualifying criteria for the Fast Track designation since AML is a serious and life-threatening condition, and a large unmet medical need exists for additional treatment strategies for this disease.
For more information on OXi4503 for AML, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
OXi4503: Pediatric AML
Pediatric AML is most common during the first 2 years of life and during the teenage years. In the United States, about 730 people under age 20 are diagnosed with AML each year. The number of deaths was 0.6 per 100,000 children per year. These rates are age-adjusted and based on 2012-2016 cases.
Compared with pediatric acute lymphoblastic leukemia (“ALL”), the outlook for pediatric AML patients is far worse. Even though pediatric AML cases are far fewer than pediatric ALL, the mortality rate is about the same, illustrating that AML is a devastating disease and the need for continuing research to identify effective treatments for these children. The prognosis for AML in children remains relatively poor, with a 5-year survival rate of 64% compared with 90% in ALL.
The FDA has granted a RPD for OXi4503 for the treatment of pediatric AML. For more information of Oxi4503 for pediatric AML, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
PDAOAI
PDAOAI is the Company’s proprietary artificial intelligence–enabled knowledge platform, developed to support scientific, translational, and regulatory activities across its oncology pipeline. The platform was initially implemented by Oncotelic Therapeutics to streamline document search, synthesis, and analysis in knowledge-intensive environments, particularly within pharmaceutical research and development. Since its initial deployment, the Company has progressively expanded PDAOAI into a core infrastructure layer supporting research generation, biomarker discovery, and regulatory documentation across multiple programs.
Unlike general-purpose artificial intelligence tools, PDAOAI has been designed specifically for pharmaceutical and biotechnology applications, with an emphasis on regulatory-grade documentation, scientific traceability, and reproducibility. The platform is intended to operate as an “evidence-interrogation” system rather than a black-box predictive engine, enabling structured ingestion, semantic indexing, and clustering of large biomedical corpora. This design allows users to query, retrieve, and synthesize information in a manner that is auditable and aligned with regulatory expectations for data provenance and scientific justification.
During 2025, the Company significantly expanded the functional scope of PDAOAI and integrated it into its translational research workflow. This included the use of PDAOAI to support the preparation of peer-reviewed manuscripts, development reports, and regulatory documentation, as well as to enable interactive interrogation of scientific literature. The Company introduced interfaces that allow users to query individual publications and their associated reference networks, thereby facilitating deeper exploration of mechanistic hypotheses and clinical correlations within defined therapeutic areas.
PDAOAI has also been applied to the assembly and interrogation of multi-omic and clinical datasets, particularly in the context of biomarker-driven oncology research. The platform has been used to identify, prioritize, and validate biomarkers associated with treatment response, disease progression, and survival outcomes. This capability has been most prominently demonstrated in the Company’s work on TGFB2 signaling and tumor microenvironment biology, where PDAOAI has supported analyses across multiple tumor types, including ovarian cancer, breast cancer, pancreatic cancer, hepatocellular carcinoma, and glioblastoma.
As disclosed in Company press releases, PDAOAI contributed to the generation of at least seven peer-reviewed publications during 2025. These publications collectively span bioinformatic biomarker discovery, tumor microenvironment analysis, nanoparticle drug delivery, and clinical outcome correlations, and include studies demonstrating prognostic and predictive roles of TGFB2 methylation and expression across multiple cancers. The Company believes that this body of work provides validation of PDAOAI’s utility as a research acceleration platform and supports its role in generating clinically relevant insights. These publications are as follows:
Qazi, S.; Richardson, S.; Potts, M.; Myers, S.; Saund, S.; De, T.; Trieu, V. Bioinformatic Approach to Identify Potential TGFB2-Dependent and Independent Prognostic Biomarkers for Ovarian Cancers Treated with Taxol. International Journal of Molecular Sciences 2025, 26, 11900.
Chang, W.-H.; Shah, D.; Myers, S.; Potts, M.; Qazi, S.; Trieu, V. Comparative Tumor Microenvironment Analysis for HCC and PDAC Using KMplotter. International Journal of Molecular Sciences 2025, 26, 11920. This paper was also the subject of a separate December 15, 2025
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De, T.; Trieu, V.; Myers, S.; Qazi, S.; Saund, S.; Lee, C. Sub-15 nm Nanoparticles for Drug Delivery: Emerging Frontiers and Therapeutic Potential. International Journal of Molecular Sciences 2025, 26, 10842.
Qazi, S.; Richardson, S.; Potts, M.; Myers, S.; Trieu, V. Bioinformatic Approach to Identify Positive Prognostic TGFB2-Dependent and Negative Prognostic TGFB2-Independent Biomarkers for Breast Cancers. International Journal of Molecular Sciences 2025, 26, 11580.
Saif, M.W.; Chang, W.-H.; Myers, S.; Potts, M.; Qazi, S.; Trieu, V. TGFB2 Expression and Methylation Predict Overall Survival in Pancreatic Ductal Adenocarcinoma Patients. International Journal of Molecular Sciences 2025, 26, 6357.
Trieu, V.; Potts, M.; Myers, S.; Richardson, S.; Qazi, S. TGFB2 Gene Methylation in Tumors with Low CD8+ T-Cell Infiltration Drives Positive Prognostic Overall Survival Responses in Pancreatic Ductal Adenocarcinoma. International Journal of Molecular Sciences 2025, 26, 5567.
Qazi, S.; Potts, M.; Myers, S.; Richardson, S.; Trieu, V. Positive Prognostic Overall Survival Impacts of Methylated TGFB2 and MGMT in Adult Glioblastoma Patients. Cancers 2025, 17, 1122.
By late 2025, the Company had further evolved PDAOAI into a large-scale knowledge platform built around a comprehensive TGF-β–centric biomedical corpus, comprising over one hundred thousand curated abstracts and associated datasets. Within this framework, PDAOAI enables semantic retrieval, clustering of related concepts, and cross-referencing of molecular, clinical, and literature-derived data. The platform is designed to generate hypotheses that are not only computationally derived but also traceable to underlying evidence, thereby facilitating scientific validation and regulatory acceptance. The Company has now positioned PDAOAI as a cross-program decision-support system integrating molecular biology, pharmacology, clinical outcomes, and regulatory-grade literature. The platform is used to inform multiple aspects of the Company’s operations, including target identification, biomarker strategy, clinical trial design, and regulatory positioning. In particular, PDAOAI is intended to complement the Company’s nanomedicine and biomarker platforms by identifying patient subpopulations most likely to benefit from specific therapeutic approaches and by supporting the development of precision oncology strategies.
The Company believes that PDAOAI represents a differentiating capability within its integrated platform, enabling the convergence of artificial intelligence, molecular biology, and clinical data into a unified framework. By embedding PDAOAI across its discovery and development processes, the Company aims to accelerate insight generation, improve decision-making, and enhance the probability of clinical and commercial success across its pipeline.
On April 2, 2026, the Company announced that it had entered into a strategic partnership with TechForce Robotics, Inc. (“TechForce”) to advance the commercialization of its PDAOAI-enabled, GMP-compliant robotics platform. This milestone reflects the culmination of several years of research and development efforts, resulting in an integrated platform designed to combine Oncotelic’s proprietary PDAOAI capabilities with TechForce’s robotics hardware and manufacturing expertise. The system under development is designed to operate within GMP-regulated environments and is intended to enable automated material handling, real-time monitoring, and PDAOAI-enhanced compliance workflows across pharmaceutical manufacturing and related applications. The key highlights of the commercialization include:
| 1. | Integrated AI + robotics platform, combining the Company’s PDAOAI capabilities with TechForce’s scalable robotics systems to automate critical operational workflows; | |
| 2. | Form a GMP-Compliant Design, designed to support regulatory requirements, including data capture, audit readiness, and validation frameworks; | |
| 3. | Improve operational efficiency and compliance, intended to reduce human intervention, minimize contamination risk, and enhance process consistency through real-time monitoring and intelligent automation; and | |
| 4. | Achieve scalable manufacturing capability, intended to leverage TechForce’s hardware expertise and manufacturing network to support commercial deployment and future growth. |
Our Strategy and Development Plan
We have been operating with significant capital constraints since the reverse merger between the Company and Oncotelic Inc, and for this time period we have been seeking to secure sufficient funding to continue our operations while we simultaneously seek to advance our all our investigational drugs, whether under the JV or ourselves, for the treatment of cancer, coronaviruses, AI technology and more recently for PD, ED and FSD. Subject to our ability to secure additional capital, we would seek to further develop our product candidates. However, our inability to access capital historically has and may significantly impair our ability to develop these compounds. In the past 2 years, a significant portion of our funding has been provided by Dr. Vuong Trieu, our CEO, directly and indirectly through Autotelic Inc. If we are able to advance any or all of our drug candidates, we would seek to develop them till commercialization, however, there is no guarantee that we would be able to fully develop our products, obtain regulatory approvals and successfully commercialize them.
We continue to discuss collaboration opportunities with other biopharmaceutical companies, although to date have not secured any agreements with companies that are willing to purchase the products from us or license the development and commercialization rights. We intend to continue to seek a partner to acquire the marketing rights to our product candidates and to finance further clinical studies and will seek to complete a transaction if we are able to reach mutual agreement on terms. In this connection, in March 2022, the Company entered into a JV with Dragon to form GMP Bio. Both entities are affiliates of GMP. GMP Bio and the Company will work together to further the development of OT-101, wherein the Company provided the technology and technical expertise and GMP Bio would fund the development expenses. In December 2023, the JV initiated a GMP manufacturing facility in San Diego, California to develop several drug candidates, which individually and collectively, could bring significant value to the JV as well as to the Company, which was approved in the fourth quarter of 2024.
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In addition to entering into transaction that would provide funding for the further development of the rest of our product candidates, other elements of our development strategy would currently include:
| ● | Initiating clinical trials of OT-101, and various other drugs, in various cancers through our JV: We have initiated one trial for OT-101, and we are evaluating conducting such trials in the US as well as other countries like China in conjunction with GMP Bio. We are looking to conduct such trials in combination with other drugs like checkpoint inhibitors. We have filed the protocols for some of the trials being planned and we hope to be able to get acceptance from the FDA and be able to initiate the trials shortly thereafter. In addition, the JV is also working on the initiation of clinical trials for the other drugs, in various stages of development and through various regulatory pathways. In addition, we are developing several nanoparticle therapies to enhance the valuation of the JV and thereby the valuation of the Company. | |
| ● | Assuming we are able to secure additional funding, initiating a clinical trial of CA4P in combination with an immuno-oncology agent or seek any collaboration for the development of CA4P. | |
| ● | Assuming we are able to secure additional funding, continuing to evaluate OXi4503 in a clinical trial or seek any collaboration for the development of OXi4503. | |
| ● | Assuming we are able to secure additional funding, ramping up the apomorphine development program and initiating noninferiority trial comparing AL-101 against subcutaneous apomorphine for the treatment of PD. We are also considering ramping up the apomorphine development programs for ED and FSD/HSDD. The development of these products is subject to the Company being able to raise funding to support the development activities or being able to partner with a third party to co-develop or even any type of a transaction that permits the Company to capitalize on the assets. |
| ● | The Company formed Pet2DAO, as a wholly owned subsidiary. Pet2DAO is a DAO technology company, integrating the strong governance of traditional corporations with the innovative DAO architecture looking to engage stakeholders, to build value through the DAO, while maintaining the rigor of traditional corporations, including governance, compliance, and accountability through a team of veterans in public companies with innovators in AI, blockchain and Web3. Pet2DAO will initially be looking to develop products for the animal health space.
In recent periods, the Company has focused a substantial portion of its operational and strategic efforts on the development and expansion of its JV nanoparticle platform, including the advancement of its two primary subsidiaries, Sapu Bio and Sapu Nano. Through Sapu Bio, the Company has concentrated on the clinical development and commercialization pathway of OT-101, its TGFβ2 antisense therapeutic, including efforts directed toward regulatory advancement, clinical trial execution, and biomarker-driven positioning. In parallel, through Sapu Nano, the Company has advanced its Deciparticle™ nanomedicine platform, including the development of multiple reformulated oncology agents designed to improve pharmacokinetics, tissue distribution, and therapeutic index.
The Company believes that this dual-focus strategy, leveraging Sapu Bio for biologics and RNA-based therapeutics and Sapu Nano for nanomedicine-enabled reformulations, has enabled it to establish a diversified and scalable development platform. Over the course of 2024 and through the date of this Report, the Company directed resources toward building out the operational infrastructure, manufacturing capabilities, and development pipeline of the JV, including the establishment of a GMP-licensed manufacturing facility, the expansion of its pipeline to multiple oncology candidates, and the advancement of lead programs into clinical-stage development.
As part of this strategy, the Company has also emphasized external validation of the JV’s value through strategic partnerships, clinical progress, and preliminary third-party valuation assessments. The Company believes that these efforts have resulted in a material increase in the implied value of the JV relative to its initial formation, although such increases remain subject to confirmation through market-based transactions, financings, or other valuation events. |
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| Having established what it believes to be a strengthened foundation for the JV, the Company is now shifting its strategic focus toward internal
growth initiatives. This transition reflects management’s view that the JV platform has reached a level of maturity sufficient
to support continued development with more balanced resource allocation between the JV and the Company’s wholly owned initiatives.
Accordingly, the Company intends to pursue capital markets activities, including a potential uplisting to a national securities exchange and associated financing transactions, to support the next phase of growth. Proceeds from such activities are expected to be directed toward expanding the Company’s internal capabilities, including further development and commercialization of its PDAOAI platform, continued advancement of its proprietary pipeline programs, and enhancement of its integrated discovery, development, and regulatory infrastructure.
In particular, the Company plans to increase investment in PDAOAI as a core component of its long-term strategy, with the objective of establishing it as a central platform for knowledge integration, biomarker discovery, and decision support across its programs. In addition, the Company intends to advance internal pipeline assets that complement its JV activities, leveraging insights generated through PDAOAI and its biomarker programs to identify and prioritize new therapeutic opportunities.
The Company believes that this next phase—transitioning from JV-focused buildout to a more balanced model of internal and external growth—positions it to capture value both from its ownership interest in the JV and from the expansion of its proprietary platforms. Management believes that successful execution of this strategy, including completion of an uplisting and associated financing, could enhance the Company’s visibility, access to capital, and ability to scale its operations, thereby supporting long-term shareholder value creation. |
REGULATORY MATTERS
Government Regulation and Product Approval
Government authorities in the United States and other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and import of products such as those we are developing. Our drug candidates must be approved by the FDA through the New Drug Application (“NDA”), process before they may be legally marketed in the United States and by comparable foreign agencies before they can be marketed in foreign countries and jurisdictions.
U.S. Drug Development Process
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to review or approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions, fines, refusal of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. The process required by the FDA before a drug may be marketed in the United States generally involves the following:
| ● | completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices (“GLP”) or other applicable regulations; | |
| ● | submission to the FDA of an Investigational New Drug Application, or IND, which must be first approved by the FDA before human clinical trials may begin; | |
| ● | performance of adequate and well-controlled human clinical trials according to Good Clinical Practices (“GCP”) to establish the safety and efficacy of the proposed drug for its intended use; | |
| ● | submission to the FDA of an NDA; | |
| ● | satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current good manufacturing practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; | |
| ● | satisfactory completion of FDA inspections of clinical sites and GLP toxicology studies; and | |
| ● | FDA review and approval of the NDA. |
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The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely basis, if at all.
Once a pharmaceutical candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity, and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND. The sponsor will also include a protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if the first phase lends itself to an efficacy evaluation. Preclinical testing continues even after the IND is submitted. The IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during clinical trials due to safety concerns or non-compliance.
All clinical trials must be conducted under the supervision of qualified investigators in accordance with GCP regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an institutional review board, or IRB, must review and approve the plan for any clinical trial before it commences at any institution. An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the information regarding the trial and the consent form that must be provided to each trial subject or his or her legal representative and must monitor the clinical trial until completed.
Each new clinical protocol must be submitted to the IND for FDA review, and to the IRBs for approval. Protocols detail, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety and efficacy in Phase 2 and 3 clinical trials.
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
| ● | Phase 1: The drug is initially introduced into human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution, and excretion. | |
| ● | Phase 2: Involves clinical trials in a limited patient population to identify possible adverse effects and safety risks, to evaluate preliminary efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. | |
| ● | Phase 3: Clinical trials are undertaken to further evaluate dosage, clinical efficacy, and safety in an expanded patient population. These studies are intended to establish the overall risk-benefit ratio of the product and provide, if appropriate, an adequate basis for product labeling. |
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA. IND Safety Reports must be submitted to the FDA, IRBs and the investigators for (a) any suspected adverse reaction that is both serious and unexpected; (b) any findings from epidemiological studies, pooled analysis of multiple trials, or clinical trials (other than those already reported in (a)); (c) any findings from animal or in vitro testing, whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug, such as reports of mutagenicity, teratogenicity, or carcinogenicity or reports of significant organ toxicity at or near the expected human exposure; and (d) any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. Phase 1, phase 2, and phase 3 testing may not be completed successfully within any specified period, if at all. The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
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Entities can also follow the 505(b)(2) pathway to regulatory approval, to further drug development in a more efficient and relatively cost effective manner. The 505(b)(2) pathway is a regulatory route in the United States under the Federal Food, Drug, and Cosmetic Act (FDCA) that allows for the approval of new drugs that are similar to already approved products. It is often used for drugs that have been previously approved but require modifications, such as new indications, dosages, formulations, or routes of administration. The 505(b)(2) pathway provides a more efficient approval process compared to the traditional New Drug Application (NDA) pathway, as it allows drug developers to rely on existing data from previously approved drugs instead of conducting all new clinical trials. It strikes a balance between the full NDA process and the Abbreviated New Drug Application (ANDA) for generics.
Key Features of the 505(b)(2) Pathway includes (1) allowing applicants to use published literature or data from previous studies, like studies conducted by the original sponsor or from publicly available sources, to support their application, rather than having to repeat all of the clinical trials. This can include data from the reference product, studies published in scientific literature, or data from other regulatory agencies; (2) used for new formulations, like changing the dosage forms, routes of administration, new combinations of active ingredients. It may also be used for new indications for an existing drug; (3) allows for faster approval than a full NDA because it leverages existing data. It can be especially useful when the applicant needs to add new data or modify an already approved drug; and (4) while the application uses data from an existing product, the 505(b)(2) pathway is not for generic drugs. A 505(b)(2) submission often involves new clinical data or modifications that distinguish it from the original approved drug. The benefits of the 505(b)(2) pathway to drug approval include:
| 1. | Reduced Clinical Trial Requirements: Instead of generating a complete set of new clinical trials, or a significantly reduced patient population for clinical trials, applicants can use existing data (like data from the original product or published studies), saving time and costs. | |
| 2. | Innovation and Flexibility: It allows drug developers to bring innovative new formulations, combinations, or indications to market more quickly, which can help improve patient care. | |
| 3. | Cost-Efficiency: It can reduce the cost of development for drug companies, as it may reduce the time and amount of clinical data they need to generate. |
U.S. FDA Review and Approval Processes
The results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling, and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. The submission of an NDA is subject to the payment of user fees; a waiver of such fees may be obtained under certain limited circumstances, which may include orphan drug status and the first NDA application for a company.
In addition, under the Pediatric Research Equity Act, or PREA, an NDA or supplement to an NDA must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted.
The FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA also may refer the NDA to an advisory committee for review, evaluation, and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. The approval process is lengthy and difficult, and the FDA may refuse to approve an NDA at its discretion, or the FDA may require additional clinical or other data and information. Even if such additional data and information are submitted, the FDA may ultimately decide that the NDA does not satisfy its criteria for approval. Data obtained from clinical trials is not always conclusive, and the FDA may interpret data differently than we or others may interpret the same data. The FDA may issue a complete response letter, which may require additional clinical or other data or impose other conditions that must be met in order to obtain approval of the NDA. The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP- compliant to assure and preserve the product’s identity, strength, quality, and purity. Before approving an NDA, the FDA will generally inspect the facility or facilities where the product is manufactured. The FDA will also generally inspect selected clinical sites that participated in the clinical studies and may inspect the testing facilities that performed the GLP toxicology studies cited in the NDA.
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NDAs receive either standard or priority review. A drug representing a significant improvement in treatment, prevention or diagnosis of disease may receive priority review. In addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval and may be approved on the basis of adequate and well- controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. Priority review and accelerated approval do not change the standards for approval but may expedite the approval process.
If a product receives regulatory approval, the approval may be limited to specific diseases or patient subpopulations and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition, approval by the FDA may include a requirement for phase 4 testing, which involves clinical trials designed to further assess a drug’s safety and effectiveness, and the FDA may require testing and surveillance programs to monitor the safety of approved products which have been commercialized.
If an applicant decides to follow the 505(b)(2) pathway to regulatory approval for a drug, then the applicant is required to (1) request meetings with the FDA to discuss the appropriate use of existing data and the studies they need to conduct for approval (2) submits the 505(b)(2) application, which includes clinical trial data, published studies, and other relevant data (3) The FDA reviews the data to assess the safety, effectiveness, and quality of the drug, considering any new information provided (4) If the FDA is satisfied with the data, it will approve the new drug or formulation. If not, additional data or studies may be requested.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years, except in very limited circumstances.
In the European Union and Japan, orphan drug exclusivity regulations provide for 10 years of market exclusivity.
CA4P has been awarded orphan drug status by the FDA for the treatment of anaplastic, medullary, Stage IV papillary and Stage IV follicular thyroid cancers, ovarian cancer, neuroendocrine tumors, and glioma. OXi4503 has been awarded orphan drug status by the FDA for the treatment of acute myelogenous leukemia. CA4P has been awarded orphan drug status by the FDA for the treatment of pancreatic cancer, melanoma, and glioblastoma.
CA4P has also been awarded orphan drug status by the European Commission in the European Union for the treatment of anaplastic thyroid cancer, ovarian cancer and neuroendocrine tumors. OXi4503 has been awarded orphan drug status by the European Commission in the European Union for the treatment of acute myelogenous leukemia. OT-101 has been awarded orphan drug status by the European Commission in the European Union for the treatment of pancreatic cancer, melanoma, and glioblastoma.
Rare Pediatric Disease Designation
The FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application or biologics license application for a product for the prevention or treatment of a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review for any subsequent marketing application and may be sold or transferred. Such vouchers can be valued at several millions of dollars, sometimes in excess of $100 million.
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The FDA granted Rare Pediatric Disease Designation for OT-101/Trabedersen for the treatment of DIPG as a drug for a rare pediatric disease.
The FDA granted Rare Pediatric Disease Designation for CA4P/ Fosbretabulin tromethamine for the treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients as a drug.
The FDA granted Rare Pediatric Disease Designation for Oxi4503 for the treatment of AML as a drug for a rare pediatric disease.
Expedited Review and Approval
The FDA has various programs, including Fast Track, priority review, accelerated approval and breakthrough therapy, which are intended to expedite or simplify the process for reviewing drugs, and/or provide for approval on the basis of surrogate endpoints. Even if a drug qualifies for one or more of these programs, the FDA may subsequently decide the drug no longer meets the conditions for qualification or the FDA may not shorten the review or approval time period. Generally, drugs that may be eligible for these programs are those for serious or life-threatening conditions, those with the potential to address unmet medical needs, and those that offer meaningful benefits over existing treatments. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. Although Fast Track and priority review do not affect the standards for approval, the FDA will attempt to facilitate early and frequent meetings with a sponsor of a Fast-Track designated drug and expedite review of the application for a drug designated for priority review. Drugs that receive an accelerated approval may be approved on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform post-marketing clinical trials.
OXi4503 has been awarded Fast Track designation for the treatment of AML.
Foreign Regulation
In addition to regulations in the United States, we are subject to a variety of foreign regulations governing clinical trials and if any of our product candidates are approved, we will be subject to additional regulations regarding commercial sales and distribution. Whether or not we obtain FDA approval to test a product candidate in the United States, we must obtain approval by the comparable regulatory authorities of foreign countries before we can commence testing any product candidate in those countries. Likewise, whether we obtain FDA approval to market a product, we must obtain approval by the comparable regulatory authorities of foreign countries before we can commence marketing of any product candidate in those countries. The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.
Under European Union regulatory systems, a company may submit marketing authorization applications, or MAAs, either under a centralized or decentralized procedure. The centralized procedure, which is compulsory for medicines produced by biotechnology, or those medicines intended to treat AIDS, cancer, neurodegenerative disorders or diabetes and optional for those medicines which are highly innovative, provides for the grant of a single marketing authorization that is valid for all European Union member states. The decentralized procedure provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may apply to the remaining member states. Within 90 days of receiving the applications and assessments report, each member state must decide whether to recognize approval. If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all member states.
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As in the United States, the European Medicines Agency, or EMA, may grant orphan drug status for specific indications if the request is made before an MAA is submitted. The EMA considers an orphan medicinal product to be one that affects less than five of every 10,000 people in the European Union. A company whose application for orphan drug designation in the European Union is approved is eligible to receive, among other benefits, regulatory assistance in preparing the marketing application, protocol assistance and reduced application fees. Orphan drugs in the European Union receive up to ten years of market exclusivity for the approved indication.
Reimbursement
Sales of any of our product candidates, if approved, will depend, in part, on the extent to which the costs of the products will be covered by third-party payors, including government health programs such as Medicare and Medicaid, commercial health insurers and managed care organizations. These third-party payors are increasingly challenging the prices charged for health care products and services. The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. The adoption or application of price controls and cost-containment measures could limit our revenue. If third-party payors do not consider our products to be cost-effective, they may not pay for our products even if we receive approval, or their level of payment may not be sufficient to allow us to sell our products on a profitable basis.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, imposes requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries. Under Part D (the Medicare prescription drug benefit), Medicare beneficiaries may enroll in prescription drug plans offered by private entities that provide coverage of outpatient prescription drugs not covered under Medicare Part B. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs. Each drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level. Federal regulations require Part D prescription drug formularies to include drugs within each therapeutic category and class of covered Part D drugs, although not necessarily all the drugs in each category or class.
In general, government payment for some of the costs of prescription drugs may increase demand for products for which we receive marketing approval. However, any negotiated prices for our products covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA or other Medicare regulations may result in a similar reduction in payments from non-governmental payors.
The Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Affordable Care Act” or “ACA”) mandated prescription drug coverage as one of ten essential health benefits that most health plans must offer, requiring coverage of at least one drug in every category and class. The ACA increased in the number of individuals covered by insurance and as a result commercial insurers and government programs have increased their emphasis on cost controls to reduce overall spending. A number of federal government leaders have expressed their intentions to repeal and replace the ACA. If full or partial repeal is enacted, many if not all the provisions of the ACA may no longer apply to prescription drugs. As a result, we expect that there will continue to be uncertainty regarding drug product pricing, reimbursement and other factors impacting the revenue we may receive if our product candidates are ultimately approved, which could have a material adverse effect on our business, financial condition, and results of operations.
In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, products launched in the European Union do not follow price structures of the United States and tend to be significantly lower.
PATENTS AND PROPRIETARY RIGHTS
We actively seek to protect the proprietary technology that we consider important to our business, in the United States and other jurisdictions internationally that we consider key pharmaceutical markets.
As of April 14, 2026, we were the exclusive licensee, sole assignee or co-assignee of five granted U.S. patents, two pending U.S. patent application, and various granted patents and/or pending applications in several other major markets, including the European Union, Canada and Japan. Our policy is to file U.S. and foreign patent applications to protect technology, inventions and improvements to inventions that are commercially important to the development of our business, including chemical species, compositions and forms, their methods of use and processes for their manufacture, as well as modified forms of naturally-expressed receptors. There can be no assurance that any of these patent applications will result in the grant of a patent either in the United States or elsewhere, or that any patents granted will be valid and enforceable or will provide a competitive advantage or will afford protection against competitors with similar technologies.
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We consider the following U.S. patents and applications owned by or exclusively licensed to us to be particularly important to the protection of our most advanced product candidates.
| Product Candidate | Patent Scope | Patent Expiration | ||
| CA4P | Use of VDAs to Enhance Immunomodulating Therapies Against Tumors | August 2036 | ||
| OT-101 – through our JV | Combination of A Chemotherapeutic Agent and An Inhibitor of the TGF-β System | July 2030 to | ||
| Combination Therapy for Treatment of Pancreatic Cancer | February 2036 | |||
| Compositions and Methods for Treating Cancer | February 2036 |
In addition to these patents, for some of our product candidates, we have patents and/or applications that cover a particular form or composition, use for a particular indication, use as part of combination therapy or method of preparation or use, as well as other pending patent applications. These issued patents, including any patents that issue from pending applications, could provide additional or a longer period of protection. We also have patent applications pending that seek equivalent or substantially comparable protection for our product candidates in jurisdictions internationally that we consider key pharmaceutical markets.
The patent expiration dates referenced above do not reflect any potential patent term extension that we may receive under the federal Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch- Waxman Act. The Hatch-Waxman Act generally permits a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. Patent extension cannot extend the remaining term of a patent beyond a total of 14 years. The patent term restoration period is generally one-half of the time between the effective date of an investigational new drug application, or IND, and the submission date of a new drug application, or NDA, plus the time between the submission date and approval date of an NDA. Only one patent applicable to an approved drug is eligible for the extension, and the extension must be applied for prior to expiration of the patent. The United States Patent and Trademark Office, in consultation with the FDA, reviews and approves applications for patent term extension.
The FDA and European Union have granted CA4P and OXi4503 orphan drug status for certain indications. We are also pursuing, and may continue to in the future to pursue, orphan drug status for other product candidates and indications. Our ability to obtain and maintain the exclusivity for our products and product candidates by virtue of their orphan drug status is an important part of our intellectual property strategy. Also as previously noted, we are emphasizing Rare Pediatric Designation to leverage on the regulatory exclusivity and voucher program associated with these designations.
We also rely upon trade secret rights to protect technologies that may be used to discover and validate targets and that may be used to identify and develop novel drugs. We seek protection, in part, through confidentiality and proprietary information agreements.
COMPETITION
The industry in which we are engaged is characterized by continual product development and intense competition. Our competitors include, among others, major pharmaceutical, biopharmaceutical and biotechnology companies, nearly all of which have financial, technical, and marketing resources significantly greater than ours. In addition, many of the small companies in our industry have also formed collaborative relationships with large, established companies to support research, development and commercialization of products that may be competitive with ours. Academic institutions, governmental agencies and other public and private research organizations are also conducting research activities and patenting new technologies in our line of business and any of these entities may commercialize products that may be competitive with ours.
