OTC: OTLC

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.

2

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.

3

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.

4

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.

5

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.

6

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.

7

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.

8

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

9

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.

10

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.

11

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.

12

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.

13

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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