We expect that, if any of our products gain regulatory approval for sale, they will compete primarily on the basis of product efficacy, safety, patient convenience, reliability, price and patent protection. Our competitive position will also depend on our ability to attract and retain qualified scientific and other personnel, develop effective proprietary products, and implement joint ventures or other alliances with large pharmaceutical companies in order to jointly market and manufacture our products.
EMPLOYEES
We had thirty eight full-time employees, five part-time employees and thirteen consultants as of December 31, 2025, however, all employees and consultants were compensated by the JV during the years ended December 31, 2025 and 2024, respectively. We rely on external consultants or outsource nearly all our research, development, preclinical testing, and clinical trial activity, although we maintain managerial and quality control over our clinical trials. We also rely on external consultants for various administrative tasks that are required for a public company. We expect to continue to rely on external service providers and to maintain a small number of executives and other employees. Our relations with our employees are good and we do not have any unions for the Company .
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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 described below, as well as the other information in this Annual Report, including our financial statements and the related notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, operating results, and growth prospects. In such an event, the market price of our common stock could decline, and you may lose part or all of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations. The risk factors also include, by reference, to any risk factors previously stated in our other regulatory filings, especially if not specified in the risks enumerated below.
RISKS RELATED TO OUR INVESTMENTS
Our principal asset is our minority investment in a JV, which makes an evaluation of our financial condition more difficult for investors.
Our principal asset is our minority interest in GMP Bio in connection with the JV. We account for our interest on the fair value method and our financial statements reflect only the fair value of that investment. Our financial statements do not include a balance sheet or statement of operations for the JV. We will adjust the value of our holdings in the JV from time to time when sufficient indications of a change in value exist, but the timing of those changes may depend on circumstances that are outside of our control. Accordingly, investors may find it more difficult to assess the underlying value of our company.
The JV is a pre-revenue life sciences venture that is difficult to value, and changes in development results, market conditions, valuation methodology or assumptions could result in material impairment charges, significant volatility in our financial results and/or a material reduction in our reported asset values.
Our principal asset is our investment in the JV. The JV is in the development stage, has not generated any revenue and has no approved or commercially marketed products. There is currently no established public trading market for interests in the JV, and the fair value of our investment is inherently difficult to determine. A recent third party ASC-compliant valuation substantially increased the estimated value of the JV and, as a result, increased the carrying value of our investment on our balance sheet. There can be no assurance that this increased valuation accurately reflects the realizable value of our investment or that such valuation will be sustained in future periods.
The valuation is based in part on management estimates and assumptions, including projections regarding development milestones, the probability of technical and regulatory success, market opportunity, timing of commercialization, comparable company or transaction metrics, discount rates and other inputs. There can be no assurance that this increased valuation is, or will remain, realizable. Future events—such as delays or failures in development, adverse clinical or regulatory outcomes, changes in the competitive landscape, deterioration in capital market conditions, higher discount rates, changes in comparable company valuations, or the JV’s inability to obtain additional financing, could cause the JV’s estimated value to decline, potentially materially.
If the carrying value of our investment is not recoverable or is otherwise required to be adjusted under applicable accounting standards, we could be required to recognize material non-cash impairment charges, mark-to-market adjustments, or other valuation-related losses in future periods. Any such charges could adversely affect our results of operations, financial condition, stockholders’ equity and key financial metrics, and could increase volatility in our reported earnings. In addition, because our ability to monetize our investment may depend on a future financing, sale, collaboration, licensing arrangement or other liquidity event at the JV level, we may not be able to realize value on a timeline or at a valuation that supports the current carrying value of our investment, or at all.
A material amount of our assets represents intangible assets, and our net income would be reduced, or our net loss would be increased, if our intangible assets became impaired.
As of December 31, 2025, our gross intangible assets and goodwill, from our 2019 PointR acquisition, represented approximately $1.1 million and approximately $2.8 million, respectively and the fair value of our investment in our JV was approximately $388 million, combined representing approximately 99% of our total assets. Goodwill is generated in our acquisitions when the cost of an acquisition exceeds the fair value of the net tangible and identifiable intangible assets we acquire. Goodwill and indefinite-lived intangible assets are subject to an impairment analysis at least annually based on fair value. Intangible assets relate primarily to in-process research and development (“IPR&D”) and patents acquired by us as part of our acquisitions of other companies and are subject to an impairment analysis whenever events or changes in circumstances exist that indicate that the carrying value of the intangible asset might not be recoverable. If market and economic conditions or business performance deteriorates, the likelihood that we would record an impairment charge would increase, which impairment charge could materially and adversely affect our financial condition and operating results.
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RISKS RELATED TO OUR FINANCIAL CONDITION
If we are unable to obtain additional funding, we may be forced to cease operations.
We have experienced net losses every year since inception, except for the year ending December 31, 2025. Since inception and as of December 31, 2024, the Company had an accumulated deficit of approximately 38.0 million. During the year ended December 31, 2025, the Company earned net income of approximately $250.3 million, primarily on account of recording a non-cash change in fair value of our investment in the JV of approximately $365.4 million and correspondingly recording a deferred tax liability of approximately $111.6 million. We have no source of product revenue and do not expect to receive any product revenue in the near future. We may generate revenues from services rendered in the future, but we do not expect that to be of a regular and of a recurring nature. If we remain in business, we expect to incur additional operating losses over the next several years, principally as a result of our plans to continue clinical trials for our investigational drugs. As of December 31, 2025, we had approximately $0.1 million in cash, other assets of approximately $1.1 million and $17.9 million in current liabilities, of which $1.3 million pertains to Mateon’s liabilities prior to the Merger and $2.6 million of contingent liabilities, incurred upon our merger with PointR Data, Inc. in November 2019, that would be issuable in shares of common stock of the Company to the PointR shareholders upon satisfaction of certain conditions. Based on our planned operations, we expect our cash to only support our operations for a short period of time.
The principal source of our capital to date has been the proceeds from the sale of equity and debt, a substantial portion of which has been provided by officers and certain insiders. If we are unable to access additional funds in the near term, whether through the sale of additional equity, debt or another means, we may not be able to continue in business. We also may not be able to continue the development of our investigational drugs. Any additional equity or debt financing, if available to us, may not be available on favorable terms and would most likely be dilutive to stockholders. Any debt financing, if available, may involve restrictive covenants and also be dilutive to current stockholders. If we obtain funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates on terms that are not favorable to us. Our ability to access capital when needed is not assured.
In the Notes to the Consolidated Financial Statements, and in their audit report with regard to our Financial Statements as of and for the years ended December 31, 2025, our independent registered public accountants, have expressed an opinion that substantial doubt exists as to whether we can continue as a going concern. Because we have limited cash resources, we believe that it will be necessary for us to either raise additional capital in the near term or to enter into a license or other agreement with a larger pharmaceutical company. If we do not succeed in doing so, we may be required to suspend or cease our business, which would likely materially harm the value of our common stock.
The JV may not be able to successfully complete its planned IPO which could reduce its access to capital and may impair the value of our investment in the JV.
The JV is planning to secure additional financing for its operations through an initial public offering in Hong Kong. While the JV has engaged an investment banker and is taking active steps to progress to an initial public offering, there are no firm commitments to underwrite any public offering at this time. We cannot assure you that any public offering will occur at all, will occur within a specific timeframe, will raise sufficient funds to meet the JV’s needs, or will be on terms that will be beneficial to the Company. If the JV is unsuccessful in its efforts to complete the IPO it will have to find alternative financing to support its operations. There are no arrangement for any such financing at this time, and a lack of capital could cause the JV to have to reduce or suspend its operations. Any adverse financing impact on the JV could decrease its value, the value of our investment and the price of our common stock.
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Due in part to our limited financial resources, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas for our product candidates, and we may be unable to pursue and complete the clinical trials that we would like to pursue and complete.
We have limited financial and technical resources to determine the indications on which we should focus the development efforts for our product candidates. Due to our limited available financial resources, we have curtailed clinical development programs and activities that might otherwise have led to more rapid progress of our product candidates through the regulatory and development processes. We currently have insufficient financial resources to complete any additional drug development work.
If we are able to raise funds and continue developing investigational drugs for cancer, we may make incorrect determinations with regard to the indications and clinical trials on which to focus the available resources that we do have. Furthermore, we cannot assure you that we will be able to retain adequate staffing levels to run our operations and/or to accomplish all the objectives that we otherwise would seek to accomplish. The decisions to allocate our research, management and financial resources toward particular indications or therapeutic areas for our product candidates may not lead to the development of viable commercial products and may divert resources from better opportunities. Similarly, our decisions to delay or terminate drug development programs may also cause us to miss valuable opportunities. In addition, from time to time, we may in-license or otherwise acquire product candidates to supplement our internal development activities. Those activities may use resources that otherwise would have been devoted to our internal programs, and with research and development programs there is no way to assure that the outcome of any trials or other activities will be positive, whether the program was internally generated or in-licensed.
RISKS RELATED TO OUR BUSINESS AND INDUSTRY
We may encounter difficulties in expanding our operations successfully if and when we evolve from a company that is primarily involved in clinical development to a company that is also involved in commercialization.
As we advance our product candidates through later stages of clinical trials, we will need to expand our development, regulatory, manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for us. As our operations expand, we expect that we will need to manage additional relationships with such third parties, as well as additional collaborators, distributors, marketers, and suppliers.
Maintaining third party relationships for these purposes will impose significant added responsibilities on members of our management and other personnel. We must be able to manage our development efforts effectively, manage our participation in the clinical trials in which our product candidates are involved effectively, and improve our managerial, development, operational and finance systems, all of which may impose a strain on our administrative and operational infrastructure.
If, following any approval of our product candidates, we enter into arrangements with third parties to perform sales, marketing or distribution services, any product revenues that we receive, or the profitability of these product revenues to us, are likely to be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell and market our products or in doing so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our products.
If we were to submit an NDA for our drug candidates in the United States or a marketing application in the EU, we would need to undertake commercial scale manufacturing activities at significant expense to us in order to proceed with the application for approval for commercialization. We or our external vendors may encounter technical difficulties that preclude us from successfully manufacturing the required registration and validation batches of active pharmaceutical ingredient, or API, and/or drug product and we may be unable to recover any financial losses associated with the manufacturing activities. Further, our research or product development efforts may not be successfully completed, any compounds currently under development by us may not be successfully developed into drugs, any potential products may not receive regulatory approval on a timely basis, if at all, and competitors may develop and bring to market products or technologies that render our potential products obsolete. If any of these problems occur, our business would be materially and adversely affected.
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We have no manufacturing capacity and have relied on, and expect to continue to rely on, third-party manufacturers to produce our product candidates.
We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates or any of the compounds that we are testing in our preclinical programs, and we lack the resources and the capabilities to do so. As a result, we currently rely, and we expect to rely for the foreseeable future, on third-party manufacturers to supply our product candidates. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured our product candidates or products ourselves, including:
| ● | reliance on third-parties for manufacturing process development, regulatory compliance and quality assurance; | |
| ● | limitations on supply availability resulting from capacity and scheduling constraints of third-parties; | |
| ● | the possible breach of manufacturing agreements by third-parties because of factors beyond our control; and | |
| ● | the possible termination or non-renewal of the manufacturing agreements by the third-party, at a time that is costly or inconvenient to us. |
If we do not maintain our developed important manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins, if any. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us, and there could be a substantial delay before new facilities could be qualified and registered with the FDA, EMA and other foreign regulatory authorities.
The FDA, EMA and other foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding foreign regulators also inspect these facilities to confirm compliance with current good manufacturing practices, or cGMPs. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA, EMA and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our product candidates and market our products after approval.
Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our ability to develop our product candidates, our ability to commercialize any products that receive regulatory approval and our potential future profit margins on these products.
Our product candidates have not completed clinical trials and may never demonstrate sufficient safety and efficacy in order to do so.
Our product candidates are in the clinical stage of development. In order to achieve profitable operations, we alone or in collaboration with others, must successfully develop, manufacture, introduce and market our products. The time frame necessary to achieve market success for any individual product is long and uncertain. The products currently under development by us may require significant additional research and development and additional preclinical and clinical testing prior to application for commercial use. A number of companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in clinical trials, even after showing promising results in early or later-stage studies or clinical trials. Although we have obtained some favorable results to date in preclinical studies and clinical trials of certain of our potential products, such results may not be indicative of results that will ultimately be obtained in or throughout such clinical trials, and clinical trials may not show any of our products to be safe or capable of producing a desired result. Additionally, we may encounter problems in our clinical trials that may cause us to delay, suspend or terminate those clinical trials.
Adverse events observed to date and associated with CA4P and OXi4503 have generally been found to be manageable for drugs treating the indications for which we are developing our product candidates. However, we will be required to continue to test and evaluate the safety of our product candidates in additional clinical trials, and to demonstrate their safety to the satisfaction of appropriate regulatory agencies, as a condition to receipt of any regulatory approvals. In clinical trials to date, transient hypertension believed to be associated with CA4P and OXi4503 has been effectively managed through pre-treatment with anti-hypertensive medication. We cannot assure you, however, that we will be able to make the necessary demonstrations of safety to allow us to receive regulatory approval for our product candidates in any indication.
Our industry is highly competitive, and our product candidates may become obsolete.
We are engaged in a rapidly evolving field. Competition from other pharmaceutical companies, biotechnology companies and research and academic institutions is intense and likely to increase. Many of those companies and institutions have substantially greater financial, technical, and human resources than we do. Many of those companies and institutions also have substantially greater experience in developing products, conducting clinical trials, obtaining regulatory approval and in manufacturing and marketing pharmaceutical products. Our competitors may succeed in obtaining regulatory approval for their products more rapidly than we do. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competitive products. Some of these competitive products may have an entirely different approach or means of accomplishing the desired therapeutic effect than products being developed by us. Our competitors may succeed in developing products that are more effective and/or cost competitive than those we are developing, or that would render our product candidates less competitive or even obsolete. In addition, one or more of our competitors may achieve product commercialization or patent protection earlier than we do, which could materially adversely affect us.
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If clinical trials or regulatory approval processes for our product candidates are prolonged, delayed or suspended, we may be unable to out-license or commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay or prevent our receipt of any proceeds from potential license agreements or product sales.
We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause us or any regulatory authority to delay or suspend those clinical trials or delay or invalidate the analysis of data derived from them. A number of events, including any of the following, could delay the completion of our other ongoing and planned clinical trials and negatively impact our ability to obtain regulatory approval for, and to market and sell, a particular product candidate:
| ● | conditions imposed on us by the FDA, EMA or another foreign regulatory authority regarding the scope or design of our clinical trials; | |
| ● | delays in obtaining, or our inability to obtain, required approvals from institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials; | |
| ● | insufficient supply of our product candidates or other materials necessary to conduct and complete our clinical trials; | |
| ● | slow enrollment and retention rate of subjects in clinical trials; | |
| ● | any compliance audits and pre-approval inspections by the FDA, EMA or other regulatory authorities; | |
| ● | negative or inconclusive results from clinical trials, or results that are inconsistent with earlier results; | |
| ● | serious and unexpected drug-related side effects; and | |
| ● | failure of our third-party contractors to comply with regulatory requirements or otherwise meet their contractual obligations to us. |
Commercialization or licensure of our product candidates may be delayed or prevented by the imposition of additional conditions on our clinical trials by the FDA, EMA or another foreign regulatory authority or the requirement of additional supportive clinical trials by the FDA, EMA, or another foreign regulatory authority. In addition, clinical trials require sufficient patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites, the availability of effective treatments for the relevant disease, the conduct of other clinical trials that compete for the same patients as our clinical trials, and the eligibility criteria for our clinical trials. Our failure to enroll patients in our clinical trials could delay the completion of the clinical trial beyond our expectations, or it could prevent us from being able to complete the clinical trial. In addition, the FDA and EMA could require us to conduct clinical trials with a larger number of subjects than we have projected for any of our product candidates. We may not be able to enroll a sufficient number of patients in a timely or cost-effective manner. Furthermore, enrolled patients may drop out of our clinical trials, which could impair the validity or statistical significance of the clinical trials.
We do not know whether our clinical trials will begin as planned, will need to be restructured, or will be completed on schedule, if at all. Delays in our clinical trials will result in increased development costs for our product candidates, and our financial resources may be insufficient to fund any incremental costs. In addition, if our clinical trials are delayed, our competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could be limited.
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If physicians and patients do not accept our future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any.
Even if any of our product candidates obtain regulatory approval, they may not gain market acceptance among physicians, patients, and third-party payers. Physicians may decide not to prescribe our drugs for a variety of reasons including:
| ● | timing of market introduction of competitive products; | |
| ● | demonstration of clinical safety and efficacy compared to other products; | |
| ● | cost-effectiveness; | |
| ● | limited or no coverage by third-party payers; | |
| ● | convenience and ease of administration; | |
| ● | prevalence and severity of adverse side effects; | |
| ● | restrictions in the label of the drug; | |
| ● | other potential advantages of alternative treatment methods; and | |
| ● | ineffective marketing and distribution support of our products. |
If any of our product candidates is approved, but fails to achieve market acceptance, we may not be able to generate significant revenue and our business would suffer.
The uncertainty associated with pharmaceutical reimbursement and related matters may adversely affect our business.
Market acceptance and sales of any one or more of our product candidates that we develop will depend on reimbursement policies and may be affected by future healthcare reform measures in the United States and in foreign jurisdictions. Government authorities and third-party payers, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. We cannot be certain that reimbursement will be available for any product candidates that we develop. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for, our products. If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize any product candidates that we develop.
In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also called the Medicare Modernization Act, or MMA, changed the way Medicare covers and pays for pharmaceutical products. The legislation established Medicare Part D, which expanded Medicare coverage for outpatient prescription drug purchases by the elderly but provided authority for limiting the number of drugs that will be covered in any therapeutic class. The MMA also introduced a new reimbursement methodology based on average sales prices for physician-administered drugs.
The United States and several foreign jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payers in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. We expect to experience pricing pressures in connection with the sale of any products that we develop due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative proposals.
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.
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We rely on a limited number of employees at the JV to manage and operate our business.
We had thirty eight full-time employees, five part-time employees and thirteen consultants as of December 31, 2025, however, all employees and consultants were compensated by the JV during the years ended December 31, 2025 and 2024, respectively. We rely on external consultants or outsource nearly all our research, development, preclinical testing, and clinical trial activity, although we maintain managerial and quality control over our clinical trials. We expect to continue to rely on external service providers and to maintain a small number of executives and other employees. Our limited financial resources require us to manage and operate our business in a highly efficient manner. We cannot assure you that we will be able to retain adequate staffing levels to run our operations and/or to accomplish all the objectives that we otherwise would seek to accomplish.
We depend on our executive officers and principal consultants and the loss of their services could materially harm our business.
We believe that our success depends, and will likely continue to depend, upon our ability to retain the services of our current executive officers, particularly our Chief Executive Officer, Chief Business Officer, Chief Medical Officer, Chief Regulatory Officer and Chief Financial Officer, our principal consultants, and others. The loss of the services of any of these individuals could have a material adverse effect on our business. In addition to these key service providers, we have established relationships with universities, hospitals and research institutions, which have historically provided, and continue to provide, us with access to research laboratories, clinical trials, facilities and patients. Additionally, we believe that we may, at any time and from time to time, materially depend on the services of consultants and other unaffiliated third parties. We cannot assure you that consultants and other unaffiliated third parties will provide the level of service to us that we require in order to achieve our business objectives.
Our business and operations could suffer in the event of system failures.
Despite the implementation of security measures, our internal computer systems and those of our third-party CROs and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Furthermore, we have little or no control over the security measures and computer systems of our third-party CROs and other contractors and consultants. While we have not experienced any material 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 programs. For example, the loss of clinical trial data for our product candidates could result in delays in our marketing approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications relating to our technology or product candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and the further development of our product candidates could be delayed.
REGULATORY AND LEGAL RISKS
If we are unable to obtain required regulatory approvals, we will be unable to market and sell our product candidates.
Our product candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing, oversight of clinical investigators, recordkeeping, and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory review and approval process are required to be successfully completed in the United States, in the European Union and in many other foreign jurisdictions before a new drug can be sold. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain, and subject to unanticipated delays. The time required to obtain approval by the FDA or the European Medicines Agency, or EMA, is unpredictable and often takes many years following the commencement of clinical trials.
In connection with the clinical development of our product candidates, we face risks that:
| ● | our product candidates may not prove to be safe and efficacious; | |
| ● | patients may die or suffer serious adverse effects for reasons that may or may not be related to the product candidate being tested; | |
| ● | we fail to maintain adequate records of observations and data from our clinical trials, to establish and maintain sufficient procedures to oversee, collect data from, and manage clinical trials, or to monitor clinical trial sites and investigators to the satisfaction of the FDA, EMA, or other regulatory agencies; |
| ● | we may not have sufficient financial resources to complete the clinical trials that would be necessary to obtain regulatory approvals; | |
| ● | the results of later-phase clinical trials may not confirm the results of earlier clinical trials; and | |
| ● | the results from clinical trials may not meet the level of statistical significance or clinical benefit-to-risk ratio required by the FDA, EMA, or other regulatory agencies for marketing approval. |
Only a small percentage of product candidates for which clinical trials are initiated are the subject of NDAs and even fewer receive approval for commercialization. Furthermore, even if we do receive regulatory approval to market a product candidate, any such approval may be subject to limitations such as those on the indicated uses for which we may market the product.
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If we or the third parties on which we rely for the conduct of our clinical trials do not perform our clinical trial activities in accordance with good clinical practices and related regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.
We currently use independent clinical investigators in all our clinical trials and, in many cases, also utilize contract research organizations, or CROs, and other third-party service providers to conduct and/or oversee the clinical trials of our product candidates and expect to continue to do so for the foreseeable future. We rely heavily on these parties for successful execution of our clinical trials. Nonetheless, we are responsible for confirming that each of our clinical trials is conducted in accordance with the FDA’s requirements and our general investigational plan and protocol. Currently, we have clinical trial activities involving CA4P and OXi4503 being conducted by clinical investigators who are independent of us, but with whom we have agreements for them to provide the results of their clinical trials to us. In order for us to rely on data from these ongoing clinical trials in support of a New Drug Application, or NDA, for approval of any of our product candidates by the FDA or similar types of marketing applications that are required by other regulatory authorities, the independent investigators are required to comply with applicable good clinical practice requirements.
The FDA and corresponding foreign regulatory authorities require us and our clinical investigators to comply with regulations and standards, commonly referred to as good clinical practices, or GCPs, for conducting and recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the trial participants are adequately protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. Third parties may not complete activities on schedule or may not conduct our clinical trials in accordance with regulatory requirements or the respective trial plans and protocols. The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates or result in enforcement action against us.
We have taken and continue to take steps to strengthen our procedures and practices, but we cannot assure you that the FDA will be satisfied with our procedures or that the FDA will not issue warning letters or take other enforcement action against us in the future. The steps we take to strengthen our procedures and conduct future clinical trials necessary for approval will be time-consuming and expensive.
The use of our products may result in product liability exposure, and it is uncertain whether our insurance coverage will be sufficient to cover all claims.
The use of our product candidates in clinical trials may expose us to liability claims in the event such product candidates cause death, injury or disease, or result in adverse effects. We may be exposed to liability claims even if our product did not cause death, injury or diseases, but is merely presumed or alleged to have caused any of these. If our product candidates are ever commercially approved, the commercial use of these products may also expose us to similar liability claims. Any of these claims could be made by health care institutions, contract laboratories, patients or others using such products. Although we have obtained liability insurance coverage for our ongoing clinical trials, this coverage may not be in amounts sufficient to protect us from any product liability claims or product recalls which could have a material adverse effect on our financial condition and prospects. Further, adverse product and similar liability claims could negatively impact our ability to obtain or maintain regulatory approvals for our technology and product candidates under development.
We and the JV intend to take advantage of regulatory pathways to accelerate product candidate development, and failure to secure such pathways would result in increased product development costs and longer regulatory approval as we seek to commercialize our product candidates.
In addition to regular pathways of filing INDs and NDAs, we, or our partners, including the JV, also plan to follow expedited pathways such as 505(b)(2) pathway of expedited approvals so as to get our products to market and patients for unmet medical needs on an expedited basis. However, we cannot guarantee that the regulatory bodies would approve our approach or approve our products as planned. If we are unable to secure approval for such expedited pathways, we will incur increased research and development costs and longer regulatory approval times as we seek to commercialize our products.
We have been granted orphan drug status for certain of our product candidates and may seek orphan drug status for additional indications for those product candidates or for additional product candidates. We may be unsuccessful in maintaining orphan drug exclusivity for our product candidates and may be unsuccessful in our efforts to seek orphan drug status and orphan drug exclusivity.
Regulatory authorities in some jurisdictions, including the United States and the European Union, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a disease with a patient population of fewer than 200,000 individuals in the United States. Our lead product candidate, OXi4503, has been awarded orphan drug status by the FDA and the European Commission for the treatment of acute myelogenous leukemia. Our other product candidate, CA4P, has been awarded orphan drug status by the FDA for the treatment of anaplastic, medullary, Stage IV papillary and Stage IV follicular thyroid cancers, ovarian cancer, neuroendocrine tumors and glioma. CA4P has also been awarded orphan drug status by the European Commission in the European Union for the treatment of anaplastic thyroid cancer, ovarian cancer and neuroendocrine tumors.
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Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the EMA or the FDA from approving another marketing application for the same drug for the same indication during the period of exclusivity. The applicable period is seven years in the United States and ten years in the European Union. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective, if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.
Even if we obtain orphan drug exclusivity for a product candidate or additional product candidates, that exclusivity may not effectively protect the product candidate from competition because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve a different drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.
Our product candidates will remain subject to ongoing regulatory review even if they receive marketing approval, and if we fail to comply with continuing regulations, we could lose these approvals and the sale of any approved commercial products could be suspended.
Even if we receive regulatory approval to market a particular product candidate, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, and record keeping related to the product will remain subject to extensive regulatory requirements. If we fail to comply with the regulatory requirements of the FDA, EMA and other applicable domestic and foreign regulatory authorities or previously unknown problems with any approved product, manufacturer, or manufacturing process are discovered, we could be subject to administrative or judicially imposed sanctions, including:
| ● | restrictions on the products, manufacturers, or manufacturing processes; | |
| ● | warning letters; | |
| ● | civil or criminal penalties; |
| ● | fines; | |
| ● | injunctions; |
| ● | product seizures or detentions; | |
| ● | pressure to initiate voluntary product recalls; | |
| ● | suspension or withdrawal of regulatory approvals; and | |
| ● | refusal to approve pending applications for marketing approval of new products or supplements to approved applications. |
Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
We are exposed to the risk that our employees, principal investigators, CROs and consultants may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violate the regulations of the FDA and other regulatory authorities, including those laws requiring the reporting of true, complete, and accurate information to such authorities; healthcare fraud and abuse laws and regulations in the United States and abroad; or laws that require the reporting of financial information or data accurately. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials or creating fraudulent data in our preclinical studies or clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation.
We have a code of conduct applicable to all of our employees, but it is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this 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 to comply with these laws or regulations. Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred. 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, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
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RISKS RELATED TO INTELLECTUAL PROPERTY
We depend extensively on the patents and proprietary technology we license from others, and we must maintain these licenses in order to preserve our business.
We have licensed rights to CA4P, OXi4503 and other programs from third parties. If our license agreements terminate or expire, we may lose the licensed rights to our product candidates, including CA4P and OXi4503, and we may not be able to continue to develop them or, if they are approved, we may not be able to market or commercialize them.
We depend on license agreements with third-parties for certain intellectual property rights relating to our product candidates, including patent rights. Currently, we have licensed certain patent rights from Arizona State University, or ASU, and the Bristol-Myers Squibb Company for CA4P and OXi4503 and from Baylor University for other programs. In general, our license agreements require us to make payments and satisfy performance obligations in order to keep these agreements in effect and retain our rights under them. These payment obligations can include upfront fees, maintenance fees, milestones, royalties, patent prosecution expense, and other fees. These performance obligations typically include diligence obligations. If we fail to pay, be diligent or otherwise perform as required under our license agreements, we could lose the rights under the patents and other intellectual property rights covered by the agreements. While we are not currently aware of any dispute with any licensors under our material agreements with them, if disputes arise under any of our in-licenses, including our in-licenses from ASU, the Bristol-Myers Squibb Company, and Baylor University, we could lose our rights under these agreements. Any such dispute may not be resolvable on favorable terms, or at all. Whether or not any disputes of this kind are favorably resolved, our management’s time and attention and our other resources could be consumed by the need to attend to and seek to resolve these disputes and our business could be harmed by the emergence of such a dispute.
If we lose our rights under these agreements, we may not be able to conduct any further activities with the product candidate or program that the license covered. If this were to happen, we might not be able to develop our product candidates further, or following regulatory approval, if any, we might be prohibited from marketing or commercializing them. In particular, patents previously licensed to us, such as the patents we previously licensed from Angiogene, might after termination be used to stop us from conducting activities in the patents’ respective fields.
We depend on patents and proprietary technology in the course of our business, and we must protect those assets in order to preserve our business.
Although we expect to seek patent protection for any compounds we discover and/or for any specific use we discover for new or previously known compounds, any or all of them may not be subject to effective patent protection. Further, the development of regimens for the administration of pharmaceuticals, which generally involve specifications for the frequency, timing and amounts of dosages, has been, and we believe, may continue to be, important to our effort, although those processes, as such, may not be patentable. In addition, the issued patents may be declared invalid, or our competitors may find ways to avoid the claims in the patents. Further, our lack of access to adequate capital may cause us to curtail payment of fees necessary to maintain patents that we otherwise would seek to maintain, and we may make incorrect decisions regarding which patents to keep and which to abandon.
Our success will depend, in part, on our ability to obtain and maintain patents, protect our trade secrets and operate without infringing on the proprietary rights of others. We are the exclusive licensee, sole assignee, or co- assignee on a number of granted United States patents, pending United States patent applications, and granted patents and/or pending applications in several other major markets, including the European Union, Canada and Japan. The patent position of pharmaceutical and biotechnology firms like us is generally highly uncertain and involves complex legal and factual questions, resulting in both an apparent inconsistency regarding the breadth of claims allowed in United States patents and general uncertainty as to their legal interpretation and enforceability. Accordingly, patent applications assigned or exclusively licensed to us may not result in patents being issued, any issued patents assigned or exclusively licensed to us may not provide us with competitive protection or may be challenged by others, and the current or future granted patents of others may have an adverse effect on our ability to do business and achieve profitability. Moreover, because some of the basic research relating to one or more of our patent applications and/or patents were performed at various universities and/or funded by grants, one or more of these universities, employees of such universities and/or grantors could assert that they have certain rights in such research and any resulting products. Further, others may independently develop similar products, may duplicate our products, or may design around our patent rights. In addition, as a result of the assertion of rights by a third-party or otherwise, we may be required to obtain licenses to patents or other proprietary rights of others in or outside of the United States. Any licenses required under any such patents or proprietary rights may not be made available on terms acceptable to us, if at all. If we do not obtain such licenses, we could encounter delays in product market introductions while our attempts to design around such patents or could find that the development, manufacture, or sale of products requiring such licenses is foreclosed. In addition, we could incur substantial costs in defending ourselves in suits brought against us or in connection with patents to which we hold licenses or in bringing suit to protect our own patents against infringement.
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We require employees and the institutions that perform our preclinical and clinical trials to enter into confidentiality agreements with us. Those agreements provide that all confidential information developed or made known to a party to any such agreement during the course of the relationship with us be kept confidential and not be disclosed to third-parties, except in specific circumstances. Any such agreement may not provide meaningful protection for our trade secrets or other confidential information in the event of unauthorized use or disclosure of such information.
RISKS RELATED TO OUR COMMON STOCK
The price of our common stock is volatile and is likely to continue to fluctuate due to reasons beyond our control.
Our stock price may be volatile. The stock market in general and the market for smaller specialty pharmaceutical companies and biotechnology, in particular, have experienced extreme volatility that has often been unrelated to the operating performance of particular companies or the quality of the underlying assets. As a result of this volatility, you may not be able to sell your common stock at or above the price you paid for such shares. The market price for our common stock may be influenced by many factors, including but not limited to:
| ● | clinical trial and research development announcements; | |
| ● | regulatory developments affecting our or our competitor’s products | |
| ● | reduction in the fair value of our investment in the JV; | |
| ● | impairment of the goodwill and intangible assets; | |
| ● | market conditions in the pharmaceutical and biotechnology sectors; | |
| ● | general economic, industry, and market conditions; and | |
| ● | the other factors described in this “Risk Factors” section. |
We cannot assure you that an investment in our common stock will not fluctuate significantly. One or more of these factors could significantly harm our business and cause a decline in the price of our common stock in the public market.
A limited trading market may increase the volatility of trading in our stock.
Our common stock is currently quoted on the OTCQB Market. The quotation of our common stock on the OTCQB Market does not assure that a meaningful, consistent, and liquid trading market currently exists, and in recent years such market has experienced extreme price and volume fluctuations that have particularly affected the market prices of many smaller companies like us. Our common stock is subject to this volatility.
Substantially all of the shares of our common stock issuable upon exercise of outstanding options and warrants have been registered or are likely to be registered for resale or are available for sale pursuant to Rule 144 under the Securities Act and may be sold from time to time. As of December 31, 2025, we had approximately 205.6 million shares of common stock underlying currently outstanding convertible debt, warrants and options. Sales of any of these shares on the market, as well as future sales of our common stock by existing stockholders, or the perception that sales may occur at any time, could adversely affect the market price of our common stock.
Sales of substantial amounts of common stock, or the perception that such sales might occur, could adversely affect prevailing market prices of our common stock and our stock price may decline substantially in a short time and our stockholders could suffer losses or be unable to liquidate their holdings.
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Our common stock is currently subject to the “Penny Stock” Rules of the SEC and the trading market in our securities is limited, which makes transactions in our stock cumbersome and may reduce the value of an investment in our stock.
As of December 31, 2025, while we had net assets of approximately $262.8 million, our common stock had a market price per share of less than $5.00. As a result, transactions in our common stock are subject to the SEC’s “penny stock” rules. The designation of our common stock as a “penny stock” likely limits the liquidity of our common stock. Prices for penny stocks are often not available to buyers and sellers and the market may be very limited. Penny stocks are among the riskiest equity investments. Broker-dealers who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the SEC. The document provides information about penny stocks and the nature and level of risks involved in investing in the penny stock market. A broker must also provide purchasers with bid and offer quotations and information regarding broker and salesperson compensation and make a written determination that the penny stock is a suitable investment for the purchaser and obtain the purchaser’s written agreement to the purchase. Many brokers choose not to participate in penny stock transactions. Because of the penny stock rules, there may be less trading activity in penny stocks. Because shares of our common stock are currently subject to these penny stock rules, your ability to trade or dispose of shares of our common stock may be adversely affected.
We may not be able to achieve secondary trading of our stock in certain states because our common stock is no longer nationally traded, which could subject our stockholders to significant restrictions and costs.
Our common stock is not currently eligible for trading on the Nasdaq Capital Market or on a national securities exchange. Therefore, our common stock is subject to the securities laws of the various states and jurisdictions of the United States in addition to federal securities law. While we may register our common stock or qualify for exemptions for our common stock in one of more states, if we fail to do so the investors in those states where we have not taken such steps may not be allowed to purchase our stock or those who presently hold our stock may not be able to resell their shares without substantial effort and expense. These restrictions and potential costs could be significant burdens on our stockholders.
We may not be able to uplist our stock to a national stock exchange which could subject our stockholders to significant restrictions and costs.
Our common stock is not currently eligible for trading on the Nasdaq Capital Market or on a national securities exchange. While we are working to get our stock to trade on a nationally recognized stock exchange, we may not be able to do so.
If we fail to maintain an effective system of internal controls over financial reporting, we may not be able to accurately report our financial results. As a result, current and potential stockholders could lose confidence in our financial reporting, which could harm our business and the trading price of our stock.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports. If we cannot maintain effective controls and reliable financial reports, our business and operating results could be harmed. For example, our small size and limited staffing levels do not allow for segregation of duties that exist at larger companies. We have conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2025, based on the criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework). Based on that evaluation, our management concluded that our internal controls over financial reporting were not effective as of December 31, 2025. While we continue to work on remedying our weaknesses and maintaining effective internal controls over financial reporting; however, there can be no assurance that a material weakness will not occur in the future, or our material weaknesses would be rectified. Any failure to implement and maintain controls over our financial reporting or difficulties encountered in the implementation of improvements in our controls could cause us to fail to meet our reporting obligations. Any failure to maintain our internal controls over financial reporting or to address identified weaknesses in the future, if they were to occur, could also cause investors to lose confidence in our reported financial information, which could have a negative impact on the trading price of our stock.
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Issuance of additional equity securities may adversely affect the market price of our common stock.
We are authorized to issue up to 750,000,000 shares of our common stock. As of December 31, 2025, we had approximately 444.2 million shares of common stock issued and outstanding, including approximately 1 million shares of common stock to be issued. As of December 31, 2025, we also had approximately 59.4 million warrants outstanding, approximately 24 million options and approximately 122.4 million shares of common stock issuable upon conversion of convertible notes.
Additionally, the Company has authorized 15,000,000 shares of Convertible Preferred Stock. As of December 31, 2025, 24,388 shares of the Company’s Preferred Stock were issued to our CEO, of which 4,065 were earned and vested and an additional 8,131 shares have been earned but not yet issued. Each share of Preferred Stock is convertible into 1,000 shares of the Company’s Common Stock, and votes with the Common Stock on an as converted basis.
To the extent that additional shares of common stock are issued, or options and warrants are exercised, holders of our common stock will experience dilution. In addition, in the event of any future issuances of equity securities or securities convertible into or exchangeable for common stock, holders of our common stock may experience dilution.
Our Board of Directors is authorized to issue preferred stock without any action on the part of our stockholders. Our Board of Directors also has the power, without stockholder approval, to set the terms of any such preferred stock that may be issued, including voting rights, conversion rights, dividend rights, preferences over our common stock with respect to dividends or if we liquidate, dissolve, or wind up our business and other terms. If we issue preferred stock in the future that has preference over our common stock with respect to the payment of dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting power of our common stock, the market price of our common stock could decrease. Any provision permitting the conversion of any such preferred stock into our common stock could result in significant dilution to the holders of our common stock.
We also consider from time-to-time various strategic alternatives that could involve issuances of additional common or preferred stock, including but not limited to acquisitions and business combinations.
We have no plans to pay dividends on our common stock, and you may not receive funds without selling your common stock.
We have not declared or paid any cash dividends on our common stock, nor do we expect to pay any cash dividends on our common stock for the foreseeable future. We currently intend to retain any future earnings, if any, to finance our operations and growth and, potentially, for future stock repurchases and, therefore, we have no plans to pay cash dividends on our common stock. Any future determination to pay cash dividends on our common stock will be at the discretion of our Board of Directors and will be dependent on our earnings, financial condition, operating results, capital requirements, any contractual restrictions, and other factors that our board of directors deems relevant.
Accordingly, you may have to sell some or all of your common stock in order to generate cash from your investment in the Company. You may not receive a gain on your investment when you sell our common stock and may lose the entire amount of your investment.
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RISKS RELATED TO MAST HILL EQUITY LINE
Mast Hill’s sales of our Shares into the open market may cause material decreases in our stock price.
On August 1, 2025 we entered into an Equity Purchase Agreement with Mast Hill Fund L.P. (“Mast Hill”). In connection with that agreement we filed a Registration Statement covering the re-sale of up to 115.6 million shares of our common stock may be sold into the market by Mast Hill under the terms of the Equity Purchase Agreement and related agreements. Under the terms of the Equity Purchase Agreement, we can issue Put Notices to sell shares of common stock to Mast Hill, at prices based on recent trading prices. The sale of shares common stock by Mast Hill under the Registration Statement could cause our stock price to decline. In turn, if our stock price declines and we issue more Put Notices, this could cause more shares to come into the market, which could cause a further drop in our stock price.
Funding from our Equity Purchase Agreement with Mast Hill will be limited by our current shares outstanding and may be insufficient to fund our operations or to implement our strategy.
Under the Equity Purchase Agreement, and subject to other conditions, we may direct Mast Hill to purchase up to $25,000,000 worth of shares of our common stock over a 24-month period. However, we have limited shares of our common stock that have not already been reserved for outstanding derivative securities. Accordingly, we have registered 100,000,000 shares for issuance under the Equity Purchase Agreement. At an assumed hypothetical purchase price of $0.0912 equal to 97% of the closing price of our common stock of $0.0940 on December 17, 2025, as defined in the section entitled “Equity Purchase Agreement with Mast Hill Fund” in this prospectus) and assuming the sale by us to Mast Hill of all 100,000,000 Shares we would receive gross proceeds of approximately $9.1 million. We would need to eliminate outstanding derivative securities, authorize additional capital stock or effect another capital reorganization in order to sell more shares to Mast Hill and secure access to the full $25,000,000 in proceeds.
There can be no assurance that we will be able to receive all or any of the total commitment from Mast Hill. In additions to limitations because of our available capital stock, the Equity Purchase Agreement contains certain limitations, restrictions, requirements, conditions and other provisions that could limit our ability to cause Mast Hill to buy common stock from us. For instance, we are prohibited from issuing a Put Notice if the amount requested in such Put Notice exceeds the Maximum Put Amount, or the sale of Shares pursuant to the Put Notice would cause us to sell or Mast Hill to purchase an aggregate number of shares of the Company’s common stock which would result in beneficial ownership by Mast Hill of more than 4.99% of our common stock (as calculated pursuant to Section 13(d) of the Exchange Act and the rules and regulations thereunder). Moreover, there are limitations with respect to the frequency with which we may provide Put Notices to Mast Hill under the Equity Purchase Agreement. Also, as discussed above, there must be an effective registration statement covering the resale of any Shares to be issued pursuant to any draw down under the Equity Purchase Agreement, and the registration statement of which this prospectus is a part covers the resale of only 100 million Shares that may be issuable pursuant to put notices under the Equity Purchase Agreement. The registration statements may be subject to review and comment by the staff of the Securities and Exchange Commission (the “SEC” or the “Commission”) and will require the consent of our independent registered public accounting firm. Therefore, the timing of effectiveness of the registration statements cannot be assured.
The extent to which we rely on Mast Hill as a source of funding will depend on a number of factors, including the amount of working capital needed, the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources. If obtaining sufficient funding from Mast Hill were to prove unavailable or prohibitively dilutive, we would need to secure another source of funding. Even if we sell all 100 million shares of common stock under the Purchase Agreement with Mast Hill, we will still need additional capital to fully implement our current business, operating plans and development plans.
The sale or issuance of our common stock to Mast Hill at a discount may cause substantial dilution and the resale of the shares of common stock by Mast Hill into the public market, or the perception that such sales may occur, could cause the price of our common stock to fall.
Under the Equity Purchase Agreement with Mast Hill and subject to other conditions, we may direct Mast Hill to purchase up to 100 million of our shares of common stock over a 24-month period. We registered an aggregate of approximately 115.6 million shares of our common stock (including 8,000,000 shares underlying the secured note, 5,350,000 shares underlying the warrants and 2,250,000 Commitment shares already issued) shares of common stock in the registration statement of which this prospectus is a part pursuant to the Registration Rights Agreement, representing shares which have been and may be issuable to Mast Hill under Note Purchase Agreement and the Equity Purchase Agreement. Notwithstanding Mast Hill’s beneficial ownership limitation set forth in the Note Purchase Agreement and Equity Purchase Agreement, if all of the approximately 115.6 million shares offered under the Registration Statement were issued and outstanding as of December 31, 2025, such shares would represent approximately 20.7% of the total number of shares of our common stock outstanding, including the 115.6 million shares offered. The number of shares ultimately offered for sale by Mast Hill under this prospectus is dependent upon a number of factors, including the number of Shares we ultimately issue and sell to Mast Hill under the Equity Purchase Agreement. Because the actual purchase price for the Shares that we may sell to Mast Hill will fluctuate based on the market price of our common stock during the term of the Equity Purchase Agreement, we are not able to determine at this time the exact number of shares of our common stock that we will issue under the Equity Purchase Agreement and, therefore, the exact number of shares we will ultimately register for resale under the Securities Act.
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Specifically, because the price per share subject to a Put Notice will be equal to a 3% discount to certain trading prices of our common stock as set forth in the Equity Purchase Agreement, Mast Hill will pay less than the then-prevailing market price for our common stock, and the actual Equity Purchase price for the Shares that we may sell to Mast Hill will fluctuate based on the VWAPs and closing prices of our common stock during the term of the Equity Purchase Agreement. As a result of this discount, Mast Hill may have a financial incentive to sell our common stock immediately to realize the profit equal to the difference between the Equity Purchase price and the market price. If Mast Hill sells the common stock, the market price of our common stock could decrease. If the market price of our common stock decreases, Mast Hill may have a further incentive to sell the common stock that it holds. These sales may have a further impact on the market price of our common stock.
Moreover, there is an inverse relationship between the market price of our common stock and the number of shares of our common stock that may be sold pursuant to the Equity Purchase Agreement. That is, the lower the market price, the more shares of our common stock that may be sold under the Equity Purchase Agreement. Accordingly, if the market price of our common stock decreases (whether such decrease is due to sales by Mast Hill in the market or otherwise) and, in turn, the Equity Purchase price of our common stock sold to Mast Hill under the Equity Purchase Agreement decreases, this could allow Mast Hill to receive greater numbers of shares of our common stock pursuant to put notices under the Equity Purchase Agreement. Although the number of shares of our common stock that our existing stockholders own will not decrease, the common stock owned by our existing stockholders will represent a smaller percentage of our total outstanding shares after any such sales to Mast Hill. Depending on market liquidity at the time, the sale of a substantial number of shares of our common stock to Mast Hill at a discount to the then-prevailing market price for our common stock under the Equity Purchase Agreement, and the resale of such shares by Mast Hill into the public market, or the perception that such sales may occur, could cause the trading price of our common stock to decline, result in substantial dilution to existing stockholders and make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
We may use the net proceeds from sales of our common stock to Mast Hill pursuant to the Equity Purchase Agreement in ways with which you may disagree.
We intend to use the net proceeds from sales of our common stock to Mast Hill pursuant to the Equity Purchase Agreement for working capital and general corporate purposes. As of the date of this report, we cannot specify with certainty all of the particular uses of the proceeds from sales of common stock to Mast Hill pursuant to the Equity Purchase Agreement. Accordingly, we will have significant discretion in the use of the net proceeds of sales of common stock to Mast Hill pursuant to the Equity Purchase Agreement. It is possible that we may allocate the proceeds differently than investors in this offering desire or that we will fail to maximize our return on these proceeds. We may, subsequent to this offering, modify our intended use of the proceeds from sales of common stock to Mast Hill pursuant to the Equity Purchase Agreement to pursue strategic opportunities that may arise, such as potential acquisition opportunities. You will be relying on the judgment of our management with regard to the use of the net proceeds from the sales of common stock to Mast Hill pursuant to the Equity Purchase Agreement, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. Any failure to apply the proceeds from sales of common stock to Mast Hill pursuant to the Equity Purchase Agreement effectively could have a material adverse effect on our business and cause a decline in the market price of our common stock.
Cautionary Note
We have sought to identify what we believe to be the most significant risks to our business, but we cannot predict whether, or to what extent, any of such risks may be realized nor can we guarantee that we have identified all possible risks that might arise. Investors should carefully consider all of such risk factors, including risk factors previously stated in any of our prior SEC filings but not specified above, before making an investment decision with respect to our common stock.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
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ITEM 1C. CYBERSECURITY RISK MANAGEMENT, STRATEGY, AND GOVERNANCE.
The Company recognizes the critical importance of developing, implementing, and maintaining robust cybersecurity measures to safeguard our information systems and protect the confidentiality, integrity, and availability of our data.
Managing Material Risks & Integrated Overall Risk Management
Engage Third-parties on Risk Management, as required
Oversee Third-party Risk
Risks from Cybersecurity Threats
The Board of Directors is acutely aware of the critical nature of managing risks associated with cybersecurity threats. The Board plans to establish robust oversight mechanisms to ensure effective governance in managing risks associated with cybersecurity threats because we recognize the significance of these threats to our operational integrity and stakeholder confidence,
Board of Directors Oversight
Management’s Role Managing Risk
| ● | Current cybersecurity landscape and emerging threats; |
| ● | Status of ongoing cybersecurity initiatives and strategies; |
| ● | Incident reports and learnings from any cybersecurity events; and |
| ● | Compliance with regulatory requirements and industry standards. |
ITEM 2. PROPERTIES
Our office is located in Agoura Hills, California, where we lease about 2,000 square feet of general office space. The lease for this office is on a month-to-month basis. We consider our office space to be adequate for our current needs. We believe that other suitable office space would be available if we moved to a different location upon the expiration of our current lease.
ITEM 3. LEGAL PROCEEDINGS
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Historically, the outcome of all such legal proceedings has not, in the aggregate, had a material adverse effect on our business, financial condition, results of operations or liquidity. There are no material pending or threatened legal proceedings at this time.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
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PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
The Company’s common stock trades on the OTCQB market, operated by OTC Markets, under the symbol “OTLC”. Quotations on the OTCQB reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions
Holders
As of April 13, 2026, there were 78 stockholders of record of the 444,197,032 outstanding shares of the Company’s common stock, including 1,019,303 shares pending to be issued to certain dissenting shareholders.
Dividends
The Company has not declared or paid any cash dividends on its common stock since its inception in 1988 and does not expect to pay cash dividends in the foreseeable future. The Company presently intends to retain future earnings, if any, to finance the growth and development of its business.
Securities Authorized for Issuance Under Equity Compensation Plans
Information relating to compensation plans under which our equity securities are authorized for issuance is presented in Part III, Item 12 of this Annual Report on Form 10-K.
Unregistered Sales of Securities
No unregistered securities were issued during the fiscal year that were not previously reported in a Quarterly Report on Form 10-Q or Current Report on Form 8-K.
ITEM 6. RESERVED
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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K (the “Annual Report” or “Report”) includes a number of forward-looking statements that reflect management’s current views with respect to future events and financial performance. Forward- looking statements are projections in respect of future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Those statements include statements regarding the intent, belief or current expectations of us and members of our management team, as well as the assumptions on which such statements are based. For a more detailed discussion on our forward-looking statements, kindly refer to “Forward Looking Statements” prior to Item 1: Part I: Business contained in this Annual Report.
Corporate History
Oncotelic Therapeutics, Inc. (“Oncotelic”), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic conducts business activities through Oncotelic and its wholly-owned subsidiaries, Oncotelic, Inc., a Delaware corporation, PointR Data, Inc. (“PointR”), a Delaware corporation, Pet2DAO Inc., a Delaware corporation and EdgePoint AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic, Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the “Company” or “We”). The Company completed a reverse merger with Oncotelic Inc in April 2019, a merger with PointR in November 2019 and formed a subsidiary Edgepoint in February 2020. For more information on these mergers, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
Company Overview
The Company is a clinical stage biopharmaceutical company developing drugs for the treatment of cancer. The Company’s proprietary product candidates have shown promising clinical activity in phase 2 trials for the treatment of gliomas and pancreatic cancers. The Company aims to translate its unique insights, which span more than three decades of original work using RNA therapeutics, into the deployment of antisense as a RNA therapeutic for diseases which are caused by TGF-β overexpression, starting with cancer and expanding to Duchenne Muscular Dystrophy and others. OT-101, the Company’s lead product candidate, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers.
Since April 2022, the Company has conducted the vast majority of its development efforts for OT-101 through a joint venture (the “JV”), with Dragon Overseas Capital (“Dragon”). In connection with the formation of the JV, the Company contributed license rights OT-101 for both U.S. and the rest of the world, in exchange for a 45% equity interest in GMP Biotechnology Limited (“GMP Bio”), the JV, and Dragon agreed to provide approximately $27.6 million of research and development funding in exchange for a 55% ownership stake in GMP Bio. The Company accounts for its holdings in GMP Bio as an equity investment under the fair value option. Accordingly, the Company accounts for only its change in fair value in the Company’s investment in GMP Bio, and the income and expenses of the JV are not consolidated in the Company’s financial statements.
The Company announced in November 2025 that the JV obtained a preliminary independent third-party valuation of approximately $2.3 billion for its therapeutic pipeline, assuming and implying an illustrative value of approximately $1 billion based on the Company’s 45% ownership interest in the JV. The Company had previously stated that this valuation was non-binding, forward-looking, and not determinative of fair value under U.S. GAAP, and that a separate ASC-compliant valuation process would be done. Under the fair value option, the Company periodically conducts a fair value assessment and records a change in the value when circumstances warrant reassessing the value of investment in GMP Bio. The Company conducted an ASC-compliant valuation, including through an independent valuation expert based on the same parameters and conditions envisioned in the valuation conducted by the JV. Based on the Company’s evaluation, the Company proceeded to record a change in the value of the Company’s interest in the JV of approximately $365.4 million. The Company relied on the inputs by the JV valuation, however, certain parameters like lack of marketability and lack of control discounts and other standard discounts, specific to the Company, have been applied to the independent valuation done by the Company to derive the ASC-compliant valuation. The Company will also appropriately adjust the fair value of the interest of the Company’s interest in the JV at the end of reporting periods and when key value inflection points are met. As previously announced, GMP Bio is progressing with its strategic and operational plans, which include efforts to secure third-party financing and a possible initial public offering in Hong Kong during 2026. For more information on, refer to Recent Joint Venture Developments below.
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Recent Joint Venture Developments
The JV’s principal activities centered on the commercialization of OT-101 for certain oncology indications in the US and looking at other territories as well. In March 2025, the JV successfully completed a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101, an antisense therapeutic targeting Transforming Growth Factor Beta 2 (TGFβ2), with checkpoint inhibitors (“CKIs”) and recombinant IL-2 (aldesleukin) (“IL-2”). The Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety and tolerability of OT-101 in combination with recombinant IL-2 in patients with advanced or metastatic solid tumors. The combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected safety signals identified. Based on the favorable safety data, the JV plans to advance OT-101 plus IL-2 into further clinical studies, exploring synergies with CKIs such as PD-1 blockers. The JV is also sponsoring investigator-initiated studies for OT-101 for other oncology indications including lung cancer (non small cell lung cancer(“NSCLC”)and Mesothelioma.(“MPM”) and has started clinical development for OT-101 for pancreatic cancer. Over ten patent families have been filed exploiting the central role of TGFB2 as prognostic indicator for cancer survival and one patent family for the intracranial delivery device of brain cancer with issued patents in China and Germany.
In addition to OT-101, the JV has developed a nanoparticle platform (“Nano Platform”) that entails the formulation of products in new nanoparticle sizes. The JV anticipates that the Nano Platform may offer superior platform for the absorption of water insoluble drugs across a broad spectrum of cancers. The JV is working on improved formulations for OT-101 with new nanoparticle sizes. In addition, the JV has identified five additional compounds as product candidates on the Nano Platform, including the following:
| ● | The JV has completed the formulation development of the first product, everolimus for injection. The JV has initiated a global clinical trial for that product, including open patient enrollment in Australia. The JV hopes to complete the Phase 1 trial and to move to a Phase 3 noninferiority trial against Affinitor. Phase 3 trial is slated to initiate within one year with completion and submission for marketing approval no less than three years thereafter. | |
| ● | The JV is developing palbociclib for injection on the Nano Platform and expects to file the investigational new drug (“IND”) and to initiate a Phase 1 trial in 2026. | |
| ● | The JV is developing docetaxel and paclitaxel for injection on the Nano Platform and expects to file the IND to initiate a Phase 1 trial for this product candidate in 2026. These are expected to go through the 505(b)2 bioequivalence pathway for a more rapid entrance into the market | |
| ● | In addition, the JV has also identified developing carboplatin and intends to begin the development as soon as the other products clinical trials are under way. |
The Nano or DeciparticleTM platform has proven robust and is being expand to other drug candidates through partnering. The platform is protected by more than 15 patent families covering chemical composition, manufacturing, and method of use.
The JV built a GMP manufacturing facility in San Diego, California (the “San Diego Facility”). In late 2024, the San Diego Facility was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. A significant portion of the manufacturing for the Nano Platform, including the development of Phase I clinical trial materials, is conducted at the San Diego Facility. Evaluation of larger commercial scale manufacturing is ongoing.
In early 2025, the Company entered into a strategic partnership with Shanghai Medicilon, Inc. (“Medicilon”) to access its industry-leading rapid IND development platform to support up to 20 IND projects, including INDs developed by the JV. All six of the compounds that the JV is developing are planned to be initiated under these INDs, and are focused on next-generation anticancer agents.
The JV was initially funded by equity contributions from Dragon under the terms of the joint venture agreement. That equity funding commitment has been fully paid as of June 30, 2025. In May 2025, GMP Bio and Golden Mountain Partners, an affiliate of Dragon, entered into a note purchase agreement and promissory note pursuant to which Golden Mountain Partners agreed to loan funds to the JV sufficient to meet its operating expenses for 2025 and beyond. The loans are made as monthly advances, bear interest at the Wall Street Journal “Prime” rate, and matures on December 31, 2026. Amounts due under the promissory note are convertible into equity of the JV at the election of Golden Mountain Partner at a price equal to 80% of the price for shares issued in connection with an equity financing of $20 million or more, or otherwise at a mutually agreed price.
The JV is planning to conduct an initial public offering on the Hong Kong Stock Exchange in approximately late 2026. In connection with the planned public offering, the JV venture has retained an investment banker and a big four accounting firm as its independent accounting firm to audit the financial statements that would be included in the public filings. The JV also hired a valuation consultant to provide guidance on the potential pricing for the planned IPO. GMP Bio completed an independent third-party valuation, which preliminarily estimated the potential value of the drug pipeline under development at approximately $2.3 billion. As of December 31, 2025, the Company owns 45% of GMP Bio.
The JV’s planned public offering is subject to a number of risks and uncertainties, some involving the JV’s ability to execute on its business plan, but others outside the JV’s control including market forces. Consequently, there is no assurance that the planned Hong Kong public offering will take place in late 2026, or at all, and there is no assurance as to what enterprise value would be ascribed to the JV at that time.
Based on the JV’s advances, including the development of the Nano Platform and pipeline and the planned Hong Kong public offering the Company believed that its ownership interest in the JV would be significantly higher than the reported value on its financial statements, which was based on the valuation at the time of its initial investment in the JV in 2022.
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All these factors formed a basis for a triggering event of significant development for the JV and justified the JV, and consequently the Company, to reassess the fair value of the JV. After the business valuation exercise by GMP Bio, the Company proceeded to conduct its own independent assessment of the valuation of the JV. The basis for the valuation was utilizing the same conditions, financial projection, risks and parameters of assessment as done by the offshore independent valuation firm, and then applying additional independent parameters required to adhere to the strict ASC-compliant standards as generally used in the United States. The Company hired the services of an independent, ASC-compliant valuation firm to review, perform and validate the assumptions considered by the Company and provide an ASC-compliant valuation of the JV under U.S. GAAP standards. The valuation conducted by the independent ASC-compliant valuation firm of the JV was based on various methods compliant with ASC and US GAAP to derive the fair value. The Company then utilized the fair value of GMP Bio, as assessed by the ASC-compliant valuation firm, attributed the ownership percentage of the Company in GMP Bio, to ascertain the Company’s interest in GMP Bio and recorded the resulting gain to the investment in GMP Bio at fair value of approximately $365.4 million. The Company relied on the inputs by the JV valuation, however, certain parameters like lack of marketability and lack of control discounts and other standard discounts, specific to the Company, have been applied to the independent valuation done by the Company to derive the ASC-compliant valuation. The Company will also appropriately adjust the fair value of the interest of the Company’s interest in the JV at the end of reporting periods and when key value inflection points are met.
PDAOAI
PDAOAI is the Company’s proprietary artificial intelligence–enabled knowledge platform, developed to support scientific, translational, and regulatory activities across its oncology pipeline. The platform was initially implemented by Oncotelic Therapeutics to streamline document search, synthesis, and analysis in knowledge-intensive environments, particularly within pharmaceutical research and development. Since its initial deployment, the Company has progressively expanded PDAOAI into a core infrastructure layer supporting research generation, biomarker discovery, and regulatory documentation across multiple programs. Unlike general-purpose artificial intelligence tools, PDAOAI has been designed specifically for pharmaceutical and biotechnology applications, with an emphasis on regulatory-grade documentation, scientific traceability, and reproducibility. The platform is intended to operate as an “evidence-interrogation” system rather than a black-box predictive engine, enabling structured ingestion, semantic indexing, and clustering of large biomedical corpora. This design allows users to query, retrieve, and synthesize information in a manner that is auditable and aligned with regulatory expectations for data provenance and scientific justification. During 2025, the Company significantly expanded the functional scope of PDAOAI and integrated it into its translational research workflow. This included the use of PDAOAI to support the preparation of peer-reviewed manuscripts, development reports, and regulatory documentation, as well as to enable interactive interrogation of scientific literature. The Company introduced interfaces that allow users to query individual publications and their associated reference networks, thereby facilitating deeper exploration of mechanistic hypotheses and clinical correlations within defined therapeutic areas. PDAOAI has also been applied to the assembly and interrogation of multi-omic and clinical datasets, particularly in the context of biomarker-driven oncology research. The platform has been used to identify, prioritize, and validate biomarkers associated with treatment response, disease progression, and survival outcomes. This capability has been most prominently demonstrated in the Company’s work on TGFB2 signaling and tumor microenvironment biology, where PDAOAI has supported analyses across multiple tumor types, including ovarian cancer, breast cancer, pancreatic cancer, hepatocellular carcinoma, and glioblastoma.
As disclosed in Company press releases, PDAOAI contributed to the generation of at least seven peer-reviewed publications during 2025. These publications collectively span bioinformatic biomarker discovery, tumor microenvironment analysis, nanoparticle drug delivery, and clinical outcome correlations, and include studies demonstrating prognostic and predictive roles of TGFB2 methylation and expression across multiple cancers. The Company believes that this body of work provides validation of PDAOAI’s utility as a research acceleration platform and supports its role in generating clinically relevant insights.
By late 2025, the Company had further evolved PDAOAI into a large-scale knowledge platform built around a comprehensive TGF-β–centric biomedical corpus, comprising over one hundred thousand curated abstracts and associated datasets. Within this framework, PDAOAI enables semantic retrieval, clustering of related concepts, and cross-referencing of molecular, clinical, and literature-derived data. The platform is designed to generate hypotheses that are not only computationally derived but also traceable to underlying evidence, thereby facilitating scientific validation and regulatory acceptance. The Company has now positioned PDAOAI as a cross-program decision-support system integrating molecular biology, pharmacology, clinical outcomes, and regulatory-grade literature. The platform is used to inform multiple aspects of the Company’s operations, including target identification, biomarker strategy, clinical trial design, and regulatory positioning. In particular, PDAOAI is intended to complement the Company’s nanomedicine and biomarker platforms by identifying patient subpopulations most likely to benefit from specific therapeutic approaches and by supporting the development of precision oncology strategies.
The Company believes that PDAOAI represents a differentiating capability within its integrated platform, enabling the convergence of artificial intelligence, molecular biology, and clinical data into a unified framework. By embedding PDAOAI across its discovery and development processes, the Company aims to accelerate insight generation, improve decision-making, and enhance the probability of clinical and commercial success across its pipeline.
On April 2, 2026, the Company announced that it had entered into a strategic partnership with TechForce Robotics, Inc. (“TechForce”) to advance the commercialization of its PDAOAI-enabled, GMP-compliant robotics platform. This milestone reflects the culmination of several years of research and development efforts, resulting in an integrated platform designed to combine Oncotelic’s proprietary PDAOAI capabilities with TechForce’s robotics hardware and manufacturing expertise. The system under development is designed to operate within GMP-regulated environments and is intended to enable automated material handling, real-time monitoring, and PDAOAI-enhanced compliance workflows across pharmaceutical manufacturing and related applications. The key highlights of the commercialization include:
| 1. | Integrated AI + robotics platform, combining the Company’s PDAOAI capabilities with TechForce’s scalable robotics systems to automate critical operational workflows; | |
| 2. | Form a GMP-Compliant Design, designed to support regulatory requirements, including data capture, audit readiness, and validation frameworks; | |
| 3. | Improve operational efficiency and compliance, intended to reduce human intervention, minimize contamination risk, and enhance process consistency through real-time monitoring and intelligent automation; and | |
| 4. | Achieve scalable manufacturing capability, intended to leverage TechForce’s hardware expertise and manufacturing network to support commercial deployment and future growth. |
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Recent Financing Transactions
In July 2025, the Company entered into a securities purchase agreement with Mast Hill Fund LP (“Mast Hill”), under which the Company issued one convertible note in the aggregate principal amount of $560,000 to Mast Hill (“2025 Mast Note”). The 2025 Mast Hill Note has an original issue discount of 10%, carries an interest rate of 10% per annum and matures on the earlier of July 31, 2026, subject to acceleration in an event of default. Mast Hill has the right, at any time, to convert all or any part of the outstanding and unpaid balance under of the 2025 Mast Hill Note into shares of Company’s Common Stock at a conversion price of $0.07 per share. In connection with the issuance of the 2025 Mast Note, the Company issued Mast Hill 2,000,000 warrants to purchase Common Stock at a strike price of $0.15 up to five years after issuance. The Company also issued to Mast Hill 2,250,000 shares of the Company’s Common Stock as a commitment fee. For more information on the 2025 Mast Note, refer to Note 5 of the Notes to the Consolidated Financial Statements included in this report.
In August 2025, the Company entered into an Equity Purchase Agreement (the “Mast EPA”) and Registration Rights Agreement with Mast Hill. Under the terms of the Mast EPA, Mast Hill agreed to purchase from the Company up to $25,000,000 of shares of the Company’s Common stock upon effectiveness of a registration statement on Form S-1 filed with the U.S. Securities and Exchange Commission and subject to certain limitations and conditions set forth in the Mast EPA. The Registration Rights Agreement provided that the Company would (i) file the Registration Statement with the SEC by October 1, 2025: and (ii) use its best efforts to have the Registration Statement declared effective by the Commission at the earliest possible date (in any event, within 90 after days after the execution date of the definitive agreements). The Company intends to file the Registration Statement on Form S-1 with the SEC as soon as possible. In connection with the EPA, the Company issued 3,350,000 warrants to Mast Hill and recorded a fair value deferred finance cost of approximately $122,000.
Following effectiveness of the Registration Statement, and subject to certain limitations and conditions set forth in the Mast EPA, the Company shall have the discretion to deliver put notices to the Investor and the Investor will be obligated to purchase shares of the Company’s Common Stock based on the investment amount specified in each put notice. The minimum amount that the Company shall be entitled to put to the Investor in each put notice is $5,000 and the maximum amount is up to the lesser of $0.5 million or twenty percent (20%) of the average daily trading value of the Company’s Common stock. Pursuant to the Equity Purchase Agreement, the Mast Hill will not be permitted to purchase, and the Company may not put shares of the Company’s Common Stock to the Investor that would result in the Investor’s beneficial ownership of the Company’s outstanding Common Stock exceeding 4.99%. The price of each put share shall be equal to ninety seven percent (97%) of the market price, which is defined as the lesser of (i) closing bid price of the Common stock on the trading date immediately preceding the respective put date, or (ii) the lowest closing bid price of the Common Stock during the seven (7) trading days immediately following the clearing date associated with the applicable put notice.
Further in January 2026, the Company entered into a Securities Purchase Agreement (the “2026 Mast Hill Purchase Agreement”), with Mast Hill Fund, LP (“Mast Hill”), and the Company issued a convertible promissory note in the aggregate gross principal amount of approximately $398,333 (the “2026 Mast Hill Note”). The 2026 Mast Hill Note is convertible into shares of the Company’s Common Stock
The 2026 Mast Hill Note has an original issue discount of 10%, carries an interest rate of 10% per annum and matures on the earlier of (a) the one-year anniversary of the date of the 2026 Mast Hill Purchase Agreement, or (b) the acceleration of the maturity of the 2026 Mast Hill Note by Mast Hill upon occurrence of an Event of Default (as defined below) or (c) on prepayment in full. The 2026 Mast Hill Note contains a voluntary conversion mechanism whereby Mast Hill may convert the outstanding principal and accrued interest under the terms of the 2026 Mast Hill Note into shares of Common Stock (the “Conversion Shares”), at a fixed price of $0.07 per share (the “Conversion Price”), subject to adjustments upon the occurrence of certain corporate events. The 2026 Mast Hill Note is secured against the assets of the Company, including all the assets owned by the Company’s direct or indirect subsidiaries, but other than and excluding the equity interests and the assets of the Company licensed or assigned within our joint venture agreement with Dragon Overseas Capital Limited, namely GMP Biotechnology and its subsidiaries. These assets include OT-101, CA4P, Oxi4503, AI and AI CDMO technologies and the nanoparticle platform. The Company also issued 1,422,613 warrants to purchase shares (the “Note Warrants”) of Common Stock of the Company at an exercise price of $0.15. Prepayment of the 2026 Mast Hill Note may be made at any time upon three trading days’ prior written notice to the respective holder, by payment of the then outstanding principal amount plus accrued and unpaid interest and reimbursement of such holder’s administrative fees. The 2026 Mast Hill Note contains customary events of default (each an “Event of Default”). If an Event of Default occurs, at the respective holder’s election, the outstanding principal amount of the 2026 Mast Hill Note, plus accrued but unpaid interest, will become immediately due and payable in cash. The 2026 Mast Hill Purchase Agreement require the Company to use the proceeds for general working capital, and not for (i) the repayment of any indebtedness owed to officers, directors or employees of the Company or their affiliates, (iii) any loan to or investment in any other corporation, partnership, enterprise or other person (except in connection with the Company’s currently existing operations), (iv) any loan, credit, or advance to any officers, directors, employees, or affiliates of the Company, or (v) in violation or contravention of any applicable law, rule or regulation. Further, on January 23, 2026, the Company entered into a Registration Rights Agreement with Mast Hill (the “Mast Hills Registration Rights Agreement - Note”), to register the shares of Common Stock issuable under and related to the 2026 Mast Hill Notes and the attached Note Warrants to purchase shares of the Company’s Common Stock.
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Jefferson Capital Ventures, LLC and Valor Nation, Inc Independent Contractor Agreements
In August, 2025, the Company entered into independent contractor agreements with each of Jefferson Capital Ventures, LLC (“Jefferson”) and Valor Nation, Inc. (“Valor”) to provide consulting and advisory services including strategic planning meetings, coordination non-legal support for SEC compliance, balance sheet and income statement optimization strategies, shareholder and investor communication planning, liaison with investment bankers, analysts, and institutional investors, operational efficiency and cost-saving recommendations and ancillary strategic services not requiring a license, corporate planning, operations and capital markets advisory services not requiring licenses. Such services shall be provided by Jefferson and Valor for a period of 18 months, unless terminated earlier by either party under certain predefined conditions. Jefferson has agreed to be compensated $20,000 per month in cash and to be issued 20,322,930 restricted shares of the Company’s Common Stock and Valor has agreed to be compensated with 4,064,586 shares of Common Stock. While the shares of Common Stock will be issued to Jefferson, they are subject to forfeiture, and Jefferson will earn the Common Stock only upon the achievement of milestones, which were a) the Company’s market capitalization exceeding $45 million on any single trading day’s close, (b) the cumulative increase of at least $10 million in shareholder equity from the start of engagement, and (c) the successful uplisting to a U.S. national exchange (e.g., Nasdaq or NYSE American) with at least one full day of trading. Subsequently, on January 6, 2026, there was an amendment to the agreement with Jefferson. The amendment amended one clause within the original agreement for Jefferson to earn the first milestone shares upon the Company reaching $45 million of market capitalization on any single trading day and which was achieved by the Company in November 2025. On the accomplishment of each milestone an amount equal to the greater of 6,774,300 or 1.663% of the Company’s fully diluted outstanding shares shall vest. For more information on the Jefferson and Valor ICAs, refer to our Current Report on Form 8-K filed with the SEC on August 12, 2025 and on January 7, 2026.
New Private Placement with JH Darbie
In December 2025, the Company entered into a series of subscription agreements with 44 accredited investors which resulted in a conversion of 87 convertible promissory notes with an aggregate principal amount of approximately $2.2 million, under the prior JH Darbie Financing into new debt to the Company. JH Darbie and the Company are parties to a May 2024 placement agent agreement (“Agreement”) pursuant to which JH Darbie has the right to sell/convert a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis. The December 2025 conversions fully converted JH Darbie PPM-2 notes into PPM-3 notes. For more information on the new JH Darbie Financing, refer to Note 8 of these Notes to the Consolidated Financial Statements.
Short-term loans from related parties / families
As of January 1, 2025, approximately $2.1 million was outstanding and payable to Autotelic. During the year ended December 31, 2025, Autotelic Inc. provided additional short-term funding of approximately $0.9 million to the Company. As such, approximately $3 million was outstanding and payable to Autotelic at December 31, 2025.
As of January 1, 2025, approximately $76,000 was outstanding and payable to the Company’s CFO. During the year ended December 31, 2025, the CFO further provided additional short-term funding of $10,000 to the Company. As such, approximately $86,000 was outstanding and payable to the Company’s CFO at December 31, 2025.
At January 1, 2025, $50,000 was outstanding and payable to the Company’s CEO. During the year ended December 31, 2025, the PPM-2 note of $125,000 with the CEO was converted into a short term loan. As such, $175,000 was outstanding to the Company’s CEO at December 31, 2025. As of December 31, 2025, approximately $210,000 was outstanding as short-term advances from certain bridge investors.
During the year ended December 31, 2025, one accredited investor from PPM-2 did not participate in PPM-3 and his balance of $50,000 was converted into short-term loan to the Company Such short term loan, including accrued interest thereon, was repaid to the investor during the first quarter of 2026, after the period covered by the financial statements included in this Annual Report.
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Critical Accounting Policies and Significant Judgments and Estimates
The preparation of financial statements in accordance with U.S. generally accepted accounting principles (“US GAAP”) requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expense during the reporting periods. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances at the time we make such estimates. Actual results and outcomes may differ materially from our estimates, judgments, and assumptions. We periodically review our estimates considering changes in circumstances, facts, and experience. The effects of material revisions in estimates are reflected in the financial statements prospectively from the date of the change in estimate. Our significant accounting policies are more fully described in Note 2 to our financial statements included elsewhere in this Annual Report.
We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. We believe the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments are the following:
Impairment of Long-Lived Assets
The Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature of the assets.
Intangible Assets
The Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale, or disposition of a significant portion of the business, or other factors.
Goodwill
Goodwill represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired. Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level or more frequently if events or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment would not be required. Otherwise, goodwill impairment is tested using a two-step approach.
The first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. The second step involves calculating the implied fair value of goodwill by deducting the fair value of all tangible and intangible assets, excluding goodwill, of the reporting unit from the fair value of the reporting unit as determined in step one. The implied fair value of the goodwill in this step is compared to the carrying value of goodwill. If the implied fair value of the goodwill is less than the carrying value of the goodwill, an impairment loss equivalent to the difference is recorded.
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Convertible Instruments
The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives and Hedging”.
ASC 815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards.
The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Original issue discounts under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records, when necessary, deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note.
ASC 815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally, if an event is not within the entity’s control could or require net cash settlement, then the contract shall be classified as an asset or a liability.
Derivative Financial Instruments Indexed to the Company’s Common Stock
We have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding, do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However, if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity offerings, we must estimate the fair value of the warrants, which is as inherently subjective as it is for stock options, and for similar reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we report any changes in their estimated fair values as gains or losses in our Consolidated Statement of Income.
Variable Interest Entity (VIE) Accounting
We evaluate our ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations. These evaluations can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical information, among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE, the entity is consolidated into the financial statements.
Investments - Equity Method
The Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses, which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.
The Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares are included in the result from continuing operations. Refer to Note 6 of these Notes to the Consolidated Financial Statements.
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Joint Venture agreement
We have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization, including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract development and manufacturing organization (CDMO) facilities and capabilities. The Company first reviewed the arrangement to determine if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture, the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii) the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition of a joint venture.
We consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf of an investor with disproportionately few voting rights in making this VIE determination. To the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary beneficiary. To the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights. Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets of the joint venture without the consent of the non- managing entity and the inability of the non-managing entity to remove us from our role as the managing entity. We use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under the equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets and liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.
When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value. As a result, the accounting for a partial sale will result in the recognition of a full gain or loss. When circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at fair value. The Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment.
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Research and Development Expense
Research and development expense consists of costs we incur for the development of our investigational drugs and, to a lesser extent, for preclinical research activities. Research and development costs are expensed as incurred. Research and development expense include clinical trial costs, salaries, and benefits of employees, including associated stock-based compensation, payments to clinical investigators, drug manufacturing costs, laboratory supplies and facility costs. Clinical trial costs are a significant component of our research and development expenses, and these can be difficult to accurately estimate. Included in clinical trial costs are fees paid to other entities that conduct certain research and development activities on our behalf, such as clinical research organizations, or CROs. We estimate clinical trial expense based on the services performed pursuant to contracts with research institutions such as CROs and the actual clinical investigators. These estimates are based on actual time and expenses incurred by the CRO and the clinical investigators. Also included in clinical trial expense are costs based on the level of patient enrollment into the clinical trial and the actual services performed under the related clinical trial agreement. Changes in clinical trial assumptions, such as the length of time estimated to enroll all patients, rate of screening failures, patient drop-out rates, number and nature of adverse event reports and the total number of patients enrolled can impact the average and expected cost per patient and the overall cost of the clinical trial. Based on patient enrollment reports and services provided, we may periodically adjust estimates for the clinical trial costs. If we do not identify costs that we have begun to incur or if we underestimate or overestimate the level of services performed, the length of time for these services or the costs of these services, our actual expenses could differ from our estimates.
Share-Based Compensation
We record the estimated fair value of all share-based payments issued to employees and other service providers. Our share-based payments consist primarily of stock options. The valuation of stock options is an inherently subjective process, since market values are not available for any stock options in our equity securities. Market values are also not available on long-term, non-transferable stock options in other equity securities. With no market values on options to trade in our common stock and no comparable market values on any long-term non-transferable stock options, the process of valuing our stock options is even more uncertain and subjective. Accordingly, we use a Black-Scholes option pricing model to derive an estimated fair value of the stock options which we issue. The Black-Scholes option pricing model requires certain input assumptions, including the expected term of the options and the expected volatility of our common stock. Changes in these assumptions could have a material impact on the estimated fair value that we record for share-based payments that we issue. We determine the term of the options based on the simplified method, which averages the vesting period and the contractual life of the stock option. We determine the expected volatility based on the historical volatility of our common stock over a period commensurate with the option’s expected term. The Black-Scholes option pricing model also requires assumptions for risk-free interest rates and the expected dividend yield of our common stock, but we feel that these values are more objective and note that changes in these values do not have a significant impact on the estimated value of the options when compared to the volatility and term assumptions.
We are also required to estimate the level of award forfeitures expected to occur and record compensation expense only for those awards that are ultimately expected to vest. Accordingly, we perform a historical analysis of option awards that are forfeited prior to vesting, and record total stock option expense that reflects this estimated forfeiture rate.
The impacts of any of the critical accounting policies and significant judgments and estimates, if applicable, have been reflected in the Notes to the Consolidated Financial Statements in this Report.
Results of Operations
Years Ended December 31, 2025 and 2024.
A comparison of the Company’s operating results for the year ended December 31, 2025, and 2024, respectively, is as follows.
December 31, 2025 | December 31, 2024 | Variance | ||||||||||
| Operating expense: | ||||||||||||
| Research and development | $ | 4,357 | $ | - | $ | 4,357 | ||||||
| General and administrative | 3,182,242 | 376,013 | 2,806,229 | |||||||||
| Goodwill impairment | - | 3,200,000 | (3,200,000 | ) | ||||||||
| Total operating expense | 3,186,599 | 3,576,013 | (389,414 | ) | ||||||||
| Income (loss) from operations | (3,186,599 | ) | (3,576,013 | ) | 389,414 | |||||||
| Change in fair value of investment in GMP Bio | 365,346,775 | - | 365,346,775 | |||||||||
| Interest expense, net | (885,488 | ) | (857,723 | ) | (27,765 | ) | ||||||
| Reimbursement for expenses – related party | - | 22,937 | (22,937 | ) | ||||||||
| Change in the value of derivatives on debt | 353,572 | (280,402 | ) | 633,974 | ||||||||
| Loss on debt conversion | (1,058,976 | ) | (88,258 | ) | (970,718 | ) | ||||||
| Miscellaneous Income | 5,631 | - | 5,631 | |||||||||
Net income (loss) before income taxes | 360,574,915 | (4,779,459 | ) | 365,354,374 | ||||||||
| Provision for income taxes (deferred) | (111,550,000 | ) | - | (111,550,000 | ) | |||||||
| Net income (loss) after income taxes | $ | 249,024,915 | $ | (4,779,459 | ) | 253,804,374 | ||||||
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Net Income (Loss)
We recorded a net income after tax of approximately $249.0 million for the year ended December 31, 2025, compared to a net loss of approximately $4.8 million for the same period in 2024. The higher net income of approximately $253.8 million for the year ended December 31, 2025, as compared to the same period of 2024, was primarily due to recording the increase in fair value in our investment in GMP Bio of approximately $365.4 million, lower goodwill impairment of approximately $3.2 million recorded in 2024, compared to no similar impairment in 2025, higher provision for deferred income taxes of approximately $111.6 million, higher general and administrative expenses of approximately $2.8 million, higher loss on conversion of debt of approximately $1.0 million, partially offset by a favorable change in the value of derivatives on debt of approximately $0.6 million and lower interest expense of approximately $28 thousand.
Research and Development Expense
Research and Development (“R&D”) expense nominally increased by approximately $4 thousand incurred during the year ended December 31, 2025 as compared to no similar expenses during the same period of 2024.
As a result of our JV, we expect our R&D expense to remain low for the remainder of the year 2026 and will be subject to our ability to secure sufficient funding to fund any planned operations.
General and Administrative Expense
General and administrative (“G&A”) expense increased by approximately $2.8 million, to approximately $3.2 million for the year ended December 31, 2025, as compared to approximately $0.4 million for the same period of 2024, primarily due to higher stock based compensation of approximately $2.4 million incurred for common stock and preferred stock issued in connection with services, approximately $0.2 million to settle litigation related to an ex-employee and approximately $0.2 million due to lower other general and administrative expenses.
Goodwill Impairment
During the year ended December 31, 2024, we recorded goodwill impairment of $3.2 million, on the approximately $12.0 million goodwill which we recorded upon our acquisition of PointR, based on the difference between our market capitalization and our net assets. No similar impairment was recorded during the year ended December 31, 2025.
Change in fair value of investment in GMP Bio
We recorded a change in fair value of our investment in GMP Bio for the year ended December 31, 2025 of approximately $365.4 million for the year ended December 31, 2024, compared to no similar change in fair value for the year ended December 31, 2024. The change in fair value was recorded based on a third-party ASC-compliant fair valuation of GMP Bio in accordance with US GAAP. As of December 31, 2025, the Company assessed that the fair value of its investment in the JV had materially changed due to all the development work that had occurred in the JV, hired the services of an ASC-compliant valuation firm to reassess the fair value of the JV and determined that a change in the fair value was required. As such, the Company recorded the change in fair value based on its 45% ownership in the JV. For more information, refer to Recent Joint Venture Developments above and Note 2 of the Notes to the Consolidated Financial Statements under Change in Fair Value of equity securities of GMP Bio.
Interest Expense, Net
We recorded interest expense, including amortization of debt costs, of approximately $0.9 million for the years ended December 31, 2025 and 2024, primarily in connection with debt raised from convertible notes and the JH Darbie Financing, March 2022 financing, May 2022 financing and July 2025 financing. For more information on debt raised from convertible notes and the JH Darbie Financing, see Note 5, Note 7 and Note 8 of the Consolidated Financial Statements of this Annual Report.
Reimbursement of expenses
There was no reimbursement of expenses from related parties for the year ended December 31, 2025, where-as the Company was reimbursed approximately $23 thousand, by Autotelic Inc. a related party, during the year ended December 31, 2024 for expenses incurred by the Company on behalf of our JV.
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Change in value of derivatives
During the year ended December 31, 2025, we recorded a gain of approximately $0.4 million, as compared to loss of approximately $0.3 million, recorded during the year ended December 31, 2024, due to the change in value of derivatives on the notes issued to our CEO and the bridge investors.
Loss on Conversion of Debt
During the year ended December 31, 2025, we recorded a loss on conversion of debt of approximately $1.1 million, as compared to a similar loss of approximately $0.1 million during the same period of 2024. The higher loss incurred during the year ended December 31, 2025 was primarily due to the conversion of the PPM-2 debt to the PPM-3 debt.
Provision for income taxes (deferred)
During the year ended December 31, 2025, we recorded deferred income tax expenses of approximately $111.6 million, as compared to no similar expenses during the same period of 2024. The higher income tax expense incurred during the year ended December 31, 2025 was due to the recording of a change in the fair value of the Company’s investment in GMP Bio of approximately $365.4 million.
Liquidity, Financial Condition and Capital Resources ($s in ‘000’s)
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, including restricted cash | $ | 109 | $ | 106 | ||||
| Working capital | (16,945 | ) | (19,065 | ) | ||||
| Stockholders’ Equity | 262,761 | 8,252 | ||||||
Except the year ending December 31, 2025, the Company has experienced net losses every year since inception. Since inception, and at the end of the year ending December 31, 2024, the Company had an accumulated deficit of approximately $38 million. As of December 31, 2025, the Company recorded net income of approximately $249 million after deferred taxes, and as such had positive equity of approximately $262.8 million. As of December 31, 2025, the Company had approximately $0.1 million in cash, approximately $1.1 million of prepaid and other current assets and current liabilities of approximately $18.1 million, of which approximately $1.3 million are net assumed liabilities of the Company as part of the Oncotelic Inc. reverse merger, $11.9 million of short term debt, including accrued interest, and $2.6 million is contingent liability to issue common shares of the Company to PointR shareholders upon achievement of certain milestones. The Company also had approximately $1.9 million of long-term debt on account of the PPM-3 and $111.6 million of deferred income taxes Management expects to incur significantly lower costs and losses, especially due to the transfer of costs over to the JV since April 2022, in the foreseeable future but also recognizes the need to raise capital to remain viable. The Company’s limited capital resources, history of recurring losses and uncertainties as to whether the Company’s operations will become profitable raise substantial doubt about its ability to continue as a going concern. The financial statements contained in this report do not include any adjustments related to the recoverability of assets or classifications of liabilities that might be necessary should the Company be unable to continue as a going concern.
The principal source of the Company’s working capital deficit to date has been the issuance of convertible notes and short term loans. A substantial part of the short term loans have been provided by officers and certain insiders, and sale of equity under the EPA with Peak One. The Company will need to raise additional capital in order to fund its operations and continue development of its product candidates. The Company is evaluating the options to further the development of the Company’s product candidates, AL-101, Artemisinin for COVID-19, developing AI technologies to support the COVID-19 therapies; in addition to evaluating the development pathway of its product candidates; OXi4503 and/or CA4P. The Company is also independently planning to develop OT-101 for certain animal health indications and contemplating using crypto currencies for that platform. The Company has been developing OT-101 for various cancers, as well as a nanoparticle platform through the JV. Substantial development on that front has occurred during the past year.
The Company hopes to raise substantial additional capital through the sale of equity securities and/or debt, but no new financing arrangements, other than the EPA with Mast Hill, is in place at this time.
If the Company is unable to access additional funds when needed, it may not be able to continue the development of these investigational drugs and the Company could be required to delay, scale back or eliminate some or all of its development programs and operations. Any additional equity financing, if available, would be dilutive to the current stockholders and may not be available on favorable terms. Additional debt financing, if available, may involve restrictive covenants and could also be dilutive. The Company’s ability to access capital is not assured and, if access is not achieved on a timely basis, would materially harm the Company’s financial condition, the value of its common stock and its business prospects.
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Cash Flows ($s in ‘000s)
| Year ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Net cash used in operating activities | $ | (1,383 | ) | $ | (740 | ) | ||
| Net cash provided by financing activities | 1,386 | 656 | ||||||
| Increase/ (decrease) in cash | $ | 3 | $ | (84 | ) | |||
Operating Activities
For the year ended December 31, 2025, net cash used in operating activities was approximately $1.4 million. This was due to the net income of approximately $249.0 million, offset by approximately $365.4 million recorded due to the change in fair value of the Company’s investment in GMP Bio; approximately recording deferred income taxes of approximately $111.6 million; $0.4 million due to the favorable change in fair value of the derivatives; increased by approximately $2.4 million stock-based expenses; by approximately $1.1 million of loss on conversion of debt; approximately $0.2 million of amortization of deferred financing costs and approximately $0.1 million due to changes in operating assets and liabilities.
For the year ended December 31, 2024, net cash used in operating activities was approximately $0.7 million. This was due to the net loss of approximately $4.8 million, primarily reduced by approximately $3.2 million of goodwill impairment, approximately $0.3 million due to a change in fair value of derivatives, approximately $0.1 million of amortization of debt and finance discounts, approximately $0.1 million of loss on conversion of debt and increased by approximately $0.3 million due to changes in operating assets and liabilities.
Financing Activities
For the year ended December 31, 2025, net cash provided by financing activities was approximately $1.4 million, due to approximately $0.5 million from convertible debt and approximately $0.9 million raised through short term loans.
For the year ended December 31, 2024, net cash provided by financing activities was approximately $0.7 million due to approximately $0.7 million raised through short term loans.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
Effects of Inflation
We do not believe that inflation has had a material impact on our business, revenues or operating results during the periods presented.
Contractual Obligations
Our current drug development programs are based on a series of compounds called combretastatins, which we have exclusively licensed from Arizona State University, or ASU. If our current drug candidates are approved, we will be required to pay low to mid-single-digit royalties on future net sales of products associated with the ASU patent rights until these patent rights expire.
We also have an exclusive license from Bristol-Myers Squibb, or BMS, for certain patent rights to particular combretastatins, including CA4P. If CA4P is approved, we will be required to pay low-single-digit royalties on future net sales of products associated with the BMS patent rights until these patent rights expire.
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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our cash is maintained in U.S. dollar accounts. We have adopted a policy for the cash that we hold, and also for any cash equivalents and investments that we may hold, the primary objective of which is to preserve principal, while also maintaining liquidity to meet our operating needs and maximize yields to the extent possible. Although our investments can be subject to credit risk, we follow procedures to limit the amount of credit exposure in any single issue, issuer or type of investment. Our investments are also subject to interest rate risk and would be likely to decrease in value if market interest rates increase. However, due to the generally conservative nature of our investments and relatively short duration, we believe that interest rate risk is mitigated.
Although we may, from time-to-time, manufacture drugs and conduct preclinical or clinical trials outside of the United States, our exposure to foreign currency risk is immaterial at this time.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
See Item 15 for a list of our Financial Statements and Schedules and any supplementary financial information filed as part of this Annual Report.
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
We maintain disclosure controls and procedures that are designed to ensure (i) that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures, our management was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives.
As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”) conducted an evaluation as of the end of the period covered by this Annual Report on Form 10-K, of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15I and 15d-15(e) under the Exchange Act. Based on that evaluation, our CEO and our CFO each concluded that our disclosure controls and procedures are not effective at that time as a result of certain material weaknesses in our internal control over financial reporting discussed below.
Material Weaknesses in Internal Control over Financial Reporting
Our management conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2025 based on the framework established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management has determined that our internal control over financial reporting as of December 31, 2025, was not effective as a result of certain material weaknesses.
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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 financial statements will not be prevented or detected on a timely basis.
The ineffectiveness of our internal control over financial reporting was due to the following material weaknesses which are observed in many small companies with a small number of accounting and financial reporting staff:
| ● | Lack of adequate independent directors on the Company’s board of directors and committees to oversee financial reporting responsibilities; |
| ● | Inadequate or lack of segregation of duties; |
| ● | Lack of dedicated resources and experienced personnel to design and implement internal control procedures to support financial reporting objectives; |
| ● | Lack of risk assessment procedures on internal controls to detect financial reporting risks on a timely manner. |
Management’s Plan to Remediate the Material Weaknesses
Management continues to implement measures, subject to the availability of resources required to design and maintain such controls, designed to ensure that control deficiencies contributing to the material weakness are remediated, such that these controls are designed, implemented, and operating effectively. The implementation and remediation measures are planned subject to the availability of financial and therefore human resources. The remediation actions planned include:
| ● | Continue to search for, evaluate and recruit qualified independent outside directors; |
| ● | Once independent directors are on Board, to augment or replace the non-independent directors to the Audit Committee and other committees. |
| ● | Identify gaps in our skills base and the expertise of our staff required to meet the financial reporting requirements of a public company; and |
| ● | Continue to monitor the effectiveness of operations on existing controls and procedures. |
Changes in Internal Control over Financial Reporting
During the year ended December 31, 2025, we continued to work on our planned implementation and remediation actions which are all intended to strengthen our overall control environment, within the limited resources available to us. Due to lack of resources, we have not made any substantial progress in our planned remediation efforts, however, we are optimistic that the Company to complete its planned execution of internal controls over financial reporting upon the availability of resources.
We are committed to maintaining a strong internal control environment and believe that these remediation efforts will represent significant improvements in our control environment. Our management will continue to monitor and evaluate the relevance of our risk-based approach and the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.
ITEM 9B. OTHER INFORMATION
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The following table sets forth certain information about our current directors and executive officers followed by individual biographies of the directors and executive officers of the Company, including their business experience and other relevant information as of December 31, 2025.
| Name | Age | Position | ||
| Vuong Trieu, Ph. D. | 61 | Chairman of the Board and Chief Executive Officer | ||
| Amit Shah | 59 | Chief Financial Officer | ||
| Saran Saund | 68 | Chief Business Officer | ||
| Anthony E. Maida III | 73 | Chief Medical Officer – Translation Medicine & Director | ||
| Steven W. King | 61 | Director and Consultant | ||
| Seymour Fein, M.D. | 77 | Chief Regulatory Officer and Chief Medical Officer (Consultant) |
Vuong Trieu, Ph.D. was the founder and Chairman of the Board of Directors of Oncotelic Inc., having served in such capacity since 2014, and now serves as the Company’s Chief Executive Officer (“CEO”) and Chairman of the Board of Directors. Dr. Trieu has been involved in drug discovery, development, and commercialization for over 25 years, including his contributions as co-inventor of Abraxane®. He previously served as Executive Chairman and Interim CEO of Marina Biotech, Inc. from 2016 to 2018. Marina Biotech was a developer of tkRNA for the treatment of FAP/CRC (Familial adenomatous polyposis/ Colorectal Cancer). Prior to that, he also served as President and CEO of IgDraSol, Inc.— a developer of a 2nd generation Abraxane—beginning in 2012 until its acquisition by Sorrento Therapeutics, Inc. in 2013. He served as Chief Scientific Officer for Sorrento Therapeutics, Inc. and a member of that company’s board of directors from 2013 until 2014. Previously, Dr. Trieu was Senior Director of Pharmacology/Biology at Abraxis Bioscience/Celgene, where he led the preclinical, clinical and PK/biomarker development of Abraxane, and was the co-inventor of the intellectual property covering Abraxane. Earlier in his career, Dr. Trieu held positions at Genetic Therapy/Sandoz (leading the adenoviral gene therapy program against atherosclerosis), Applied Molecular Evolution (AME)/Lily (leading the expression, purification, and preclinical testing of mAb therapeutics) and Parker Hughes Institute (Director of Cardiovascular Biology program that evaluated a series of small molecules and biologics against preclinical models of atherosclerosis, dyslipidemia, stroke, ALS, and restenosis). Dr. Trieu holds a PhD in Microbiology, BS in Microbiology and Botany. He is a member of ENDO, ASCO, AACR, and many other professional organizations. Dr. Trieu is published widely in oncology, cardiovascular, and drug development.
Dr. Trieu has over 100 patent applications and 39 issued U.S. patents.
The Board believes that Dr. Trieu’s extensive experience as an executive at various biotechnology and biopharmaceutical companies as well as his service on private and public company boards qualifies him to serve on the Board.
Amit Shah was appointed as our Chief Financial Officer effective in July 2019. Mr. Shah has served as a senior financial officer for a number of life science companies, including Chief Financial Officer at Marina Biotech, Inc., a publicly traded biotechnology company from 2017 to 2018; Vice President of Finance & Accounting Insightra Medical Inc. from 2014 to 2015, Acting Chief Financial Officer of Insightra Medical Inc. in 2015; VP Finance and Acting Chief Financial Officer at IgDraSol Inc. in 2013; Corporate Controller & Director of Finance at ISTA Pharmaceuticals from 2010 to 2012; Corporate Controller at Spectrum Pharmaceuticals from 2007 to 2010: and as Controller / Senior Manager Internal Audits at Caraco Pharmaceuticals Laboratories from 2000 to 2007. In addition to his work with life sciences companies, Mr. Shah served as the Chief Financial Officer at Eagle Business Performance Services, a management consulting and business advisory firm from end of 2018 through March 2019 and as a consultant and ultimately Senior Director of Finance – ERP, at Young’s Market Company from 2015 to 2017. Mr. Shah received a Bachelor’s of Commerce degree from the University of Mumbai, and is an Associate Chartered Accountant from The Institute of Chartered Accountants of India. Mr. Shah is also an inactive CPA from Colorado, USA.
Saran Saund has served as the Chief Business Officer of the Company since November 2019. Prior to that, he was the Chief Executive Officer and Founder of PointR Data Inc. from 2016 to 2019 where the revenue generating startup developed an innovative AI for cashier-less automated retail stores. From 2013 to 2016 Saran Saund served as managing partner of Astralync LLC that specialized in open source AI frameworks and developed an industry consortium. Previously, Saran Saund held positions as General Manager, founder and CEO at various companies, including Cambridge Silicon Radio (acquired by Qualcomm), Marvell Semiconductors Inc., and PicoMobile Inc (acquired by Marvell). Mr. Saund received his MSc. Tech in Computer Science from BITS Pilani (India) and MS Computer Science from Penn State University.
Anthony E. Maida III, Ph.D., M.A., M.B.A. was appointed to the Board in May 2020. Dr, Maida was also appointed as a consultant Chief Medical Officer of the Company in April 2020. Dr. Maida has been involved in the clinical development of immunotherapy for over 27 years in various executive management positions. Since June 2010 till June 2020, Dr. Maida served as Senior Vice President, Clinical Research for Northwest Biotherapeutics, Inc., a cancer vaccine company focused on therapy for patients with glioblastoma multiforme and prostate cancer. From June 2009 through June 2010, Dr. Maida served as Vice President of Clinical Research and General Manager, Oncology, Worldwide for PharmaNet, Inc., a clinical research organization. From 1997 through 2010, Dr. Maida served as Chairman, Founder and Director of BioConsul Drug Development Corporation and Principal of Anthony Maida Consulting International, advising pharmaceutical and investment firms, in the clinical development of therapeutic products and product/company acquisitions. From 1992 to September of 1999, Dr. Maida was President and Chief Executive Officer of Jenner Biotherapies, Inc., an immunotherapy company. Dr. Maida is currently a member of the board of directors and audit chair of Spectrum Pharmaceuticals, Inc. and Vitality Biopharma, Inc. (OTCQB: VBIO) and was formerly a member of the board of directors and audit chair of OncoSec Medical Inc. (OTCQB: ONCS). Dr. Maida holds a B.A. in Biology and History, an M.B.A., an M.A. in Toxicology and a Ph.D. in Immunology. He is a member of the American Society of Clinical Oncology, the American Association for Cancer Research, the Society of Neuro-Oncology, the International Society for Biological Therapy of Cancer and the American Chemical Society.
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The Board believes that Dr. Maida is qualified to serve on the Board and as the consultant Chief Medical Officer due to his extensive experience as an executive at various biotechnology and biopharmaceutical companies as well as his service on private and public company boards.
Steven W. King was appointed to the Board in May 2020. He previously served as the CEO of Peregrine Pharmaceuticals, Inc. and its wholly owned biomanufacturing subsidiary Avid Bioservices, Inc., during which time the company advanced its lead compound through Phase 3 development, while growing revenues to over $55 million. Prior to joining Peregrine, Mr. King was employed at Vascular Targeting Technologies, Inc., which was acquired by Peregrine in 1997. Mr. King served in a variety of executive roles at Peregrine, including Director of Research and Development from 1997 to 2000; Vice President Technology and Product Development from 2000 to 2002; Chief Operating Officer from 2002 to 2003; and Chief Executive Officer from 2003 to 2017. Mr. King served on the board of directors of Peregrine from 2003 until 2017. Mr. King previously worked at the University of Texas Southwestern Medical Center and is co-inventor on over 40 U.S. and foreign patents and patent applications in the vascular targeting agent field. Mr. King received his Bachelor’s and Master’s degrees from Texas Tech University in Cell and Molecular Biology. The Board believes Mr. King is qualified to serve as a director because of his extensive scientific understanding of technologies in development and expertise in developing and manufacturing biologics, combined with the perspective and experience he brings from having previously served on the boards of public companies.
Seymour Fein, M.D. was appointed to in May 2022 as the Company’s Consulting Chief Regulatory Officer. Dr. Fein has been managing partner of the clinical and regulatory consulting organization, CNF Pharma, LLC for the last 20 years and in that capacity has worked closely with numerous new drug reviewing divisions at the FDA including the divisions of oncologic drug products. Dr. Fein’s professional activities have been focused on drug development research for over 35 years. He has been extensively involved in the successful development of numerous drugs, biologics and medical devices during this time leading to FDA approvals for over 20 drugs (NDAs, sNDAs, BLAs) and devices (PMAs). Dr. Fein began his career at Hoffmann-La Roche Ltd. as a senior research physician and was responsible for a clinical development program that led to U.S. Food and Drug Administration (FDA) approval of recombinant interferon-alpha for cancer treatment. Dr. Fein was also the medical director of Bayer Healthcare Pharmaceuticals (U.S.) where he was responsible for therapeutic areas including gastroenterology, oncology, and cardiology. He later served as medical director for Rorer Group (now part of Sanofi) and Ohmeda (now part of Baxter). Dr. Fein founded and has been managing partner of a clinical and regulatory consulting organization and has worked closely with the numerous new drug review divisions at the FDA including the divisions of oncologic drug products. Dr. Fein has successfully overseen entrepreneurial drug development leading to the FDA approval of two orphan drug products in the field of gastroenterology and the first drug approved for the treatment of nocturia in the field of urology. Dr. Fein received his B.A. degree from the University of Pennsylvania and his M.D. degree with honors from New York Medical College. He completed a three-year residency in internal medicine at Dartmouth and a three-year fellowship in medical oncology and hematology at Harvard Medical School, where he served as an instructor of medicine during his final fellowship year. Dr. Fein is board-certified in both oncology and internal medicine.
The Board had three standing committees, which consisted of the Audit Committee, the Compensation Committee and the Nominating and Corporate Governance Committee (collectively, the “Committees”), We have discontinued all the Committees since July 2021 and since that date, the full Board serves in lieu of all Committees. As our finances permit, we intend to engage independent directors to the Board and restart the Committees. Members on the committees will serve until their resignation or as otherwise determined by our Board.
Audit Committee
For the year ended December 31, 2025, the full Board acted in lieu of an Audit Committee. The full Board met four times during the year ended December 31, 2025 in lieu of the Audit Committee.
Our Audit Committee had the authority to retain and terminate the services of our independent registered public accounting firm, reviews our annual financial statements, considers matters relating to accounting policy and internal controls, and reviews the scope of our annual audits. Such functions are currently being managed by our full Board.
The Board had adopted a charter for the Audit Committee, which is to be reviewed and reassessed annually by the Audit Committee. Due to a lack of the Committee, such review and evaluation has not been done. A copy of the Audit Committee’s written charter is publicly available on our website at www.oncotelic.com.
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Compensation Committee
For the year ended December 31, 2025, the full Board acted in lieu of Compensation Committee. The full Board did not meet during the year ended December 31, 2025, since there were no compensation-based decisions to be made as the JV employs all of the individuals providing services for the Company.
The Compensation Committee’s responsibilities include making recommendations to the Board regarding the compensation philosophy and compensation guidelines for our executives, the role and performance of our executive officers, and appropriate compensation levels for our CEO, which are determined without the CEO present, and other executives based on a comparative review of compensation practices of similarly situated businesses. The Compensation Committee also makes recommendations to the Board regarding the design and implementation of our compensation plans and the establishment of criteria and the approval of performance results relative to our incentive plans. Our Compensation Committee also administers our 2005 Stock Plan, our 2015 Equity Incentive Plan and our 2017 Equity Incentive Plan. Currently, none of the members of the Compensation Committee qualifies as independent under the definition promulgated by The NASDAQ Stock Market and qualifies as a “Non-Employee Director” within the meaning of Rule 16b-3 under the Exchange Act.
The Compensation Committee shall review and assess the three main components of each named executive officer’s compensation: base salary, incentive compensation, and equity compensation. Adjustments to base salary are generally only made when there has been a change in the scope of the responsibilities of the named executive officer or when, based on a review of the base salary component of executive officers in companies of a similar size and stage of development, the Compensation Committee members believe that an adjustment is warranted in order to remain competitive. The executive management of the Company determines and agrees with the Compensation Committee on its corporate goals and objectives for the ensuing year. At the end of each year, the attainment of each objective is assessed and incentive awards may be made to each executive based on his or her contribution to achieving the objectives. Awards are made based on either provision of an executive’s employment agreement, or an assessment of each executive’s equity compensation position relative to the Company’s other executives.
The Compensation Committee also typically reviews our director compensation on at least an annual basis. The Compensation Committee has the authority to directly retain the services of independent consultants and other experts to assist in fulfilling its responsibilities. Currently there are no independent compensation consultants retained by the Company.
Nominating and Governance Committee
For the year ended December 31, 2025, the Company had no Nominating and Governance Committee. The full Board acted in lieu of the Nominating and Governance Compensation Committee. The full Board did not meet during the year ended December 31, 2025, since there was no nominating or governance based decisions to be made.
The Nominating and Governance Committee’s responsibilities include making recommendations to the full Board as to the size and composition of the Board and making recommendations as to particular nominees to the Board. All members of the Nominating and Governance Committee qualify as independent under the definition promulgated by The NASDAQ Stock Market.
Board Attendance at Board of Directors, Committee and Stockholder Meetings
Our Board met 7 times, which included four times in lieu of the Audit Committee, approved certain corporate actions by unanimous written consents four times during the fiscal year ended December 31, 2025. Each of our directors serving during fiscal 2025 attended all the meetings of the Board and in lieu of the Committees of the Board upon which such director served and that were held during the year ended December 31, 2025.
Although we do not have a formal policy regarding attendance by members of the Board at our annual meeting of stockholders, directors are encouraged to attend.
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Board Leadership Structure
Our Board has the discretion to determine whether to separate or combine the roles of Chair of the Board and Chief Executive Officer. Dr. Trieu has served in both roles since his appointment to the Board after the reverse merger with Oncotelic and our Board continues to believe that his combined role is most advantageous to the Company and its stockholders. Dr. Trieu possesses in-depth knowledge of the issues, opportunities and risks facing us, our business and our industry and is best positioned to fulfill the Board Chair’s responsibility to develop meeting agendas that focus the Board’s time and attention on critical matters and to facilitate constructive dialogue among Board members on strategic issues.
In addition to Dr. Trieu’s leadership, the Board maintains effective independent oversight through a number of governance practices, including, open and direct communication with management, input on meeting agendas, and regular executive sessions.
Risk Oversight
Our Board oversees a company-wide approach to risk management, determines the appropriate risk level for us generally, and assesses the specific risks faced by us to reviews the steps taken by management to mitigate those risks. While we continue to operate without committees, our Board has ultimate oversight responsibility for the risk management.
Compensation Committee Interlocks and Insider Participation
None of our executive officers, except Dr. Trieu, served as a member of the Board or Compensation Committee, or other committee serving an equivalent function, of any entity that has an executive officer and who serves on our Board or Compensation Committee since 2019. After the merger of the Company with Oncotelic Inc., our Chief Executive Officer, Dr. Trieu has been identified and is a control person of Autotelic, Inc.
Also, Mr. Steven King, was the CEO of Edgepoint Inc., an AI company that is a non-controlling interest subsidiary of the Company. Dr. Maida is currently consulting as the Chief Medical Officer – Translation Medicine with the Company in regards to its planned trials for OT-101 for our oncology indications.
Corporate Code of Ethics
We have adopted a Corporate Code of Conduct and Ethics (the “Code of Conduct”) that applies to all of our employees, including our CEO and CFO. The text of the Code of Conduct had been filed as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 2014, and is posted on our website at www.oncotelic.com. Disclosure regarding any amendments to, or waivers from provisions of the code of conduct and ethics that apply to our directors and principal executive and financial officers will be included in a Current Report on Form 8-K within four business days following the date of the amendment or waiver.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires our directors, executive officers and persons who own more than 10% of our common stock to file with the SEC and us initial reports of beneficial ownership and reports of changes in beneficial ownership of our common stock and other equity securities. For these purposes, the term “other equity securities” would include options granted under the Company’s 2005 Stock Plan (the “2005 Stock Plan”), the Company’s 2015 Equity Incentive Plan (the “2015 Plan”) and the Company’s 2017 Equity Incentive Plan (the “2017 Plan”). To our knowledge, based solely on a review of the forms and written representations received by us from our Section 16 reporting persons, during the fiscal year ended December 31, 2019, all Section 16(a) filing requirements applicable to the reporting persons were properly and timely satisfied.
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ITEM 11. EXECUTIVE COMPENSATION
Summary Compensation Table
The following table provides information regarding the compensation paid during the years ended December 31, 2025, and 2024 to our principal executive officer, principal financial officer and certain of our other executive officers, who are collectively referred to as “named executive officers” elsewhere in this Annual Report.
| Name and Principal Position | Year | Salary $(1) |
Bonus $ |
Stock
Awards $(2) |
All
Other Compensation $ |
Total $ |
||||||||||||||||||
| Vuong Trieu, Ph. D. | 2025 | — | — | — | — | — | ||||||||||||||||||
| President and Chief Executive Officer | 2024 | — | — | — | — | — | ||||||||||||||||||
| Anthony E. Maida III, Ph. D., M.D. MBA | 2025 | — | — | — | — | — | ||||||||||||||||||
| Chief Medical Officer (May 2020) Consultant | 2024 | — | — | — | — | — | ||||||||||||||||||
| Saran Saund | 2025 | — | — | — | — | — | ||||||||||||||||||
| Chief Business Officer | 2024 | — | — | — | — | — | ||||||||||||||||||
| Amit Shah | 2025 | — | — | — | — | — | ||||||||||||||||||
| Chief Financial Officer | 2024 | — | — | — | — | — | ||||||||||||||||||
(1) Assuming the continuation of the cash compensation and benefits continue to be borne by the JV, the Company will not report such compensation information as part of the Company’s Executive Compensation.
(2) During the years 2025 and 2024, the Company has not granted any stock awards to any of its executive officers or directors, as the Company does not have a sufficient pool under the stock option plans to make such awards.
Narrative Disclosure to Summary Compensation Table
Vuong Trieu, Ph. D., Saran Saund and Amit Shah
Commencing in August 2019, the Company entered into Employment Agreements and incentive compensation arrangements with each of its executive officers. The Employment Agreements provide for annual base salaries for each year of the term, subject to review and adjustment by the Board or the Compensation Committee from time to time. Each Employment Agreement provides that the executive shall be eligible for an annual discretionary cash bonus expressed as a percentage the executive’s base salary, subject to their achievement of performance targets and goals established by the Board or the Compensation Committee. Mr. Saund was appointed as an Executive Officer in November 2019 after the PointR merger. Dr. Maida was appointed as our consultant Chief Medical Officer – Translation Medicine in May 2020 and does not have an Employment Agreement. Each of the executive officers entered into the Company’s standard form of indemnification agreement.
Dr. Fein was appointed as the Chief Regulatory Officer in May 2022. Further, Dr. Fein was appointed as Chief Medical Officer in February 2023.
The initial base salaries and discretionary cash bonus amounts had been set for the executives as follows:
| Executive | Title | Initial Base Salary | Discretionary Bonus (% of Base) | |||||||
| Vuong Trieu | Chief Executive Officer | $ | 450,000 | 50 | % | |||||
| Amit Shah | Chief Financial Officer | $ | 320,000 | 40 | % | |||||
| Saran Saund | Chief Business Officer | $ | 230,000 | 40 | % | |||||
| Anthony E. Maida III(1) | Chief Medical Officer | $ | 180,000 | NA | ||||||
| (1) | Dr. Maida is a consultant to the Company and currently does not have an Employment Agreement. |
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The Company did not grant any increases in cash compensation to any of its Executive Officers, other than Mr. Saund whose compensation was increased to $320,000 in 2023, since the initial employment agreement due to the financial condition of the Company. However, such compensation was paid to Mr. Saund by the JV and hence not reported above. Further, as disclosed previously, our JV has paid the cash compensation to our employees, including all the other executive officers named above, since the first quarter of 2023.
The stock-based compensation on the issuance the stock options has been reported under Summary Compensation Table above, if and when granted.
Outstanding Equity Awards at Fiscal Year-End
The following table shows all outstanding grants of stock options as of December 31, 2025, to each of the executive officers named in the Summary Compensation Table. The table below reflects the options and restricted shares that are issuable to Messrs. Trieu, Maida, Saund and Shah for each of the years when the options were granted.
| Option Awards | ||||||||||||||||
| Name | Type | Number of Securities Underlying Unexercised Options Exercisable | Number of Securities Underlying Unexercised Options Unexercisable | Option Exercise Price |
Option
Expiration Date | |||||||||||
| Vuong Trieu, Ph. D. (1) | ||||||||||||||||
| Chief Executive Officer & President- 2022 | ISO | 200,000 | 800,000 | $ | 0.10 | 7/22/2032 | ||||||||||
| 2021 | ISO | 360,000 | — | $ | 0.1398 | 7/8/2031 | ||||||||||
| 2021 | ISO | 200,000 | — | $ | 0.1626 | 9/3/2031 | ||||||||||
| Saran Saund (1) | ||||||||||||||||
| Chief Business Officer- 2022 | ISO | 200,000 | 800,000 | $ | 0.10 | 7/22/2032 | ||||||||||
| 2021 | ISO | 675,000 | — | $ | 0.1398 | 7/8/2031 | ||||||||||
| 2021 | ISO | 100,000 | — | $ | 0.1626 | 9/3/2031 | ||||||||||
| Anthony Maida (1) 2022 | ||||||||||||||||
| Chief Medical Officer – Consultant- 2022 | ISO | 200,000 | 800,000 | $ | 0.10 | 7/22/2032 | ||||||||||
| 2021 | NQSO | 400,000 | — | $ | 0.1398 | 7/8/2031 | ||||||||||
| 2021 | NQSO | 400,000 | — | $ | 0.1626 | 9/3/2031 | ||||||||||
| Amit Shah (1) | ||||||||||||||||
| Chief Financial Officer- 2022 | ISO | 200,000 | 800,000 | $ | 0.10 | 7/22/2031 | ||||||||||
| 2021 | ISO | 400,000 | — | $ | 0.1626 | 7/8/2031 | ||||||||||
| (1) | The stock awards had been approved by the board. The stock compensation thereon has been computed and expensed when granted and reported in the Summary Compensation Table. |
Pension Benefits
We do not have any qualified or non-qualified defined benefit plans.
Nonqualified Deferred Compensation
We do not have any non-qualified defined contribution plans or other deferred compensation plans.
Potential Payments Upon Termination or Change-In-Control
We have entered into certain agreements and maintain certain plans that may require us to make certain payments and/or provide certain benefits to Dr. Trieu, Mr. Saund and Mr. Shah in the event of a termination of their employment or a change of control of the Company. The following table summarizes the potential payments to Dr. Trieu; and Messrs. Saund and Shah assuming that one of the described termination events occurs. The table assumes that the event occurred on December 31, 2025, the last day of our fiscal year and that each of the named officers were eligible to earn the full initial base compensation. On the final trading day of our fiscal year the closing price of our common stock on OTCQB Market was $0.04 per share.
The Employment Agreements each have a term that continues until terminated by the Company or the executive. In the event that the Company terminates an executive for “Cause”, or an executive voluntarily resigns his employment, on termination the executive will be entitled to receive all accrued and unpaid base salary, any accrued and unused paid time off, and reimbursement of outstanding business expenses. If the Employment Agreements are terminated by the Company without “Cause” or the executive resigns for “Good Reason” (each as defined in the Employment Agreement) then the executive will be entitled to additional severance benefits including: (a) a lump sum payment equal to 12 months’ of the executive’s then current base salary (18 months in the case of Dr. Trieu); (b) accelerated vesting of all outstanding stock options and incentive compensation awards, and (c) insurance benefits or COBRA coverage for 12 months (18 months in the case of Dr. Trieu) in addition to payment of accrued and unpaid personal time.
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Vuong N. Trieu, Ph. D.
| Executive Benefits and Payments Upon Termination | Termination within 12 months Following Change in Control | Voluntary Termination by Executive or Death | Involuntary Not for Cause Termination or Termination by Executive with Good Reason | For Cause Termination | Disability | |||||||||||||||
| Base Salary | $ | 675,000 | $ | — | $ | 675,000 | $ | — | $ | — | ||||||||||
| Annual Bonus (50% of Base Salary) | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | N/A | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | |||||||||||||||
| Acceleration of Vesting of Equity | 100 | % | 0 | % | 100 | % | 0 | % | 0 | % | ||||||||||
| Stock Options: | ||||||||||||||||||||
| Number of Stock Option | 1,998,255 | — | 1,998,255 | — | — | |||||||||||||||
| Value upon Termination* | $ | 99,913 | $ | — | $ | 99,913 | $ | — | $ | — | ||||||||||
| Vested Stock / Received: | ||||||||||||||||||||
| Number of Shares | 1,198,255 | — | 1,198,255 | — | — | |||||||||||||||
| Value upon Termination* | $ | 59,913 | $ | — | $ | 59,913 | $ | — | $ | — | ||||||||||
| Relocation Reimbursement | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
| Deferred Compensation Payout | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
| Post-Term Health Care | Up to 18 months | N/A | Up to 18 months | N/A | N/A | |||||||||||||||
| $ | 18,964 | $ | — | $ | 18,964 | $ | — | $ | — | |||||||||||
| Excise Tax Gross Up | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
Saran Saund
| Executive Benefits and Payments Upon Termination | Termination within 12 months Following Change in Control | Voluntary Termination by Executive or Death | Involuntary Not for Cause Termination or Termination by Executive with Good Reason | For Cause Termination | Disability | |||||||||||||||
| Base Salary | $ | 320,000 | $ | — | $ | 320,000 | $ | — | $ | — | ||||||||||
| Annual Bonus (40% of Base Salary) | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | N/A | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | |||||||||||||||
| Acceleration of Vesting of Equity | 100 | % | 0 | % | 100 | % | 0 | % | 0 | % | ||||||||||
| Stock Options: | ||||||||||||||||||||
| Number of Stock Options (1) | 1,993,798 | — | 1,993,798 | — | — | |||||||||||||||
| Value upon Termination* | $ | 99,690 | $ | — | $ | 99,690 | $ | — | $ | — | ||||||||||
| Vested Stock Received: | ||||||||||||||||||||
| Number of Shares (1) | 1,193,798 | — | 1,193,798 | — | — | |||||||||||||||
| Value upon Termination* | $ | 59,690 | $ | — | $ | 59,690 | $ | — | $ | — | ||||||||||
| Relocation Reimbursement | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
| Deferred Compensation Payout | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
| Post-Term Health Care | Up to 12 months | N/A | Up to 12 months | N/A | N/A | |||||||||||||||
| $ | 5,671 | $ | — | $ | 5,671 | $ | — | $ | — | |||||||||||
| Excise Tax Gross Up | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
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Amit Shah
| Executive Benefits and Payments Upon Termination | Termination within 12 months Following Change in Control | Voluntary Termination by Executive or Death | Involuntary Not for Cause Termination or Termination by Executive with Good Reason | For Cause Termination | Disability | |||||||||||||||
| Base Salary | $ | 320,000 | $ | — | $ | 320,000 | $ | — | $ | — | ||||||||||
Annual Bonus (50% of Base Salary) | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | N/A | Executive entitled to Annual Bonus related to most recently completed calendar year if earned and not already paid | |||||||||||||||
| Acceleration of Vesting of Equity | 100 | % | 0 | % | 100 | % | 0 | % | 0 | % | ||||||||||
| Stock Options: | ||||||||||||||||||||
| Number of Stock Options (1) | 1,997,093 | — | 1,997,093 | — | — | |||||||||||||||
| Value upon Termination* | $ | 99,855 | $ | — | $ | 99,855 | $ | — | $ | — | ||||||||||
| Vested Stock Received: | ||||||||||||||||||||
| Number of Shares (1) | 1,197,093 | — | 1,197,093 | — | — | |||||||||||||||
| Value upon Termination* | $ | 59,885 | $ | — | $ | 59,885 | $ | — | $ | — | ||||||||||
| Relocation Reimbursement | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
| Deferred Compensation Payout | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
| Post-Term Health Care | Up to 12 months | N/A | Up to 12 months | N/A | N/A | |||||||||||||||
| $ | 11,208 | $ | — | $ | 11,208 | $ | — | $ | — | |||||||||||
| Excise Tax Gross Up | N/A | N/A | N/A | N/A | N/A | |||||||||||||||
*Based on the stock price of the Company as of December 31, 2025, of $0.05 and assuming the number of shares granted are vested and earned. Assuming that the JV would be responsible for the cash compensation and the health benefits that any of the executive officers named above, that cost may not be paid for by the Company Dr. Maida is a consultant Chief Medical Officer – Translation Medicine and is not subject to potential payments upon termination or change-in-control, and as such his information has not been compiled for this table.
The information set forth above is described in more detail in the Narrative Disclosure to the Summary Compensation Table.
As defined in the employment agreements, a “Change in Control” means the following during the employment term:
| (1) | any “Person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becomes the “Beneficial Owner” (as defined in Rule 13d-3 under said Act), directly or indirectly, of securities of the Company representing more than fifty percent of the total voting power represented by the Company’s then outstanding voting securities (excluding for this purpose any such voting securities held by the Company or its affiliates or by any employee benefit plan of the Company) pursuant to a transaction or a series of related transactions which the Board of Directors does not approve; or |
| (2) | a merger or consolidation of the Company whether or not approved by the Board of Directors, other than a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or the parent of such corporation) at least fifty percent of the total voting power represented by the voting securities of the Company or such surviving entity or parent of such corporation, as the case may be, outstanding immediately after such merger or consolidation; or |
| (3) | the stockholders of the Company approve an agreement for the sale or disposition by the Company of all or substantially all of its assets; or |
| (4) | a change in the composition of the Board of Directors, as a result of which fewer than a majority of the directors are Incumbent Directors, and provided in each such case the Change in Control also meets the requirements of a “Change in Control Event” within the meaning of Section 409A(a)(2)(A)(v) of the Code and Treasury Regulation Section 1.409A-3(i)(5). “Incumbent Directors” mean the directors who either (A) are directors of the Company as of the date of this Agreement, or (B) are elected, or nominated for election, to the Board of Directors with the affirmative votes of at least a majority of the Incumbent Directors at the time of such election or nomination (but shall not include an individual whose election or nomination is in connection with an actual or threatened proxy contest relating to the election of directors to the Company). |
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In each such case the Change of Control must also meet the requirements of a “Change of Control Event” within the meaning of Section 409(a)(2)(A)(v) of the Code.
Each of Drs. Trieu, Saund and Mr. Shah will be entitled to certain benefits as described in the table above if his employment is terminated by the Company for reasons other than cause or by him with good reason. “Cause,” as defined in the employment agreements, means:
| (1) | Substantial failure to perform any of his duties or to follow reasonable, lawful directions of the Board or any officer to whom the party reports; |
| (2) | willful misconduct or willful malfeasance in connection with his employment; |
| (3) | commission of, conviction of, or plea of nolo contendere to, any crime constituting a felony under the laws of the United States or any state thereof, or any other crime involving moral turpitude; |
| (4) | material breach of any provision of the employment agreement, the By-laws or any other written agreement with the Company; |
| (5) | engaging in misconduct that causes significant injury to the Company, financial or otherwise, or to its reputation; or |
| (6) | any act, omission or circumstance constituting cause under the law governing the employment agreement. |
“Good Reason,” as defined in the employment agreements, means the Company:
| (1) | materially reduces the officer’s title or responsibilities; |
| (2) | relocates its headquarters more than sixty (60) miles from their current location (unless the relocation results in the headquarters being closer to the officer’s residence); |
| (3) | materially reduces the officer’s base salary; or |
| (4) | breaches a material term of the officer’s employment agreement. |
Good Reason must also meet the requirements for a good reason termination in accordance with Code Section 409A, and any successor statute, regulation and guidance thereto.
Director Compensation
For the year ended December 31, 2025, and 2024, none of our directors, including Steven King our sole non-employee director, were paid in cash or stock awards for their services as a director.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth information, as of April 14, 2026, regarding the beneficial ownership of our common stock by:
| ● | each of our directors and our director nominees; | |
| ● | each of our executive officers; | |
| ● | our directors and executive officers as a group; and | |
| ● | each person known to us to beneficially own more than 5% of our common stock. |
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The address for each beneficial owner listed is c/o Oncotelic Therapeutics, Inc. 29397 Agoura Road, Suite 107, Agoura Hills, California, 91301. Each of the stockholders listed has sole voting and investment power with respect to the shares beneficially owned by the stockholder, subject to community property laws where applicable.
In accordance with applicable SEC rules, the number of shares reflected as beneficially owned by each entity, person, director or executive officer is determined in accordance with the rules of the SEC. Under those rules, beneficial ownership includes any shares over which the individual has sole or shared voting power or investment power as well as any shares that the individual has the right to acquire within 60 days after the Record Date through the exercise of any stock option, warrants or other rights.
We have computed the percentage of shares beneficially owned on the basis of 444,197,032 shares of our Common Stock outstanding as of April 14, 2026. Shares of our Common Stock that a person has the right to acquire within 60 days after the Record Date through other means, such as a stock option or warrant, are deemed outstanding for purposes of computing the percentage ownership of the person holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person (other than the percentage ownership of all directors and executive officers as a group).
| Name of Beneficial Owner | Common
Stock Beneficially Owned | Percentage
of Common Stock | ||||||
| Directors and Officers: | ||||||||
| Vuong Trieu | 133,808,826 | (1) | 29.0 | % | ||||
| Steven W. King | 4,188,059 | (2) | 0.9 | % | ||||
| Anthony E. Maida III | 3,137,314 | (3) | 0.7 | % | ||||
| Amit Shah | 2,584,871 | (4) | 0.6 | % | ||||
| Saran Saund | 18,347,759 | (5) | 4.1 | % | ||||
| Seymour Fein, MD | - | - | ||||||
| All officers and directors as a group (6 persons) | 166,066,829 | (6) | 35.4 | % | ||||
| Beneficial owners of more than 5% | ||||||||
| Vuong Trieu | 133,808,826 | (1) | 29.0 | % | ||||
| Balaji Bhakta | 44,85,256 | (7) | 10.0 | % | ||||
| Larn Hwang | 25,714,323 | (8) | 5.8 | % | ||||
* < 1%
| (1) | Includes: (a) 93,388,297 shares owned directly and beneficially by the reporting person; 11,669,415 shares of common stock issuable upon conversion of debt, 1,738,953 shares issuable upon exercise of stock options; and 8,491,000 shares of common stock issuable upon conversion of Series A Convertible Preferred Stock; (b) 16,780,384 shares registered in the name of Autotelic, Inc., and 1,388,889 shares issuable upon conversion of debt held by Autotelic, Inc., and (c) 6,872,529 shares registered in the name of Dr. Trieu’s spouse. Dr. Trieu is the Chief Executive Officer of Autotelic, Inc. and in that capacity has the sole authority to control the voting and the disposition of common stock and preferred stock owned by Autotelic, Inc. Dr. Trieu disclaims beneficial ownership of the shares held by Autotelic, Inc., except to the extent of his beneficial interest therein. |
| (2) | Shares held in the name of Artius Bioconsulting, LLC, consists of (i) 3,330,647 shares of common stock and (ii) 857,412 shares issuable upon exercise of stock options granted to Mr. King. |
| (3) | Consists of (i) 1,137,314 shares of common stock and (ii) 2,000,000 shares issuable upon exercise of stock options. |
| 59 |
| (4) | Consists of (i) 358,837 shares of common stock, (ii) 527,778 shares of common stock issuable upon conversion of debt and (iii) 1,698,256 shares of common stock upon exercise of options. |
| (5) | Consists of (i) 16,456,480 shares of common stock, and (ii) 1,891,279 shares issuable upon exercise of stock options. |
| (6) | Consists of (i) 136,980,409 shares of common stock, (ii) 5,838,885 shares issuable upon conversion of debt, and (iii) 8,185,900 shares issuable upon exercise of options. |
| (7) | Consists of (i) 41,630,811 shares of common stock, (ii) (iii) 694,445 shares of common stock upon conversion of debt and 2,500,000 upon conversion of warrants. |
| (8) | Consists of (i) 23,455,990 shares of common stock, (ii) 1,208,333 shares of common stock issuable upon conversion of debt and (iii) 1,050,000 shares of common stock upon exercise of options. |
Equity Compensation Plan Information
The following table provides certain aggregate information with respect to all of the Company’s equity compensation plans in effect as of December 31, 2025.
| Plan Category | Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights | Weighted- Average Exercise Price of Outstanding Options | Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) | |||||||||
| Equity compensation plans approved by security holders | 22,527,761 | $ | 0.22 | 4,972,739 | ||||||||
| Equity compensation plans not approved by security holders | 1,650,000 | 0.30 | 350,000 | |||||||||
| Total | 24,177,761 | $ | 0.23 | 5,322,739 | ||||||||
Brief Description of equity compensation plan not approved by security holders
In January 2017, the Board of Directors adopted and approved the 2017 Plan. The 2017 Plan allows the Company, under the direction of the Compensation Committee, to make grants of stock options, restricted and unrestricted stock awards, and other stock-based awards to employees, consultants and directors. The purpose of these awards is to attract and retain key individuals, further align employee and stockholder interests, and provide additional incentive for them to promote our success. The 2017 Plan provides for the issuance of up to 2,000,000 shares of the Company’s common stock. Any stock options granted under the 2017 Plan must be non-qualified stock options, which are not intended to meet the requirements of Section 422 of the Internal Revenue code. Options generally vest over a period of time, may not be exercised unless they are vested, and no option may be exercised after the end of the term set forth in the award agreement.
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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
Our Board of Directors has reviewed the materiality of any relationship that each of our directors has with the Company, either directly or indirectly. Based upon this review, our Board has determined that none of the directors, qualify as “independent directors” as defined under the OTC Market Rules for U.S. Companies.
Master Service Agreement with Autotelic Inc.
Oncotelic Inc. entered into a Master Service Agreement dated On March 9, 2020 (the “MSA”) with Autotelic Inc. Dr. Trieu, our Chairman and CEO, is a partial owner and control person in Autotelic Inc. Autotelic Inc. currently owns less than 10% of the Company. Under the MSA, Autotelic Inc. provides business functions and services to the Company in exchange for a fee, such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The MSA requires a 90-day written termination notice in the event either party requires to terminate such services.
Expenses related to the MSA were approximately $2,000 for the years ended December 31, 2025 and 2024, respectively. The Company owed Autotelic, Inc. approximately $0.3 million at December 31, 2025 and 2024 respectively.
License Agreement with Autotelic Inc.
In September 2021, the Company entered into an exclusive License Agreement with Autotelic. For more information on the exclusive license Agreement with Autotelic, refer to our 2024 Annual Report on Form 10-K filed with SEC on April 15, 2025. There we no payments to Autotelic, Inc. in connection with the License Agreement for the years ended December 31, 2025 and 2024.
Notes Payable and Short-Term Loan – Related Party
From time to time, Dr. Trieu our Chairman and CEO, advanced funds to the Company. At December 31, 2025 approximately $713,000, and payable to Dr. Trieu, was outstanding including: approximately $164,000 for a 2019 debenture, approximately $371,000, including accrued interest thereon, in a Fall 2019 Note bearing interest at five percent (5%) per annum, and $175,000 in short terms unsecured notes bearing no interest.
From time to time, Autotelic, Inc. has advanced funds to the Company. At December 31, 2025 approximately $3.2 million was outstanding including: $302,000 in August 2021 Notes bearing interest at five percent (5%) per annum, including accrued interest thereon, and approximately $2.9 million in short terms unsecured notes bearing no interest.
Artius Consulting Agreement
In March 2020, the Company and Artius Bioconsulting, LLC (“Artius”), for which Mr. King is the Managing Member, entered into an amendment to an existing Consulting Agreement, under which Artius agreed to serve as a consultant to the Company for services related to the Company’s business from time to time. For more information on this Agreement, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
No expense was recorded during the years ended December 31, 2025 and 2024, respectively, related to this Agreement.
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Maida Consulting Agreement
Effective May 5, 2020, the Company and Dr. Maida entered into an independent consulting agreement, commencing April 1, 2020, under which Dr. Maida will assist the Company in providing medical expertise and advice from time to time in the design, conduct and oversight of the Company’s existing and future clinical trials. For more information on this Agreement, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
Effective April 1, 2022, Dr Maida’s compensation has been borne by the JV. No expense was recorded during the years ended December 31, 2025 and 2024, respectively, related to this Agreement.
Mosaic ImmunoEngineering, Inc.
In April 2024, the Company entered into a Term Sheet with Mosaic. For more information on the Term Sheet, refer to Note 1 of this Quarterly Report. Steven King, our Board member, is the CEO of Mosaic. The Company had advanced $40 thousand to Mosaic in accordance with the terms of the Term Sheet, and Mosaic has repaid the amount, with interest, to the Company as of December 31, 2024. In addition, the Company, on behalf of our JV, had entered into an agreement with Mosaic to provide consulting services related to CMC activities for the JV. The expenses for these services have been paid for by the JV. As such, the Company has not recorded any expenses or accounts payable in this regard during the years ended December 31, 2025 or 2024.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The following table presents fees for professional audit services rendered by our independent public accounting firm, Rose Snyder and Jacobs, LLP (“RSJ”) for the audit for the years ended December 31, 2025 and December 31, 2024, respectively, and other services rendered during that period.
| 2025 | 2024 | |||||||
| Audit fees (1) | $ | 110,500 | $ | 99,000 | ||||
| Audit-related fees | — | — | ||||||
| Tax fees | — | — | ||||||
| All other fees | — | — | ||||||
| $ | 110,500 | $ | 99,000 | |||||
| (1) | Audit fees consisted of audit work performed on the audit of the annual financial statements, review of quarterly financial statements, as well as work that generally only the independent registered public accounting firm can reasonably be expected to provide, such as the provision of consents in connection with the filing of registration statements and statutory audits.
We have been invoiced $110,500 by RSJ in connection with the reviews for the quarters ended March 31, 2025, June 30, 2025 and September 30, 2025; and for the year ended December 31, 2025.
We have been invoiced $99,000 by RSJ in connection with the reviews for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024; and for the year ended December 31, 2024. |
| 62 |
Policy on Audit Committee Pre-Approval of Audit and Permissible Non-audit Services of Independent Registered Public Accounting Firm
Consistent with SEC policies regarding auditor independence, the Audit Committee has responsibility for appointing, setting compensation, and overseeing the work of the independent registered public accounting firm. In recognition of this responsibility, the Audit Committee has established a policy to pre-approve all audit and permissible non-audit services provided by the independent registered public accounting firm.
Prior to engagement of the independent registered public accounting firm for the next year’s audit, management will submit an aggregate of services expected to be rendered during that year for each of four categories of services to the Audit Committee for approval.
| 1. | Audit services include audit work performed in the preparation and audit of the annual financial statements, review of quarterly financial statements, as well as work that generally only the independent auditor can reasonably be expected to provide, such as the provision of consents and comfort letters in connection with the filing of registration statements. |
| 2. | Audit-related services are for assurance and related services that are traditionally performed by the independent auditor, including due diligence related to mergers and acquisitions, employee benefit plan audits, and special procedures required to meet certain regulatory requirements. |
| 3. | Tax services consist principally of assistance with tax compliance and reporting, as well as certain tax planning consultations. |
| 4. | Other Fees are those associated with services not captured in the other categories. The Company generally does not request such services from the independent auditor. |
Prior to engagement, the Audit Committee pre-approves these services by category of service. The fees are budgeted, and the Audit Committee requires the independent registered public accounting firm and management to report actual fees versus the budget periodically throughout the year by category of service. During the year, circumstances may arise when it may become necessary to engage the independent registered public accounting firm for additional services not contemplated in the original pre-approval. In those instances, the Audit Committee requires specific pre-approval before engaging the independent registered public accounting firm.
The Audit Committee may delegate pre-approval authority to one or more of its members. The member to whom such authority is delegated must report, for informational purposes only, any pre-approval decisions to the Audit Committee at its next scheduled meeting.
In the absence of an Audit Committee, the responsibilities of the Audit Committee are fulfilled by the Board of Directors of the Company. As such, for the year ended December 31, 2025, the Board of Directors approved the appointment and services of RSJ.
| 63 |
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
| (a) | The following documents are filed as part of this Annual Report on Form 10-K. |
| (1) | Financial Statements |
See financial statements listed in the accompanying “Index to Financial Statements” covered by the Report of Independent Registered Public Accounting Firm.
| (2) | Financial Statement Schedule |
No schedules are submitted because they are not applicable, not required or because the information is included in the Financial Statements as Notes to Financial Statements.
| (3) | Exhibits |
| 64 |
| 65 |
| 66 |
| 67 |
| 68 |
| * | Confidential treatment has been granted for portions of this Exhibit. Redacted portions filed separately with the Securities and Exchange Commission. |
| + | Management contract or compensatory plan or arrangement. |
| 69 |
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.
| Oncotelic Therapeutics, Inc. | ||
| (Formerly Mateon Therapeutics, Inc.) | ||
| /s/ VUONG TRIEU | ||
| By: | VUONG TRIEU, PH. D. | |
| Chief Executive Officer | ||
Date: April 15, 2026
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.
| Signature | Title | Date | ||
| /s/ VUONG TRIEU | President, Chief Executive Officer and Chairman of | April 15, 2026 | ||
| Vuong Trieu, Ph. D. | the Board and Director (Principal executive officer) | |||
| /s/ AMIT SHAH | Chief Financial Officer (Principal financial and | April 15, 2026 | ||
| Amit Shah | accounting officer) | |||
| /s/ STEVEN KING | Director | April 15, 2026 | ||
| Steven King | ||||
| /s/ ANTHONY MAIDA | Director | April 15, 2026 | ||
| Anthony Maida, M.D., Ph. D. |
| 70 |
Oncotelic Therapeutics, Inc.
Index to Financial Statements
The following financial statements of Oncotelic Therapeutics, Inc.:
| F-1 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Oncotelic Therapeutics, Inc.
Opinion on the Financial Statements
Going Concern Uncertainty
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has experienced recurring losses from operations and has an accumulated deficit and a working capital deficiency that raise substantial doubt about its ability to continue as a going concern. Management’s plans regarding these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated 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 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 audit 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 audit, 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 audit included performing procedures to assess the risks of material misstatement of the consolidated 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 consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our 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, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
Evaluation of Investment in GMP Biotechnology Limited at Fair Value
Description of the Matter
As discussed in Note 6 to the consolidated financial statements, the Company holds a 45% non-controlling interest in GMP Biotechnology Limited. The Company determined that it did not control the activities of GMP Biotechnology Limited but that it did have significant influence over GMP Bio. As a result, the Company accounted for its investment using the equity method of accounting. During 2022, the year GMP Biotechnology LImited was formed, the Company elected the fair value option under FASB ASC 825 relating to the accounting for its equity method investment in GMP Biotechnology Limited. The Fair Value Option requires management to adjust the carrying value of the investment in GMP Biotechnology Limited to fair value each reporting period.
Auditing management’s estimate of fair value was complex because of the significant judgment required to evaluate management’s assumptions used to determine the fair value of its investment in GMP Biotechnology Limited.
How We Addressed the Matter in our Audit
Our audit procedures related to the evaluation of the fair value of the investment in GMP Bio included the following, among others:
| 1. | We evaluated the appropriateness of managements significant accounting policies related to the fair value of investments. | |
| 2. | We inquired of management of the Company regarding clinical activities, capital fundraising, and budget to actual assessments for GMP Biotechnology Limited’s operations. | |
| 3. | With respect to the Company’s valuation of its investment in GMP Biotechnology Limited |
| a. | We assessed the qualifications and competence of management | |
| b. | We assessed the qualifications and competence of the Company-hired valuation specialist engaged to evaluate the fair value of the Company’s investment in GMP Biotechnology Limited | |
| c. | We evaluated the methodologies used to determine the fair value of the Company’s investment in GMP Biotechnology Limited | |
| d. | We engaged a third-party valuation expert to evaluate the reasonableness of management’s valuation by: |
| i. | Assess the appropriateness of valuation methodologies and approaches | |
| ii. | Review key assumptions and inputs used in the discounted cashflow model | |
| iii. | Agree projected financial metrics to supporting documentation and/or market benchmarks | |
| iv. | Evaluate projected capital requirements to support commercialization | |
| v. | Evaluated sensitivity to changes in key assumptions | |
| vi. | Review mathematical accuracy of management’s valuation report |
| e. | We considered whether there were any events that would contradict management’s assumptions. |
| We have served as the Company’s auditor since 2021. | |
| April 15, 2026 |
| F-2 |
ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Restricted cash | ||||||||
| Accounts receivable | ||||||||
| Prepaid & other current assets | ||||||||
| Total current assets | ||||||||
| In process R&D | ||||||||
| Goodwill, net | ||||||||
| Investment in GMP Bio at fair value | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | $ | ||||||
| Accounts payable - related party | ||||||||
| Contingent Consideration | ||||||||
| Derivative liability on notes | ||||||||
| Convertible and short-term debt, net of costs | ||||||||
| Convertible debt and short-term debt - related party, net of costs | ||||||||
| Total current liabilities | ||||||||
| Convertible long-term debt, net of costs | ||||||||
| Deferred income tax liability | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 13) | ||||||||
| Stockholders’ equity: | ||||||||
| Convertible Preferred stock, $ par value, shares authorized; and shares issued and outstanding | ||||||||
| Common stock, $ par value; shares authorized; and issued and outstanding, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated equity (deficit) | ( | ) | ||||||
| Total Oncotelic Therapeutics, Inc. stockholders’ equity | ||||||||
| Non-controlling interests | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
The accompanying footnotes are an integral part of these consolidated financial statements.
| F-3 |
ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| For the Year Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | $ | ||||||
| General and administrative | ||||||||
| Goodwill impairment (See note 2 and 3) | ||||||||
| Total operating expenses | ||||||||
| Income/(Loss) from operations | ( | ) | ( | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of investment in GMP Bio | ||||||||
| Interest expense, net | ( | ) | ( | ) | ||||
| Reimbursement for expenses - related party | ||||||||
| Change in fair value of derivative on debt | ( | ) | ||||||
| Loss on debt conversion | ( | ) | ( | ) | ||||
| Miscellaneous income | ||||||||
| Total other income (expense) | ( | ) | ||||||
| Net income (loss) before income taxes | ( | ) | ||||||
| Provision for income taxes | ( | ) | ||||||
| Net income (loss) after income taxes | ( | ) | ||||||
| Net income (loss) before non-controlling interests | ( | ) | ||||||
| Net loss attributable to non-controlling interests | ( | ) | ( | ) | ||||
| Net income (loss) attributable to Oncotelic Therapeutics, Inc. | $ | $ | ( | ) | ||||
| Basic net income (loss) per share attributable to common stock | $ | $ | ( | ) | ||||
| Basic weighted average common stock outstanding | ||||||||
| Basic and diluted net income (loss) per share attributable to common stock | $ | $ | ( |
) | ||||
| Basic and diluted weighted average common stock outstanding | ||||||||
The accompanying footnotes are an integral part of these consolidated financial statements.
| F-4 |
ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE YEAR ENDED DECEMBER 31, 2025
| Preferred Stock | Common Stock | Additional Paid-in | Accumulated | Non-controlling | Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Interests | Equity | |||||||||||||||||||||||||
| Balance at January 1, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | | |||||||||||||||||||||
| Common shares issued upon partial conversion of debt | ||||||||||||||||||||||||||||||||
| Common shares issued for services | ||||||||||||||||||||||||||||||||
| Preferred shares issued for services | - | |||||||||||||||||||||||||||||||
| Warrants issued in connection with private placement | ||||||||||||||||||||||||||||||||
| Net income (loss) | ( | ) | ||||||||||||||||||||||||||||||
| Balance at December 31, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
The accompanying footnotes are an integral part of these consolidated financial statements.
| F-5 |
ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE YEAR ENDED DECEMBER 31, 2024
| Preferred Stock | Common Stock | Additional Paid-in | Accumulated | Non-controlling | Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Interests | Equity | |||||||||||||||||||||||||
| Balance at January 1, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | | |||||||||||||||||||||
| Common shares issued in connection with debt conversion | - | |||||||||||||||||||||||||||||||
| Warrants issued with convertible notes | - | |||||||||||||||||||||||||||||||
| Net Loss | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance as of December 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
The accompanying footnotes are an integral part of these consolidated financial statements.
| F-6 |
ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Twelve Months Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net income (loss) | $ | $ | ( | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Goodwill impairment | ||||||||
| Amortization of debt discount and deferred finance costs | ||||||||
| Change in fair value of investment in GMP Bio | ( | ) | ||||||
| Deferred income taxes | ||||||||
| Stock compensation expense | ||||||||
| Loss on debt conversion | ||||||||
| Change in fair value of derivative | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Accounts payable and accrued expenses | ||||||||
| Accounts payable to related party | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Net proceeds from convertible debt | ||||||||
| Proceeds from short term loans, others | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase (decrease) in cash | ( | ) | ||||||
| Cash and restricted cash - beginning of period | ||||||||
| Cash and restricted cash - end of period | $ | $ | ||||||
| Supplemental cash flow information: | ||||||||
| Cash paid for: | ||||||||
| Interest paid | $ | $ | ||||||
| Income taxes paid | $ | $ | ||||||
| Common shares issued upon partial conversion of debt | $ | $ | ||||||
The accompanying footnotes are an integral part of these consolidated financial statements.
| F-7 |
ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Description of Business
Oncotelic Therapeutics, Inc. (“Oncotelic” or the “Company”) was originally incorporated in the State of New York in 1988 as OXiGENE, Inc. The Company reincorporated in the State of Delaware in 1992, changed its name to Mateon Therapeutics, Inc. (“Mateon”) in 2016, and subsequently changed its name to Oncotelic Therapeutics, Inc. in November 2020. The Company conducts business through Oncotelic and its wholly owned subsidiaries, including Oncotelic, Inc., PointR Data, Inc. (“PointR”), Pet2DAO, Inc. (“Pet2DAO”), and EdgePoint AI, Inc. (“EdgePoint”), a consolidated subsidiary with non-controlling interests. (Collectively, “Oncotelic,” “we,” “our,” or “the Company”). Further detail on prior mergers and corporate history is provided in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on April 15, 2025.
The Company is principally focused on the development of immuno-oncology therapeutics, including OT-101, a transforming growth factor-beta (TGF-β) inhibitor being advanced for difficult-to-treat cancers and viral respiratory diseases. OT-101 is being developed through our joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology Limited (“GMP Bio”), affiliates of Golden Mountain Partners (“GMP”).
As
of December 31, 2025, the Company owns
Oncotelic conducted an assessment of the change in fair value and hired the services of a separate, ASC-compliant valuation firm to perform a valuation of GMP Bio under U.S. GAAP standards. The results of this valuation that indicated a change in the value of the Company’s holdings in GMP Bio have been incorporated into this, consistent with the Company’s fair value reporting under U.S. GAAP. The valuation conducted by the independent valuation firm conducted a fair value of GMP Bio based on various methods compliant with US GAAP to derive the fair value. The Company then utilized the fair value of GMP Bio as assessed by the valuation firm, attributed the ownership of the Company in GMP Bio to ascertain the Company’s interest in GMP Bio, and recorded the resulting gain to the investment in GMP Bio at fair value. The Company relied on the inputs by the JV valuation, however, certain parameters like lack of marketability, lack of control discounts and other standard discounts, specific to the Company, have been applied to the independent valuation done by the Company to derive the ASC-compliant valuation. In the future, the Company will appropriately adjust the fair value of the Company’s interest in the JV at the end of reporting periods and when key value inflection points are met.
The
Company entered into a JV with Dragon to form GMP Bio in March 2022. The Company’s ownership interest in GMP Bio is
The JV continues preparing for planned Phase 2 and Phase 3 trials for OT-101 in high-grade glioma, pancreatic cancer, and other indications. The JV is also sponsoring investigator-initiated clinical studies in additional oncology applications. In addition, the JV is developing five additional therapeutic candidates, which, if successfully developed and approved, are anticipated to contribute significant revenues, income and meaningful long-term value to both the JV and the Company.
In addition to the development of OT-101 (also referred to as Sapu-002), the JV is advancing the development of five additional therapies:
| a. | Sapu-001 – A paclitaxel-based taxane therapy, which can address cancers like breast cancer, non small cell lung cancer, pancreatic cancer and ovarian cancer |
| F-8 |
| b. | Sapu-003 – An evorolimus formulation, which can address renal cell cancer, neuroendocrine tumors and tuberous sclerosis complex (renal angiomyolipoma and subependymal giant cell astrocytoma) | |
| c. | Sapu-004 – A carboplatin formulation, which can address small cell lung cancer, head and neck cancer and testicular cancer | |
| d. | Sapu-005 – A palbociclib formulation, which would address HR+, HER2- breast cancer | |
| e. | Sapu-006 – A docetaxel formulation, which can address prostate cancer and gastric cancer. |
Each of these therapies, and the various cancers the address, have shown they are increasing in terms of incidences and that opens up the avenue to be able to generate revenues ranging from several millions of dollars to several hundreds of millions of dollars, if successfully developed and commercialized.
Although no assurances can be given, GMP Bio currently intends to conduct an initial public offering of the JV, at a future date, on either the Hong Kong Exchange or other stock exchange. For more information on the JV, refer to Note 6 of the unaudited Notes to the Consolidated Financial Statements.
The Company’s core scientific focus is the development of its proprietary self-immunization protocol (“SIP™”), designed to stimulate a patient’s immune system to recognize and target tumors without requiring tumor extraction or antigen identification. The SIP™ platform is supported by more than three decades of RNA-based research and is being applied initially to oncology, with potential expansion to Duchenne Muscular Dystrophy (“DMD”) and other diseases driven by TGF-β overexpression.
Separately from the JV, the Company plans to develop OT-101 for select animal-health indications and is evaluating the use of digital assets and blockchain-based technologies to support that platform. The Company has also acquired apomorphine for potential uses in Parkinson’s disease, erectile dysfunction, and female sexual dysfunction. The Company continues to evaluate advancement opportunities for OXi4503 (for acute myeloid leukemia and myelodysplastic syndromes) and CA4P (in combination with checkpoint inhibitors for metastatic melanoma). The development of all these products will be subject to the availability of resources to develop them.
In April 2026, the Company announced that it had entered into a strategic partnership with TechForce Robotics, Inc. (“TechForce”) to advance the commercialization of its PDAOAI-enabled, GMP-compliant robotics platform. This milestone reflects the culmination of several years of research and development efforts, resulting in an integrated platform designed to combine Oncotelic’s proprietary PDAOAI capabilities with TechForce’s robotics hardware and manufacturing expertise. The system under development is designed to operate within GMP-regulated environments and is intended to enable automated material handling, real-time monitoring, and PDAOAI-enhanced compliance workflows across pharmaceutical manufacturing and related applications. The key highlights of the commercialization include:
| 1. | Integrated AI + robotics platform, combining the Company’s PDAOAI capabilities with TechForce’s scalable robotics systems to automate critical operational workflows; | |
| 2. | Form a GMP-Compliant Design, designed to support regulatory requirements, including data capture, audit readiness, and validation frameworks; | |
| 3. | Improve operational efficiency and compliance, intended to reduce human intervention, minimize contamination risk, and enhance process consistency through real-time monitoring and intelligent automation; and | |
| 4. | Achieve scalable manufacturing capability, intended to leverage TechForce’s hardware expertise and manufacturing network to support commercial deployment and future growth. |
Fundraising
Mast Hill July 2025 Note
In
July 2025, the Company entered into a Securities Purchase Agreement with Mast Hill, pursuant to which the Company issued convertible
promissory notes in the aggregate principal amount of $
For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.
Mast Hill Equity Purchase Agreement
In
August, 2025, the Company entered into an Equity Purchase Agreement (the “Mast EPA”) and a Registration Rights Agreement
(the “Mast Registration Rights Agreement”) with Mast, pursuant to which the Company shall have the right, but not
the obligation, to direct Mast, to purchase up to $
For more information on the Mast EPA, refer to Note 10 of the Notes to the Consolidated Financial Statements.
| F-9 |
Jefferson Capital Ventures, LLC and Valor Nation, Inc Independent Contractor Agreements
In
August, 2025, the Company entered into independent contractor agreements (“ICA”) with Jefferson Capital Ventures,
LLC (“Jefferson”) and Valor Nation, Inc. (“Valor”) for providing certain consulting and advisory
services. The ICAs call for Jefferson and Valor to provide consulting and advisory services including strategic planning meetings, coordination
non-legal support for SEC compliance, balance sheet and income statement optimization strategies, shareholder and investor communication
planning, liaison with investment bankers, analysts, and institutional investors, operational efficiency and cost-saving recommendations
and ancillary strategic services not requiring a license, corporate planning, operations and capital markets advisory services not requiring
licenses. Such services shall be provided by Jefferson and Valor for a period of 18 months from the signing of the ICA, unless terminated
earlier by either party under certain predefined conditions. Jefferson has agreed to be compensated $
Private Placement 3 & JH Darbie Financing
In
December 2025, the Company completed the conversion of debt of forty-seven (47) accredited investors from the JH Darbie Financing from
PPM-2 into the new subscription agreements under the new financing (“PPM-3”) in three tranches, which resulted in
conversion of approximately $
March 2022 Notes
In
March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, LLC (“Fourth Man”), pursuant
to which the Company issued convertible promissory note in the aggregate principal amount of $
For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.
May 2022 Note
In
May 2022, the Company entered into a Securities Purchase Agreement with Mast Hill Fund, L.P. (“Mast Hill”), pursuant
to which the Company issued convertible promissory notes in the aggregate principal amount of $
| F-10 |
June 2022 Note
In
June 2022, the Company entered into a Securities Purchase Agreement with Blue Lake Partners, LLC (“Blue Lake”), pursuant
to which the Company issued convertible promissory notes in the aggregate principal amount of approximately $
For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.
Forever Prosperity (previously GMP) Note purchase agreements and unsecured notes
Between
June 2020 and January 2022, the Company entered into various purchase agreements and promissory notes with GMP, cumulatively totaling
$
For more information on the GMP debt financing, refer to Note 5 of the Notes to the Consolidated Financial Statements.
Mosaic ImmunoEngineering, Inc. Term Sheet
In April 2024, the Company entered into a binding term sheet (the “Term Sheet”) with Mosaic ImmunoEngineering, Inc. (“Mosaic”). For more information on the Term Sheet, refer to the Current Report on Form 8-K filed with the SEC on April 29, 2024. In August 2024, Mosaic and the Company mutually agreed to extend the date of the Term Sheet to expire at the earlier of (1) the signing of definitive agreements or (2) December 31, 2024. In December 2024, the Company and Mosaic further extended the term of the term-sheet to expire at the earlier of (1) the signing of definitive agreements or (2) June 30, 2025. Currently, both parties are in discussions to extend the timeline to complete the due diligence and finalize the signing of definitive agreements to a date mutually acceptable to both.
| F-11 |
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Oncotelic, PointR; and Edgepoint for which there are non equity-controlling interests. Intercompany accounts and transactions have been eliminated in consolidation. The Company’s investment in GMB Bio is recorded and reported as a minority investment in equity securities.
Basis of Presentation
The accompanying consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission including Form 10-K and Regulation S-X.
Liquidity and Going Concern
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. Since inception and till
December 31, 2024, the Company had incurred net losses of approximately $
The
Company’s long-term plans include continued development of its current pipeline of products, in addition to continue the development
of OT-101 which is exclusively out-licensed to the JV and the JV will be responsible for the funding required to support the development
in entirety, to generate sufficient revenues, through either technology transfer or product sales, or raise additional financing to cover
its anticipated expenses. Until the Company is able to generate sufficient revenues from its current pipeline, the Company plans on funding
its operations through the sale of equity and/or the issuance of debt, combined with or without warrants or other equity instruments.
The Company obtained short term loans of approximately $
Although no assurances can be given as to the Company’s ability to deliver on its revenue plans, or that unforeseen expenses may arise, management believes that the potential equity and debt financing or other potential financing will provide the necessary funding for the Company to continue as a going concern. Also, management cannot guarantee any potential debt or equity financing will be available on favorable terms or at all. As such, management does not believe the Company has sufficient cash for 12 months from the date of this report. If adequate funds are not available on acceptable terms, or at all, the Company will need to curtail operations, or cease operations completely.
| F-12 |
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions and disclosure of contingent liabilities at the date of the financial statements and revenues and expense during the reporting period. Actual results could materially differ from those estimates.
The Company believes the following critical accounting policies affect its more significant judgments and estimates used in the preparation of the financial statements. Significant estimates include the valuation of goodwill and intangible assets for impairment, deferred tax asset and valuation allowance, and fair value of financial instruments.
Cash
As
of December 31, 2025 and 2024, respectively, the Company held all its cash in banks in the United States of America. The Company considers
investments in highly liquid instruments with a maturity of three months or less to be cash equivalents. The Company did
Debt issuance Costs and Debt discount
Issuance costs are specific incremental costs that are (1) paid to third parties and (2) directly attributable to the issuance of a debt or equity instrument. The issuance costs attributable to the initial sale of the instrument are offset against the associated proceeds in the determination of the instrument’s initial net carrying amount.
Debt issuance costs and debt discounts are being amortized over the lives of the related financings on a basis that approximates the effective interest method. Costs and discounts are presented as a reduction of the related debt in the accompanying balance sheets if related to the issuance of debt or presented as a reduction of additional paid in capital if related to the issuance of an equity instrument. The Company applies the relative fair value to allocate the issuance costs among freestanding instruments that form part of the same transaction.
If the Company amends the terms of its convertible notes, the Company reviews and applies the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments, evaluates and concludes whether the terms of the agreements were or were not substantially different as of a particular reporting date and accounts the transaction as a debt modification or a troubled debt restructuring.
Fair Value of Financial Instruments
The carrying value of cash, accounts payable and accrued expense approximate their fair values based on the short-term maturity of these instruments. As defined in ASC 820, “Fair Value Measurements and Disclosures,” fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent measurement.
The three levels of the fair value hierarchy defined by ASC 820 are as follows:
| ● | Level 1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and listed equities. |
| F-13 |
| ● | Level 2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities, time value, volatility factors and current market and contractual prices for the underlying instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments in this category generally include non- exchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars. |
| ● | Level 3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed methodologies that result in management’s best estimate of fair value. |
The Company did not have any Level 1 or Level 2 assets and liabilities at December 31, 2025 and 2024.
Investment in equity securities
The following table summarizes the cumulative gross unrealized gains and losses and fair values for long- term investments accounted for at fair value under the fair value option for the investment in GMP Bio, with the unrealized gains and losses reported within earnings on the Condensed Consolidated Statements of Operation as of December 31, 2025 and 2024. The Company has reported this under Level 3 assets:
Initial Book Value | Cumulative Gross Unrealized Gains | Cumulative Gross Unrealized Losses | Fair Value | |||||||||||||
| December 31, 2025 | ||||||||||||||||
| Investment in GMP Bio (equity securities) | $ | $ | | $ | $ | |||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
Initial Book Value | Cumulative Gross Unrealized Gains | Cumulative Gross Unrealized Losses | Fair Value | |||||||||||||
| December 31, 2024 | ||||||||||||||||
| Investment in GMP Bio (equity securities) | $ | $ | $ | $ | ||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
The table above sets forth a summary of the recording of the initial value of the long-term value of investment in equity securities of GMP Bio, based on a third-party valuation report, and changes in the fair value of such equity securities, if such change occurs, as a Level 3 fair value as of December 31, 2025 and 2024. During the year ended December 31, 2025, there has was a change in the long-term value of the Company’s investment in equity securities of GMP Bio and as such has been recorded as above. For more information, see Change in Fair Value of Equity Securities of GMP Bio below.
| F-14 |
Change in Fair Value of Equity Securities of GMP Bio
On March 31, 2022, the Company entered into the JV with Dragon, contributing a license agreement for rights to OT-101for the territory within the United States of America with Sapu Holdings, LLC, a wholly owned subsidiary of GMP Bio and a license agreement for rights to OT-101 for the rest of the world with GMP Bio. For more information on the JV and the related agreements, refer to our 2022 Annual Report on Form 10-K/A filed with the SEC on April 19, 2023.
As
of the effective date of the formation of the JV, the Company received a
The investment in GMP Bio has been accounted for under the fair value method of accounting. Similarly, during the year ended December 31, 2025, the Company determined that a remeasurement of its investment to fair value was appropriate.
All the factors described below allowed the Company to form a basis for a triggering event of significant development for the JV and justified the JV, and consequently the Company, to reassess the fair value of the JV.
The JV’s principal activities centered on the commercialization of OT-101 for certain oncology indications in the US and looking at other territories as well. In March 2025, the JV successfully completed a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101, an antisense therapeutic targeting Transforming Growth Factor Beta 2 (TGFβ2), with checkpoint inhibitors (“CKIs”) and recombinant IL-2 (aldesleukin) (“IL-2”). The Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety and tolerability of OT-101 in combination with recombinant IL-2 in patients with advanced or metastatic solid tumors. The combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected safety signals identified. Based on the favorable safety data, the JV plans to advance OT-101 plus IL-2 into further clinical studies, exploring synergies with CKIs such as PD-1 blockers. The JV is also sponsoring investigator-initiated studies for OT-101 for other oncology indications including lung cancer (non small cell lung cancer- NSCLC- and ugh Mesothelioma.- MPM) and has started clinical development for OT-101 for pancreatic cancer. Over ten patent family has been filed exploiting the central role of TGFB2 as prognostic indicator for cancer survival and one patent family for the intracranial delivery device of brain cancer with issued patent in China and Germany.
In addition to OT-101, the JV has developed a nanoparticle platform (“Nano Platform”) that entails the formulation of products in new nanoparticle sizes. The JV anticipates that the Nano Platform may offer superior platform for the absorption of water insoluble drugs across a broad spectrum of cancers. The JV is working on improved formulations for OT-101 with new nanoparticle sizes. In addition, the JV has identified five additional compounds as product candidates on the Nano Platform, including the following:
| ● | The JV has completed the formulation development of the first product, everolimus for injection. The JV has initiated a global clinical trial for that product, including open patient enrollment in Australia. The JV hopes to complete the Phase 1 trial and to move to a Phase 3 noninferiority trial against Affinitor. Phase 3 trial is slated to initiate within one year with completion and submission for marketing approval no less than three years thereafter. | |
| ● | The JV is developing palbociclib for injection on the Nano Platform and expects to file the investigational new drug (“IND”) and to initiate a Phase 1 trial in 2026. | |
| ● | The JV is developing docetaxel and paclitaxel for injection on the Nano Platform and expects to file the IND to initiate a Phase 1 trial for this product candidate in 2026. These are expected to go through the 505(b)2 bioequivalence pathway which should result in rapid entrance into the market | |
| ● | In addition, the JV has also identified developing carboplatin and intends to begin the development as soon as the other products clinical trials are under way |
The DeciparticleTM platform has proven robust and is being expand to other drug candidates through partnering. The platform is protected by more than 15 patent families covering chemical composition, manufacturing, and method of use.
The JV built a GMP manufacturing facility in San Diego, California (the “San Diego Facility”). In late 2024, the San Diego Facility was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. A significant portion of the manufacturing for the Nano Platform, including the development of Phase I clinical trial materials, is conducted at the San Diego Facility. Evaluation of larger commercial scale manufacturing is ongoing.
In early 2025, the Company entered into a strategic partnership with Shanghai Medicilon, Inc. (“Medicilon”) to access its industry-leading rapid IND development platform to support up to 20 IND projects, including INDs developed by the JV. All six of the compounds that the JV is developing are planned to be initiated under these INDs, and are focused on next-generation anticancer agents.
During
the year ended December 31, 2025, GMP Bio completed an independent third-party valuation by an offshore independent valuation firm, which
preliminarily estimated the potential value of the drug pipeline under development at approximately $
| F-15 |
The Company proceeded to conduct its own independent assessment of the valuation of the JV. The basis for the valuation was by placing reliance on the valuation report of the third party offshore valuation firm, the financial projection, risks and parameters of assessment as done by the offshore independent valuation firm, and then applying additional independent parameters, like discounts for lack of marketability and lack of control, and other standard discounts, required to adhere to the strict ASC-compliant standards as generally used in the United States. The Company hired the services of an independent, ASC-compliant valuation firm to review, perform and validate the assumptions considered by the Company and provide an ASC-compliant valuation of the JV under U.S. GAAP standards. The valuation conducted by the independent ASC-compliant valuation firm of the JV was based on various methods compliant with ASC and US GAAP to derive the fair value. The Company then utilized the fair value of GMP Bio, as assessed by the ASC-compliant valuation firm, attributed the ownership percentage of the Company in GMP Bio, to ascertain the Company’s interest in GMP Bio and recorded the resulting gain to the investment in GMP Bio at fair value. In addition, the Company will appropriately adjust the fair value of the interest of the Company’s interest in the JV at the end of future reporting periods and when key value inflection points are met.
As many of the inputs considered for the purpose of the valuation are unobservable inputs including, but not limited to, the potential revenue projections, the probability of success, the conduct of the clinical trials under accelerated timelines of approvals by the territorial regulatory bodies similar to the 505(b)(2) pathway under the US FDA regulations, the timing of completion of the clinical trials and approvals of the products, timing of product launches, estimates for working capital, additional research and development and general and administrative expenses, estimated tax rates, interest rates of potential debt and many others.
The fair value of the Company’s investment was determined in accordance with ASC 820 Fair Value Measurement and is classified within Level 3 of the fair value hierarchy due to the use of significant unobservable inputs.
The valuation was performed with the assistance of an independent third-party valuation specialist and utilized an income approach (discounted cash flow method) and market-based approach (guideline public company multiples) and recent transactions, where available, to corroborate the results of the income approach. The final value was then arrived at by calculating the average of the values under the two approaches. The income approach of valuation incorporates assumptions that market participants would use in pricing the asset, including estimates of future financial performance and the selection of an appropriate discount rate.
Fair Value Hierarchy
The Company’s investment in the JV is classified within Level 3 of the fair value hierarchy under ASC 820 Fair Value Measurement due to the use of significant unobservable inputs, including projected cash flows and discount rates.
The fair value measurement was determined on a recurring basis as of December 31, 2025 and December 31, 2024. There were no transfers between Levels 1, 2, or 3 during the period.
The following table presents the fair value of the Company’s investment by level within the fair value hierarchy as of December 31, 2025:
| (in million) | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
| Fair value of investment in JV | $ | $ | ||||||||||||||
Quantitative Information about significant unobservable inputs (Level 3)
| Valuation Technique | Unobservable Input | Range | ||
| Discounted Cash Flow | Revenue growth rate | - | ||
| Discounted Cash Flow | EBIT margin | - | ||
| Discounted Cash Flow | Discount rate (WACC) | |||
| Discounted Cash Flow | Terminal growth rate | |||
| Discounted Cash Flow | Product penetration rates |
| F-16 |
The
projected revenue growth rates reflect an initial period of accelerated growth associated with the commercialization and market adoption
of one product followed by additional products, subsequently followed by a gradual decline as the business matures and reaches a more
stable and then stagnant growth phase as generics enter the market. The pharmaceutical industry often exhibits a financial profile characterized
by initially negative EBIT margins, transitioning to high or blockbuster EBIT margins over financial projections. This J-curve trajectory
is driven by extreme R&D costs, long development timelines and regulatory protection for a successful drug. The discount rate of
Sensitivity and Measurement Uncertainty
The
fair value of the Company’s investment in the JV is based on significant unobservable inputs and, as a result, is subject to substantial
measurement uncertainty. Changes in key assumptions could result in a materially different fair value. For example, a 100 basis point
increase in the discount rate could result in a decrease in the estimated fair value of approximately $
| ● | The JV’s ability to successfully execute its business strategy | |
| ● | Market adoption of its products and services | |
| ● | Competitive dynamics within the industry | |
| ● | Changes in macroeconomic conditions and capital markets |
Given the early-stage nature of the JV and the absence of an active market for its equity interests, the fair value measurement is particularly sensitive to changes in key assumptions, including projected revenue growth rates, profitability, and the discount rate. Accordingly, actual results could differ materially from those reflected in the valuation, and such differences could have a material impact on the Company’s financial position and results of operations in future periods. The valuation does not represent a guaranteed realizable value and may differ significantly from amounts that could be realized in an actual transaction.
Restrictions on Transfer
The Company’s ownership interest in the Joint Venture is subject to certain contractual restrictions on transfer under the JV Agreement. In accordance with ASU 2022-03 Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, such restrictions were considered in the determination of fair value.
Concentration of Credit Risk
The Company does not believe that it is exposed to significant concentrations of credit risk related to its investment in the Joint Venture.
Additional Considerations
The
fair value of the Company’s investment reflects its
| F-17 |
Derivative Liability Related to 2019 Bridge Financing
The Company has certain derivative liabilities associated with its 2019 bridge financing Convertible Notes (see Note 5), consisted of conversion feature derivatives at December 31, 2025 and 2024, are Level 3 fair value measurements. The table below sets forth a summary of the changes in the fair value of the Company’s derivative liabilities classified as Level 3 as of December 31, 2025 and 2024:
December 31, 2025 Conversion Feature | December 31, 2024 Conversion Feature | |||||||
| Balance at January 1, 2025 and 2024 | $ | $ | ||||||
| Change in fair value | ( | ) | ||||||
| Balance at December 31, 2025 and December 31, 2024 | $ | $ | ||||||
At December 31, 2025 and 2024, respectively, the Company estimated the fair value of the conversion feature derivatives embedded in the convertible debentures based on assumptions used in the Black-Scholes valuation model. The key valuation assumptions used consists, in part, of the price of the Company’s Common Stock, a risk-free interest rate based on the yield of a Treasury note and expected volatility of the Company’s Common Stock all as of the measurement dates. The Company used the following assumptions to estimate fair value of the derivatives as of December 31, 2025 and 2024:
December 31, 2025 |
December 31, 2024 |
|||||||
| Risk free interest | % | % | ||||||
| Market price of share | $ | - | $ | - | ||||
| Life of instrument in years | ||||||||
| Volatility | % | % | ||||||
| Dividend yield | % | % | ||||||
A
contingent consideration liability of $
If, and when, the Company changes its valuation inputs for measuring financial liabilities at fair value, either due to changes in current market conditions or other factors, it may need to transfer those liabilities to another level in the hierarchy based on the new inputs used. The Company recognizes these transfers at the end of the reporting period that the transfers occur. For the years ended December 31, 2025 and 2024, there were no transfers of financial assets or financial liabilities between the hierarchy levels.
Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted- average number of common shares outstanding during the period. Diluted net income (loss) per share includes the effect of Common Stock equivalents (notes convertible into Common Stock, stock options and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. During the year ended December 31, 2025, the Company had equivalent shares of its Common Stock attributable to notes, convertible into Common Stock. No stock options or warrants were included as the stock options and warrants were not in the money. During the year ended December 31, 2024, no equivalent shares of the Common Stock were included as the Company had incurred losses during this period and addition of such stock equivalents in the computation would have been anti-dilutive.
| F-18 |
A tabular representation of the dilutive common stock equivalents as of December 31, 2025 is shown below. No similar dilutive common stock equivalents were present as of December 31, 2024.
Dilutive common stock equivalents | December 31, 2025 | |||
| Convertible debt | ||||
| Warrants | ||||
| Stock options | ||||
| Total | ||||
A tabular presentation of the reconciliation of basic weighted average common stock outstanding to basic and diluted weighted average common stock outstanding for the year ended December 31, 2025 is presented below. No similar dilutive common stock equivalents were present as of December 31, 2024 as the Company had incurred losses during this period and addition of such stock equivalents in the computation would have been anti-dilutive
| December 31, 2025 | ||||
| Basic weighted average common stock outstanding | ||||
| Add: Dilutive common stock equivalents | ||||
| Total | ||||
The Company applies the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and non-employees, including employee stock options, in the statements of operations.
For stock options issued, the Company estimates the grant date fair value of each option using the Black- Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.
For warrants issued in connection with fund raising activities, the Company estimates the grant date fair value of each warrant using the Black-Scholes pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the warrant, the expected volatility of the Common Stock consistent with the expected life of the warrant, risk-free interest rates and expected dividend yields of the Common Stock. If the warrants are issued upon termination or cancellation of prior issued warrants, then the Company estimates the grant date fair value of the new warrants using the Black-Scholes pricing model and evaluates whether the new warrants are deemed as equity instruments or liability instruments. If the warrants are deemed to be equity instruments, the Company records stock compensation expense and an addition to additional paid in capital. If however, the warrants are deemed to be liability instruments, then the fair value is treated as a deemed dividend and credited to additional paid in capital.
For shares issued in connection with provision of services, the Company estimates the cost of the shares at the price of the Company’s stock on the date of issuance and records that cost as a stock-based compensation cost.
Impairment of Long-Lived Assets
The
Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances
indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the
forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined
to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets
of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature
of the assets. For the years ended December 31, 2025 and 2024, there were
| F-19 |
Intangible Assets
The
Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews
the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not
that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating
performance, competition, sale or disposition of a significant portion of the business, or other factors. If the review indicates the
impairment, an impairment loss would be recorded for the difference of the value recorded and the new value. For the years ended December
31, 2025 and 2024, there were
Goodwill
Goodwill represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired. Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level or more frequently if events or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment would not be required. Otherwise, goodwill impairment is tested using a two-step approach.
The
first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is
determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined
to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. The second step involves
calculating the implied fair value of goodwill by deducting the fair value of all tangible and intangible assets, excluding goodwill,
of the reporting unit from the fair value of the reporting unit as determined in step one. The implied fair value of the goodwill in
this step is compared to the carrying value of goodwill. If the implied fair value of the goodwill is less than the carrying value of
the goodwill, an impairment loss equivalent to the difference is recorded. For the year ended December 31, 2025, impairment was recognized
towards goodwill. For the year ended December 31, 2024, we recorded an impairment loss of approximately $
Derivative Financial Instruments Indexed to the Company’s Common Stock
We have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding, do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However, if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity offerings, we must estimate the fair value of the warrants based on the price of our Common Stock as of December 31 each year, which is as inherently subjective as it is for stock options, and for similar reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we report any changes in their estimated fair values as gains or losses in our Consolidated Statement of Income.
Convertible Instruments
The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives and Hedging”.
ASC 815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards as “The Meaning of Conventional Convertible Debt Instrument.”
| F-20 |
The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Original issue discounts (“OID”) under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records, when necessary, deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note.
ASC 815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally, if an event occurs that is not within the entity’s control could or would require net cash settlement, then the contract shall be classified as an asset or a liability.
Variable Interest Entity (VIE) Accounting
The
Company evaluates its ownership, contractual relationships and other interests in entities to determine the nature and extent of the
interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations.
These evaluations can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical
information, among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE,
the entity is consolidated into the financial statements. At December 31, 2025 and 2024, the Company identified EdgePoint to be the Company’s
sole VIE. At December 31, 2025, and 2024, the Company’s ownership percentage of EdgePoint was
Investments - Equity Method
The Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses, which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. The Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares shall be included in the financial results from other income. Refer to Note 6 to these Notes to the Consolidated Financial Statements.
Joint Venture agreement
We have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization, including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract development and manufacturing organization (“CDMO”) facilities and capabilities. The Company first reviews the arrangement to determine if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture, the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii) the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition of a joint venture.
We consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf of an investor with disproportionately few voting rights in making this VIE determination.
| F-21 |
To the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary beneficiary.
To the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights. Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets of the joint venture without the consent of the non- managing entity and the inability of the non-managing entity to remove us from our role as the managing entity.
We use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under the equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets and liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.
When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value. As a result, the accounting for a partial sale will result in the recognition of a full gain or loss.
When circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at fair value.
The Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment, as the Company believes that the fair value option is most appropriate for a company in the biotechnology industry, The fair value option is more appropriate for companies that are involved in extensive and usually very expensive research and development efforts, which are not appropriately reflected in the market value or reflective of the true value of the development activities of the Company.
Revenue Recognition
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers.
Under ASC 606, the Company recognizes revenue when its customers obtain control of the promised good or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company applies the following five-step process: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company identifies the performance obligation(s) in the contract by assessing whether the goods or services promised within each contract are distinct. The Company then recognizes revenue for the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
| F-22 |
The Company does not anticipate generating revenues from rendering services to other third party customers for the development of certain drug products and/or in connection with certain out-licensing agreements, at least in the near future. In the case of services rendered for development of the drugs, revenue is recognized upon the achievement of the performance obligations or over time on a straight-line basis over the extended service period. In the case of out-licensing contracts, the Company records revenues either (i) upon achievement of certain pre-defined milestones when there is no obligation of the Company achieve any performance obligations in connection with the said pre-defined milestones, or (ii) upon achievement of the performance obligations if the milestones require the Company to provide the performance obligations.
The Company may occasionally collect advance payments from customers toward commitments to provide services or performance obligations, in which case the advance payment is recorded as a liability until the obligations are fulfilled and revenue is recognized.
Research & Development Costs
In accordance with ASC 730-10-25 “Research and Development”, research and development costs are charged to expense as and when incurred.
Recent Accounting Pronouncements
All newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.
NOTE 3 – ACQUISITIONS, GOODWILL AND INTANGIBLE ASSETS
Goodwill from 2019 Reverse Merger with Oncotelic and Merger with PointR
The Company completed the reverse merger with Oncotelic Inc. (“Merger”) in April 2019. The Company completed the merger with PointR Data Inc (“PointR Merger”) in November 2019. For more details on the two mergers, refer to our 2020 Annual Report on Form 10-K for the year ended December 31, 2020 filed by the Company on April 15, 2021.
The
Oncotelic merger gave rise to Goodwill of approximately $
Further,
we added goodwill of approximately $
We have one operating segment and reporting unit. Accordingly, our review of goodwill impairment indicators was performed at the entity-wide level. In performing our annual impairment assessment, we determined if we should qualitatively assess whether it was more likely than not the fair value of goodwill was less than its carrying amount (the qualitative impairment test). The factors we considered in the assessment included our market capitalization, general macroeconomic conditions, conditions specific to the industry and market and whether there had been sustained declines in our share price. If we concluded, it was more likely than not, the fair value of the reporting unit was less than its carrying amount, or elected not to use the qualitative impairment test, a quantitative impairment test would be performed.
| F-23 |
We
have used our market capitalization as an indicator of fair value. While we believe the fair value measurement need not be based solely
on the quoted market price of an individual share of our Common Stock, and that we also could consider the impact of a control premium
in measuring the fair value of its reporting unit. In the absence of any other valuation metrics, the Company believed using a control
premium utilized would not be appropriate under the current circumstances. We also considered some other market comparables’ trends
in our stock price as well as the industry over a period of two successive quarters and prospective quarter to evaluate whether the fair
value of our reporting unit was greater than our carrying amount. As such, we performed a quantitative impairment assessment of goodwill
for our single reporting unit at the end of 2024, due to a sustained decline in our market capitalization and an increase in negative
economic outlook for biotech markets We estimated and reconciled the fair value of our reporting unit utilizing our market capitalization
based on the stock price of our Common Stock as of December 31, 2024. Before completing our goodwill impairment test, we first tested
our indefinite-lived intangible asset then our remaining long-lived assets for impairment. We concluded our indefinite-lived intangible
assets were not impaired. Based on the market capitalization, we further concluded the fair value of our single reporting unit was less
than its carrying value and therefore recognized an impairment charge of $
A summary of our goodwill as of December 31, 2025 and 2024 is shown below:
| December
31, 2025 | December
31, 2024 | |||||||
| Balance at January 1, 2025 and 2024 | $ | $ | ||||||
| Less: Goodwill impairment due to market capitalization | ( | ) | ||||||
| Balance at December 31, 2025 and 2024 | $ | $ | ||||||
In general, the goodwill is tested on an annual impairment date of December 31, unless we observe any further deterioration in our market capitalization, in which case we may, depending on the materiality of the impairment, record an impairment at the end of other reporting periods.
In-Process Research & Development (“IPR&D”) Summary
The
IPR&D assets were acquired in the PointR Merger during the year ended December 31, 2019. Since January 2021, the Company has determined
that the IPR&D should be reported as an indefinitely lived asset and therefore will evaluate, on an annual basis, for any impairment
on the IPR&D and will record an impairment if identified. The balance of IPR&D as of December 31, 2025 and December 31, 2024
was $
| F-24 |
NOTE 4 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expense consists of the following amounts:
December 31, 2025 | December 31, 2024 | |||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| $ | $ | |||||||
December 31, 2024 | December 31, 2024 | |||||||
| Accounts payable – related party | $ | $ | ||||||
NOTE 5 – CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT
As of December 31, 2025 and December 31, 2024, special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued interest, if any, consist of the following amounts:
December 31, 2025 | December 31, 2024 | |||||||
| Current Debt | ||||||||
| Convertible debentures | ||||||||
| 10% Convertible note payable, due April 23, 2022 – Bridge Investor | $ | $ | ||||||
| 10% Convertible note payable, due April 23, 2022 – Related Party | ||||||||
| 10% Convertible note payable, due August 6, 2022 – Bridge Investor | ||||||||
| Fall 2019 Notes | ||||||||
| 5% Convertible note payable – Stephen Boesch | ||||||||
| 5% Convertible note payable – Related Party | ||||||||
| 5% Convertible note payable – Dr. Sanjay Jha (Through his family trust) | ||||||||
| 5% Convertible note payable – CEO & CFO – Related Parties | ||||||||
| 5% Convertible note payable – Bridge Investors | ||||||||
| August 2021 Convertible Notes | ||||||||
| 5% Convertible note – Autotelic Inc– Related Party | ||||||||
| 5% Convertible note – Bridge investors | ||||||||
| 5% Convertible note – CFO – Related Party | ||||||||
| March 2022 Notes | ||||||||
| 16% Convertible Notes – Accredited Investors | ||||||||
| Debt for Clinical Trials – Forever Prosperity ( Formerly GMP) | ||||||||
| 2% Convertible Notes – Forever Prosperity | ||||||||
| May and June 2022 Note | ||||||||
| 16% Convertible Notes – Accredited Investors | ||||||||
| JH Darbie PPM-2 Debt | ||||||||
| 16% Convertible Notes - Non-related parties | ||||||||
| 16% Convertible Notes – CEO – Related Party | ||||||||
| Accrued Interest | ||||||||
| July 2025 Note | ||||||||
| 10% Convertible Note – Accredited Investor | ||||||||
| Other Debt | ||||||||
| Short term debt – Bridge investors | ||||||||
| Short term debt from CFO – Related Party | ||||||||
| Short term debt – Autotelic Inc. – Related Party | ||||||||
| Short term Debt from CEO – Related Party | ||||||||
| Short term loan from Accredited investor | ||||||||
| Total of short term convertible debentures & notes and other debt | $ | |||||||
| F-25 |
December 31, 2025 | December 31, 2024 | |||||||
| Long Term Debt | ||||||||
| JH Darbie PPM-3 Debt | ||||||||
| 12% Convertible Notes – Accredited Investors | $ | |||||||
Convertible Debentures
As
of December 31, 2025, the Company had a derivative liability of approximately $
Bridge Financing
Notes with Officer and Bridge Investor
In
April 2019, the Company entered into a Securities Purchase Agreement (the “Bridge SPA”) with our CEO and the Bridge
Investor with a commitment to purchase convertible notes in the aggregate of $
Fall 2019 Debt Financing
In
December 2019, the Company closed its Fall 2019 Debt Financing, raising an additional $
| F-26 |
All
the Fall 2019 Notes provided for interest at the rate of
There
was no activity during the year ended December 31, 2025 and 2024. The total unamortized principal amount of the Fall 2019 Notes was $
Further,
the Company recorded interest expense of approximately $
Forever Prosperity (Formerly GMP) Notes
In
June 2020, the Company secured $
In
September 2021, the Company secured a further $
In
October 2021, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “October Purchase Agreement”)
with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $
Between
June 2020 and January 2022, the Company entered into four Unsecured Convertible Note Purchase Agreements with Forever Prosperity, for
a total amount of $
During
the years ended December 31, 2025 and 2024, the Company incurred approximately $
August 2021 Notes
In
August 2021, the Company entered into Note Purchase Agreements with Autotelic - a related party, our CFO – a related party, and
certain accredited investors (the “August 2021 investors”), whereby the Company issued four convertible notes in the aggregate
principal amount of $
| F-27 |
As of December 31, 2025 and 2024, the August 2021 convertible notes, net of debt discount, consist of the following amounts:
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Autotelic Related party convertible note, 5% coupon December 2024 | $ | $ | ||||||
| CFO Related party convertible note, 5% coupon December 2024 | ||||||||
| Accredited investors convertible note, 5% coupon December 2024 | ||||||||
| $ | $ | |||||||
During
the years ended December 31, 2025 and 2024 the Company recognized approximately $
At
December 31, 2025, and 2024, accrued interests on these convertible notes totaled approximately $
March 2022 Financing
In
March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible
promissory note in the aggregate principal amount of $
As of December 31, 2025, and December 31, 2024, the Fourth Man convertible note, net of debt discount, consist of the following amounts:
December 31, 2025 | December 31, 2024 | |||||||
| Fourth Man Convertible note, 16% coupon March 2023 inclusive of accrued interest and default provision | $ | $ | ||||||
| Unamortized debt discount | ||||||||
| Convertible notes, net | $ | |||||||
| F-28 |
During
the year ended December 31, 2025, the Company converted approximately $
As
of December 31, 2024, the balance includes the remaining principal of $
The
Company recognized approximately $
May 2022 Mast Financing
In
May 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible
note in the aggregate principal amount of $
As of December 31, 2025, and December 31, 2024, convertible note under the May 2022 Mast Financing, net of debt discount, consist of the following amounts:
December 31, 2025 | December 31, 2024 | |||||||
| Mast Hill Convertible note, 12% coupon May 2025, inclusive of accrued interest and penalty | $ | $ | ||||||
| Convertible notes, net | $ | $ | ||||||
During
the year ended December 31, 2025, the Company converted approximately $
Accrued
interest was approximately $
June 2022 Blue Lake Financing
In
June 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible
note in the aggregate principal amount of $
| F-29 |
In
May 2024, Blue Lake converted the balance of their note of approximately $
July 2025 Mast Financing
On
July 31, 2025, the Company entered into a securities purchase agreement with Mast, whereby the Company issued a secured convertible note
in the aggregate principal amount of $
As of December 31, 2025, and 2024, the July 2025 Mast Note, net of debt discount, consist of the following amounts:
December 31, 2025 | December 31, 2024 | |||||||
| Mast Hill Convertible note, inclusive of accrued interest 10% coupon due August 2026 | $ | $ | ||||||
| Convertible notes, gross | $ | $ | ||||||
| Less: debt discount recorded | ( | ) | ||||||
| Amortization of debt discount | ||||||||
| Convertible notes, net | $ | $ | ||||||
The
Company recognized approximately $
Other short-term advances
As of December 31, 2025 compared to December 31, 2024, other short-term advances consist of the following amounts obtained from various employees and related parties:
| Other Advances | December 31, 2025 | December 31, 2024 | ||||||
| Short term advance from CFO – Related Party | $ | $ | ||||||
| Short term advance from CEO – Related Party | ||||||||
| Short term advances – bridge investors & others | ||||||||
| Short term advances – Autotelic Inc. – Related Party | ||||||||
| Short term advance – CEO – Related Party | ||||||||
| Short term advance – Accredited investor | ||||||||
| $ | $ | |||||||
| F-30 |
As
of January 1, 2024, approximately $
As
of January 1, 2024, approximately $
In
the year ended December 31, 2025, two accredited investors from PPM 2 did not participate in PPM 3 and their balance of $
NOTE 6 - JOINT VENTURE WITH GMP BIO AND AFFILIATES, EQUITY METHOD INVESTMENT
On March 31, 2022, the Company entered into (i) an agreement to form the JV with Dragon and GMP Bio, both affiliates of GMP, (ii) a license agreement for rights to OT-101for the territory within the United States of America with Sapu Holdings, LLC, a wholly owned subsidiary of GMP Bio and (iii) a license agreement for rights to OT-101 for the rest of the world with GMP Bio. For more information on the JV and the related agreements, refer to our 2022 Annual Report on Form 10-K/A filed with the SEC on April 19, 2023.
As
of the effective date of the formation of the JV, the Company received a
The JV has initiated phase 2 and 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer. In late 2023, the JV initiated a plan to start evaluating various nanoparticles that could treat various cancers. In this regard, the JV identified a total of 4 compounds, in addition to OT-101, which had the potential of significant revenue generation for the JV. In the same year, the JV signed a lease agreement to set up a GMP manufacturing facility in San Diego (“SD”), California. The main purpose of this facility was to initially commence an aggressive formulation development of newly planned nanoparticle platform (“Nano Platform”). The GMP manufacturing facility was initiated in January 2024. Upon the initiation of this facility by the JV, the JV commenced the development work on two of the four identified compounds, as well as other activities, in tandem with the development of OT-101. The JV has since completed the formulation development of one of the products and is moving to complete the formulation development for the three additional products. The JV is also working on improved formulations for OT-101 with new nanoparticle sizes. The JV also has started clinical development for OT-101 for pancreatic cancer. Significant progress has been made in the development of the products and the JV anticipates to complete the formulation development work in 2026 and pushing to initiate clinical trials for the various compounds. In late 2024, the GMP facility in San Diego was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. Further, in late 2024, the JV identified a sixth candidate as a compound for development for the JV and has already started to work on the formulation development of that compound as well. All developmental and manufacturing, including for Phase 1 clinical trial materials, will be performed at the SD site.
| F-31 |
In
early 2025, the Company announced that it had entered into a strategic partnership with Shanghai Medicilon, Inc.
(“Medicilon”) to access its industry-leading rapid investigational new drug (“IND”)
development platform to support up to 20 IND projects, which the JV can also utilize to support their INDS. All six of our compounds
the JV is developing are planned to be these INDs and are focused on becoming next-generation anticancer agents. The JV anticipates
that all these six anticancer agents have the potential to become significant growth contributors to the JV, which in turn would add
substantial value to the Company. The Company successfully completed a Phase 1 clinical trial evaluating OT-101, in combination with
IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101, an antisense
therapeutic targeting Transforming Growth Factor Beta 2 (TGFβ2), with checkpoint inhibitors (“CKIs”) and
recombinant IL-2 (aldesleukin) (“IL-2”). The Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety
and tolerability of OT-101 in combination with recombinant IL-2 in patients with advanced or metastatic solid tumors. The
combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected safety signals identified. Based on
the favorable safety data, Oncotelic plans to advance OT-101 plus IL-2 into further clinical studies, exploring synergies with CKIs
such as PD-1 blockers. The Company elected the fair value option under subsection of Section 825-10-15 to account for its
equity-method investment as the Company believes that it the most appropriate method to properly value the Company and record a
change in value when and upon conducting a fair value assessment. As of December 31, 2025, as the development and IPO operations of
the JV are proceeding as planned, the Company assessed the fair value of its investment in the JV. The Company also utilized the
services of an ASC-compliant third party valuation firm to validate the Company’s assessment. Based on the Company’s
assessment and report, and considering the Company’s
| December 31, 2025 | December 31, 2024 | |||||||
| Balance at January 1, 2025 and 2024 | $ | $ | ||||||
| Add: change in fair value of investment in GMP Bio | ||||||||
| Balance at December 31, 2025 and 2024 | $ | $ | ||||||
For detailed and more information on the fair value of our investment in GMP Bio, refer to Note 2 to the Consolidated Financial Statements: Change in Fair Value of Equity Securities of GMP Bio.
For information on the various notes from GMP, refer to Note 5 – GMP Notes of the Notes to the Consolidated Financial Statements above.
NOTE 7 - PRIVATE PLACEMENT -2 (PPM-2) AND JH DARBIE FUNDING
During
the period between July 2023 to January 2024, the Company entered into a series of subscription agreements with forty-six accredited
investors, whereby the Company issued and converted a total of Units from a previous offering, which resulted in conversion of $
| ● | One
|
| ● | warrants to purchase an equivalent number of shares of the Company’s common stock at a strike price of $ per share. |
| F-32 |
In
December 2025, the Company converted the debt of forty-seven accredited investors from the JH Darbie Financing from PPM-2 into the new
subscription agreements under the new financing (“PPM-3”- See Note 8 below) in three tranches, which resulted in conversion
of approximately $
JH
Darbie and the Company were parties to a March 2023 placement agent agreement, pursuant to which DH Darbie had the right to sell a minimum
of Units and a maximum of Units on a best-efforts basis. For the 4 tranches of conversion related to PPM 2, placement agent fees
of $
As of December 31, 2025, and December 31, 2024, the PPM2 - JH Darbie Financing, net of debt discounts, consisted of the following amounts:
December 31, 2025 | December 31, 2024 | |||||||
| Convertible promissory notes | ||||||||
| PPM-2 Darbie Financing, inclusive of accrued interest, including related parties | $ | $ | ||||||
| Total PPM-2 Darbie Financing, net of discounts | $ | $ | ||||||
The
Company incurred approximately $
Management
reviewed the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt- Modifications and Extinguishments and
concluded that the terms of the agreements were substantially different and, accounted for the transaction as a debt extinguishment.
The transaction related to T4 during the year ended December 31, 2024 resulted in a loss from debt extinguishment of approximately $
| Expected Term | ||||
| Expected volatility | % | |||
| Risk-free interest rates | % | |||
| Dividend | % |
The
Company recorded approximately $
During
the years ended December 31, 2025 and 2024, the Company incurred approximately $
| F-33 |
NOTE 8 – PRIVATE PLACEMENT -3 (PPM-3) AND JH DARBIE FUNDING
In
December 2025, the Company entered into a series of subscription agreements with certain accredited investors pursuant to the JH Darbie
Financing, whereby the Company issued and converted a total of Units from the previous PPM-2, into the current subscription agreements
under the PPM-3, which resulted in conversion of approximately $
| ● | One
| |
| ● | warrants to purchase an equivalent number of shares of the Company’s common stock at a strike price of $ per share (“Oncotelic warrant”) with a contractual term of two years. |
In
December 2025, in a series of three tranches, the Company converted the debt of forty-seven (47) accredited investors from the previous
PPM (“PPM -2”- See Note 8 above) into the current subscription agreements under the PPM-3, which resulted in conversion
of $
In connection with the consummation of the PPM-3 financing, the Company entered into Registration Rights Agreements granting certain registration rights with respect to the shares of the Company’s Common Stock issued in connection with the financing, as well as the shares of the Company’s Common Stock issuable upon exercise of the Warrants. The issuance of the Units is exempt from the registration requirements of the Securities Act, in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506 of Regulation D promulgated thereunder. The shares of common stock and warrants and any shares of common stock issuable upon exercise of the warrants, have not been registered under the Securities Act or any other applicable securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.
As of December 31, 2025, and December 31, 2024, debt recorded under the December 2025 JH Darbie Financing, net of debt discounts, consist of the following amounts:
December 31, 2025 | December 31, 2024 | |||||||
| Convertible promissory notes | ||||||||
| Subscription agreements - accredited investors | $ | $ | ||||||
| Total convertible promissory, net of discounts | $ | $ | ||||||
The
Company incurred approximately $
Concurrently with the sale of the Units, JH Darbie was granted a total of stock warrants, exercisable over a two-year period.
| F-34 |
The terms of convertible notes are summarized as follows:
| ● | Term: through December 31, 2027 | |
| ● | Coupon:
| |
| ● | Convertible at the option of the holder at any time into the Company’s common stock | |
| ● | Conversion
price is set at $ |
Management
reviewed the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments and
concluded that the terms of the agreements were substantially different and, accounted for the transaction as a debt extinguishment.
The transaction resulted in a loss from debt extinguishment of approximately $
The
estimated volume weighted grant date fair value of approximately $
| Expected Term | ||||
| Expected volatility | % | |||
| Risk-free interest rates | % | |||
| Dividend | % | |||
The
Company recorded an initial debt discount of approximately $
NOTE 9 - RELATED PARTY TRANSACTIONS
Master Service Agreement with Autotelic Inc.
In October 2015, Oncotelic entered into a Master Service Agreement (the “MSA”) with Autotelic Inc., a related party that is partly-owned by the Company’s CEO Vuong Trieu, Ph.D. Dr. Trieu, a related party, is a control person in Autotelic Inc. Autotelic Inc. currently owns less than 10% of the Company. The MSA stated that Autotelic Inc. would provide business functions and services to the Company and allowed Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA includes personnel costs allocated based on amount of time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The Company had minimally used the services under the MSA since the formation of the JV with Dragon. The MSA requires a 90-day written termination notice in the event either party requires to terminate such services.
Expenses
related to the MSA were approximately $
License Agreement with Autotelic Inc.
In September 2021, the Company entered into an exclusive License Agreement with Autotelic. For more information on the exclusive license Agreement with Autotelic, refer to our 2024 Annual Report on Form 10-K filed with SEC on April 15, 2025.
| F-35 |
Notes Payable and Short-Term Loan – Related Party
In
April 2019, the Company issued a convertible note to Dr. Trieu totaling $
In November 2025, the Company entered into a restricted stock agreement (the “RSA”) with Dr. Trieu, to provide incentive compensation for his extra-ordinary efforts and time to raise capital and successful achievement of certain milestones. The restricted stock agreement provides for a grant of up to shares of our unissued Series A preferred stock (“Preferred Stock”), subject to achievement of certain milestones. Each share of Preferred Stock is convertible into shares of the Company’s Common Stock, par value $ per share of Common Stock upon conversion and votes with the Common Stock on an as converted basis. Dr. Trieu has achieved the first milestone and has earned shares of Preferred Stock.
As
of January 1, 2024, approximately $
Artius Consulting Agreement
In March 2020, the Company and Artius Bioconsulting, LLC (“Artius”), for which Mr. King is the Managing Member, entered into an amendment to an existing Consulting Agreement, under which Artius agreed to serve as a consultant to the Company for services related to the Company’s business from time to time. For more information on this Agreement, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
Mosaic ImmunoEngineering, Inc.
In
April 2024, the Company entered into a Term Sheet with Mosaic. For more information on the Term Sheet, refer to Note 1 of this Quarterly
Report. Steven King, our Board member, is the CEO of Mosaic. The Company had advanced $
Maida Consulting Agreement
Effective May 5, 2020, the Company and Dr. Maida entered into an independent consulting agreement, commencing April 1, 2020, under which Dr. Maida will assist the Company in providing medical expertise and advice from time to time in the design, conduct and oversight of the Company’s existing and future clinical trials. For more information on this Agreement, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
Effective April 1, 2022, Dr Maida’s compensation has been borne by the JV. No expense was recorded during the years ended December 31, 2025 and 2024, respectively, related to this Agreement.
| F-36 |
NOTE 10 - EQUITY PURCHASE AGREEMENT AND REGISTRATION RIGHTS AGREEMENT (MAST HILL)
On
August 1, 2025, the Company entered into an Equity Purchase Agreement (“EPA”) and Registration Rights Agreement with
Mast Hill. Under the terms of the EPA, the Company issued warrants to purchase
Following
effectiveness of the Registration Statement, and subject to certain limitations and conditions set forth in the Equity Purchase Agreement,
the Company shall have the discretion to deliver put notices to the Investor and the Investor will be obligated to purchase shares of
the Company’s Common Stock based on the investment amount specified in each put notice.
In
connection with the EPA, the Company issued
NOTE 11 – STOCKHOLDERS’ EQUITY
The following transactions affected the Company’s Stockholders’ Equity:
In
March 2025, Fourth Man partially converted approximately $
In July 2025, the Company issued shares of Common stock as commitment shares to Mast Hill as part of the secured convertible note purchase agreement.
In
August 2025, the Company issued
shares of Common stock as service fees of approximately $
For more information on Jefferson and Valor, refer to Note 1: to these Notes to Consolidated Financial Statements.
| F-37 |
In
August 2025, Mast Hill partially converted approximately $
In
October 2025, Fourth Man partially converted approximately $
In
November 2025, Fourth Man partially converted approximately $
In
December 2025, the Company issued shares of Common stock as service fee of approximately $
Issuance of Common Stock during the year ended December 31, 2024
In
February 2024, Fourth Man partially converted $
In
May 2024, Blue Lake converted the balance of their $
NOTE 12 – PREFERRED STOCK
The Company has authorized shares of Convertible Preferred Stock, par value $per share (“Preferred Stock”), of which, shares have been designated as Series A Convertible Preferred Stock. On November 17, 2025, the Company entered into a restricted stock agreement (“RSA”) with Dr. Vuong Trieu, our CEO, and granted him shares of our Preferred Stock, which were subject to a vesting schedule upon achievement of certain corporate milestones and subject to forfeiture if any or all the milestones were not achieved. As of December 31, 2025, shares of the Company’s Preferred Stock were issued to Dr. Trieu, but Dr. Trieu would earn the Preferred Shares as and when he achieved certain milestones. As of December 31, 2025, Dr. Trieu had earned shares of Preferred Stock. Each share of Preferred Stock is convertible into shares of the Company’s Common Stock, and votes with the Common Stock on an as converted basis. The Company recognizes compensation expense as the milestones are achieved.
| Shares | Amount | |||||||
| Balance at January 1, 2025 and 2024 | $ | |||||||
| Issuance of preferred stock | ||||||||
| Balance at December 31, 2025 | $ | |||||||
The
Company calculated the grant date fair value of the Preferred Stock for the RSA issued to Dr. Trieu as approximately $
| F-38 |
Compensation for services
In
August 2025, the Company issued shares of Common stock as service fees of approximately $
In
August 2025, the Company issued shares of Common stock as service fee of approximately $
In
December 2025, the Company issued shares of Common stock as service fee of approximately $
Options
Pursuant to the Merger, the Company’s Common Stock and corresponding outstanding options survived. The below information details the Company’s associated option activity.
As of December 31, 2025, the Company had options to purchase Common Stock that were outstanding under three stock option plans – the 2017 Equity Incentive Plan (the “2017 Plan”), the 2015 Equity Incentive Plan (the “2015 Plan”) and the 2005 Stock Plan (the “2005 Plan”). No further awards may be granted under the 2005 Plan, although options previously granted remain outstanding in accordance with their terms. Under the 2017 Plan, up to shares of the Company’s Common Stock may be issued to directors, officers, employees or consultants pursuant to awards granted in the form of nonqualified stock options, restricted and unrestricted stock awards, and other stock-based awards. Under the 2015 and 2005 Plans, taken together, up to shares of the Company’s Common Stock may be issued pursuant to awards granted in the form of incentive stock options, nonqualified stock options, restricted and unrestricted stock awards, and other stock-based awards
| Weighted | ||||||||
| Average | ||||||||
| For the year ended December 31, 2025 | Shares | Exercise Price | ||||||
| Outstanding at January 1, 2025 | $ | | ||||||
| Expired or cancelled | ( | ) | ||||||
| Outstanding at December 31, 2025 | $ | |||||||
| Options exercisable at December 31, 2025 | $ | |||||||
| Weighted | ||||||||
| Average | ||||||||
| For the year ended December 31, 2024 | Shares | Exercise Price | ||||||
| Outstanding at January 1, 2024 | $ | |||||||
| Expired or cancelled | ||||||||
| Outstanding at December 31, 2024 | $ | |||||||
| Options exercisable at December 31, 2024 | $ | |||||||
| Exercise prices | Outstanding Options |
Weighted- Average Remaining Life In Years |
Weighted- Average Exercise Price |
Number Exercisable |
||||||||||||||
| $ | to $ | $ | ||||||||||||||||
| to $ | ||||||||||||||||||
| to $ | ||||||||||||||||||
| to $ | ||||||||||||||||||
| $ | ||||||||||||||||||
The compensation expense attributed to the issuance of the options is recognized as they are vested. The employee stock option plan stock options are generally exercisable for from the grant date and vest over various terms from the grant date to .
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As of December 31, 2025, there was unamortized stock compensation cost related to the stock options granted during the year ended December 31, 2023. . For more information on the stock options, refer to 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
The Company amortized $ stock compensation expense during the years ended December 31, 2025 and 2024, respectively on previously issued grants.
Warrants
The Company has issued warrants in connection with the various financings conducted by the Company. For more information on the warrant issuances, refer to our 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025.
The issuance of warrants to purchase shares of the Company’s Common Stock, including those attributed to debt issuances, for the years ended December 31, 2025 and 2024, respectively are summarized as follows:
| For the year ended December 31, 2025 | Shares | Average Exercise Price | ||||||
| Outstanding at January 1, 2025 | $ | |||||||
| Issued during the year ended December 31, 2025 | ||||||||
| Exercised / cancelled during the year ended December 31, 2025 | ( | ) | ||||||
| Outstanding at December 31, 2025 | $ | |||||||
| For the year ended December 31, 2024 | Shares | Average Exercise Price | ||||||
| Outstanding at January 1, 2024 | $ | |||||||
| Issued during the year ended December 31, 2024 | ||||||||
| Exercised / cancelled during the year ended December 31, 2024 | ( | ) | ||||||
| Outstanding at December 31, 2024 | $ | |||||||
The following table summarizes information about warrants outstanding and exercisable at December 31, 2025:
| Outstanding and exercisable | ||||||||||||||||||
| Exercise Price | Number Outstanding |
Weighted- Average Remaining Life in Years |
Weighted- Average Exercise Price |
Number Exercisable |
||||||||||||||
| $ | ||||||||||||||||||
| - | ||||||||||||||||||
| $ | ||||||||||||||||||
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NOTE 14 – INCOME TAXES
Significant components of the Company’s deferred tax assets and liabilities for federal and state income taxes as of December 31, 2025 and 2024 are as follows in thousands:
| December 31, 2025 | December 31, 2024 | |||||||
| Deferred tax assets: | ||||||||
| Stock-based compensation | $ | $ | ||||||
| Intangible assets | ||||||||
| Liability accruals | ||||||||
| R&D Credit | ||||||||
| Capital Loss | ||||||||
| Deferred state tax | ( | ) |
( |
) | ||||
| Net operating loss / (income) carry forward | ||||||||
| Total gross deferred tax assets | ||||||||
| Less - valuation allowance | ( | ) |
( |
) | ||||
| Net deferred tax assets | $ | $ | ||||||
| Deferred income tax liability: | - | - | ||||||
| Investment in equity securities | ( | ) |
||||||
| Deferred income tax liability | $ | ( | ) |
$ | ||||
The Company had gross deferred tax assets, which primarily relate to net operating loss carryforwards. As of December 31, 2025, the Company had gross federal and state net operating loss carryforwards, which are available to offset future taxable income, if any. The Company recorded a valuation allowance in the full amount of its net deferred tax assets since realization of such tax benefits has been determined by our management to be less likely than not.
Portions of these carryforwards will expire through 2039, if not otherwise utilized. The Company’s utilization of net operating loss carryforwards could be subject to an annual limitation. as a result of certain past or future events, such as stock sales or other equity events constituting a “change in ownership” under the provisions of Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitations could result in the expiration of net operating loss carryforwards and tax credits before they can be utilized. We have not performed a formal analysis, but we believe our ability to use such net operating losses and tax credit carryforwards will be subject to annual limitations, due to change of ownership control provisions under Section 382 and 383 of the Internal Revenue Code, which would significantly impact our ability to realize these deferred tax assets.
During
the year ended December 31, 2025, the Company recorded an increase in fair value of its investment in GMP Bio of $
The following is a reconciliation of the Company’s effective income tax rate to the federal statutory income tax rate for the years ended December 31, 2025 and 2024.
| December 31, 2025 | December 31, 2024 | |||||||||||||||
| Pretax Book Income (Loss) | $ | $ | ( | ) | ||||||||||||
| Income tax computed at federal statutory tax rate | $ | % | $ | ( | ) | % | ||||||||||
| Change in valuation allowance | $ | % | $ | - | % | |||||||||||
| State income taxes, net of federal benefit | $ | % | $ | ( | ) | % | ||||||||||
| Other permanent differences | $ | % | $ | - | % | |||||||||||
| Effective income tax rate | $ | % | $ | |||||||||||||
NOTE 15 – COMMITMENTS AND CONTINGENCIES
Leases
Currently, the Company is leasing an office located at 29397 Agoura Road, Suite 107, Agoura Hills, CA 91301 on a month-to-month basis until such time a new office is identified. The Company believes the office is sufficient for its current operations.
PointR Merger Consideration
The
total purchase price in the PointR Merger of $
Other claims
From time to time, the Company may become involved in certain claims arising in the ordinary course of business.
During
the year ended December 2022, a former employee brought suit for breach of employment contract claim against the Company in Honorable
Supreme Court of California. The Company filed a counter claim against the former employee. Both litigations were settled in October
2025, and the Company paid the ex-employee of approximately $
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NOTE 16 – SUBSEQUENT EVENTS
Amendment 1 to Restricted Stock Agreement – Vuong Trieu
On
January 2, 2026, the Company entered into an amendment to a RSA dated November 17, 2025, between the Company and Dr. Vuong Trieu, the
CEO of the Company. Similar to the ICA, the RSA called for Dr. Trieu to earn certain convertible Preferred Stocks of the Company upon
the achievement certain corporate milestones.
Restricted Stock Award - Vuong Trieu
On
January 22, 2026, the Company entered into an RSA with Dr. Vuong Trieu, our chief executive officer. Under the terms of the RSA the Company
will issue to Dr. Trieu, subject to adjustments, up to shares of the Company’s convertible Preferred Stocks, based to the
achievement of certain performance milestones related to improving the Company’s capital structure.
Dr.
Trieu achieved the first milestone and received
shares of Preferred Stock for this first milestone. In addition, Dr. Trieu can receive an additional
shares of Preferred Stock, which will vest in 3 tranches a total of
shares of Preferred Stock per milestone achieved. The grant date fair value of the Preferred Stock was approximately $
Securities Purchase Agreement and Convertible Note with Mast Hill
On
January 23, 2026, the Company entered into an SPA (the “2026 Mast Hill Purchase Agreement”), with Mast Hill. In this
connection, the Company issued a convertible promissory note in the aggregate gross principal amount of approximately $
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